Debate Erupts Over WHO Police Work Against “Counterfeit” Drugs Trade

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A battle broke out yesterday at the World Health Organization over whether it should continue its relationship with an in-house anti-counterfeiting law enforcement and customs group, and what that decision might mean for the role of the organisation in the fight against fake medicines.

Some countries seem to be “trying to disguise trade and commercial interests under public health,” the ambassador of Brazil told a committee on the counterfeit issue at the annual World Health Assembly yesterday. “This is what is at stake in this negotiation.”

Brazil and India yesterday claimed that WHO’s work against counterfeit and substandard medicines is being influenced by brand-name drug producers with an interest in undermining legitimate generic competition. The Brazilian ambassador told Intellectual Property Watch there is a “hidden agenda” against generics from countries like Brazil.

“What is the mandate of the WHO? Is it a police organisation?” Or should it be concentrating on matters of quality, safety and efficacy, she said to the committee in an intervention that received a round of applause from many governments.

At issue is the fate of the International Medical Products Anti-Counterfeiting Taskforce (IMPACT), which opponents say has led the WHO – perhaps intentionally – to confuse the issue of substandard, falsified or otherwise low quality or unsafe drugs with “counterfeit” medicines. But supporters of IMPACT, mainly developed countries with large brand-name producers, argue that the group was intended to address public health and not patents, and should remain involved with WHO.

More generally, WHO members are wrestling with how WHO should proceed with work on fake medicines – including how to refer to such medicines.

No consensus appeared forthcoming on substantive issues late Wednesday evening, though a proposed way forward may be addressed Thursday morning. A way forward supported by some India and several South American countries would tackle difficult substantive issues in a new intergovernmental committee. These issues include effects of using different terms, the relationship between WHO and IMPACT, and an examination of three draft resolutions on fake medicines that have been submitted to the WHO (IPW, WHO, 18 May 2010).

WHO Director General Margaret Chan failed to directly address many of the concerns brought up with regards to IMPACT during the meeting yesterday. The call for intergovernmental processes in this issue and a new working group on research and development financing (IPW, WHO, 14 May 2010) may indicate a lack of trust on the part of some countries that the secretariat will act on their best interests, some say.

The World Health Assembly is taking place from 17-21 May.

Time for WHO to ‘Divorce’ IMPACT?

IMPACT “functions outside the purview of WHO member states” and thus lacks accountability to them or a mandate from them, said the delegate of Iraq, a position that was supported by many other developing countries. But it has been acting as though it represents WHO expertise in Africa, said Kenya.

Kenya’s law on counterfeit products resulted from advice given by IMPACT, said the delegate of the country. This law has been problematic for health and access to medicine, he said.

When IMPACT approached Kenya on the issue of counterfeit, it went through the ministry of trade, and the law was passed without consulting the ministry of health. They presented model legislation, and used the trusted letterhead of the WHO, he added. They have also been approaching other countries in Africa, such as South Africa.

“Who is pushing this?” the delegate asked, later adding “If you’re not happy in a marriage, you obviously get divorced… [we are] seeking that this marriage between WHO and IMPACT come to an end and we start proceedings on the divorce.”

Venezuela asked for Chan’s help in abolishing the group, and said WHO support was needed to contribute to the interests of developing counties. Brazil said it could have a life of its own if it found “some other spouse” but objected to its closeness with WHO.

India said it could not accept any IMPACT document becoming a WHO document without express debate in a WHO governmental committee. The statement of India is available here.

Several developing countries brought up concerns that IMPACT had conflicts of interest and was overly influenced by pharmaceutical companies and developed countries.

Developed countries defended the work of IMPACT as doing essential work to protect the public from dangerous products. IMPACT was established “to enable its broad range of partners to work towards common goals under WHO leadership,” said Spain on behalf of the European Union, and Switzerland acknowledged that the groups mandate needed clarifying but said it appreciated its technical work.

The “threats surrounding counterfeit, falsified or substandard medicine require active engagement by a diverse range of all stakeholders,” said the United States, recognising the leadership of IMPACT and as well as the secretariat’s “actions to more carefully articulate the role of WHO within IMPACT.” The US emphasised that “WHO is the forum to address the public health issues related to counterfeit, falsified or substandard medical products,” and other issues could be addressed in other forums. The US statement is available here.

