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“Anti-counterfeit deal threatens accessibility of drugs” 0

LONDON – A proposed anti-counterfeit trade deal between 10 countries and the European Union (EU) could create “a new set of barriers to the export of generic medicines to low income countries”.

This warning comes from Rohit Malpani, senior advisor at Oxfam America, who spoke to IPS on the eve of the ninth round of negotiations on the Anti-Counterfeiting Trade Agreement (ACTA) taking place this week in Lucerne, Switzerland.

ACTA is aimed at tackling the trade in fake products — from luxury watches and cosmetics to car parts and medicine – and those persons infringing on intellectual property (IP) rights by strengthening powers of customs officials in signatory countries to seize counterfeit goods.

International trade of IP-infringing products is worth over 150 billion euro per year, according to estimates of the Organisation for Economic Cooperation and Development (OECD), representing rich countries.

Instigated by the U.S. and Japan in 2006, the ACTA negotiators now include the EU, Australia, Canada, Korea, Mexico, Morocco, New Zealand, Singapore and Switzerland.

But, critics warn, by not clearly distinguishing between fake medicines and legal generic drugs, which are often subject to patent dispute, the agreement could lead to the wrongful seizure of generic medicines en route to developing countries.

“ACTA is not just focusing on issues related to trademark law – that is, medicines that are illegally and deceptively mislabelled – but will also include patent law, which means that generic drugs will be covered,” explains Joel Lexchin, MD, professor in the school of health policy and management at York University, Canada.

A patent involves the exclusive right, granted by a government, to use an invention for a specific period of time.

According to Lexchin, ACTA’s inclusion of patents “could substantially impede the flow of generic medicines. For instance, a company could claim that its IP rights have been violated in the production of a generic drug.” That drug could then be seized by customs officials when it enters the country.

According to the World Trade Organisation’s (WTO’s) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs), WTO members must grant exclusive patent rights on medicines.

However, they can in some circumstances allow the production of lower-cost, generic versions of patented drugs in exchange for royalties paid to the patent holder.

But, crucially, TRIPs only allows such medicines to be sold in the domestic market of the developing country that produces it. Problems thus arise when low income countries, which cannot make their own generics, import them from larger developing countries like India, and in transit they enter a country where the patent is active.

“Under ACTA, a multinational pharmaceutical company can say to customs officials in the transit country: ‘That product infringes our patent in this territory, so even though the medicine is safe and can be legally exported from one developing country to another, we still want you to prevent it from reaching its destination’,’” Malpani explains.

Such seizures occurred after the European Commission (EC) issued a crackdown on IP infringement which led to shipments of generic drugs being wrongfully intercepted.

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By Adam Robert Green IPS

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