World AIDS Day Brings Calls For Legislative Caution, Reform

Canada’s Parliament has the power to save lives of millions afflicted with HIV around the world if they will act to ease intellectual property-related restrictions on their access to medicines, Canadian civil society groups said today.

A variety of groups worldwide called for increased mobilisation of services to victims of the global HIV/AIDS pandemic on 1 December, which is World AIDS Day.

In 2009, 1.8 million people died of AIDS, including 260,000 children, said a 1 December letter signed by Canadian civil society groups. Nearly all of them – 97 percent – were in low and middle income countries.

“They die not because life-saving medicines do not exist,” said the letter. “They die because they are too poor to buy the medicines that those of us in wealthy countries such as Canada so often take for granted.”

The letter calls for reform of Canada’s Access to Medicines Regime (CAMR) by supporting legislation before the Parliament that proponents say will ease overly cumbersome procedures for licensing to generic manufacturers who can produce and export the needed drugs more cheaply. Details on this bill and its background are below.

Humanitarian aid group Médecins Sans Frontières (Doctors Without Borders, MSF) also issued a warning this week that progress in combatting AIDS is “threatened by a double blow” as donations for critical AIDS treatment programmes have failed to meet the organisations’ funding needs.

The Global Fund, a key funder in the fight to combat neglected diseases in poor countries, received only US$11.7 billion of the $20 billion it asked for at its recent replenishment pledge, said the MSF press release, and the US President’s Emergency Plan for AIDS Relief (PEPFAR), which supports half of all people on HIV/AIDS treatment in the developing world, is “flat-lining funding for the third year in a row.”

A release from PEPFAR said it is increasing the number of patients it supports on antiretroviral treatment and called for “smart investments” to continue saving lives.

MSF also said rich countries are increasing pressure to patent more medicines in India, where there are currently tight restrictions on what is eligible for a patent in the pharmaceutical sector, in an attempt to protect public health. In particular, MSF is concerned about the European Union free trade agreement under negotiation with India.

Being pushed as a part of the agreement are new IP measures that some say will threaten the Indian drug manufacturing sector (IPW, Public Health, 3 September 2010, 27 April 2010). Many of the drugs available in the developing world are low-cost generics manufactured in India.

The World Health Organization also today released new guidelines [pdf] calling for HIV-positive children and adults to take regular preventative medication to prevent infection from tuberculosis, a deadly illness that causes a significant number of AIDS-related deaths. AIDS kills indirectly from opportunistic infections able to take hold with more fatal consequences in those whose immune systems have been weakened by the AIDS virus.

Reforming Canada’s Medicines Regime

CAMR is the country’s implementation of the World Trade Organization “Paragraph 6” waiver. Normally under WTO rules, medical products manufactured under compulsory licences must be used primarily in the country of manufacture. But this does not help countries who lack the manufacturing capacity to make their own drugs, which are often the most in need of cheaper generic solutions.

The 2003 Paragraph 6 waiver allows for the export of the majority of a drug manufactured under compulsory licence, but it has been criticised by developing countries and civil society groups for being cumbersome. It has only been used once, when a Canadian generics pharmaceutical company manufactured medicines for export to Rwanda. The WTO committee on intellectual property rights has been discussing the efficacy of the waiver, most recently holding a substantive review of it (IPW, WTO/TRIPS, 29 October 2010).

Civil society groups say that the CAMR is also too bureaucratic to really increase access to generic drugs in poor countries – currently it requires a single compulsory licence for each order for each country for a pre-determined amount of a drug, and this can only be done once a company issuing a compulsory licence has negotiated with patent holders and submitted a request to the Canadian Commissioner of Patents, according to a paper [pdf] by the Canadian non-governmental group Aids Law, which is advocating the reform bill the CAMR.

The proposed reform to Canadian law would introduce a “one licence” solution that would allow the drug under compulsory licence to be exported to any eligible country, and would not limit the amount of medicine exported.