|
||
|
TWN Info Service
on Intellectual Property Issues (Nov08/07) IMPACT has become controversial as it is largely run by the multinational companies and developed countries and is spearheading initiatives on IP enforcement that will undermine access to medicines. It runs many of its initiatives through WHO. The pressure from generic companies, SMEs and NGOs comes as IMPACT is holding several meetings in November and December. IMPACT will meet on the 25th -26th November
to review and finalize a draft revised version of IMPACT's " Principles
and Elements for National Legislation against Counterfeit Medical Products"
so that it also includes counterfeit medical devices. It is also holding
a General meeting from 3-5 December in News reports also
mention SECURE (at World Customs Organisation) and of developed countries'
initiative called the Anti Counterfeiting Trade Agreement (ACTA). In a letter to the DCGI, the IPA said that counterfeiting medicines is a vile and serious criminal offence that needed coordinated efforts of all stakeholders at the international level to combat it. But, instead of focusing on the counterfeit medicines, most programmes of EU Council Regulation (EC) No. 1383/2003 of 22 July 2003, International Medical Products Anti-Counterfeiting Taskforce (IMPACT) by WHO, Standards Employed by Customs for Uniform Rights Enforcement (SECURE) by World Customs Organization and Anti Counterfeiting Trade Agreement (ACTA) initiated by the USTR have degenerated into using them as a tool to create barrier to generic medicines. IPA's response comes in the wake of the Indian government reopening discussion, apparently under pressure from the WHO, with the Indian drug industry on the WHO proposal which Indian authorities had earlier turned down on the ground that the new definition will act against the interest of the Indian drug industry. Interestingly, IPA was not invited for a government-industry meeting on the issue called by the Union health ministry on November 14. Finding fault with the WHO definition on counterfeit drugs, IPA suggested that the WHO defines counterfeit medicines as 'medicines which are deliberately and fraudulently mislabelled with respect to identity or source. Counterfeiting occurs both with branded and generic products and counterfeit medicines may include products with the correct ingredients but fake packaging, with wrong ingredients, without active ingredients or with insufficient active ingredients'. The problem with this definition is that it clubs 'substandard' medicines with 'counterfeit' medicines. The IMPACT defines 'a medical product as counterfeit when there is a false representation in relation to its identity, history or source. This applies to the product, its container, packaging or other labelling information. Counterfeiting can apply to both branded and generic products. Counterfeits may include products with correct ingredients or components, with wrong ingredients or components, without active ingredients, with incorrect amounts of active ingredients, or with fake packaging'. The problem with this definition is that besides clubbing 'substandard' with 'counterfeit', it adds a new dimension to definition by inserting the word 'history' without being specific. This raises concerns of the public health activists and the generic industry that it may be interpreted in a manner that will create barrier to generics, IPA said. IPA also urged the DCGI to exclude infringement of patent rights, parallel importation of original goods from a third country where they have been sold by the appropriate right-holder and the diversion of supplies of authorized items from the scope and definition of counterfeit medicines, because since the focus of the issue is on public and personal health implications of use of counterfeit medicines, the new definition should not include these provisions. Calling upon the
developing countries to unite at the WHO to establish one and uniform
definition of counterfeits for medical products, the IPA has said that
the IMPACT background document had defined its scope and stated, 'the
focus of these principles is on public and personal health implications
in relation to counterfeit medical products'. Therefore, it should not
address infringement of aspects of intellectual property rights (IPR)
related to patent rights, or parallel importation of original goods
from a third country where they have been sold be the appropriate right-holder
and explicitly cover other illegal activities such as diversion of supplies
of authorized medical products, or theft of authorized medical products.
