Declaration – WMA – The World Medical Association

Adopted by the 18^th WMA General Assembly, Helsinki, Finland, June 1964
and amended by the:
29^th WMA General Assembly, Tokyo, Japan, October 1975
35^th WMA General Assembly, Venice, Italy, October 1983
41^st WMA General Assembly, Hong Kong, September 1989
48^th WMA General Assembly, Somerset West, Republic of South Africa, October 1996
52^nd WMA General Assembly, Edinburgh, Scotland, October 2000
53^rd WMA General Assembly, Washington DC, USA, October 2002 (Note of Clarification added)
55^th WMA General Assembly, Tokyo, Japan, October 2004 (Note of Clarification added)
59^th WMA General Assembly, Seoul, Republic of Korea, October 2008
64^th WMA General Assembly, Fortaleza, Brazil, October 2013
and by the 75^th WMA General Assembly, Helsinki, Finland, October 2024

PREAMBLE

The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human participants, including research using identifiable human material or data.

The Declaration is intended to be read as a whole, and each of its constituent paragraphs should be applied with consideration of all other relevant paragraphs.

While the Declaration is adopted by physicians, the WMA holds that these principles should be upheld by all individuals, teams, and organizations involved in medical research, as these principles are fundamental to respect for and protection of all research participants, including both patients and healthy volunteers.

GENERAL PRINCIPLES

The WMA Declaration of Geneva binds the physician with the words, “The health and well-being of my patient will be my first consideration,” and the WMA International Code of Medical Ethics declares “The physician must commit to the primacy of patient health and well-being and must offer care in the patient’s best interest.”

It is the duty of the physician to promote and safeguard the health, well-being and rights of patients, including those who are involved in medical research. The physician’s knowledge and conscience are dedicated to the fulfilment of this duty.

Medical progress is based on research that ultimately must include participants.

Even well-proven interventions should be evaluated continually through research for their safety, effectiveness, efficiency, accessibility, and quality.

Medical research involving human participants is subject to ethical standards that promote and ensure respect for all participants and protect their health and rights.

Since medical research takes place in the context of various structural inequities, researchers should carefully consider how the benefits, risks, and burdens are distributed.

Meaningful engagement with potential and enrolled participants and their communities should occur before, during, and following medical research. Researchers should enable potential and enrolled participants and their communities to share their priorities and values; to participate in research design, implementation, and other relevant activities; and to engage in understanding and disseminating results.

The primary purpose of medical research involving human participants is to generate knowledge to understand the causes, development and effects of diseases; improve preventive, diagnostic and therapeutic interventions; and ultimately to advance individual and public health.

These purposes can never take precedence over the rights and interests of individual research participants.

While new knowledge and interventions may be urgently needed during public health emergencies, it remains essential to uphold the ethical principles in this Declaration during such emergencies.

It is the duty of physicians who are involved in medical research to protect the life, health, dignity, integrity, autonomy, privacy, and confidentiality of personal information of research participants. The responsibility for the protection of research participants must always rest with physicians or other researchers and never with the research participants, even though they have given consent.

Physicians and other researchers must consider the ethical, legal and regulatory norms and standards for research involving human participants in the country or countries in which the research originated and where it is to be performed, as well as applicable international norms and standards. No national or international ethical, legal or regulatory requirement should reduce or eliminate any of the protections for research participants set forth in this Declaration.

Medical research should be designed and conducted in a manner that avoids or minimizes harm to the environment and strives for environmental sustainability.

Medical research involving human participants must be conducted only by individuals with the appropriate ethics and scientific education, training and qualifications. Such research requires the supervision of a competent and appropriately qualified physician or other researcher.

Scientific integrity is essential in the conduct of medical research involving human participants. Involved individuals, teams, and organizations must never engage in research misconduct.

Groups that are underrepresented in medical research should be provided appropriate access to participation in research.

Physicians who combine medical research with medical care should involve their patients in research only to the extent that this is justified by its potential preventive, diagnostic or therapeutic value and if the physician has good reason to believe that participation in the research will not adversely affect the health of the patients who serve as research participants.

Appropriate compensation and treatment for participants who are harmed as a result of participating in research must be ensured.

Risks, Burdens, and Benefits

In medical practice and in medical research, most interventions involve risks and burdens.

Medical research involving human participants may only be conducted if the importance of the objective outweighs the risks and burdens to the research participants.

All medical research involving human participants must be preceded by careful assessment of predictable risks and burdens to the individuals and groups involved in the research in comparison with foreseeable benefits to them and to other individuals or groups affected by the condition under investigation.

Measures to minimize the risks and burdens must be implemented. The risks and burdens must be continuously monitored, assessed, and documented by the researcher.

Physicians and other researchers may not engage in research involving human participants unless they are confident that the risks and burdens have been adequately assessed and can be satisfactorily managed.

When the risks and burdens are found to outweigh the potential benefits or when there is conclusive proof of definitive outcomes, physicians and other researchers must assess whether to continue, modify or immediately stop the research.

Individual, Group, and Community Vulnerability

Some individuals, groups, and communities are in a situation of more vulnerability as research participants due to factors that may be fixed or contextual and dynamic, and thus are at greater risk of being wronged or incurring harm. When such individuals, groups, and communities have distinctive health needs, their exclusion from medical research can potentially perpetuate or exacerbate their disparities. Therefore, the harms of exclusion must be considered and weighed against the harms of inclusion. In order to be fairly and responsibly included in research, they should receive specifically considered support and protections.

Medical research with individuals, groups, or communities in situations of particular vulnerability is only justified if it is responsive to their health needs and priorities and the individual, group, or community stands to benefit from the resulting knowledge, practices, or interventions. Researchers should only include those in situations of particular vulnerability when the research cannot be carried out in a less vulnerable group or community, or when excluding them would perpetuate or exacerbate their disparities.

Scientific Requirements and Research Protocols

Medical research involving human participants must have a scientifically sound and rigorous design and execution that are likely to produce reliable, valid, and valuable knowledge and avoid research waste. The research must conform to generally accepted scientific principles, be based on a thorough knowledge of the scientific literature, other relevant sources of information, and adequate laboratory and, as appropriate, animal experimentation.

The welfare of animals used for research must be respected.

The design and performance of all medical research involving human participants must be clearly described and justified in a research protocol.

The protocol should contain a statement of the ethical considerations involved and should indicate how the principles in this Declaration have been addressed. The protocol should include information regarding aims, methods, anticipated benefits and potential risks and burdens, qualifications of the researcher, sources of funding, any potential conflicts of interest, provisions to protect privacy and confidentiality, incentives for participants, provisions for treating and/or compensating participants who are harmed as a consequence of participation, and any other relevant aspects of the research.

In clinical trials, the protocol must also describe any post-trial provisions.

Research Ethics Committees

The protocol must be submitted for consideration, comment, guidance, and approval to the concerned research ethics committee before the research begins. This committee must be transparent in its functioning and must have the independence and authority to resist undue influence from the researcher, the sponsor, or others. The committee must have sufficient resources to fulfill its duties, and its members and staff must collectively have adequate education, training, qualifications, and diversity to effectively evaluate each type of research it reviews.

The committee must have sufficient familiarity with local circumstances and context, and include at least one member of the general public. It must take into consideration the ethical, legal, and regulatory norms and standards of the country or countries in which the research is to be performed as well as applicable international norms and standards, but these must not be allowed to reduce or eliminate any of the protections for research participants set forth in this Declaration.

When collaborative research is performed internationally, the research protocol must be approved by research ethics committees in both the sponsoring and host countries.

The committee must have the right to monitor, recommend changes to, withdraw approval for, and suspend ongoing research. Where monitoring is required, the researcher must provide information to the committee and/or competent data and safety monitoring entity, especially about any serious adverse events. No amendment to the protocol may be made without consideration and approval by the committee. After the end of the research, the researchers must submit a final report to the committee containing a summary of the findings and conclusions.

Privacy and Confidentiality

Every precaution must be taken to protect the privacy of research participants and the confidentiality of their personal information.

Free and Informed Consent

Free and informed consent is an essential component of respect for individual autonomy. Participation by individuals capable of giving informed consent in medical research must be voluntary. Although it may be appropriate to consult family members or community representatives, individuals capable of giving informed consent may not be enrolled in research unless they freely agree.

In medical research involving human participants capable of giving informed consent, each potential participant must be adequately informed in plain language of the aims, methods, anticipated benefits and potential risks and burdens, qualifications of the researcher, sources of funding, any potential conflicts of interest, provisions to protect privacy and confidentiality, incentives for participants, provisions for treating and/or compensating participants who are harmed as a consequence of participation, and any other relevant aspects of the research.

The potential participant must be informed of the right to refuse to participate in the research or to withdraw consent to participate at any time without reprisal. Special attention should be given to the specific information and communication needs of individual potential participants as well as to the methods used to deliver the information.

After ensuring that the potential participant has understood the information, the physician or another qualified individual must then seek the potential participant’s freely given informed consent, formally documented on paper or electronically. If the consent cannot be expressed on paper or electronically, the non-written consent must be formally witnessed and documented.

All medical research participants should be given the option of being informed about the general outcome and results of the research.

When seeking informed consent for participation in research the physician or other researcher must be particularly cautious if the potential participant is in a dependent relationship with them or may consent under duress. In such situations, the informed consent must be sought by an appropriately qualified individual who is independent of this relationship.

In medical research involving human participants incapable of giving free and informed consent, the physician or other qualified individual must seek informed consent from the legally authorized representative, considering preferences and values expressed by the potential participant.

Those persons incapable of giving free and informed consent are in situations of particular vulnerability and are entitled to the corresponding safeguards. In addition to receiving the protections for the particularly vulnerable, those incapable of giving consent must only be included if the research is likely to either personally benefit them or if it entails only minimal risk and minimal burden.

When a potential research participant who is incapable of giving free and informed consent is able to give assent to decisions about participation in research, the physician or other qualified individual must seek that assent in addition to the consent of the legally authorized representative, considering any preferences and values expressed by the potential participant. The potential participant’s dissent should be respected.

Research involving participants who are physically or mentally incapable of giving consent (for example, unconscious patients) may be done only if the physical or mental condition that prevents giving informed consent is a necessary characteristic of the research group. In such circumstances the physician or other qualified individual must seek informed consent from the legally authorized representative. If no such representative is available and if the research cannot be delayed, the research may proceed without informed consent provided that the specific reasons for involving participants with a condition that renders them unable to give informed consent have been stated in the research protocol and the research has been approved by a research ethics committee.

Free and informed consent to remain in the research must be obtained as soon as possible from a legally authorized representative or, if they regain capacity to give consent, from the participant.

The physician or other researcher must fully inform potential participants which aspects of their care are related to the research. The refusal of a patient to participate in research or the patient’s decision to withdraw from research must never adversely affect the patient-physician relationship or provision of the standard of care.

Physicians or other qualified individuals must obtain free and informed consent from research participants for the collection, processing, storage, and foreseeable secondary use of biological material and identifiable or re-identifiable data. Any collection and storage of data or biological material from research participants for multiple and indefinite uses should be consistent with requirements set forth in the WMA Declaration of Taipei, including the rights of individuals and the principles of governance. A research ethics committee must approve the establishment and monitor ongoing use of such databases and biobanks.

Where consent is impossible or impracticable to obtain, secondary research on stored data or biological material may be done only after consideration and approval of a research ethics committee.

Use of Placebo

The benefits, risks, burdens, and effectiveness of a new intervention must be tested against those of the best proven intervention(s), except in the following circumstances:

If no proven intervention exists, the use of placebo, or no intervention, is acceptable; or
If for compelling and scientifically sound methodological reasons the use of any intervention other than the best proven one(s), the use of placebo, or no intervention is necessary to determine the efficacy or safety of an intervention; and the participants who receive any intervention other than the best proven one(s), placebo, or no intervention will not be subject to additional risks of serious or irreversible harm as a result of not receiving the best proven intervention.

Extreme care must be taken to avoid abuse of this option.

Post-Trial Provisions

In advance of a clinical trial, post-trial provisions must be arranged by sponsors and researchers to be provided by themselves, healthcare systems, or governments for all participants who still need an intervention identified as beneficial and reasonably safe in the trial. Exceptions to this requirement must be approved by a research ethics committee. Specific information about post-trial provisions must be disclosed to participants as part of informed consent.

Research Registration, Publication, and Dissemination of Results

Medical research involving human participants must be registered in a publicly accessible database before recruitment of the first participant.

Researchers, authors, sponsors, editors, and publishers all have ethical obligations with regard to the publication and dissemination of the results of research. Researchers have a duty to make publicly available the results of their research on human participants and are accountable for the timeliness, completeness, and accuracy of their reports. All parties should adhere to accepted guidelines for ethical reporting. Negative and inconclusive as well as positive results must be published or otherwise made publicly available. Sources of funding, institutional affiliations, and conflicts of interest must be declared in the publication. Reports of research not in accordance with the principles of this Declaration should not be accepted for publication.

Unproven Interventions in Clinical Practice

When an unproven intervention is utilized in an attempt to restore health or alleviate suffering for an individual patient because approved options are inadequate or ineffective and enrollment in a clinical trial is not possible, it should subsequently be made the object of research designed to evaluate safety and efficacy. Physicians participating in such interventions must first seek expert advice, weigh possible risks, burdens, and benefits, and obtain informed consent. They must also record and share data when appropriate and avoid compromising clinical trials. These interventions must never be undertaken to circumvent the protections for research participants set forth in this Declaration.

Disclaimer: ©2024 World Medical Association. All Rights Reserved. All intellectual property rights in the Declaration of Helsinki are vested in the World Medical Association. The WMA has granted JAMA exclusive rights to publish the English-language version of the Declaration through December 31, 2024.

Adopted by the 75^th WMA General Assembly, Helsinki, Finland, October 2024

PREAMBLE

The impact of air pollution on health – especially among vulnerable populations – necessitates targeted guidelines for healthcare professionals. By recognizing air pollution’s unique characteristics, this declaration aims to advocate for better health, foster cross-border collaboration, and reinforce the connection between environmental quality and human well-being.

Air pollution and its impact on health

Air pollution poses a major global environmental risk to human health, contributing significantly to avoidable morbidity and mortality worldwide. 8.1 million premature deaths occur each year due to the combined effects of ambient and household air pollution.

Air pollutants are a leading risk factor for the burden of non-communicable diseases, leading to stroke, myocardial infarctions, lung cancer as well as chronic respiratory illnesses. It also increases the risk of childhood asthma and asthma severity.

Air pollutants are a diverse range of harmful substances that contaminate the air we breathe. These include gases such as sulphur dioxide, nitrogen oxides, carbon monoxide, methane, and volatile organic compounds, as well as particulate matter like smoke, soot (black carbon), and fine dust.

In 2022, WHO estimated that 99% of the global population was exposed to air pollution concentrations that exceeded WHO’s air quality limits.

While no region of the world has been spared, low and middle-income countries bear the largest burden of premature mortality associated with air pollution.

Without implementation of aggressive interventions, the number of premature deaths caused by ambient air pollution is projected to rise by over 50% by the year 2050.

The sources of air pollution

Fossil fuel combustion, petrol- and diesel-powered vehicle emissions have been highlighted as the major contributor to air pollution-related mortalities, particularly in urban areas.

Diesel soot is a proven carcinogen with toxic effects on cardiovascular and respiratory systems.

Household air pollution, caused largely by open cooking fires and inefficient stoves, is a leading risk factor for childhood mortality, contributing to approximately 50% of deaths from acute lower respiratory infections, including pneumonia, in children under the age of five.

Beyond traditional airborne pollutants, biological air pollution – airborne pathogens such as bacteria, viruses, and fungi, particularly indoors – has gained attention.

Infected individuals can contribute to such air contamination, emphasizing the need for appropriate prevention strategies and comprehensive air quality control.

Plastics contribute to air pollution directly through its open-air combustion and through microplastics carried by wind and air currents.

RECOMMENDATIONS

The WMA acknowledges the severity of consequences stemming from air pollution and urges the following stakeholders to promptly take action to achieve clean air:

The WMA and its constituent members should:

Engage with local, regional, and national authorities to raise public awareness about the health impacts of air pollution and the importance of its prevention.
Work together with governments to develop and implement strategies to improve air quality, as identified in the WHO air quality guidelines, and mitigate the effects of air pollution. These strategies should consider the local context and reflect the latest scientific evidence.
Advocate for and support the integration of health impacts of air pollution and its solutions into medical curricula and professional educational programs, fostering a comprehensive understanding and proactive approach among healthcare professionals.
Encourage collaboration between organised medicine and other stakeholders, including government agencies and international organizations, to develop best practices for minimising greenhouse gas emissions and plastic use in healthcare settings.

The WMA urges governments to:

Recognise that air pollution negatively impacts human health and environmental sustainability and that existing health inequities exacerbate susceptibility to environmental hazards.
Recognise the important role of social and environmental determinants of health and strive to include these in policy-making processes, for example by conduction of health equity impact assessments.
Allocate resources and funding for reducing and monitoring air quality and implement effective pollution prevention and control measures, particularly in densely populated areas, in line with WHO’s air quality standards.
Enhance early warning systems for anticipated poor air quality periods and prepare health systems to handle air pollution-related health impacts effectively.
Implement measures that improve air quality, such as increasing access to clean energy and creating green spaces.
Take measures toward sustainable healthy transport by implementing strategies to decarbonise the transportation sector, such as enforcing stricter vehicle emission standards, promoting public transportation and implementing cycling and walking infrastructure.
Invest in and support research and innovation for cleaner healthcare sector technologies and practices.
Establish guidelines and standards for acceptable levels of biological contaminants in indoor air, including policies to reach those objectives such as by ensuring adequate ventilation and air filtration.
Strive towards good environmental governance by developing sustainable strategies, policies, and measures to address environmental hazards and take a precautionary principle approach to protect health.

The WMA recommends that international and intergovernmental agencies:

Recognize and promote access to clean, breathable air free from harmful pollutants as a basic human right for all people worldwide.
Work with governments to update public health policies, prioritize air pollution control and strengthen efforts in health promotion and pollution reduction.
Advocate for the maximum reduction of all sources of air pollution, recognising that it is critical for sustainability that anthropogenic (human) activities operate within the safe limits of the Earth’s ecosystem.
Promote and support governments in conducting health impact assessments across relevant policy sectors, empowering them to proactively reduce exposure to air pollution and safeguard public health.

