Coming Into Force of the Jean Chrétien Pledge to AfricaOTTAWA, May 13, 2005 — The Honourable David L. Emerson, Minister of Industry, and the Honourable Ujjal Dosanjh, Minister of Health, today announced the May 14, 2005 coming into force of Bill C-9, An Act to Amend the Patent Act and the Food and Drugs Act (the Jean Chrétien Pledge to Africa — "JCPA") and its accompanying regulations. The regulations will be published in Part II of the Canada Gazette on June 1, 2005.
"With the coming into force of the Jean Chrétien Pledge to Africa, the Government of Canada has established a legal framework allowing lower-cost versions of patented pharmaceutical products to be exported to less fortunate countries unable to manufacture their own such products. It now falls to the private sector and non-governmental organizations (NGOs) to identify opportunities to assist these countries," said the Honourable David L. Emerson, Minister of Industry. "This groundbreaking initiative is the end result of extensive consultation with pharmaceutical industry stakeholders, NGOs and Parliamentarians."
"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 Ujjal Dosanjh, Minister of Health.
The legislation amends the Patent Act and the Food and Drugs Act in order to implement an August 30, 2003, decision of the World Trade Organization (WTO) waiving certain obligations set out in the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights. That decision allows developed countries, such as Canada, to authorize someone other than the patent holder to manufacture a lower-cost version of a patented pharmaceutical product in order to export it to a developing country with insufficient or no pharmaceutical manufacturing capacity.
The Jean Chrétien Pledge to Africa complements other humanitarian efforts by the Government of Canada to assist least-developed and developing countries in their struggle against HIV/AIDS, malaria, tuberculosis and other epidemics.
For more information, please contact:
Christiane Fox
Office of the Honourable David L. Emerson
Minister of Industry
(613) 995-9001
Adèle Blanchard
Office of the Honourable Ujjal Dosanjh
Minister of Health
(613) 957-0200
Media Relations
Industry Canada
(613) 943-2502
Backgrounder
The Jean Chrétien Pledge To Africa (JCPA)
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 (HIV) and acquired immune deficiency syndrome (AIDS), tuberculosis, malaria and other epidemics.
On August 30, 2003, the Doha Ministerial Declaration culminated in a decision by the WTO General Council to waive certain provisions of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), which appeared to prevent developing and least-developed WTO-member countries from importing less-expensive versions of patented pharmaceutical products produced under compulsory licence.
Canada was the first country to take concrete steps toward implementing this decision. The challenge in doing so is to establish an effective system that removes barriers to the delivery of affordable pharmaceutical products to countries in need while ensuring that the regime not be used for industrial or commercial objectives. It is also important to ensure that the products manufactured under the regime are not diverted from their intended beneficiaries and that the regime as a whole respects the intellectual property rights that are so critical to the development of new and improved pharmaceutical products.
The amendments to the Patent Act and the Food and Drugs Act necessary to implement the WTO decision were first tabled in November 2003 as Bill C-56 but died on the order paper shortly thereafter when Parliament was prorogued. The Bill was subsequently identified by Prime Minister Paul Martin as a key legislative priority and was reinstated as Bill C-9, An Act to Amend the Patent Act and the Food and Drugs Act (The Jean Chrétien Pledge to Africa (JCPA)) on February 12, 2004.
In reviewing the legislation, Parliament heard from dozens of stakeholders, including representatives of the generic and brand name pharmaceutical industry and non-governmental organizations (NGOs) such as Médecins Sans Frontières (MSF) and Oxfam. Stakeholder suggestions on how to improve the legislation were reflected in a substantial number of government amendments tabled in the House in April 2004 and the JCPA so-amended was adopted by Parliament on May 14, 2004.
In order for the JCPA to become operational, passage of a subordinate set of regulations under the Patent Act and the Food and Drugs Act was also necessary. On October 2, 2004, the Government pre-published a draft version of those regulations in Part I of the Canada Gazette. Pre-publication was followed by a 75 day consultation period during which interested parties were invited to submit their comments on the draft regulations.
Before the regulations could be finalized, two further technical amendments to the Patent Act were necessary. The amendments in question properly place the JCPA Schedules inside the Patent Act and provide for the equal participation of the Senate in assessing and recommending eligible candidates for an expert committee charged with advising the government on the pharmaceutical products which should be eligible for export under the JCPA.
The amendments were introduced via Bill C-29, An Act to Amend the Patent Act, and adopted by Parliament on May 5, 2005. Cabinet has approved the regulations, as well as the order fixing May 14, 2005, as the coming into force date of the JCPA regime as a whole. The JCPA regulations will be published in Part II of the Canada Gazette on June 1, 2005.
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