Government of Canada Launches Review of Canada's Access to Medicines Regime

OTTAWA, November 24, 2006 — Today, the Government of Canada took the first step in reviewing Canada's Access to Medicines Regime (CAMR) with the release of a consultation paper. The purpose of the paper is to focus dialogue on how CAMR might better meet its humanitarian objective of facilitating access to medicines in the developing world, while respecting international trade obligations and maintaining the integrity of the domestic patent system.

"By undertaking an early review of the relevant Patent Act provisions of CAMR, the government is demonstrating its continued commitment to being a global leader in improving access to medicines in developing and least-developed countries," said the Honourable Maxime Bernier, Minister of Industry.

"CAMR is one part of Canada's broader response to fighting public health problems such as HIV/AIDS, tuberculosis, malaria and other epidemics afflicting the developing world," said the Honourable Tony Clement, Minister of Health.

In force since May 14, 2005, CAMR implements an August 30, 2003, decision of the World Trade Organization (WTO) that waives certain trade obligations. This gives members that have pharmaceutical manufacturing capacity the right to grant compulsory licences authorizing the export of patented pharmaceutical products to countries that are unable to manufacture their own. The legislation establishing CAMR amended the Patent Act to permit the Commissioner of Patents to grant export-only compulsory licences to pharmaceutical manufacturers in Canada that wish to supply eligible importing countries with needed medicines. It also amended the Food and Drugs Act to require that any products exported under CAMR meet the same safety, efficacy and quality standards as those approved for sale in Canada.

The consultation paper is available online at http://www.camr-rcam.gc.ca, and interested parties are invited to respond by submitting written comments to Industry Canada or Health Canada by January 24, 2007. To enhance transparency of the consultation process, all submissions will be posted on the website. The review of CAMR will be completed by May 2007, and will be followed by the tabling of a report in both houses of Parliament by the Minister of Industry.

For more information, please contact:

Isabelle Fontaine
Office of the Honourable Maxime Bernier
Minister of Industry
613-995-9001

Media Relations
Industry Canada
613-943-2502

Erik Waddell
Office of the Honourable Tony Clement
Minister of Health
613-957-0200

Alastair Sinclair
Media Relations
Health Canada
613-957-1803

Backgrounder
Canada's Access to Medicines Regime

In the November 2001 Doha Ministerial Declaration, the World Trade Organization (WTO) recognized that WTO members that have insufficient or no pharmaceutical manufacturing capacity could face difficulties in making effective use of compulsory licensing under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), and instructed members to find an expeditious solution to this problem. On August 30, 2003, the WTO General Council decided to waive certain provisions of the TRIPS Agreement. This gives members that have pharmaceutical manufacturing capacity the right to grant compulsory licences authorizing the export of pharmaceutical products to countries that are unable to manufacture their own and that are facing public health problems, such as HIV/AIDS, tuberculosis, malaria and other epidemics.

In September 2003, Canada became the first WTO member to announce its intention to implement the WTO decision, and on May 14, 2004, the legislative framework for Canada's Access to Medicines Regime (CAMR) received royal assent. This framework consists of amendments to the Patent Act, authorizing the Commissioner of Patents to grant compulsory licences allowing the manufacture and export of lower-cost versions of patented pharmaceutical products, and to the Food and Drugs Act, authorizing Health Canada to review these products for safety, efficacy and quality. One year later, on May 14, 2005, following passage of the regulations necessary to round out this legislative framework, CAMR came into force. CAMR also includes a provision requiring the Minister of Industry to review the relevant sections of the Patent Act (sections 21.01 to 21.19) within two years of its coming into force, and to table a report on the results of that review in both houses of Parliament.

Before a drug may be exported under CAMR, the WTO decision requires an eligible importing country to publicly notify the WTO of its intention to import under the terms of the waiver. To date, no country has taken this step, and there have been no exports under CAMR or under the similar regimes of other developed countries that have implemented the WTO waiver. Recognizing the pressing humanitarian and international development concerns that underlie CAMR, in August 2006, the Minister of Health announced that the review of CAMR would be accelerated. The November 24, 2006, release of the consultation paper on CAMR is further to that announcement.

Canada's Access to Medicines Regime complements other humanitarian efforts by the Government of Canada to assist least-developed and developing countries in responding to public health problems, especially those resulting from HIV/AIDS, tuberculosis, malaria and other epidemics. For more information on Canada's other global health initiatives, please see the accompanying document entitled "Canada's Role in Promoting Access to Medicines."

Backgrounder
Canada's Role in Promoting Access to Medicines

While global health has improved significantly over the past few decades, the greatest burden of disease is still borne primarily by developing countries.

In recognition of this, Canada actively supports a number of international development and humanitarian efforts that address the range of factors that impede the treatment of HIV/AIDS, tuberculosis, malaria and other diseases in developing countries. Canada's Access to Medicines Regime (CAMR) is one part of Canada's multi-faceted approach in this regard. Other initiatives include the following:

• contributing to global health initiatives such as the Global Fund to Fight AIDS, Tuberculosis and Malaria; the Global Alliance for Vaccines and Immunization; the Global Polio Eradication Initiative; the Stop TB Partnership; and the World Health Organization's 3 by 5 Initiative



• supporting efforts to combat other infectious diseases, such as the recent contribution to the Advance Market Commitment pilot project to develop a vaccine for pneumococcal disease



• supporting Canadian organizations working in global health



• supporting bilateral and multilateral efforts to strengthen health systems, such as the recent commitment to support efforts to build strong and effective African health systems



• providing support in developing countries for strengthening regulatory capacity; training and quality assurance programs for HIV clinical laboratory testing, epidemiology, surveillance and modelling; and sharing lessons learned.

These actions aim to reduce global health disparities by increasing the availability of appropriate medicines and by improving access to treatment for diseases that disproportionately affect developing countries.