[Ip-health] Pharma-linked organisations involved in WHO Guideline drafting

Mirza Alas mirzalas at gmail.com
Fri May 27 02:43:39 PDT 2016

*TWN Info Service on Health Issues (May16/07) *
*27 May 2016 **Third World Network*

*Pharma-linked organisations involved in WHO Guideline drafting*

Geneva, 26 May (K M Gopakumar) – The World Health Organization’s
Secretariat engages organisations linked to the pharmaceutical companies to
draft guideline, which is considered as a norms and standard setting

This is despite the Secretariat’s declared position is that it does not
involve any non-State actors in the norms and standard setting activities.

The draft Framework of Engagement with Non-State Actors (FENSA) in
Paragraph 6 which sets out the principle of engagements states: “… protect
WHO from any undue influence, in particular on the processes in setting and
applying policies, norms and standards”. The footnote defines policies,
norms and standard as including “information gathering, preparation for,
elaboration of and the decision on the normative text”.

The FENSA drafting group last night reached a compromise in language which
excludes financial and in-kind resources from the WHO’s normative work.
However, it is not very clear is the term ‘normative work’ includes all
type of norms and standard setting activities.

Third World Network (TWN) learned that the WHO’s Regulatory System
Strengthening (RSS) team, which is part of the Essential Medicines and
Health Products Department, has engaged organisations linked to the
pharmaceutical industry to draft and consult on a guideline on Good
Regulatory Practice (GRP) for national medical products regulatory

[GRP contains a list of principles and process including the regulatory
impact assessment while setting norms and standards to achieve public
policy objectives in the context of medical products. Thus GRP contains
overarching guidelines for Member States in norm setting activities for the
regulation of medical products, including the updating of existing norms.]

TWN also learned that one of the drafters, Mr. Michael Gropp, is former
Vice President of Global Regulatory Strategy in Medtronic. According to the
Stanford Byer Center for BioDesign, Stanford University, “Mr. Gropp retired
from his corporate position in May 2013. He continues to chair the RAPS
Global Advisory Council. In addition, he is lead RAPS faculty for the newly
formed Medical Device Regulatory Affairs course at the National University
of Singapore, Department of Bioengineering, and is co-editor of a RAPS book
on global regulatory strategy (under development). In 2014, he was
appointed to the Advisory Board of the newly formed Centre for Regulatory
Excellence of the Duke University Graduate Medical School and National
University of Singapore in Singapore.” (

(RAPS means the Regulatory Affairs Professionals Society.)

The draft GRP document circulated for the consultation states:  “This
document has been prepared for the purpose of inviting comments and
suggestions on the proposals contained therein, which will then be
considered by the Expert Committee on Biological Standardization (ECBS) and
the Expert Committee on Specifications for Pharmaceutical Preparations

Once these bodies adopt the document it is considered as a WHO Guideline.
Often nobody knows about the story behind the drafting of such documents.
Normally, a WHO Guideline does not adequately explain the rationale and
drafting process undertaken, when it is resent to the WHO Executive Board
‘to take note of the document’.

The WHO Secretariat organised four days of stakeholder consultation on GRP
on 2-5 May at the WHO Headquarters, Geneva. The Secretariat describes these
consultations as a targeted consultation, to which were invited selected
Member States and pharmaceutical industry associations and entities linked
to the pharmaceutical industry. These included the International Federation
of Pharmaceutical Manufacturing Association (IFPMA), Centre for Innovation
in Regulatory Science, Regulatory Affairs Professionals Society,
Organisation of Economic Cooperation and Development (OECD) and Bill and
Melinda Gate Foundation (Gates Foundation).

TWN learned that there was no representation from civil society
organizations and generic pharmaceutical companies especially those from
the developing countries. However, regulatory authorities from developing
countries such as Brazil, India, Indonesia, Saudi Arabia, Thailand, etc.
attended the consultation.

