Adopted by the 57th WMA General Assembly, Pilanesberg, South Africa, October 2006,
revised by the 73rd WMA General Assembly, Berlin, Germany, October 2022,
and revised in its recommendation 14 by the 75th WMA General Assembly, Helsinki, Finland, October 2024

 

PREAMBLE

Assisted Reproductive Technology [ART] encompasses a wide range of techniques designed primarily to aid individuals unable to conceive without medical assistance.

ART is defined as any fertility treatment in which either gametes or embryos are handled.

Assisted reproductive technologies may raise profound ethical and legal issues. Views and beliefs on assisted reproductive technologies vary both within and among countries  and are subject to different regulations in different countries.

Central to much of the debate in this area are issues around the moral status of the embryo, the way in which ART is viewed morally, societally and religiously, the child/ren born from ART, and the rights of all participants involved, i.e. donors, surrogates, the child/ren and the intended parents are just some of the issues central to the debate in ART. Whilst consensus can be reached on some issues, there remain fundamental differences of opinion that are more difficult to resolve.

Assisted conception differs from the treatment of illness in that the inability to become a parent without medical intervention is not always regarded as an illness. Notwithstanding, the inability to conceive may also be a result of prior illness.

In many jurisdictions, the process of obtaining consent must follow a process of information giving and the offer of counselling and might also include a formal assessment of the patient in terms of the welfare of the potential child.

Faced with the progress of new technologies of assisted reproduction, physicians should keep in mind that not everything that is technically feasible is ethically acceptable. Genetic manipulation that does not have a therapeutic purpose is not ethical, nor is the manipulation on the embryo or foetus without a clear and beneficial diagnostic or therapeutic purpose.

 

RECOMMENDATIONS

1.Physicians involved in providing assisted reproductive technologies should always consider their ethical responsibilities towards all parties involved in a reproductive plan, which may include the future child/ren, donor, surrogate or parents. If there is compelling evidence that a future child, donor, surrogate or parent would be exposed to serious harm, treatment should not be provided.

2. As with all other medical procedures, physicians have an ethical obligation to limit their practice to areas in which they have relevant expertise, skill, and experience and to respect the autonomy and rights of patients.

3. In practice this means that informed consent is required as with other medical procedures; the validity of such consent is dependent upon the adequacy of the information offered to the patient and their freedom to make a decision, including freedom from coercion or other pressures or influences to decide in a particular way.

4. The consent process should include providing the participant/s with understandable, accurate and adequate information about the following:

  • The purpose, nature, procedure, and benefits of the assisted reproductive technology that will be used.
  • The risks, burdens and limitations of the assisted reproductive technology that will be used.
  • The success rates of the treatment and possible alternatives, such as adoption.
  • The availability of psychological support for the duration of the treatment and, in particular, if a treatment is unsuccessful.
  • The measures protecting confidentiality, privacy and autonomy, including data security measures.

5. The following should be discussed during the informed consent process:

  • Detailed medical risks;
  • whether or not all biological samples involved in ART, including but not limited to donor eggs, sperm, gametes and genetic information, may be used for research purposes;
  • The risks of multiple donations and donating at multiple clinics;
  • Confidentiality and privacy issues;
  • Compensation issues.

6. Donors, surrogates and any resulting child/ren seeking assisted reproductive technologies are entitled to the same level of confidentiality and privacy as for any other medical treatment.

7. Assisted reproductive technology involves handling and manipulation of human gametes and embryos. There are different levels of concern with the handling of such material, yet there is general agreement that such material should be subject to specific safeguards to protect from inappropriate, unethical, or illegal use.

8. Physicians should uphold the principles in the WMA Statement on Stem Cell Research, WMA Statement on Human Genome Editing, the WMA Declaration of Helsinki, and the WMA Declaration of Reykjavik – Ethical Considerations Regarding the Use of Genetics in Health Care.

9. Physicians should, where appropriate, provide ART in a non-discriminatory manner. Physicians should not withhold services based on nonclinical considerations such as marital status.

Multiple pregnancies

10. Replacement of more than one embryo will raise the likelihood of more than one embryo implanting. This is offset by the increased risk of premature labour and other complications in multiple pregnancies, which can endanger the health of both the mother and child/ren. Practitioners should follow professional guidance on the maximum number of embryos to be transferred per treatment cycle.

11. If multiple pregnancies occur, selective termination or fetus reduction will only be considered on medical grounds and with the consent of all participants involved to increase the chances of the pregnancy proceeding to term, provided this is compatible with applicable laws and codes of ethics.

Donation

12. Donation should follow counselling and be carefully controlled to avoid abuses, including coercion or undue influence of potential donors. Explicit instructions should be provided about what will be done with any donated samples if the donor is known to have died prior to implantation.

13. The WMA holds the view that gamete donation should at best not be commodified, thus serving a humanitarian benefit.

14. Appropriate controls and limits on methods used to encourage donations should be ensured. All donations must comply with national legislation and appropriate ethical guidance, including the maximum amount of gamete donations per person. Guidance on the maximum number of children allowed through donation from a single donor should be developed and adhered to, to avoid unintended incest, inbreeding and psychological harm to those involved. Physicians should advocate for and contribute to the development of such ethical guidance, if such guidance does not exist.

15. Due to the widespread use of genetic technology and registries, it has become possible to identify donors, despite clinics and donors’ attempts to maintain strict confidentiality.A child/ren born as a result of donation may in future contact donors. Potential donors must be made aware of this possibility as part of the consent process.

16. Where a child is born following donation, families should be encouraged and supported to be open with the child about this, irrespective of whether or not domestic law entitles the child to information about the donor. This may require the development of supportive materials, which should be produced to a national normative standard.

Surrogacy

17. Where a woman is unable, for medical reasons, to carry a child to term, surrogate pregnancy may be used to overcome childlessness unless prohibited by national law or the ethical rules of the National Medical Association or other relevant organizations. Where surrogacy is legally practiced, great care must be taken to protect the interests of all parties involved.

18. Prospective parents and surrogates should receive independent and appropriate legal counsel.

19. Medical tourism for surrogacy purposes should be discouraged.

20. Commercial surrogacy should be condemned. However, this must not preclude compensating the surrogate mother for necessary expenses.

21. The rights of surrogate mothers must be upheld, and great care must be taken to ensure that they are not exploited. The rights of surrogate mothers include, but are not limited to:

  • Having her autonomy respected;
  • Where appropriate, having health insurance;
  • Being informed about any medical procedure and the potential side effects;
  • Where possible, choosing her medical team if side effects develop;
  • Having psychological help at any point during the pregnancy;
  • Having medical expenses such as doctor visits, the actual birthing process, fertilization and any examinations related to the surrogacy covered by the intended parent/s;
  • Loss if income covered if unable to work during the pregnancy;
  • Receiving the compensation and/or reimbursements agreed to in any legal agreement

Pre-implantation Genetic Diagnosis (PGD)

22. Pre-implantation genetic diagnosis (PGD) and pre-implantation genetic screening (PGS) may be performed on early embryos to search for the presence of genetic or chromosomal abnormalities, especially those associated with severe illness and very premature death, and for other ethically acceptable reasons, including identifying those embryos most likely to implant successfully in women who have had multiple spontaneous abortions.

23. It is recommended to encourage screening for infectious diseases in sperm donors and to determine whether to inform donors of positive tests.

24. Physicians must never be involved with sex selection unless it is used to avoid a serious sex-chromosome related condition, such as Duchenne’s Muscular Dystrophy.

Research

25. Physicians have an ethical duty to comply with such regulation and to help inform public debate and understanding of these issues.

26. Research on human gametes and embryos should be carefully controlled and monitored and in accordance with all applicable national laws and ethical guidelines.

27. Views and legislation differ on whether embryos may be created specifically for, or in the course of, research. Physicians should act in accordance with the declarations of Taipei and Helsinki, as well as all applicable local laws and ethical and professional standards advice.

28. The principles of the Convention on Human Rights and Biomedicine should be followed.

 

Adopted by the 43rd World Medical Assembly, Malta, November 1991,
revised by the 57th WMA General Assembly, Pilanesberg, South Africa, October 2006
by the 67th WMA General Assembly, Taipei, Taiwan, October 2016
and
 reaffirmed with minor revisions by the 227th WMA Council, Helsinki, Finland, October 2024

 

PREAMBLE

The past several decades have witnessed a dramatic change in causes of adolescent mortality. Previously, adolescents mostly died of natural causes, whereas now they are more likely to die from preventable causes. The suicide rate among adolescents has risen in all regions of the world. In the adolescent population, suicide is currently one of the leading causes of death. Suicides are probably under-reported due to cultural and religious stigma attached to self-destruction and to an unwillingness to recognize certain traumas, such as some automobile accidents, as self-inflicted.

Adolescent suicide is a tragedy that affects not only the individual but also the family, peers and larger community in which the adolescent lived. Suicide is often experienced as a personal failure by parents, friends and physicians who blame themselves for not detecting warning signs. It is also viewed as a failure by the community, serving as a vivid reminder that modern society often does not provide a nurturing, supportive and healthy environment in which children can grow and develop.

Factors contributing to adolescent suicide are varied and include: affective disorders, trauma, emotional isolation, low self-esteem, excessive emotional stress, eating disorders, physical disease, discrimination and harassment (school bullying, cyber bullying and sexual harassment), romantic fantasies, thrill-seeking, drug and alcohol abuse, the availability of firearms and other agents of self-destruction, and media reports of other adolescent suicides, which may inspire imitation acts. In addition, the prolonged exposure to electronic media, which predominantly affects adolescents through their use of computer games and social media, can contribute to social isolation, school failure and malaise amongst young people.

Youth within correctional facilities are at a higher risk for suicide than the general population, yet they have fewer resources available to them. The lack of resources makes it difficult to identify those at risk for suicide.

The incidence of adolescent suicide is observed to be greater in the “first peoples” of some nations. The reasons for this are complex.

The health care of adolescents is best achieved when physicians provide comprehensive services, including both medical and psychosocial evaluation and treatment. Continuous, comprehensive care provides the physician the opportunity to obtain the information necessary to detect adolescents at risk for suicide or other self-destructive behaviour. This service model also helps to build a socially supportive patient-physician relationship that may moderate adverse influences adolescents experience in their environment.

In working to prevent adolescent suicide, the World Medical Association recognizes the complex nature of adolescent bio-psycho-social development; the changing social world faced by adolescents; and the introduction of new, more lethal, agents of self-destruction.

In response to these concerns, the World Medical Association recommends that its constituent members adopt the following guidelines for physicians. In doing so, we recognise that many other players – parents, governmental agencies, schools, communities, social services – also have important roles in this area.

 

RECOMMENDATIONS

  1. All physicians should receive, during medical school and postgraduate training, education in child psychiatry and adolescent bio-psycho-social development, including education in the risk factors for suicide.
  2. Physicians should be educated to identify early signs and symptoms of physical, emotional, and social distress of adolescent patients. They should also be educated to identify the signs and symptoms of psychiatric disorders, like depression, bipolar disorder and substance use disorders, that may contribute to suicide as well as other self-destructive behaviours.
  3. Physicians should be taught how and when to assess suicidal risk in their adolescent patients, taking into account the adolescent’s environment, including the potential availability of firearms.
  4. Physicians should be taught and keep up-to-date on the treatment and referral options appropriate for all levels of self-destructive behaviours of their adolescent patients. The physicians with the most significant education in adolescent suicide are child and adolescent psychiatrists, so the patient should be referred to one if available.
  5. Physicians should collaborate with the families or guardians of the adolescents as well as other relevant stakeholders, such as social workers, school officials, and psychologists who bear expertise in child and adolescent behavior.
  6. When caring for adolescents with any type of trauma, physicians should consider the possibility that the injuries might have been self-inflicted.
  7. When caring for adolescents who demonstrate deterioration in thinking, feeling or behaviour, the possibility of substance abuse and addiction should be considered, and the threshold should be lower, with reference to adequate scientific evidence, for urine toxicology assessment.
  8. Health care systems should facilitate the establishment of mental health consultation services aimed at preventing suicide and should pay for the socio-medical care given to patients who have attempted suicide. Services should be tailored to the specific needs of adolescent patients. A medical consultation for adolescents is highly recommended to enable doctors to detect any disorders in their patients.
  9. Epidemiological studies on suicide, its risk factors and methods of prevention should be conducted, and physicians should keep up-to-date with such studies.
  10. When caring for adolescents with psychiatric disorders or risk factors for suicide, physicians should educate parents or guardians to watch for the signs of suicide and about the options for evaluation, and encourage them to seek support for themselves.
  11. Physicians should advocate for the identification of at-risk groups of adolescents with the mobilization of specifically targeted resources directed at prevention and risk reduction.

 

 

Adopted by the 66th WMA General Assembly, Moscow, Russia, October 2015
and reaffirmed with minor revisions by the 227th WMA Council, Helsinki, Finland, October 2024

 

PREAMBLE

Mass media, including social media, can effectively play diverse roles in medical communication. Physicians, as professionals and experts, can contribute to improved public health by providing the public with accurate health related information. Mass media provides a channel through which physicians may contribute to society by leveraging mass media appearances in positive ways.

However, the increase in instances of physicians’ frequent appearances on mass media to recommend unproven treatments or products and to use such appearances for marketing purposes is posing a serious concern. The public may readily accept groundless recommendations by physicians and may develop unrealistic expectations. The subsequent confusion and disappointment can damage the patient-physician relationship.

This issue is more serious in some countries where there are different systems of medicine, including alternative medicine.

 

GUIDELINES

  1. The WMA recalls its Statement on the Professional and Ethical Use of Social Media and recommends the following guidelines regarding mass media appearances by physicians to prevent them from being involved in commercial activities that may compromise professional ethics and to contribute to patient safety by ensuring physicians providing accurate, timely, and objective information.

Accurate and Objective Delivery of Scientifically Proven Medical Information

  1. When appearing in media, physicians shall provide objective and evidence-based information and shall not recommend medical procedures or products that are not medically proven or justified.
  2. A physician shall not use expressions that may promote unrealistic patient expectations or mislead viewers about the function and effect of medical procedures, drugs or other products.
  3. Physicians shall include important information, such as possible adverse effects and risks, when explaining medical procedures, drugs, or other products.

Not Abusing Mass Media as a Means of Advertisement

  1. Physicians should not recommend specific products by either specifically introducing or intentionally highlighting the name or trademark of a product.
  2. Physicians shall practice prudence regarding personal appearances on home shopping programs. The physician should have no financial stake in the products being sold.
  3. Physicians shall not be a part of mass media advertisement on any product which is harmful to humans and/or the environment.

Maintaining Professional Integrity

  1. Physicians shall not require or receive economic benefits for mass media appearances other than a customary appearance fee.
  2. Physicians shall not provide economic benefits to broadcasting personnel in order to secure mass media appearances.
  3. Physicians shall not engage in the promotion, sale or advertising of commercial products and shall not introduce false or exaggerated statements regarding their qualifications, such as academic background, professional experience, medical specialty and licensure as a specialist, for the benefit of the economic interests of any commercial entity.

 

Adopted by the 68th General Assembly, Chicago, October 2017
and revised by the 75th WMA General Assembly, Helsinki, Finland, October 2024

 

PREAMBLE

History demonstrates that new diseases will emerge, and old diseases re-emerge unpredictably and pose significant threats to global health.

Epidemics and pandemics highlight deep-rooted inequalities, hitting less-resourced regions hardest due to their constrained resources, fragile health systems, and significant disease burdens. The common but differentiated responsibilities (CBDR) principle can be applied to pandemic prevention, preparedness and response (PPPR) in order to bring equity and justice in cooperation between states.

The accelerating pace of epidemic-prone diseases, compounded by the repercussions of geopolitical conflicts, environmental degradation, climate change, increased human encroachment into natural ecosystems, antimicrobial resistance, widening socio-economic disparities, global travel, and the intrinsic link between the health of humans, animals, and our shared environment, underscores the vulnerability of global health security.

Integrating the One Health approach acknowledges the critical interdependence of all living organisms and their habitats, essential for understanding the emergence and spread of diseases and highlighting the need for a multisectoral, interdisciplinary and evidence-based approach to global health threats.

Robust and effective global surveillance is pivotal for improving the prevention and response to infectious diseases, enabling earlier detection and identification of emergent threats. The rapid spread of epidemics and pandemics in regions with underfunded and underdeveloped public health infrastructures highlights the urgent need for a global cooperative framework. Such a framework must prioritise the development of resilient health systems capable of withstanding the challenges posed by infectious diseases, thereby safeguarding the health and well-being of populations worldwide.

An investment in strengthening public health, primary care and other aspects of health systems is crucial for enhancing the capacity to prevent, detect, contain, and manage disease outbreaks, laying a solid foundation for core public health functions essential.

Particular attention should be paid to individuals in fragile, conflict-affected, and vulnerable settings; additionally other individual vulnerabilities factors should also be addressed including but not limited to disability, age, gender, indigeneity, ethnicity, etc..

 

RECOMMENDATIONS

The WMA calls on the following stakeholders to: 

WHO and United Nations

  1. Global Pandemic Infrastructure: Strengthen global infrastructure for preventing, monitoring, and responding to pandemics under the leadership of the World Health Organization (WHO). Ensure that this bolsters WHO’s pivotal role in leading international health efforts, while fostering a comprehensive commitment across all levels of government and society.
  1. Political Commitment: Ensure engagement at the highest level in each country for political commitment to pandemic prevention and preparedness between emergencies and to respond during emergencies.
  1. Global Health Equity: Promote global equity by addressing social determinants of health and tackling inequalities that may drive epidemics and pandemics. Put in place mechanisms to ensure timely and equitable access to countermeasures for all, while prioritizing resource allocation to public health needs. Strengthen health systems and continue broader societal efforts to enhance equity and the effectiveness of the global response. 
  1. Communication and Misinformation: Ensure consistent public messaging and monitor public discourse including on social media and combat misinformation and disinformation. 
  1. Legal Frameworks: Strengthen means of implementation and enforcement of international legal instruments for pandemic response, ensuring the effectiveness of the International Health Regulations and developing a comprehensive international pandemic legal instrument. 
  1. Data Collection, Sharing, and Universal Reviews: Strengthen data collection on infectious diseases and ensure its sharing across stakeholders, including health personnel, non-state actors (NSAs), and governments. Implement Universal Health and Preparedness Reviews with strengthened independent monitoring. Define benchmarks for equitable resource distribution, healthcare access, and outcomes across populations. Monitor disparities to guide equitable interventions.
  1. Stakeholder Collaboration: Broaden partnerships with governments and NSAs for an effective multi-sectoral response, focusing on pathogen and benefits sharing, and addressing intellectual property regulations for equitable resource distribution.
  1. Other Sources of Pandemic Risk: Enhance global health security by integrating climate change, environmental degradation, and conflict risk into pandemic preparedness giving particular attention to vulnerable populations through health system strengthening in climate and conflict-affected regions to improve resilience and response capabilities. 