The WMA urges individual physicians to:

Stay informed regarding health effects of air pollution.
Consider air pollution as a potential environmental risk factor in relevant patient consultations and where relevant, promote lifestyle modifications and preventive measures that minimize exposure to pollutants.

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

PREAMBLE

The ageing of the population due to increased life expectancy is one of the main challenges of many health systems given the increasing amount of resources needed to provide healthcare for the elderly population. This puts a strain on these systems, since ageing often causes a higher demand for care, with a high dependence on medical, pharmaceutical and hospital services. On the other hand, older people are perceived as recipients of help, care and financial support, which is inaccurate, as they make significant contributions to the well-being of their environment, which has a high social value.

The increase in longevity must be accompanied by appropriate quality-of-care standards, promoting health, reducing risk factors, and providing accessible and sustainable quality health and social services that are accessible, affordable, sustainable and which are of quality.

Biological age should never be used as a basis for discrimination, although it can be a relevant factor in medical decision-making. Reference to age can therefore be professionally sound.

Health discrimination in elderly patients

Elderly individuals experience all kinds of discrimination with one of the main types of discrimination being related to health. The elderly may be perceived as a burden on the healthcare systems and their financial sustainability. Elderly individuals are not uniquely responsible for the increase in healthcare costs in developed countries. There are other factors that play a key role in healthcare costs, such as the improvement in standards of living, accessibility to health services, quality of care and the use of new technologies.

Rationing of certain costly and time-consuming diagnostic or therapeutic procedures or particular settings that have a certain more expensive intensity of care is more common in the elderly population. Clinical trials often exclude patients of a certain age, even if they meet the criteria for enrolment.

Age has become a barrier when putting patients forward for certain interventions. The reasons tend to be physical; however, these may be underpinned by economic motivations, such as the recovery time being higher which increases the length of hospital stay, or by arguing that there are scarce resources and that elderly people have a shorter life expectancy.

There is consensus that from a physiological and psychological point of view, the determining factors for health in ageing patients are intrinsically linked to gender; therefore, the solutions need to address the differences between genders in order to reduce inequalities.

Health discrimination experienced by elderly individuals may have a negative impact on their physical, mental and social well-being and contributes to deterioration in their quality of life, loss of autonomy, confidence, safety and an active lifestyle, in turn, decreasing their levels of health. Is therefore a complex topic that requires the involvement of professionals, institutions, healthcare systems and authorities. Dealing with such discrimination requires awareness and coordination aided by moral and legal principles.

The need for a holistic approach

Healthcare systems do not always adapt to the changing population needs, as may occur with some hospitals, designed to care for adult patients with acute illnesses yet not elderly patients with chronic illnesses.

An increase in longevity must be accompanied by the highest quality-of-care standards, and should promote health, reduce risk factors, and provide accessible, sustainable and quality health and social services. Emphasis should be on patient-focused medicine that heals, cares for, alleviates and comforts.

The ethical duty of physicians

In line with the WMA Declaration of Geneva, physicians must strive to improve the health, well-being and quality of life for all patients without any forms of discrimination towards the elderly.

RECOMMENDATIONS

Recalling its Declarations of Geneva and of Lisbon on the Rights of the Patient, and its Statement on Ageing, the WMA makes the following recommendations:

To governments, medical associations and physicians

As priority actions, to defend the human rights and health of all individuals, including the elderly, as well as to ensure that their dignity is respected;

To governments

Develop appropriate and non-discriminatory healthcare policies for the elderly based on the efficient use of available healthcare resources;
To establish measures to eradicate discrimination against elderly individuals in healthcare;
Provide sufficient resources which ensure adequate healthcare for elderly individuals;

To the WMA, its members and the medical profession in general

To commit to eliminating all forms of discrimination due to health and age;
Promote training for primary care physicians on how to approach health problems in elderly individuals;
Promote development of the geriatric specialty or supplementary post-graduate training and increase of the number of physicians in this field, an increase of the number of physicians in this speciality and an adequate number of geriatric departments in hospitals and consultants, in order to ensure the availability of comprehensive care for elderly individuals;
Raise awareness and take action against discrimination of elderly individuals;
Promote ethical, responsible, effective and efficient practices for treating the elderly;
To set ethical standards that aim to prevent discrimination against any individual due to age;
To actively try to include elderly patients in medical scientific research;

To physicians

Not limit or impede patients’ autonomy on the basis of their age;
Provide healthcare of scientific and human quality according to good medical practice to all patients, without any discrimination;
Not apply limitations solely based on age in protocols for diagnosis and treatment;
To report any discrimination against the elderly that is observed in healthcare.

Adopted by the 35^th World Medical Assembly, Venice, Italy, October 1983
Revised by the 57^th WMA General Assembly, Pilanesberg, South Africa, October 2006
and by the 73^rd WMA General Assembly, Berlin, Germany, October 2022

PREAMBLE

When a patient is seriously ill and the restoration of health may not be possible, the physician and the patient are often faced with a complex set of decisions regarding medical treatment.

The end of life must be recognized and respected as an important part of a person’s life.

Advances in medical science have improved the ability of physicians to address many issues associated with end-of-life care. While the priority of research to cure disease should not be compromised, more attention must be paid to developing palliative treatments and improving assessment and response to the physical, psychological, social and spiritual or existential components of terminal illnesses and other conditions at the end of life.

WMA remains firmly opposed to euthanasia and physician-assisted suicide, as set forth in the WMA Declaration on Euthanasia and Physician-Assisted Suicide.

Ethically-appropriate care at the end of life should routinely promote patient autonomy and shared decision-making, and be respectful of the values of the patient, his or her family or intimate associates, and surrogate(s). The WMA recognizes that attitudes and beliefs toward death and dying vary widely from culture to culture and among different religions, and palliative care resources are unevenly distributed. The approach to medical care at the end of life will be influenced significantly by these factors, and thus attempting to develop detailed universal guidelines on terminal care is neither practical nor wise. Therefore, the WMA articulates the following:

RECOMMENDATIONS

Pain and Symptom Management

Palliative care at the end of life is part of good medical care. The objective of palliative care is to maintain patient dignity and freedom from distressing symptoms. Care plans should emphasize keeping a patient as comfortable as possible and the patient’s pain controlled while recognizing the importance of attention to the social, psychological and spiritual needs of the patient, and his or her family and intimate associates.
The clinical management of pain in patients at the end of life is of paramount importance in terms of alleviating suffering. The WMA Resolution on Access to Adequate Pain Treatment (2020) makes recommendations for physicians and governments that optimize treatment of pain and other distressing symptoms. Physicians and National Medical Associations should promote the dissemination and sharing of information regarding pain management to ensure that all physicians involved in end-of-life care have access to best practice guidelines and the most current treatments and methods available. National Medical Associations should oppose laws or regulations that unduly inhibit physicians from providing intensive, clinically appropriate symptoms management for patients at the end of life in keeping with recognized best practices.
When a patient at the end of life experiences severe pain or other distressing clinical symptoms that do not respond to intensive, symptom-specific palliation, it can be appropriate to offer sedation to unconsciousness as an intervention of last resort. Sedation to unconsciousness must never be used to intentionally cause a patient’s death and should be restricted to patients in the final stages of life. Thorough efforts should be made to obtain consent of the patient or the patient’s surrogate(s).
Palliative care is often provided by multidisciplinary healthcare teams. When possible, the physician should be the leader of the team, being responsible, amongst other obligations, for diagnosis and medical treatment plans. A carefully kept medical record is of the utmost importance. The rationale for all symptom management interventions, including medications for symptom relief, should be documented in the medical record, including the degree and length of sedation and specific expectations for continuing, withdrawing, or withholding future life-sustaining treatments.
The health care team should promote collaborative care of the patient and offer bereavement support after the patient’s death. The needs of children and families or intimate associates may require special attention and competence, both when children are patients and when they are dependents of patients.

Education and Research

Education of healthcare professionals should include the teaching of end-of-life medical care. Where it does not exist, the establishment of palliative medicine as a medical specialty should be considered. In countries where palliative medicine is not a recognized specialty, post-graduate training in palliative medicine can nevertheless improve the quality of palliative care provided.
Physician education should help to develop the skills necessary to increase the prevalence and quality of meaningful patient advance care planning for patients with life-threatening illness and the right of patients to use written advance directives that describe their wishes and goals regarding care in the event that they are unable to communicate. Physicians should receive education to encourage their patients to formally document their goals, values and treatment preferences and to appoint a substitute health care decision maker with whom the patient can discuss in advance his or her values regarding health care and treatment.
Governments and research institutions are encouraged to invest additional resources in developing treatments to improve end-of-life care. This includes, but is not limited to, supporting research on general medical care, specific treatments, psychological implications and organization to improve end-of-life care.
When employing treatments, the physician must carefully consider the balance between the intended benefits to the patient and the potential harm. National Medical Associations should support the formulation of palliative treatment guidelines.
The physician must also communicate to the patient a willingness to discuss at any time the natural course of the disease and what to expect during the dying process, while also providing guidance about treatments and alternatives that could ease the patient’s suffering, including palliative care or psychotherapy. If a patient indicates a desire to die or expresses suicidal thoughts, the physician has a duty to engage in open and confidential discussions with the patient to understand the motives and reasoning behind these thoughts.
Physicians should assist the dying patient in maintaining an optimal quality of life by controlling symptoms and addressing psychosocial and spiritual needs, to enable the patient to die with dignity and in comfort. Physicians should inform patients of the availability, benefits and other aspects of palliative care. Discussions about patient preferences should be initiated early, routinely offered to all patients and should be revisited regularly to explore any changes patients may have in their wishes, especially as their clinical condition changes. Information and communication among the patient, his or her family or intimate associates, surrogates and members of the health care team are one of the fundamental pillars of quality care at the end of life.
Physicians should endeavor to identify, understand and address the psychosocial and spiritual needs of their patients, especially as they relate to patients’ physical symptoms. Physicians should try to ensure that psychological, social and spiritual resources are available to patients, their families and intimate associates, to help them deal with the anxiety, fear and grief associated with the end of life.
Physicians should encourage patients to designate a substitute decision-maker/surrogate to make decisions that are not expressed in an advance directive. In particular, physicians should discuss the patient’s wishes regarding the approach to life-sustaining interventions as well as palliative measures that might have the additional effect of accelerating death. Because documented advance directives are sometimes not available in emergency situations, physicians should emphasize to patients the importance of discussing treatment preferences with individuals who are likely to act as substitute health care decision-makers/surrogates. Whenever possible and consented to by the patient, the patient’s substitue decision-makers/surrogates should be included in these conversations.
If a patient has decision-making capacity, his or her autonomous right to refuse any medical treatments or interventions must be respected even if the patient’s life may be shortened. Physicians should make sure that the patient is adequately treated for pain and discomfort before consent for end-of-life care is obtained in order to ensure that unnecessary physical and mental suffering do not interfere with decision making. Laws regarding the decision-making capacity of minor patients vary greatly, but discussions with the family, and child, if possible, are encouraged.
Upon a patient’s death, physicians may apply such means as are necessary to keep organs viable for transplantation, provided that they act in accordance with the ethical guidelines established in the WMA Declaration of Sydney on the Determination of Death and the Recovery of Organs. In addition, any transplantation must be in accordance with the principles in the WMA Statement on Organ and Tissue Donation.

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

PREAMBLE

The patient-physician relationship is part of a human relationship model that dates back to the origins of medicine. It represents a privileged bond between a patient and a physician based on trust. It is a space of creativity where information, feelings, visions, help and support are exchanged.

The patient-physician relationship is a moral activity that arises from the obligation of the physician to alleviate suffering and respect the patient’s beliefs and autonomy. It is usually initiated by mutual consent – expressed or implied – to provide quality medical care.

The patient-physician relationship is the fundamental core of medical practice. It has a universal scope and aims at improving a person’s health and wellbeing. This is made possible by knowledge sharing, common decision making, patient and physician autonomy, help, comfort and companionship in an atmosphere of trust. Trust is an inherent component of the relationship that can be therapeutic in and of itself.

The patient-physician relationship is essential to patient-centred care. It requires both the physician and the patient to be active participants in the healing process. While the relationship encourages and supports collaboration in medical care, competent patients make decisions that direct their care. The relationship may be terminated by either party. The physician must then assist the patient in securing transfer of care and refer the patient to another physician with the necessary ability to continue the care.

The patient-physician relationship is a complex issue subject to myriad cultural, technological, political, social, economic or professional influences. It has evolved throughout history, according to culture and civilisation, in the pursuit of what is most appropriate based on scientific evidence for patients by improving their mental and physical health and well-being and alleviating pain. The relationship underwent deep changes as a result of momentous milestones such as the Universal Declaration of Human Rights (1948), the WMA declarations of Geneva (1948), Helsinki (1964), and the Lisbon (1981).The relationship has slowly progressed towards the empowerment of the patient.

Today, the patient-physician relationship is frequently under threat from influences both within and outside health care systems. In some countries and health care systems, these influences risk alienating physicians from their patients and potentially harming patients. Amongst those challenges likely to undermine the therapeutic efficacy of the relationship, we note a growing trend to:

A technologization of medicine, sometimes leading to a mechanistic view of health care, neglecting human considerations;
The dilution of trustworthy relationships between people in our societies, which negatively influences healthcare relationships;
A primary focus on economic aspects of medical care to the detriment of other factors, posing sometimes difficulties to establish genuine relationships of trust between the physician and the patient.

It is of the utmost importance that the patient-physician relationship addresses these factors of influence in such a way that the relationship is enriched, and that its specificity is warranted. The relationship should never be subject to undue administrative, economic, or political interferences.

RECOMMENDATIONS

Reiterating its Declaration of Geneva, the International Code of Medical Ethics and its Lisbon Declaration on Patient Rights and given the vital importance of the relationship between physician and patient in history and in the current and future context of medicine, the WMA and its Constituent Members:

Reaffirm that professional autonomy and clinical independence are essential components of high-quality medical care and medical professionalism, protecting the right of the patients to receive the health care they need.
Urge all actors involved in the regulation of the patient-physician relationship (governments and health authorities, medical associations, physicians, and patients) to defend, protect and strengthen the patient-physician relationship, based of high-quality care, as a scientific, health, cultural and social heritage.
Call on Constituent Members and individual physicians to preserve this relationship as the fundamental core of any medical action centred on a person, to defend the medical profession and its ethical values, including compassion, competence, mutual respect, and professional autonomy, and to support patient-centred care.
Reaffirm its opposition to interference from governments, other agents and institutional administrations in the practice of medicine and in the Patient-physician
Reaffirm its dedication to providing competent medical service in full professional and moral independence, with compassion and respect for human dignity.
Commit to address emerging factors which could pose a threat to the patient-physician relationship and to take action to mitigate against those factors.

Portuguese translation

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

DEFINITIONS

“Pseudoscience” (false science) refers to the set of statements, assumptions, methods, beliefs or practices that, without following a valid and recognised scientific method, are falsely presented as scientific or evidence-based.
“Pseudotherapies” (false therapies) are those practices intended for curing diseases, alleviating symptoms or improving health with procedures, techniques, products or substances based on criteria without the support of available up-to-date scientific evidence; and which may have significant potential risks and harms.

PREAMBLE

Medical practice must be based on the best available up-to-date scientifically proven evidence. The differences between conventional medicine and other practices that are not supported by scientific evidence make up the complex universe of pseudosciences and pseudotherapies.

Pseudosciences and pseudotherapies represent a complex system of theories, assumptions, assertions and methods erroneously regarded as scientific, they may cause some patients to perceive a cause-and-effect relationship between pseudotherapies and the perception of improvement, hence they may be very dangerous and are unethical.

There are therapies and techniques accepted by the scientific community that, used in a complementary manner (such as nutritional, comfort or wellness, environmental and relaxation therapies, psychotherapeutic support or reinforcement, affectivity and the use of placebos), provide benefits to the validated main and effective medical therapy.

Many countries lack the regulatory framework to address these pseudotherapies, which has allowed their proliferation. In the past, the medical profession considered them to be harmless due to their perceived lack of side effects, but nowadays there is enough evidence to suggest that they can pose a risk to patient safety.

Pseudoscience and Pseudotherapies may have significant potential risks and harms for various reasons:

There is a risk that patients abandon effective proved-to-be effective medical treatments or prevention measures in favour of practices that have not demonstrated therapeutic value, sometimes leading to treatment failure for critical conditions that may even lead to death.
There are frequent likelihood of dangerous delays and loss of opportunity in the application of medicines, procedures and techniques recognised and endorsed by the scientific medical community as evidence-based effective interventions.
They may cause patients to suffer financial damages psychological-physical traumas, and go against the dignity of people, threatening their moral integrity.
Unproven therapies may contribute to the rising costs of healthcare procedures.

All new diagnostic, preventive and therapeutic methods should be tested in accordance with scientific methods and ethical principles in order to assess their safety, efficiency, efficacy and scope of application.

A physician’s duty is to provide quality medical care to all patients based on best available scientific evidence, as referred in the WMA Declaration of Geneva and the International Code of Medical Ethics commending the highest ethical norms and quality care for the safety of the patient. The interest of the patient must be placed before any other interest, including the physician’s own.

The WMA reaffirms its Lisbon Declaration on Patient Rights and recalls that Patient Safety requires addressing all opportunities for the patient to receive appropriate, evidence-based care.

RECOMMENDATIONS

Thus, the WMA makes the following recommendations:

National Health Authorities

Appropriate and rigorous regulation commensurate with best practices is necessary to address the risks and reduce the potential harms arising from pseudotherapies and pseudoscience.
National authorities and healthcare systems should decline approval of and reimbursement of costs providing pseudotherapies.
In collaboration with professional medical organisations, scientific societies and patients’ associations, national authorities should develop public campaign raising awareness on the risk of pseudotherapies and pseudosciences.

WMA Constituent members and the medical profession

WMA constituent members and the medical profession must recognize and be aware of the risks of pseudotherapies and pseudosciences.
Pseudotherapies and pseudosciences should not be regarded as medical specialties recognized by the scientific community and legally endorsed as a specialist or sub-specialist pseudoscience.
All acts of professional intrusion, pseudoscience and pseudotherapy activities that put public health at risk must be reported to the competent authorities, including misleading advertising and unaccredited healthcare websites that offer services and/or products and that put the health of patients at risk, yet patient confidentiality has to be respected. The role of the general and specialized media for transparency and truthfulness in increasing critical public scientific awareness is essential.
Constituent members should work with governments to establish the highest level of protection for patients treated with pseudotherapies/pseudosciences. When such a practice is found to be harmful or unethical to apply, there should be a system in place to either immediately stop or substantially restrict any given treatment classified as complementary and/or alternative in order to protect public health.