IFPMA is a federation of national and regional associations of
research-based biopharmaceutical companies, i.e. pharmaceutical
transnational corporations (TNCs).  It also acts as the Secretariat for the
International Council for Harmonisation of Technical Requirements for
Pharmaceuticals for Human Use (ICH), a closed private sector-led norms and
standard setting body.

Serious concerns have been expressed about the ICH standards with regard to
affordable generic medicines. A WHO report on a 2001 meeting of regulatory
authorities stated: "Setting such norms may have considerable repercussions
on current manufacturing practices, as only pharmaceutical companies with
substantial resources can achieve the necessary standards. This is a
concern if the guidelines are intended for global application. Smaller
pharmaceutical companies, generic companies and many larger companies
responsible for essential drug production in developing countries may be
effectively squeezed out of drug manufacturing if ICH guidelines start to
be interpreted as the only global standard”. (*The Impact of Implementation
of ICH Guidelines in Non-ICH Countries - Regulatory Support Series No. 009*

The Centre for Innovation in Regulatory Science (CIRS) is described on its
website as follows: “CIRS – The Centre for Innovation in Regulatory Science
– is a neutral, independent UK-based subsidiary company, forming part of
the Intellectual Property and Science business of Thomson Reuters. It is
governed pursuant to constitutional documents that assure it is operated
for the sole support of its members’ activities. CIRS has its own dedicated
management and advisory boards, and its funding is derived from membership
dues, related activities and grants.”

Pharma TNCs from the United States, Europe and Japan have membership in
CIRS. Other members include: “USA: AbbVie, Allergan, Amgen, Biogen,
Celgene, Eli Lilly and Company, Johnson & Johnson, Merck & Co, Pfizer and
Shire. Europe: Actelion, AstraZeneca, Bayer, GlaxoSmithKline, Merck KGaA,
Novartis, Novo Nordisk, Roche, Sanofi and Servier. Japan: Astellas,
Daiichi-Sankyo, Eisai, Takeda and Zeria.

According to its website, the Regulatory Affairs Professionals Society
(RAPS) is the largest global organization of and for those involved with
the regulation of healthcare and related products, including medical
devices, pharmaceuticals, biologics and nutritional products. Founded in
1976, RAPS helped establish the regulatory profession and continues to
actively support the professional and lead the profession as a neutral,
non-lobbying non-profit organization. RAPS offers education and training,
professional standards, publications, research, knowledge sharing,
networking, career development opportunities and other valuable resources,
including Regulatory Affairs Certification (RAC), the only post-academic
professional credential to recognize regulatory excellence"

However, RAPS provides corporate membership known as Enterprise Membership
with the following benefits to all employees: Special enterprise-only rates
on training and professional development resources, 24/7 access to global
regulatory information, networking and connections, access to the RAPS
media library.  The Enterprise Membership list includes the following
pharma TNCS: Abbott, Gilead sciences, Pfizer, Astra Zeneca, Novartis, Eli
Lilly among others.

This is not the first time WHO has involved non-State actors with conflict
of interest to draft policies.  A Steering Committee appointed by the Bill
& Melinda Gates Foundation drafted the Global Vaccine Action Plan, which
was adopted by the World Health Assembly in 2012. Interestingly there is
nothing in the document that describes the involvement of the Gates
Foundation in this drafting work. (

The only reference in the document submitted to the WHA in 2012 is that
“The estimated figure for future deaths averted was developed by a working
group that included staff from WHO, the GAVI Alliance, the Bill & Melinda
Gates Foundation and PATH. The estimate uses a mix of static and dynamic
cohort models and various data sources across the 10 vaccines, including
the Lives Saved Tool. Vaccine coverage projections are from the GAVI
Strategic Demand Forecast 4.0 (4 October 2011) and from the GAVI Adjusted
Demand Forecast.” (
http://apps.who.int/gb/ebwha/pdf_files/WHA65/A65_22-en.pdf). However, the
WHO publication titled Global Vaccine Action Plan 2011-2020 acknowledges
the role of Gates Foundation in the framing and implementation of the plan.

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