UPDATE 3 Nov 2010 – Garneau responds.
Xtra caught up with Liberal Industry critic Marc Garneau after Question Period on Tuesday, Nov 2 to ask about his opposition to the one-licence solution clause in Bill C-393.
The clause would have allowed generic pharmacutical companies to supply multiple eligible countries with flexible quantities of a drug under a single licence. Currently, specific countries and quantities must be licenced on a case-by-case basis, a system that opponents say mires the distribution of life saving drugs in bureaucracy.
“This was a very difficult decision for me personally and I will say once again the objective, which is to give urgent medicines to those who need them in Africa is one that I subscribe to 100 percent,” Garneau says.
Garneau says the one-licence solution clause would have given “carte blanche” to licenced generic drug makers.
“It was far too open-ended from my perspective, and I will come back again and again to the fact that CAMR essentially works in the sense that in the once case where it was used, in my opinion, the brand-name pharmaceuticals responded in a timely fashion and on both the occasions when they were asked to give their approval.”
When asked about Apotex’s position that their biggest hurdle was the requirements under CAMR to have the country and quantity of drugs named before they could apply for a licence, Garneau expressed his disappointment that Apotex did not appear before the committee.
“I am extremely disappointed with that, and to be honest with you, the fact that they could not be bothered to come, and have instead communicated their views indirectly or through other people, I find that completely disrespectful of the process,” Garneau says.
“Apotex is the only generic company that was involved in a successful use of the CAMR regime, and they could not even be bothered to turn up to answer the kinds of questions that you’ve just asked, and that I was certainly going to ask, because I wanted to hear it from the horse’s mouth, and they didn’t even bother turning up.”
Apotex previously appeared before the Senate Banking, Trade and Commerce committee when they considered a similar CAMR reform bill, S-232, last year.
1 NOV, 2010 – Bill C-393, which aims to reform Canada’s Access to Medicines Regime (CAMR), has survived the Commons industry committee, but has been virtually gutted with the omission of the one-licence solution clause. Liberal industry critic Marc Garneau was the only opposition MP on the committee to vote with the government, eliminating that provision from the bill.
NDP MP Brian Masse, who is shepherding the bill, withdrew several of the bill’s clauses in the spirit of compromise, but the loss of the one-licence solution was the biggest blow.
“It’s unfortunate, because we missed a real opportunity,” Masse says. “That’s pretty remarkable when you think about the fact that we were able to reverse some of the other negative trends, and we also compromised quite significantly along the way by adding a bunch of clauses back that were raised as issues. It was a real tragic moment I think for this effort.”
Richard Elliott, executive director of the HIV/AIDS Legal Network, is taking stock of what little remains in the bill.
“We are left with a limited list of drugs that can be subject to compulsory licensing for export, and a cumbersome process to add drugs to that list, which is already out of date if we’re just talking about AIDS drugs,” Elliott says. “We’re left with a two-year limit on the term of any compulsory licence that might, despite all the odds, be issued.
“We did succeed in getting rid of the discriminatory double standard that developing countries who do not belong to the WTO must meet in order to be eligible to import generics from Canadian manufacturers.”
But the loss of the one-license solution is what worries him the most. Bill C-393 would have allowed a generic drug manufacturer to get one license authorizing it to supply multiple eligible countries with flexible quantities. Currently, a specific country and quantity must be identified before a licence can be granted.
This barrier was cited by Apotex, the sole Canadian generic drug company to use CAMR, as one of the reasons they would not use the CAMR provisions again.
“It was the experience of Médicins Sans Frontiers, when they tried to place an order for the medication, they could not get a country to be identified ahead of time for a variety of reasons, including fear of retaliation,” Elliott says. He adds that without the one-licence solution, it remains doubtful that anyone will use CAMR again.
For Conservative MP Mike Lake, the parliamentary secretary to the minister of industry, Bill C-393 had larger flaws in terms of the protection on intellectual property.
“If you take a look at what the bill does, it strips away tons and tons of language in the Patent Act that refers to trade organizations, trade agreements we have, that all have a significant impact,” Lake says.
“The main concern I have … is unintended consequences,” Lake says. “We can all agree on a personal level that we want to see the people in Africa and other parts of the world that are suffering with HIV and AIDS — and malaria or other diseases — get the help they need.”
There are still some other hurdles, including the fact that it must obtain unanimous consent from the House to proceed with Masse as its sponsor after the resignation of its original author, Judy Wasylycia-Leis. There are presently rumours that the Conservatives will kill the bill at that point.
“There’ll be continued public pressure in terms of where we’re going with this,” Masse says. “Whether we can fix some of those things when we bring it to the House of Commons, and we also have to get unanimous consent to bring it forward. That’ll be interesting to see because we haven’t heard the support from others on that issue as of today.”
Liberal MP Dan McTeague, who takes credit for the birth of CAMR in 2000, says that on the road of good intentions, they’ve fallen off.
“C-393 is not a perfect piece of legislation, but it addresses some of the fundamental problems in terms of time, in terms of volume, and in terms of requests by countries to formulate their own abilities to help themselves,” McTeague says.
While he says that they have done their best on the bill, McTeague is evasive on the question of Marc Garneau siding with the Conservatives to eliminate the one-licence solution.
Garneau did not respond to a request for interview.
“One conclusion is clearly that any member who is looking at this cannot but conclude that we have to go back to the drawing board and get this right, and we have to do it soon,” McTeague says. “The issue of pandemics and particularly the issue of pediatrics is vital and Canada can play a lead role in that area, while observing our international drug patent laws.”