Al Jazeera examines international trade agreement negotiations, access to generic medicines in low-income countries

Nov 7 2010

Al Jazeera examines what the outcomes of two international trade agreement negotiations - one regarding free trade between the EU and India and the other over anti-counterfeiting measures - could mean for patients living with HIV/AIDS in low-income countries.

"The charity Medecins sans Frontieres (MSF) says that hidden clauses in the free trade agreement (FTA) currently being negotiated between Europe and India will prevent the manufacture and distribution of crucial generic medicines produced in the country," the news service writes. The WHO has also expressed concerns over what a deal involving any regulations on the production of generic medicines would mean for populations dependent on low-cost medicines, according to the news service.

"India is a well known supplier of generic medicine," said Hans Hogerzeil, director of the essential medicines and pharmaceutical policies department of the WHO, the news service writes. "For example, at least half of the five million AIDS patients in Africa already on treatment rely on Indian generic medicines for their treatment," he added.

"The issue hinges on a so-called 'data exclusivity' provision in the free trade agreement, which campaigners say would effectively copyright information gathered in the clinical trials that prove the effectiveness and safety of medicines," Al Jazeera writes. "At present, generic manufacturers rely on the results of the original clinical trials carried out by the drug developer to get their cheap version registered. If this information were to become exclusive, Indian companies would be left without the data they need to register their drugs," according to the news service. Such changes "would delay the market entry of generics" and present ethical challenges in the case where generic manufacturers were forced to carry out additional clinical trials on patients "when the data are already available," Hogerzeil said.

Al Jazeera continues, "[h]ealth experts have also become increasingly concerned about a separate treaty" known as the anti-counterfeiting trade agreement (ACTA) currently under negotiation that is "aimed at tackling the international counterfeiting trade. … The treaty is supposed to block the production of fake medicines, but activists say that counterfeit medicines are deliberately being conflated with generic medicines to interfere with their production and distribution."

"There's a real threat from the FTA and ACTA in the way counterfeit medicines will be defined," according to MSF's Tido von Schoenangerer, who runs the organization's campaign for essential medicines. "Everyone agrees we need to fight against fake medicines, but counterfeiting rules are being used to protect trade interests," he said.

"The European [Union] Commission has flatly denied that its negotiations will have a negative impact on India's generic medicine industry," Al Jazeera writes. "We are not trying to limit the capacity of key Indian generic producers to export to other developing countries," EU Trade Spokesman John Clancy said, according to the news service.

The article also includes comments on the issues by DG Shah, secretary general of the Indian Pharmaceutical Alliance and a patient living with HIV/AIDS in India, who the news service reports takes "Indian-made generic medicines" (Wander, 11/4).