Chan said she would review “WHO’s engagement with other international organisations,” but added that not every partnership is approved by the World Health Assembly, citing the example of drug-purchasing mechanism UNITAID and asking if governments also wanted that relationship reviewed.

She acknowledged that in IMPACT “most of these countries are from the developed world” but said participation of others is welcome.

Confusing Definition and Role of WHO

The only internationally agreed definition of “counterfeits” is at the World Trade Organization, where it is defined as a violation of trademarks, say those who oppose the term. It is “devoid of value” in the absence of a clear understanding said India yesterday and as such is a “nonstarter.” There is further concern that the vague definition could interfere with trade of low cost generic medicines. Brazil said falsification of medicines was a critical issue, but it had a problem when “private commercial interests wage a war” within the WHO against generic medicines. Spain on behalf of the European Union Wednesday acknowledged that the term counterfeit gives rise to certain confusion, but said the term could be clarified.

The Brazilian ambassador told Intellectual Property Watch there are concerns about both fake generics and fake brand-name medicines. But, “if we want to fight medicines that have intellectual property problems, let’s go to the WTO, WIPO [World Intellectual Property Organization].” At WHO, the focus should remain on “quality, safety, and efficacy.”

Michelle Childs and Tido von Schoen-Angerer from Médecins Sans Frontières (MSF, Doctors Without Borders) told Intellectual Property Watch that the experience of the organisation from its field work is that substandards are the primary threat, not counterfeit. The credibility of the WHO needs to be in addressing these concerns and helping to find a solution, they added, saying the drive for intergovernmental processes indicated a lack of certainty from some states that WHO would act in a way that protects their interests.

Kaitlin Mara may be reached at kmara@ip-watch.ch.

Creative Commons License"Debate Erupts Over WHO Police Work Against “Counterfeit” Drugs Trade" by Intellectual Property Watch is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.

Comments

  1. says

    What are we talking about? We´re talking about BIG MONEY.

    Within the next 5 years letters of patent for some HIV medicine expire. We´re talking about 89 Billion US Dollars profit . . . .

    But now, with an estimated $89 billion in brand-name drug sales in the United States at risk to generic competition over the next five years, according to IMS Health, some drug makers are selling generics to offset revenue declines — as well as wring some post-patent profits from the innovative drugs they developed.
    http://www.nytimes.com/2010/02/16/business/16generic.html

    Check the backgrounds of the Advisors and Experts of the WHO and you l be surprised to find out who is making donations to the firms, laboratoiris and institutes they work for or own.

    That s what it s really all about . . .

  2. NPC says

    The issue here is about legal concepts and language. The reality is more complex than simple, idiosincratic approaches permit. Instead of simply dividing the world of medicines between legitimate and fake, good and bad, pharmaceuticals can be classified in four different sorts: (1) original ip-covered (under patents, trademarks, test data); (2) generic or non original ip-covered (the qualifier results from the fact that generic products can have their own brands and some processes of their manufacture can be patented); (3) ip-infringing (or counterfeit); and (4) fake, that is, in breach of governmental norms of safety and quality. Categories (1) and (2) are entirely legitimate and lawful; category (3) is unlawful but it is not neccessarily harmful to health; (4) the fourth category is a scourge. One could write a treaty to explain in detail the differences between the four categories, but it is clear that no health agency, national or otherwise, should worry with the first 3 categories. Those are a problem for IP agencies and courts. Only the latter raises problems of public health.

  3. Miles Teg says

    Yes yes, pandering for BigOligopPharma… put IFPMA in charge of norm setting on this issue, what could be more reasonable… and then WHO wonders why there is a mess and pro-IPR enforcement groups wonder why there is a mess… yes there is a categorisation problem… can IMPACT say Vioxx?

  4. says

    There are all sorts of practices and products that present health risks. There are also issues of infringement of patents and trademarks. Governments should play a key role in regulating the quality of drugs, and the marketing of those drugs to consumers. The true counterfeiting of trademarked products should be subject to tough civil and criminal penalties, whether the products are of high quality or low quality. Disputes over the infringement of patent rights should be resolved by private parties. In all of these cases, you don’t want to make the pharmaceutical industry the policy maker for the WHO.

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