National Governments 

  1. Preparedness, Response, and Governance: Develop a robust national preparedness architecture by learning from previous pandemics, including local and regional manufacturing of health products, local stockpiling, and enhance national governance with anti-corruption measures. Medical associations and physicians from all specialties must be involved in epidemic planning, preparedness, and response at all levels to enhance health system effectiveness during crises.
  1. Financing: Provide sufficient and sustainable funding for global PPPR including for the WHO, for research and development, and for national health systems strengthening.
  1. Equitable Resource Allocation: Use a common but differentiated approach in establishing obligations for financing. Ensure resources are directed to those most in need while maintaining critical health services in order to mitigate the severity and duration of pandemics. 
  1. Health Workforce Strengthening: Support the health workforce with appropriate education on PPPR and support for response, including mental health, safe working environments including access to protection measures, and sufficient human and material resources to deliver the services required. 
  1. Health System Strengthening: Ensure health system continuity so that regular healthcare services continue to be provided and that the viability of services is not compromised by public health measures.
  1. Mental Health Service: Expand mental health services to ensure comprehensive support for all affected populations during and after pandemics including integrating mental health care into primary health services, establishing dedicated mental health teams, and facilitating access to psychological support for patients, health personnel, and communities. 
  1. Digital Technology: Continue to develop digital health infrastructure to enhance PPPR capabilities while ensuring equitable and secure access to digital health services for all populations, with particular attention to remote and underserved communities.
  1. Social Protection: Implement socio-economic support measures during pandemics to protect populations from the adverse effects of health crises. 
  1. Manufacturing infrastructure: Develop infrastructure for pandemic-related research and production of critical equipment, diagnostics, therapeutics, vaccines and personal protective equipment (PPE). 
  1. Science-Guided Response: Guide response measures by scientific and expert recommendations, adapting to local contexts as necessary. Develop National Pandemic Preparedness Plans. 
  1. Communication Management: Invest in public health education to improve health literacy. Implement laws, regulations, and administrative rules targeting the spread of disinformation. Provide prompt, accurate and transparent crisis communication guided by science. 

Medical associations and scientific societies 

  1. Education and Training: Promote the integration of pandemic preparedness and response into higher education curricula and continuous professional development education for health personnel, including courses to integrate knowledge and skills related to emerging infectious diseases. 
  1. One Health: Collaborate with organizations in the animal environmental health fields to implement a One Health approach to epidemic risk management in order to establish new methods for surveillance and control of epidemics and pandemics.
  1. Research and Innovation Dissemination: Advocate for information sharing platforms that foster collaborative research and the exchange of data across the global scientific community.
  1. Partnerships in innovation: Promote partnerships between public institutions and private entities as appropriate to drive innovation, ensuring that the management of intellectual property rights promotes universal access to crucial medical technologies and treatments. Advocate for equitable and affordable access to innovations including medicines and patient-oriented technology. 
  1. Community Involvement: Promote strong relationships between the public and healthcare providers for inclusive pandemic management. 
  1. Resource Forecasting: Assist governments in resource forecasting and advocate for safe work environments and the access to quality assured PPE, and countermeasures with a specific focus on the protection in all clinical workplaces. 
  1. Misinformation Counteraction: Support the fight against misinformation and disinformation including by partnering with social media and online platforms to effectively identify incorrect information and disseminate accurate, evidence-based information. Treat the spread of disinformation by healthcare professionals as an unethical behavior with relevant sanctions.
  1. Health Literacy: Organize campaigns to increase health literacy and awareness about medical misinformation and disinformation.
  1. Research Acceleration: Encourage investment in research and fast-track ethical and peer review processes for pandemic-related research, while ensuring full respect for the principles in the WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Participants. 

Physicians

  1. People-Centred Communication Skills: Physicians should cultivate clear, empathetic communication skills to effectively convey accurate and evidence-based medical information, address misconceptions, and educate patients on identifying credible information in accordance with the WMA Declaration of Cordoba on Patient-Physician Relationship. 
  1. Advocacy: Report critical resource shortages, health system failures, misinformation and disinformation, and inequities in access to health and public health.
  1. Contribution to public health: Stay informed about epidemics and collaborate with public health authorities on PPPR while meeting obligations of declaring pathogens of concern and facilitating appropriate interventions in the communities served.

Adopted by the 64th General Assembly, Fortaleza, Brazil, October 2013
and revised by the 75th WMA General Assembly, Helsinki, Finland, October 2024

 

PREAMBLE

Human papillomavirus (HPV) vaccination presents a unique and valuable opportunity for physicians to substantially prevent morbidity and mortality from certain cancers in all populations, and to improve maternal health. This may result in economic benefits for countries who achieve widespread HPV vaccination in their population in the current move towards preventive and promotive healthcare. The HPV vaccine therefore merits consideration by the World Medical Association (WMA) separately from other vaccines.

HPV is, for the most part, sexually transmitted virus and is so common that most sexually active adults become infected at some point in their lives. Most infections are asymptomatic and resolve without medical intervention. However, HPV is the cause of nearly 100% of cervical cancer cases. Thirteen of the 40 types of HPV are oncogenic and, when they cause a persistent infection can produce cervical cancer as well as cancer of the vagina, vulva, anus, penis, the head and neck, oropharynx and anogenital area.

Few diseases reflect global inequities as much as cancer of the cervix. It is the fourth most common cancer in females globally, and most cervical cancer cases and deaths are in low and middle-income countries.

HPV vaccines protect against infections caused by targeted HPV types. All available vaccines afford protection against types 16 and 18, which are the most oncogenic types and can also offer protection against anogenital warts. HPV vaccination is recommended for females and males from 9-45 years of age and the immunocompromised people. HPV vaccines are safe, effective, and well tolerated.

WHO recommends a one or two-dose schedule HPV vaccination for females between 9-14 and 15-20 years old. Females older than 21 years require two doses with a 6-month interval.[1] Benefits of vaccinating young males include protection against genital warts and cancer in addition to preventing transmission of HPV to sexual partners.

In 2020 the World Health Assembly adopted the Global Strategy for cervical cancer elimination. To achieve accelerated elimination of cervical cancer, by 2030, 90% of girls will be fully vaccinated with the HPV vaccine by the age of 15, screening programs using a high-performance test will be running to screen 70% of women by the age of 35 and again by the age of 45 and 90% of women with invasive cancer will be managed.

School-based vaccination or systematic community programs are strategies that will increase vaccine accessibility to the appropriate age groups, particularly targeting youths prior to the commencement of sexual activity to ensure maximum benefit.

 

RECOMMENDATIONS

  1. Reaffirming its Statement on Access of Women and Children to Healthcare and its Statement on the Prioritisation of Immunisation, the WMA insists on the rights of all women, children, and indeed all people to adequate, safe medical care and urges governments to commit resources to immunisation programs.
  2. The WMA encourages expedited development and funding of programs to make safe, high quality HPV vaccines widely available to both females and males.
  3. The WMA strongly advocates for the provision of reliable, fast, and accessible cervical cancer screening programs for the detection and treatment of precancerous lesions in all countries, especially in those that have high mortality rates from cervical cancer.
  4. WMA clearly points out that HPV vaccination should not replace cervical cancer screening programs.
  5. WMA advises that cancer treatment and palliative care should be accessible to all individuals diagnosed with cervical cancer.
  6. A key recommendation is for school-based vaccination or systematic community programs to increase vaccine accessibility to the appropriate age groups, particularly targeting youths prior to the commencement of sexual activity to ensure maximum benefit.
  7. The WMA urges national health authorities, in collaboration with health professionals’ associations and other relevant health actors, to carry out intensive education and advocacy to:
  • In all individuals regardless of sex, improve awareness and understanding of HPV and associated diseases (such as, but not limited to, cervical cancer, head and neck cancer, anal cancer, and genital cancer), the availability and efficacy of HPV vaccinations, and the need for routine HPV related cancer screening in the general public;
  • Improve awareness that condoms do not provide sufficient protection against HPV infection because they do not cover the entire anogenital area and that HPV also causes cancers of the oropharynx, anus and penis;
  • Communicate the availability and efficacy of HPV vaccines to educate the population about the importance of getting the HPV vaccination;
  • Recommend HPV vaccination and routine cervical cancer screening and treatment for all eligible people regardless of the socioeconomic, cultural, or religious background, including those that are hard to reach (including for example those with disability, refugees and asylum seekers, and people of diverse sexual orientation and gender identity);
  • Support the availability of the HPV vaccine and routine cervical cancer screening for patient groups that benefit most from preventive measures, including but not limited to low-income and pre-sexually active populations;
  • Integrate HPV vaccination (either primary or catch-up immunisation) into all appropriate health care settings and visits involving eligible people; Routine cervical examination (whether vaccinated or not against HPV) should also be incorporated;
  • HPV vaccination and routine cervical cancer screening should also be offered to people who are incarcerated;
  • Integrate and understand the crucial need for routine cervical cancer screening in all appropriate health care settings and visits, and the enhanced sensitivity and effectiveness of HPV based screening compared with Pap smears, VIA (visual assessment with acetic acid), and VILI (visual assessment with lugols iodine);
  • Integrate HPV cancer prevention methods, early detection, early screening, diagnosis, treatment and palliative care into existing programs and pre-service training. Such training will leverage existing support for HPV programs and help to increase vaccination efforts;
  • Fund research aimed towards discovering screening methodology and early detection methods for other non-cervical HPV associated cancers;
  • Encourage and provide training for cervical cancer survivors to advocate for HPV vaccination and screening;
  • Sustain vaccination efforts to work towards and raise awareness of the WHO’s 90-70-90 Global Strategy to accelerate the elimination of cervical cancer as a public health problem;
  • Support and promote advocacy for HPV vaccination campaigns.
  1. The WMA urges physicians to educate themselves and their patients about HPV, associated diseases, HPV vaccination and routine cervical cancer screening.

 

Adopted by the 74th WMA General Assembly, Kigali, Rwanda, October 2023

 

PREAMBLE

Primary health care (PHC) is a key part of any health system, due to its wide coverage and distribution, its accessibility and its ability to solve the health problems of the population. For this reason, it is a fundamental element for social cohesion that corrects health inequalities between people and territories, guaranteeing equity in health care, and energizing close, accessible, and efficient health care that adapts to health changes.

PHC must enhance its positive aspects: high quality, safe, comprehensive, integrated, accessible, available, and affordable for everyone and everywhere, provided with compassion, respect, and dignity to solve the majority of the health problems of the population.

The PHC approach is foundational to achieving our shared global goals in Universal Health Coverage (UHC) and the health-related Sustainable Development Goals (SDGs).

PHC comprises a broad range of personal medical care, including preventive, diagnostic, palliative, therapeutic, curative, counseling and rehabilitative care, over time. It is not an exclusive disease-centered approach, but a person-centered approach. Furthermore, PHC is multi-sectoral health care and aims to empower individuals, families and communities to take an active role in improving their health. PHC should be provided in a manner that is accessible, comprehensive and led by a physician to ensure appropriate and high-quality care. It offers the full spectrum of essential health services across all ages.

PHC usually is the first contact of the people with the health care system. It can address the majority of health needs of the population through comprehensive and integrated services in a continuous and longitudinal way.

PHC offers a comprehensive care of essential health services across all ages.

Strong PHC is vital for efficient, cost-effective, equitable, appropriate and sustainable health care systems. A significant portion of health needs can be addressed at the primary care level, redistributing the workload and relieving strained emergency systems as well as secondary or tertiary health care. The provision of longitudinal care and a trustful patient-primary physician relationship will reduce parallel care demand and unnecessary referrals. Continuity of care has also been shown to reduce mortality, acute hospitalizations and out-of-hours care.

PHC contributes to the prevention, early detection, risk-factor identification and mitigation, and timely response to infectious, communicable diseases and noncommunicable diseases outbreaks, and optimal adherence to treatments and rehabilitation.

Robust PHC can enhance the responsiveness of health systems by adapting to the existing or future health needs of the population, contributing to a socially accountable care by actively engaging and mobilising communities, and allowing patients access to participatory and multidisciplinary care.

PHC is in a unique position to address the social determinants of health inequalities and to enhance individual physical and mental health and social well-being.

Specialist education in general practice/family medicine has developed differently in different regions. In some countries the specialty is as comprehensive and reputed as other specialties.

Where case management or coordination might limit access to appropriate medical care, patients should have the freedom to see a physician appropriate for the services they need, regardless of specialty. Above all, the best interests of the patient must be paramount.

PHC must consider the new challenges that health systems are facing, such as the high prevalence of chronic diseases, the risks of epidemics and pandemics, the environmental impact and climate change on health or the problem of antimicrobial resistance, as the main threats to health in the coming years, as indicated by the World Health Organization, prioritizing PHC actions and acting on these risks to respond to the main global health challenges.

 

RECOMMENDATIONS

The World Medical Association recommends that national governments/national health authorities:

  1. Strengthen PHC within health systems and plan and ensure adequate financial resources and equipment provision in PHC facilities, including a sufficient, well-trained supply of primary care physicians–family physicians, general internists, general pediatricians, and obstetricians/gynecologists – to meet the nation’s current and projected demand for health care services.
  2. Promote PHC with adequate human and material resources and means to make it more decisive, effective, efficient and sustainable.
  3. Ensure responsiveness to the health needs of the population through adaptation of health systems and enable community participation through adaptation of PHC systems to the population health needs.
  4. Establish functional referral systems and mechanisms that foster the coordination and integration of care across different levels (primary, secondary, tertiary) and the collaboration of PHC physicians with other medical specialists ensuring care continuity.
  5. Ensure workforce planning and adequate size of the PHC workforce by providing decent working conditions for the PHC workforce, including the improvement of working conditions and of remuneration, use of recruitment and retention strategies that take special consideration of hard-to-reach geographic areas and isolated socio-demographic groups and prioritize training of sufficient medical and paramedical personnel to ensure adequate future staffing in PHC.
  6. Develop other administrative support mechanisms to assist primary care physicians in the logistics of their practices, along with enhanced efforts to reduce administrative activities unrelated to patient care, to help ensure professional satisfaction and practice sustainability.
  7. Promote PHC as close health care connected to people as a basis for positive knowledge.

The World Medical Association recommends that its constituent members as well as medical professionals:

  1. Advocate for a sustainable PHC system that delivers integrated and comprehensive services inclusive of promotive, preventive, curative, rehabilitative and palliative care.
  2. Increase the resolution capacity and reduce the bureaucratic burden of the PHC.
  3. Reaffirm the need for high quality PHC services through the development and use of clinical guidelines, standardized training and accreditation of the PHC workforce.
  4. Develop professional autonomy and involvement in the management of PHC physicians.
  5. Work with national governments and academia to optimize the higher and postgraduate education of the PHC personnel. Such actions can include:
  • Develop and expand medical education programs to educate primary care physicians in increasing numbers.
  • Promote training opportunities for medical graduates to fulfill the estimated demand of the PHC workforce, as well as primary care experiences for all students that feature increasing levels of student responsibility and use of ambulatory and community-based settings.
  • Make available Continuous Medical Education that considers the particular needs of the PHC workforce.
  • Advocate for the establishment of a structured specialized education for general practitioners and family medicine doctors or other specialized education programmes for physicians working in PHC and give it prestige and make it attractive.
  1. Ensure that in a context of violence or in a military setting, PHC can also be delivered according to the needs of the population, ethically and with high quality.
  2. Provide students career counseling related to the choice of a primary care specialty and ensure that primary care physicians are well-represented as teachers, mentors, and role models to future physicians.
  3. Enhance the visibility of primary care faculty members and encourage positive attitudes toward primary care among all faculty members.
  4. Encourage efforts to align the representation of PHC physicians with specialized/ hospital-based physicians in political decision making and national medical organizations and to reduce inappropriate remuneration imbalances between physicians with comparable training in different levels of care.
  5. Advocate for PHC systems that involve patients and communities and can adapt and respond to specific settings and population health needs.
  6. Support the appropriate use of technologies, information systems, digital devices and big data tools that foster and improve PHC services.
  7. Support research on health service delivery in the primary care setting, promoting the research culture.
  8. Fulfill the international commitment of States to strengthen PHC as an essential step towards achieving universal health coverage, building sustainable PHC and towards achieving the highest attainable standard of health (Astana Declaration).
  9. To promote, through PHC a more accessible, close and humane medicine, centered in the person, and prioritizing the needs and interest of patients.

 Adopted by the 74th WMA General Assembly, Kigali, Rwanda, October 2023


PREAMBLE

Understanding that early life experiences can impact health in later life and that the major drivers of health lie outside healthcare is essential to direct action to improve health where it is most needed. This is supported by Paragraph 11 of General Comment No. 14 of the Committee on Economic, Social and Cultural Rights, and by Article 24 of the Convention on the Rights of the Child, both of which recognise the importance of the role of the state in providing good living standards and healthy environments for their citizens. The WMA Declaration of Oslo on Social Determinants of Health and WMA Statement on Sustainable Development acknowledge that conditions, including environmental conditions, in which people are born, grow, are educated, live, work and age (sometimes termed “social” or “wider” determinants”) are major influences on healthy life expectancy, quality of life[i] and the magnitude of health inequalities.

Human health is a cardinal component of a society’s ability to prosper; declining human health adversely affects a nation’s productivity, and therefore a nation’s economy, which in turn limits many actions to prevent ill health and deliver healthcare to treat illness.

Therefore, in addition to health practitioners, many actors share in the responsibility to preserve and improve human health. For example, the ability to influence these wider determinants of health are spread across multiple government departments.

A cardinal challenge in striving for improved population health lies in the fact that decision makers tend to focus on short-term economic indicators, such as Gross Domestic Product (GDP)/Gross National Income (GNI), as the primary driver of government policy.

Investment in the health of the population has a long-term positive economic impact, but the focus on GDP/GNI often acts to the detriment of health. Many activities that increase GDP/GNI, such as smoking and the use of fossil fuels, damage health. Conversely, activities such as breastfeeding and parenting, which improve health, are not measured in GDP.

 

RECOMMENDATIONS

Recognizing this, the World Medical Association and its constituent members on behalf of their physician members, call on Governments to:

  1. Recognise that well-functioning health systems accessible to all are important, but the principal determinants of health and wellbeing lie outside healthcare;
  2. Prioritise population health and wellbeing in government policy decisions and incorporate metrics of population health and wellbeing into measures of national progress and performance;
  3. Acknowledge that securing and safeguarding population health and wellbeing are crucial to a sustainable future;
  4. Promote equity in health and address inequalities in whatever sphere they exist, by supporting actions that address the wider determinants of health.

 

[i] WMA Declaration of Oslo on Social Determinants of Health – WMA – The World Medical Association

Adopted by the 74th WMA General Assembly, Kigali, Rwanda, October 2023

 

PREAMBLE

Public health emergencies (PHEs) are regular occurrences that put the life and health of populations at risk. They have multiple origins and are frequently characterised by urgency, uncertainty and rapidly escalating demands to which health services may struggle to respond. Public health emergencies frequently transcend jurisdictional boundaries giving rise to co-ordination challenges for governments and other actors. They can also involve large scale displacement of people. Some of the PHEs are localised, some present threats of international concern. Climate change, conflict and extremes of global inequality are direct drivers of PHEs.

World Health Organization (WHO) defines a public health emergency as “an occurrence or imminent threat of an illness or health condition, caused by bioterrorism, epidemic or pandemic disease, or (a) novel and highly fatal infectious agent or biological toxin, that poses a substantial risk of a significant number of human fatalities or incidents or permanent or long-term disability”. Public health emergencies can result from a wide range of hazards and complex emergencies.

