That's as close as it comes.
At the outset, I'd like to acknowledge that I'm not speaking to you on behalf of the University of British Columbia but rather as a member of the university community, and the views expressed are my own.
I'm very proud to say that in 2007, UBC was the first Canadian university to publicly adopt the global access principles, which, stated briefly, make a commitment to making UBC technologies available to developing countries for health, environmental, and security purposes. This position was strengthened in 2009 as we worked with Yale and Harvard to develop the statement of principles and strategies for equitable dissemination of medical technologies.
To date, UBC has included a number of global access provisions in its licence agreements, including requirements for compulsory licensing, at-cost provision of medicines, and return of country of source. UBC and its affiliated hospitals conduct over half a billion dollars of research annually, and about 60% of that is in the life sciences.
My world has changed dramatically in the past five years, and technology licensing is increasingly difficult with the global distress of both the biotech and venture capital industries. Meanwhile, government is asking us to demonstrate a return on investment on the considerable funds that they have given us to conduct research.
It's in this difficult environment that I am seeking global access terms in my licence agreements, and it can be a very difficult sell. Drug development is an expensive and risky business without adding global access provisions that would only be implemented after drug approval some 10 or 15 years hence, when the world that we all know will look considerably different than it does today.
In reviewing Bill C-393 and the previous hearings, some things are clear to me. Everyone salutes the goal of making medicines available globally to those in need. There are many stars that must align, from the access to affordable drugs, to local infrastructure, medical personnel, water, sanitation, and other social determinants. While Bill C-393 may help alleviate the access to affordable drugs issue, in and of itself it is insufficient to ensure access to those in need. However, it does seem reasonable to remove the cost barrier in areas where they may exist, and such is the intent of Bill C-393.
Given the need for pediatric formulations, access to second-line drug regimes, and changing patent laws in India and China, the need to access patent medicines may arise more frequently.
My caution lies in the implementation and the potential unintended consequences as the pendulum swings from regulations that, by virtue of Apotex's Rwanda experience, have been seen to be cumbersome and unwieldy to the one-licence, all-country unlimited solution proposed by Bill C-393, which, in my opinion, lacks sufficient checks and balances.
In particular, I am troubled by the lack of country-by-country approval process and a licence bound by time. Couple this with the opportunity for countries to accept drugs not approved by Health Canada or the pre-qualified program of the WHO and there is potential for drugs without adequate safety or efficacy profiles to be in circulation. Removing requirements for specific marking, colouring, or labelling invites diversion opportunities both to other countries and also to other economic classes within the country of destination.
While diversion has not been a substantive issue to date, I know that 95% of the WHO's essential medicines are off patent and the incentive for diversion will increase with the costing control in the differential associated with patented drugs, which is the subject of Bill C-393.
Another legitimate concern expressed to me by companies in the first world market is the potential for first world market consequences of third world market adverse medical events. This could result in the regulatory halt of the drugs used in Canada and/or a substantive drop in market opportunities.
Finally, I think we need to consider the possible consequences of one major event related to either diversion or adverse medical events. This, in my belief, would reduce the R and D investment potentially funded by pharmaceuticals in Canada. That being the case, it could diminish our ability to develop drugs within the country and certainly my abilities to license them in the university environment. If that's the case, it could result in reduced access to medicines by Canadians.
Pharmaceutical development is a global business, and it's possible for industry to avoid jurisdictions that present unacceptable risks.
In summary, I support the revisions to the Canadian access to medicines regime to improve the efficiencies and effectiveness, but this must be balanced with adequate checks and balances to ensure that access is delivered in a controlled and accountable manner.
Thank you.