In the November 2001 Doha Ministerial Declaration, World Trade Organization (WTO) members recognized the gravity of the public health problems afflicting many developing and least-developed countries, especially those resulting from human immunodeficiency virus and acquired immune deficiency syndrome (HIV/AIDS), 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 Intellectual Property Rights (TRIPS), which appeared to prevent nations in need from importing less-expensive versions of pharmaceutical products.

As the first WTO member to announce its intention to domestically implement this decision, Canada's challenge 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 developing and least-developed countries. Canada's proposed regime fully reflects the outcome negotiated among WTO members.

The agreement stipulates that the decision 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, when implemented, will allow for vital health and development goals to be advanced, while also respecting the intellectual property rights that promote the development of new pharmaceutical products.

The proposed amendments to the Patent Act and the Food and Drugs Act, once approved by Parliament, won't result in better health for the developing world overnight, however, this is a move in the right direction. It complements the work Canada is doing in a broad range of international programs, exemplified by the commitments made in the Africa Action Plan introduced at the G-8 Summit in Kananaskis, Alberta.

Canada will continue to work with the WTO, the World Health Organization (WHO) and the World Intellectual Property Organization (WIPO) to develop effective international means of implementing the WTO decision on access to pharmaceutical products.

In November 2003, the WTO will implement a notification system for countries that wish to import drugs using compulsory licences. The TRIPS Council will discuss this when it meets from November 16-18.

In Geneva, Canada is working closely with the WTO, the WHO, the WIPO and other international bodies to advance this issue.

Amendments to the Patent Act

The Government of Canada is proposing amendments to the Patent Act in order to add a new section authorizing third party use of patented inventions to address public health problems afflicting developing and least-developed countries especially those resulting from HIV/AIDS, TB, malaria and other epidemics. The new section in question will allow for the issuance of compulsory licences to Canadian firms, typically generic drug companies, authorizing them to manufacture in Canada specific patented pharmaceutical products for the sole purpose of exporting them to least-developed and developing countries that are unable to produce domestically the pharmaceuticals needed to respond to their public health problems.

The proposed amendments to the Patent Act, developed in consultation with Canada's pharmaceutical industry and non-governmental organizations (NGOs), are designed to implement the provisions of a waiver to certain obligations in the WTO Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) which had until now prevented developed countries like Canada from issuing licences to pharmaceutical companies to produce patented brand name pharmaceutical products for export to least-developed and developing countries. In conceiving the amendments, the Government of Canada was mindful of the importance of continuing to protect the intellectual property rights of domestic patent holders and of respecting its other international trade obligations in this regard.

Once amended, the Patent Act will include Schedules which identify the specific pharmaceutical products and importing countries which are eligible under this new regime. The Schedules setting out the eligible importing countries consist of the WTO member countries which qualify under the terms of the Waiver but also includes non-WTO members that have been identified as least-developed-countries by the United Nations. The Schedules will not include the 23 WTO members that have self-identified as non-importing countries under the regime.

In signing on to the WTO Waiver, Canada, as well as stakeholders, recognized that it was not conceived to apply to all pharmaceutical products but rather is targeted at the medicines needed to treat grave public health problems. The World Health Organization (WHO) List of Essential Medicines (which lists the most efficacious, safe, and cost-effective medicines for priority conditions in a basic health care system) provides a sound guide for establishing the initial schedule of 46 eligible products that are currently subject to a patent in Canada.

The amendments retain flexibility by providing a regulatory mechanism to add to or delete from these Schedules as the need arises or as international consensus emerges. They also enable the creation of an expert advisory committee by the Ministers of Health and Industry, composed of medical health practitioners and other experts in relevant fields, which may be asked to provide advice on amending the Schedule of pharmaceutical products.

Consistent with Canada's TRIPS obligations, and in keeping with the underlying objective to expedite the provision of pharmaceutical products to countries in need, under the amended Patent Act, patent-holding brand name companies will be given the opportunity to be the first supplier of a requested pharmaceutical product. Following a notice of intent by a pharmaceutical company seeking a compulsory licence, the patent holder will have 30 days in which to decide whether to fulfill the supply opportunity. If the patent-holder decides not to do so, the other company may proceed with its application for a compulsory licence. Such a licence will be subject to the following terms and conditions:

• Use of the patented pharmaceutical product must be limited to a specific quantity and for use in a specific country;
• A website must be established disclosing the information relating to the licence; The licencee must pay a royalty of two percent of the value to the importing country of the exported pharmaceutical product;
• The licence shall have an effective period of two years from date of grant; and
• Health Canada must notify the Commissioner that the pharmaceutical product meets the requirements of the Food and Drug Regulations including that it be distinguishable from the domestic brand product (eg. by labelling, packaging, marking, embossing etc.) in order to discourage re-importation and diversion.

Subject to Parliament's approval, the legislative amendments and their subordinate regulations will come into force on the same day. In the absence of an international infrastructure for implementing the WTO Waiver, the development of which is unlikely for some time, the proposed amendments contain a clause stipulating that the legislation be reviewed by the Minister of Industry three years after its coming into force, following which a report is to be tabled before both Houses of Parliament.

Evaluating the drugs and medical devices exported under the WTO agreement

The Government of Canada's objective is to improve access to less-expensive pharmaceutical products that are urgently needed by the world's least-developed countries to fight these public health issues. This will not affect Canadians' access to drugs.

Health Canada to review drugs so they meet Canadian standards

The countries eligible under this regime are particularly vulnerable, and may have limited capacity to conduct their own evaluations. Health Canada will therefore conduct a regulatory review to ensure that the drugs and medical devices destined for these countries are manufactured in compliance with Canadian standards.

Amending the Food and Drugs Act and Food and Drug Regulations

The bill will amend Section 37 of the Food and Drugs Act (relating to exportation), so that products intended for export under this program come under the same scientific assessment as those intended for the Canadian market.

Subsequent changes to the Food and Drug Regulations will make necessary new regulations to implement the WTO decision. These deal with the requirement for Health Canada to notify the Commissioner of Patents that the products comply with the Regulations (i.e., they meet Canadian standards) and that they carry distinguishing markings as compared to those available on the Canadian market.

Canadian efforts to fight infectious diseases in developing countries

Canada recognizes that people in developing countries suffer from a lack of basic medical supplies and has responded with wide-ranging initiatives to help fight the spread of infectious diseases.

Canadian funding for HIV/AIDS initiatives in developing countries will increase to $80 million per year by 2005, representing a five-year commitment of $270 million. In addition, Canada is also contributing $50 million over five years to the International AIDS Vaccine Initiative and to the African AIDS Vaccine Programme.

Canada also supports multilateral initiatives that manage and disburse resources through public-private partnerships to mitigate the impact of infectious diseases. For example, a total of US$100 million is being provided over four years to the Global Fund for AIDS, Tuberculosis and Malaria. Canada is also a founding member and strong supporter of the Global Tuberculosis Drug Facility, having earmarked $80 million to help eradicate this disease. Canada also provides immunization and vitamin A capsules to vulnerable children in more than 40 countries in Africa, Asia and Latin America, saving more than 1.5 million lives.

Regarding polio, Canada has been a substantial supporter of eradication efforts around the world, funding a total of $95 million to the Global Polio Eradication Initiative over the last five years.

Source: Government of Canada's website ______________________________________