Physicians

With the support of the relevant organisations and authorities involved in the governance and regulation of the medical profession, physicians must continue to practice medicine as a service based on the application of critical scientific current knowledge, specialist skills and ethical behaviour and to maintain their skills up to date on developments in their professional field.
For the patient’s safety and quality of care, the physician must have the freedom to prescribe, while respecting scientific evidence and the standard of care.
The patient must be kept duly informed about the available therapy options, their effectiveness and risks, and be able to participate in the best therapeutic decision-making. Good communication, mutual trust and person-centered healthcare are cornerstones of the physician-patient relationship. Patients and physicians should and must be able to discuss the risks of pseudoscience and pseudotherapies. Health education is fundamental.
Physicians should be educated to identify pseudoscience/pseudotherapies, logical fallacies, and cognitive biases and counsel their patients accordingly. They should be aware that some patient groups, such as patients with cancer, psychiatric illnesses or serious chronic diseases, as well as children, are particularly vulnerable to the risks associated with using pseudotherapies.

When obtaining the patient’s history (anamnesis), the physician should inquire about all therapeutic measures (proven or otherwise) the patient has been exposed or is still exposed to. If necessary, the physician should inform the patient on potential harms associated with the previous use of Pseudotherapies and pseudosciences.
The physician must inform the patient that complementary treatment is not a therapeutic alternative or substitute for a validated main medical treatment.

Note: The aim of this declaration is not the traditional ancestral medicines nor the so-called indigenous medicines, firmly rooted in peoples and nations, forming an intrinsic part of their culture, rites, traditions and history.

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

The WMA reiterates its strong commitment to the principles of medical ethics and that utmost respect has to be maintained for human life. Therefore, the WMA is firmly opposed to euthanasia and physician-assisted suicide.

For the purpose of this declaration, euthanasia is defined as a physician deliberately administering a lethal substance or carrying out an intervention to cause the death of a patient with decision-making capacity at the patient’s own voluntary request. Physician-assisted suicide refers to cases in which, at the voluntary request of a patient with decision-making capacity, a physician deliberately enables a patient to end his or her own life by prescribing or providing medical substances with the intent to bring about death.

No physician should be forced to participate in euthanasia or assisted suicide, nor should any physician be obliged to make referral decisions to this end.

Separately, the physician who respects the basic right of the patient to decline medical treatment does not act unethically in forgoing or withholding unwanted care, even if respecting such a wish results in the death of the patient.

Adopted by the 59^th WMA General Assembly, Seoul, Korea, October 2008
And amended by the 69^th WMA General Assembly, Reykjavik, Iceland, October 2018

The WMA reaffirms the Declaration of Madrid on professionally-led regulation.

The World Medical Association recognises the essential nature of professional autonomy and physician clinical independence, and states that:

Professional autonomy and clinical independence are essential elements in providing quality health care to all patients and populations. Professional autonomy and independence are essential for the delivery of high quality health care and therefore benefit patients and society.
Professional autonomy and clinical independence describes the processes under which individual physicians have the freedom to exercise their professional judgment in the care and treatment of their patients without undue or inappropriate influence by outside parties or individuals.
Medicine is highly complex. Through lengthy training and experience, physicians become medical experts weighing evidence to formulate advice to patients. Whereas patients have the right to self-determination, deciding within certain constraints which medical interventions they will undergo, they expect their physicians to be free to make clinically appropriate recommendations.
Physicians recognize that they must take into account the structure of the health system and available resources when making treatment decisions. Unreasonable restraints on clinical independence imposed by governments and administrators are not in the best interests of patients because they may not be evidence based and risk undermining trust which is an essential component of the patient-physician relationship.
Professional autonomy is limited by adherence to professional rules, standards and the evidence base.
Priority setting and limitations on health care coverage are essential due to limited resources. Governments, health care funders (third party payers), administrators and Managed Care organisations may interfere with clinical autonomy by seeking to impose rules and limitations. These may not reflect evidence-based medicine principles, cost-effectiveness and the best interest of patients. Economic evaluation studies may be undertaken from a funder’s not a users’ perspective and emphasise cost-savings rather than health outcomes.
Priority setting, funding decision making and resource allocation/limitations processes are frequently not transparent. A lack of transparency further perpetuates health inequities.
Some hospital administrators and third-party payers consider physician professional autonomy to be incompatible with prudent management of health care costs. Professional autonomy allows physicians to help patients make informed choices, and supports physicians if they refuse demands by patients and family members for access to inappropriate treatments and services.
Care is given by teams of health care professionals, usually led by physicians. No member of the care team should interfere with the professional autonomy and clinical independence of the physician who assumes the ultimate responsibility for the care of the patient. In situations where another team member has clinical concerns about the proposed course of treatment, a mechanism to voice those concerns without fear of reprisal should exist.
The delivery of health care by physicians is governed by ethical rules, professional norms and by applicable law. Physicians contribute to the development of normative standards, recognizing that this both regulates their work as professionals and provides assurance to the public.
Ethics committees, credentials committees and other forms of peer review have long been established, recognised and accepted by organised medicine as ways of scrutinizing physicians’ professional conduct and, where appropriate, may impose reasonable restrictions on the absolute professional freedom of physicians.
The World Medical Association reaffirms that professional autonomy and clinical independence are essential components of high quality medical care and the patient-physician relationship that must be preserved. The WMA also affirms that professional autonomy and clinical independence are core elements of medical professionalism.

Adopted by the 68^th WMA General Assembly, Chicago, United States, October 2017

PREAMBLE

The goals of medical education are to prepare practitioners to apply the latest scientific knowledge to promote health, to prevent and cure human diseases, and to impart the ethical standards governing the thought and behavior of physicians. All physicians have a responsibility to themselves, the profession, and their patients to maintain high standards for basic medical education.

Well-planned and well-executed quality assurance programs are essential to ensuring that medical schools meet these goals and expectations. There are many threats to the quality of basic medical education. The ability to deliver a high standard of education can be affected by the availability of infrastructure, clinical resources, faculty, and finances. Also, the growth of basic medical education globally, with a rapid increase in the number of medical schools in some countries, raises concerns about the quality of graduates. A well-developed quality assurance program allows schools to identify and address conditions that threaten the quality of their basic medical education. Such programs need to be implemented as far as possible at medical schools around the world.

BACKGROUND

Standards developed by and for a medical school are designed to reflect what the school believes to be important quality measures. Institutional reviews using such internally-developed standards can ensure that the school’s missions are being met and that students are being prepared to achieve the desired outcomes. The presence of an institutional quality assurance program that uses its own defined criteria and is supported by knowledgeable personnel can be important to ensure educational program quality over time.

However, a better outcome will more likely be achieved by also including a second dimension of review that includes an external perspective. A national quality assurance system includes the use of standards of quality that are developed and approved at the national or regional level. Evaluating a medical school based on what a country or region expects of its basic medical educational programs leads to a higher and more consistent level of student preparation.

Unless compliance with standards set by a national evaluation system is required of medical schools, there is no guarantee that schools will undertake an internal evaluation or correct problems that interfere with educational quality. The World Medical Association (WMA) recognises the need for and importance of sound global standards for assuring the quality of basic medical education programs.

An accreditation/recognition system is a quality assurance mechanism that is increasingly common around the world. Accreditation/recognition systems are based on standards of educational quality that are developed to meet national needs and that use valid, reliable, and widely-accepted processes to assess the attainment of these standards by schools. After evaluating compliance with standards, cooperation and coordination among various stakeholder groups within and external to a medical school is needed to implement solutions to the problems identified.

PRINCIPLES FOR ACCREDITATION SYSTEMS

An accreditation system reviews educational programs or institutions using a pre-determined (typically national) set of process and outcome standards. The accreditation systems that exist around the world differ in several ways. In some countries, accreditation of medical schools has been occurring for decades; in other countries, accreditation is relatively new. Participation in accreditation is either mandatory or voluntary for medical schools and reviews take place over different intervals.

Accreditation is defined as the evaluation of educational programs or institutions based on a clear and specific set of standards. Accreditation guidelines should be articulated as standards that have been created with national needs in mind and with the input of relevant stakeholder groups within the country.

Certain general principles should form the basis for an accreditation system to ensure that the process is valid and decisions related to educational program quality are trustworthy. These principles include transparency, absence of conflict of interest, and reliability/consistency. Transparency means that the accreditation standards and processes are known to and understood by schools, evaluators, and decision-makers. To reduce the potential for conflict of interest, evaluators and decision-makers should have no ties to the institution being evaluated or to other institutions that may affect their ability to make a judgment free from positive or negative bias. Reliability and consistency require a common understanding of what constitutes compliance with standards and that, as far as possible, this understanding is applied consistently in reviews and decisions across schools.

Accreditation standards are measurable, but need not be quantitative. Standards are normally developed for both the process and the outcomes of a medical education program. Specific information should be identified to evaluate compliance. For example, the standards related to process could address the objectives for and structure of the curriculum; the qualifications of entering students and teaching faculty; and the availability of resources for program support, including adequate finances, sufficient faculty, and an appropriate educational infrastructure for the scientific and clinical phases of training. The outcomes of the medical education program are then evaluated to determine if graduates have been adequately prepared based on the school’s objectives.

In order to be most effective, standards used in accreditation need to be widely disseminated and thoroughly explicated so that medical schools, evaluators, and decision-makers share a common understanding of their meaning and the expectations for compliance. For the sake of process effectiveness and transparency, the medical school faculty, the evaluators who review the medical schools’ compliance with accreditation standards, and the decision-makers who determine accreditation status will require training.

Institutions will have achieved their objectives if they have continually complied with accreditation standards and when internal monitoring becomes a formal responsibility for one or more individuals within the medical school who have access to relevant quality-linked information (e.g., the results of student satisfaction surveys and student performance data). Ongoing review of some or all accreditation standards allows schools to correct problem areas before they are identified as part of the formal accreditation review and ensures that educational program quality remains high.

If an accreditation review identifies areas where improvement is needed, a medical school should promptly correct the deficiencies. The accreditation/recognition body normally sets a timeline for follow-up by the end of which the educational program should be able to demonstrate the actions that have been taken and the outcomes that have been achieved. This may require the medical school/university to provide financial resources and to provide faculty time, effort, and adequate infrastructure, to make the needed corrections.

To assist schools in addressing identified deficiencies, support and consultation could be provided by the staff of the accrediting body or other trained individuals. To avoid conflict of interest, those who provide consultation should not take part in accreditation reviews or in decisions about accreditation status.

RESPONSIBILITIES OF STAKEHOLDERS GROUPS WITHIN AND EXTERNAL TO MEDICAL SCHOOLS

The creation of an accreditation system that meets the principles for validity and trustworthiness requires actions by a variety of stakeholder groups, such as:

Entities that sponsor accrediting bodies (e.g., governments, medical associations) need to ensure that the accrediting body is appropriately funded and staffed for its activities. Funding may come from the sponsors and/or from the accrediting body’s ability to generate its own funding from accreditation review fees. Accrediting bodies in certain countries may require additional funding and staffing to address the increase in the number of medical schools.
It is advisable for school leadership to encourage an environment that values educational quality assurance activities. Faculty should be given time and recognition for their participation in program evaluation and accreditation activities, and medical students should be prepared and encouraged to provide feedback on all relevant aspects of the medical education program.

RECOMMENDATIONS

The WMA calls upon National Medical Associations (NMAs)to encourage medical schools to develop quality assurance programs regarding ongoing review of educational program quality.

The WMA urges NMAs to support and promote the ongoing development of national and regional accreditation/recognition systems for medical schools. These systems should be designed and led by physicians in collaboration with experienced medical educators and with input from other relevant experts.

The WMA calls upon NMAs to urge national governmental and private-sector policy-makers to ensure that the national accreditation system has adequate and appropriate resources for its activities. This includes sufficient and consistent funding to support the infrastructure and staffing of the accrediting body.

The WMA recommends that accreditation systems use nationally-relevant standards applied consistently by trained evaluators and decision-makers when reviewing medical schools.

The WMA encourages NMAs to advocate to policy-makers that participation in the national accreditation system should be required for all medical schools within a country.

The WMA calls upon NMA’s to urge national accreditation systems to participate in external reviews of their policies, practices, and standards. This may include seeking recognition by the World Federation for Medical Education (WFME). Recognised accrediting bodies and similar organisations are urged to establish a forum for discussion and collaboration among national accrediting bodies to share best practices and mechanisms to overcome challenges.

Physicians should be encouraged to lead and actively participate in national accreditation activities as evaluators and decision-makers and in quality assurance activities at their own medical schools.

Adopted by the 30th World Medical Assembly Sao Paulo, Brazil, October 1976
and revised by the 36th World Medical Assembly Singapore, October 1984
and rescinded at the WMA General Assembly, Santiago 2005

Preamble

The World Medical Association, having considered the problem of pollution at its Scientific Conference held in Sao Paulo in 1976, emphasizes the importance of the ecological balance between people and their surroundings and stresses that as countries undergo social and economical development they should take steps for the improvement of the quality of their environment.

The problem of pollution affects not only the viability and beauty of the environment, but constitutes a growing threat to the very health of the humans who occupy it. Thus physicians must play a major role in prevention of disease due to pollution.

Definition

Environmental pollution may be defined as the result of actions taken by people, either consciously or due to neglect or ignorance, that degrade or contaminate the natural environment. For example, the indiscriminate disposal of chemical wastes may lead to irreparable contamination of precious acquifers from which come water that is essential to human life.

Certain adverse physical factors, ionizing radiation and chemicals such as chromium, asbestos, and those in tobacco are associated with cancer and other fatal or disabling illnesses, including birth and developmental defects among the descendants of exposed persons. Controlling exposures to such factors would have a salutary effect on people’s health and survival. Therefore, high priority should be given to the elimination of adverse physical factors in the home, school, workplace, and elsewhere.

Microbiological and chemical agents may prominently and adversely affect the health of workers and of the general population. Micro-biological agents can cause communicable diseases, as is apparent from decades of recorded experience. Chemicals can cause non-communicable hazards. Persons who are involved with food production and distribution have the responsibility of minimizing consumers’ exposures, not only to harmful microbiological agents, but also to agricultural chemicals used to increase crop production and to unsafe additives that may be used to preserve foods.

Component of Problem

Among the specific contributors to the problem of pollution, the following may be mentioned:

Air pollution involving oxides of nitrogen, photochemical oxidents, hydrocarbons, sulfur dioxide, lead, and certain particulates in the ambient air. Such substances can cause adverse pathophysiologic effects in children and adults and can damage plants and property.
Water pollution due to discharge of improperly treated human sewage wastes, and of agricultural and industrial wastes, into bodies of water. Such discharges contaminate drinking water with viruses, bacteria and other infectious micro-organisms; inorganic and organic chemicals, and radio-active substances. Water pollution also results in the reduction of recreational opportunities and of commercial fishing resources.
Solid wastes that attract rodents and insects at disposal sites and degrade the air and water; wastes can release toxic materials into the environment.
Excessive sound levels produced by industrial sources, transportation systems, audio systems and other means, may lead to permanent hearing loss, other pathophysiologic effects, and emotional disturbances.

Responsibility of Physicians

Physicians have the responsibility to educate the public and to encourage the establishing and maintaining of programs of environmental protection for their communities.

Recommendation

Individual physicians and National Medical Associations should take appropriate action to discharge the foregoing responsibility.

Adopted by the 38th World Medical Assembly Rancho Mirage, CA, USA, October 1986
and rescinded at the WMA General Assembly, Santiago 2005

The World Medical Association, Inc., recognizing the importance of the physician’s independence and professional freedom, hereby adopts the following declaration of principles:

Physicians must recognize and support the rights of their patients, particularly as set forth in the World Medical Association Declaration of Lisbon (1981).

Physicians must have the professional freedom to care for their patients without interference. The exercise of the physician’s professional judgement and discretion in making clinical and ethical decisions in the care and treatment of patients must be preserved and protected.

Physicians must have the professional independence to represent and defend the health needs of patients against all who would deny or restrict needed care for those who are sick or injured.

Within the context of their medical practice and the care of their patients, physicians should not be expected to administer governmental or social priorities in the allocation of scarce health resources. To do so would be to create a conflict of interest with the physician’s obligation to his patients, and would effectively destroy the physician’s professional independence, upon which the patient relies.

While physicians must be conscious of the cost of medical treatment and actively participate in cost containment efforts within medicine, it is the physician’s primary obligation to represent the interests of the sick and injured against demands by society for cost containment that would endanger patients’ health and perhaps patients’ life.

By providing independence and professional freedom for physicians to practice medicine, a community assures the best possible health care for its citizens, which in turn contributes to a strong and secure society.

Adopted by the 42nd World Medical Assembly Rancho Mirage, CA., USA, October 1990
and rescinded at the WMA General Assembly, Santiago 2005

The World Medical Association draws the attention of the medical profession throughout the world to the dangers presented by chemical and biological weapons. Among other, more obvious, dangers, it should be noted:

The use of such weapons would have a devastating effect on civilian populations in addition to military personnel, and not only in the target area but also in distant places, perhaps beyond the national boundaries of the combatants.
The effects of exposure to chemical and biological weapons present a continuing threat to the health of human beings on a long term basis, possibly causing illness, injury, disease and defects in the population over a long period of time.
The effects of exposure to chemical and biological weapons may also result in permanent, complex and unpredictable changes in the natural environment, including animals, plant life and water supply, thus destroying the food source of human beings and resulting in extensive morbidity.
Existing health care services, technology and manpower may be helpless to relieve the suffering caused by exposure to chemical and biological weapons.

The World Medical Association Declaration of Geneva asks physicians to consecrate their lives to the service of humanity, to pledge that the health of the patient will be the physician’s first consideration, and that the physician will not used medical knowledge contrary to the laws of humanity.

The World Medical Association Declaration of Helsinki states that it is the mission of the physician to safeguard the health of the people. The physician’s knowledge and conscience are dedicated to the fulfillment of this mission.

The World Medical Association Declaration of Tokyo begins with the following statement:

“It is the privilege of the medical doctor to practice medicine in the service of humanity, to preserve and restore bodily and mental health without distinction as to persons, to comfort and ease the suffering of his or her patients. The utmost respect for human life is to be maintained even under threat, and no use made of any medical knowledge contrary to the laws of humanity.”

