[Ip-health] Fwd: TWN IP Info: WHO alliance with industry raises concerns over medicine regulation

K.M. Gopakumar kumargopakm at gmail.com
Mon May 19 22:47:44 PDT 2014

*Title :* TWN IP Info: WHO alliance with industry raises concerns over
medicine regulation
*Date :* 19 May 2014


TWN Info Service on Intellectual Property Issues (May14/06)
20 May 2014
Third World Network

*WHO: Alliance with industry raises concerns over medicine regulation
Published in SUNS #7807 dated 20 May 2014*

Geneva, 19 May (K. M. Gopakumar) -- There are concerns that the World
Health Organisation (WHO)'s alliance with an industry-led body facilitates
regulatory capture of medicine regulation by pharmaceutical multinational
corporations (MNCs).

A recent news report brought out the conflict of interest involved in the
WHO's norms and standard-setting related to medicines due to the
involvement of the International Conference on Harmonisation of Technical
Requirements for Registration of Pharmaceuticals for Human Use (ICH).


The article provides further details of the deep-rooted conflict of
interest and regulatory capture through the WHO-ICH alliance. This "unholy
alliance" with ICH is expected to come up during the World Health Assembly
(WHA), which started its current annual session in Geneva on Monday.

A draft resolution titled "Regulatory System Strengthening for the Medical
Products" urges Member States to implement the ICH guidelines.

The resolution refers to "implementing relevant guidance and science-based
outputs of international regulatory harmonization and convergence efforts
such as, where applicable, the Conference on Harmonisation of Technical
Requirements for Registration of Pharmaceuticals for Human Use".

The text is currently in brackets, signifying lack of consensus among WHO
member countries, and enjoys the full support of developed countries,
especially the European Union.

However, Third World Network learnt that the United States is negotiating
with the EU to remove the explicit reference to ICH.

The proposal is to remove reference to ICH but to retain words such as
harmonisation and to push for regulatory harmonisation (read as ratcheting
up of regulatory standards suited for pharmaceutical MNCs).

The WHO-ICH alliance also casts doubt on the effectiveness of WHO's
framework for engagement with the private sector.

The current WHA session is expected to take a decision on whether to adopt
the draft framework for Non-State Actors (NSAs), which includes a draft
policy for engagement with the private sector.

The Draft NSA policy states that: "WHO's processes in setting norms and
standards must be protected from any undue influence".

Further, the policy proposes the exclusion of NSAs from participating in
the process of setting policies or norms. It also prevents the acceptance
of resources for normative work.

Thus, the participation of WHO is contrary to the proposed draft policy on
engagement with NSAs, which sets a boundary for such engagement.

However, in order to create room for participation of the private sector,
especially initiatives like ICH norm-setting activities, the policy divides
the norm-setting activities into three phases viz. Phase 1: Information
gathering; Phase 2: Preparation for, elaboration of and decision on the
normative text; and Phase 3: Implementation.

It further states that reference to specific protection of the norms and
standard-setting process refers to the second phase.

Thus, the draft policy creates room for the participation of the private
sector in the early phase of norm-setting activities, in the form of
information gathering.

The very participation of WHO in ICH activities de facto legitimises
guidelines developed by the pharmaceutical multinational industrial
association and developed country regulators together, with a primary
objective of serving the interest of pharmaceutical MNCs.

Apart from this push for formal adoption of ICH guidelines, WHO has
facilitated the backdoor entry of ICH guidelines into WHO's various
guidelines adopted through the WHO's Expert Committee on Specifications for
Pharmaceutical Substances (Expert Committee).

The Regulatory System Strengthening (RSS) resolution is an attempt to
formally legitimise an alliance, which contradicts the neutrality of
norm-setting and allows regulatory capture.

The WHO-ICH alliance is problematic in terms of the process as well as
content. Apart from the concerns on the implication of ICH outcomes to
affordability of medicines, it raises concerns on the neutrality and
evidence-based decision-making, along with issues of participation and
transparency in WHO's decision-making.

The implication on affordability of medicines is discussed below.