PHEs confront physicians, other health professionals, public authorities and at times the international community with severe challenges. Although fundamental ethical principles in medicine remain unchanged, the combination of urgency, uncertainty and extreme shortages of health resources can present health professionals with extreme difficulties in applying them. The familiar tension in medicine between obligations to individual patients and obligations to the public good can be distinctly pronounced during PHEs. This is particularly the case where the need for life-saving interventions overwhelms the available supply. PHEs can also require restrictions on individual and population rights and liberties that present their own ethical challenges.

This statement focuses on the medical ethical aspects of public health emergencies.

 

BASIC PRINCIPLES

  1. During a PHE, physicians and all other health responders should consider the following principles:
  • The obligation to help reduce overall suffering;
  • The obligation to show full and equal respect to all;
  • The requirement for justice and fairness in the allocation of scarce resources;
  • The requirement that any restrictions on individual choice or liberty must be proportionate, lawful and evidence-based;
  • The obligation to maximise overall health outcomes.
  1. Some physicians and health professionals will solely be focussing on population aspects of the response to PHEs. Their primary concern will be maximising benefits and minimising harms at a population level. The above principles will guide them as they seek to realise the greatest overall benefit for the largest number of people.

Issues of particular ethical concern during PHEs

  1. Although the basic ethical duties of physicians do not change during a PHE, their application in certain areas can be challenging. Issues of particular ethical concern during a PHE include but are not limited to:

Confidentiality

  1. Access to large amounts of accurate, real-time data is an essential part of the health response to many PHEs. Physicians and other health professionals retain ordinary duties of confidentiality to their patients. Information can be disclosed during a PHE where a patient or legal surrogate consents to its disclosure. In the absence of consent such information can be disclosed where there is a lawful justification or for overriding reasons of public interest. The disclosure of information should be limited only to the necessary information for the treatment of PHEs. Consideration must also be given to ensuring the ethical use of data including what happens to the data after the purposes for which it was collected are achieved.

Consent

  1. Patients retain the right to consent to or refuse treatment at all times during a PHE. Some compulsory interventions that do not amount to treatment may be acceptable where there is a lawful and ethical mandate supporting them. For example, where individuals present a serious risk of harm to others, and they refuse to accept necessary public health restrictions, confinement may be considered.

Restrictions of liberty

  1. PHEs, particularly where they involve emerging communicable pathogens, may require restrictions on individual and population freedoms. Social distancing and self-isolation are highly effective public health interventions and may be mandated by law during a PHE. Any interference with fundamental rights, including restrictions of liberty, must be justified in the public good, necessary, proportionate, based on lawfully-provided powers and authority, and only imposed for as long as necessary based on scientific evidence. The basic needs of any confined person must be met at all times.

Public engagement

  1. PHEs can have a profound effect on individuals, communities and societies. They are frequently characterised by fear, uncertainty, and involve severe socio- economic disruption. During PHEs, there is a risk of the widespread circulation of misinformation including conspiracy theories and direct attempts to undermine medical and scientific expertise. Clear communication of evidence-based medical and scientific information, including the justification for any decisions that impact social or economic functions, is essential. Active steps should be taken to tackle misinformation and disinformation, especially when it is coming from health professionals.
  1. PHEs frequently require challenging decisions involving trade-offs between fundamental goods. All people affected have a right to know that such decisions are being made and the criteria on which the decisions are based.

Resource allocation and triage

  1. Serious PHEs are often characterised by extreme shortages of health resources. This can present physicians and other health professionals with difficult decisions. In ordinary circumstances priority should be given to those with the greatest health need, provided they have capacity to benefit from the health intervention. Those with equal health needs have equal rights to health resources, whether or not the need arises directly from the PHE.
  1. In some circumstances, where health needs overwhelm available resources, it may be necessary to triage patients. Triage is a form of resource allocation that involves sorting or prioritizing individuals based on their health needs and their likelihood of responding to an intervention. In extreme conditions it can involve setting aside some people for non-treatment where others have a higher likelihood of benefiting from treatment, or where more people can be saved.
  1. Any form of triage must be based on open and defensible ethical principles and must be flexible enough to respond to rapidly changing circumstances. Triage must principally be based on factors determined by the medical community and directly relevant to an individual’s health status.
  1. Attention must also be paid to health trade-offs arising from decisions made to tackle public health emergencies. A focus on tackling communicable pathogens may, for example, require health resources to be diverted away from other health needs. Any such decision must be based on good moral reasons.

The rights and interests of health professionals

  1. There is a limit to the risks that health professionals can be expected to take during the exercise of their duties in a PHE. Physicians and other health professionals should be knowledgeable of ethical and legal issues and disaster response, including their rights and responsibilities to protect themselves from harm, issues surrounding their responsibilities and rights as volunteers, and associated liability issues. Where health professionals are exposed to risk, corresponding duties arise on employing bodies to mitigate those risks as far as possible.
  1. Health professionals responding to PHEs must be properly equipped to deal with the risks they will face, including access to appropriate personal protective equipment (PPE) at all times.
  1. Where health professionals face particular risks as a result of their role in responding to PHEs it may be appropriate for them to have priority access to interventions such as vaccines.

Research

  1. Research is an essential part of the health response to PHEs. Ethical principles guiding research in ordinary conditions are not changed during PHEs. Undertaking research in PHEs can nevertheless be challenging. Those participating in research can also be particularly vulnerable. It is essential that research in PHEs is undertaken with full respect for the principles set out in the WMA Declarations of Geneva, the WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects, and the WMA Declaration of Taipei on Ethical Considerations Regarding Health Databases and Biobanks.

PHEs of international concern

  1. Some PHEs, such as those caused by communicable pathogens or highly-dispersed toxins, can rapidly cross national boundaries and present regional or global health risks. During these emergencies of international concern, the ethical principles outlined above remain unchanged. Given the persistence of serious global inequalities, particular attention must however be paid to transnational questions of justice and fairness in the allocation of health resources.

 

 

Adopted by the 73rd WMA General Assembly, Berlin, Germany, October 2022

 

PREAMBLE

The interaction between the physicians and their relatives seeking medical care can be complex. Moreover, this possibility is highly conditioned by cultural aspects. Interaction can start with asking for simple advice, consultation for minor ailments, and general questions about healthcare and health promotion. This can escalate to seeking medical care and even surgery. Physicians are often their relatives’ first point of call for medical and emotional support. Physicians may be able to offer immediate care in cases of emergency and contribute to well-informed, evidence-based self-care. Other than in emergencies, offering general health information or for minor health problems, physicians should avoid treating those close to them.

The ethical principles governing the work of physicians are equally important and valid when treating relatives. Respect for autonomy may be compromised by lack of privacy, unintentional breaches of confidentiality, and failure to seek informed consent. The relationship with the physician might compromise the patient’s ability to make independent decisions.

Treating relatives may pose challenges in the following circumstances:

  • When objectivity is compromised and decisively affected by emotional factors, there could be a risk of either under- or over-treating relatives or of encountering problems that are beyond the physician’s expertise or abilities, which could cause serious harms.
  • When there are potential barriers to considering sensitive medical history and/or conducting an appropriate physical examination, which may result in incorrect medical diagnosis and treatment.
  • When the physician fails to fulfil requirements concerning patient clinical records, which may result in difficulties if the related patient needs follow-up treatment or when liability issues arise.
  • When a negative medical outcome could compromise the relationship between the physician and the related patient.
  • When the treatment is not in the best interest or against the will of the related patient.
  • When the physician risks providing relatives, perhaps unintentionally and unconsciously, with undue advantages.

 

RECOMMENDATIONS

1.Physicians should avoid routinely acting as a relative’s primary care physician or serving as the attending physician when treating a potentially life-threatening condition. Physicians may provide care to a relative in emergencies, for minor health problems or when there is no other qualified physician available.

2. Related patients may ask for a second opinion about another physician’s care. If a second opinion is shared, it should be consistent with these recommendations and fulfil the duties of physicians to colleagues. Care should be taken to only discuss the treatment, which is most appropriate and recommended, rather than any judgements about the other treating physician’s care and advice.

3. If a physician treats a relative, the physician should be mindful of the following:

  • Strict respect for medical ethics, the patient’s autonomy and consent, with special consideration for minors.
  • The physician has the duty to respect a patient’s right to confidentiality and should not share information with anyone else without a lawful basis, including other family members, with the exception of necessary clinical documentation when referring to other health care personnel.
  • If a relative indicates an intention to seek a second opinion about another physician’s care, that intention must be respected.
  • Consent for treatment must be given by the patient, including competent minors, and for that consent to be valid, it must be fully informed.
  • Depending on the nature of the relationship, taking a sensitive history and performing a physical examination may be emotionally difficult or uncomfortable for the patient or the physician. In such situations the physician and the patient should consider consulting another physician.
  • Clear and concise patient records must be maintained at all times.

4. If the physician cannot accommodate the recommendations above, the physician should avoid treating relatives.

5. While physicians are encouraged not to treat relatives except in certain circumstances, it is acknowledged that physicians are often approached by their relatives for medical advice or treatment, and their help is frequently beneficial and appreciated.

6. In all circumstances, physicians shall maintain the highest professional and ethical standards, in accordance with the Declaration of Geneva, the WMA International Code of Medical Ethics, and the WMA Declaration of Lisbon on the Rights of the Patient.

 

 

Adopted by the 72nd WMA General Assembly (online), London, United Kingdom, October 2021

 

INTRODUCTION

Over the past decade, pressure on supply has led to shortages of certain medical products, including vaccines.  In many situations, these shortages result from putting economic objectives before public heath. These shortages are detrimental to patient care, to maintaining public health and to the organisation of healthcare systems.

The world is going through rapid change; technological progress, radical progress in matters of communication and access to information as well as the increasing power of multi-nationals are transforming the global landscape, including the pharmaceutical industry. Unfortunately, some of these developments have encouraged the production and sale of medical products which do not meet the required safety standards, whether due to the manufacturing process or inappropriate storage, or due to the criminal manufacture and fraudulent distribution of sub-standard or falsified medicines.

According to the WHO’s Global Surveillance and Monitoring System (GSMS) for sub-standard and falsified medical products, around one out of ten medicines is either of a sub-standard quality or falsified in countries with low or medium income. This observation is not limited to the most expensive medicines or the most well-known brands, but also concerns patented and generic products. The medicines most often flagged are the antimicrobials and antimalarials.

The WMA reiterates its position on biosimilar medicines, its resolution on prescribing medicines, its position on the substitution of medicines and resistance to antimicrobials.

The rational use of medicines implies ensuring that research, regulation, production, distribution, prescription, financing, delivery and proper administration of these medicines comply with coherent and rational scientific, professional, economic and social criteria.

From a healthcare point of view, a shortage of medicines is unacceptable, as it has a negative impact on confidence for patients, doctors, pharmacists and the healthcare system, it leads to insecurity and uncertainty and compromises treatment continuity; with all the risks that this implies.

With the objective of combatting the intolerable missed opportunities that such shortages represent for patients, undermining public trust in the healthcare system, the WMA is calling for the implementation of the following recommendations:

 

RECOMMENDATIONS

Availability of medicines

  1. As a public health issue and out of concerns for safety, the WMA urges national governments to improve the availability of medicines.
  2. National governments and regulatory authorities should:
    • Create a national entity responible for gathering and communicating information relative to demand and offer for medicines under their jurisdiction. Establish standards and mechanisms guaranteeing the continuity and the supply of medicines and thus avoid shortages.
    • Improve the monitoring of medical product supply chains, as the weakness of regulatory structures make the application of good medical product distribution particularly difficult.
    • Design contingency strategies to counter the dependence of States on foreign medicine production due to the delocalisation and centralisation of the majority of structures which produce the main pharmaceutical components used in the composition of major medicines.
    • Encourage national healthcare authorities to maintain stocks of essential medicines in order to minimise the risk of shortages. Indeed, the Covid-19 health crisis has demonstrated the limits of stocks held by States and has constrained them to reorganise and restrict access to certain medicines.
    • In the case of global epidemic, to pool scientific research and clinical trials with the objective of accelerating the development of vaccines and/or treatments to eradicate the pandemic.
    • Support legislative and regulatory initiatives which guarantee an appropriate national capacity to produce pharmaceutical products, in the interests of the well-being of the populace and national security.
    • Identify and create sustainable mechanisms which will guarantee sufficient stocks and sufficient access to necessary medicines.
    • Promote co-operation between governments in the prevention and the management of medicine and vaccine shortages.
    • Encourage governments to be more directive in their dealings with the pharmaceutical industry, notably in terms of adjusting quotas, of accelerating approvals and of importing substitute medicines when pharmaceutical companies are not able to ensure a continuous and adequate supply of medicines.
    • Consider demanding that medicine producers establish a continuity plan for the supply of vital and necessary medicines and vaccines in order to avoid production shortages wherever possible.
    • Ensure the transparancy, sharing and availability of quality information coming from reliable sources in order to establish a trustworthy flow of communications between all stake-holders and healthcare professionals and to the patients. In the case of shortages, governments should divulge and detail the causes to all stake-holders.
    • Enable WMA member states to acquire, via common supply contracts, healthcare and vaccine products in sufficient quantities during a pandemic and thus to have greater influence in negotiations with laboratories.
    • Avoid the ‘first come, first served’ approach, notably during a pandemic, leading to counter productive competition acting against the safeguarding of public health.
    • Allow an industrial level of security of supply in line with the deployment of Interpol’s programme combatting pharmaceutical criminality.

Safety of medicines

  1. The objective is to set up active supply processes to ensure the continuity of quality medical supplies while guaranteeing their safety.
  2. Elements of a high-quality, active supply process comprise:
    • Improvements in quantification, including forecasting.
    • Direct communication between supply agents and the manufacturers on the question of sustainable capacity.
    • Deliberate and well-considered approaches to a specific situation for each product (long term, short term, split contracts, etc.)
    • Responsible pricing with the emphasis on quality
    • Rational and necessary contracts.
    • Establish frameworks which limit the excessive accumulation of medicines and the useless scrapping of unused medicines with the objective of preserving the quality of their pharmaceutical properties.
    • Encourage governments to promote the sharing of public information on the real price of medicines. The authorities must regulate and limit the possibility of reaching agreements on price and discounting confidentiality in the medicine evaluation process. The system must be made more transparent in all areas, including the evaluation of new medicines.
  1. The WMA is clear on the fact that the quality of medicines is a public health priority and is recommending national medical associations and doctor members to:
    • Increase awareness among the public and medical practitioners of sub-standard and fake products.
    • Create a list of ‘essential’ medicines meeting a country’s healthcare needs.
    • Create an early alert system, based around vital medicines and those intended to treat a debilitating pathology, in particular those for which no alternative therapeutic options are available. The activation of such a system would trigger a sequence of measures for all the stake-holders (licensed manufacturers, wholesalers, hospital pharmacists) alongside reporting obligations and a close monitoring of corrective actions.
    • Create a scenario and emergency programmes, including a stress test for manufacture and inspection systems at regular intervals, with appropriate communication strategies adapted to the different stake-holders.
    • Persue efforts to harmonise regulatory standards between the countries and beyond regions.
    • Set up proactive and productive collaboration between all the essential stake-holders in order to prevent medicine shortages and mitigate the harmful effects these have on patient care.
    • Work with healthcare user associations to fight against the growing culture of ill-advised self-diagnosis, self-prescription and self-medication, which could make the supply chain vulnerable to the introduction of non-approved or counterfeit products.
    • Restrict the prevalence of low quality medicines by implementing and applying current good practices in manufactuting, storage and distribution which respect the environment (cGMP) and by preventing the deterioration of medicines.
    • Encourage the pharmaceutical sector to undertake to guarantee the continuity of supply of medicines, in order to avoid any interruptions in treatment.
  1. The WMA is insisting that national governments, in tandem with healthcare user associations and other stake-holders, do everything possible to ensure awareness of medicine safety for all patients.
    • At an international level and working together, Health Ministers and Medical Regulators should recommend that national medical associations actively oppose the illegal misappropriation of medicines, the illegal sales of medicines on the internet, the illegal importing of medicines and the counterfeiting of medicines.
    • Improve regulation and monitoring of the online pharmaceutical market through national regulation of e-commerce activities.
    • Regulations and mechanisms should be adopted to immediately close all websites illegally offering medical products not controlled by state authorities.
    • Improve the identification and the revelation of counterfeit medical products all over the world.
    • Launch international campaigns warning of the health risks linked to the use of counterfeit medical products, informing people about the dangers of buying medicines, or products offered as such, on the internet (counterfeit or fake medicines, etc.).
    • Improvement in detecting falsified and sub-standard medicines, including vaccines and other medical products, and their reporting worldwide. Falsified and sub-standard medicines, including vaccines and other other medical products, should be reported to the appropriate authorities whenever they are discovered. Pharmacies, hospital pharmacies and patients must be prevented by whatever means from being supplied with falsified or sub-standard medicines. All adverse side-effects of a falsified or sub-standard medicine must be immediately highlighted via an efficient and adapted reporting system.
    • Strengthen and align international rules against conterfeit medical products, allowing an efficient fight against the growing challenges of the systems of governance caused by the globalisation of manufacturing processes and supply chains.

Covid-19 health crisis

  1. The Covid-19 health crisis has highlighted the fundamental problems of availability, quality and safety of medicines.
  2. The already significant problems of availability, quality and safety of medicines have been starkly brought to light by the Covid-19 health crisis. The importance of these questions is even bigger, on a global scale, and the Covid-19 pandemic has created unprecedented challenges for the authorities of every State. A pandemic leads to a sharp increase in demand for certain medicines and major expectations of specific medicines and vaccines, creating the conditions for multiple tensions.
  3. The problem of medicine availability is particularly apparent for anesthetics and curares in life support, which are subject to closely monitored delivery in order to avoid any break in supply. The prescription and delivery of certain other medicines have been closely supervised in order to maintain supply for chronic illnesses.
  4. As a response to the unequal access to vaccinations, the implementation of the COVAX mechanism must be developed in the future so as to promote access to and distribution of vaccines, with the objective of protecting the people of all countries.
  5. The WHO warns and cautions consumers, healthcare professionals and health authorities about medicine safety: the growing offer of falsified medical products in the context of the Covid-19 pandemic is aided by the possibility of shortages.
  6. Concerning the quality of medicine, the health crisis has highlighted the risks of self-medication and the need for the States to set up information systems aimed at the general population. False hopes of possible cures for or prevention of Covid-19 by scientifically unproven methods have been known to have serious consequences for the health of the individual.
  7. Economic and/or political interests must not be in competition with the health of the public. Pooling of public health interests must be developed in order that economic and/or political interests are not the cause of failure to manage the situation, of stock shortages or of anti-competitive behaviour.
  1. The evolution of the current health crisis and notably the arrival of new variants show that States must be able to respond scientifically to this evolution without being hampered by overly-restrictive international regulations.

Adopted by the 49th WMA General Assembly, Hamburg, Germany, November 1997
and amended by the 59th WMA General Assembly, Seoul, Korea, October 2008,
by the 70th WMA General Assembly, Tbilisi, Georgia, October 2019 and
by the 72nd
WMA General Assembly (online), London, United Kingdom, October 2021

 

PREAMBLE 

For centuries, women and girls worldwide have suffered from gender inequality and an uneven balance of power between men and women. Historically based gender bias has led to women and girls being restricted in their access to, inter alia, employment, education and health care.

Gender inequality creates dangers in medical treatment. When both genders are not offered equal quality treatment and care for the same medical complaints or when different manifestations of disease are not considered based on sex, patient outcomes will suffer.