Therefore, the World Medical Association considers that it would be unethical for the physician, whose mission is to provide health care, to participate in the research and development of chemical and biological weapons, and to use his or her personal and scientific knowledge in the conception and manufacture of such weapons.

Furthermore, the World Medical Association:

Condemns the development and use of chemical and biological weapons.
Asks all governments to refrain from the development and use of chemical and biological weapons.
Asks all National Medical Associations to join WMA in actively supporting this Declaration.

Adopted by the 44th World Medical Assembly Marbella, Spain, September 1992
and rescinded at the WMA General Assembly, Santiago 2005

PREAMBLE

The Human Genome Project is based on the assumption that the information contained in the gene will enable us to diagnose a large number of genetic diseases in utero or even before that; it will enable us to make decisions before procreation.

The key to the understanding of genetic diseases is in the identification and characterization of the genes after mutation. Henceforth, one can state that the understanding of all the human biology is enclosed in the identification of 50,000 to 100,000 genes in the human body’s chromosomes.

The Human Genome Project can enable us to identify and characterize the genes involved in the main genetic diseases; later on, it would be possible to identify and characterize the genes involved in diseases with a genetic component together with other factors such as Diabetis, Schizophrenia and Alzheimer. In these diseases the gene creates a predisposition to the disease rather than being the cause itself. These diseases cause severe social problems and if it is possible to diagnose the predisposition before the appearance of the disease, it might be possible to prevent it by changes in life-style, by diet modification and periodic check-ups.

In the second half of the 20th century a conceptional revolution has occurred when one started thinking of diseases in terms of biochemistry. A new revolution is happening now which locates in the gene the instructions for all the biochemical processes in the body’s cells.

Policy Problems

There are many important ethical reasons to get the genetic information as quickly as possible so that we may better understand many diseases. However, this information may be frustrating unless we develop at the same time therapeutic means and unless we will inform the public of the various genetic options so that the individual may select the best ones.

Another question is whether the invested efforts are justified compared with other ways to reach those objectives with lesser cost. Should the project aspire to a comprehensive inventory or is it preferable to start step by step with less pretentiousness, and progress modularly ?

Funding the Project

The Human Genome Project is considered a formidable project, similar to the space program, therefore one may claim that there is no proportion between the investment and its return. The estimated cost of the project is $3 billion during 15 years, i.e. $200 million a year. This cost may not seem extraordinary when we know that the Cystic Fibrosis Foundation, in the USA, only, has spent $120 million in the last four years, for this disease alone. Thus, the financial scarecrow should not prevent the development of the project.

Another disturbing factor stems from the interdiction – in some countries – to allocate funds for clinical research in human embryos. After having spent money on mapping the genes there could be no money allocated for clinical research based on the outcomes.

Conflict between the protection of privacy and the need for scientific collaboration

The mapping of the human genes has to be anonymous, but the information acquired will apply to every human being regardless of individual differences, colour or race. The information should be general property and should not be used for business aims. Therefore no patents should be given for the human genome or parts of it.

Genetic discrimination in private insurance and employment

here is a conflict between the increasing potential of new technologies to reveal genetic heterogeneity and the criterion for private insurance and employment. It may be desirable, regarding genetic factors, to adopt the same tacit consensus which prohibits the use of race discrimination in employment or insurance.

Genetic mapping may become a source of stigmatization and social discrimination, and the “risky population” may turn into a “defective population”.

The danger of Eugenics and the use of genes for non-medical aims

Eugenics is based on the assumption that the genes have a decisive importance, and the way to change their distribution in the population is to change reproductive behaviour. According to this concept the general good justifies the limitations on the individual’s liberty. The power of information raises concern about how it will be used. There is still fear of government eugenics programs for “the improvement of the race”, and the use of medical technology not for medical purposes.

RECOMMENDATIONS

The ethical issues raised by the Human Genome Project are not linked with the technology itself but with its proper use. Due to the power of this new tool, its ethical, legal and social issues should be examined whilst the program is still at its start.

Some of the opposition stems from the fear that the researcher may tend “to play God” or to interfere with the laws of nature. If we free ourselves from an uncompromising opposition to the Human Genome Project, we can assess the ethical outcomes with the same parameters that guide us whenever we examine a new diagnostic or therapeutic method. The main criteria remain the evaluation of risk versus advantage, the respect of a person as a human being and the respect of autonomy and privacy.

There is a need to state general ethical and legal guidelines to prevent discrimination and the genetic stigma of the population at risk.

The basic guidelines are:

The genetic service should be easily accessible to everyone in order to prevent its exploitation by only those who have resources which will increase social inequality.
There is a need for international information and transfer of technology and knowledge between all countries.
One should respect the will of persons screened and their right to decide about their participation and about the use of the information obtained.
Full information should be given to the patient or his legal agent. Medical secrecy should be kept and information should not be passed on to a third party without consent. Even if family members of the patient may be at risk, medical secrecy has to be kept unless there is a serious harm and this harm could be avoided by disclosing the information; the confidentiality can be breached only as a last resort when all trials to convince the patient to pass on the information by himself, have failed; even in this case, the relevant genetic information only should be disclosed.
The disclosure of information to a third party or the accessibility to personal genetic data should be allowed only with the patient’s informed consent.

Adopted by the 43rd World Medical Assembly Malta, November 1991
and rescinded at the WMA General Assembly, Pilanesberg, South Africa, 2006

Medical Education is a continuum of learning beginning with admission to medical school and ending with retirement from active practice. As such, it is a prime concern of all National Medical Associations and of the World Medical Association.

Medical Associations in every country should dedicate themselves to marshalling the resources needed to provide for and guide quality medical education. This should be done in the context of appropriately sized classes with access to adequate faculty, facilities, and funding.

To focus professional and public support for medical education, medical associations in all countries should be acutely aware of the needs, opinions, expectations, and personal dignity of their citizens.

As a result of deliberations at the 5th World Conference on Medical Education, the World Medical Association declares the following:

The goal of medical education should be to produce competent and ethical physicians, who respect their roles in the physician-patient relationship.
The elements of competence must include knowledge, skills, values, behaviors, and ethics which provide quality preventive and curative care for individual patients and the community.
Research, teaching, and ethical patient care are inseparable and essential to achieving the goal of physician competence.
An international core curriculum should be developed that will produce and maintain a competent physician whose skills transcend international borders.
Internationally standardized methods of assessing professional competence and performance should be developed and applied in undergraduate, graduate, and continuing medical education.
Free and prompt international dissemination of professionally generated and analysed medical information should be exchanged on epidemiological and public health problems to guide the development of public policies, the education of physician, and the public.
International standards should be established for the evaluation of educational programs across the continuum.
Education throughout a physician’s lifetime should be incorporated as a moral responsibility in an international code of ethics for all physicians.
Medical Associations in all countries should be prompt in responding to forces that threaten the integrity of medical education.
The effectiveness, safety, and applications of new technologies should be expeditiously identified and integrated into the continuum of medical education.

Adopted by the 39th World Medical Assembly Madrid, Spain, October 1987
and rescinded at the WMA General Assembly, Pilanesberg, South Africa, 2006

PREAMBLE

Medical Education is a continuum of learning beginning with admission to medical school and ending with retirement from active practice. Its purpose is to prepare medical students, resident physicians and practicing physicians to apply latest scientific advances for the prevention and cure of human diseases and the alleviation of presently incurable diseases. Medical Education also inculcates into physicians ethical standards of thought and behaviour, that emphasize service to others rather than personal gain. All physicians, whatever their practice, are members of one profession. As members of the medical profession, all physicians must accept the responsibility for not only maintaining high personal standards of medical education but also for maintaining high standards of medical education for the profession. This education must be grounded in the following principles:

PRINCIPLES OF MEDICAL EDUCATION

PRINCIPLE I
BASIC PRINCIPLES OF MEDICAL EDUCATION

Medical Education includes the education leading to the first professional degree, the clinical education that is preparatory to the practice of general medicine or a specialty and the continuing education that must undergird the lifelong work of the physician.

The profession, the faculties and other educational institutions, and the government share the responsibility for guaranteeing the high standards and quality of medical education.
PRINCIPLE II
UNDERGRADUATE MEDICAL EDUCATION

The goal of medical education is to educate physicians who are entitled, consistent with their training, to practice the profession without limitation.

The first professional degree should represent completion of a curriculum that qualifies the student for a spectrum of career choices, including patient care, public health, clinical or basic research, or medical education. Each career choice will require additional education beyond that required for the first professional degree.
PRINCIPLE III
EDUCATION BY THE FACULTY

Medical Education leading to the first professional degree must be conducted by an organized faculty. The faculty must possess the appropriate academic qualifications that can only be achieved through formal training and experience. The selection of faculty should be based upon the individual’s qualifications without consideration of age, sex, race, creed, political persuasion and national origin.

The faculty is responsible for creating an academic environment in which learning and inquiry can thrive in a maximal way. As such, active research to advance medical knowledge and the provision of the highest quality of care must occur in academic settings to demonstrate the highest medical standards. The goals, content, format and evaluation of the educational experiences provided are the responsibility of the faculty with participation of National Medical Associations. The faculty is responsible for providing its own obligatory basic curriculum in a academic environment of freedom in which learning and inquiry can thrive in a maximal way. Frequent reviews of the curriculum, allowing for the needs of the community and for input from practicing physicians should be conducted by the faculty, to the extent that community needs do not harm the quality of medical education. Recognition of faculty requires that library resources, research laboratories, clinical facilities, and study areas be available in sufficient quantity to meet the needs of all learners. In addition, the proper administrative structure and academic records must be maintained. When the necessary elements are available the clinical education of practitioners and specialists can be sponsored by either a university or a hospital.
PRINCIPLE IV
CONTENT OF MEDICAL EDUCATION

The educational experience should include the study of the biological and behavioral sciences and the socio-economics of health care. These sciences are basic to the understanding of clinical medicine. Critical thinking and self-learning should also be required, as should firm grounding in the ethical principles upon which the profession is built.
PRINCIPLE V
CLINICAL EDUCATION

The clinical component of medical education must be centered on the supervised study of patients and must involve direct experiences in the diagnosis and treatment of disease. The clinical component should include personal diagnostic and therapeutical experiences with gradual access to responsibilities. An adequate relation of the numbers admitted for training and teaching at the bedside of the individual patient must be observed.

Before beginning independent practice, every physician should complete a formal program of clinical education. This program, usually of at least one year’s duration, should be characterized by a supervised increase of responsibility for the management of clinical problems.

The faculty is responsible for determining that students who receive the first professional degree, have acquired a basic understanding of clinical medicine, the basic skills needed to evaluate clinical problems and take appropriate action independently, and have the attitude and character to be an ethical physician.
PRINCIPLE VI
SELECTION OF STUDENTS

A broad liberal education is highly desirable before embarking on the study of medicine. Students should be selected for the study of medicine on the basis of their intellectual ability, motivation, previous training, and character. The numbers admitted for training must not exceed the available educational resources and the needs of the population. Selection of students should not be influenced by age, sex, race, creed, political persuasion or national origin.
PRINCIPLE VII
POSTGRADUATE MEDICAL EDUCATION

It is desirable that the doctor takes up postgraduate medical education following the first professional degree, and he should make his choice between specialising for patient care, public health, clinical or basic research, or medical education. Formal programs of clinical education should precede the practice of unsupervised medicine including both general medicine and specialty. The medical profession is responsible for determining the satisfactory completion of programs of clinical education that follow the first professional degree.
PRINCIPLE VIII
CONTINUING MEDICAL EDUCATION

All Physicians are committed to lifelong learning. These educational experiences are essential if the physician is to keep abreast of developments in medicine and if the physician is to maintain the knowledge and skills necessary to provide high quality care; scientific advances are essential to an adequate health care of the people. Medical schools, hospitals and professional societies share the responsibility for developing and making available to all physicians opportunities for continuing medical education.

The demand to provide medical care, prevent disease and give advice in health matters calls for the highest standards of undergraduate postgraduate and continuing medical education.

Adopted by the 53^rd WMA General Assembly, Washington, DC, USA, October 2002
and revised by the 67^th WMA General Assembly, Taipei, Taiwan, October 2016

PREAMBLE

1. The Declaration of Helsinki lays down ethical principles for medical research involving human subjects, including the importance of protecting the dignity, autonomy, privacy and confidentiality of research subjects, and obtaining informed consent for using identifiable human biological material and data.

2. In health care provision, health information is gathered by physicians or other members of the medical team to record health care events and to aid physicians in the on-going care of their patient.

3. This Declaration is intended to cover the collection, storage and use of identifiable data and biological material beyond the individual care of patients. In concordance with the Declaration of Helsinki, it provides additional ethical principles for their use in Health Databases and Biobanks.

This Declaration should be read as a whole and each of its constituent paragraphs should be applied with consideration of all other relevant paragraphs.

4. A Health Database is a system for collecting, organizing and storing health information. A Biobank is a collection of biological material and associated data. Biological material refers to a sample obtained from an individual human being, living or deceased, which can provide biological information, including genetic information, about that individual. Health Databases and Biobanks are both collections on individuals and population, and both give rise to the similar concerns about dignity, autonomy, privacy, confidentiality and discrimination.

5. Research using Health Databases and Biobanks can often significantly accelerate the improvement in the understanding of health, diseases, and the effectiveness, efficiency, safety and quality of preventive, diagnostic and therapeutic interventions. Health research represents a common good that is in the interest of individual patients, as well as the population and the society.

6. Physicians must consider the ethical, legal and regulatory norms and standards for Health Database and Biobanks in their own countries as well as applicable international norms and standards. No national or international ethical, legal or regulatory requirement should reduce or eliminate any of the protections for individuals and population set forth in this Declaration.

When authorized by a national law adopted through a democratic process in respect of human rights, other procedures could be adopted to protect the dignity, autonomy and privacy of the individuals. Such procedures are only acceptable when strict rules on data protection are implemented.

7. Consistent with the mandate of WMA, the Declaration is addressed primarily to physicians. The WMA encourages others who are involved in using data or biological material in Health Databases and Biobanks to adopt these principles.

ETHICAL PRINCIPLES

8. Research and other Health Databases and Biobanks related activities should contribute to the benefit of society, in particular public health objectives.

9. Respecting the dignity, autonomy, privacy and confidentiality of individuals, physicians have specific obligations, both ethical and legal, as stewards protecting information provided by their patients. The rights to autonomy, privacy and confidentiality also entitle individuals to exercise control over the use of their personal data and biological material.

10. Confidentiality is essential for maintaining trust and integrity in Health Databases and Biobanks. Knowing that their privacy will be respected gives patients and donors the confidence to share sensitive personal data. Their privacy is protected by the duty of confidentiality of all who are involved in handling data and biological material.

11. The collection, storage and use of data and biological material from individuals capable of giving consent must be voluntary. If the data and biological material are collected for a given research project, the specific, free and informed consent of the participants must be obtained in accordance with the Declaration of Helsinki.

12. If the data or biological material are collected and stored in a Health Database or a Biobank for multiple and indefinite uses, consent is only valid if the concerned individuals have been adequately informed about:

The purpose of the Health Database or Biobank;
The risks and burdens associated with collection, storage and use of data and material;
The nature of the data or material to be collected;
The procedures for return of results including incidental findings;
The rules of access to the Health Database or Biobank;
How privacy is protected;
The governance arrangements as stipulated in paragraph 21;
That in case the data and material are made non-identifiable the individual may not be able to know what is done with their data/material and that they will not have the option of withdrawing their consent;
Their fundamental rights and safeguards established in this Declaration; and
When applicable, commercial use and benefit sharing, intellectual property issues and the transfer of data or material to other institutions or third countries.

13. In addition to the requirements set forth in the Declaration of Helsinki, when persons who were not able to consent, whose data and biological materials have been stored for future research, attain or regain the capacity to consent, reasonable efforts should be made to seek the consent of those persons for continued storage and research use of their data and biological materials.

14. Individuals have the right to request for and be provided with information about their data and its use as well as to request corrections of mistakes or omissions. Health Databases and Biobanks should adopt adequate measures to inform the concerned individuals about their activities.

15. Individuals have the right, at any time and without reprisal, to alter their consent or to ask for their identifiable data to be withdrawn from the Health Database and their biological material to be withdrawn from a Biobank. This applies to future use of the data and biological materials.

16. In the event of a clearly identified, serious and immediate threat where anonymous data will not suffice, the requirements for consent may be waived to protect the health of the population. An independent ethics committee should confirm that each exceptional case is justifiable.

17. The interests and rights of the communities concerned, in particular when vulnerable, must be protected, especially in terms of benefit sharing.

18. Special considerations should be given to the possible exploitation of intellectual property. Protections for ownership of materials, rights and privileges must be considered and contractually defined before collecting and sharing the material. Intellectual property issues should be addressed in a policy, which covers the rights of all stakeholders and communicated in a transparent manner.

19. An independent ethics committee must approve the establishment of Health Databases and Biobanks used for research and other purposes. In addition the ethics committee must approve use of data and biological material and check whether the consent given at the time of collection is sufficient for the planned use or if other measures have to be taken to protect the donor. The committee must have the right to monitor on-going activities. Other ethical review mechanisms that are in accordance to par 6 can be established.

GOVERNANCE

20. In order to foster trustworthiness, Health Databases and Biobanks must be governed by internal and external mechanisms based on the following principles:

Protection of individuals: Governance should be designed so the rights of individuals prevail over the interests of other stakeholders and science;
Transparency: any relevant information on Health Databases and Biobanks must be made available to the public;
Participation and inclusion: Custodians of Health Databases and Biobanks must consult and engage with individuals and their communities.
Accountability: Custodians of Health Databases and Biobanks must be accessible and responsive to all stakeholders.

21. Governance arrangements must include the following elements:

The purpose of the Health Database or Biobank;
The nature of health data and biological material that will be contained in the Health Database or Biobank;
Arrangements for the length of time for which the data or material will be stored;
Arrangements for regulations of the disposal and destruction of data or material;
Arrangement for how the data and material will be documented and traceable in accordance with the consent of the concerned persons;
Arrangement for how the data and material will be dealt with in the event of change of ownership or closure;
Arrangement for obtaining appropriate consent or other legal basis for data or material collection;
Arrangements for protecting dignity, autonomy, privacy and preventing discrimination;
Criteria and procedures concerning the access to and the sharing of the health data or biological material including the systematic use of Material Transfer Agreement (MTA) when necessary;
The person or persons who are responsible for the governance;
The security measures to prevent unauthorized access or inappropriate sharing;
The procedures for re-contacting participants where relevant;
The procedures for receiving and addressing enquiries and complaints.