The ICH was established in 1990 as a public-private partnership (PPP)
primarily to lower down the norms of registration (marketing approval) of
new chemical entities. However, as shown below, increasingly the ICH
started setting standards to build a set of technical barriers to prevent
competition from the generic industry.

The founding members of ICH are the drug regulatory authorities of the EU
(European Agency for the Evaluation of Medicinal Products, EMEA), Japan
(Ministry of Health, Labour and Welfare, JMHLW), and the US (Food and Drug
Administration, US FDA) and the research-based pharmaceutical industry
associations of those countries (the European Federation of Pharmaceutical
Industries' Associations, EFPIA; the Japan Pharmaceutical Manufacturers
Association, JPMA; and the Pharmaceutical Research and Manufacturers of
America, PhRMA).

These founding members along with the International Federation of
Pharmaceutical Manufacturers Associations (IFPMA), a federation of national
associations of research-based pharmaceutical industry associations, WHO,
Health Canada (Canadian regulatory agency), and the European Free Trade
Area constitute the highest decision-making body of ICH, the steering

However, only the steering committee members enjoy voting rights and the
other four members including WHO have no voting rights. The ICH secretariat
operates out of the Geneva office of IFPMA.

According to the ICH website, since its establishment in 1990, each of its
six co-sponsors (EMEA, EFPIA, JMHLW, JPMA, US FDA, and PhRMA) has had two
seats on the steering committee. Other parties have a significant interest
in ICH and have been invited to nominate observers to the committee.

According to researcher Stephanie Dagron: "The steering Committee oversees
all activities. First, it determines the harmonization activities to be
pursued (i. e. initiative for guidelines and other instruments). Second, it
adopts the guidelines and instruments that have been finalized and accepted
by the parties through consensus. Third, it supervises the implementation
and monitoring of ICH commitments. The IFPMA exercises an important role
since it provides the secretariat and participates..."


There is an effort to reach out and co-opt ICH-established Global
Cooperation Groups (GCG).

GCG includes Regional Harmonisation Initiatives (RHIs) namely, APEC, ASEAN,
EAC, GCC, PANDRH and SADC, in addition to eight Drug Regulatory
Authorities/Departments of Health (DRAs/DoH) in Australia, Brazil, China,
Chinese Taipei, India, Republic of Korea, Russia and Singapore that are
invited to the ICH bi-annual meetings.

RHI/DRA/DoH representatives participate in the Global Cooperation session
of the ICH Steering Committee to discuss capacity-building and share
experience/challenges on the implementation of ICH Guidelines.

Dragon notes: "In 1999 the ICH-SC created the Global Cooperation group as a
subcommittee, to allow the ‘participation' of representatives from non-ICH
regions. In 2008, the ICH (steering committee) also created a structure
called the Regulators Forum. But these two structures do not offer any
participation opportunities to their members within the elaboration process
of the ICH guidelines. They only constitute platforms for discussion,
information, and training. Their role is to allow the dissemination of ICH
standards worldwide".

According to the ICH website, representatives also listen to ICH technical
topics discussed by the steering committee during meetings and are invited
to nominate technical experts in Expert Working Groups/Implementation
Working Groups to contribute to the development of ICH Guidelines. However,
participation in the GCG is without any substantial say, without voting

Industry representatives act as one of the coordinators as well as in the
working group. The role of WHO is not limited merely to an observer to ICH.
It actively participates in the ICH Expert Working Group.


The ICH, during the last 24 years, has worked as a partnership between the
regulatory agencies of industrialised countries and pharmaceutical industry
without any effective participation from developing countries and generic

However, the important question is how regulatory agencies and WHO set
norms in a body where the industry has a veto power through voting?

Thanks to the alliance with WHO, many ICH guidelines found a place in the
Report of WHO's Expert Committee on Specifications for Pharmaceutical

In other words, the norms and standards set by ICH without the
participation of a substantial majority of Member States got imported to
the WHO Expert Committee process and adopted as norms and standards for the
regulation of medicines.

For instance, the Pharmaceutical Development of Multisource (generic)
Pharmaceutical Products contained in the 46th Report of the Expert
Committee states that "... document provides a structured approach for
industry following the International Conference on Harmonisation (ICH)
common technical document (CTD) format".

