Consensus_Framework-vF
PDF Upload
Consensus Framework
for Ethical Collaboration
between Patients’
Organisations,
Healthcare Professionals
and the Pharmaceutical
Industry
A Consensus Framework established for ethical
collaboration between patients’ organisations,
healthcare professionals and the pharmaceutical
industry, in support of high quality patient care. This
Consensus Framework and the accompanying resources
are intended to serve as a toolkit for those associations,
groups and alliances who wish to develop their own
policies. It neither aims to be comprehensive nor does it
constitute a single common policy of the organisations
involved. The individual policies of the participating
organisations set out each organisation’s detailed
commitments and offer more diverse and in depth
information and guidance.
January 2014
As developed and developing countries
strive to address pressing health challenges
in the complex and fast-evolving healthcare
environment, collaboration between all partners
is essential in ensuring proper delivery of the
most appropriate care for patients worldwide.
In the 1980s international codes and guidelines
were approved including the first IFPMA Code
of Pharmaceutical Marketing Practices in 1981
and the WHO Ethical Criteria for Medicinal Drug
Promotion in 1985. Since then progress has
been made to ensure appropriate interactions
and ethical promotion of medicines globally,
including through self-regulatory and voluntary
mechanisms such as codes of conduct and
principles. These highlight the need for patients’
organisations, healthcare professionals, and the
pharmaceutical industry to work together for
the benefit of patients, while recognizing each
other’s professional role in the context of the
healthcare value delivery chain and maintaining
their professional independence.
There is an important link between patients,
healthcare professionals, the pharmaceutical
industry and their organisations in providing
best solutions to patients’ health needs and
each partner has a unique role and responsibility
in ensuring that patients receive the most
appropriate care. Patients must be informed
and empowered to, along with their caregivers,
decide on the most appropriate treatment
options for their individual health needs and to
participate responsibly in use of health resources
and managing their own health. In this respect,
healthcare professionals must ensure that
the treatment options they offer to patients
are appropriate. In turn, the pharmaceutical
industry has a duty to provide accurate, fair,
and scientifically grounded information for
their products, so that the responsible use of
medicines can be facilitated.
The Consensus Framework for Ethical
Collaboration is characterized by four
overarching principles: Put Patients First;
Support Ethical Research and Innovation; Ensure
Independence and Ethical Conduct; and Promote
Transparency and Accountability. The Consensus
Framework outlines some of the key areas that
should be considered by all partners to help
guide ethical collaborations at the individual
and organisational levels1
, and is based on
the common elements within the documents
listed in the Tools and Resources section of
the Framework. It encompasses a shared
commitment of organisations representing
patients, healthcare professionals, and the
pharmaceutical industry to continually improve
global health and ensure, in collaboration with
other stakeholders, that all patients receive
appropriate treatment. This Framework aims
to complement the various national, regional
and global codes and guidelines and serve as
a model for similar joint initiatives between
patient organisations, healthcare professionals
and pharmaceutical industry associations at the
national level.
The Consensus Framework is currently
supported by IAPO2
, ICN3
, IFPMA4
, FIP5
and
WMA6
, as all partners have a mutual interest in
ensuring that the relationship between patients,
healthcare professionals, the pharmaceutical
sector, and their organisations, is based on
ethical and responsible decision making. The
Consensus Framework is a living document
and is open to other key partners working in
life-sciences and healthcare delivery, which are
welcome to endorse it and comment upon it.
1
The Joint Framework is based on the common elements within the documents listed in the Tools & Resources section.
2
International Alliance of Patients’ Organizations (IAPO)
3
International Council of Nurses (ICN)
4
International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)
5
International Pharmaceutical Federation (FIP)
6
World Medical Association (WMA)
Preamble
Consensus Framework for Ethical Collaboration
Put Patients First
Patients are our priority.
For example:
1 Optimal Care for All – Working as partners,
at both the individual and organization level,
to ensure that collaboration between patients,
healthcare professionals, and pharmaceutical
companies support patients and their
caregivers in making the best decision
regarding their treatment.
2 Partnerships – All partners working in
healthcare have a right and responsibility to
collaborate to improve healthcare access and
delivery. Establishing partnerships will aim to
deliver greater patient benefits.
Support Ethical
Research and
Innovation
Partners encourage clinical and related
research conducted to generate new
knowledge about effective and appropriate
use of health treatments.
