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Where they’re needed most

Legislation hinders developing countries’ access to life-saving medicine

Ten million people die needlessly each year – mostly in the developing world – because they lack access to medicines. This past Friday, the McGill Global AIDS Coalition, in partnership with Universities Allied for Essential Medicines (UAEM), Nurses Without Borders, and the Post-Graduate Students’ Society, hosted a public forum on the challenges developing countries and their partner NGOs face in getting access to generic drugs manufactured in Canada. Featuring speakers from the Canadian HIV/AIDS Legal Network and UAEM, the discussion centred on Canada’s Access to Medicines Regime (CAMR), and the reasons behind recent calls for its reform.

Obtaining a license under CAMR is a lengthy process. A developing country and a Canadian manufacturer of generic drugs must first establish what medication is going to be produced and in what quantity. While the developing country notifies the World Trade Organization, the drug manufacturer must get approval from Health Canada, which is responsible for ensuring that all medications sold in this country pass standards of safety, quality, and efficacy. No medication may be exported unless it complies with Canadian regulations. The next step requires that the generic drug manufacturer negotiate with the original patent-holder for a voluntary license of their product. At this point, full details of the deal – including number of doses and recipient country – must be disclosed. If the companies fail to reach an agreement within 30 days, the manufacturer may apply to the Canadian government for a compulsory license, which overrides a patent.

Developing countries can incur high political costs when taking advantage of the compulsory licensing schemes offered by Western countries. After the public disclosure of the importing country’s identity, developing nations can face measures of retaliation if they do not suspend their request for a compulsory license. In 2007, Thailand issued a compulsory license for lopinavir, an AIDS medication produced by the U.S.-based Abbott Laboratories. In response, the United States placed Thailand on the Priority Watch List of countries that do not respect intellectual property law. The adverse reaction spread to other Western states, with the European Union also condemning the move.

“A lot of our partner countries that we approached sent a request to their department of foreign affairs and got a response that: ‘There’s no way we’re touching this,’” explained Rachel Kiddell-Monroe, president of the board at UAEM.

One of the strongest criticisms of the CAMR system is that the delay in getting a license and potential political damage to the recipient country are strong disincentives for the regime to be used effectively. In the five years that CAMR has been in operation, there has only been one drug produced under its aegis, in an order placed by Médecins sans frontières (MSF) for its projects in Rwanda. Although the NGO started the process in May 2004, it did not receive the first shipment of drugs until September 2007. Of all the generic manufacturers that MSF approached in 2004, only the Toronto-based Apotex agreed to become involved. The pharmaceutical company has since stated that, unless CAMR is reformed, it has no interest in joining a compulsory license request again.

Reforms to CAMR are currently being considered by Parliament. The main improvements would be a boost to confidentiality, which would help shield developing countries from retaliation, and added flexibility to the compulsory license. Once a request has been approved, the generic drug manufacturer would not need to go through the application process repeatedly if the developing country needs to increase the size of an order. With Parliament back in session, the Industry, Science, and Technology Committee is expected to discuss the proposed measures (Bill C-393) as the first item on its agenda.

At second reading, C-393 was passed with 143 MPs voting in favour and 127 opposing the measure. The Conservative government enforced party discipline to urge cabinet members to vote against the legislation, but allowed the rest of its caucus a free vote. The Bloc Québécois voted in favour of the bill, but claimed that it intended to seek amendments to the legislation at the committee stage. Marc Garneau, McGill’s local MP and a member of the Industry Committee, has stated his opposition to the measure. If C-393 clears the House of Commons, it will still have to go through the same lengthy process in the Senate, ensuring that Canadian medicines can count security at the airport as the shortest part of their trip to the developing world.