Friday, October 9, 2009

Government officials say CAMR reform largely unnecessary

[cross-posted from Hill Queeries, Xtra's Ottawa blog by Dale Smith]

The Senate Committee on Banking, Trade and Commerce met to consider Bill S-232 for the first time today. The bill would amend Canada’s Access to Medicines Regime (CAMR), a piece of legislation which theoretically enables generic drug manufacturers to provide cheap drugs for Tuberculosis, malaria and HIV/AIDS in developing nations that cannot access these drugs in any other way. Because it deals with changes to the Patent Act, it falls under this committee and not one relating to health or foreign affairs.

The Senate Private Members’ Bill was first introduced seven months ago by Liberal Senator Yoine Goldstein, who has since reached the mandatory age of retirement, but is now being shepherded through by Liberal Senator Sharon Carstairs.

Goldstein and Carstairs first testified before the committee to defend the necessity of the bill – that in the five years since CAMR legislation was first adopted in Canada – and similar legislation in other countries – only ours has been accessed once by Apotex for a single shipment of AIDS meds to Rwanada. Apotex later declared the process to burdensome, and that it would no longer send shipments. Clearly something needs to be done.

The changes would also allow for NGOs like Doctors Without Borders or Save the Children Canada to purchase the drugs directly, rather than going through a given country’s procurement process, thus speeding process – especially in those nations who do not have a government capable of such bureaucratic processes.

The second group of witnesses were from four government departments who are affected by CAMR, but their testimony poured cold water onto the arguments for the bill. Industry Canada led the group, and suggested in large part that despite the original legislation operating under waivers for World Trade Organisation rules, and that this bill would not alter those portions of the legislation, they nevertheless argued that these changes could bring about WTO challenges. Foreign Affairs’ witness said that they had consulted with their legal department about these potential challenges, but could not provide a formal written legal opinion on the matter – something which did not impress Liberal Senator Pierrette Ringuette during her line of questioning.

The Industry Canada witness also raised the concerns about anti-diversion measures – that is, to ensure that these drugs don’t wind up in countries where they are not intended, or into markets where they would compete with patented drugs. Goldstein had already mentioned in his testimony that the anti-diversion mechanisms already in place – that these drugs are specifically formulated for the virus strains in sub-Saharan Africa, that they are closely supervised by WTO officials and that they are specially shaped, coloured and stamped for use only in the designated countries, and that the brand-name pharmaceutical companies employ these same methods for their own products in similar markets. An official from CIDA also suggested that perhaps more money was being spent on prevention measures in this countries than treatment, which could be why CAMR has only been accessed the once – not that most Senators appeared to believe this.

Liberal Senator Paul Massicotte also raised the very interesting question of whether or not some countries might be subject to blackmail by pharmaceutical giants, which was why they may not be accessing CAMR currently. No government official would comment on that speculation.

After the hearing, I spoke to Senator Ringuette and former Senator Goldstein about the testimony.

Senator Pierrette Ringuette
Q: What were your concerns based on the testimony from the government officials?
A: The government “messengers?” I found I was very disappointed. This bill has been introduced for seven months, and they come in front of a Senate committee, very ill-prepared, making assumptions, not being able to back them with facts, and to me that’s very discouraging because I think that the Canadian people are entitled to better services from our officials.

Former Senator Yoine Goldstein
Q: What was your reaction to the government officials’ testimony?
A: Industry [Canada] perceives itself as having a particular role to play, and it plays it well. It has a concern, conservative small-c, to make sure, that whatever legislation is adopted is WTO and TRIPS compliant. There are a number of significant legal opinions that say that this proposed legislation is compliant, and I drafted it with those opinions in mind. Let me tell you what a big problem would be and isn’t – the big problem, which would make this kind of legislation not compliant would be if there were a blanket licence. That is, a general license forever. I didn’t draft it that way. The way it’s drafted, you have to go before the Commissioner of Patents to get a compulsory licence, and you have to fill certain requirements in terms of information and ongoing information to maintain that licence. What Industry just said a few moments ago is frankly incorrect, and if you come to the rest of the hearings, you’ll find out why it’s incorrect. To suggest that the Apotex application was dealt with in three months was gross nonsense. Absolute nonsense. And Apotex will be here to tell us why.


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