For example:
3 Clinical Research – Continuing to advocate
and support the principle that all human
subject research must have a legitimate
scientific purpose, aims to improve health
outcomes, and be ethically conducted,
including that participants are appropriately
informed as to the nature and purpose of the
research.
4 Objective Clinical Results – Continuing
to ensure that compensation for research is
appropriate and does not compromise
objective clinical results of the research.
Ensure Independence
and Ethical Conduct
Interactions are at all times ethical,
appropriate and professional.
For example:
5 Gifts – Nothing should be offered or provided
by a company in a manner or on conditions
that would have an inappropriate influence.
No financial benefit or benefit in kind should
be sought, offered, provided or accepted
in exchange for prescribing, recommending,
dispensing or administering medicines.
6 Sponsorship – Continuing to advocate
that the purpose and focus of all symposia,
congresses, scientific or professional
meetings (an “Event”) for healthcare
professionals and patient organisations
should be to provide scientific or educational
information. The primary purpose of an event
must be to advance knowledge and all
materials and content must be balanced
and objective. All events must be held in an
appropriate venue. Moderate and reasonable
refreshments and/or meals incidental to the
main purpose of the event can be provided to
participants of the event.
7 Affiliation – Business arrangements and
professional relationships between partners
should not inappropriately influence their
practice, compromise their professional
integrity or their obligations to patients.
Business arrangements and relationships
should respect professional integrity and
should be transparent.
Consensus Framework Principles
January 2014
Promote
Transparency and
Accountability
Partners support transparency and
accountability in their individual and
collaborative activities.
For example:
8 Fees for Services – Working together to
ensure that all arrangements requiring
financial compensation for services, such as
consultancy or clinical research, have a
legitimate purpose and a written contract
or agreement in place in advance of the
commencement of services. Remuneration
for services rendered should not exceed
that which is commensurate with the services
provided.
9 Clinical Research Transparency – Continuing
to support the premise that both the positive
and negative outcomes of research evaluating
medicines, other products and services should
be disclosed. Clinical research in patients
and related results should be transparent
while respecting patient privacy.
Partners are encouraged to develop their own
self-regulatory codes and principles for ethical
collaboration and interactions and ensure their
effective implementation. Systems to monitor
and report breaches of the set standards should
be established to support ethical practices and
ensure accountability both at the institutional
and individual levels. These may include,
for example, public statements detailing
collaborative agreements and external review
mechanisms.
◆ WMA Declaration of Helsinki – Ethical
Principles for Medical Research Involving
Human Subjects (2013)
https://www.wma.net/en/30publications/10policies/b3/
◆ IAPO Healthcare Industry
Partners Framework (2012)
http://www.patientsorganizations.org/partners
◆ FIP Rules of Procedure – Guidelines
for Sponsorship (2012) (internal document)
◆ IFPMA Code of Practice
(established in 1981; last revision 2012)
http://www.ifpma.org/ethics/ifpma-code-of-practice/ifpma-
code-of-practice.html
◆ ICN Code of Ethics for Nurses (2012)
http://www.icn.ch/about-icn/code-of-ethics-for-nurses/
◆ WMA Statement Concerning the
Relationships b/w Physicians and
Commercial Enterprises (2009)
https://www.wma.net/en/30publications/10policies/r2/
◆ ICN Position Statement:
Informed Patients (2008)
http://www.icn.ch/images/stories/documents/publications/
position_statements/E06_Informed_Patients.pdf
◆ FIP/WHO Developing pharmacy practice
– a focus on patient care (2006);
Chapter II-3: Information management
and the use of evidence.
http://www.fip.org/good_pharmacy_practice
◆ ICN Position Statement: Nurse Industry
Relations (2006)
http://www.icn.ch/images/stories/documents/publications/
position_statements/E09_Nurse_Industry_Relations.pdf
◆ IAPO Organizational Values (2005)
http://www.patientsorganizations.org/attach.pl/700/278/
IAPO7s0Organizational0Values.pdf
◆ FIP Statement on Professional Standards –
Code of Ethics for Pharmacists (2004)
www.fip.org/statements
◆ WHO Ethical Criteria for Medicinal Drug
Promotion (1985)
http://archives.who.int/tbs/promo/whozip08e.pdf
Implementation, Monitoring
and Reporting Mechanism
Tools and Resources
Consensus Framework for Ethical Collaboration