Month: May 2007

In 2005, Canada fiddled with its patent laws so that developing countries — the reform initiative was called the “Jean Chretien Pledge To Africa Act” — could get cheap access to drugs that could help fight AIDS, tuberculosis and other diseases. Since the passage of the “Canada’s Access to Medicines Regime” (CAMR) legislation, not one pill has ever been exported.

The House of Commons Standing Committee on Industry, Science, and Technology thinks that’s a rotten record of achievement and it wants to see what can be done about it. That committee’s chair, Conservative MP James Rajotte, has written a letter to Industry Minister Maxime Bernier about the problem:

I am writing on behalf of the House of Commons Standing Committee on Industry, Science and Technology concerning Canada’s Access to Medicines Regime (CAMR). The Committee is concerned that since the passage of the legislation that created CAMR in 2005, no pharmaceutical products have been exported to any country under the regime . . .

Here is an excerpt of testimony the committee heard last month from the CEO of generic drug maker, Apotex, Jack Kay:

  In Africa, hundreds of thousands of people die needlessly from HIV/AIDS every year because they do not have access to [the right] 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.

Immigration Minister Diane Finley was mighty unhappy at the grilling bureaucrats in her department received recently at the Standing Committee on Citizenship and Immigration. A letter from Finley to the committee members was sent at the end of last week, on May 16. Some opposition MPs say it represents interference by the Minister in the workings of the Committee. House of Commons Committees are, by tradition and parliamentary rules of order, pretty much masters of their own destiny. When Stephen Harper was in opposition he decried attempts by Liberal ministers to interfere in committee business.

Now, in her letter of May 16, Finley says she has advised her bureaucrats that “if the witnesses have any doubt about answering a question put to them by Committee memberes, the should not answer immediately, but provide a response, in writing, at a later date.” She says this is for their protection.

Here are some extracts from her letter:

I am writing to express my deep dismay with respect to the appearance, on May 2,2007, of various CIC officials before the Committee, and the manner in which that appearance unfolded. At times, the atmosphere and questioning were very hostile and I believe attempts were made to intimidate the witnesses. Innuendoes and accusations were made that, in effect, called into question the witnesses' integrity and truthfulness, without any basis whatsoever. What we members of Parliament sometimes see as the normal cut and thrust of Parliamentary debate 1s certainly not the kind of treatment that should be meted out to any witnesses appearing before this Committee, including members of the federal
public service, and with good reason . . .

The public servants who will appear before the Committee will present fie best information they can, within the limitations placed upon them in their role as public servants. On May 2nd and gth, the assertion is plainly made that certain Committee members felt that witnesses had lied and this is why they needed to be sworn in. Such an allegation is tembly inappropriate, and frankly could well be actionable if uttered outside the protection of the Committee. Whether or not public servants are placed under oath prior to testifying, they will provide the best information they can. In an abundance of caution, now, I will ask that my Deputy'Minister indicate that, if the witnesses have any doubt about answering a question put to them by Committee members, they should not answer immedately, but provide a response, in writing, at a later date, This may delay the Committee receiving full and complete answers to their legitimate questions, but as it is your intention to swear them in, this guidance is for their protection.