Published on 28 June 2011 @ 12:11 pm
Inside Views: Amending Canada’s Access To Medicines Regime (CAMR): The New Fate Of Bill C-393
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Intellectual Property Watch
A Canadian bill to improve global access to medicines might get another shot in the new Parliament.
The newly elected Canadian Parliament resumed on 2 June amidst pleas for the attention of majority Conservative government. But Bill C-393 is quite different matter than a plea. Determining whether or not to reintroduce and pass this bill is a crucial humanitarian issue that transcends partisan interests while posing a bet on Canada’s credibility. Bill C-393 would actually play as a working way of effectively getting medicines to those still dying in the developing countries.
Just under 5 billion people (43 percent relying on less than US$2 daily) live in the resource-limited countries where communicable diseases, including HIV, malaria and tuberculosis, are most prevalent, according to the WHO Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property.
Patent protection, by permitting the application of monopoly prices for brand medicines, keeps the poorest people, mainly in Sub-Saharan Africa, from non-discriminatory access to life-saving treatments. Such is the case notwithstanding the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), which encompasses flexibilities (including compulsory licenses, or CLs) to help income-constrained populations equitably access low-priced medicines. (A CL is a government provision that allows a generic manufacturer to produce and bring out less expensive, generic – i.e., not brand-name – copies of a medicine without the consent of the patent holder.)
The WTO in November 2001 recognised that TRIPS Article 31(f) limited the use of CLs “predominantly” for the purpose of supplying the domestic market of the country where the licence was issued (see the Doha Declaration on TRIPS and Public Health [pdf]). Permission for export under CL was then agreed upon through a WTO 2003 temporary waiver (the “August 30th Decision”, voted as permanent amendment on 6 December 2005 and still awaiting ratification by members).
CAMR, the Flawed Canadian Way
As a federal law aimed at helping get medicines for public health needs to the developing countries, Canada’s Access to Medicines Regime (CAMR) came into force in 2005 as an implementation of the WTO 2003 waiver. While a few other countries also have introduced laws to implement the waiver, Canada is the only country till now that has really translated legislation into action. Unfortunately, CAMR is a lengthy and cumbersome process with restrictions going beyond the minimum standards in WTO 2003 waiver. Presently, developing countries interested in accessing, under CAMR, affordable copies of brand-name medicines from Canada must wait until a Canadian generic firm can get a CL on a country-by-country and order-by-order basis, for a specific quantity of medicines (additional drug shipping is not permitted) and for a limited period (two years, extendable up to another two years only to finish delivery of the original order). As such, CAMR has been used only once for two shipments of medicines for HIV infection from Canada’s largest generic firm Apotex Inc.(Toronto) to Rwanda in 2008 and 2009, after three years were spent conforming to all regulatory requirements and the over 100 riders the law is enmeshed with (see IP-Watch, October 29, 2010).
Calls by developing countries and public interest groups in Canada and elsewhere are steadily being renewed to streamline the barely-used regime into a “one-license solution” that would authorise a company to produce the same medicine for export to any country that submits notifications to WTO, regardless of the quantity of medicine. Should CAMR be amended, Apotex has publicly pledged to work to develop and deliver a generic three-in-one fixed-dose medication for treating children with HIV in developing countries, where half of all children born with HIV die before their second birthday because they don’t have access to appropriate medicines.
Betting on Bill C-393
In May 2009, proposed legislation Bill C-393, which aims to make CAMR expeditious and easier to use while complying with obligations under WTO’s trade rules, was introduced in the Canadian House of Commons.
In addition to the “one-licence solution” [pdf], its contents include the removal of unnecessary limits on medicines that can be supplied under CAMR, and the transformation of a motion of four-year duration limit for CAMR reforms into a four-year review, instead of an automatic repeal of them.
Irrespective of strong opposition, reportedly from Big Pharma lobbies and some Conservative government members, broad-range, steadily growing support is currently backing the Canadian campaign for CAMR reform (see here, here, and here).
On 9 March, the majority of MPs in the House of Commons voted in favor of Bill C-393 and passed it on to the Senate of Canada. Unexpectedly, however, the bill stalled there and died, being prevented from coming to a vote and becoming law, with the dissolution of Parliament on 25 March. .http://thevarsity.ca/articles/45372
The New Parliament: Still a Chance for Bill C-393?
Ballot box results from the 2 May Canada’s parliamentary elections ratified the victory of the Conservative Party, which remains in power (167seats out of 308: 155 needed to form majority). The New Democratic Party (NDP) gained the second largest number of seats of any party (102) and became the official opposition, signalling a key change in Canadian politics. The Green Party won its first election for a seat, whereas the Liberal Party (LP) collapsed (34 seats) and the Bloc Québécois was decimated (4 seats down from 48).
Is there room for hope that Bill C-393 might survive now and pass into law in Canada’s new 41st Parliament? Answering this question must consider, aside from the new balance of power inside the 41st Parliament composition, also the fact that many MPs of the dissolved Parliament already agreed that CAMR needs reforming.
Interestingly, four out of five party leaders (from Bloc Québécois, Green Party, LP, NDP; no response from Conservative Party) replied affirmatively to an 11 April question posed by the Canadian HIV/AIDS Legal Network whether, if elected, they and their party would support legislation to fix Canada’s Access to Medicines Regime by creating a simple one-licence process, without additional and unnecessary restrictions, in order to improve access to affordable medicines for people in need in developing countries.
As regards the fate of Bill C-393, the election results, with significantly more power assigned to NDP added to the information above, means that Conservatives now have to face a firmly united opposition. Indeed, the NDP, LP and the Green Party fought for healthcare and shared similar values during the election campaign. Besides, it can mean a lot that strong supporters of the bill, such as its official sponsor, Paul Dewar (NDP), NDP leader Jack Layton, and Green Party leader Elizabeth May, have a seat in the new Parliament.
On these grounds, coupled with consideration that amending CAMR is a non-partisan humanitarian issue, there is hope that Bill C-393 will attract new support from members of all Parties in the House of Commons, and that the Conservative government will allow its backbenchers freedom of conscience on it. But, if Bill C-393 is to be passed, civil society organisations must continue campaigning and mobilising political will in Parliament.
Daniele Dionisio is a member of the European Parliament Working Group on Innovation, Access to Medicines and Poverty-Related Diseases. He is reference advisor for “Medicines for the Developing Countries”, SIMIT (Italian Society for Infectious and Tropical Diseases), and a member of the Italian Global Health Watch. Dionisio is former director, Infectious Disease Division, Pistoia Hospital, Pistoia (Italy). He can be reached at email@example.com.