First Generic Drugs En Route to Africa under 5-Year-Old WTO Deal

25 September 2008

Canadian drug maker Apotex announced on Tuesday that it would begin shipping generic versions of a patented HIV/AIDS drug to Rwanda, five years after a WTO decision made it possible for the cheaper copies to be produced for export to people in poor countries.

Seven million tablets of Apo-TriAvir, a triple-combination HIV/AIDS drug, will be shipped from Toronto to Rwanda on 24 September, Apotex said. A second set of 7 million tablets - enough medicine to treat 21,000 people for one year - is to be delivered in September 2009.

The shipment is the first batch of drugs to be delivered under the '30 August 2003' decision at the WTO, in which Members agreed to waive provisions under the WTO's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) so that countries could legally export generic drugs produced without the patent-holders' consent to developing countries that are unable to produce pharmaceuticals themselves. The 30 August Decision was the result of a 2001 declaration on TRIPS and public health that promised an "expeditious" solution to the problem.

In September 2003, Canada became the first Member of the WTO to declare its intention to put the decision into action. To date, Apotex is the only company to have sought approval through the Canadian Access to Medicines Regime (CAMR), a domestic programme that aims to facilitate the implementation of the WTO decision.

While the Canadian programme has received some praise for strengthening poor governments' hand while negotiating drug purchase prices, critics say that the approval process is so complicated that it has discouraged drug makers from taking part.

"While we are extremely pleased to be able to make this important and historic contribution, there is a reason no other company has tried to provide medicines under this regime," Jack Kay, the chief of Apotex, said on Tuesday. "It is too complex and has to be repeated for every request that comes in from a country. For Canada to truly be able to provide help, the regime must be changed," he said.

Even Apotex will not be going through the process again unless the regulations are amended, the company said.

"It's a huge process, with huge costs involved," said Elie Betito, director of public affairs for Apotex, Canwest News reported. "We will not be doing this again."

But public health groups have said that the 30 August Decision itself is overly complicated in that it requires too much complex notification, and that the Canadian programme simply adds to the already-onerous requirements of the WTO provision, with devastating results.

"The delivery of these medicines is way past due," said Richard Elliott, the Executive Director of the Canadian HIV/AIDS Legal Network. "It's taken more than four years to get to this point. People are dying because they can't pay high prices for patented, brand-name drugs - they can't afford such delays."

ICTSD reporting. "Canadian to ship AIDS drugs to Rwanda for first, perhaps last time," CANWEST NEWS SERVICE, 22 September 2008.

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