2024_International Consensus Framework

1
Ethical Collaboration in
Health: An International
Consensus Framework
Revised and Adopted 2025
A Consensus Framework established for ethical
collaboration between diverse health stakeholders 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.
First established in 2014, this Consensus Framework
was revised in 2024 to coincide with its tenth
anniversary and adopted in 2025.
2
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 health
stakeholders 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 health
stakeholders 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 International Consensus Framework for
Ethical Collaboration in Health is
characterized by five overarching principles: Put
Patients First; Support Ethical Research and
Innovation; Ensure Independence and Ethical
Conduct; Promote Transparency and
Accountability; and Uphold Responsible Use of
Health Data and Technology.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 by partners 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 health
stakeholders at the national level.
The Consensus Framework is currently
supported by IAPO2
, ICN3
, IFPMA4
, FIP5
WMA6
and IHF7
as all partners have a mutual interest
in ensuring that the relationship between
health stakeholders 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 Frameworkisbased on the common elementswithin the documentslisted 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)
7
International Hospital Federation (IHF)
Preamble
3
Put Patients First
Patients are our priority.
For example:
1 Optimal Care for All –Workingas
partners, at both the individual and
organization level, to ensure that collaboration
between health stakeholders supports
patients and their caregivers in making the
best decision regarding their treatment.
Partners will empower patients and ensure
people-centered care.
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
knowledgeabout effectiveandappropriate
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, to identify best practices, and be
ethically conducted, including that
participants are appropriately informed as to
the nature and purpose of the research.
4 Objective ClinicalResults–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 orprovided
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”) partners 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
4
Promote
Transparency and
Accountability
Partners support transparency and
accountability in their individual and
collaborativeactivities.
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 ResearchTransparency–
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.
10 Health Data and technology–Working
together to realize the opportunities of health
data and technology through embracing
transparency and accountability in their
development and use.
Uphold Responsible Use
of Health Data and
Technology
Partners embrace the responsible development
and use of data and technology, including tools
like artificial intelligence, that empower a
healthy and thriving humanity.
For example:
11 Autonomy, Control, and
Empowerment – Data should be collected
and used in a manner that advances human
health while respecting an individual’s
privacy, upholding human rights and safety,
and honoring confidentiality. Measures
should be taken to describe and make
available when and how health data is used.
Technologies utilizing health data, such as
artificial intelligence, should be designed
and deployed to empower humans while
ensuring their control and oversight. This
includes detailing how the technology is
used, the goals and assumptions driving the
technology, and the technology limitations.
Protecting partners’ professional autonomy
as well as working together and within our
respective communities to eliminate
exclusion, inequities, and bias is essential
as opportunities to advance human health
are pursued.
12 Stewardship–All partners working to advance
human health have access to data and technology,
such as artificial intelligence, that requires careful
stewardship to realize their benefits. This includes
extending the utmost respect for all individuals
whom the data represents, and that the technology
is used to serve. It also prioritizes upholding quality
through continuous validation (i.e., monitoring and
testing) as well as the responsible use and sharing
of data and technology.
13 Collaboration–Ongoing collaboration among the
partners is vital as opportunities to develop and use
health data and technology progresses. This will
help ensure open communication and continuous
feedback to foster alignment while improving patient
care and public health.
5
Implementation, Monitoring
and Reporting Mechanism
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 (2024)
https://www.wma.net/policies-post/wma-declaration-of-
helsinki/
◆ IFPMA Decision-Making Framework Toolkit
(2024)
https://www.ifpma.org/blog/resources/our-ethos-in-action-
decision-making-framework-toolkit/
◆ IAPO Healthcare Industry Partners
Framework (2022)
https://www.iapo.org.uk/healthcare-industry-partners
◆ IFPMA Artificial Intelligence Principles (2022)
https://www.ifpma.org/blog/publications/ifpma-artificial-
intelligence-principles/
◆ ICN Code of Ethics for Nurses (2021)
https://www.icn.ch/resources/publications-and-
reports/icn-code-ethics-nurses
◆ WMA Statement Concerning the
Relationships b/w Physicians and
Commercial Enterprises (2020)
https://www.wma.net/policies-post/wma-statement-
concerning-the-relationship-between-physicians-and-
commercial-enterprises/
◆ IFPMA Code of Practice
(2019)
https://www.ifpma.org/subtopics/new-ifpma-code-of-
practice-2019/
◆ IFPMA Ethoscope: Upholding Ethics and
Business Integrity (2019)
https://www.ifpma.org/areas-of-work/upholding-ethics-
and-business-integrity/
◆ WMA Declaration of Taipei on Ethical
Considerations Regarding Health Databases
and Biobanks (2016)
https://www.wma.net/policies-post/wma-declaration-of-
taipei-on-ethical-considerations-regarding-health-
databases-and-biobanks/
◆ FIP Statement on Professional Standards –
Code of Ethics for Pharmacists (2014)
https://www.fip.org/file/1586
◆ IAPO Organizational Values (2005)
https://www.iapo.org.uk/our-values
◆ WHO Ethical Criteria for Medicinal Drug
Promotion (1985)
http://archives.who.int/tbs/promo/whozip08e.pdf
◆ FIP’s BU-F1 FIP Guidance for Working with
Sponsors and Funders (internal document)
https://www.fip.org/index.php?page=login_members&redir
ect=fip-rules-of-procedures
◆ Joint FIP/WHO Guidelines on Good
Pharmacy Practice (GPP): Standards for
Quality of Pharmacy Services
https://www.fip.org/file/5593
◆ IAPO
info@iapo.org.uk
◆ ICN
icn@icn.ch
◆ IFPMA
admin@ifpma.org
◆ FIP
fip@fip.org
◆ WMA
wma@wma.net
◆ IHF
ihf.secretariat@ihf-fih.org
Tools and Resources
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