In addition, in some countries, female healthcare providers have been prevented from, or face barriers to practicing their profession or being promoted to leadership positions due to religious and/or cultural convictions, or discrimination based on the intersecting grounds of sex and religion/ethnicity. A lack of gender representation and diversity within the medical profession may lead to female patients and their children not having equitable access to health care.

Discrimination against girls and women damages their health expectation. It serves as a barrier to accessing health services, affects the quality of health services provided, and reinforces exclusion from society for women and girls. For example, the education of girls positively affects their health and well-being as adults. Education also improves the chances of their children surviving infancy and contributes to the overall well-being of their families. Conversely, secondary discrimination due to social, religious and cultural practices – which diminishes women’s freedom to make decisions for themselves and to access employment and healthcare opportunities – has a negative impact on health expectation.

National laws, policies and practices can also foster and perpetuate discrimination in health care settings, prohibiting or discouraging women and girls from seeking the broad range of health care services they may need. Evidence demonstrates the harmful health and human rights impacts of such laws. For example, in some countries and due to national laws, legislations or social norms, women and girls lack decision-making power about their own medical treatment, surgery, childbearing or contraception.

Addressing discrimination in health care settings will contribute to the achievement of many of the United Nations Sustainable Development Goads (SDGs), ensuring that no woman or girl is left behind. It is fundamental to securing progress towards SDG 3, Good health and wellbeing, including achieving universal health coverage and ending the AIDS and tuberculosis epidemics; SDG 4, Quality education; SDG 5, Gender equality and women’s empowerment; SDG 8, Decent work and inclusive economic growth; SDG 10, Reduced inequalities; and SDG 16, Peace, justice and strong institutions.

Gender is a social determinant of health and health problems may manifest themselves differently in men and women. There is a need to address the differences in health and unequal health care between men and women, including both the biological and socio-cultural dimensions.

Access to healthcare, including both therapeutic and preventative strategies, is a fundamental human right. This imposes an obligation on government to ensure that these human rights are fully respected and protected.  Gender inequalities must be addressed and eradicated in all aspects of healthcare.

Machine learning, predictive algorithms and artificial intelligence (AI) in healthcare are expected to drastically change the way healthcare is practiced and managed. For example, AI could change the way in which diseases such as cancer are diagnosed and treated. However, even with the introduction of AI in healthcare, resource limitations may prevent most women globally from accessing such healthcare. In order not to amplify any gender inequalities, information being programmed into artificial intelligence algorithms being created to inform medical diagnoses and management must take into account the specific health considerations of women, for example women may present with different symptoms to men.

The WMA Declaration of Geneva establishes the physician’s respect for human dignity and that it should not allow considerations of gender to come between “my duties and my patients.”

 

RECOMMENDATIONS

Therefore, the World Medical Association urges its constituent members to:

  1. Promote the equal human right of health for women and children;
  2. Categorically condemn violations of the basic human rights of women and children, including violations stemming from social, political, religious, economic and cultural practices;
  3. Insist on the rights of all women and children to full and adequate medical care, especially where religious, social, and cultural restrictions or discrimination may hinder access to such medical care, and promote women’s and children’s health and access to health as human rights;
  4. Advocate for parity of health insurance premiums and coverage to ensure that women’s access to care is not impeded by prohibitively high expenses;
  5. Governments have an obligation to ensure that the information being programmed into artificial intelligence algorithms being created to inform medical diagnoses and management must include a representative sample of data from women to ensure the gender inequality gap is not amplified further.
  6. Ensure universal access to sexual and reproductive healthcare;
  7. Promote the provision of pre-conception, prenatal and maternal care, and post-natal care including immunization, nutrition for proper growth and healthcare development for children.
  8. Advocate for educational, employment and economic opportunities for women and for their access to information about healthcare and health services.
  9. Work towards the achievement of the human right to gender equality of opportunity and gender equality of treatment.

Adopted by the 72nd WMA General Assembly (online), London, United Kingdom, October 2021

 

PREAMBLE

Surgery and anesthesia care encompass all clinical fields and all health care providers dealing with surgical disease and pathologies. This includes, but is not limited to anesthesia, obstetrics and gynaecology and surgery including all of its subspecialties. They have historically been a neglected part of global health with very little investments made in developing surgical health systems, while an estimated quarter of the burden of disease worldwide can be attributed to surgical diseases. Moreover, the majority of the world’s population lacks access to safe, timely and affordable surgical care.

A workforce of 20 surgical, anesthesia and obstetric physician providers for every 100.000 members of the population is necessary to provide 80% of the world population essential and emergency surgical care within 2 hours. This includes emergency surgical and obstetric care such as caesarian sections and surgical care to prevent death and disability due to illnesses likely to benefit from surgical treatment such as injuries, cataracts and cancer.  The majority of low- and middle-income countries (LMICs) fall far below this target, with the need being especially great in the poorest regions of the world.

Surgeon shortages may be exacerbated by a lack of gender equity in the surgical workforce which remains a challenge. Despite the fact that in a number of countries, there are more female than male medical students, men still outnumber women by far in the surgical workforce.

Surgery and anesthesia care have been proven to be cost-effective, especially in LMICs. Surgical interventions are as cost-effective as common public health interventions like malaria bed nets, HIV drugs or childhood vaccinations.

Sixty percent of cancer patients and eighty percent of trauma patients will need some form of surgical intervention throughout their treatment. Considering both non-communicable diseases (NCDs) and injuries are on the rise globally, the demand for surgical care is expected to continue to increase.

In 2015 the World Health Assembly recognized surgery and anesthesia care as a vital component of Universal Health Coverage (UHC) through their Resolution 68.15 “Strengthening emergency and essential surgical care and anesthesia as a component of universal health coverage”.

 

RECOMMENDATIONS

WMA recommends that the relevant national authorities:

  1. Integrate quality surgical and anesthesia care in all levels of health care, including comprehensive primary health care in order to realize UHC and Sustainable Development Goals by 2030.
  1. Develop specific surgery and anesthesia guidelines and policies for their respective countries or jurisdictions adapted to local needs and capacities.
  1. Implement policies regulating the process of task shifting in surgery and anesthesia care in line with the “WMA Resolution on Task Shifting from the Medical Profession”.
  1. Invest in health system strengthening and advocate for increased financing and budgetary allocation for surgery and anesthesia care without depriving other areas of necessary funds.
  1. Provide the necessary infrastructure and procurement lines for hospitals to deliver safe, high-quality surgical care.
  1. Ensure policies, including narcotic and regulated drugs policies, do not hamper access to necessary surgical medications including analgesia and anesthetic agents.
  1. Create clinical protocols or guidelines at the national or regional level to assure antibiotics use in the peri-operative period are prescribed in a sustainable manner and in line with applicable antimicrobial resistance guidelines.
  1. Include surgical care and diseases in relevant courses to fight the dogma that surgical care is too expensive and complex to provide in low-resource settings.
  1. Offer equitable residency training opportunities to locally trained medical students of both genders in the field of surgery and anesthesia based on scientifically projected needs of the country or region in line with the “WMA Statement on Gender Equality” and contributing to the Global strategy on human resources for health: Workforce 2030.
  1. Allow adaptive training and work schedules to accommodate the potential need for maternity or paternity leave, and a healthy work-life balance, in order to make training programs more accessible irrespective of the trainee’s family responsibilities.
  1. Seek regional, national and international collaboration in clinical and academic domains where local capacity and resources may be lacking and where exposure could be beneficial to those from areas without high capacity or resources, such as through bilateral exchange programs.
  1. Support national initiatives on surgical data collection, capacity building, advocacy, policy planning and systems strengthening through collaboration with NGOs, universities, research initiatives, local communities, development banks, governmental organizations, and other stakeholders;

WMA commits to:

  1. Advocate at local, regional and national, and international fora in favor of person-centered care creating a more holistic health care system, offering medical, surgical, mental health and preventive health services in a national UHC approach, supporting WHA Resolution 68.15 “Strengthening emergency and essential surgical care and anesthesia as a component of universal health coverage”. 

 

 

Adopted by the 72nd WMA General Assembly (online), London, United Kingdom, October 2021

 

PREAMBLE

The sun is a great source of health benefits, but it is important to know its harmful consequences as well. The prevention of the harmful effects of the sun on our skin is advisable at all ages, especially in children and adolescents. Solar radiation generates a series of biological and physiological effects in the body that depend on the proportion and intensity of the radiation and that have beneficial effects, such as stimulating the synthesis of vitamin D, favoring the formation of hemoglobin and improving the mood, while other effects are harmful and aggressive to the skin, such as erythema, photoaging of the skin and precancerous or cancerous lesions. Dermatoses produced or aggravated by sun exposure are a health problem that healthcare professionals face most frequently.

Solar light is composed of a continuous spectrum of electromagnetic radiation divided into three major groups: ultraviolet (UV), visible and infrared. UV radiation is classified as UV-A, UV-B and UV-C.

The intensity of UV radiation can be measured by international standardized instruments such as the UV index which measures the strength of sunburn-producing solar UV radiation at a particular place and time.

Solar UV radiation, especially through UV-B, is an extremely important, yet neglected causative factor for skin cancers, both melanoma and non-melanoma, for ocular pathologies (e.g., cataracts, and age-related macular degeneration), and harmful effects on the immune system [3]. Recurrent and severe sunburns are a risk factor for non-melanoma skin cancer.

Solar radiation can also induce the onset and exacerbation of chronic actinic dermatitis (CAD) and melasma. Blue light plays an important role as well in the pathogenesis of melasma, therefore broad-spectrum photoprotection should be advocated and the intake of photosensitive foods and drugs should be reduced.

Risk of skin cancer differs according to skin type as well as the duration and intensity of solar light exposure. Chronic, long-term, cumulative UV exposure is associated with actinic keratosis and squamous cell carcinomas, while high-intensity, intermittent UV exposure, especially at a young age, is associated with basal cell carcinomas and melanomas. Therefore, photoprotection is important in young ages.

The World Health Organization (WHO), through the International Agency for Research on Cancer has raised the issue of solar UV radiation being a carcinogen since 1992 and since 2012 has classified solar UV radiation as a group 1 carcinogen (carcinogen to humans). Other well-known group 1 carcinogens are plutonium, asbestos and ionizing radiation.

Furthermore, current climate changes and the depletion of the ozone layer by approximately 4% per decade since the 1970s has led to a diminished filtration of UV-A and UV-B radiation and to increased UV radiation that reaches sea-level.

As a consequence, the incidence of melanoma and non-melanoma skin cancer is increasing worldwide.

WHO evidence indicates that four out of five cases of skin cancer can be prevented and simple preventive measures, such as limiting UV exposure in the midday sun, wearing UV protective clothing and hats or using mineral-based sunscreens, are recommended.

Photoprotection also includes make-up products, sunglasses, and windshields.

The WHO recognizes that while protection against UV exposure is recommended globally, there is concern that lack of UV exposure may reduce beneficial effects of vitamin D, including its potential to reduce the risk of some types of cancer.

 

RECOMMENDATIONS

1.     Photoprotection is a key preventative health strategy as most skin cancers are a result of UV solar exposure.

National Governments should:

2.     Inform health professionals and the public about the characteristics that sunscreen should meet (one that provides balanced, safe and easy-to-use protection) in order to avoid variability between the products supplied by laboratories, as well as improve safety and the labelling of the sunscreen.

3.     Recognize solar UV exposure as an important risk factor for developing skin cancer. UV exposure also is a prime cause of some ocular diseases and immune system dysfunctions.

4.     Work together to develop a Global Action Plan for the Prevention of Skin Cancer based on Photoprotective measures. This should include action against climate change to help reduce damage from ultra-violet radiation.

5.     Support skin cancer screening campaigns.

6.     Recognize prevention of skin cancer as a national health priority.

7.     Improve skin cancer’s screening, diagnosis and management.

8.     Include all forms of skin cancer in all Nationals Cancer Registries and improve the reporting of UV induced skin cancers and legislative frameworks to protect outdoor workers (recognition as occupational disease).

9.     Work with relevant stakeholders to liaise, engage and organize online and offline skin cancer prevention campaigns and educational programs on sun protection, with a primary focus on ages 0 – 18, in order to raise awareness of this health hazard and to encourage sun safety (use of protective clothing and hats, adequate sunscreen use, avoidance of excessive exposure) and healthy lifestyle choices among the young.

10.  Promote policies to fight climate change and air pollution.

11.  Consider the environmental impact of sunscreen.

WMA and its members should:

12.  Interact with healthcare providers and medical practitioners who have a significant role in empowering and educating their patients in the promotion of skin cancer awareness, sun-protective measures and encouraging patient access to screening, diagnosis and treatment.

13.  Educate primary care physicians and occupational physicians to recognise and refer patients with suspect lesions to dermatologists.

14.  Support the development of national guidelines on photoprotective measures and continued scientific research in this field to derive the risk-benefit balance of UV exposure.

15.  Support continued research and development of adequate protective clothing.

16.  Promote campaigns to encourage the measurement of UV exposure within each nation.

17.  Support media campaigns and educational programs that explain the harmful effects of UV exposure and optimal photoprotective measures targeting the most vulnerable, such as children and teenagers, fair skinned people, outdoor workers (e.g. agriculture, fishery, construction, forestry, athletes, swimming pool attendants).

18.  Promote health education and information on sunscreens and the most recommended and healthy habits for the skin, establishing correct sun protection habits that make it possible to enjoy the beneficial effects of the sun and avoid sun damage.

Individual physicians should:

19.  Counsel patients about the major health risks associated with excessive solar UV radiation exposure, inform patients about appropriate sun protective measures (e.g. skin coverage, sunscreen, and sunglasses) and encourage patients to undergo regular medical check-ups and to participate in skin cancer screening campaigns, where available.

20.  Counsel patients to self-examine their skin.

21.  Counsel those patients at risk (for example, patients on certain anti-cancer drugs) to understand the extra importance of protective measures.

22.  Counsel employers on UV light as a work-related health risk.

 

Adopted by the 71st WMA General Assembly (online), Cordoba, Spain, October 2020

 

PREAMBLE

In 2017, almost 140,000 solid organ transplants were performed worldwide. Although impressive, this activity provided for only 10% of the global need for transplanted organs. The disparity between supply and demand of organs has led to the emergence of transplant-related crimes, including trafficking in persons for the purpose of the removal of organs and trafficking in human organs.

These crimes violate fundamental human rights and pose serious risks to both individual and public health. The true extent of transplant-related crimes remains unknown, but it is estimated that 5% to 10% of transplants globally take place in the context of the international organ trade, often involving transplant tourism to destinations where laws against the sale and purchase of human organs are nonexistent or poorly enforced. Trafficking in persons for the purpose of the removal of organs and trafficking in human organs can also take place within the boundaries of a given jurisdiction, not involving travel for transplantation. In all cases, the most vulnerable parts of the population often become victims of exploitation and coercion.

Concerned by the increasing demand for organs and by emerging unethical practices in the field, the World Health Organization has called on governments and health professionals to pursue self-sufficiency in transplantation, through strategies targeted at decreasing the burden of diseases treatable with transplantation and increasing the availability of organs, maximising donation from the deceased and ensuring the overall protection of the living donor. Progress towards self-sufficiency in transplantation is consistent with the establishment of official cooperation agreements between countries to share organs or to facilitate patients’ access to transplant programs that have not been developed in their countries of origin. Agreements between countries should be based on the principles of justice, solidarity and reciprocity.

Progress towards self-sufficiency in transplantation is the best long-term strategy to prevent transplant-related crimes.

The distinctive feature of transplant-related crimes is the necessary involvement of health professionals. It is precisely this feature that provides a unique opportunity to prevent and combat these crimes. Health professionals are key in evaluating prospective living donor and recipient pairs. They also care for desperate patients who are vulnerable and at risk of engaging in illicit transplant activities. In addition, since patients who receive a transplant require long-term specialised care, physicians must deal with the many challenges of providing care to patients who have received an organ through illicit means, while unveiling trafficking rings.

International organisations, including the Council of Europe, the European Union and the United Nations, as well as international professional platforms, have developed treaties, resolutions and recommendations for a concerted fight against transplant-related crimes.

The WMA emphasises the responsibility of physicians in preventing and combatting trafficking in persons for the purpose of the removal of organs and trafficking in human organs, as well as the important role of physicians and other health-care professionals in assisting international organisations, medical associations and policy makers in the fight against these criminal activities.

In the fight against transplant-related crimes it is of utmost importance that the principles of transparency of practice, traceability of organs and continuity of care are guaranteed for every transplant procedure performed nationally or abroad.

The WMA reaffirms its Statement on organ and tissue donation and its Declaration of Sydney on the determination of death and the recovery of organs. Condemning all forms of trafficking in persons for the purpose of the removal of organs and trafficking in human organs, the WMA calls for the implementation of the following recommendations.

