OTTAWA, May 13, 2004 -- The Government of Canada's initiative to provide lower-cost pharmaceutical products to least-developed and developing countries moved a step closer to implementation today with the passage of Bill C-9. "The Government of Canada has shown tremendous leadership in this move to help people in developing and least-developed countries fight HIV/AIDS, malaria, tuberculosis and other public health problems by facilitating their access to safe, effective and much-needed medicines," said the Honourable Pierre Pettigrew, Minister of Health. Bill C-9 amends the Patent Act and the Food and Drugs Act to provide the legislative framework to enable Canada to respond to the August 30, 2003 decision of the World Trade Organization (WTO) on the Agreement on Trade-Related Aspects of Intellectual Property Rights and Public Health. The WTO decision allows developed countries, such as Canada, to authorize someone other than the patent holder to manufacture a lower-cost version of a patented medicine in order to export it to a developing country with insufficient or no pharmaceutical manufacturing capacity. "Canada is very proud to be the first country to take concrete action to implement this important decision, which will go a long way toward improving global health," said the Honourable Bill Graham, Minister of Foreign Affairs. "We encourage other countries to follow suit by taking steps to address the public health problems facing developing countries." "Canada is actively working with both our development partners and developing countries to increase their pharmaceutical manufacturing capacity to make the most of this legislation," said the Honourable Aileen Carroll, Minister for International Cooperation. "We are collaborating with the World Bank Institute, for example, to assist developing countries to better understand how to manage the drugs required for treating HIV/AIDS." "We are showing our WTO partners that a novel WTO decision can effectively be implemented," said the Honourable Jim Peterson, Minister of International Trade. "We remain dedicated to ensuring that the multilateral trading system works to improve the lives of people in developing countries, who need it most." "This groundbreaking legislation has benefited greatly from the input of Canada's pharmaceutical industry, non-governmental organizations and parliamentarians," said the Honourable Lucienne Robillard, Minister of Industry and Minister responsible for the Economic Development Agency of Canada for the Regions of Quebec. "We believe that we have created an effective and workable model that will enable us to meet our humanitarian objectives while maintaining the integrity of our intellectual property regime." Bill C-9 is part of a coordinated Canadian strategy to fight epidemic diseases in developing countries. In December 2003, the government announced a $100-million contribution over five years to strengthen African-led strategies and programs for the care, treatment, support and prevention of HIV/AIDS. On May 10, 2004, the Prime Minister announced a $100-million contribution to the World Health Organization's 3 by 5 Initiative -- reaching 3 million AIDS patients in developing countries with antiretroviral therapy by the end of 2005. On May 12, the Minister for International Cooperation announced that Canada will extend its contribution to the Global Fund to Fight HIV/AIDS, Tuberculosis and Malaria with an additional $70 million in 2005, effectively doubling the federal government's annual contribution. Bill C-9 will come into effect once the regulations necessary to complete the legislative framework have been passed. This is expected to take place in fall 2004, after the draft regulations have been published in the Canada Gazette for public input. In recognition of the commitment of the former Prime Minister to this issue, the legislation is now known as the Jean Chrétien Pledge to Africa Act. For more information, please contact: Isabelle Savard Office of the Honourable Bill Graham Minister of Foreign Affairs (613) 995-1851 Media Relations Foreign Affairs Canada and International Trade Canada (613) 995-1874 Andrew Graham Office of the Honourable Aileen Carroll Minister for International Cooperation (819) 953-3160 Media Relations Canadian International Development Agency (819) 953-6534 Sébastien Théberge Office of the Honourable Pierre Pettigrew Minister of Health (613) 957-0200 Media Relations Health Canada (613) 957-2983 Andrea Lanthier Office of the Honourable Jim Peterson Minister of International Trade (613) 992-7332 Media Relations Foreign Affairs Canada and International Trade Canada (613) 995-1874 Daniel Grenier Director of Communications Office of the Honourable Lucienne Robillard Minister of Industry and Minister responsible for the Economic Development Agency of Canada for the Regions of Quebec (613) 995-9001 Media Relations Industry Canada (613) 943-2502 Backgrounder Bill C-9 -- The Jean Chrétien Pledge to Africa Act Historical Background In the November 2001 Doha Ministerial Declaration, World Trade Organization (WTO) members recognized the gravity of the public health problems afflicting many least-developed and developing countries, especially those resulting from human immunodeficiency virus and acquired immune deficiency