The Commons industry committee is now studying Bill C-393, which seeks to reform Canada’s Access to Medicines Regime, in order to streamline the process by which generic drug manufacturers can obtain licenses to make cheap AIDS drugs for the developing world.
The committee had previously heard from government officials on the bill, and the view was resoundingly negative. Of course, the witnesses the departments put forward weren’t necessarily qualified to really be addressing the bill (for example, the Foreign Affairs official was their air negotiator, not their Intellectual Property negotiator, which would have been appropriate), while others were simply unhelpful (the CIDA official would only talk about how much money they’ve put into foreign aid budgets).
Today the witnesses were Richard Elliott, executive director of the Canadian HIV/AIDS Legal Network, and Dr. Don Kilby, president of the Canada-Africa Community Health Alliance (CASHA). Each were looking to counter some of the negative assessments of the bill, put forward by the departments, or from the brand-name pharmaceutical industry.
To that end, Elliott pointed out that the heart of the matter is a World Trade Organisation agreement in 2003 to help generic drug companies lower patent barriers and make effective use of compulsory licenses, which would then allow the market system to lower drug prices through competition. The pharmaceutical companies wouldn’t be disadvantaged by this because they would be making money from royalties paid by the generic companies, and these drugs are destined for markets where the brand-names don’t have a presence anyway. Kilby added that the fact that Apotex did manage to use the existing CAMR law to get a single shipment of AIDS drugs to Rwanda exceeded their expectations, and that CAHSA supports the one-licence solution proposed by Bill C-393, and adds that the anti-diversion mechanisms in the law would remain in place. (Diversion is where these generic drugs would wind up on a black market elsewhere).
In response to questions by MPs, Elliott pointed out that Bill C-393 was drafted with the help of people with expertise in the WHO regulations that allow CAMR to exist, and that they ensured that it was in compliance with the TRIPS provisions. He also pointed out that the bill gives companies more than one route to gain clearance than just through Health Canada, such as the World Health Organisation’s pre-clearance process – currently the law says only a Health Canada review is necessary, which is more than other drugs we manufacture for export need.
When asked if India – the current supplier for most generic drugs for developing nations – has the capacity to meet the current demand, the answer is no – especially because right now only 5.2 million in Africa people are being treated and we need double that amount. As well, with more than 20 percent of people needing to move from first-line drugs to more expensive second-line drugs, as drug resistance and toxicity become an issue, fewer people will be able to afford the necessary treatment. As well, the HIV strain in western Africa is different and more difficult to treat – and therefore more expensive – than strains in other parts of the world.
It was also pointed out that the landscape for generic drugs in India is changing since they signed onto WTO agreements in 2005, and going forward, as more people need to move to second-line treatments, their generic industry won’t be as competitive as it used to be. This changes the landscape as far as the Canadian industry’s ability to compete. There is also a paragraph in Indian patent law which might allow for compulsory licenses like CAMR allows, but because its wording is vague and provides no fee structure for royalties, it would likely be challenged in court if it were ever accessed.
Overall, there were a few good questions from MPs, but a lot that seemed to be non-sequiturs – repeating testimony from the aforementioned government officials that maybe CAMR wasn’t being used because there were better mechanisms already in place around the world, wondering about the tangible effect on foreign aid by this bill, questions about how this might affect malaria drugs. One MP went so far to wonder if generic drugs were less effective than brand-name ones. (No, seriously).
Hearings resume on Tuesday morning, with a marathon four-and-a-half hour session of witnesses.