 

RECOMMENDATIONS

Policy makers and health actors:

  1. Governments should develop, implement and vigorously enforce legislative frameworks that prohibit and criminalise trafficking in persons for the purpose of the removal of organs and trafficking in human organs, these should include provisions to prevent these crimes and protect their victims.
  2. Governments should consider ratifying or acceding to the United Nations Convention against Transnational Organised Crime and the Protocol to Prevent, Suppress and Punish Trafficking in Persons, Especially Women and Children, supplementing the United Nations Convention against Transnational Organised Crime, as well as the Council of Europe Convention against Trafficking in Human Organs. They should also consider cooperating with existing international organisations for a more effective fight against transplant-related crimes. The WMA should play a leading role in influencing ethical practices in donation and transplantation.
  3. Health authorities should develop and maintain registries to record information regarding each organ recovery and transplantation procedure, as well as information on the outcomes of living donors and organ recipients, to ensure the traceability of organs, with due regard to professional confidentiality and personal data protection. Registries should be designed to record information on procedures that take place within a country and on transplant and living donation procedures on residents of that country carried out in other destinations.
  4. Countries are encouraged to periodically contribute this information to the Global Observatory on Donation and Transplantation developed in collaboration with the World Health Organization.
  5. Health authorities and medical associations should ensure that all health professionals are trained in the nature, extent and consequences of transplant-related crimes, as well as in their responsibilities and duties in preventing and fighting these criminal activities and in the means to do so.
  6. As self-sufficiency is the best long-term strategy to prevent transplant-related crimes, health authorities and policy makers should develop preventive strategies to decrease the burden of diseases treatable with transplantation and increase the availability of organs.
  7. Increasing organ availability should be based on the development and optimisation of ethically sound deceased donation programs following the determination of death by neurological and by circulatory criteria. Of note is that donation after the determination of death by circulatory criteria is accepted in a limited number of countries. Governments should explore whether donation after the circulatory determination of death is a practice acceptable within their community and, should this be the case, consider introducing it within their jurisdiction.
  8. In addition, governments should develop and optimise living donation programs based on recognised ethical and professional standards and ensure due protection and follow-up of living donors.
  9. Health authorities and/or insurance providers should not reimburse the costs of transplant procedures that have occurred in the context of transplant-related crimes. However, the costs of medications and post-transplant care should be covered, as for any other transplant patient.
  10. Authorities should also ensure that medical and psychosocial care is provided to victims of trafficking in persons for the purpose of organ removal and of trafficking in human organs. Consideration should be given to effective compensation of these persons for the damage suffered.
  11. National Medical Associations should advocate for and cooperate with authorities in developing frameworks for health professionals to report any confirmed or suspected case of trafficking of persons for the purpose of the removal of organs and of trafficking in human organs to the relevant authorities. National Medical Associations should advocate for the ability of health professionals to report suspected trafficking of individual persons, on an anonymous basis if necessary, to protect the safety of the reporter. Where applicable, the reporting of trafficking cases should be a permitted exception to the physician’s obligation to maintain patient confidentiality

Physicians and other health professionals:

  1. Physicians should never perform a transplant using an organ that has been illicitly obtained. If there are reasonable concerns about the origin of an organ, the organ must not be used. If a physician or a surgeon is asked to perform a transplant with an organ that has been obtained through a financial transaction, without the valid consent of the donor or without the authorisation required in a given jurisdiction, they must refrain from performing the transplant and should explain the reasons to the potential recipient.
  2. Physicians who participate in the preoperative evaluation of potential living donors should not only assess the medical suitability of the individual, but also attempt to ensure that the person has not been subject to coercion of any kind or is participating in the procedure for financial gain or any other comparable advantage. The legitimacy of the donor-recipient relationship and the altruistic motivations for donation should be scrutinised. Physicians should be particularly vigilant of “red flags” suggestive of a transplant-related crime. Non-resident living donors may be particularly vulnerable and should be given special consideration. For linguistic, cultural and other reasons, assessing the validity of their consent to donation can be especially challenging, as can ensuring that appropriate follow-up is offered to them. A referring physician should be identified in the country of origin of the living donor – and in that of their intended recipient, where appropriate.
  3. Physicians should never promote or facilitate the engagement of patients in transplant-related crimes. Moreover, they should inform patients of the risks these activities pose for their own health, that of their loved ones and, more generally, for public health. Patients should also understand that these activities entail an exploitation of vulnerable individuals who may themselves suffer from severe medical and psychosocial complications. By counselling patients, professionals may dissuade them from engaging in illicit transplant activities.
  4. Physicians have a duty to care for transplant patients, even if their organ was illicitly Should a physician have ethical or moral objections about caring for a patient who has received an illicit organ, they should make the necessary arrangements to transfer the care of the patient to another physician.
  5. Physicians should contribute to guaranteeing transparency of practices and traceability of organs. When patients who have undergone a donation or a transplantation procedure abroad seek follow-up care in their country of residence, all relevant information should be recorded in national transplant-registries and reported to health authorities, as should happen for all donation and transplantation procedures performed within the national transplant system.
  6. . Physicians have a responsibility to increase the deceased donor pool in order to satisfy the transplantation needs of patients. Physicians also have a duty towards possible organ donors in considering and facilitating organ donation if this is consistent with patients’ values and principles. Donation should be routinely offered as an option at the end of life, always in a respectful manner, taking into account the culture and religion of the potential donor and their surrogates. Conversations about donation opportunities should be led by experienced and trained professionals.
  7. Physicians should promote research in the field of donation and transplantation, in particular research targeted at increasing the availability of organs for transplantation, improving the outcomes of transplanted organs, and identifying alternative organ replacement strategies, as in the case of bioartificial organs.

 

Adopted by the 71st WMA General Assembly (online), Cordoba, Spain, October 2020

 

PREAMBLE

Hypertension is the single most important risk factor for cardiovascular death globally. It accounts for more deaths from cardiovascular disease than any other modifiable risk factor. More than half of people who die from coronary heart disease and stroke had hypertension. “As populations age, adopt more sedentary lifestyles, and increase their body weight, the prevalence of hypertension worldwide will continue to rise.

Uncontrolled hypertension is a major cause of stroke and other co-morbid, chronic conditions, such as heart failure, kidney disease, vision loss, or mild cognitive impairment. Because hypertension can be asymptomatic, it may often go undiagnosed.

In 2010, hypertension emerged as the leading risk factor for disease burden in every region of the world. Moreover, elevated systolic blood pressure (SBP) is a leading global health risk. The WHO Global Plan of Action for the prevention of non-communicable diseases calls for a 25% reduction in the prevalence of elevated blood pressure by 2025.

Prevalence

Worldwide prevalence of hypertension has grown significantly over the past four decades, and most with hypertension are not achieving optimal control.

Of concern is an increasing disparity in hypertension prevalence between high-income and low/middle–income countries. Almost three times as many people with hypertension live in low/middle–income countries than in high-income countries. Low-income countries in south Asia, sub-Saharan Africa, and central and eastern Europe, are particularly impacted. Moreover, the prevalence of elevated blood pressure was highest in certain regions of Africa in both sexes.

Risk Factors

Hypertension risk factors are attributes that increase the likelihood of developing the disease. Risk factors include the following:

  • Lifestyle/Diet: Unavailability of healthy food choices, lack of access to safe neighborhoods for exercising, and unhealthy lifestyle habits can raise the risk of hypertension. Unhealthy lifestyle habits include unhealthy eating patterns such as eating too much sodium and highly processed food, drinking too much alcohol, smoking, and being physically inactive.
  • Age: Blood pressure (BP) tends to increase with age. However, the risk of hypertension is increasing for children and teens, possibly due to the rise in the number of children and teens who are overweight or obese.
  • Socioeconomic Status: In high-income countries, the greatest absolute burden of hypertension disease is in age groups 60 years and older, whereas in low/middle-income countries, the greatest absolute burden is in the middle-aged groups, such as 40 to 59 years. The age-standardized prevalence of hypertension is higher in low/middle-income countries than in high-income countries.
  • Sex: Before age 55, men are more likely than women to develop hypertension. After age 55, women are more likely than men to develop it.
  • Genetics/Family History: Research has identified many gene variations associated with small increases in the risk of developing hypertension. Some people are genetically predisposed to dietary sodium sensitivity.

Accurate blood pressure measurement

The accurate measurement of BP—both within the clinical setting and at home—is essential for the diagnosis and management of hypertension. In many countries, national clinical guidelines recommend how to achieve an accurate BP measurement and offer best practice recommendations.

Policy implications

Policies and actions at the global, national, and local levels are necessary to recognize and combat hypertension. Much effort is needed worldwide to improve awareness, treatment, and control for all populations. Current guidelines to diagnose and treat hypertension, and evidence-based guidance on the importance of proper BP measurement, offer anchors for national policies on BP measurement and control. Implementation can make significant progress towards lowering global hypertension prevalence and improving patient outcomes. To address the risk factors for hypertension, policies should also focus on addressing socioeconomic, lifestyle and dietary factors which contribute to the development of the disease.

 

RECOMMENDATIONS

  1. The World Medical Association recommends that national governments:
  • Recognize hypertension as the single most important risk factor for cardiovascular disease and death.
  • Declare hypertension control a national health priority.
  • Support campaigns to raise public awareness of hypertension, including recognition of its widespread and asymptomatic nature, and its risk of contributing to development of other serious diseases.
  • Deploy adequate resources to improve hypertension awareness, diagnosis, measurement, and management.
  • Develop country-specific strategies which address the risk factors for hypertension and advocate for improvements in awareness, diagnosis, measurement and management.
  • Promote the recommendations adopted by the WMA as stated in the Statement on Reducing Dietary Sodium Intake.
  1. The World Medical Association recommends that its constituent members:
  • Advocate at the international, national, and local levels to promote hypertension awareness, healthy lifestyles, and patient access to hypertension diagnosis and treatment including medications. This includes supporting the concept that social determinants of health are part of hypertension disease prevention.
  • Recognize and support national guidelines and strategies for measuring BP accurately.
  • Support the exchange of hypertension research, information, tools, and other resources amongst healthcare teams and patients.
  • Support the development of medical curricula that respond to societal hypertension needs with a focus on community-based primary care training and BP measurement and management skills.
  • Promote research on the causes, mechanisms and effective treatments of hypertension.
  • Advocate for sustained availability antihypertensive medications.
  1. The World Medical Association recommends that physicians:
  • Emphasize the risk factors for hypertension and ways to mitigate them, paying special attention to prevention and treatment in high-risk populations.
  • Emphasize team-based care to help prevent and, where it has been diagnosed by a physician, to treat hypertension.
  • Implement BP measurement best practices and techniques, including training and retraining of all healthcare team members.
  • Promote patient hypertension treatment adherence by facilitating ongoing patient BP self-management and involvement in the patient’s own care.

 

Adopted by the 71st WMA General Assembly (online), Cordoba, Spain, October 2020

 

PREAMBLE

Genome editing, enabled by recent scientific advances, can generate targeted insertions and deletions in DNA and may even offer enough precision to modify a single base pair within the genome of an organism. Basic science research with genome editing is now underway in laboratories globally.

Human genome editing is also advancing rapidly, with clinical trials now in progress for prevention and treatment of various human diseases. These trials, which are currently in early stages, involve somatic (non-reproductive) cells, and thus are not anticipated to introduce genetic changes that will be passed on to offspring or the germline (reproductive) cells.

While genome editing holds great potential to help improve human lives, the technology raises profound safety, ethical, legal, and social concerns. These concerns are compounded by the fact that regulatory and ethical guidance often lag rapid technological developments.

Safety concerns for genome editing include the risk of unintended or unforeseen pleiotropic effects off-target effects (edits in the wrong place) unwanted on-target modifications (imprecise edits), and mosaicism (when only some cells carry the edit), and abnormal immunological responses.

Ethical issues regarding genome editing include concerns that editing may be used for non-therapeutic and enhancement purposes rather than for therapeutic purposes, i.e. improving health or curing disease. There are also concerns that germline modifications could create classes of individuals defined by the quality of their engineered genome, possibly enabling eugenics, which could exacerbate social inequalities or be used coercively.

The effect of epigenomic changes are unpredictable, and there is disquiet as to how this will affect the existing healthy biological systems, including interactions with other genetic variants, and societal norms. Once introduced into the human population, genetic alterations would be difficult to remove and would not remain within any single community or country. The effects could remain uncertain for many subsequent generations, during which time deleterious modifications could be dispersed throughout the population.

Legal issues include providing clarity for risk management and assignment of duties and liabilities, particularly when modifications can be passed to subsequent generations. There are also risks, both legal and ethical, involved in the proliferation of unvalidated direct-to-consumer CRISPR (clustered regularly interspaced short palindromic repeats) kits that allow individuals to undertake gene editing independently in a home setting.

At a social level, debates revolve around the concerns that access to beneficial genome editing will be inequitable (e.g., only the wealthy will have access) and will increase existing disparities in health and medical care.

The WMA reaffirms principles in the Declaration of Reykjavik on the  ethical considerations regarding the use of genetics in health care, the Declaration of Taipei on Ethical Considerations regarding Health Databases and Biobanks and the Declaration of Helsinki and makes the following recommendations:

 

RECOMMENDATIONS

  1. Human genome-editing, like any other medical intervention, should be implemented according to appropriate evidence that is collected via well-conducted and ethically approved research studies.
  2. When contemplating use of germline cells for research purposes, germline editing should be permitted only within a separate ethical and legal framework, distinct from an ethical and legal framework applied to somatic genome editing.
  3. Governments should:
  • Develop robust and enforceable regulatory frameworks for genome editing in their own countries.
  • Urge continued development of an international consensus, grounded in science and ethics, to determine permissible therapeutic applications of germline genome editing.
  1. WMA constituent members should:
  • Be cognisant of the advances in research in genomic medicine and inform their members on scientific advances in genome
  • Advocate for research to understand (i) the benefits and risks of human genome editing, (ii) the socio-political, ethical, and legal aspects of editing the human germline and (iii) the necessity of physician involvement in therapeutic genome editing.
  • Develop and promote ethical guidelines for genome editing for their members, taking into consideration societal perspectives, professional consensus, national laws and regulations, and international standards.
  • Advocate for the development of appropriate laws and regulations for genome editing in accordance with both international and national norms and standards.
  • Where human genome editing is safe and effective, advocate for equal patient access to the technology.
  1. Physicians should:
  • Educate themselves on the technical, ethical, social, and legal aspects of genome editing.
  • Familiarise themselves with the international and local ethical frameworks regulating genome
  • Follow all ethical standards for approved research in these areas, including appropriate informed consent.

Adopted by the 70th WMA General Assembly, Tbilisi, Georgia, October 2019

 

PREAMBLE

The WHO constitution states that “the extension to all people of the benefits of medical, psychological and related knowledge is essential to the fullest attainment of health”. Access to relevant, reliable, unbiased, up-to-date and evidence-based healthcare information is crucial for the public, patients and health personnel for every aspect of health, including (but not limited to) health education, informed choice, professional development, safety and efficacy of health services, and public health policy.

Lack of access to healthcare information is a major contributor to morbidity and mortality, especially in low- and middle-income countries, and among vulnerable groups in all countries.

Healthcare information is only useful if it is relevant, appropriate, timely, updated, understandable and accurate. It covers a broad spectrum of issues and refers to diseases, treatments, services, as well as the promotion and preservation of health.

Health literacy is a key factor in understanding how health services work and how to use them. Health professionals need access to adequate training and support to communicate with patients with low health literacy or with those who have difficulty understanding healthcare information, for example because of a disability.

Globally, thousands of children and adults die needlessly because they do not receive basic life-saving interventions. Some interventions may be available locally but are simply not provided due to indecision, delays, misdiagnosis and incorrect treatment. Failure to provide basic life-saving interventions more commonly affects those who are socioeconomically disadvantaged.

In the case of children with acute diarrhea, for example, the widespread misconception among parents that they should withhold fluids, and among health workers that they should give antibiotics rather than oral rehydration, contributes to thousands of unnecessary deaths every day worldwide.

Governments have a moral obligation to ensure that the public, patients and health workers have access to the healthcare information they need to protect their own health and the health of those for whom they are responsible. This obligation includes providing adequate education, in form and content, to identify and use such information effectively.

The public, patients and healthcare workers need easy, reliable access to evidence-based, relevant healthcare information as part of a learning process throughout the life-course to enhance understanding, and to make informed and conscious decisions about their health, healthcare options and the health care they receive. These groups need information in the right language, and in a format and technical level that is understandable to them, with relevant services signposted as appropriate. This should take into account the characteristics, customs and beliefs of the population to which it is directed, and a feedback process should be established. The public, patients and families need information that is appropriate to their specific context and situation, which may change over time. They need guidance on when and how to make important health decisions, which are usually best made when there is time to consider, understand and discuss the issue at hand.

Meeting the information needs of the public, patients and healthcare providers is a prerequisite for the realisation of quality universal health coverage and the UN Sustainable Development Goals (SDGs).” UN SDG Target 3.8 on universal health coverage specifically aims to deliver ‘quality essential health-care services and access to safe, effective, quality and affordable essential medicines and vaccines for all’. Achieving this requires empowerment of the public and patients, as well as health workers, with the healthcare information they need to recognize and assume their rights and responsibilities to access, use and provide appropriate services and to prevent, diagnose and manage disease.

The development and availability of evidence-based, relevant healthcare information depends on the integrity of the global healthcare information system. This system comprises researchers, publishers, systematic reviewers, producers of end-user content (including academic publishers, health education, journalists and others), information professionals, policymakers, frontline health professionals and patient representatives, among others.

 

RECOMMENDATIONS

Recognizing this, the World Medical Association and its constituent members on behalf of their physician members, will support and commit to the following actions:

  1. Promote initiatives to improve access to timely, current, evidence-based healthcare information for health professionals, patients and the public to support appropriate decision-making, lifestyle changes, care-seeking behaviour and improved quality of care – thereby upholding the right to health.
  2. Promote standards of good practice and ethics to be met by information providers, guaranteeing reliable and quality information that is produced with the participation of physicians, other health professionals, and patient representatives.
  3. Support research to identify enablers and barriers to the availability of healthcare information, including how to improve the production and dissemination of evidence-based information for the public, patients and health professionals, and measures to increase health literacy and the ability to find and interpret such information.
  4. Ensure that health professionals have access to evidence-based information on diagnosis and treatment of diseases, including unbiased information on medicines. Particular attention should be paid to those working in primary care in low- and middle-income countries.
  5. Combat myths and misinformation around healthcare through validated scientific and clinical evidence, and by urging the media to report responsibly on health issues. This includes the study of health-related beliefs stemming from cultural or sociological differences. This will improve the effectiveness of health promotion activities and allow the dissemination of healthcare information to be adequately targeted to different segments of the population.
  6. Urge governments to recognize their moral obligation to take measures to improve the availability and use of evidence-based healthcare information. This includes:
    • resources to select, compile, integrate and channel scientifically validated information and knowledge. This should be adapted to target various different recipients;
    • measures to increase availability of healthcare information for healthcare workers and patients at health centres;
    • leveraging modern communication technology and social media;
    • policies that support efforts to increase the availability and use of reliable healthcare information.
  7. Urge governments to provide the political and financial support needed for ‘WHO’s function to ensure access to authoritative and strategic information on matters that affect peoples’ health’, based on the WHO General Programme of Work 2019-23.

 

Adopted by the 70th WMA General Assembly, Tbilisi, Georgia, October 2019

 

PREAMBLE

Non-communicable diseases (NCDs) are the leading causes of death worldwide. Every year 40 million people die from NCDs [1]. The most common causes of these diseases are poorly balanced diet and physical inactivity. A high level of free sugar consumption has been associated with NCDs because of its association with obesity and poor dietary quality.

According to the World Health Organization (WHO), free sugar is sugar that is added to foods and beverages by the manufacturer, cook or consumer that results in excess energy intake which in turn may lead to parallel changes in body weight.

WHO defines free sugar as ‘all sugars that are added during food manufacturing and preparation as well as sugars that are naturally present in honey, syrups, fruit juices, and fruit concentrates.’

Sugar has become widely available and its global consumption has grown from about 130 to 178 million tonnes over the last decade.

Excess free sugar intake, particularly in the form of sugar-sweetened beverages, threatens the nutrient quality of the diet by contributing to the overall energy density but without adding specific nutrients. This can lead to unhealthy weight gain and increases the risk of dental disease, obesity and NCDs. Sugar-sweetened beverages are defined as all types of beverages containing free sugars (include monosaccharides and disaccharide) including soft drinks, fruit/vegetables juices and drinks, liquid and powder concentrates, flavored water, energy and sports drinks, ready-to-drink tea, ready-to-drink coffee and flavored milk drinks.

The World Health Organization recommends reducing sugar intake to a level that comprises 5% of total energy intake (that is around 6 teaspoons per day) and not to exceed 10% of total energy intake [2].

The price elasticity of sugar-sweetened beverages according to a meta-analysis published in USA, is -1.21. This means that for each 10% increase in the price of sugar-sweetened beverages, there is a -12.1% decrease in consumption. Successful examples of price elasticity were seen in Mexico as the consumption of sugar-sweetened beverages decreased after imposing the sugar tax.

Data and experience from across the world demonstrate that a tax on sugar works best as part of a comprehensive set of interventions to address obesity and related chronic diseases. Such interventions include food advertising regulations, food labelling, educational campaigns, and subsidy on healthy foods.

 

RECOMMENDATIONS

The World Medical Association (WMA) and its constituent members should:

  • call upon the national governments to reduce the affordability of free sugar and sugar-sweetened beverages through sugar taxation. The tax revenue collected should be used for health promotion and public health preventive programs aimed at reducing obesity and NCDs in their countries;
  • encourage food manufacturers to clearly label sugar, if present, in their products and urge governments to mandate such labeling;
  • urge governments to strictly regulate the advertising of sugar containing food and beverages targeted especially at children;
  • urge national governments to restrict availability of sugar-sweetened beverages and products that are highly concentrated with free sugar from educational and healthcare institutions and replace with healthier alternatives.