The 44th Report of the WHO Expert Committee also contains WHO Good
Manufacturing Practices for Active Pharmaceutical Ingredients (API), which
are based on the ICH guidelines.

It states: "A major change to the analytical procedure, or in the
composition of the product tested, or in the synthesis of the API, will
require re-validation of the analytical procedure. Note: Further guidance
on validation of analytical procedures is available in the following:
Guideline elaborated by the International Conference on Harmonisation of
Technical Requirements for Registration of Pharmaceuticals for Human Use

The ICH and IFPMA participate at the meetings of the WHO Expert Committee
on Specifications on Pharmaceutical Substances.

Researchers also question the ICH claims that its guidelines are purely
science-based. They point out that commercial and political interests play
an important role in the finalisation of ICH guidelines.

A set of research papers shows that ICH served the pharmaceutical MNCs'
interest in two ways.

First, it set norms to lower the threshold level of technical requirements
for the registration of medicines containing new chemical entities and new
products obtained by biotechnology through harmonising the drug
registration process.

Second, ICH started setting norms and standards for generic products and
pharmaceutical substances (starting materials) and created a new entry
barrier for small brand name and generic companies, especially those in
developing countries.

Health researchers even warn against the drive on harmonisation.

In an article, Karin Timmermans writes: "... increasing the standards
beyond the technological capacity of pharmaceutical companies in developing
countries would effectively exclude their competitive, generic products
from the international market".

Another researcher warns that: "The production of generics but also of
pharmaceutical starting material in developing countries is endangered. In
fact, ICH guidelines have introduced a tightening of specifications for
pharmaceutical starting materials, which is not always justified by
additional safety benefits. Another source of prohibitive costs for smaller
companies is the Good Manufacturing Practice Guide for active
pharmaceutical ingredients adopted by ICH in 2000".

The same sentiment is expressed by an expert consultation organised by WHO
in 2001.

The experts state: "ICH has relied increasingly on advanced pharmaceutical
technology in its standard setting, on the assumption that this technology
will lead to greater safety of new drugs, while the ICH guidelines relating
to drug quality have introduced a general tightening of specifications for
pharmaceutical starting materials. For example, ICH guideline Q3A
("Impurities in new drug substances") includes the requirement that each
organic impurity (whether identified or unidentified) present in a
substance in the amount of 0.1% or more (in some cases 0.05% or more)
should be considered as a qualified impurity (i. e. its safety should be
established). This raises the question of the basis for the selection of
the borderline figure, as the additional safety benefits from these
rigorous standards have not been demonstrated but the costs incurred by
manufacturers in meeting the requirements are significant."

Further, the experts warn against making ICH norms as global standards.

The report states: "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."

However, the experts recommended to continue WHO's engagement with ICH.

The report states: "WHO attends meetings of the ICH Steering Committee and
the Global Cooperation Group as an observer. These roles are important and
should be maintained. However, appropriate strategies for consultation and
communication with Member States need to be developed to ensure that WHO is
not seen as de facto automatically endorsing ICH products, but as providing
advice on the potential impact of those products on non-ICH Member States."

The WHO has continued with the ICH process for more than 24 years without
the close scrutiny of Member States because the issues of norms and
standards are considered as technical subjects; therefore, the World Health
Assembly never deliberates the merits of the Expert Committee Reports,
which contain norms and standards for the regulation of medicine.

The Report of the Expert Working Group is placed before the WHA Executive
Board to take note of the Report along with many other expert reports.
Normally, the Executive Board takes note of expert reports without any

The ICH adopts guidelines with political and economic considerations and
successfully projects these guidelines as science-based and exported to WHO
Expert Committees. The WHO's alliance with ICH facilitates this repackaging.

In the past, Member States had forced WHO to discontinue its engagement
with the International Medical Product Anti-Counterfeit Task Force (IMPACT)
due to its close association with the pharmaceutical industry.

The challenge at this point is for Member States to scrutinise WHO's
alliance with ICH and prevent any further conflict-of-interest situations. +

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