syndrome, tuberculosis, malaria and other epidemics. On August 30, 2003, negotiations among WTO members resulted in a decision waiving certain provisions of the Agreement on Trade-Related Aspects of Intellectual Property Rights, which appeared to prevent nations in need from importing less-expensive versions of pharmaceutical products produced under compulsory licence. Canada is the first country to adopt legislation to implement the WTO decision. The challenge in doing so is to demonstrate leadership in the promotion of an effective international system that will remove barriers to the quick delivery of affordable pharmaceutical products to least-developed and developing countries. The WTO decision stipulates that the agreement must be used in good faith to deal with public health problems, and not for industrial or commercial objectives, and that it is important to ensure that these products are not diverted from their intended beneficiaries. Canada's approach respects these terms, while allowing for the advancement of vital health and development goals and respecting the intellectual property rights that are so critical to the development of new pharmaceutical products. The proposed amendments to the Patent Act and the Food and Drugs Act were first tabled in November 2003, as Bill C-56. This legislation had passed through second reading in the House of Commons when Parliament was prorogued in November 2003. The bill was subsequently identified by Prime Minister Paul Martin as a key legislative priority and was reinstated as Bill C-9 on February 12, 2004, and referred to the House of Commons Standing Committee on Industry, Science and Technology. In reviewing the legislation, the Standing Committee heard from dozens of stakeholders, including representatives of the generic and brand name pharmaceutical manufacturers, non-governmental organizations (NGOs) and medical practitioners. Stakeholder suggestions on how to improve the legislation were reflected in amendments tabled with the Standing Committee on April 20, 2004. The amendments reflected the necessary balance between Canada's humanitarian objectives of facilitating the flow of life-saving pharmaceutical products to developing countries while maintaining the integrity of its intellectual property regime and ensuring that its international obligations in this area are respected. These improvements reflected the spirit of compromise that many of the stakeholders displayed throughout the process. The legislation was reviewed by the Senate Standing Committee on Foreign Affairs on May 12, 2004, and approved by the Senate on May 13. Bill C-9 will come into effect once the regulations necessary to complete the legislative framework have been passed. This is expected to take place in fall 2004, after the draft regulations have been pre-published in the Canada Gazette for public input. Backgrounder The Fight Against Infectious Diseases Context More than 1 billion people do not have access to sufficient health care, enough food or clean water.Each year, more than 10 million children die from preventable diseases and malnutrition. More than 1 million people, most of them children under the age of five years, die of malaria annually.Every day, more than 8000 people die of acquired immune deficiency syndrome (AIDS), most of them in sub-Saharan Africa. Every year, nearly 2 million people die from tuberculosis, with human immunodeficiency virus (HIV)/AIDS fuelling the resurgence of this infectious disease. In fact, at least one-third of those who are infected with HIV are also infected with tuberculosis. Canada's Response Since 1990, the Canadian International Development Agency (CIDA) has provided over $50 million to prevent and control malaria in developing countries. Canada's support includes contributions towards malaria research, the promotion of traditional and alternative medical treatments, and community work in malaria control. Canada is the founding donor and a leading contributor to the Global Drug Facility (GDF). The GDF is a global drug procurement mechanism to expand access to, and availability of, high-quality TB drugs to facilitate the global expansion of tuberculosis treatment. To date, Canada has provided $41.92 million to the GDF. Canada has responded to the HIV/AIDS pandemic with strong strategic leadership, a generous financial commitment, and a comprehensive, coordinated approach to HIV/AIDS programming. Canada works closely with other donors and stakeholders, such as the William J. Clinton Presidential Foundation, the Global Fund to Fight AIDS, Tuberculosis and Malaria, and UNAIDS, as well as governments in developing countries, because a broad coalition of support is required to address the far-reaching effects of the pandemic. Canada is currently the vice-chair of the governing body of UNAIDS and will take over as chair in June 2004. Canada is a leading supporter of the World Health Organization 3 by 5 Initiative, with a contribution of $100 million. The 3 by 5 drive seeks to have 3 millions suffering from AIDS in developing countries in treatment by the end of 2005. There are currently six million people infected with HIV in the developing world who need access to antiretroviral (ARV) therapy to survive. ARVs can dramatically reduce death rates, prolong lives