Mr. Speaker, if you give me a notice that I have a minute left, I will wrap it up.
It is my honour to stand here with this opportunity to address Bill C-393, which seeks to make substantial operational changes to the legislative framework for Canada's access to medicines regime under the Patent Act and under the Food and Drugs Act.
While I and I am sure other hon. members in the House are committed to improving access to medicines in the developing world via Canada's access to medicines regime and other initiatives, I have some strong reservations about Bill C-393 and its proposed revisions.
However, let me begin today with some background on Canada's access to medicines regime. The stated purpose of the regime is to increase access to lower-cost, Canadian-made generic versions of patented pharmaceutical products needed to address public health problems in developing and least-developed countries. The development of Canada's access to medicines regime was a landmark event as there was no other international precedent at the time.
Thus, in crafting the regime, the government focused on three important objectives: first, to increase access to patented drugs and medical devices in the developing world; second, to continue to respect Canada's international trade obligations; and third, to maintain the integrity of our domestic patent system for pharmaceuticals.
In 2004, the then-Liberal government introduced legislation to establish the regime by amending the Patent Act and the Food and Drugs Act. Shortly thereafter, Bill C-9 received royal assent with the unanimous support of all parties on both sides of the House and the Senate.
I will now turn to discuss some of the problematic elements of Bill C-393 that propose to alter the scope of eligible drugs for export under the regime, and the health and safety review that these pharmaceutical products go under.
First, I am concerned that Bill C-393 seeks to eliminate the list of pre-approved products for export in Canada's access to medicines regime. While some critics of the regime allege that the list makes CAMR too rigid and inflexible, it does serve an important and practical purpose. Specifically, the list of pre-approved products for export minimizes the discretionary elements of the regime and, as a result, expedites the decision making process. It also provides prospective users with the assurance that, assuming all other statutory requirements are met, an application for authorization under the regime will be used by the commissioner of patents.
Second, I am concerned about the proposed changes in the drug review process in Bill C-393. If passed, these changes would significantly alter the level of domestic oversight regarding the safety and quality of the products exported under CAMR. This is because Bill C-393 suggests, among other things, to make the existing mandatory Health Canada review optional.
Further, it suggests allowing the export of eligible products under Canada's access to medicines regime to be made on the basis of a review by a foreign regulatory authority. Such an abeyance of Health Canada's review would not be permitted for drugs and medical devices destined for the Canadian market.
In addition, during the statutory review of the regime in 2007, developing countries and generic drug manufacturers expressed strong approval of the very drug review that Bill C-393 seeks to remove. These potential users of CAMR went on record as saying that Health Canada's review was a useful mechanism for ensuring that products sent to the developing world under this system were safe and of high quality.
Some critics of Canada's access to medicines regime state that the Health Canada drug review is unnecessary and allege that it duplicates the World Health Organization's pre-qualification process for listing pharmaceutical products that are eventually purchased by international aid agencies and developing and least-developed countries without appropriate regulatory capacities. However, I do not agree with them.
Health Canada has a long-lasting and excellent relationship with the World Health Organization in this regard, both in undertaking reviews for the international organization's pre-qualification program, and in working with the World Health Organization and other initiatives to build regulatory health and safety capacity in developing and least developed countries.
Furthermore, since Health Canada's reviews are accepted by the World Health Organization for an alternate listing process, Canada's domestic drug reviews are not duplicated. The alternate listing process, which is an abbreviated process for listing drugs to the pre-qualified program, is available for drugs reviewed by Health Canada, the United States Food and Drug Administration and the European Medicines Agency.
I would like to conclude by reiterating that while the government remains committed to Canada's access to medicines regime and a broader, long-term approach to fighting public health diseases in the developing world, it opposes Bill C-393 and its proposed changes to the regime.
In my opinion, several of the changes to the Patent Act and the Food and Drugs Act raise concerns about the potential impact on the effective operation of CAMR. Many of these changes also do not support the humanitarian objective of improving access to safe medicines for the developing world.
Finally, there is little evidence that Bill C-393's proposed amendments will make a meaningful difference in the volume and frequency of exports under Canada's access to medicines regime.
To date, Canada's compulsory licensing and export regime is the only one of its kind worldwide to have successfully authorized and exported drugs to a country in need.
For all of these reasons, I urge hon. members in the House not to support Bill C-393. I do want to say in closing, however, that I do appreciate the efforts of the member for Winnipeg North in this matter. I have had a number of meetings in my riding with citizens who are deeply concerned that this regime is not working, but this bill does not meet their needs, based on our review of how it has been laid out. However, I do appreciate the member bringing this to the attention of the House of Commons.