E-DRUG: NGOs urge govt to boycott WHO meeting on definition of counterfeit drugs (8)
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Thanks Michele Forzley for your comment "Suggestions that the IMPACT is an anti-generic movement are not substantiated by its history, its intent nor its current work product. Countries remain free to define a counterfeit as they wish subject to any applicable national or international legal requirements".
If it is true that the changed definition will not hurt the generics as is feared, then IMPACT should categorically state so.
Countries otherwise also remain free!
Quoting some of the points from the article "Counterfeit Drugs" by Dr K Balasubramaniam. See http://lists.kabissa.org/lists/archives/public/pha-exchange/msg04145.html for full version.
1. A counterfeit drug is a legal and criminal issue which should not be mixed with quality and patient safety.
2. There is at present international debates regarding the negative impact of intellectual property rights (IPRs) on access to knowledge, public interest and development.
3. If in this scenario where access to drugs is threatened by patent protection, any attempt to enforce IP infringement will further deny people living in the developing countries access to drugs.
4. Why are the US, EU and the multinational drug companies (MNCs) negotiating an Anti-Counterfeit Trade Agreement (ACTA) behind closed doors? This is a classic example of strategic forum shifting from one forum to another in order to enforce strong patent protection.
5. The present focus on counterfeit drugs and the Anti-counterfeit Trade Agreement (ACTA) is the latest in the strategic forum shifting by the US, EU and the multinational drug industry to ensure strict enforcement of intellectual property rights (IPRs).
6. WHO has developed the following definition of counterfeits. "A medicine which is deliberately and fraudulently mislabelled with respect to identity and /or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with correct ingredients or with the wrong ingredients without ingredients, with insufficient active ingredients, or with fake packaging".
7. In the WHO definition, counterfeits clearly apply only to "mislabelling" of medicines and only to those situations in which the mislabelling is carried "deliberately" and "fraudulently". Thus it excludes those situations in which there are legitimate disputes about the trade mark status of a label and the burden of proof is with the accuser. On the other hand IMPACT (International Medical Products Anti-counterfeiting Task Force) a WHO initiative, gives "new definition" of counterfeit medical product. A medical product is counterfeit when there is a false representation in relation to identity, history or source. This applies to the product, its container or other packaging or labelling in formations. Counterfeits can apply to both branded and generic products. Counterfeit may include products with correct ingredients/components, with wrong ingredients components, without active ingredients with incorrect amount of active ingredients or with fake packaging", by avoiding the terms, "deliberately and fraudulently" relieving the investigators of the onus of proving voluntary possession of counterfeit medical products and transferring the burden of proving their good intentions on those found in possession of counterfeits. This is a traversity of the normal forms of justice where the guilty person has to prove he is innocent and not guilty.
8. Member States should ask the WHO why IMPACT, changed its original definition. The new definition is designed to assist MNCs to get their IPRs strongly protected. On the other hand the developing countries will face more problems to get access to life saving drugs.
9. WHO appears to initiate IP enforcement through its initiative IMPACT which is supported by the International Federation of Pharmaceutical Association (IFPMA), representatives of WTO, WIPO, OECD and Interpol.
10. IMPACT tends to be industry oriented and to blur the distinction between counterfeits on the one hand and generics, parallel trade and compulsory licensing which are legitimate business practices, on the other.
11. The strategy behind the whole issue seems to be to casually mix every thing together including piracy, compulsory licensing, parallel imports and generics under the single banner of the emotive term "counterfeit" use it to frighten consumers, harness the power of public health safety concerns, link it with IP protection and enlist public sector support in enforcing private rights meaning that taxpayers dollars would be used to protect private rights
12. The presentation Dr V Reggie of WHO Geneva gave to WHO/SEARO, New Delhi on 7th August. The presentation was entitled "Counterfeits Kill!" The graphic shows a venomous hooded cobra ready to strike! This will certainly frighten consumers. However, it is not factually correct. The two definition of "Counterfeit" given in the presentation includes medicines with the correct ingredients. These counterfeits will certainly not kill. Therefore a sweeping title is misleading; another statement refers to "the 'perfect copy' myth without defining what a perfect copy is. This is blatant thinly veiled attempt to equate generics with "perfect copy" and thereby call quality and safety of generics into question. Another department in the WHO actively promoted the use of generics. When experts within WHO disagree where do the general public go?
13. The presentation quite correctly, states that not all substandard drugs are counterfeit. Therefore a system to monitor infringement of IPRs and to strictly enforce patent protection to keep counterfeits out of the market can never weed out all substandard drugs from this market. It is also accepted that strict enforcement of IPRs will reduce access to life saving drugs.
14. To remove counterfeits, the best solution is to remove the cause. In developing countries, counterfeits enter the market because of the lack of required drugs. The solution to counterfeit is, therefore, for the government to ensure the availability of the required supply of needed drugs at affordable price by implementing the new WHO Global Strategy and Plan of Action on Public Health Innovation and Intellectual Property approved at the WHA in May 2008. This should be the priority for the WHO not to redefine counterfeit and call counterfeit a killer.
Well, well the issue seems to be getting clearer now.
Dr Vijay Thawani
vijaythawani@rediffmail.com
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