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On 20 January 2014, a joint event was hosted by
the International Alliance for Patients’ Organizations
(IAPO), International Council of Nurses (ICN),
International Federation of Pharmaceutical
Manufacturers and Associations (IFPMA),
International Pharmaceutical Federation (FIP) and
the World Medical Association (WMA) in Geneva
to introduce and sign the Consensus Framework for
Ethical Collaboration between Patients’ Organizations,
Healthcare Professionals and the Pharmaceutical
Industry. The keynote address was given by Dr.
Edward Kelley, Director, Service Delivery and Safety,
Health Systems and Innovation Cluster at the World
Health Organization, and was followed by statements
by senior representatives from IAPO, ICN, IFPMA,
FIP and WMA. The Consensus Framework was
formally adopted in a signing ceremony.
Putting patients first
Five global healthcare organizations sign Consensus
Framework for Ethical Collaboration
About the Consensus
Framework
The Consensus Framework aims to complement
the various national, regional and global codes
and guidelines and to serve as a model for similar
joint initiatives between patients’ organizations,
healthcare professionals and pharmaceutical industry
associations at the national level. The Consensus
Framework and accompanying resources are
intended to serve as a toolkit for any organization
(e.g. associations, companies, and alliances) that
wish to develop their own policies. The Consensus
Framework does not aim to be comprehensive or
binding and has no formal enforcement mechanism.
Event Highlights 20th January 2014
The Consensus Framework outlines some key areas that
should be considered by all partners to help guide ethical
collaborations at the individual and organizational levels,
and encompasses a shared commitment of organizations
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.
Introducing the event,
Ms. Joanna Groves,
CEO of IAPO, said that the
Consensus Framework
demonstrated a common
commitment to professional
integrity as well as addressed
the need to promote ethical
interactions worldwide. It is based on the shared
values and principles currently found in the codes or
guidelines of each signatory partner. It also contains four
overarching principles: Putting Patients First; Supporting
Ethical Research and Innovation; Ensuring Independence
and Ethical Conduct; and Promoting Transparency and
Accountability.
Dr. Kelley congratulated
IAPO, ICN, IFPMA, FIP
and WMA for taking the
initiative of developing the
Consensus Framework and
said that while it provides
a link to existing codes
and guidelines, one of its
strengths is that it also addresses new concerns relating
to ethics in health research and healthcare. In this sense,
the Consensus Framework “can be considered as an
updated complement to the 1988 WHO Ethical Criteria
for Medicinal Drug Promotion.” Kelley also highlighted
the importance of “putting patients first” and recognizing
their role in healthcare, R&D, the global debate on health
priorities and equitable access to safe treatments, and in
promoting ethical conduct in health research.
In recent years, WHO has supported many initiatives
promoting transparency such as the Medicines
Transparency Alliance (MeTA). WHO also announced that
two further initiatives related to the 3rd Global Patient
Safety Challenge of the World Alliance for Patient Safety
will be launched during 2014-2015. Kelley echoed an
earlier message by Marie-Paule Kieny, WHO Assistant
Director-General for Health Systems and Innovation, by
encouraging all organizations involved to examine ways
to develop monitoring mechanisms that support the
principles contained in the framework agreement.
Dr. Otmar Kloiber,
Secretary General of WMA
said that in recent years
healthcare has become
more effective but also more
complex. Patient care now
requires a higher degree of
cooperation between health
professionals, as well as with industries that provide
medicines, technologies and services. To be effective,
healthcare requires trust and confidence in what health
professionals do for their patients. Providing care also
requires a team effort and cooperation must be based
on transparency, accountability and professionalism. He
added that caring and ethics were not in themselves
enough and that medicine needs scientific research to
provide new solutions for healthier societies.
Mr. Kin-ping Tsang,
Chair of IAPO, said that his
organization represents around
365 million patients across
the world and is committed
to achieving the best possible
outcomes by putting the
patient first and achieving
greater transparency. While each signatory partner is
responsible for its own code of practice or respective
guidelines, it is nonetheless clear that health outcomes
are improved when regular information-sharing takes
place between all partners. This broad-based consensus
framework applied across much of the healthcare
community to include interactions involving patients,
nurses, pharmacists, doctors, and the healthcare
industry. Echoing an earlier comment by Joanna Groves,
he said that navigating the healthcare system could be
very challenging for patients; therefore, patients need
to trust that the care they received is based on accurate
information. He added that each partner has their own
role and responsibility in the health sector and should
design and deliver the appropriate service to meet patient
needs.
The Consensus Framework is the result of
a dialogue which began in 2011 between
IAPO, ICN, IFPMA, FIP, andWMA.
Event Highlights: Putting Patients First
Mr. Russell Williams,
Chair of the IFPMA Code
Compliance Network
(CCN) & President of
Rx&D Canada, said that
the Consensus Framework
promotes partnerships
on behalf of patients and
will lead to increased interactions between medical
professionals and the healthcare industry. This, in turn,
will eventually lead to better treatments and better
outcomes for patients. The Consensus Framework
provides an opportunity to promote an atmosphere of
trust leading to stronger relationships among health
partners and more sustainable health systems. He added
that the framework confirms ethical principles shared
by IAPO, ICN, IFPMA, FIP, and WMA to the broader
healthcare community. In his concluding remarks, Mr.
Williams took the opportunity to challenge all jurisdictions
and associations to build on this framework and replicate
these efforts at the regional and national levels to support
partnerships that deliver greater patient benefits and high
quality patient care.
Following the partner statements, discussions followed
on the role of health system strengthening and innovation
as an economic drivers and whether the Consensus
Framework could stimulate innovative practices.
Participants stressed the important role of the healthcare
sector in economies and that the return on investment
in innovation in this sector is high. Innovation is the
lifeblood of quality healthcare delivery and the outputs of
innovation include new tools and greater effectiveness
that benefit patients worldwide.
Comments about the
Consensus Framework
“ More than ever, healthcare delivery
requires multiple interactions between
patients, healthcare professionals,
industry and other stakeholders.”

