Thank you for allowing Apotex the opportunity to present our real-life experience of trying to manoeuvre through CAMR, Canada's access-to-medicines regime legislation.
The Apotex Group is a leader in the research and development of generic innovative and biotechnology medicines in this country. We plan to spend over $2 billion over the next ten years on research and development. As I speak, we have over 600 medicines under development. With close to 5,000 employees, we plan to add another 350 people to expand our production capacity from one billion tablets and capsules per month to over 1.4 billion. Over 300 of the medicines we presently manufacture are exported to over 115 countries, all of this to meet our core Apotex value: to provide access to lifesaving, affordable medicines.
In Africa, hundreds of thousands of people die needlessly from HIV/AIDS every year because they do not have access to such medicines. The reason is simple: the multinational pharmaceutical industry does not like to reduce its prices, and it's better to sell to industrialized countries, where it can charge higher prices.
After listening to a speech by Stephen Lewis, we made a corporate commitment to do something about the problem. In 2002 we made an offer to the federal government of the day that we would produce five antiretrovirals at our cost, as long as the government got them to where they could be used in Africa. The government never even offered to look at our proposal. Part of the problem was that there was no mechanism to facilitate the process, and there was a lack of infrastructure for effective distribution. In the meantime, millions continue to die from HIV and AIDS.
Then in 2003 Bill C-9 was tabled, and hope was high that something was going to get done.
Here is a recap of the Apotex experience. We worked in consultation with Médecins Sans Frontières, who outlined the HIV/AIDS medicines that were in critical need and advised us that a combination drug of Lamivudine, Zidovudine, plus Nevirapine was needed. We started working on Apo-TriAvir, and a special R and D team was assigned to this project. They doubled their efforts, working weekends and overtime to complete the submission dossier. Many worked on their own because they wanted to do something important for HIV/AIDS patients in Africa. This drug could potentially save millions of lives, and Apotex was committed to providing Apo-TriAvir at cost.
At the same time, Health and Industry Canada defined an expedited approval route. Work on the fixed-dosage combination began in April 2005, and the submission dossier was finalized in December of that year. The dossier was approved by Health Canada in June 2006, and pre-qualification at the World Health Organization was achieved following the Canadian approval. This assured recipient countries of its efficacy and safety, authenticity and availability.
Apotex has invested over $2 million to date on the research and development of this drug.
Yet, having done ail of this to get this important HIV/AIDS medicine ready, the real problem for Apotex is the legislation, as the CAMR requirements are impossible to navigate. First, it's a voluntary license versus a compulsory license, requiring the recipient country to be identified up front, and the recipient country needs to initiate the request. The entire burden is left on the shoulders of the poor countries, who do not have the expertise or the resources. The legislation is designed for pharmaceutical companies doing business in the industrialized world, not Africa.
The effectiveness of the legislation is compromised by its lack of clarity. Maybe the objective of CAMR has to be clearly defined: quality medicines for critical diseases in a timely manner.
The current complex legislation tries to balance the interests of big pharma first. Why? We need to get our priorities right as Canadians and focus on those who are dying every day from AIDS in Africa.
This legislation perpetuates the human crisis, without getting anything done. Also, there is nothing stopping the multinational pharmaceutical industry from unilaterally making these drugs available at affordable prices, but they have not. All of their efforts have been focused on impeding the legislation.
In conclusion, our recommendation, having experienced the process, is that we need to move to a defined compulsory licence upon regulatory approval. This will speed up the process and limit legal costs, which can be substantial.
Thank you.