MSF warns Indian
govt of developed countries' attempt to trap generics under "By confusing the issues of counterfeit medicines and substandard medicines, WHO and governments are attacking the wrong problem, which does nothing to improve the quality of medicines, which is a far greater public health concern. Counterfeit is a trademark and IPR issue that should not be confused with quality issues," MSF's project manager for India Leena Menghaney said. In a letter to Union
health minister Dr Anbumani Ramadoss, the MSF urged the Indian government
to project a true picture in this regard at the forthcoming international
meeting called by IMPACT of the WHO on giving new definition to counterfeit
drugs. DCGI Dr Surinder
Singh and joint secretary in the Union health ministry Debashish Panda
are scheduled to attend the meeting to be held in The MSF is seriously concerned that legally manufactured generics could fall under the definition of counterfeiting being proposed under international resolutions, agreements or treaties. Indeed the 'Anti Counterfeiting Trade Agreement (ACTA)' negotiations are being conducted with little participation from developing countries. In addition, the anti-counterfeit issue also needs to be seen in the context of moves by the European Union and other developed countries to strengthen intellectual property enforcement. One such mode of enforcement is to amend regulations that govern practices by customs authorities towards counterfeit goods across the globe. In conjunction, this could lead to customs authorities, seizing or delaying the transit of legitimate generic medicines, on suspicion of being 'counterfeit'. As a consequence, there is a risk that life-saving essential medicines imported from India may be banned or held up, such as those used by Médecins Sans Frontières in African countries to treat people living with HIV/AIDS. The consequences on access to life-saving medicines and on the sustainability of AIDS and other treatment programmes that rely on generic production or importation would be devastating, MSF warned the Indian government. MSF currently treats
1.4 lakh people living with HIV/AIDS in 27 countries including SPIC urges govt
to safeguard export business of SME units while reframing The SME Pharma Industries Confederation (SPIC), in a letter to the health department officials, called for safeguarding the export interests of the SME sector by excluding the trademark violations issue from the ambit of the definition. The move under the pressure from the WHO was described as an attempt to put up barriers for the generic drugs and the SME units surviving on exports to developing and underdeveloped countries would be hit harder, SPIC vice chairman Lalit Kumar Jain said. SPIC has urged the government to drop the words 'correct ingredients (components)' and exclude drugs already approved by the regulatory authorities in the country of origin from the original definition. "A medicine/a medical product (medicine, vaccine, diagnostic or medical device) is counterfeit when it is deliberately and fraudulently mislabeled with respect to its identity and/ or source. Counterfeit can apply to both branded and generic products. Counterfeit includes [components], with wrong ingredients, without active ingredients, with incorrect amounts of active ingredients, with fake packaging, or not approved by the regulatory authority in the country of origin," it said. "A counterfeit
can be defined as an imitation designed to deceive or defraud. With
the deletion of words with correct ingredients, separates the quality
issue and trade issue of copyright. Issues of compulsory licensing as
per The definition should not involve transit problems through developed/third countries. WHO is concerned only with the question of quality and since the quality apprehensions of IMPACT have been address to, WHO should not exceed its jurisdiction of WTO, which is a body concerned with the trade issues. When the quality issue has been addressed in the amended definition, the trade issue if any can be taken up in WTO, the association suggested. The addition of 'words or medicine not approved b y the regulatory authority of the country of origin' would stop supply of all products by multinationals to developing nations which are not approved in their own country. This will boost Indian exports to developing countries, SPIC said. http://pharmabiz.com/article/detnews.asp?articleid=47069§ionid=&z=y
DCGI Dr Surinder
Singh and joint secretary in the Union health ministry Debashish Panda
are to attend the meeting to be held in Questioning the legitimacy of the IMPACT in changing the definition of counterfeit drugs, the NGOs said that counterfeit is not an IPR issue and this is basically a quality issue which should be discussed in the World Health Assembly. The NGOs also raised this issue at a government-industry meeting convened by the Union health ministry on November 14 to discuss WHO's proposal to give a new definition to counterfeit drugs which the ministry had earlier turned down due to the resistance of the Indian drug industry. All the major industry associations like IDMA, IPA, FOPE, SPIC, CIPI, etc participated in the meeting. The industry pleaded with the government that the new definition will act against the Indian drug industry, especially the generic drug manufacturers as the new definition considers apparent 'trademark violations' as 'counterfeiting' cases. The Indian drug manufacturers, especially the small scale sector, are concerned over the WHO proposal as they fear the efforts would be another attempt by the big multinational companies to kill the Indian generic drug makers. As per the proposal by the IMPACT, apparent 'trademark violations' will be considered as 'counterfeiting' cases which the Indian drug makers said would harm exports of generic drug makers. The current definition of WHO says counterfeit drugs are 'medicines which are deliberately and fraudulently mislabeled with respect to identity or source. Counterfeiting occurs both with branded and generic products and counterfeit medicines include products with the correct ingredients but fake packaging, with the wrong ingredients, without active ingredients or with insufficient active ingredients'. The definition proposed by IMPACT removes the clause 'deliberately and fraudulently' and replaces it with 'a medical product is counterfeit when there is a false representation in relation to its identity, history, or source'. It also says that 'this applies to the product, its container, packaging or other labeling information'. IMPACT also wants
to see that WHO definition on counterfeiting 'can apply to both branded
and generic products and include products with correct ingredients/components,
with wrong ingredients/components, without active ingredients, with
incorrect amounts of active ingredients, or with fake packaging'.
|
||
