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Goldstein Introduces Patent Reform Bill To Ease Access To Medicines

By Michael Geist

For many years, countries such as Canada have avoided the uncomfortable truth that millions are dying in the developing world due partly to legal barriers that render access to medicines unaffordable.  In 2003, the World Trade Organization reached agreement designed to facilitate the export of medicines by opening the door to a compulsory licence for developing countries without manufacturing capabilities. Canada became an early adopter of the agreement by reforming the Patent Act to allow the Canadian Commissioner of Patents to issue a compulsory licence to a pharmaceutical company to allow for the manufacture and export of an eligible drug or medical device to an eligible importing country. Titled the Jean Chretien Pledge to Africa Act after the former Prime Minister's commitment to development support in Africa, the reforms were touted as an illustration of Canadian leadership on development issues.  

My weekly technology law column (Toronto Star version, homepage version) notes that several years later, most agree the policy have been a near-total failure.  The law has only been used once and the company involved in the process found it so burdensome that it has vowed not to repeat it.  Moreover, other countries, including the European Union, the Netherlands, Switzerland, China, India and South Korea, have also implemented the WTO reforms in a manner that leaves the Canadian Access to Medicines Regime (CAMR) looking unduly restrictive and outdated by comparison.

On March 31st, Senator Yoine Goldstein took an important step forward to address the problem by introducing Bill S-232, a Private Member's bill that includes several important reforms to the Patent Act.  The bill will undoubtedly face opposition from some pharmaceutical companies who argue that the current system is "fair, functional, and efficient."

Under that system, it can take years for a country and drug manufacturer to overcome the barriers to get the medicines delivered.  For example, the only use of CAMR involved a 2007 export of AIDS medicines to Rwanda.  The Rwandan government, working with Canadian-based Apotex, sought to import 260,000 packs of TriAvir, an AIDS combination drug.  Rwanda had previously obtained similar medicines from Brazil and India, but found their supplies dwindling in response to international patent rules that restricted generic production in those countries.

Apotex had earlier made a corporate commitment to export medicines to countries in need. Yet when it began to work through the CAMR process, it repeatedly encountered barriers as it took months to obtain the necessary approvals.  Indeed, according to an Apotex executive, "I don't know whether we did the developing world a favour or a disservice by getting that first shipment of TriAvir out.  It seems to have appeased the conscience of the legislators and of the brand industry, and let them think we don't need to do anything else. That's unconscionable."

Bill S-232 would not remove all barriers, but it would help to streamline the process of obtaining the necessary approvals. Most importantly, it would establish a "one-licence solution" to enable generic pharmaceutical manufacturers to send shipments of the same medication to a multiple countries without needing new approvals for each shipment.  At the moment, approvals are needed for each shipment.

The bill would also extend the groups who can make use of CAMR system. At the moment, only governments are permitted to buy medicines on behalf of their citizens.  Bill S-232 would make it easier for the many non-governmental organizations focused on access to medicines to buy and distribute generic medications.

A House of Commons committee examined the CAMR system in 2007, with the Government expressing the hope that the Rwanda case would be the first of many.  More than two years later, that has not happened and CAMR appears to be no closer to getting medicines to those in need.  It is time for Canada to face up to its uncomfortable truth by reforming the Patent Act and removing the barriers to access to medicines.

Full post as published by Michael Geist on April 14, 2009 (boomark / email).