Constituent members of the WMA and their physician members should work with national stakeholders to:

  • advocate for healthy sustainable food with limited free sugar intake that is less than 5% of total energy intake;
  • encourage nutrition education and skills programs toward preparing healthy meals from foods without added sugar;
  • initiate and/or support campaigns focused on healthy diets to reduce sugars intake;
  • advocate for an inter-sectoral, multidisciplinary and comprehensive approach to reducing free sugar intake.

 

References

[1] http://www.who.int/fr/news-room/fact-sheets/detail/noncommunicable-diseases

[2] WHO Guideline: Sugars Intake for Adults and Children 2015

Adopted by the 70th WMA General Assembly, Tbilisi, Georgia, October 2019

 

PREAMBLE

Artificial Intelligence (AI) is the ability of a machine to simulate intelligent behavior, a quality that enables an entity to function appropriately and with foresight in its environment. The term AI covers a range of methods, techniques and systems. Common examples of AI systems include, but are not limited to, natural language processing (NLP), computer vision and machine learning. In health care, as in other sectors, AI solutions may include a combination of these systems and methods.

(Note: A glossary of terms appears as an appendix to this statement.)

In health care, a more appropriate term is “augmented intelligence”, an alternative conceptualization that more accurately reflects the purpose of such systems because they are intended to coexist with human decision-making (1). Therefore, in the remainder of this statement, AI refers to augmented intelligence.

An AI system utilizing machine learning employs an algorithm programmed to learn (“learner algorithm”) from data referred to as “training data.” The learner algorithm will then automatically adjust the machine learning model based on the training data. A “continuous learning system” updates the model without human oversight as new data is presented, whereas “locked learners” will not automatically update the model with new data. In health care, it is important to know whether the learner algorithm is eventually locked or whether the learner algorithm continues to learn once deployed into clinical practice in order to assess the systems for quality, safety, and bias. Being able to trace the source of training data is critical to understanding the risk associated with applying a health care AI system to individuals whose personal characteristics are significantly different than those in the training data set.

Health care AI generally describes methods, tools and solutions whose applications are focused on health care settings and patient care. In addition to clinical applications, there are many other applications of AI systems in health care including business operations, research, health care administration, and population health.

The concepts of AI and machine learning have quickly become attractive to health care organizations, but there is often no clear definition of terminology used. Many see AI as a technological panacea; however, realizing the promise of AI may have its challenges, since it might be hampered by evolving regulatory oversight to ensure safety and clinical efficacy, lack of widely accepted standards, liability issues, need for clear laws and regulations governing data uses, and a lack of shared understanding of terminology and definitions.

Some of the most promising uses for health care AI systems include predictive analytics, precision medicine, diagnostic imaging of diseases, and clinical decision support. Development in these areas is underway, and investments in AI have grown over the past several years [1]. Currently, health care AI systems have started to provide value in the realm of pattern recognition, NLP, and deep learning. Machine learning systems are designed to identify data errors without perpetuating them. However, health care AI systems do not replace the need for the patient-physician relationship. Such systems augment physician-provided medical care and do not replace it.

Health care AI systems must be, transparent, reproducible, and be trusted by both health care providers and patients. Systems must focus on users’ needs. Usability should be tested by participants who reflect similar needs and practice patterns of the end user, and systems must work effectively with people. Physicians will be more likely to accept AI systems that can be integrated into or improve their existing practice patterns, and also improve patient care.

Opportunities

Health care AI can offer a transformative set of tools to physicians and patients and has the potential to make health care safer and more efficient. By automating hospital and office processes, physician productivity would improve. The use of data mining to produce accurate useful data at the right time may improve electronic health records. and access to relevant patient information. Results of data mining may also provide evidence for trends that may serve to inform resource allocation and utilization decisions. New insights into diagnosis and best practices for treatment may be produced because of analyzing all known data about a patient. The potential also exists to improve the patient experience, patient safety, and treatment adherence.

Applications of health care AI to medical education include continuing medical education, training simulations, learning assistance, coaching for medical students and residents, and may provide objective assessment tools to evaluate competencies. These applications would help customize the medical education experience and facilitate independent individual or group learning.

There are a number of stakeholders and policy makers involved in shaping the evolution of AI in health care besides physicians. These include medical associations, businesses, governments, and those in the technology industry. Physicians have an unprecedented opportunity to positively inform and influence the discussions and debates currently taking place around AI. Physicians should proactively engage in these conversations in order to ensure that their perspectives are heard and incorporated into this rapidly developing technology.

Challenges

Developers and regulators of health care AI systems must ensure proper disclosure and note the benefits, limitations, and scope of appropriate use of such systems.  In turn, physicians will need to understand AI methods and systems in order to rely upon clinical recommendations. Instruction in the opportunities and limitations of health care AI systems must take place both with medical students and practicing physicians, as physician involvement is critical to successful evolution of the field. AI systems must always adhere to professional values and ethics of the medical profession.

Protecting confidentiality, control and ownership of patient data is a central tenet of the patient-physician relationship. Anonymization of data does not provide enough protection to a patient’s information when machine-learning algorithms can identify an individual from among large complex data sets when provided with as few as three data points, which could put patient data privacy at risk. Current expectations patients have for confidentiality of their personal information must be addressed, and new models that include consent and data stewardship developed.  Viable technical solutions to mitigate these risks are being explored and will be critical to widespread adoption of health care AI systems.

Data structure, and integrity are major challenges that need to be addressed when designing health care AI systems. The data sets on which machine learning systems are trained are created by humans and may reflect bias and contain errors. Because of this, these data sets will normalize errors and the biases inherent in their data sets. Minorities may be disadvantaged because there is less data available about minority populations. Another design consideration is how a model will be evaluated for accuracy and involves very careful analysis of the training data set and its relationship to the data set used to evaluate the algorithms.

Liability concerns present significant challenges to adoption. As existing and new oversight models develop health care AI systems, the developers of such systems will typically have the most knowledge of risks and be best positioned to mitigate the risk. As a result, developers of health care AI systems and those who mandate use of such systems must be accountable and liable for adverse events resulting from malfunction(s) or inaccuracy in output. Physicians are often frustrated with the usability of electronic health records. Systems designed to support team-based care and other workflow patterns but often fall short. In addition to human factors in the design and development of health care AI systems, significant consideration must be given to appropriate system deployment. Not every system can be deployed to every setting due to data source variations.

Work is already underway to advance governance and oversight of health care AI, including standards for medical care, intellectual property rights, certification procedures or government regulation, and ethical and legal considerations.

 

RECOMMENDATIONS

That the WMA:

  • Recognize the potential for improving patient outcomes and physicians’ professional satisfaction through the use of health care AI, provided they conform to the principles of medical ethics, confidentiality of patient data, and non-discrimination.
  • Support the process of setting priorities for health care AI.
  • Encourage the review of medical curricula and educational opportunities for patients, physicians, medical students, health administrators and other health care professionals to promote greater understanding of the many aspects, both positive and negative, of health care AI.

The WMA urges its member organizations to:

  • Find opportunities to bring the practicing physician’s perspective to the development, design, validation and implementation of health care AI.
  • Advocate for direct physician involvement in the development and management of health care AI and appropriate government and professional oversight for safe, effective, equitable, ethical, and accessible AI products and services.
  • Advocate that all healthcare AI systems be transparent, reproducible, and be trusted by both health care providers and patients.
  • Advocate for the primacy of the patient-physician relationship when developing and implementing health care AI systems. 

 

(1) For purposes of this statement, the term “health care AI” will be used to refer to systems that augment, not replace, the work of clinicians.

 

APPENDIX: GLOSSARY OF TERMS USED IN HEALTH CARE AUGMENTED INTELLIGENCE

Algorithm is a set of detailed, ordered instructions that are followed by a computer to solve a mathematical problem or to complete a computer process.

Artificial intelligence consists of a host of computational methods used to produce systems that perform tasks which exhibit intelligent behavior that is indistinguishable from human behavior.

Augmented intelligence (AI) is a conceptualization of artificial intelligence that focuses on artificial intelligence’s assistive role, emphasizing that its design enhances human intelligence rather than replaces it.

Computer vision is an interdisciplinary scientific field that deals with how computers can be made to gain high-level understanding from digital images or videos and seeks to automate tasks that the human visual system can do.

Data mining is an interdisciplinary subfield of computer science and statistics whose overall goal is to extract information (with intelligent methods) from a data set and transform the information into a comprehensible structure for further use.

Machine learning (ML) is the scientific study of algorithms and statistical models that computer systems use to effectively perform specific tasks with minimal human interaction and without using explicit instructions, by learning from data and identification of patterns.

Natural language processing (NLP) is a subfield of computer science, information engineering, and artificial intelligence concerned with the interactions between computers and human (natural) languages, in particular how to program computers to process and analyze large amounts of natural language data.

Training data is used to train an algorithm; it generally consists of a certain percentage of an overall dataset along with a testing set. As a rule, the better the training data, the better the algorithm performs. Once an algorithm is trained on a training set, it’s usually evaluated on a test set. The training set should be labelled or enriched to increase an algorithm’s confidence and accuracy.

 

Reference

[1] CB Insights. The Race for AI: Google, Baidu, Intel, Apple in a Rush to Grab Artificial Intelligence Startups. https://www.cbinsights.com/research/top-acquirers-ai-startups-ma-timeline/.

Adopted by the 70th WMA General Assembly, Tbilisi, Georgia, October 2019

 

PREAMBLE

Population displacement resulting from war, violence or persecution has wide-ranging implications for the entire global community. Refugees – that is, individuals who have been forced to flee their respective countries of origin for these reasons – generally must undergo rigorous procedures for determining their legal status according to the national legislation of the country in which they are seeking asylum.

An increasing number of refugees fall under the category of unaccompanied minors, which are defined as people under the age of 18 who have been separated from or who have fled their countries of origin without their families. In light of their unique vulnerability, unaccompanied minor refugees are eligible for special protections, as outlined in the United Nations’ Convention on the Rights of the Child, which states that the best interests of the child must be the primary consideration in all stages of the displacement cycle.

Given the differences in how adults and unaccompanied minors are processed and protected when seeking asylum, recipient countries have an interest in verifying the age of applicants outside the context of criminal proceedings. However, some asylum seekers either do not have access to documentation confirming their age or originate from countries in which there is no central birth registry. In cases where there is doubt as to whether an asylum seeker is a child or an adult, e.g. if the authenticity of available documentation is called into question or if there is reason to believe the applicant’s physical appearance suggests a discrepancy between the reported age and the actual age, the competent authorities may resort to medical and/or non-medical methods for assessing the applicant’s age.

Medical age assessments carried out by medical professionals may take the form of X-ray scans of the jaw, hand or wrist; CT scans of the collarbone; MRI scans of the knee; or the examination of secondary sex characteristics to determine the applicant’s stage of puberty. However, ethical concerns have been raised about these and other forms of examination, as they can potentially endanger the health of those being examined and violate the privacy and dignity of young people who may already be severely traumatized [1]. Furthermore, there is conflicting evidence about the accuracy and reliability of the available methods of medical age assessment, which may generate significant margins of error [2]. For example, some available studies do not appear to take into account potential delays in skeletal maturation caused by malnutrition, which is just one factor that could translate into a risk of age misclassification among asylum seekers [3]. Comparative assessments are further impeded by a lack of standard images from certain world regions and limited representation in age assessment reference data, much of which was compiled on the basis of European and North American populations [4]. An imprecise assessment of an individual’s age can have far-reaching administrative, ethical, psychological and other significant consequences, including potential breaches of children’s rights.

The following recommendations apply explicitly and exclusively to cases outside the context of the criminal justice system.

 

RECOMMENDATIONS

  1. The WMA recognizes that there is sometimes a need to assess the age of asylum seekers to ensure that all unaccompanied minors receive the protections afforded them under international and national law. 
  2. The WMA recommends that medical age assessments only be carried out in exceptional cases and only after all non-medical methods have been exhausted. The WMA recognizes that non-medical methods, e.g. questioning children about traumatic events, may also have a negative impact and must therefore be carried out with great care. Each case must be evaluated carefully based on the totality of circumstances and the preponderance of available evidence.
  3. The WMA asserts that, in cases where medical age assessment is unavoidable, the health and safety and dignity of the young asylum seeker must be the highest priority. Physical examinations must be carried out by a qualified physician with appropriate pediatric examination experience in accordance with the highest medical and ethical standards, in observance of the principles of proportionality, in adherence to the standards of prior informed consent and with consideration of cultural and religious sensitivities and potential language barriers. The asylum seeker must always be made aware that the examination is carried out as part of the age assessment procedure and not to provide healthcare.
  4. The WMA underscores that any medical methods that could involve a health risk for the applicant, e.g. radiological examinations without medical indication, or that infringe upon the dignity or privacy of an already potentially traumatized asylum seeker, e.g. genital examinations, must be avoided.
  5. The WMA stresses that medical certificates indicating the results of medical age assessment examinations should include information concerning the accuracy and reliability of the methods used and the relevant margins of error.
  6. The WMA urges constituent members to develop or promote the development of internationally accepted interdisciplinary guidelines which outline the scientific basis, as well as ethical and legal or regulatory principles of medical age assessment of asylum seekers, including the potential health risks and psychological impact of specific procedures.
  7. The WMA emphasizes that, in cases where doubts regarding the age of an asylum seeker cannot be resolved or confirmed with absolute certainty, any remaining uncertainty should be interpreted in favor of the asylum seeker.

 

References:

[1] Zentrale Ethikkommission der Bundesärztekammer (2016): Stellungnahme “Medizinische Altersschätzung bei unbegleiteten jungen Flüchtlingen. Deutsches Ärzteblatt 2016; A1-A6. / German Medical Association’s Central Ethics Committee: Statement on Medical Age Assessment of Unaccompanied Minor Refugees.

[2] Separated Children in Europe Programme (2012): Position Paper on Age Assessment in the Context of Separated Children in Europe. Online http://www.separated-children-europe-programme.org/separated_children/good_practice/index.html. Last accessed 03.07.2018.

[3] Sauer PJJ, Nicholson A, Neubauer D, On behalf of the Advocacy and Ethics Group of the European Academy of Paediatrics (2016): Age determination in asylum seekers: physicians should not be implicated. European Journal of Pediatrics 175, (3): 299-303.

[4] Aynsley-Green et al. (2012): Medical, statistical, ethical and human rights considerations in the assessment of age in children and young people subject to immigration control. British Medical Bulletin 2012; 102: 39.

Adopted by the 69th WMA General Assembly, Reykjavik, Iceland, October 2018

PREAMBLE

1.     The WMA notes the increasing trend around the world for women to enter medical schools and the medical profession, and believes that the study and the practice of medicine must be transformed to a greater or lesser extent in order to support all people who study to become or practice as physicians, of whatever gender. This is an essential process of modernization by which inclusiveness is promoted by gender equality. This statement proposes mechanisms to identify and address barriers causing discrimination between genders.

2.     In many countries around the world, the number of women studying and practicing medicine has steadily risen over the past decades, surpassing 50% in many places.

3.     This development offers opportunities for action, including in the following areas:

  • Greater emphasis on a proper balance of work and family life, while supporting the professional development of individual physicians.
  • Encouragement and actualization of women in academia, leadership and managerial roles.
  • Equalization of pay and employment opportunities for men and women, the elimination of gender pay gaps in medicine, and the removal of barriers negatively affecting the advancement of female physicians.

4.     The issue of women in medicine was previously recognized in the WMA Resolution on Access of Women and Children to Health Care and the Role of Women in the Medical Profession which, among other things, called for increased representation and participation in the medical profession, especially in light of the growing enrolment of women in medical schools. It also called for a higher growth rate of membership of women in National Medical Associations (NMAs)  through empowerment, career development, training and other strategic initiatives.

RECOMMENDATIONS

Increased presence of women in academia, leadership and management roles.

5.     National Medical Associations/Medical Schools/Employers are urged to facilitate the establishment of mentoring programs, sponsorship, and active recruitment to provide medical students and physicians with the necessary guidance and encouragement necessary to undertake leadership and management roles.

6.     NMAs should explore opportunities and incentives to encourage both men and women to pursue diverse careers in medicine and apply for fellowships, academic, senior leadership and management positions.

7.     NMAs should lobby for gender equal medical education and work policies.

8.     NMAs should encourage the engagement of both men and women in health policy organizations and professional medical organizations.

Work-Life Balance

9.     Physicians should recognize that an appropriate work-life balance is beneficial to all physicians, but that women may face unique challenges to work-life balance imposed by societal expectations concerning gender roles that must be addressed to solve the issue. Healthcare employers can show leadership and help tackle this imbalance by:

  • Ensuring women who go on maternity leave are able to access all their rights and entitlements;
  • Introducing programmes which encourage men as well as women to take parental leave, so that women are able to pursue their careers and men are able to spend important time with their families.

10.  Hospitals and other places of employment should strive to provide and promote access to high quality, affordable, flexible childcare for working parents, including the provision of onsite housing and childcare where appropriate. These services should be available to both male and female physicians, recognizing the need for a better work-life balance. Employers should provide information on available services which support the compatibility of work and family.

11.  Hospitals and other places of employment should be receptive to the possibility of flexible and family-friendly working hours, including part-time residencies, posts, and professional appointments.

12.  There is a need for increased research on alternative work schedules and telecommunication opportunities that will allow flexibility in balancing work-life demands.

13.  NMAs should advocate for the enforcement and, where necessary, the introduction of policy mandating appropriate paid parental leave and rights in their respective countries.

14.  Medical workplaces and professional organisations should have fair, impartial and transparent policies and practices to give all physicians and medical students equal access to employment, education and training opportunities in medicine.

Pregnancy and Parenthood

15.  It should be illegal for employers to ask applicants about pregnancy and/or family planning in relation to work.

16.  Employers should assess the risks to pregnant physicians and their unborn children, when a physician has recently given birth and when she is breastfeeding.  Where it is found, or a medical practitioner considers, that an employee or her child would be at risk were she to continue with her normal duties, the employer should provide suitable alternative work for which the physician should receive her normal rate of pay. Physician should have the right to not work night shifts or on-call shifts during the later part of pregnancy, without negative consequences on salary, employment or progression in residency.

17.  Pregnant physicians should have equal training opportunities in post-graduate training.

18.  Parents should have the right to take adequate parental leave without negative consequences on their employment, training or career opportunities.

19.  Parents should have the right to return to the same position after parental leave, without the fear of termination.

20.  Employers and training bodies should provide necessary support to any physician returning after a prolonged period of absence including parental, maternity and elder-care leave.

21.  Mothers should be able to breastfeed (or be given protected time for breast pumping) during work hours, within the current guidelines from the WHO.

22.  Workplaces should provide adequate accommodation for women who are breastfeeding including designated areas for breastfeeding, breast pumping, and milk storage, which are quiet, hygienic, and private.

Changes in organisational culture

23.  The medical profession and employers should work to eliminate discrimination and harassment on the basis of gender and create a supportive environment that allows equal opportunities for training, employment and advancement.