22. Those professionals contributing to or working with Health Databases and Biobanks must comply with the appropriate governance arrangements.

23. Health Databases and Biobanks must be operated under the responsibility of an appropriately qualified professional assuring compliance with this Declaration.

24. The WMA urges relevant authorities to formulate policies and law that protect health data and biological material on the basis of the principles set forth in this document.

Adopted by the 22^nd World Medical Assembly, Sydney, Australia, August 1968
and amended by the 35^th World Medical Assembly, Venice, Italy, October 1983
by the 57^th WMA General Assembly, Pilanesberg, South Africa, October 2006
and by the 67^th WMA General Assembly, Taipei, Taiwan, October 2016

Determination of death can be made on the basis of the irreversible cessation of all functions of the entire brain, including the brain stem, or the irreversible cessation of circulatory and respiratory functions. This determination will be based on clinical judgment according to accepted criteria, supplemented, if necessary, by standard diagnostic procedures, and it will be made by a physician.

Even without intervention, cell, organ and tissue activity in the body may continue temporarily after a determination of death. Cessation of all life at the cellular level is not a necessary criterion for determination of death.

The use of deceased donor organs for transplantation has made it important for physicians to be able to determine when mechanically-supported patients have died.

After death has occurred, it may be possible to maintain circulation to the organs and tissues of the body mechanically. This may be done to preserve organs and tissues for transplantation.

Prior to post-mortem transplantation, the determination that death has occurred shall be made by a physician who is in no way immediately involved in the transplantation procedure.

Following the determination of death, all treatment and resuscitation attempts may be ceased and donor organs may be recovered, provided that prevailing requirements of consent and other relevant ethical and legal requirements have been fulfilled. Physicians should follow the protocol on organ donation for deceased donors as outlined in the WMA Statement on Organ and Tissue Donation.

Adopted by the 66^th WMA General Assembly, Moscow, Russia, October 2015
and revised by the 68th WMA General Assembly, Chicago, United States, October 2017

PREAMBLE

1. The burden of disease and injury associated with alcohol consumption is a critical challenge to global public health and development around the world. The World Medical Association offers this declaration on alcohol as its commitment to reducing excessive alcohol consumption and as a means to support its members in promulgating harm-reduction policies and other measures.

2. There are significant health, social and economic problems associated with excessive alcohol use. Overall, there are causal relationships between alcohol consumption and more than 200 types of disease and injury including traffic fatalities. The harmful use of alcohol kills approximately 3.3 million people every year (5.9 % of all deaths worldwide), and is the third leading risk factor for poor health globally, accounting for 5.1 % of disability-adjusted life years lost. Beyond the numerous chronic and acute health effects, alcohol use is associated with widespread social, mental and emotional consequences. The problem has a special magnitude among young people and adolescents who are beginning to consume alcohol at earlier ages, and the risk to their physical, mental and social health is of concern.

3. Although alcohol consumption is deeply rooted in many societies, alcohol cannot be considered an ordinary beverage or consumer commodity. It is a substance that causes extensive medical, psychological and social harm by means of physical toxicity, intoxication and dependence.

There is increasing evidence that genetic vulnerability to alcohol dependence is a risk factor for some individuals. Foetal alcohol syndrome and foetal alcohol effects, preventable causes of intellectual disability, result from alcohol consumption during pregnancy.

Adolescence is a stage of significant vulnerability because the neurological development is not complete and alcohol has a negative impact on it. Growing scientific evidence has demonstrated the harmful effects of consumption prior to adulthood on the brains, mental, cognitive and social functioning of youth and increased likelihood of adult alcohol dependence and alcohol related problems among those who drink before full physiological maturity. Regular alcohol consumption and binge drinking in adolescents can negatively affect school performance, increase participation in crime and adversely affect sexual performance and behaviour.

4. Effective alcohol harm-reduction policies and measures will include legal and regulatory measures that target overall alcohol consumption in the population, as well as health and social policy interventions that specifically target high-risk drinkers, vulnerable groups and harms to people affected by those who consume alcohol, e.g. domestic violence.

When developing policies it should be taken into account that the majority of alcohol-related problems in a population are associated with harmful or hazardous drinking by non-dependent ‘social’ drinkers, particularly when intoxicated. This is particularly a problem of young people in many regions of the world who drink with the intent of becoming intoxicated.

5. There are many evidence-based alcohol policies and prevention programmes that are effective in reducing the health, safety and socioeconomic problems attributable to harmful use of alcohol. International public health advocacy and partnerships are needed to strengthen and support the ability of governments and civil society worldwide to commit to, and deliver on, reducing the harmful use of alcohol through effective interventions, including action on social determinants of health.

Health professionals in general and physicians in particular have an important role to play in preventing, treating and mitigating alcohol-related harm, and in using effective preventive and therapeutic interventions.

The World Medical Association encourages and supports the development and implementation of evidence-based national alcohol policies by promoting and facilitating partnerships, information exchange and health policy capacity building.

POLICY OBJECTIVES

In developing alcohol policies, the WMA recommends the following broad objectives:

6. Strengthen health systems to identify and improve a country’s capacity to develop policy and lead actions that target excessive alcohol consumption.

7. Promote the development and evaluation in all countries of national alcohol strategies which are comprehensive, evidence-based and include measures to address the supply, distribution, sale, advertising, sponsorship and promotion of alcohol. The WHO ‘best buys’ cost effective policies should be particularly promoted, such as (i) increasing alcoholic beverage taxes, (ii) regulating the availability of alcoholic beverages, (iii) restricting marketing of alcoholic beverages and (iv) drink-driving countermeasures. Strategies should be routinely reviewed and updated.

8. Through government health departments, accurately measure the health burden associated with alcohol consumption through the collection of sales data, epidemiological data, and per capita consumption figures.

9. Support and promote the role of health and medical professionals in early identification, screening and treatment of harmful alcohol use.

10. Dispel myths and dispute alcohol control strategies that are not evidence-based.

11. Reduce the impact of harmful alcohol consumption in at risk populations.

12. Foster multi-disciplinary collaboration and coordinated inter-sectoral action.

13. Raise awareness of alcohol-related harm through public education and information campaigns.

14. Promote social determinants of health approach in fighting harmful alcohol consumption.

RECOMMENDATIONS

The following priorities are suggested for WMA members, National Medical Associations and governments when developing integrated and comprehensive policy and legislative responses.

15. Regulate affordability, accessibility and availability

15.1 Pricing policies

Evidence from epidemiological and other research demonstrates a clear link between the price of alcohol and levels of consumption, especially amongst young drinkers and those who are heavy alcohol users.

Therefore, action is needed to increase alcohol prices, through volumetric taxation of products based on their alcohol strength, and other proven pricing mechanisms, to reduce alcohol consumption, particularly in heavy drinkers and high risk groups.

Setting a minimum unit price at a level that will reduce alcohol consumption is a strong public health measure, which will both reduce average alcohol consumption throughout the population and be especially effective in heavy drinkers and young drinkers.

15.2 Accessibility and availability

Regulate access to, and availability of, alcohol by limiting the hours and days of sale, the number and location of alcohol outlets and licensed premises, and the imposition of a minimum legal drinking age. Governments should tax and control the production and consumption of alcohol, with licensing that emphasises public health and safety and empowers licensing authorities to control the total availability of alcohol in their jurisdictions. Governments should also control importation and sale of illegal alcohol across borders.

Public authorities must strengthen the prohibition of selling to and by minors and must systematically request proof of age before alcohol can be purchased in shops or bars.

16. Regulation of non-commercial alcohol

The production and consumption of non-commercial forms of alcohol, such as home brewing, illicit distillation, and illegal diversion alcohol to avoid taxes, should be curtailed using appropriate taxing and pricing mechanisms.

17. Regulation of alcohol marketing

Alcohol marketing should be restricted to prevent the early adoption of drinking by young people and to minimise their alcohol consumption. Regulatory measures range from wholesale bans and restrictions on measures that promote excessive consumption, to restrictions on the placement and content of alcohol advertising and sponsorship that are attractive to young people. There is evidence that industry self-regulation and voluntary codes are ineffective at protecting vulnerable populations from exposure to alcohol marketing and promotion.

Increase public awareness of harmful alcohol consumption through mandatory product labelling that clearly states alcoholic content in units, advice on recommended drinking levels and a health warning, supported by public awareness campaigns.

In conjunction with other measures, social marketing campaigns should be implemented together with the media to educate the public about harmful alcohol use, to adopt driving while intoxicated policies, and to target the behaviour of specific populations at high risks of harm.

18. The role of health and medical services in prevention

Health, medical and social services professionals should be provided with the training, resources and support necessary to prevent harmful use of alcohol and treat people with alcohol dependence, including routinely providing brief interventions to motivate high-risk drinkers to moderate their consumption. Health professionals also play a key role in education, advocacy and research.

Specialised treatment and rehabilitation services should be available in due time and affordable for alcohol dependent individuals and their families.

Together with national and local medical societies, specialty medical organizations, concerned social, religious and economic groups (including governmental, scientific, professional, nongovernmental and voluntary bodies, the private sector, and civil society) physicians and other health and social professionals can work to:

18.1 Reduce harmful use of alcohol, especially among young people and pregnant women, in the workplace, and when driving;

18.2 Increase the likelihood that everyone will be free of pressures to consume alcohol and free from the harmful and unhealthy effects of drinking by others;

18.3 Promote evidence-based prevention strategies in schools and communities;

18.4 Assist in informing the public of alcohol related harm and demystifying the myth of health enhancing properties of alcohol.

Physicians have an important role in facilitating epidemiologic and health service data collection on the impact of alcohol with the aim of prevention and promotion of public health. Data collection must respect the confidentiality of health data of individual patients.

19. Driving while intoxicated measures

Key deterrents should be implemented for driving while intoxicated, which include a strictly enforced legal maximum blood alcohol concentration for drivers of no more than 50mg/100ml, supported by social marketing campaigns and the power of authorities to impose immediate sanctions.

These measures should also include active enforcement of traffic safety measures, random breath testing, and legal and medical interventions for repeat intoxicated drivers.

20. Limit the role of the alcohol industry in alcohol policy development

The commercial priorities of the alcohol industry are in direct conflict with the public health objective of reducing overall alcohol consumption. Internationally, the alcohol industry is frequently included in alcohol policy development by national authorities, but the industry is often active in opposing and weakening effective alcohol policies. Ineffective and non-evidence-based alcohol control strategies promoted by the alcohol industry and the social organisations that the industry sponsors should be countered. The role of the alcohol industry in the reduction of alcohol-related harm should be confined to their roles as producers, distributors and marketers of alcohol, and not include alcohol policy development or health promotion.

21. Convention on Alcohol Control

Promote consideration of a Framework Convention on Alcohol Control similar to that of the WHO Framework Convention on Tobacco Control.

22. Exclude alcohol from trade agreements

Furthermore, in order to protect current and future alcohol control measures, advocate for alcohol to be classified as an extra-ordinary commodity and that measures affecting the supply, distribution, sale, advertising, sponsorship, promotion of or investment in alcoholic beverages be excluded from international trade agreements.

23. Action against positive media messaging

It is important to act on the impact of media messages on beliefs, intentions, attitudes and social norms. Well-designed media campaigns can have direct effects on behavior. The media also influence the social conception of a problem, and indirectly influence political decision-making on measures for intervention on alcohol.

Adopted by the 62^nd WMA General Assembly, Montevideo, Uruguay, October 2011,
the title (Statement to Declaration) changed by the 66^th WMA General Assembly, Moscow, Russia, October 2015
Amended by the 71^st WMA General Assembly (online), Cordoba, Spain, October 2020

PREAMBLE

The social determinants of health are the conditions in which people are born, grow, are educated, live, work and age; and the societal influences on these conditions. The social determinants of health are major influences on both quality of life, including good health, and length of disability-free life expectancy. Social determinants of health also include the impact of racism and discrimination, not just from an individualized or interpersonal perspective, but from structural and institutional perspectives.

While health care aims to cure and restore health, it is these social, cultural, environmental, economic and other factors that are the major causes of rates of illness and, in particular, the magnitude of health inequities.

Achieving health equity for all requires strong commitment from governments, the health care sector, health professionals and the international community among others. The UN Sustainable Development Goals (SDG)^[1] specifically aims to ensure healthy lives and promote well-being for all at all ages (goal 3), to ensure inclusive and equitable education and promote lifelong learning opportunities for all (goal 4) and to reduce inequality within and among countries (goal 10). In the WMA Statement on Access to Health Care, the WMA stresses the importance of health care access for all and suggests ways to act on inadequate access and health inequalities. The WMA further supports and promotes the introduction of adequate Universal Health Coverage in all countries. Universal Health Coverage will improve access to appropriate health care for all and thus promote awareness of and action on the social determinants of health.

Historically, the primary role of physicians and other health care professionals has been to treat the sick – a vital and much cherished role in all societies. To a lesser extent, health care professionals have dealt with individual exposures to the causes of disease – smoking, obesity, and alcohol in chronic disease, for example. These familiar aspects of lifestyle can be thought of as ‘proximate’ causes of disease.

The work on social determinants goes far beyond this focus on proximate causes and considers the “causes of the causes”. For example, smoking, obesity, alcohol, sedentary lifestyle are all causes of illness. A social determinants approach addresses the causes of these causes; and in particular how they contribute to social inequities in health. This approach focuses not only on individual behaviors but seeks to address the social and economic circumstances that give rise to premature poor health, throughout the life course. The voice of the medical profession has been and continues to be important in tackling these causes of the causes.

In many societies, unhealthy behaviors follow the social gradient: the lower in the socioeconomic hierarchy, the higher the rate of smoking, the worse the diet, and the less the physical activity. Central to the issue of addressing social determinants of health is the close interrelation between poverty and illness. A major, but not the only, cause of the social distribution of these causes is level of education. Structural inequity can also make access to healthy food difficult.

Specific examples of addressing the causes of the causes are: regulating the price and availability of alcohol, which are key drivers of alcohol consumption; and promoting tobacco taxation, package labeling, bans on advertising and smoking in public places, all of which have had demonstrable effects on tobacco consumption.

There is a growing movement globally that seeks to address gross inequities in health and length of life through action on the social determinants of health. This movement has involved the World Health Organization, several national governments, civil society organizations, and academics. Solutions are being sought and knowledge shared. Physicians need to be well informed about the implications of perpetuating inequalities and be willing to participate in this debate. They can be advocates for action on social conditions that have important effects on health and for strengthening of primary care and public health institutions. The medical profession can contribute significantly to public health, including through working with other sectors to find innovative solutions.

RECOMMENDATIONS

The WMA and National Medical Associations should take an active role in combating social and health inequities and barriers to obtaining health care, striving to enable physicians to provide equal, high quality health care to all. Adequate Universal Health Coverage in all countries should be a core objective as it will help reduce health inequity.
The WMA can add significant value to the global efforts to address the social determinants of health by helping physicians, other health professionals and National Medical Associations to understand what the emerging evidence shows and what works in different circumstances. WMA can call on physicians to lobby more effectively within their countries and across international borders and ensure that medical knowledge and skills are shared.
The WMA should help to gather data on successful initiatives and help to engage physicians and other health professionals in sharing experiences and implementing new and innovative solutions.
The WMA should work with National Medical Associations to promote education to medical students and physicians on health inequity and the social determinants of health, and to put pressure on national governments and international bodies to take the appropriate steps to minimise health inequity and these root causes of premature poor health.
The WMA and National Medical Associations should encourage governments and international bodies to take action on and implement specific policies and tools addressing health inequity and the social determinants of health. Some governments have taken initial steps to reduce health inequity by taking action on the social determinants of health; local areas have drawn up plans of action; there are good examples of general practice that work across sectors improving the quality of people’s lives and hence reduce health inequity. The WMA should gather examples of good practice from its members and promote further work in this area.

[1] https://www.un.org/sustainabledevelopment/sustainable-development-goals/

Adopted by the 65th WMA General Assembly, Durban, South Africa, October 2014
and rescinded and archived by the 73^rd WMA General Assembly, Berlin, Germany, October 2022

Preamble

The right to health is a fundamental element of human rights which does not change in situations of conflict and violence. Access to medical assistance for the sick and wounded, whether they have been engaged in active combat or not, is guaranteed through various international agreements, including the Geneva Convention and the Basic Principles on the Use of Force and Firearms by Law Enforcement Officials of the United Nations.

The primary obligation of physicians is always to their patients, and physicians have the same ethical responsibilities to preserve health and save life in situations of violence or armed conflicts as in peacetime. These are as set out in the WMA Regulations in Times of Armed Conflict and Other Situations of Violence.

It is essential to ensure the safety and personal security of healthcare workers in order to enable the provision of the highest standard of care to patients. If healthcare workers are not safe, they might not be able to provide care, and patients will suffer.

In situations of violence, the delivery of healthcare is frequently obstructed and the sick and wounded deprived of essential treatment through:

1. Medical workers being prevented from attending to the injured;

2. Interference by the state or others in positions of power through intimidation, detention or other legal measures;

3. Patients being denied access to medical facilities;

4. Targeted attacks upon medical facilities and medical transport;

5. Targeted attacks upon medical personnel, including kidnapping;

6. Non-targeted violent acts which result in the damage to or destruction of facilities or vehicles, or cause injury or death to medical personnel.

Such actions have serious humanitarian implications and violate international standards of medical neutrality as set out in the provisions of international human rights and humanitarian law and codes of medical ethics.

Attacks on the fundamental ethical principles of the medical profession, such as attempts to coerce medical professionals into providing details regarding those under their care, can undermine the confidence of patients and discourage injured people from seeking necessary treatment.

RECOMMENDATIONS

The WMA calls upon governments and all parties involved in situations of violence to:

1. Ensure the safety, independence and personal security of healthcare personnel at all times, including during armed conflicts and other situations of violence, in accordance with the Geneva Conventions and their additional protocols;

2. Enable healthcare personnel to attend to injured and sick patients, regardless of their role in a conflict, and to carry out their medical duties freely, independently and in accordance with the principles of their profession without fear of punishment or intimidation;

3. Safe access to adequate medical facilities for the injured and others in need of medical aid should not be unduly impeded;

4. Protect medical facilities, medical transport and the people being treated in them and provide the safest possible working environment for healthcare workers and protect them from interference and attack;

5. Respect and promote the principles of international humanitarian and human rights law which safeguard medical neutrality in situations of conflict;

6. Establish reporting mechanisms to document violence against medical personnel and facilities as set out in the WMA Statement on the Protection and Integrity of Medical Personnel in Armed Conflicts and Other Situations of Violence.