Luc Besancon, General Secretary and CEO of the
International Pharmaceutical Federation (FIP).
“ By signing this document, each
organization commits to open,
transparent and informed
decision-making and action, resulting
in clear accountability in our actions.”

David Benton, Chief Executive Officer of the
International Council of Nurses.
“ In seeking to promote cooperation
among health professionals,
the Consensus Framework is also
facilitating cooperation in ethical
research and innovation.”

Otmar Kloiber, Secretary General of the World
Medical Association.
Resources
The Consensus Framework for Ethical Collaboration between Patients’ Organizations,
Healthcare Professionals and the Pharmaceutical Industry is accessible at å
http://www.ifpma.org/fileadmin/content/Publication/2014/Consensus_Framework-vF.pdf.
The related codes and guidelines referenced in the Consensus Framework are available
on respective websites of IAPO, ICN, IFPMA, FIP, WMA.
20th January 2014
About signatory partners
About IAPO:
IAPO is the only global alliance
representing patients of all
nationalities across all disease areas
and promoting patient-centered healthcare worldwide. Our
members are patients’ organizations working at the local,
national, regional and international levels to represent and
support patients, their families and care givers. IAPO has over
200 members which span over 60 countries and 60 disease
areas and through its membership represents an estimated 365
million patients worldwide.
About ICN:
The International Council of Nurses (ICN) is a
federation of more than 130 national nurses
associations representing the millions of
nurses worldwide. Operated by nurses and
leading nursing internationally, ICN works to ensure quality care
for all and sound health policies globally.
About FIP:
The International Pharmaceutical
Federation (FIP) is the global federation of
national associations of pharmacists and
pharmaceutical scientists and is in official
relations with the World Health Organization (WHO). Through
its 126 Member Organisations FIP represents and serves more
than three million practitioners and scientists around the world.
Its mission is to improve global health by advancing pharmacy
practice and science to enable better discovery, development,
access to and safe use of appropriate, cost-effective, quality
medicines worldwide.
About IFPMA:
IFPMA represents the research-based
pharmaceutical companies and associations
across the globe. The research-based
pharmaceutical industry’s 1.3 million
employees research, develop and provide medicines and
vaccines that improve the life of patients worldwide. Based in
Geneva, IFPMA has official relations with the United Nations
and contributes industry expertise to help the global health
community find solutions that improve global health.
About WMA:
The World Medical Association (WMA) is
an international organization representing
physicians. The organization was created to
ensure the independence of physicians and
to work for the highest possible standards of ethical behavior
and care by physicians, at all times. The purpose of the WMA
is to serve humanity by endeavoring to achieve the highest
international standards in Medical Education, Medical Science,
Medical Art and Medical Ethics, and Health Care for all people
in the world.
Event Highlights: Putting Patients First 20th January 2014
Consensus Framework
Principles
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. It declares that the concerned
organizations should work as partners to ensure
that collaboration between patients, healthcare
professionals, and pharmaceutical companies
support patients and their caregivers in making
the best decision regarding their health treatment.
It is underpinned by the premise that 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.
The Consensus Framework further states that,
among others, all human subject research must have
a legitimate scientific purpose, should be aimed
at improving health outcomes, and be ethically
conducted. No financial benefit or benefit in kind
should be sought, offered, provided or accepted in
exchange for prescribing, recommending, dispensing
or administering medicines by any party. The purpose
and focus of all symposia, congresses, scientific or
professional meetings for healthcare professionals
and patient organization-ns should be to provide
scientific or educational information. Business
arrangements and professional relationships between
partners should not inappropriately influence their
practice, compromise their professional integrity or
their obligations to patients.
Partners are encouraged to ensure a proper
environment for ethics, including developing their
own self-regulatory codes and principles for ethical
collaboration and interactions and ensuring 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.