Mr. Speaker, I am pleased to have the opportunity to address Bill C-393, An Act to amend the Patent Act (drugs for international humanitarian purposes) and to make a consequential amendment to another Act, which aims to modify certain fundamental aspects of Canada's Access to Medicines Regime.
Canada's Access to Medicines Regime's stated purpose is to improve access to lower cost, Canadian-made generic versions of patented drugs and medical devices to address public health problems in developing countries. It was designed to achieve this humanitarian objective, while respecting Canada's international trade obligations and maintaining the integrity of Canada's patent system.
Members of the House view Canada's Access to Medicines Regime as a key component of Canada's long-term approach to addressing serious public health problems that affect many developing and least developed countries, such as HIV-AIDS, tuberculosis, malaria and other epidemics. In addition to Canada's Access to Medicines Regime, this approach includes significant contributions from the Government of Canada to other global mechanisms and alliances which have come into existence in recent years and have become leading instruments for procuring lower cost drugs to respond to the needs of developing and least developed countries.
For example, the government has contributed more than $500 million to the global fund to fight AIDS, tuberculosis and malaria. It has also pledged another $450 million to the fund over the next three years. In addition, the government is working with the Bill & Melinda Gates Foundation to fund the development on an HIV-AIDS vaccination.
The government has serious concerns with Bill C-393's proposed modification to the regime's legislative framework. If passed by Parliament, the bill will result in the elimination of many of the key operational elements in Canada's Access to Medicines Regime in order to adopt a very broad, one-licence approach. This could have serious negative implications for continued pharmaceutical investment and growth in Canada. In addition, many of the bill's proposed legislative changes may not be in keeping with the spirit of the World Trade Organization decision on which Canada's Access to Medicines Regime is based.
This decision was the result of years of intensive international negotiations by members of the World Trade Organization. Those negotiations sought a solution to international patent obligations that impeded the export of critical medicines from countries with pharmaceutical manufacturing capabilities to countries without.
In August 2003, WTO members reached a landmark decision. They agreed to waive two of the patent obligations in the WTO's Agreement on Trade-Related Aspects of Intellectual Property Rights, known as TRIPS, in order to improve access to patented drugs and medical devices needed to address public health problems in developing and least developed countries.
Canada's regime is one of the nine regimes in existence to have implemented the World Trade Organization decision, but it is the only one to have successfully authorized the export of drugs to a developing country. This important event occurred on September 24, 2008, when a Canadian drug manufacturer, Apotex Inc., sent approximately seven million tablets of HIV-AIDS therapy to Rwanda.
In 2007 the government completed a statutory review of the regime as part of this process. It reviewed all public input in Canada's Access to Medicines Regime. That input included the extensive written submissions received in response to a 2006 consultation paper on the regime, expert testimony heard at separate hearings by the House of Commons Standing Committee on Industry, Science and Technology in April 2007, and I was a part of that committee, as well as input from developing countries at a workshop organized by non-governmental organizations.
In December 2007 the Minister of Industry tabled a report on the results of the statutory review in Parliament. The report concluded that insufficient evidence was accumulated to warrant making changes to the regime at that juncture.
This conclusion remains valid today, since the case for making legislative or regulatory changes to Canada's Access to Medicines Regime has still not been made. The fact that Canada is the only country today to see drugs shipped to a country in need under its access to medicines regime demonstrates that our system does work.
However, for Canada's Access to Medicines Regime to be used again, another country in need must inform the World Trade Organization of its intent to import lower-cost versions of patented pharmaceutical products under the terms of the August 2003 WTO decision.
The government has and continues to encourage developing and least developed countries to use the system and hopes that such a notification happens. In the meantime, however, it will continue to support Canada's access to medicines, while fighting diseases and helping improve public health conditions in the developing world through other initiatives in the government's long-term comprehensive strategy on access to medicines.
It is for these reasons that I urge all hon. members of this House not to support Bill C-393.