7. Raise awareness of international norms on the protection of healthcare workers and cooperate with different actors to identify strategies to tackle threats to healthcare. The collaboration between the WMA and the International Committee of the Red Cross on the Health Care in Danger project provides one example of this.

Adopted by the 53^rd WMA General Assembly, Washington, DC, USA, October 2002, and
revised by the 63^rd WMA General Assembly, Bangkok, Thailand, October 2012 and
by the 74^th WMA General Assembly, Kigali, Rwanda, October 2023, and
renamed “Declaration of Kigali” by the 75^th WMA General Assembly, Helsinki, Finland, October 2024

PREAMBLE

Medical technology has come to play a key role in modern medicine. It has helped provide significantly more effective means of prevention, diagnosis, treatment and rehabilitation of illness, for example through the development and use of information technology, such as telehealth, digital platforms and large-scale data collection and analyses, or the use of advanced machinery and software in areas like medical genetics and radiology, including assistive, artificial, and augmented intelligences.

The importance of technology for medical care will continue to grow and the WMA welcomes this progress. The continuous development of medical technologies – and their use in both clinical and research settings – will create enormous benefits for the medical profession, patients, and society.

However, as for all other activities in the medical profession, the use of medical technology for any purpose, must take place within the framework provided by the basic principles of medical ethics as stated in the WMA Declaration of Geneva: The Physician’s Pledge, the International Code of Medical Ethics and the Declaration of Helsinki.

Respect for human dignity and rights, patient autonomy, beneficence, confidentiality, privacy and fairness must be the key guiding points when medical technology is developed and used for medical purposes.

The rapidly developing use of big data has implications for confidentiality and privacy. Using data in ways which would damage patients’ trust in how health services handle confidential data would be counterproductive. This must be borne in mind when introducing new data driven technology. It is essential to preserve high ethical standards and achieve the right balance between protecting confidentiality and using technology to improve patient care.

Additionally, bias through for example social differences in the collection of data may skew the intended benefits of data driven medical treatment innovations.

As medical technology advances and the potential for commercial involvement grows, it is important to protect professional and clinical independence.

RECOMMENDATIONS

Beneficence

The use of medical technology should have as its primary goal benefit for patients’ health and well-being. Medical technology should be based on sound scientific evidence and appropriate clinical expertise. Foreseeable risks and any increase in costs should be weighed against the anticipated benefits for the individual as well as for society, and medical technology should be tested or applied only if the anticipated benefits justify the risks.

Confidentiality and privacy

Protecting confidentiality and respecting patient privacy are central tenets of medical ethics and must be respected in all uses of medical technology.

Patient autonomy

The use of medical technology must respect patient autonomy, including the right of patients to make informed decisions about their health care and control access to their personal information. Patients must be given the necessary information to evaluate the potential benefits and risks involved, including those generated by the use of medical technology.

Justice

To ensure informed choices and avoid bias or discrimination, the basis and impact of medical technology on medical decisions and patient outcomes should be transparent to patients and physicians. In support of fair and equitable provision of health care, the benefits of medical technology should be available to all patients and prioritized based upon clinical need and not on the ability to pay.

Human rights

Medical technology must never be used to violate human rights, such as use in discriminatory practices, political persecution or violation of privacy.

Professional independence

To guarantee professional and clinical independence, physicians must strive to maintain and update their expertise and skills, i.e., by developing the necessary proficiency with medical technology. Medical curricula for students and trainees as well as continuing education opportunities for physicians must be updated to meet these needs. Physicians shall be included in contributions to research and development. Physicians shall remain the expert during shared decision making and not be replaced by medical technology.
Health care institutions and the medical profession should:

help ensure that innovative practices or technologies that are made available to physicians meet the highest standards for scientifically sound design and clinical value;
require that physicians who adopt innovations into their practice have relevant knowledge and skills;
provide meaningful professional oversight of innovation in patient care;
encourage physician-innovators to collect and share information about the resources needed to implement their innovations safely, effectively, and equitably; and
assure that medical technologies are applied and maintained appropriately in accordance with their intended purpose.

The relevance of these general principles is stated in detail in several existing WMA policies. Of particular importance are:

The WMA encourages all relevant stakeholders to embody the ethics guidance provided by these documents.

Adopted by the 62^nd WMA General Assembly, Montevideo, Uruguay, October 2011

In the last decade, the attention of the world has been drawn to a number of severe events which seriously tested and overwhelmed the capacity of local healthcare and emergency medical response systems. Armed conflicts, terrorist attacks and natural distasters such as earthquakes, floods and tsunamies in various parts of the world have not only affected the health of people living in these areas but have also drawn the support and response of the international community. Many National Medical Associations have sent groups to assist in such disaster situations.

According to the World Health Organization (WHO) Center for Research on the Epidemiology of Disasters (CRED), the frequency, magnitude, and toll of natural disasters and terrorism have increased throughout the world. In the previous century, about 3.5 million people were killed worldwide as a result of natural disasters; about 200 million were killed as a result of human-caused disasters (e.g., wars, terrorism, genocides). Each year, disasters cause hundreds of deaths and cost billions of dollars due to disruption of commerce and destruction of homes and critical infrastructure.

Population vulnerability (e.g., due to increased population density, urbanization, aging) has increased the risk of disasters and public health emergencies. Globalization, which connects countries through economic interdependencies, has led to increased international travel and commerce. Such activity has also led to increased population density in cities around the world and increased movement of people to coastal areas and other disaster-prone regions. Increases in international travel may speed the rate at which an emerging infectious disease or bioterrorism agent spreads across the globe. Climate change and terrorism have emerged as important global factors that can influence disaster trends and thus require continued monitoring and attention.

The emergence of infectious diseases, such as H1N1 influenza A and severe acute respiratory syndrome (SARS), and the recent arrival of West Nile virus and monkey pox in the Western hemisphere, reinforces the need for constant vigilance and planning to prepare for and respond to new and unexpected public health emergencies.

The growing likelihood of terrorist-related disasters affecting large civilian populations affects all nations. Concern continues about the security of the worldwide arsenal of nuclear, chemical, and biological agents as well as the recruitment of people capable of manufacturing or deploying them. The potentially catastrophic nature of a “successful” terrorist attack configures an event that may demand a disproportionate amount of resources and healthcare professionals preparedness.. Natural disasters such as tornadoes, hurricanes, floods, and earthquakes, as well as industrial and transportation-related catastrophes, are far more common and can also severely stress existing medical, public health, and emergency response systems.

In light of recent world events, it is increasingly clear that all physicians need to become more proficient in the recognition, diagnosis, and treatment of mass casualties under an all-hazards approach to disaster management and response. They must be able to recognize the general features of disasters and public health emergencies, and be knowledgeable about how to report them and where to get more information should the need arise. Physicians are on the front lines when dealing with injury and disease-whether caused by microbes, environmental hazards, natural disasters, highway collisions, terrorism, or other calamities. Early detection and reporting are critical to minimize casualties through astute teamwork by public- and private-sector health and emergency response personnel.

The WMA, representing the doctors of the world, calls upon its members to advocate for the following:

To promote a standard competency set to ensure consistency among disaster training programs for physicians across all specialties. Many NMAs have disaster courses and previous experiences in disaster response. These NMAs can share this knowledge and advocate for the integration of some standardized level of training for all physicians, regardless of specialty or nationality.

To work with national and local governments to establish or update regional databases and geographic mapping of information on health system assets, capacities, capabilities, and logistics to assist medical response efforts, domestically and worldwide, when needed. This could include information on local response organizations, the condition of local hospitals and health system infrastructures, endemic and emerging diseases, and other important public health and clinical information to assist medical response in the event of a disaster. In addition, systems for communicating directly with physicians and other front line health care providers should be identified and strengthened.

To work with national and local governments to ensure the developing and testing of disaster management plans for clinical care and public health including the ethical basis for delivering such plans.

To encourage governments at national and local levels to work across normal departmental and other boundaries in developing the necessary planning.

The WMA could serve as a channel of communication for NMAs during such times of crisis, enabling them to coordinate activities and work together.

Adopted by the 62^nd WMA General Assembly, Montevideo, Uruguay, October 2011
and reaffirmed with minor revisions by the 218^th Council session (online), London, United Kingdom, October 2021

Leprosy is a widespread public health problem, with approximately 200.000 new cases diagnosed annually worldwide. It is a curable disease and after starting treatment, the chain of transmission is interrupted. Leprosy is a disease that have been inadequately addressed from the point of view of investments in research and medical treatment.

The World Medical Association recommends to all National Medical Associations to defend the right of the people affected with leprosy and members of their families, that they should be treated with dignity and free from any kind of prejudice or discrimination. Physicians, health professionals and civil society should be engaged in combating all forms of prejudice and discrimination. Research centers should acknowledge leprosy as a major public health problem and continue to research this disease since there are still gaps in understanding its patho-physiological mechanisms. These gaps in knowledge may be overcome through the allocation of resources to new research, which will contribute to more efficient control worldwide. Medical schools, especially in countries with high prevalence of leprosy, should enhance its importance in the curriculum. The public, private, and civil sectors should unify their best efforts in order to disseminate information that would counteract prejudice towards leprosy and that acknowledges its curability.

Adopted by the 62^nd WMA General Assembly, Montevideo, Uruguay, October 2011
and rescinded and archived by the 73^nd WMA General Assembly, Berlin, Germany, October 2022

INTRODUCTION

All people have the right to high-quality, scientifically-based, and humane healthcare. Therefore, receiving appropriate end-of-life medical care must not be considered a privilege but a true right, independent of age or any other associated factors. The WMA reaffirms the principles articulated in the WMA Declaration on Terminal illness and the WMA Declaration on Euthanasia. These Declarations support and complement the Declaration on End of Life Medical Care.

Palliative care at the end of life is part of good medical care. The need for access to improved quality palliative care is great, especially in resource-poor countries. The objective of palliative care is to achieve the best possible quality of life through appropriate palliation of pain and other distressing physical symptoms, and attention to the social, psychological and spiritual needs of the patient.

Palliative care may be provided at home as well as in various levels of health care institutions.

The physician must adopt an attitude to suffering that is compassionate and humane, and act with empathy, respect and tact. Abandonment of the patient when he or she needs such care is unacceptable medical practice.

RECOMMENDATIONS

1. Pain and symptom management

1.1 It is essential to identify patients approaching the end of life as early as possible so that the physician can perform a detailed assessment of their needs. A care plan for the patient must always be developed; whenever possible, this care plan will be developed in direct consultation with the patient.

For some this process may begin months or a year before death is anticipated. It includes recognising and addressing the likelihood of pain and other distressing symptoms and providing for patients’ social, psychological and spiritual needs in the time remaining to them. The primary aim is to maintain patients’ dignity and their freedom from distressing symptoms. Care plans pay attention to keeping them as comfortable and in control as possible and recognise the importance of supporting the family and treating the body with respect after death.

1.2 Important advances in the relief of pain and other distressing symptoms have been made. The appropriate use of morphine, new analgesics, and other measures can suppress or relieve pain and other distressing symptoms in the majority of cases. The appropriate health authorities must make necessary medications accessible and available to physicians and their patients. Physician groups should develop guidelines on their appropriate use, including dose escalation and the possibility of unintended secondary effects.

1.3 In a very limited number of cases, generally in the very advanced stages of a physical illness, some symptoms may arise that are refractory to standard therapy. In such cases, palliative sedation to unconsciousness may be offered when life expectancy is a few days, as an extraordinary measure in response to suffering which the patient and clinician agree is intolerable. Palliative sedation must never be used to intentionally cause a patient’s death or without the agreement of a patient who remains mentally competent. The degree and timing of palliative sedation must be proportionate to the situation. The dosage must be carefully calculated to relieve symptoms but should still be the lowest possible to achieve a benefit.

2. Communication and consent; ethics and values

2.1 Information and communication among the patient, their family and members of the health care team is one of the fundamental pillars of quality care at the end of life. The patient should be encouraged to express his or her preferences regarding care, and his or her emotions and existential angst must be taken into consideration.

2.2 Ethically-appropriate care at the end of life should routinely promote patient autonomy and shared decision-making, and be respectful of the values of the patient and his or her family.

2.3 Physicians should directly discuss a patient’s preferences with the patient and/or the patient’s substitute health care decision maker, as appropriate. These discussions should be initiated early and routinely offered to all patients and should be revisited regularly to explore any changes patients may have in their wishes, especially as their clinical conditions change. Physicians should encourage their patients to formally document their goals, values and treatment preferences and to appoint a substitute health care decision maker with whom the patient can discuss in advance his or her values regarding health care and treatment. Patients who are in denial about the implications of their condition may not want to engage in such discussion at some stages of their illness, but should know that they can change their minds. Because documented advance directives are often not available in emergency situations, physicians should emphasize to patients the importance of discussing treatment preferences with individuals who are likely to act as substitute health care decision makers.

2.4 If a patient is capable of giving consent, care should be based on the patient’s wishes as long as preferences can be justified medically, ethically and legally. Consent needs to be based on sufficient information and dialogue, and it is the physician’s obligation to make sure that the patient is adequately treated for pain and discomfort before consent is obtained in order to assure that unnecessary physical and mental suffering do not interfere with the decision-making process.

2.5 The patient’s next-of-kin or family should be informed and involved in the decision-making process, provided the patient is not opposed to this. If the patient is unable to express consent and an advance directive is not available, the views of the health care substitute decision maker, appointed by the patient on care and treatment, must be considered.

3. Medical records and medico-legal aspects

3.1 Physicians caring for a patient in the final stages of life must carefully document treatment decisions and the reasons for choosing particular procedures, including the patient’s and family’s wishes and consent, in the progress notes of the medical records. An adequate medical record is of the utmost importance for continuity and quality of medical care in general and palliative care in particular.

3.2 The physician must also take into account that these notes may serve a medico-legal purpose, e.g., in determining the patient’s decision-making capacity.

4. Family members

It is necessary to acknowledge the importance of the family and the emotional environment of the patient. The needs of the family and other close caregivers throughout the course of the illness must be recognized and attended to. The heath care team should promote collaboration in the care of the patient and provide bereavement support, when required, after the patient’s death. Children’s and families’ needs may require special attention and competence, both when children are patients and dependents.

5. Teamwork

Palliative care is usually provided by multiprofessional and interdisciplinary teams of healthcare and non-healthcare professions. The physician must be the leader of the team, being responsible, amongst other obligations, for diagnosis and medical treatment. Continuity of care is very important. The team should do all it can to facilitate a patient’s wish to die at home, if applicable and possible.

6. Physician training

The increasing number of people who require palliative care and the increased availability of effective treatment options mean that end-of-life care issues should be an important part of undergraduate and postgraduate medical training.

7. Research and education

More research is needed to improve palliative care. This includes, but is not limited to, general medical care, specific treatments, psychological implications and organization. The WMA will support efforts to better educate physicians in the skills necessary to increase the prevalence and quality of meaningful advance care planning.

CONCLUSION

The care that a people give to dying patients, within available resources, is an indication of their degree of civilisation. As physicians representing the best humanitarian tradition, we should always commit ourselves to delivering the best possible end-of-life care.

The WMA recommends that all National Medical Associations develop a national policy on palliative care and palliative sedation based on the recommendations in this declaration.

Adopted by the 62^nd WMA General Assembly, Montevideo, Uruguay, October 2011
and revised by the 73^rd WMA General Assembly, Berlin, Germany, October 2022

PREAMBLE

The right to health and medical assistance is a basic human right that should be guaranteed at all times; ethical principles of healthcare remain the same in times of emergencies and in times of peace. Healthcare personnel must be duly protected.

Various international agreements, including the Geneva Conventions (1949), Additional Protocols to the Geneva Conventions (1977, 2005) and the Basic Principles on the Use of Force and Firearms by Law Enforcement Officials of the United Nations, must guarantee safe access to medical assistance as well as the protection of healthcare personnel.

The United Nations Security Council Resolution 2286 (2016) condemns attacks and threats against health care personnel, demands an end to impunity for those responsible, and that all parties to armed conflict comply fully with their obligations under international law.

Despite recognized international standards and the mobilization of humanitarian and human rights stakeholders over the last years denouncing the surge of violence against healthcare worldwide, the WMA notes with great concerns persistent attacks and misuses of hospitals and other medical facilities, as well as threats, killings and other violence against patients and healthcare personnel in emergency contexts.

The WMA condemns in the strongest terms this scourge of violence against healthcare personnel and facilities, which has disastrous humanitarian implications with critical impacts on the capacity of the health system to provide the care needed, resulting in unjustifiable suffering and death. Violence against healthcare personnel constitutes an international emergency, requiring urgent actions.

Recalling its Statement on Armed Conflicts, the WMA reaffirms that armed conflicts should always be a last resort and that States and other authorities who enter into armed conflict must accept responsibility for the consequences of their actions.

The safety and personal security of physicians and other healthcare personnel are essential in enabling them to provide care and save lives in situations of conflicts. They must always be respected as neutral and should never be prevented from fulfilling their duties. Healthcare personnel and facilities should never be instrumentalised as means of war.

Recalling its Regulations in Times of Armed Conflict and Other Situations of Violence, the WMA reaffirms that the primary obligation of physicians and other healthcare personnel is always to their patients; they have the same ethical responsibilities in situation of violence or armed conflicts as in peacetime, the same duty of preserving health and saving lives; they shall at all times act in accordance with the ethical principles of the profession, relevant international and national law, and their conscience.

