Government Of Canada Introduces Legislative Changes To
Enable Export Of Much-Needed, Lower-Cost Pharmaceutical Products To Developing Countries
OTTAWA, November 6, 2003 — The Government of Canada is leading the global movement to address public health problems,
especially human immunodeficiency virus and acquired immune deficiency syndrome (HIV/AIDS), tuberculosis, malaria and
other epidemics, by introducing today legislative changes that will help give developing and least-developed countries
greater access to much-needed, low-cost pharmaceutical products.
The proposed changes to the Patent Act and the Food and Drugs Act make Canada the first country to take concrete
measures to implement the World Trade Organization’s (WTO) recent Declaration on the Trade-Related Aspects of
Intellectual Property Rights Agreement and Public Health (Doha Declaration). The legislative changes will make it easier
for Canadian pharmaceutical companies to export their products to countries in need.
Under the WTO agreement, member countries may allow patented products to be manufactured under licence by
someone other than the patent holder for a limited period of time and in response to a public demand by a country with
insufficient pharmaceutical manufacturing capacity.
“These proposed legislative changes are broad, flexible and faithful to what WTO members have spent so long
negotiating. We hope that our leading role encourages developed countries around the world to follow suit,” said Pierre
Pettigrew, Minister for International Trade. “These actions demonstrate Canada’s strong commitment to the development
objectives set out in the WTO Doha Development Agenda.”
“Our goal is to address a pressing humanitarian problem, and we have worked with the two pharmaceutical
associations and with non-governmental organizations who provide on-the-ground public health assistance to develop
legislation that will be part of the solution,” said
Allan Rock, Minister of Industry. “At the same time, we recognize the need to respect intellectual property rights,
which are critical to the development of new products and therapies in Canada. The input of the industry and
non-governmental organizations has been invaluable, and I thank all who have participated in these consultations.”
“Canada has one of the most rigorous drug approval systems in place, and as Minister of Health, I am committed to
ensuring that the system is used to ensure that the pharmaceutical products sent to less-developed countries meet
Canadian safety standards,” said Anne McLellan, Minister of Health. “This is an important step in helping other
countries fight HIV/AIDS, malaria, tuberculosis and other diseases.”
“This is one of the most important steps Canada can take to advance global health and human rights, and we hope
to see other G-8 countries following suit,” said Bill Graham, Minister of Foreign Affairs. “As United Nations
Secretary-General Kofi Annan said last week, our action today could save millions of lives. This is a major breakthrough
in the international community’s capacity to address not just the prevention of AIDS and other diseases in the
developing world, but also the provision of treatment and access to pharmaceutical products for those in need.”
“Nothing disrupts development like the burden of disease,” said Susan Whelan,
Minister for International Cooperation. “Some of the most powerful things we can do to improve the well-being of people
overseas involve changes to how we do things right here in our own country, such as changing our patent and drug
legislation.”
With legislation now introduced, the Government of Canada will put in place the complementary regulatory
frameworks as soon as possible. As the government proceeds, it will continue to actively consult with and engage those
who will contribute to the ultimate success of this initiative.