Thank you, and thank you for providing me with the opportunity to speak to you today. I'm appearing on behalf of the International Human Rights Program's access to drugs initiative, based out of the University of Toronto's faculty of law.
In my submission today and my accompanying written brief, I will touch upon three major obstacles that are built into the access to medicine regime.
As much as possible, we have tried to approach our review of CAMR from the perspective of Ghana, one of the countries that were intended to use this legislation. Officials from Ghana have now travelled halfway across the world twice to visit Canada and to learn how Canada might provide Ghana with access to treatment for the tens of thousands of Ghanaians who are dying of HIV/AIDS, but despite their efforts, Canada's regime has proved to be impenetrable.
To remedy this, I would urge you to consider the concrete amendments proposed by the Canadian HIV/AIDS Legal Network, but we would also like to implore you to ensure that a revised system includes the three recommendations that follow.
First, you must ensure that CAMR is compatible with standard international procurement protocols. It is unacceptable for Canada to adopt a system that seems to encourage developing countries to break their own domestic procurement laws in order to have access to Canadian medicine. Standard procurement protocols require governments to issue calls for tender based on the supply of medicine, and to select the top tenderer based on objective criteria. CAMR does not facilitate the implementation of these procurement laws.
Under CAMR, a compulsory licence can only be obtained once the manufacturer and the importing country have already reached an agreement. This means that at the point that a manufacturer would come forward to bid on an international tender, this bid would have to be conditional upon receipt of a prospective licence. Such a tender would not be compatible with Ghanian tender laws, and even if it were compliant with these laws, it would be so uncertain as to nullify the bid. CAMR must be amended to permit a manufacturer to apply for a licence prior to entering into an agreement with an importing country. To facilitate this, the manufacturer should not be required to specify the person or entity to whom the product is to be sold.
Our second recommendation is that CAMR must explicitly permit licences to supply regional trade groups. Small countries have insufficient market potential to benefit from the economies of scale that bulk purchasing can achieve. CAMR's failure to explicitly include subsection 6(i) of the general council's decision of August 30, 2003, must be remedied to permit developing and least-developed countries to take advantage of all of the TRIPS flexibilities that were specifically made available to them, including the ability under subsection 6(i) to regionally redistribute medicine under the authority of one compulsory licence.
Our third recommendation is that CAMR must eliminate schedule 1 and specify that the regime includes active pharmaceutical ingredients.
With respect to schedule 1, the existence of this list serves as an immediate detractor to developing-country government officials. I have seen the faces of foreign ministers of health as they read this list. They are confused, they are disappointed, and they are angry. This list contains virtually none of the medicines they are most interested in and most desperate to provide to their populations.
The restricted list of medicines further exacerbates uncertainty and establishes a perception—and rightly so—that Canadian companies would be unable to respond promptly to tenders to fill drug needs.
With respect to active pharmaceutical ingredients, much of our analysis of CAMR has focused on the supply of finished pharmaceutical products to the developing world. In 2001 the WTO pledged to make positive efforts to ensure that developing countries would have a share in the growth of world trade through capacity-building programs. They also pledged to address the marginalization of these developed countries in international trade.
The August 30, 2003, decision also supported these commitments, specifying that this regime should be used in a way that would promote the facilitation of local production of medicine in developing and least-developed countries. Canada would be greatly remiss if we failed to look beyond the supply of medicine to other ways in which we can support a long-term and sustainable supply globally, including helping to promote local production.
The Economic Community Of West African States, which Ghana belongs to, is increasingly looking to bulk procurement and domestic production of essential medicine as viable alternatives to imports. Such efforts will not render CAMR moot. Rather, CAMR will be just as vital for the active pharmaceutical ingredients that it can provide. Canada and Canadian generic producers should be providing technology transfer and capacity building in local pharmaceutical sectors, as specifically contemplated by the general council decision.
In conclusion, corporate Canada and our elected representatives have made sweeping promises to address the continuing lack of access to medicine in the developing world. We need to start thinking creatively about ways in which we can make access a reality. It would mean the world to those who otherwise face certain death, and if we keep our word this time, we just might be the leaders that this crisis is demanding.
Thank you.