WHO Members Show Dismay At Delay On Counterfeit Medicines Group

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World Health Organization members today raised strong concerns that a working group they mandated last May to address problems with WHO policy on counterfeit and substandard medicines has yet to be formed – with four months remaining before it must report back to members.

One delegation called for a halt to WHO activities on anti-counterfeiting until the outcome of the working group is accepted by member states.

WHO Director General Margaret Chan told members of the WHO Executive Board today that a first meeting of a dedicated working group would be held in late February. The Board is meeting from 17-25 January.

Countries said falsified medicines were a threat for global public health but according to some delegates, the solution can not be dominated by intellectual property rights enforcement concerns.

The UN health agency’s HIV/AIDS strategy also was discussed yesterday with a request from countries to emphasise prevention.

At the last World Health Assembly (WHA), in May 2010, decision WHA63.10 [pdf] established a “time-limited and results-oriented working group on substandard/spurious/falsely-labelled/falsified/counterfeit medical products comprised of and open to all member states.” Member states asked that the WHO Director General convene and facilitate the work of the working group. The working group was then supposed to report back to the 64th WHA, in May this year.

However, Board document EB128/11 [pdf] said that the meeting of the working group was to be held from 9 -11 December but “following consultations with member states, the meeting was postponed to early 2011.” It appears that at the opening of this week, no new dates had been provided by WHO to the member states.

Several countries raised concerns about the fact that the working group had not met yet, let alone even constituted. India, which made a strong statement on the issue, said valuable time was lost.

Chan attempted to reassure delegates, saying the focus of the WHO is on public health and that a “room has been booked for this.” The meeting should be taking place from 28 February-2 March.

The Indian delegate said that the working group was supposed to “look into” the International Medical Products Anti-Counterfeiting Taskforce (IMPACT). IMPACT is a project of international police agency Interpol, [Clarification: Interpol is only one participant in this project] housed within WHO.

The task force is meant to “halt the production, trading and selling of fake medicines around the globe.” However, it has been criticised in the past by some countries because they deemed the effort had led to some confusion between substandard, falsified or unsafe drugs with legal, reliable generic medicines.

The Indian delegate said intellectual property rights were at the heart of IMPACT but were not in the mandate of WHO. IP rights are diverting WHO from its mission of global public health, he said.

India asked that the work of IMPACT be suspended for the moment until the working group could evaluate its work.

No substantive discussions were expected to take place on this agenda item this week since there was no report from the group yet. The Board did not take any actions on this issue during the meeting.

India also expressed concerns about the recently completed plurilateral Anti-Counterfeiting Trade Agreement, its possible impact on the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The delegate said a seminar was held with Brazil and South Africa, and the outcome of the seminar would be shared in the upcoming WHO working group (IPW, Public Health, 22 October 2010).

Brazil said they fully supported the intervention from India and the issue was pressing and time was short.

The European Union said drug safety was a key component of global health policies while the United States said that given the increasing complexity and reduced transparency of the global supply chain, regulatory systems were necessary and they said they strongly support IMPACT.

Mauritania, on behalf of the African Region said falsified medicines are a threat to public health but they also are undermining public trust towards medicines. The delegate said the weakness of pharmaceutical regulations in Africa and the intense traffic of falsified medicine were two important challenges.

South Africa wondered about the time elapsed since the 2010 WHA to constitute the working group and said countries should have enough time to go through the report of the working group before the May 2011 Assembly.

Vaccines and Vision

On 18 January, the global immunization vision and strategy (EB 128/9) [pdf] was discussed as well as the draft WHO HIV/AIDS strategy for 2011-2015 (EB 128/10) [pdf].

On the HIV/AIDS strategy, several countries asked that a particular effort be made on prevention, and asked that the strategy be amended to be clearer and shorter. Brazil asked for a work plan attached to the strategy. China said that the situation in different countries should be taken fully into account, and asked for a full account of the cost involved to reach the strategy’s goals.

The United States said voluntary licences and the new Medicines Patent Pool were key opportunities to ensure that there is an open competitive market for antiretroviral drugs to contain their costs. They said the strategy encouraged the “use of differential pricing for patent protected medicines to ensure affordable access, but recent studies have demonstrated that differential pricing does not always have the impact on the pricing of medicines that robust generic competition does.” The Medicines Patent Pool, they said, could encourage innovation and enhance competition to bring the prices down in developing countries. He called more companies to join the pool.

Meeting chair Mihali Kökény of Hungary said that to improve and further develop the strategy in light of comments, the secretariat would approach the delegates having concrete proposals for further discussion before the end of the Executive Board session.

On the global immunisation vision and strategy, Michelle Childs from Médecins Sans Frontières (Doctors Without Borders) said in a statement that if new vaccines are necessary, that should not mean that “momentum is lost as regards the need to ensure basic immunisation.”

“To maximise the potential of vaccination, technologies better adapted to the realities of resource-limited settings need to be developed,” she said. “Too much emphasis has been put on incentivising multinational pharmaceutical companies, at the expense of investing in support to emerging producers that can produce quality vaccines at dramatically reduced prices.”

Catherine Saez may be reached at info@ip-watch.ch.

Creative Commons License"WHO Members Show Dismay At Delay On Counterfeit Medicines Group" by Intellectual Property Watch is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.


  1. Miles Teg says

    So WHO cannot take a stand on access to medicines regarding patented HIV medicines because IP is not in its mandate but it is HAPPY to be “hired” for BigPharma interests (sponsored I think by European and American taxes) on enforcing IP rights through anti-counterfeiting. (And if you really think IMPACT is about medicines safety just inquire if the “killer” legal drug Vioxx is included and deduce your answer).
    If ‘conflicts of interest’ at WHO were taken seriously, it would have balked at a BigPharma person being the head of IMPACTs “Legislative” unit. And this is what makes India’s statement (above) sound like it is way too polite for the shenanigans that are really going on (perhaps Japan pressured Ranbaxy to get India to moderate?).
    Is it really that unreasonable to expect WHO “good management principles” (with commercial entities) to have safeguarded the process by ENSURING its composition is above reproach?
    Ostensibly WHO started working on IMPACT based on old resolutions addressing counterfeiting. But the current work of IMPACT excludes ANY reference to high prices (of patented medicines) as an inducement to counterfeit, contrary to what is in the alleged “mandate” and WHOs own research. High prices like generic competition hurt profits so this seems like a “business as usual” approach from WHO – as long as the mandarins get paid, job content matters naught.
    And the Africans’ concerns are certainly legitimate, as there is a real problem with quality medicines. [Let us not forget that Africa IS the dumping ground and WHO even had to develop a code to stop the rich countries from dumping OBSOLETE medical devices there!] But what do they get, say, compared to what IMPACT gave the Chinese? Africans get patent lists and policemen to run around breaking counterfeit “cells”! China gets mobile testing laboratories with built in fast chemical scanning technology in serious off road vehicles to take testing rural! Africans seem to come cheap it seems, too cheap… and the “hired hand” Jacques Chirac is the salesmen for the idea on the continent! Big bucks this be!
    Perhaps the appeal of IMPACT that it is simply ACTA with the best disguise: protect IP because you cannot be FOR bad medicines right?
    And for more fun reading on WHO and conflicts of interest that are by the Secretariat’s own admission an “internal management issue” (well because they deserve to be, right?) see “Guidelines on Working with the Private Sector to achieve health outcomes (EB107/20)”…
    And please don’t mention that countries who attended IMPACT (and related) Drug Regulatory Conferences participated apparently in their personal (not official) capacities because this tends to take the “legitimacy” wind out of the sails of IMPACT/WHO…


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