24.  Family friendliness should be part of the organizational culture of hospitals and other places of employment.

Workforce planning and research

25.  NMAs should encourage governments to take the increasing number of women entering medicine into consideration in the context of long-term workforce planning. A diverse workforce is beneficial to the health care system and to patients. Organizations delivering healthcare should focus on ensuring systems are appropriately resourced to ensure that all those working within them are able to deliver safe care to patients and are appropriately and equitably rewarded. Governments should also work to counteract negative attitudes and behaviour, bias, and/or outdated norms and values from organizations and individuals.

26.  NMAs should encourage governments to invest in research to identify those factors that drive women and men to choose certain fields of specialization early on in their medical education and training and strive to address any identified barriers in order to achieve equal representation of men and women in all fields of medicine.

27.  NMAs should encourage governments and employers to ensure that men and women receive equal compensation for commensurate work and strive to eliminate the gender pay gap in medicine.

Adopted by the 69th WMA General Assembly, Reykjavik, Iceland, October 2018

PREAMBLE

  1. The expiry of patents for original biotherapeutics has led to the development and approval of copies, called ‘similar biological medicinal products’ or ‘biosimilars’ that are highly similar to a previously approved biological product, known as the originator or reference product.
  2. In light of the fact that biosimilars are made in living organisms, there may be some minor differences from the reference medicine, as minor variability is a characteristic attribute of all biological medicines. The manufacture of biosimilars is generally more complex than the manufacture of chemically derived molecules. Therefore, the active substance in the final biosimilar can have an inherent degree of minor variability. Innovator biologics also have inherent batch-to-batch variability, and for that reason biosimilars are not always interchangeable with the reference products, even after regulatory approval.
  3. Biosimilars are not the same as generics. A generic drug is an identical copy of a currently licenced pharmaceutical product that has an expired patent protection and must contain the ‘same active ingredients as the original formulation’. A biosimilar is a different product with a similar, but not identical, structure that elicits a similar clinical response. As a result, biosimilar medicines have the potential to cause an unwanted immune response. Whereas generics are interchangeable, biosimilars are not always interchangeable.
  4. Biosimilars have been available in Europe for almost a decade following their approval by the European Medicines Agency (EMA) in 2005. The first biosimilar was approved by the Food and Drug Administration (FDA) for use in the United States in 2015.
  5. Biosimilar medicines have transformed the outlook for patients with chronic and debilitating conditions, as it is possible to obtain similar efficacy as that of the reference product at a lower cost.
  6. Biosimilars will also increase availability for patients without access to the bio-originator. Greater global access to effective biopharmaceuticals can reduce disability, morbidity, and mortality associated with various chronic diseases.
  7. Nonetheless, the potentially lower cost of biosimilars raises the risk that insurers and health care providers  may favor them over the originator product, even when they may not be appropriate for an individual patient or in situations when they have not demonstrated adequate clinical equivalence to an original biological product. The decision to prescribe biosimilars or to switch patients from reference medicine to a biosimilar must be made by the attending physicians, not by health insurance companies. 

RECOMMENDATIONS

  1. National medical associations should work with their governments to develop national guidance on safety of biosimilars.
  2. National medical associations should advocate for delivering biosimilar therapies that are as safe and effective as their reference products.
  3. National medical associations should strive to ensure that physician autonomy is preserved in directing which biologic product is dispensed.
  4. Where appropriate, national medical associations should lobby against allowing insurers and health funds to require biosimilar and originator product’s interchangeability, and for safe regulations of interchanging biosimilar medicines where this is allowed.
  5. Physicians must ensure that patient medical records accurately reflect the biosimilar medicine that is being prescribed and taken.
  6. Physicians shouldn’t prescribe a biosimilar to patients already showing success with the originator product, unless clinical equivalence has been clearly demonstrated and established and patients are adequately informed and have given consent. There should be no substitution between biosimilars and other drugs without the attending physcian’s permission.
  7. Physicians should seek to improve their understanding of the distinctions between biosimilar products that are highly similar to or are interchangeable with an originator product; raise awareness of the issues surrounding biosimilars and interchangeability; and promote clearly delineated labelling of biosimilar products.
  8. Physicians should remain vigilant and report to the manufacturer, as well as through the designated regulatory pathways, any adverse events suffered by patients using originator biological products or biosimilars.

Adopted by the 69th WMA General Assembly, Reykjavik, Iceland, October 2018

PREAMBLE

The WMA believes that both a continuum of care and family empowerment is necessary to improve the health and wellbeing of the mother and child. The reduction of maternal mortality ratio and infant deaths was an important objective of the Millennium Development Goals (MDGs). The reductions of the maternal mortality ratio, neonatal mortality rate and the under-five mortality rate are important targets to be achieved under the Sustainable Development Goals (SDGs).

The maternal and child health (MCH) handbook is a comprehensive home-based booklet designed to provide relevant health information and include integrated mother and child health records. The MCH handbook covers health records and information on pregnancy, delivery, neonatal and childhood periods, and child growth and immunizations. The MCH handbook supports the integration of maternal, neonatal and child health services. The MCH handbook is not only about health education, but about creating ownership with women and families.

In 1948, Japan became the first country in the world to create and distribute a maternal and child health (MCH) handbook, in order to protect and improve the health and wellbeing of the mother and child.

There are now approximately 40-country versions of the MCH handbook, all adapted to the local culture and socio-economic context. There are a variety of handbooks and educational materials concerned to MCH in many countries. The use of MCH handbooks has helped improve the knowledge of mothers on maternal and child health issues, and has contributed to changing behaviors during pregnancy, delivery and post-delivery period.

The MCH handbook can promote the health of pregnant women, neonates and children by using it as a tool for strengthening a continuum of care. Physicians can make better care decisions, by referring to the patient’s medical history and health-check data recorded in the MCH handbook. The MCH handbook alone has not been shown to improve health indicators. The benefits are maximized when women and children have access to relevant healthcare services based on information recorded in the handbook. Such benefits of the handbook could be shared globally.

In Japan, a digital handbook is spreading progressively. The digital handbook is expected to be utilized in a way that protects confidentiality of the patient’s health information. Some private kindergarten and primary schools request access to the MCH as part of their admission process, placing pressure on parents and physicians to modify the answers to questions in the handbook.

RECOMMENDATIONS

  1. The WMA recommends that the constituent member associations encourage their health authorities and health institutions to provide accessible and easy to understand information regarding maternal and child health. The MCH handbook, or equivalents, can be an important tool to improve continuity of care and benefit health promotion for mothers, neonates and children.
  2. The WMA recommends that the constituent member associations and medical professionals promote the adaptation to local setting and the utilization of MCH handbooks, or equivalents, in order to leave no one behind with respect to SDGs, especially for non-literate people, migrant families, refugees, minorities, people in underserved and remote areas.
  3. When using a MCH handbook or similar documentation, in either digital or print form, the confidentiality of the individual health information and the privacy of mothers and children should be strictly protected. It should be used exclusively to improve health and wellbeing of mothers, neonates, and children. It should not be used in the admission procedures of schools.
  4. The constituent member associations should promote local research to evaluate the utilization of the MCH handbooks, or equivalents, and make recommendations to improve the quality of care in the local setting.

Adopted by the 49th WMA General Assembly, Hamburg, Germany, November 1997
and reaffirmed by the WMA Council Session, Berlin, Germany, May 2007
and amended by t
he 69th WMA General Assembly, Reykjavik, Iceland, October 2018

 

SCOPE AND DEFINITIONS

The scope of this Statement includes the following specified crimes: genocide, war crimes, and crimes against humanity, as defined by the Rome Statute of the International Criminal Court.

PREAMBLE

  • Physicians are bound by medical ethics to dedicate themselves to the good of their patients. Physicians who have been convicted of genocide, war crimes or crimes against humanity1, have violated medical ethics, human rights and international law and are therefore unworthy of practising medicine.
  • In accordance with the principle of the presumption of innocence, only physicians who have been convicted of the specified crimes should be declared unworthy of practising medicine.

DISCUSSION

  1. Physicians seeking to work in any country are subject to the regulations of that country’s relevant authorities or jurisdiction. The duty to demonstrate suitability to practice medicine rests with the person seeking licensure.
  2. Physicians who have been convicted of genocide, war crimes or crimes against humanity must not be allowed to practise in another country or jurisdiction.
  3. The relevant licensing authorities must ensure both that physicians have the required qualifications and that they have not been convicted of genocide, war crimes or crimes against humanity.
  4. Physicians who have been convicted of the specified crimes have sometimes been able to leave the country in which these crimes were committed and obtain a licence to practise medicine from the relevant licensing authority in another country.
  5. This practice is contrary to the public interest, damaging to the reputation of the medical profession, and may be detrimental to patient safety.

RECOMMENDATIONS

  1. The WMA recommends that physicians who have been convicted of the specified crimes be denied a license to practice medicine and membership to national medical associations by the relevant regulatory and licensing authority of that jurisdiction.
  2. The WMA recommends that relevant regulatory and licensing authorities use their own authority to inform themselves, in so far as is possible, if verifiable allegations of participation in genocide, war crimes or crimes against humanity have been made against physicians, while at the same time respecting the presumption of innocence.
  3. National Medical Associations must be sure that a thorough investigation into those allegations is performed by an appropriate authority.
  4. The WMA recommends that national medical associations ensure that there is efficient communication amongst themselves and that where possible and appropriate they inform relevant national regulatory and licensing authorities of physicians’ convictions of genocide, war crimes, or crimes against humanity.

1 As defined by the Rome Statute of the International Criminal Court

Adopted by the 24th World Medical Assembly, Oslo, Norway, August 1970
and revised by the 35th World Medical Assembly, Venice, Italy, October 1983,
the 57th WMA General Assembly, Pilanesberg, South Africa, October 2006,
and
the 69th WMA General Assembly, Reykjavik, Iceland, October 2018

 

Preamble

  1. Medically-indicated termination of pregnancy refers only to interruption of pregnancy due to health reasons, in accordance with principles of evidence-based medicine and good clinical practice. This Declaration does not include or imply any views on termination of pregnancy carried out for any reason other than medical indication.
  2. Termination of pregnancy is a medical matter between the patient and the physician. Attitudes toward termination of pregnancy are a matter of individual conviction and conscience that should be respected.
  3. A circumstance where the patient may be harmed by carrying the pregnancy to term presents a conflict between the life of the foetus and the health of the pregnant woman. Diverse responses to resolve this dilemma reflect the diverse cultural, legal, traditional, and regional standards of medical care throughout the world.

Recommendations

  1. Physicians should be aware of local termination of pregnancy laws, regulations and reporting requirements. National laws, norms, standards, and clinical practice related to termination of pregnancy should promote and protect women’s health, dignity and their human rights, voluntary informed consent, and autonomy in decision-making, confidentiality and privacy. National medical associations should advocate that national health policy upholds these principles.
  2. Where the law allows medically-indicated termination of pregnancy to be performed, the procedure should be performed by a competent physician and only in extreme cases by another qualified health care worker, in accordance with evidence-based medicine principles and good medical practice in an approved facility that meets required medical standards.
  3. The convictions of both the physician and the patient should be respected.
  4. Patients must be supported appropriately and provided with necessary medical and psychological treatment along with appropriate counselling if desired.
  5. Physicians have a right to conscientious objection to performing an abortion; therefore, they may withdraw while ensuring the continuity of medical care by a qualified colleague. In all cases, physician must perform those procedures necessary to save the woman’s life and to prevent serious injury to her health.
  6. Physicians must work with relevant institutions and authorities to ensure that no woman is harmed because medically-indicated termination of pregnancy services are unavailable.

 

Adopted by the 69th WMA General Assembly, Reykjavik, Iceland, October 2018

Preamble

1. The WMA believes that health and well-being are dependent upon social determinants of health (SDHs), the conditions in which people are born, grow, live, work and age. These social determinants will directly influence the achievement of the United Nations Sustainable Development Goals (SDGs).  Many of the SDG goals, targets and indicators that have been developed to measure progress towards them, will also be useful measures of the impact of action is having on improving the SDH and, in particular, on reducing health inequities.

2. This statement builds upon WMA policy on Social Determinants of Health as set out in the Declaration of Oslo, and upon the basic principles of medical ethics set out in the Declaration of Geneva.

3. The WMA recognizes the important efforts undertaken by the United Nations with the adoption on 25 September 2015 of the resolution “Transforming our world: the 2030 Agenda for Sustainable Development”. The Sustainable Development Agenda is based upon five key themes: people, planet, prosperity, peace and partnership and the principle of leaving no one behind. The WMA affirms the importance of global efforts on sustainable development and the impact that they can bring to humanity.

4. SDGs are built on the lessons learned from successes and failures in achieving the Millennium Development Goals (MDGs), including inequity in many areas of life. While there is no overarching concept unifying the SDGs, the WMA believes that inequity in health and wellbeing encapsulates much of the 2030 Agenda. The WMA notes that while only SDG 3 is overtly about health, many of the goals have major health components.

5. The WMA recognizes all governments must commit and invest to fully implement the goals by 2030, in alignment with the Addis Ababa Action Agenda. The WMA also recognizes the risk that the SDGs might be considered unaffordable due to their estimated potential cost of between US$ 3.3 and US$ 4.5 trillion a year.

6. The WMA emphasises the need for cross and inter-sectoral work to achieve the goals and believes that health must be addressed in all SDGs and not only under health specific SDG 3.

Policy priorities:

7. Recognition of Health in All Policies and the Social Determinants of Health / Whole of Society approach.

8. Policy areas that are essential to achieving the SDG 3:

  • Patient Empowerment and Patient Safety
  • Continuous Quality Improvement in Health Care
  • Overcoming the Impact of Aging on Health Care
  • Addressing Antimicrobial Resistance
  • The safety and welfare of Health care staff

9. Ensuring policy alignment among all the UN Agencies and the work of regional governmental organizations such as EU, African Union, Arab League, ASEAN, and Organization of American States.

10. The WMA commits to support implementation of the other three global agreements regarding the sustainable development process:

  • The Addis Ababa Action Agenda as the mechanism that will provide the financial support for the 2030 Agenda.
  • The Paris Agreement is the binding mechanism of the sustainable development process that sets out a global action plan to put the world on track to avoid dangerous climate change by limiting global warming to well below 2°C above pre-industrial levels.
  • The Sendai Framework for Disaster Risk Reduction as the agreement which recognizes that the State has the primary role to reduce disaster risk but that responsibility should be shared with local government, the private sector and other stakeholders.

Recommendations and Commitments

11. The WMA commits to work with other intergovernmental organizations, including the UN, the WHO, healthcare professionals’ organizations and other stakeholders, for the implementation and follow-up of this Agenda and related international agreements, and for policy and advocacy alignment.

12. The WMA commits to collaborate with its constituent member Associations to support their work at regional and national levels, and with their governments on the 2030 Agenda implementation.

13. The WMA recommends that NMAs create strategies regarding data collection, implementation, capacity building and advocacy, to enhance policy coherence and to maximise the 2030 Agenda implementation at national and global levels.

14. The WMA also recommends that NMAs collaborate with development banks, NGOs, intergovernmental organisations and other stakeholders who are also working to implement of the 2030 Agenda, especially in their own countries.

15. The WMA encourages the UN and the WHO to develop guidelines on how financing for health will be implemented to reach the targets established by the 2030 Agenda and the economic implications of NCDs, aging and antimicrobial resistance.

Adopted by the 69th WMA General Assembly, Reykjavik, Iceland, October 2018

PREAMBLE

  1. Medical tourism is an expanding phenomenon, although to date it has no agreed upon definition and, as a result, practices and protocols in different countries can vary substantially. For purposes of this statement, medical tourism is defined as a situation where patients travel voluntarily across international borders to receive medical treatment, most often at their own cost. Treatments span a range of medical services, and commonly include: dental care, cosmetic surgery, elective surgery, and fertility treatment (OECD, 2011).
  2. This statement does not cover cases where a national health care system or treating hospital sends a patient abroad to receive treatment at its own cost or where, as in the European Union, patients are allowed to seek care in another EU Member State according to legally defined criteria, and their home health system bears the costs. Also not covered is a situation in which people are in a foreign country when they become ill and need medical care.
  3. If not regulated appropriately, medical tourism may have medico-legal and ethical ramifications and negative implications, including but not limited to: internal brain drain, establishment of a two-tiered health system, and the spread of antimicrobial resistance. Therefore, it is imperative that there are clear rules and regulation to govern this growing phenomenon.
  4. Medical tourism is an emerging global industry, with health service providers in many countries competing for foreign patients, whose treatment represents a significant potential source of income. The awareness of health as a potential economic benefit and the willingness to invest in it rise with the economic welfare of countries, and billions of dollars are invested each year in medical tourism all over the world. The key stakeholders within this industry include patients, brokers, governments, health care providers, insurance providers, and travel agencies.  The proliferation of medical tourism websites and related content raise concerns about unregulated and inaccurate on-line health information.
  5. A medical tourist is in a more fragile and vulnerable situation than that of a patient in his or her home country. Therefore, extra sensitivity on the part of caretakers is needed at every stage of treatment and throughout the patient’s care, including linguistic and cultural accommodation wherever possible.  When medical treatment is sought abroad, the normal continuum of care may be interrupted and additional precautions should therefore be taken.
  6. Medical tourism bears many ethical implications that should be considered by all stakeholders. Medical tourists receive care in both state-funded and private medical institutions and regulations must be in place in both scenarios. These recommendations are addressed primarily to physicians. The WMA encourages others who are involved in medical tourism to adopt these principles.

RECOMMENDATIONS

General

  1. The WMA emphasises the importance of developing health care systems in each country in order to prevent excessive medical tourism resulting from limited treatment options in a patient´s home country. Financial incentives to travel outside a patient’s home country for medical care should not inappropriately limit diagnostic and therapeutic alternatives in the patient’s home country, or restrict treatment or referral options.
  2. The WMA calls on governments to carefully consider all the implications of medical tourism to the healthcare system of a country by developing comprehensive, coordinated national protocols and legislation for medical tourism in consultation and cooperation with all relevant stakeholders. These protocols should assess the possibilities of each country to receive medical tourists, to agree on necessary procedures, and to prevent negative impacts to the country´s health care system.
  3. The WMA calls on governments and service providers to ensure that medical tourism does not negatively affect the proper use of limited health care resources or the availability of appropriate care for local residents in hosting countries. Special attention should be paid to treatments with long waiting times or involving scarce medical resources. Medical tourism must not promote unethical or illegal practices, such as organ trafficking. Authorities, including government, should be able to stop elective medical tourism where it is endangering the ability to treat the local population.
  4. The acceptance of medical tourists should never be allowed to distort the normal assessment of clinical need and, where appropriate, the development of waiting lists, or priority lists for treatment. Once accepted to treatment by a health care provider, medical tourists should be treated in accordance with the urgency of their medical condition. Whenever possible patients should be referred to institutions that have been approved by national authorities or accredited by appropriately recognised accreditation bodies.

