Good morning.
I appreciate the opportunity to appear before the committee regarding the bill to enact proposed changes to the CAMR.
I appeared before this committee on March 10, 2004, during what was then consideration of Bill C-9, which, as amended, was ultimately enacted as the CAMR. In the course of dialogue with committee members in 2004 I raised several concerns regarding the terms of the then draft legislation. I was of the view that a number of the restrictions and limitations under consideration would hamper effective use of the legislation as then proposed.
Though some improvements were made in the legislation prior to its adoption, it was clear that Canada had decided not to take full or effective advantage of the flexibilities in the TRIPS agreement, the Doha declaration, and the August 30 waiver. It was foreseeable that limitations would significantly restrict the ability of the CAMR to address very serious public health problems confronting developing countries, with limited or no capacity to give effect to compulsory licensing. It's therefore not surprising that this committee is revisiting CAMR with the objective of making it a more effective and useful mechanism.
Let me spend a few moments explaining why I might reasonably be considered to have expertise on the subject of legislation to implement the August 30 decision. I've written and published extensively on the subjects of the TRIPS agreement, trade and IPRs, and on the relationship between that subject matter and public health, including access to medicines. I regularly have served as an expert consultant to the World Health Organization, the World Bank, the WTO, UNCTAD, and other multilateral organizations regarding trade, IP, and public health matters.
I served as legal consultant to the group of developing countries that formulated the proposal for the 2001 Doha declaration, worked with those countries throughout the process in which it was negotiated and adopted, and subsequently advised a core group of developing countries that was primarily responsible for negotiating the August 30 waiver at the WTO from the inception to the completion of that process. I have written and published about those negotiating processes in the American Journal of International Law and The Journal of International Economic Law.
I prepared for the World Bank a set of model-implementing legislation and documents for developing countries to implement the August 30 decision. I would note that one of my draft notification forms was used by Rwanda in its notification to the WTO. I've been to Canada again in the review of the CAMR. I've participated as an expert consultant at UNDP to reconsider this bill.
Finally, I would note, as a matter of disclosure, that I'm presently advising the Government of India in dispute settlement consultations at the WTO, where India and Brazil have initiated consultations with the European Union concerning the seizure of generic drugs in transit through airports in the European Union, and that Canada is a third-party participant in that set of consultations.
The August 30 decision has been criticized by NGOs promoting access to medicines, by some academics, by some generic producers, and by some developing countries for establishing an overly cumbersome set of rules that make it difficult to give effect to the basic objective of permitting export of low-priced generic pharmaceutical products to developing countries. I've consistently observed that the decision was a process of a long and intensive negotiation involving stakeholders with decidedly different perspectives, and that the August 30 decision represented a compromise between those perspectives.
Neither the NGOs seeking to provide the easiest mechanism for facilitating access to medicines nor the originator pharmaceutical industry found or find the August 30 decision to reflect an ideal world of either access to medicines or industrial protection. But my own view is that it can be made workable with appropriate implementing legislation and with conscientious work by lawyers, pharmaceutical procurement specialists, and others, in giving effect to the provisions of the August 30 decision. Nonetheless, for whatever reason, the CAMR was designed to add obstacles to the provisions of the August 30 decision, which make it more difficult to implement in practice.
Why the approach of Bill C-393?
Bill C-393 seeks to streamline CAMR to take advantage of flexibilities inherent in the August 30 decision by providing a pharmaceutical producer with the opportunity to obtain a single licence from the commissioner of patents that will authorize it to make and use a patented pharmaceutical invention for purposes of export to developing countries that identify public health needs.
A principal reason for proposal of the single licence is to solve a significant problem affecting the way international pharmaceutical procurement works in practice.
Many or most pharmaceutical procurement authorities acquire medicines by publishing a request for bids or proposals for supply of medicines, soliciting a response from industry. Competitive bidding isn't always practised. Nonetheless, it's extremely difficult for a producer, for example a prospective Canadian supplier, to respond to a bid request conditionally, indicating that supply is predicated upon obtaining a compulsory licence and that obtaining that compulsory licence may be a lengthy process that involves modifying a government list to add the subject-matter medicine to a list of products, opening negotiations with a patent holder or patent holders for a voluntary licence, and awaiting an ultimate determination by the commissioner of patents regarding whether a licence should be issued.
A public health procurement authority in a developing country would and should be understandably reluctant to award a contract based upon the fulfilment of an uncertain set of contingencies on the part of the producer-supplier.
Requiring a Canadian producer to request a compulsory licence on a case-by-case, country-to-country basis presents obvious difficulties. It presumes that a producer can and should develop a pharmaceutical production line to fulfill a single contract to be negotiated and put into effect over a protected period of time. But the licence is set to terminate after two years.
Simply put, you have heard and undoubtedly will hear from Canadian generic producers that this is a non-economic proposition. It's almost certain to drain business and personnel resources--