RECOMMENDATIONS

The WMA calls upon all parties involved in situations of violence to:

1.Fully comply with their obligations under international law, including human rights law and international humanitarian law, in particular with their obligations under the Geneva Conventions of 1949 and the obligations applicable to them under the Additional Protocols of 1977 and 2005;

2. Ensure the safety, independence and personal security of healthcare personnel at all times, including during armed conflicts and other situations of violence, in accordance with the Geneva Conventions and their additional protocols;

3. Respect and promote the principles of international humanitarian and human rights law which safeguard medical neutrality in situations of conflict;

4. Protect medical facilities, medical transport and the people being treated in them, provide the safest possible working environment for healthcare personnel, and protect them from threats, interference and attack;

5. Never misuse hospitals and other health facilities for military purposes and dedicate them exclusively to health care;

6. Enable healthcare personnel to treat injured and sick patients, regardless of their role in a conflict, and to carry out their medical duties freely, independently and in accordance with the principles of their profession without fear of punishment or intimidation;

7. Ensure that safe access to adequate medical facilities for the injured and others in need of medical aid is not unduly impeded;

8. Ensure that the equipment, including personal protection equipment, necessary for the safety of healthcare workers, is available to them as needed, and that the staffing is adequate;

9. Support and strictly respect the ethical rules of the medical profession as defined, among other documents, in the Ethical Principles of Health Care in Times of Armed Conflict and Other Emergencies and in the WMA Regulations in Times of Armed Conflict and Other Situations of Violence, and to never require from physicians or force them to breach or renounce these rules, in particular:

privileges and facilities afforded to physicians and other health care professionals in times of armed conflict and other situations of violence must never be used for purposes other than health care;
physicians must at all times show appropriate respect for medical confidentiality;
physicians must never accept acts of torture or any other form of cruel, inhuman or degrading treatment under any circumstances; they must never be present at nor take part in such acts;
physicians have a duty to recognize and support vulnerable populations, including women, children, refugees, the disabled and displaced persons;
physicians and WMA constituent members should alert governments and non-state actors of the human consequences of warfare;
where conflict appears to be imminent and inevitable, physicians should ensure that authorities are planning for the protection of the public health infrastructure and for any necessary repair in the immediate post-conflict period.

The WMA calls upon governments to:

10. Establish efficient, secure and unbiased reporting mechanisms with sufficient resources to collect and disseminate data regarding assaults on physicians, other healthcare personnel and medical facilities;

11. Provide to the WHO the necessary support to fulfil its leadership role in documenting attacks on healthcare personnel and facilities[1];

12. Foster the mechanisms of investigating and bringing to justice those responsible for reported violations of the international agreements pertaining to the protection of healthcare personnel in armed conflicts and other situations of violence, and of enforcing the sanctions when such have been decided;

13. Develop and implement more efficient legal protection for medical and other healthcare personnel, so that whoever attacks a nurse, physician or another healthcare personnel knows that such actions will be severely penalised.

The WMA calls upon governments, its member organisations and the appropriate international bodies to:

14. Raise awareness of international norms on the protection of healthcare personnel and cooperate with different actors to identify strategies to tackle threats to healthcare and strengthen the mechanism of investigating the reported violations;

15. Raise awareness at both national and local level of the fundamental importance of protecting the healthcare personnel and of upholding their neutrality in times of conflict;

16. Support the development of pregraduate, postgraduate and continuous education for the healthcare personnel to ensure their competencies and their security and to minimize the psychological toll when confronted with armed conflicts and other situations of violence.

[1] The WMA recognizes that in some circumstances, documenting and denouncing acts of torture or other violence may put the physician, and those close to him or her, at great risk. Doing so may have excessive personal consequences. Physicians must avoid putting individuals in danger while assessing, documenting or reporting signs of torture and cruel, inhuman and degrading treatment and punishments.

Adopted by the 50^th World Medical Assembly, Ottawa, Canada, October 1998,
revised by the 60^th WMA General Assembly, New Delhi, India, October 2009
and by the 71^st WMA General Assembly (online), Cordoba, Spain, October 2020

PREAMBLE

Science has now proven that to reach their potential, children need to grow up in an environment where they can thrive – spiritually, emotionally, mentally, physically and intellectually. That place must be characterized by four fundamental elements:

A healthy, safe and sustainable physical and emotional environment.
the opportunity for optimal growth and development;
adequate health services for healthy child development; and
monitoring and research for evidence-based continual improvement into the future

Physicians know that the future of our world depends on our children. Early childhood experiences strongly influence future development, including basic learning, school success, economic participation, social citizenry, and health. In most situations, parents and caregivers are only able to provide nurturing environments with help from local, regional, national and international organizations.

The principles of this Declaration apply to all children in the world from birth to 18 years of age, regardless of race, age, ethnicity, nationality, political affiliation, creed, language, gender, sex, disease or disability, physical ability, mental ability, sexual orientation, cultural history, life experience or the socioeconomic status of the child or her/his parents or legal guardian. In all countries of the world, regardless of resources, meeting these principles should be a priority for parents, communities and governments. The United Nations Convention on the Rights of Children (1989) and National Children’s rights Charters, set out the broader rights of all children and young people, but those rights cannot exist without health. Furthermore, the United Nations Sustainable and Development Goals, especially SDG3, SDG4, SDG5, and SDG6, apply directly to the health of children and the social determinants of health. Responsibility for giving effect to the principles herein lies with the government of the region where the child is primarily domiciled.

All children should be treated with dignity, tolerance and respect and be taught the same.

All children have the right to the highest attainable standard of physical and mental health and wellbeing.

Addressing the social determinants of health is essential to achieving equity in health and healthcare in children.

While children are generally regarded as the vulnerable groups, the most vulnerable groups of children include children with special needs, orphans, the homeless, refugees and asylum seekers, disabled, children from low-income homes and conflict zones. These groups require special consideration in all areas.

A healthy, safe and sustainable physical and emotional environment comprises the following elements:

A safe and sustainable physical environment with minimum climate change, optimum ecosystem free from water, air and soil pollution and degradation;
Urgent implementation of climate change adaptation and mitigation strategies, and age-appropriate education on climate change to achieve a better and more sustainable environment for all children;
A safe home, a family setting, available parental care and a community that cares;
Healthy, safe and stable families, homes, schools and communities;
Protection from bullying and an environment that promotes positive mental health;
Protection from discrimination based on age, disease or disability, creed, ethnic origin, gender, nationality, political affiliation, race, sexual orientation, social standing or any other factor;
Access to a safe infrastructure, including safe sanitation, transportation, and places to play;
Protection from natural and man-made disasters;
Protection from physical, sexual, emotional and verbal abuse and neglect;
Prevention of exploitation in the form of child labour;
Protection from harmful traditional practices;
Freedom from witnessing and participating in violence and armed conflict including forced recruitment as child soldiers or into gangs;
Protection from the harms associated with alcohol, tobacco and substance abuse, including the right to age-appropriate information.

All infants should be officially registered within one month of birth or as soon as possible to enable them to have an official identity, access to health care, social security and any other resources where identification is mandatory.

Asylum seeking children, whether accompanied or unaccompanied, should not be detained, separated from the parents and families sent back to a place where they are at risk of human rights violations.

The opportunity for optimal growth and development entails:

Access to adequate healthy and nutritious food to promote long-term health development. This includes the promotion of exclusive breastfeeding, where possible, for the first six months of life as long as the mother and baby are comfortable, access to adequate safe food that satisfies dietary diversity, and protection from obesogenic environments through regulation of unhealthy and processed food and beverages;
Promotion and encouragement of nutritional literacy, physical activity and physical education from an early age;
Access to education from early childhood through secondary education with provisions for those without access;
Access to age-appropriate information as it pertains to health, including the provision of evidence-based comprehensive sexuality education;
Access to social assistance.

Access to the full range or appropriate and high-quality healthcare services for all stages of childhood development entails:

The best interests of the child shall be the primary consideration in the provision of health care. The following principles of child health care must be ensured:

Appropriate preventive, curative, rehabilitative and emergency care for mother and child;
Prenatal and maternal care for the best possible health at birth and good postnatal care to ensure the best possible outcomes for mother and child;
Respect for the privacy of children;
Medical care for all children of asylum seekers and refugees;
Specialized training necessary to enable caregivers to respond appropriately to the specific medical, physical, emotional and developmental needs of children & their families;
Basic health care including developmental assessment, health promotion, recommended immunization, early detection of disease, access to medicines, oral and eye-health;
Multidisciplinary (i.e. consisting of physicians, social workers, psychologists, therapists, occupational therapists, education specialists and others) and community-based mental health prevention, care and prompt referral for intervention when problems are identified;
Priority access to emergency medical care for life-threatening conditions;
Hospitalization when appropriate. Hospitals should provide access to parental facilities and policies for continuous parental care;
Specialist diagnosis, care and treatment when needed;
Rehabilitation services and supports within the community;
Pain management and care and prevention (or minimization) of suffering;
End of life care / Palliative care;
Informed consent is necessary before initiating any diagnostic, therapeutic, rehabilitative, or research procedure on a child.  In the majority of cases, the consent shall be obtained from the parent(s) or legal guardian, or, in some cases, by extended family, although the wishes of a competent child should be taken into account before consent is given.  Where a child lacks competence and is able to express a view, his/her wishes should still be taken into account before consent is given. Where appropriate (e.g. reproductive health services), competent children should be allowed to consent to treatment without parental consent. In case of a life-threatening, and when competent children cannot give consent and parents/caregivers are not accessible, for treatment, consent should be presumed for life-saving treatment;
The full range of sexual and reproductive health services for adolescents including access to abortion according to national legislation;
Respect for the sexual and gender identity of the child. Harmful practices like genital mutilation or so-called conversion therapies must be forbidden;
Social assistance and mechanisms to provide for universal access to health care are ensured for all particularly vulnerable children;
The homeless, orphaned, asylum seeker, refugees and children from conflict zones should be provided with essential and emergency medical care without discrimination.

Monitoring & and research for evidence-based continual improvement into the future includes:

The principles of the Declaration of Helsinki must be observed in any research study involving children as research subjects.

Adopted by the 60^th WMA General Assembly, New Delhi, India, October 2009
and amended by the 68th WMA General Assembly, Chicago, United States, October 2017

PREAMBLE

1. Human influence on the climate system is clear, and recent emissions of green-house gases are the highest in history. Recent climate changes have had widespread impacts on human and natural systems.

2. Compelling evidence substantiates the numerous health risks posed by climate change, which threaten all countries. These include more frequent and potentially more severe heatwaves, droughts, floods and other extreme weather events including storms and bushfires. Climate change, especially warming, is already leading to changes in the environment in which disease vectors flourish. There is reduced availability and quality of potable water, and worsening food insecurity leading to malnutrition and population displacement. Climate Change is universal but its effects are uneven and many of the areas most affected are least able to manage the challenges it poses.

3. Tackling climate change offers opportunities to improve health and wellbeing both because of the health co-benefits of low carbon solutions and because mitigation and adaptation may allow action on all the social determinants of health. Transition to renewable energy, the use of active transport, and dietary change including a reduction in consumption of beef and other animal products, may all contribute to improving health and wellbeing.

4. The social determinants of health are those factors that correlate to health through exposure before and after people are born and as they grow live, and work. They vary between and within countries. Those with generally the poorest health and lowest life and health expectancy will be least able to adapt to the adverse effects of climate change thereby exacerbating adverse social determinants of health.

5. Climate change research and surveillance is important. The WMA supports studies that describe the patterns of disease attributed to climate change, including the impacts of climate change on communities and households; the burden of known and emergent disease caused by climate change, and those diseases projected to occur with new development activities (Health Impacts Assessment). Such studies should also define the most vulnerable populations.

6. The Paris Agreement highlights a transition to a new model of global collaboration to address climate change and is an opportunity for the health sector to contribute to climate action. It includes a series of actions to be undertaken by each party to achieve a long-term goal of keeping the increase in global average temperature to less than 1.5 C above pre-industrial levels. Whether or not individual states are parties to the Paris agreement, NMAs have an obligation to consider the effects of climate change on the planet and on human, animal, and environmental sustainability and to take action as follows.

RECOMMENDATIONS

7. The World Medical Association and its Constituent Members:

· Urge national governments and non-state actors to recognize the serious health consequences of climate change and to adopt strategies to adapt to and mitigate its effects;

· Urge national governments to ensure the fulfilment of national commitments to international agreements, including both mitigation and adaptation measures as well as action on losses and damage;

· Urges national governments to provide climate financing that includes designated funds to support the strengthening of health systems, and health and climate co-benefit policies and, provide sufficient global, regional and local financing for climate mitigation, adaptation measures, disaster risk reduction, and the attainment of the Sustainable Development Goals (SDGs);

· Urge national governments to facilitate the active participation of health sector representatives in the creation and implementation of climate change preparedness plans and emergency planning and response on local, national and international levels;

· Urge national governments to provide for the health and wellbeing of people displaced by environmental causes including those becoming refugees due to the consequences of climate change;

· Asks national governments to invest in public health and climate change research to ensure of better understanding of adaptation needs and health co-benefits at national level;

· Urge national governments to facilitate collaboration between Ministry of Health and other ministries to ensure that health is considered in their national commitments and sustainable strategies.

8. National Medical Associations and their physician members should:

· Advocate for sustainable, environmentally responsible low-carbon practices across the health sector to reduce the environmental impact of health care facilities and practices;

· Prepare for the infrastructure disruptions that accompany health emergencies, in particular by planning in advance for the delivery of services and increased patient care demands during these crisis situations;

· Encourage and support advocacy for environmental protection and greenhouse gas emissions reductions including through emissions trading systems and/or carbon taxes;

· Become educated as to the health effects of climate change and be prepared to treat and manage them in individual patients;

· Promote medical research into improved use of antibiotherapy to be able to respond, in the future, to the new infectious diseases linked to climate change.

9. The WMA and its Constituent Members should:

· Encourage sustainable low-carbon living respectful of planetary limits including active lifestyle and sustainable production and consumption patterns;

· Seek to build professional and public awareness of the importance of the environment and climate change to personal, community and societal health;

· Work towards the integration of key climate change concepts and competencies in undergraduate, graduate and continuing medical education curricula;

· Collaborate with the WHO and other stakeholders as appropriate, to produce educational and advocacy materials on climate change for national medical associations, physicians, other health professionals, as well as the general public;

· Advocate for their respective governments to finance, promote research into the effects of climate change on health and collaborate with NGOs and other health professionals;

· Work collaboratively with government, NGOs, businesses, civil societies and others to create alert systems to ensure that health care systems and physicians are aware of climate-related events as they unfold, and receive timely accurate information regarding the management of emerging health events;

· Have climate change as a priority issue on their agendas and actively participate in the creation of policies and initiatives that mitigate the effects of climate change on health.

10. The WMA urges National Medical Associations to:

· Work with health-care institutions, and individual physicians to adopt climate policies and act as role models by reducing their carbon emissions;

· Recognize environmental factors as a key social determinants of health (SDH), and encourage governments to foster collaboration between the health and non-health sectors in addressing these determinants.

Adopted by the 56^th WMA General Assembly, Santiago, Chile, October 2005,
revised by the 60^th WMA General Assembly, New Delhi, India, October 2009
and by the 70^th WMA General Assembly, Tbilisi, Georgia, October 2019

PREAMBLE

Genetics contributes to the growing understanding of the causes, developments, classifications and treatments of diseases. The use of genetics is increasing, moving from the identification of monogenic diseases and use in cancer treatment towards predicting risks of multifactorial diseases and manipulation of individual genes. In these ways, the use of genetics does and increasingly will create great value at an individual as well as at a societal level. However, the use of genetic information about individuals also raises issues concerning confidentiality, privacy and the risk of psychological distress, stigmatization, and discrimination.

This declaration provides recommendations for the use of medical genetics that respects the ethical challenges that such use entails. It is primarily aimed at the use of genetics in the provision of health care. The collection, storage and use of genetic data beyond the individual care of patients should adhere to the principles put forward in the WMA Declaration of Taipei on Ethical Considerations regarding Health Databases and Biobanks. The use of genetics in medical research involving human subjects, including research on identifiable human material and data, should adhere to the principles put forward in the WMA Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects.

This Declaration should be read as a whole and each of its constituent paragraphs should be applied with consideration of all other relevant paragraphs. The declaration should be updated in accordance with developments in the field of genetics.

Genetic information has characteristics that are ethically significant. Individually, these characteristics can also be found in other types of health care information. However, the combination of these characteristics makes genetic information particularly sensitive. This sensitivity – combined with the intense interest in genetic information from many different stakeholders – underscores the importance of respecting the fundamental principles of medical ethics, particularly the patient’s right to autonomy, confidentiality, privacy and benefit in relation to generating, storing, using or sharing genetic information.

Central among the ethically significant characteristics are:

Genetic information is identifying for an individual.
Genetic analysis can generate extensive and detailed information about an individual.
Genetic analysis may generate additional findings.
The full significance of the information generated by genetic analysis is not yet known.
Genetic information about an individual cannot be fully anonymized, and de-identified genetic information may be re-identified.
Genetic data contains information not only about the individual who has undergone testing, but also about individuals who are genetically related to the tested individual.
Genetic testing of one individual may entail that the physician asks for access to health care information about – or genetic testing of – genetically related persons (family members).

ETHICAL PRINCIPLES

Benefit

Genetic testing in the context of healthcare provision should primarily be done for the benefit of the patient being tested.

Relevance

Genetics test should not be wider in scope than what is relevant for the purpose of the test.

Informed consent

Genetic testing should only be done with the informed consent of the individual or his/her legal guardian. Genetic testing for predisposition to disease should be performed on children only if there are clear clinical indications and being aware of the test results would be in the best interests of the child.
The consent process must include providing the patient with understandable, accurate and adequate information about the following:
- The purpose, nature and benefits of the test.
- The risks, burdens and limitations of the test.
- The nature and significance of the information to be generated by the test.
- The procedures for return of results including additional findings and future discoveries.
- The options for responding to the results, including possible treatments.
- How, where, and for how long the test results, data and biological samples will be stored, and who can gain access to current and future results.
- The possible secondary uses of the information generated by the test
- The measures protecting confidentiality, privacy and autonomy, including data security measures
- The procedures for managing results that have implications for genetically related persons
- When applicable, commercial use and benefit sharing, intellectual property issues and the transfer of data or material to third parties.

Additional findings (secondary and incidental findings)

A genetic test may generate additional findings that are not related to the primary purpose of the test, also referred to as secondary or incidental findings. Procedures for handling such findings should be determined before the test, and information about these procedures should be communicated to the patient as part of the consent process.
The principles for managing additional findings must include consideration for:
- The patient’s preferences regarding the management of additional findings.
- The significance of the additional findings for the patient’s health and other interests.
- The significance of the findings for the health and other interests of persons who are genetically related to the patient.
- The scientific validity of the additional findings.
- The strengths of the evidence for the correlation between the additional findings and health related risks for the patient.
- The degree to which the additional findings are actionable, medically or otherwise.

Genetic counselling

Appropriate genetic counselling should always be offered when genetic tests or genetics-based treatments are offered or performed and for the interpretation of results. Counselling should enable the patient to make informed decisions according to their own values and interests. Counselling must not be biased by the personal values of the counsellor. The individual’s right not to be tested should be protected, and if the individual has been tested, there should be no obligation for the individual to act on the results of the test.
Medical students and physicians should receive education and training in genetic counselling, particularly counselling related to pre-symptomatic diagnosis of disease.