and improve quality of life. The WHO's 3 by 5 drive will provide front-end technical assistance, helping to ensure that developing countries can build health systems to treat large numbers of people and make it possible for other initiatives, such as Bill C-9 and the Global Fund, to work most effectively. Canada is also extending its contribution to the Global Fund to Fight AIDS, Tuberculosis and Malaria by another year with an additional $70 million in 2005, doubling our contribution for one year. Canada was an early supporter of the Global Fund, having committed $150 million in 2001 over four years. The Global Fund was created to dramatically increase resources to fight three of the world's most devastating diseases, and to direct those resources to areas of greatest need. These pledges reflect Canada's broader commitment to the Millennium Development Goals and to reducing the burden of disease in the developing world. CIDA is investing up to $100 million in African-led strategies for care, treatment and prevention of HIV/AIDS. Canada has also pledged $62 million from the Canada Fund for Africa toward the development of an AIDS vaccine and to support the work of a Canadian coalition on HIV/AIDS on the social impact of the disease, including youth education, labour and family structures. CIDA has a number of large HIV/AIDS interventions that have focused primarily on prevention and on regional approaches, such as the Southern Africa AIDS Training Program and the Canada-Southeast Asia Regional HIV/AIDS Program. In addition, in Africa, CIDA has also put strong emphasis on integrating HIV/AIDS components into all developmental programming. In many parts of the world, the HIV/AIDS pandemic is disproportionately affecting and infecting women and young girls. CIDA recently pledged $1 million to UNAIDS in support of the newly announced Global Coalition on Women and AIDS. Some current CIDA-funded projects that seek to build health care capacity in developing countries are: The World Bank Institute to train developing countries-which will soon have access to lower-cost Canadian anti-retroviral (ARV) generic drugs for the treatment of HIV/AIDS -- to better understand the process of procuring, shipping, storing and distributing treatment drugs for HIV/AIDS.Mozambique's Common Fund of Support for the Health Sector will quickly scale up Mozambique's health sector's response to HIV/AIDS in an effort to promote a comprehensive approach to care, support and treatment for those infected and/or affected by the disease, including through the provision of anti-retrovirals for those who need them.The National AIDS Commission of Malawi works to reduce the incidence of HIV/AIDS and improve the development of the capacities of the Government of Malawi. The National AIDS Commission focuses on behavioural change, surveillance and blood safety, counseling and testing, care and support of people with HIV/AIDS and their families, and mitigation of effects on communities. It also oversees anti-retroviral programs managed by the Malawi Ministry of Health and Population. The Canada-South Africa Nurses HIV/AIDS Initiative focuses on participatory research, training and upgrading of nurses skills, developing effective HIV/AIDS home-care models, and capacity-building activities for the Democratic Nursing Organization of South Africa and its partners. West Africa Project to Combat AIDS Phase III, seeks to minimize the transmission of HIV/AIDS and sexually transmitted infections (STIs) in West Africa, to ensure the sustainable control of STIs through the network of primary health services and strengthened community associations, and to improve the integration of health programs to fight STIs/HIV/AIDS with overall strategies of the health ministers of participating countries.The Regional AIDS Training Network will create and implement a dynamic and sustainable network of training institutions in East and Southern Africa that will provide skills training, and extend services and technical assistance to health-care professionals and other workers in the field of STIs/HIV/AIDS. Project activities focus on developing and supporting a regional network of training institutions, and a larger and overlapping regional network of expertise.Peru's Ministry of Health is working to intensify its tuberculosis (TB) prevention and control efforts. Peru's National Tuberculosis Control Program has become an international model of success. It links and supports all levels of TB public health intervention, from the country's central and regional health units all the way down to the primary health care level in local communities, where daily monitoring of treatment is essential.The DESAPER (Development of Perinatal Health Project) model is based on four main elements: the development of health institutions and professionals, technological development, effective organization and a participatory process. Through extensive training programs, DESAPER strengthened national, regional and local health care organizations in Bolivia, Honduras, Nicaragua and Peru to better develop and deliver maternal, perinatal and infant health care services. The model is now part of each country's national health plan and is even being used in health care areas not involving maternity or childcare services.