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

    Published on 20 May 2010 @ 9:56 am

    By , Intellectual Property Watch

    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.

     

    Comments

    1. alivenkickn 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. White House IP Czar Releases Intellectual Property Enforcement Update « Innovators Network Blog says:

      [...] their respective sides of the argument. Kaitlin Mara reports on the situation in her topical piece, Debate Erupts Over WHO Police Work Against “Counterfeit” Drugs Trade. At the center of the debate is Brazil. A battle broke out yesterday at the World Health [...]

    4. Intellectual Property Watch » Blog Archive » New Resolution Gives Governments Control Of WHO Work On False Medicines says:

      [...] Latest CommentsNPC on Debate Erupts Over WHO Police Work Against “Counterfeit” Drugs TradeThe issue here is about legal concepts and languag… »Miles Teg on WHO: No Evidence Of [...]

    5. 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?

    6. James Love 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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    We welcome your participation in article and blog comment threads, and other discussion forums, where we encourage you to analyse and react to the content available on the Intellectual Property Watch website. By participating in discussions or reader forums, or by submitting opinion pieces or comments to articles, blogs, reviews or multimedia features, you are consenting to these rules.

    We welcome your participation in article and blog comment threads, and other discussion forums, where we encourage you to analyse and react to the content available on the Intellectual Property Watch website.

    By participating in discussions or reader forums, or by submitting opinion pieces or comments to articles, blogs, reviews or multimedia features, you are consenting to these rules.

    1. You agree that you are fully responsible for the content that you post. You will not knowingly post content that violates the copyright, trademark, patent or other intellectual property right of any third party or which you know is under a confidentiality obligation preventing its publication and that you will request removal of the same should you discover that you have violated this provision. Likewise, you may not post content that is libelous, defamatory, obscene, abusive, that violates a third party's right to privacy, that otherwise violates any applicable local, state, national or international law, that amounts to spamming or that is otherwise inappropriate. You may not post content that degrades others on the basis of gender, race, class, ethnicity, national origin, religion, sexual preference, disability or other classification. Epithets and other language intended to intimidate or to incite violence are also prohibited. Furthermore, you may not impersonate others.

    2. You understand and agree that Intellectual Property Watch is not responsible for any content posted by you or third parties. You further understand that IP Watch does not monitor the content posted. Nevertheless, IP Watch may monitor the any user-generated content as it chooses and reserves the right to remove, edit or otherwise alter content that it deems inappropriate for any reason whatever without consent nor notice. We further reserve the right, in our sole discretion, to remove a user's privilege to post content on our site. IP Watch is not in any manner endorsing the content of the discussion forums and cannot and will not vouch for its reliability or otherwise accept liability for it.

    3. By submitting any contribution to IP Watch, you warrant that your contribution is your own original work and that you have the right to make it available to IP Watch for all purposes and you agree to indemnify IP Watch, its directors, employees and agents against all damages, legal fees and others expenses that may be incurred by IP Watch as a result of your breach of warranty or of these terms.

    4. You further agree not to publish any personal information about yourself or anyone else (for example telephone number or home address). If you add a comment to a blog, be aware that your email address will be apparent.

    5. IP Watch will not be liable for any loss including but not limited to the following (whether such losses are foreseen, known or otherwise): loss of data, loss of revenue or anticipated profit, loss of business, loss of opportunity, loss of goodwill or injury to reputation, losses suffered by third parties, any indirect, consequential or exemplary damages.

    6. You understand and agree that the discussion forums are to be used only for non-commercial purposes. You may not solicit funds, promote commercial entities or otherwise engage in commercial activity in our discussion forums.

    7. You acknowledge and agree that you use and/or rely on any information obtained through the discussion forums at your own risk.

    8. For any content that you post, you hereby grant to IP Watch the royalty-free, irrevocable, perpetual, exclusive and fully sub-licensable license to use, reproduce, modify, adapt, publish, translate, create derivative works from, distribute, perform and display such content in whole or in part, world-wide and to incorporate it in other works, in any form, media or technology now known or later developed.

    9. These terms and your posts and contributions shall be governed and interpreted in accordance with the laws of Switzerland (without giving effect to conflict of laws principles thereof) and any dispute exclusively settled by the Courts of the Canton of Geneva.

     

     
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