Prior to travel

  1. Patients should be made aware that treatment practices and health care laws may be different than in their home country and that treatment is provided according to the laws and practices of the host country. Patients should be informed by the physician/service provider of their rights and legal recourse prior to travelling outside their home country for medical care, including information regarding legal recourse in case of patient injury and possible compensation mechanisms.
  2. The physician in the host country should establish a treatment plan, including a cost estimate and payment plan, prior to the medical tourist’s travel to the host country. In addition, the physician and the medical tourism company (if any) should collaborate in order to ensure that all arrangements are made in accordance with the patient´s medical needs. Patients should be provided with information about the potential risks of combining surgical procedures with long flights and vacation activities.
  3. Medical tourists should be informed that privacy laws are not the same in all countries and, in the context of the supplementary services they receive, it is possible that their medical information will be exposed to individuals who are not medical professionals (such as interpreters). If a medical tourist nonetheless decides to avail him or herself of these services, he or she should be provided with documentation specifying the services provided by non-medical practitioners (including interpreters) and an explanation as to who will have access to his or her medical information, and the medical tourist should be asked to consent to the necessary disclosure.
  4. All stakeholders (clinical and administrative) involved in the care of medical tourists must be made aware of their ethical obligations to protect confidentiality. Interpreters, and other administrative staff with access to health information of the medical tourist should sign confidentiality agreements.
  5. The medical tourist should be informed that a change in his or her clinical condition might result in a change in the cost estimate and in associated travel plans and visa requirements.
  6. If the treatment plan is altered because of a medical need that becomes clear after the initial plan has been established, the medical tourist should be notified of the change and why it was necessary. Consent should be obtained from the patient for any changes to the treatment plan.
  7. When a patient is suffering from an incurable condition, the physician in the host country shall provide the patient with accurate information about his or her medical treatment options, including the limitations of the treatment, the ability of the treatment to alter the course of the disease in an appreciable manner, to increase life expectancy and to improve the quality of life. If, after examining all the data, the physician concludes that it is not possible to improve the patient’s medical condition, the physician should advise the patient of this and discourage the patient from travelling.

Treatment

  1. Physicians are obligated to treat every individual accepted for treatment, both local and foreigner, without discrimination. All the obligations detailed in law and international medical ethical codes apply equally to the physician in his or her encounter with medical tourists.
  2. Medical decisions concerning the medical tourist should be made by physicians, in cooperation with the patient, and not by non-medical personnel.
  3. At the discretion of the treating physicians, and where information is available and of good quality, the patient should not be required to undergo tests previously performed, unless there is a clinical need to repeat tests.
  4. The patient should receive information about his or her treatment in a language he or she understands. This includes the right to receive a summary of the treatment progress and termination by the treating physician and a translation of the documents, as needed.
  5. Agreement should be reached before treatment begins, on the transfer of test results and diagnostic images, back to the home country of the patient.
  6. Where possible, communication between the physicians in the host and home country should be established in order to ensure appropriate aftercare and clinical follow-up of the medical problems for which the patient was treated.
  7. The physician who prepares the treatment plan for the patient should confirm the diagnosis, the prognosis and the treatments that the medical tourist has received.
  8. The patient should receive a copy of his or her medical documents for the purpose of continuity of care and follow-up in his or her home country. Where necessary, the patient should be given a detailed list of medical instructions and recommendations for the period following his or her departure.  This information should include a description of the expected recovery time and the time required before travelling back to his or her home is possible.

Advertising

  1. Advertising for medical tourism services, whether via the internet or in any other manner, should comply with accepted principles of medical ethics and include detailed information regarding the services provided. Information should address the service provider’s areas of specialty, the physicians to whom it refers the benefits of its services, and the risks that may accompany medical tourism.  Access to licensing/accreditation status of physicians and facilities and the facility’s outcomes data should be made readily available.  Advertising material should note that all medical treatment carries risks and specific additional risks may apply in the context of medical tourism.
  2. National Medical Associations should do everything in their power to prevent improper advertising or advertising that is in violation of medical ethical principles, including advertising that contains incorrect or partial information and/or any information that is liable to mislead patients, such as overstatement of potential benefits.
  3. Advertising that notes the positive attributes of a specific medical treatment should also present the risks inherent in such treatment and should not guarantee treatment results or foster unrealistic expectations of benefits or treatment results.

Transparency and the prevention of conflicts of interest

  1. Possible conflicts of interest may be inevitable for physicians treating medical tourists, including at the behest of their employing institution. It is essential that all clinical circumstances and relationships are managed in an open and transparent manner.
  2. A physician shall exercise transparency and shall disclose to the medical tourist any personal, financial, professional or other conflict of interest, whether real or perceived, that may be connected to his or her treatment.
  3. A physician should not accept any benefit, other than remuneration for the treatment, in the context of the medical treatment, and should not offer the medical tourist nor accept from him or her any business or personal offer, as long as the physician-patient relationship exists. Where the physician is treating the medical tourist as another fee paying patient, the same rules should apply as with his/her other fee paying patients.
  4. A physician should ensure that any contract with a medical tourism company or medical tourist does not constitute a conflict of interest with his or her current employment, or with his or her ethical and professional obligations towards other patients.

Transparency in payment and in the physician’s fees

  1. A treatment plan and estimate should include a detailed report of all costs, including a breakdown of physician’s fees, such as: consultancy and surgery and additional fees the patient might incur, such as: hospital costs, surgical assistance, prosthesis (if separate), and costs for post-operative care.
  2. The cost estimate may be changed after the treatment plan has been given only in the event that the clinical condition of the patient has changed, or where circumstances have changed in a way that it was impossible to anticipate or prevent. If the pricing was thus changed, the patient must be informed as to the reason for the change in costs in as timely a fashion as possible.

Adopted by the 57th WMA General Assembly, Pilanesberg, South Africa, October 2006
and amended by the 69th WMA General Assembly, Reykjavik, Iceland, October 2018 

Preamble

Pandemic influenza occurs approximately three or four times every century. It usually occurs when a novel influenza A virus emerges that can easily be transmitted from person-to-person, to which humans have little or no immunity. Infection control and social distancing practices can help slow down the spread of the virus. Vaccine development can be challenging as the pandemic strain may not be accurately predicted. Adequate supplies of antivirals are key for treatment of specific at-risk populations and controlling further spread of the outbreak.

Avian influenza is a zoonotic infection of birds and poultry, and can cause sporadic human infections. Birds act as reservoir and shed the virus in their feces, mucous and saliva. In addition, a new pandemic virus could develop if a human became simultaneously infected with avian and human influenza viruses, resulting in gene swapping and a new virus strain for which there may be no immunity. Humans are infected if they are exposed through the mouth, eyes, or from the inhalation of virus particles. Limited evidence of human to human transmission has been reported as well.

This statement alongside with WMA Statement on Epidemics and Pandemics provides guidance to National Medical Associations and physicians on how they should be involved in their respective country’s pandemic influenza planning and how to respond to Avian Influenza or pandemic influenza.

Recommendations

Avian Influenza

In the event of an avian influenza outbreak, the following measures should be taken:

  • Sources of exposure should be avoided when possible as this is the most effective prevention measure.
  • Personal protective equipment should be used and hand hygiene practices emphasized for personnel handling poultry as well as members of the healthcare team.
  • All infected/exposed birds should be destroyed with proper disposal of carcasses, and rigorous disinfection or quarantine of farms.
  • Stockpiles of vaccines and antivirals should be maintained for use during an outbreak.
  • Antiviral medications such as neuraminidase inhibitors may be used for treatment.

Pandemic Influenza Preparedness

WHO and National Public Health Officials:

  • The coordination of the international response to an influenza pandemic is the responsibility of the World Health Organization (WHO). The WHO currently uses an all-hazards risk based approach, to allow for a coordinated response based on varying degrees of severity of the pandemic.

The WHO should:

  • Offer technical and laboratory assistance to affected countries if needed and continuously monitor activity levels of potential pandemic influenza strains continuously, ensuring that the designation of “Public Health Emergency of International Concern” is done in a timely manner if needed.
  • Monitor and coordinate processes by which governments share biological materials including virus strains, to facilitate the production of and ensure access to vaccines globally.
  • Communicate available information on influenza activity of concern as early as possible to allow for a timely response.

National governments are urged to develop National Action plans to address the following points:

  • Ensure that there is adequate local capacity for diagnosis and surveillance to allow continuous monitoring of influenza activity around the country.
  • Consider the surge capacity of hospitals, laboratories, and public health infrastructure and improve them if necessary.
  • Identify legal and ethical frameworks as well as governance structures in relation to the pandemic planning.
  • Identify the mechanisms and the relevant authorities to initiate and escalate interventions to slow the spread of the virus in the community such as school closures, quarantine, border closures etc.
  • Prepare risk and crisis communication strategies and messages in anticipation of public and media fear and anxiety.
  • Governments are also urged to share biological materials namely virus strains and others, to facilitate the production and ensure access to vaccines globally.
  • Ensure that diagnostics and surveillance efforts are continued and that adequate vaccine and antiviral stockpiles are established.
  • Establish protocols to manage patients in the community, carry out triage in healthcare facilities, provide ventilation management, and handle infectious waste.
  • Allocation of vaccine doses, antivirals and hospital beds should be coordinated with experts.
  • Priority for vaccination should be given to the highest risk groups including those required to maintain essential services, including health care services.
  • Guidance and timely information to regional health departments, health care organizations, and physicians.
  • Preparation for an increase in demand for healthcare services and absences of health care providers especially if clinical severity of the illness is high. In such cases prioritization and coordination of available resources is essential. This may include tapping into private sector capacity where state resources are insufficient.
  • Ensure adequate funding is allocated for pandemic preparedness and response as well as its health and social consequences.
  • Make sure that mechanisms are in place to ensure the safety of healthcare facilities, personnel and the supply chains for vaccines and antivirals
  • Promote and fund research to develop vaccines and effective treatments with lasting effects against influenza.
  • Encourage collaboration between human and veterinary medicine in the prevention, research and control of avian influenza.

National Medical Associations are urged to:

  • Delineate their involvement in the national pandemic influenza preparedness plan, which may include increasing capacity building amongst physicians, participating in guideline development and communication with healthcare professionals.
  • Help educate the public about avian and pandemic influenza.
  • When feasible, coordinate with other healthcare professionals’ organizations as well as other NMAs to identify common issues and congruent policies related to pandemic influenza preparedness and response.
  • Consider implementing support strategies for members involved in the response including mental health services, facilitation of health emergency response teams, and locum relief.
  • Advocate before and during a pandemic, for allocation of adequate resources to meet foreseeable and emerging needs of healthcare, patients and the general public.
  • Encourage health personnel to protect themselves by vaccination.
  • Develop their own organization-specific business contingency plans to ensure continued support of their members.

Physicians:

  • Must be sufficiently knowledgeable about pandemic influenza and transmission risks, including local, national and international epidemiology.
  • Should implement infection control practices and vaccination, to protect themselves as well as other staff members during seasonal and pandemic influenza outbreaks.
  • Must participate in local/regional pandemic influenza preparedness planning and training.
  • Should develop contingency plans to deal with possible disruptions in essential services and personnel shortages.

Adopted by the 58th WMA General Assembly, Copenhagen, Denmark, October 2007
amended by the
 69th WMA General Assembly, Reykjavik, Iceland, October 2018
and rescinded and archived by the 73rd WMA General Assembly, Berlin, Germany, October 2022

DEFINITION

Telemedicine is the practice of medicine over a distance, in which interventions, diagnoses, therapeutic decisions, and subsequent treatment recommendations are based on patient data, documents and other information transmitted through telecommunication systems.

Telemedicine can take place between a physician and a patient or between two or more physicians including other healthcare professionals.

PREAMBLE 

  • The development and implementation of information and communication technology are creating new and different ways for of practicing medicine. Telemedicine is used for patients who cannot see an appropriate physician timeously because of inaccessibility due to distance, physical disability, employment, family commitments (including caring for others), patients’ cost and physician schedules. It has capacity to reach patients with limited access to medical assistance and have potential to improve health care.
  • Face-to-face consultation between physician and patient remains the gold standard of clinical care.
  • The delivery of telemedicine services must be consistent with in-person services and supported by evidence.
  • The principles of medical ethics that are mandatory for the profession must also be respected in the practice of telemedicine.

PRINCIPLES

Physicians must respect the following ethical guidelines when practicing telemedicine:

1. The patient-physician relationship should be based on a personal examination and sufficient knowledge of the patient’s medical history. Telemedicine should be employed primarily in situations in which a physician cannot be physically present within a safe and acceptable time period. It could also be used in management of chronic conditions or follow-up after initial treatment where it has been proven to be safe and effective.

2. The patient-physician relationship must be based on mutual trust and respect. It is therefore essential that the physician and patient be able to identify each other reliably when telemedicine is employed. In case of consultation between two or more professionals within or between different jurisdictions, the primary physician remains responsible for the care and coordination of the patient with the distant medical team.

3. The physician must aim to ensure that patient confidentiality, privacy and data integrity are not compromised. Data obtained during a telemedicine consultation must be secured to prevent unauthorized access and breaches of identifiable patient information through appropriate and up to date security measures in accordance with local legislation. Electronic transmission of information must also be safeguarded against unauthorized access.

4. Proper informed consent requires that all necessary information regarding the distinctive features of telemedicine visit be explained fully to patients including, but not limited to:

  • explaining how telemedicine works,
  • how to schedule appointments,
  • privacy concerns,
  • the possibility of technological failure including confidentiality breaches,
  • protocols for contact during virtual visits,
  • prescribing policies and coordinating care with other health professionals in a clear and understandable manner, without influencing the patient’s choices.

5. Physicians must be aware that certain telemedicine technologies could be unaffordable to patients and hence impede access. Inequitable access to telemedicine can further widen the health outcomes gap between the poor and the rich.

Autonomy and privacy of the Physician

6. A physician should not to participate in telemedicine if it violates the legal or ethical framework of the country.

7. Telemedicine can potentially infringe on the physician privacy due to 24/7 virtual availability. The physician needs to inform patients about availability and recommend services such as emergency when inaccessible.

8. The physician should exercise their professional autonomy in deciding whether a telemedicine versus face-to-face consultation is appropriate.

9. A physician should exercise autonomy and discretion in selecting the telemedicine platform to be used.

Responsibilities of the Physician

10. A physician whose advice is sought through the use of telemedicine should keep a detailed record of the advice he/she delivers as well as the information he/she received and on which the advice was based in order to ensure traceability.

11. If a decision is made to use telemedicine it is necessary to ensure that the users (patients and healthcare professionals) are able to use the necessary telecommunication system.

12. The physician must seek to ensure that the patient has understood the advice and treatment suggestions given and take steps in so far as possible to promote continuity of care.

13. The physician asking for another physician’s advice or second opinion remains responsible for treatment and other decisions and recommendations given to the patient.

14. The physician should be aware of and respect the special difficulties and uncertainties that may arise when he/she is in contact with the patient through means of tele-communication. A physician must be prepared to recommend direct patient-doctor contact when he/she believes it is in the patient’s best interests.

15. Physicians should only practise telemedicine in countries/jurisdictions where they are licenced to practise. Cross-jurisdiction consultations should only be allowed between two physicians.

16. Physicians should ensure that their medical indemnity cover include cover for telemedicine.

Quality of Care

17. Healthcare quality assessment measures must be used regularly to ensure patient security and the best possible diagnostic and treatment practices during telemedicine procedures. The delivery of telemedicine services must follow evidence-based practice guidelines to the degree they are available, to ensure patient safety, quality of care and positive health outcomes. Like all health care interventions, telemedicine must be tested for its effectiveness, efficiency, safety, feasibility and cost-effectiveness.

18. The possibilities and weaknesses of telemedicine in emergencies must be duly identified. If it is necessary to use telemedicine in an emergency situation, the advice and treatment suggestions are influenced by the severity of the patient´s medical condition and the competency of the persons who are with the patient. Entities that deliver telemedicine services must establish protocols for referrals for emergency services.

RECOMMENDATIONS

  1. Telemedicine should be appropriately adapted to local regulatory frameworks, which may include licencing of telemedicine platforms in the best interest of patients.
  2. Where appropriate the WMA and National Medical Associations should encourage the development of ethical norms, practice guidelines, national legislation and international agreements on subjects related to the practice of telemedicine, while protecting the patient-physician relationship, confidentiality, and quality of medical care.
  3. Telemedicine should not be viewed as equal to face-to-face healthcare and should not be introduced solely to cut costs or as a perverse incentive to over-service and increase earnings for physicians.
  4. Use of telemedicine requires the profession to explicitly identify and manage adverse consequences on collegial relationships and referral patterns.
  5. New technologies and styles of practice integration may require new guidelines and standards.
  6. Physicians should lobby for ethical telemedicine practices that are in the best interests of patients.

Adopted by the 41st World Medical Assembly Hong Kong, September 1989
and rescinded at the WMA General Assembly, Santiago 2005

Preamble

Present requirements of health reporting fails to provide an accurate estimate of the incidence and prevalence of worldwide individuals in a persistent vegetative state (PVS). Ten years ago, a prevalence of 2 to 3 per 100,000 was estimated for Japan. It seems likely that the absolute number of such cases has risen appreciably as a consequence of current practices in critical medicine, cardiorespiratory support, parenteral feeding, and control of infections in severely brain damaged patients. How to deal with this emotionally painful, financially costly, and generally unwanted outcome of modern medical treatment is an increasing problem.

Persistent Vegetative State

Pathologic loss of consciousness may follow a variety of insults to the brain including, among others, nutritional insufficiency, poisoning, stroke, infections, direct physical injury, or degenerative disease. Abrupt loss of consciousness usually consists of an acute sleep-like state of unarousability called coma that may be followed either by varying degrees of recovery or severe, chronic neurologic impairment. Persons with overwhelming damage to the cerebral hemispheres commonly pass into a chronic state of unconsciousness called the vegetative state in which the body cyclically awakens and sleeps but expresses no behavioral or cerebral metabolic evidence of possessing cognitive function or of being able to respond in a learned manner to external events or stimuli. This condition of total cognitive loss can follow acute injuries causing coma or can develop more slowly as an end result of progressive structural disorders, such as Alzheimer’s disease, that in their end stages also can destroy the phychological function of the cerebrum. When such cognitive loss lasts for more than a few weeks, the condition has been termed a persistent vegetative state (PVS) because the body retains the functions necessary to sustain vegetative survival. Recovery from the vegetative state is possible, especially during the first few days or weeks after onset, but the tragedy is that many persons in PVS live for many months or years if provided with nutritional and other supportive measures.

Recovery

Once qualified clinicians have determined that a person is awake but unaware, the permanence of the vegetative state depends on the nature of the brain injury, the duration of the period of unawareness, and the estimated prognosis. Some persons less than 35 years old with coma after head trauma, as well as an occasional patient with coma after intracranial hemorrhage, may recover very slowly; thus, what appears to be a PVS at one to three months after an event causing coma may in rare cases evolve into a lesser degree of impairment by six months. On the other hand, the chances of regaining independence after being vegetative for three months are vanishingly small. Rare exceptions are claimed, but some of these may have represented patients who entered an unrecognized locked-in state shortly after reawakening from a coma-causing injury. Ultimately, all have been severely disabled.

Guidelines

These rare examples notwithstanding, the data indicate that unawareness for six months predicts nonrecovery or overwhelming disability with a high degree of certainty regardless of the nature of the insult to the brain. Therefore, a conservative criterion for the diagnosis of PVS would be observed unawareness for at least 12 months although cognitive recovery after six months is exceedingly rare in patients over 50.

The risk of prognostic error from widespread use of the above criterion is so small that a decision that incorporates it as a prognostic conclusion seems fully justifiable. A physician’s determination that a person is unlikely to regain consciousness is the usual prelude to deliberations about withdrawing or withholding life support. Although the family may be the first to raise the issue, until a physician has ventured an opinion about prognosis, the matter of withholding treatment is not generally considered. Once the question of withholding or withdrawing life support has been raised, its legal and ethical dimensions must be considere.