Senator Yoine Goldstein on Wednesday tabled a Bill to amend Canada's Access to Medicines Regime (CAMR), a Patent Act that deals with the manufacture and export of drugs for humanitarian purposes. The Act creates exemptions to intellectual property rules, enabling generic drug manufacturers to produce low-cost medication to treat HIV, tuberculosis and malaria in developing countries, particularly in Africa.
Using the Regime, Rwanda managed to secure a 7million pills-shipment of Apo TriAvir, a combination of three medications into one pill, last September. Another consignment of 7million pills will arrive in September, but part of the first contract with Canadian pharmaceutical Apotex Inc.
However, after which, Mr. Elie Betito – Director of public affairs, said Apotex is “not ready to participate if the rules are the same” – a decision that shocked Rwanda – which is grappling with a massive HIV/Aids problem.
“This (Canadian) government is not interested in reviewing (the legislation again)”, Mr. Betito told Embassy, a Canadian foreign policy newsweekly.
The company has also committed to make a pediatric formula of Apo-TriAvir for children. Ideally, the drug could come in syrup or powder form because kids can't swallow pills. But all this is dependant on whether the current law is changed.
Campaigners also argue that what compounds the seriousness of the problem is thousands of Rwandan children that have HIV/Aids, but with no access to pediatric drugs. According to the National Aids Commission (CNLS), some 22,000 people have been on the Canadian pills out of the 53,000 that are taking ARVs. Rwanda has up to 290,000 people infected with the HIV/Aids virus.
History
Canada’s Parliament unanimously passed the Regime in 2004. The generic medicines regime is one of only a few in existence in the world and is based on an agreement hammered out by the WTO in 2003.
The agreement loosened patent rules so generic drug companies like Apotex could work with the compulsory licensing of patented medicines and proceed with legally producing and exporting lower-cost versions of brand-name medicines.
But by the time the Canadian government got around to conducting a mandatory review of the legislation in 2007, not a single pill had been produced and exported.
Bitter grand mothers
Pressure has been coming in from all sides to push the Canadian government here to review the law, to no success. And the groups demanding the changes are not about to give up.
On March 06, the Canadian Grandmothers for Africa group, with help from the opposition, presented a petition backed with 32,000 signatures from grand-mums across Canada to Parliament. The petition also had support from 140 politicians and prominent campaigners demanding that the government acts “with urgency” to send life-saving medicines to combat HIV/Aids and more aid to developing countries.
“African grandmothers are burying their children and struggling against extreme poverty to raise their grandchildren in the midst of an HIV/Aids epidemic”, said Ms. Peggy Edwards, co-chair of the Grandmothers’ National Advocacy Steering Committee.
“We want to see our parliamentarians show the moral courage to give to these women and these 13 million orphaned children regardless of our own economic woes.”
The project has also won vigorous support from Former top UN envoy Stephen Lewis – who has been a very close friend to President Paul Kagame, and a campaigner for increased support to countries battling HIV. Last week at a press conference, Mr. Lewis described the reluctance of Canada to act as a “death sentence” to people living with HIV and millions of children.
Though the process to have the bill debated and finally incorporated into the system could take months or even more than a year, the old law will eventually change because government minority support in Parliament, Mr. Lewis told RNA later.
“CAMR is cumbersome”
Senator Yoine Goldstein says his amendment would eliminate the “unnecessary and counterproductive features currently hindering the efficacy of the Regime”. It brings in 13 specific proposals.
The senator's private member's bill proposes what is known as the "one-licence solution," allowing a generic manufacturer to send multiple shipments of the same medication to a variety of countries without having to requalify for every shipment, as is currently the case.
The amendment also comes to make it easier for non-governmental organizations like Medicins Sans Frontiers (MSF) to buy and distribute generic ARVs under the Regime, something only governments are allowed to do at the moment.
According to Mr. Richard Elliott, executive director of the Canadian HIV/AIDS Legal Network, the existing process has been cumbersome. Mr. Elliott has been a very active and vocal driving force behind the new changes. He is the one who has lobbied hard to have the new bill in Parliament.
"It's an unnecessarily complicated process for the suppliers and the purchasers – and the people who end up paying the price are the patients, because this logjam doesn't end up getting broken", he told RNA.
This would allow faster, cheaper and ultimately more competitive pricing and markets for life-saving medicine, he pointed out in an interview in Ottawa, Canada’s capital.
No control or influence
Though Rwandan officials said they had not been informed of the Apotex’s intention to end production due to the complexity and cost of the process, they seemed to count on the contrary – that probably the company will continue making the pills.
Mr. Deo Nkusi, First Counselor at the Rwandan Embassy told Embassy magazine “there has not been any communication from my government in Kigali over any other course of action”.
“The bottowline is that experts from (Rwanda) selected Apotex because it provided a combination with fewer tablets and was cheaper”, Mr. Nkusi said.
Dr. Jules Mugabo, from Rwanda’s Treatment and Research Aids Center (TRAC Plus) – which negotiated the Apotex deal, said Rwanda will wait for what happens in Canada.
“We will go through the same process: from tendering to when the medication will reach us because we don’t have control or any influence over those mechanisms”, he said in a telephone interview from Kigali, Rwanda’s capital.
“Being able to get the medication that our people need so much from Apotex, was an opportunity we could not just leave”.
The lengthy mechanism which Rwanda prefers to go through than without the pills involves a process spanning over four years, which the Canadian HIV/AIDS Legal Network says does not match the situation's urgency.
South Africa “harassed”
Critics also blame intense lobbying by the big brand-name pharmaceutical companies at the WTO and in Canada which they argue has made this “obvious solution impossible”.
“For 12 years the response from the brand-name pharmaceutical industry has been: block it, stop it, slow it down, make it difficult, (and) harass the governments and generic drug makers”, said Mr. Jeff Connell, Director of Public Affairs with the Canadian Generic Pharmaceutical Association (CGPA).
He told Embassy that “big pharma intentions” were made clear when 58 multinational drug companies “lined up” to sue South Africa which had sought to change its Patents Act in 1998 as a vehicle to import cheap generic drugs from Brazil and India.
The lobby group representing brand name pharmaceuticals in Canada Tuesday disagreed that there was any need to re-open the Patent Act, the Ottawa Citizen newspaper reported.
"Parliament has reviewed it and come to the conclusion that it doesn't need changing," Russell Williams, president of RX& D told the daily. "The bill is fair, functional and efficient.
"It is an emotional debate but I believe that targeting CAMR is a problem," said Williams. "I don't see it as a barrier."
However, Ms. Stephanie Kale, a Carleton University Masters of Journalism student preparing a documentary on the Apotex pills that were sent in September last year, says the company’s role is over exaggerated.
“I'm pretty sure these drugs are available from other generic companies and (Rwanda) can secure their supply from them”, she said in an email from Kigali, mentioning India, as a possible source.