Confidentiality

Like all medical records, information from genetic testing or genetic therapy must be kept strictly confidential and must not be revealed to third parties in identifiable form without the consent of the individual tested. Third parties, to whom results may in certain circumstances be released, are identified in paragraph 15.

Informing third parties

In the case of a test result that may have implications for third parties such as close relatives, the individual tested should be encouraged to discuss the results of the test with such third parties. In cases where not disclosing the results involves an expected harm that is serious and unavoidable except by disclosure, and clearly greater than the harm likely to result from disclosure, the physician may reveal necessary information to such third parties without the consent of the patient but should usually discuss this with the patient first. If the physician has access to an ethics committee, it is preferable to consult such a committee prior to revealing information to third parties.

Data protection

The collection, storage and use of genetic data requires the highest level of data protection.

Discrimination

No individual or group must be discriminated against in any way based on genetic makeup, including the fields of human rights, employment and insurance. This protection should apply to those individuals who have undergone genetic testing or genetic therapy as well as those individuals about whom genetic information can be inferred. Particular care should be taken to protect vulnerable individuals and groups.

Cost of testing

The decision to include genetic analysis as part of medical care can introduce significant cost for the patient and the health care system. Therefore, such a decision should always be based on the expectation that the costs of the analysis are justified by the benefits for the patient.

Reliability and limitations

The identification of disease-related genes has led to an increase in the number of available genetic tests, analyses and treatments. As the number, types and complexity of these increase, great care must be taken to ensure their reliability, accuracy and quality and to inform patients about their limitations.
The benefit of a genetic test for an individual may depend on the availability of information about the relevant background population. Medical professionals should be aware of the scope and the limitations of genetic background data and health information stored in databases used in providing clinical genetic testing services.

Direct-to-consumer tests

If genetic tests are offered directly to consumers for medical purposes, they must meet the same technical, professional, legal and ethical standards as tests offered by certified laboratories and must be in accordance with the recommendations put forward in this statement. In particular, providers of direct-to-consumer tests must provide understandable, accurate and adequate information about the reliability and limitations of their services.

Clinical use of data from research

For research projects that involve genetic testing, and where the participant can be identified, the research participant must be informed about the possibility of findings that indicate a serious threat to the health of the participant. If there are such findings, the participant should be offered a referral to genetic counseling and appropriate medical intervention.

Gene therapy and editing

Gene therapy and editing represents a combination of techniques used to manipulate disease related genes. The use of these techniques should adhere to the following guidelines:

The use of gene therapy and somatic genome editing should conform to standards of medical ethics and professional responsibility.
Patient autonomy should be respected, and informed consent should always be obtained. This informed consent process should include disclosure of the risks of gene therapy and editing, including the fact that the patient may have to undergo multiple rounds of gene therapy, the risk of an immune response, the potential problems arising from the use of viral vectors and off-target genome effects.
Gene therapy and editing should only be undertaken after a careful analysis of the risks and benefits involved and an evaluation of the perceived effectiveness of the therapy, as compared to the risks, side effects, availability and effectiveness of other treatments.
Gene editing of germline cells has scientifically unresolved risks and should not be clinically applied. This does not preclude testing gene editing or other similar research.

Cloning

Cloning includes both therapeutic cloning, namely the cloning of individual stem cells to produce a healthy copy of a diseased tissue or organ for transplant, and reproductive cloning, namely the cloning of an existing human to produce a genetic duplicate of that human. The WMA opposes reproductive cloning of humans.

Adopted by the 49^th World Medical Assembly, Hamburg, Germany, November 1997,
revised by the 60^th WMA General Assembly, New Delhi, India, October 2009 and
reaffirmed with minor revision by the 213^th WMA Council Session, Tbilisi, Georgia, October 2019

PREAMBLE

The purpose of health care is to prevent, diagnose and treat illness and to maintain and to promote the health of the population. The goal of quality review in health care is continuous improvement of the quality of services provided for patients and the population, and of the ways and means of producing these services. The ultimate goal is to improve both individual patient outcomes and population health.

The obligation to continuously improve one’s professional ability and to rigorously evaluate the methods one uses has long been a fundamental tenet of the ethical codes of physicians. According to these codes, a physician must always strive to maintain and increase his/her knowledge and skills. The physician shall recommend only examinations and treatments that are believed to be effective and appropriate according to the best available evidence-based medicine.

Physicians and health care institutions have an ethical and professional obligation to strive for continuous quality improvement of services and patient safety, as stated in particular in WMA International Code of Medical Ethics, the Lisbon Declaration on the Rights of the Patient and the Resolution on Standardisation in Medical Practice and Patient Safety. These guidelines are intended to articulate the ethical grounds for these obligations and to strengthen quality review practices.

Ethical guidelines for health care quality improvement matter to all physicians, as well as to institutions providing health care services for patients, those providing continuous quality improvement services to assist physicians and organizations, health care payers and regulators, patients, and every other stakeholder in the health care system.

The Obligation to Establish Standards for Good Quality Work

Professionals, by definition, are responsible for specifying the standards that constitute good quality in their work and the processes needed for the evaluation of that quality. Health professionals, therefore, must define high quality health care and determine the best methods of measuring the quality of care delivered.

The Obligation to Collect Data

In order to assess quality of care, it is necessary to obtain reliable data on the patients and populations served as well as on care processes and outcomes. Patient records, whether recorded on paper, digitally or in any other way, must be created written and preserved with care and, with attention to confidentiality requirements in accordance with the WMA Declaration of Taipei. Procedures, decisions and other matters connected with patients should be recorded in a format that will allow information for measuring specific standards to be available on a timely basis when needed.

The Role of Professional Education

Health care professionals should have adequate opportunities to maintain and develop their knowledge and skills by participating in continuing medical education and/or continuing professional development. Clinical guidelines based on professional standards for high quality care should be created and made easily available to those requiring them. Health care training should include specific instruction in quality improvement techniques, including opportunities for hands-on practice in measuring and improving quality. Health care institutions should create quality improvement systems for their own use and to ensure that instructions concerning such systems are followed.

Good quality work requires resources. Every effort should be made to make sure that adequate time and economic means are available for quality work.

Attention to inappropriate use of services

Inappropriate use of health care services includes overuse, underuse and misuse. Quality measurement in health care should include a balanced set of measures in all three areas.

Overuse of services occurs when health care services are provided under circumstances in which the potential for harm exceeds the possible benefit. Physicians can improve quality by reducing overuse, thus sparing patients the unnecessary risk that results from inappropriate health services.

Underuse of services is the failure to provide health care services that would be likely to produce a favourable outcome for the patient. Physicians should strive to expand the use of beneficial health care services that are underused.

Misuse of services occurs when an incorrect diagnosis is made or when an appropriate service has been selected for a correct diagnosis but the patient does not receive the full potential benefit of the service because of a preventable adverse event. Misuse of services can be greatly reduced by using risk management and error prevention strategies.

Monitoring Quality: Clinical Audits

Active participation in critical self-evaluation, usually through clinical audit programs, is a useful mechanism for healthcare professionals, including healthcare administrators and physicians, and the institutions in which they work, to improve the quality of their work. External independent examination and accreditation of the institution can also be of use, when carried out appropriately and with due attention to potential unintended effects.

Healthcare professionals and institutions should systematically record and reflect on adverse incidents and medical error for the purposes of learning and quality improvement. This should occur in an environment of trust (and confidentiality when appropriate) and to actively avoid a blame culture.

Internal and External Quality Assessment

At the individual level, a physician should continuously update their knowledge and skills and subject their level of ability to critical self-appraisal.

In organizations, the quality of health care can be assessed by both internal and external methods.

Health care institutions should create internal quality improvement systems for their own use and ensure that instructions concerning such systems are followed. These systems should include continuous conducting of internal clinical peer review and learning from adverse incidents, review examination and treatment methods and their attendant results, tracking of the organization’s ability to react to quality data, and monitoring of patient feedback.

External quality review initiatives, such as external peer review and audit, should be carried out regularly and with a frequency corresponding to the evolution of the field or when there is special reason for external assessment. Any review should take into account risk adjustment of the patient population under consideration.

Whether internal or external, if the results of any quality assessment carry significant opportunities for benefit or threats of harms for the organization or individual being assessed, special attention must be paid to potential unintended and dangerous consequences of such quality assessments. It is especially important to monitor the results of quality improvement measurement and intervention strategies over time, with attention to their effects on especially vulnerable patient populations.

Protocols to be used for quality review should be replicable and transparent. Appeals mechanisms should be built into the protocols.

Confidentiality of Patient Records

Patient records are an invaluable source of data for quality improvement. As with other uses of individually identifiable patient-based information, consent is usually required from the patient prior to use. If consent cannot reasonably be obtained, then all attempts should be made to ensure that medical records are anonymised or pseudonimised for use in quality improvement efforts. In every case, patient records used for quality improvement must only be accessible to those who need to see them for the purposes of quality improvement.

Confidentiality of Peer Review

For peer review to be most effective, all parties involved must participate and recognize its importance. It is recommended that informed voluntary consent be obtained from those to be reviewed. Within a healthcare team, the work of each physician must be able to be evaluated. Information regarding an individual physician’s evaluation should not be published without the consent of the physician concerned. It is recommended that consent be obtained prior to publishing information regarding an individual physician’s evaluation.

A provider of services may inform his/her patients about the results of quality review.

If reviews are made available to the public, careful monitoring must be undertaken to track the effects, intended and unintended, of such public reporting of performance data.

Ethical Review of Quality Improvement Activities

National codes of medical ethics and ethical principles and guidelines that relate to continuous quality improvement, audit and clinical review must be followed.

Quality improvement should be an ongoing and integral part of the operations of every health care organization. As such, the majority of quality improvement projects will not require specific review by an ethics committee. If there are doubts about specific issues or if a project poses more than minimal risk compared to the existing processes for care, then the project should be referred to an appropriate ethics committee or institutional review board. When such formal ethical review is needed, it should be undertaken by a committee with members who are knowledgeable about quality improvement techniques.

Competence and Impartiality of the Reviewer

Those who conduct performance reviews must be competent in quality improvement techniques and in clinical audit as well as experienced in the clinical field relating to the review. Where medical care is being reviewed, the reviewer should be a physician whose knowledge and experience is accepted by those being reviewed.

The reviewer should be impartial and independent. Whilst he/she must be aware of the activities under review, he/she must be objective in the report and base conclusions on critical evaluation of observation and facts. Commercial or competitive matters should not be allowed to influence the content of the reviewer’s report.

Separation of Quality Reviews and Supervision by Authorities

Quality improvement of services and of health care systems is a requirement for every physician and health care institution. It is not supervision of professional activities by authorities and it must be kept independent of this. The results of performance reviews or audits of physician activities should be used by supervising authorities only subject to a separate agreement between them and the physicians concerned unless national legislation mandates an alternative approach. These activities must be fully cognizant of the local legal framework and must not expose participating physicians to litigation.

Adopted by the 60^th WMA General Assembly, New Delhi, India, October 2009
and revised by the 70^th WMA General Assembly, Tbilisi, Georgia, October 2019

The WMA reaffirms the Declaration of Seoul on professional autonomy and clinical independence of physicians.

The medical profession must play a central role in regulating the conduct and professional activities of its members, ensuring that their professional practice is in the best interests of citizens.

The regulation of the medical profession plays an essential role in ensuring and maintaining public confidence in the standards of care and of behaviour that they can expect from medical professionals. That regulation requires very strong independent professional involvement.

Physicians aspire to the development or maintenance of systems of regulation that will best protect the highest possible standards of care for all patients. Professionally led models can provide an environment that enhances and assures the individual physician’s right to treat patients without interference, based on his or her best clinical judgment. Therefore, the WMA urges its constituent members and all physicians to work with regulatory bodies and take appropriate actions to ensure effective systems are in place. These actions should be informed by the following principles:

Physicians are accorded a high degree of professional autonomy and clinical independence, whereby they are able to make recommendations based on their knowledge and experience, clinical evidence and their holistic understanding of the patient including his/her best interests without undue or inappropriate outside influence. This is expounded in more detail in the Declaration of Seoul.
The regulation of the profession must be proportionate and facilitative and not be burdensome, and be based on a model that applies to every physician equally and that protects and benefits patients and is based upon an ethical code. The planning and delivery of all types of health care is based upon an ethical model and current evidence-based medical knowledge by which all physicians are governed. This is a core element of professionalism and protects patients. Physicians are best qualified to judge the actions of their peers against such normative standards, bearing in mind relevant local circumstances.
The medical profession has a continuing responsibility to be strongly involved in regulation or self-regulating. Ultimate control and decision-making authority must include physicians, based on their specific medical training, knowledge, experience and expertise. In countries where Professionally led regulation is in place physicians must ensure that this retains the confidence of the public. In countries that have a mixed regulation system physicians must seek to ensure that it maintains professional and public confidence.
Physicians in each country are urged to consider establishing, maintaining and actively participating in a proportionate, fair, rigorous and transparent system of professionally-led regulation. Such systems are intended to balance physicians’ rights to exercise medical judgment freely with the obligation to do so wisely and temperately.
National Medical Associations must do their utmost to promote and support the concept of well-informed and effective regulation amongst their membership and the public. To ensure that any potential conflicts of interest between their representative and regulatory roles are avoided they must ensure separation of the two processes and pay rigorous attention to a transparent and fair system of regulation that will assure the public of its independence and fairness.
Any system of professionally-led regulation must enhance and ensure:
- the delivery of high quality safe and competent healthcare to patients
- the competence of the physician providing that care the professional, including ethical, conduct of all physicians
- the protection of society and the rights of patients
- the promotion of trust and confidence of patients, their families and the public
- the quality assurance of the regulation system
- the maintenance of trust by patients and society
- the development of solutions to potential conflicts of interest
- a commitment to wide professional responsibilities
To ensure that the patient is offered quality continuing care, physicians should participate actively in the process of Continuing Professional Development, including reflective practice, in order to update and maintain their clinical knowledge, skills and competence. Employers and management have a responsibility to enable physicians to meet this requirement.
The professional conduct of physicians must always be within the bounds of the Code of Ethics governing physicians in each country. National Medical Associations must promote professional and ethical conduct among physicians for the benefit of patients, and ethical violations must be promptly recognized, reported to the relevant regulatory authority and acted upon. Physicians are obligated to intervene in a timely manner to ensure that impaired colleagues do not put patients or colleagues at risk and receive appropriate assistance from a physician health program or appropriate training enabling a return to active practice.
The regulatory body should, when the judicial or quasi-judicial processes are complete, and assuming that a case is found against the physician, publish their findings and include details of the remedial action taken. Lessons learned from every case should, to the extent possible, be extracted and used in professional education processes.
The regulation process should ensure that the incorporation of such lessons is, as far as possible, seamless.
National Medical Associations are urged to assist each other in coping with new and developing challenges including potential threats to professionally-led regulation. The ongoing exchange of information and experiences between National Medical Associations is essential for the benefit of patients.
Whatever judicial or regulatory process a country has established, any judgment on a physician’s professional conduct or performance must incorporate evaluation by the physician’s professional peers who, by their training, knowledge and experience, understand the complexity of the medical issues involved.
An effective and responsible system of professionally-led regulation must not be self-serving or internally protective of the profession. National Medical Associations should assist their members in understanding that professionally-led regulation, in countries where that system exists, must maintain the safety, support and confidence of the general public, including their health-related rights, as well as the honour of the profession itself.

PREAMBLE

GENERAL PRINCIPLES

Risks, Burdens, and Benefits

Individual, Group, and Community Vulnerability

Scientific Requirements and Research Protocols

Research Ethics Committees

Privacy and Confidentiality

Free and Informed Consent

Use of Placebo

Post-Trial Provisions

Research Registration, Publication, and Dissemination of Results

Unproven Interventions in Clinical Practice

PREAMBLE

Air pollution and its impact on health

The sources of air pollution

RECOMMENDATIONS

PREAMBLE

Health discrimination in elderly patients

The need for a holistic approach

The ethical duty of physicians

RECOMMENDATIONS

To governments, medical associations and physicians

To governments

To the WMA, its members and the medical profession in general

To physicians

PREAMBLE

RECOMMENDATIONS

Pain and Symptom Management

Education and Research

PREAMBLE

RECOMMENDATIONS

DEFINITIONS

PREAMBLE

RECOMMENDATIONS

Preamble

Definition

Component of Problem

Responsibility of Physicians

Recommendation

PREAMBLE

Policy Problems

Funding the Project

Conflict between the protection of privacy and the need for scientific collaboration

Genetic discrimination in private insurance and employment

The danger of Eugenics and the use of genes for non-medical aims

RECOMMENDATIONS

The basic guidelines are:

PREAMBLE

PRINCIPLES OF MEDICAL EDUCATION

PRINCIPLE I BASIC PRINCIPLES OF MEDICAL EDUCATION

PRINCIPLE II UNDERGRADUATE MEDICAL EDUCATION

PRINCIPLE III EDUCATION BY THE FACULTY

PRINCIPLE IV CONTENT OF MEDICAL EDUCATION

PRINCIPLE V CLINICAL EDUCATION

PRINCIPLE VI SELECTION OF STUDENTS

PRINCIPLE VII POSTGRADUATE MEDICAL EDUCATION

PRINCIPLE VIII CONTINUING MEDICAL EDUCATION

PREAMBLE

ETHICAL PRINCIPLES

GOVERNANCE

PREAMBLE

RECOMMENDATIONS

Preamble

RECOMMENDATIONS

PREAMBLE

RECOMMENDATIONS

Beneficence

Confidentiality and privacy

Patient autonomy

Justice

Human rights

Professional independence

INTRODUCTION

RECOMMENDATIONS

CONCLUSION

PREAMBLE

RECOMMENDATIONS

PREAMBLE

PREAMBLE

ETHICAL PRINCIPLES

PRINCIPLE I
BASIC PRINCIPLES OF MEDICAL EDUCATION

PRINCIPLE II
UNDERGRADUATE MEDICAL EDUCATION

PRINCIPLE III
EDUCATION BY THE FACULTY

PRINCIPLE IV
CONTENT OF MEDICAL EDUCATION

PRINCIPLE V
CLINICAL EDUCATION

PRINCIPLE VI
SELECTION OF STUDENTS

PRINCIPLE VII
POSTGRADUATE MEDICAL EDUCATION

PRINCIPLE VIII
CONTINUING MEDICAL EDUCATION