[Ip-health] Conflict of interest in setting norms for pharmaceuticals in WHO

K.M. Gopakumar kumargopakm at gmail.com
Sat May 17 14:35:31 PDT 2014

Printed from
Conflict of interest in setting norms for pharmaceuticals in WHORema
Nagarajan,TNN | May 17, 2014, 05.03 PM IST
NEW DELHI: The World Health Organisation's (WHO) work of setting up norms
and standards for production of medicines seems to be flawed by a
fundamental conflict of interest. At the heart of its standard setting work
is an entity the International Conference on Harmonization (ICH) in which
majority of the WHO member countries have no voting rights and which is
dominated by pharmaceutical industry groups. This glaring conflict of
interest seems to fly in the face of WHO's policy on engagement with
private entities which states that the development of norms, standards,
policies and strategies which lies at the heart of WHO's work would be
protected from influence by any form of vested interest.
To begin with, the International Federation of Pharmaceutical Manufacturers
and Associations (IFPMA), closely involved with ICH since its inception,
hosts the ICH secretariat in Geneva. So, the two share the same address
--15, chemin Louis-Dunant, PO Box 195, 1211 Geneva-20. IFPMA participates
in the steering committee of the ICH as a non-voting member.
The six sponsors of ICH are the European Commission and the European
Federation of Pharmaceutical Industries' Associations (EFPIA); the Japanese
Ministry of Health, Labour and Welfare (JMHLW) and the Japan Pharmaceutical
Manufacturers Association (JPMA); and the United States Food and Drug
Administration (FDA) and the Pharmaceutical Research and Manufacturers of
America (PhRMA). These six are the voting members of the ICH Steering
Committee. Thus, ICH represents big multinational drug companies and 17
countries comprising 15% of the world's population and accounting for more
than three quarter of the global pharmaceutical sales. The WHO, Health
Canada and the European Free Trade Association (EFTA) are just observers in
ICH. When WHO gets influenced by ICH guidelines, these guidelines made by a
small section becomes applicable to the bulk of the world's population
without any of these populations having a say in their framing.
In the name of global cooperation, the ICH also invites representatives of
many countries including India, China, Brazil and so on. But none of these
countries have any participation in the decision-making process or any
voting rights in the ICH. The ICH also does not have any representation of
generic manufacturers from outside the ICH regions (EU, US and Japan) or
members of the civil society, professional groups, patient or consumer
advocacy groups.
ICH is primarily an attempt to harmonise drug approval requirements to
enable industry to bring drugs into the market faster and start earning
maximum revenue during the period the drug is under patent. Harmonisation
helps prevent loss of patent period time and money on regulatory hurdles.
However, most of the rhetoric on harmonization is about how ICH serves
public interest by bringing new breakthrough or innovative drugs faster to
patients. However, there has been wide-spread criticism that the drug
industry, through the ICH, influences not only regulatory approvals
mechanism for drugs introduction but also guidelines for pharmacovigilance
in the form of post marketing surveillance and reporting of adverse drug
reactions and guidelines for clinical trials, trying to relax the safety
standards for trials. According to critics it would be naive to see the ICH
process as involving purely technical matters as it also affects patients
and consumers. Hence, there has been a push for greater public debate,
scrutiny and accountability in the harmonization process.
A WHO publication of 2002 titled The Impact of ICH Guidelines in Non-ICH
Countries stated: "In many countries, essential drugs required for the
prevention and treatment of locally endemic conditions are not supplied by
the major multinationals, but by local industry or by generic
manufacturers. If these suppliers are unable to meet what may be
unsubstantiated quality standards, the adverse impact of the withdrawal of
these drugs on the health of the population might well be far more dramatic
than that of any hypothetical risk posed by failing to achieve the ICH
standards." Critics have also warned that harmonisation of regulatory
standards is being used by the drug industry to create new entry barriers
for drugs from the developing world to prevent competition.
The WHO document stated that although ICH countries import large quantities
of pharmaceuticals from non-ICH countries with weak regulatory systems,
many countries are led to think that adoption of the guidelines is a
necessary move to gain access to the pharmaceutical markets of ICH
countries." This "spontaneous" dissemination of ICH products is not
necessarily consistent with national priorities and represents a pressure
that may lead to diverting limited national resources to unnecessary
expenses entailed by the adoption of more costly regulatory requirements,"
said the document.
The document further noted that "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". It added that ICH process has involved only 17
industrialized countries in the decision-making process, and that the
views, priorities, and needs of the majority of WHO Member States have only
sporadically been taken into consideration.Despite being aware of this
conflict, the ICH has not been democratized or made more transparent in its
working and it continues to influence WHO guidelines.
Yet, many of the ICH guidelines have become part of the WHO guidelines on
pharmaceutical manufacture and registration process despite questions being
raised about the guidelines of the WHO being influenced or even being
decided by an organization which is primarily driven by business interests
of association whose primary purpose is to protect their own commercial
interests. WHO is yet to respond in any effective manner to these concerns.
And in the upcoming World Health Assembly the WHO is pushing a resolution
that urges member nations to implement relevant guidance and science-based
outputs of international regulatory harmonization and convergence efforts
and to use where applicable, the Conference on Harmonisation of Technical
Requirements for Registration of Pharmaceuticals for Human Use.
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