[Ip-health] Media items re: Canada's law on compulsory licensing of pharmaceuticals for export

Richard Elliott relliott at aidslaw.ca
Sun Jan 30 10:41:40 PST 2011

Below are three recent media items, including an editorial by the largest daily circulation newspaper in the country, in advance of resumption of debate in Parliament on Monday, January 31st regarding a bill (Bill C-393) to fix the flaws in Canada's law on compulsory licensing of pharmaceuticals for export (the implementation of the WTO General Council Decision of August 30th, 2003).

For more information, please visit the Canadian HIV/AIDS Legal Network's page on Canada's Access to Medicines Regime at www.aidslaw.ca/camr.

For Canadian residents, please also visit www.LetParliamentVote.ca to take action to prevent Bill C-393 from being derailed by the government on a procedural technicality.

Richard Elliott
Canadian HIV/AIDS Legal Network


Guest blog post: Richard Elliott

Fri, Jan 28 2011 The Ed Board blog 
Dying children deserve an answer from Parliament

When Parliament resumes on Monday, an important piece of legislation will be centre stage in the effort to reform Canada's (broken) Access to Medicines Regime (CAMR) -- and the urgent fight to keep people from dying of treatable diseases in developing countries.  The debate on Bill C-393 will touch on a number of issues that reach beyond the modest and sensible proposals contained in the legislation. These include restoring Canada's international reputation and our commitment to eradicating diseases such as AIDS. 
But the debate is also expected to highlight a weakness in Canada's democratic process.

Bill C-393 will make it easier to send affordable, life-saving generic medicines to developing countries. CAMR, which passed with unanimous consent in 2004, is currently all tied up in red tape. High hopes were raised when CAMR was passed, but the legislation in practice is an abysmal failure. Only a single licence was issued to supply a single medicine to a single country (Rwanda). Neither generic drug manufacturers in Canada nor countries in desperate need of medicines are able to use it effectively. Thus people continue to suffer and die. 
Bill C-393 will cut this red tape and make it easier for generic pharmaceutical companies to get a licence to produce and sell to developing countries a generic version of a brand-name drug. They will also pay a royalty to the brand-name pharmaceutical company. Everyone wins. 
But the fate of the bill may not rest on logical arguments.  Bill C-393, incredibly, may die on a procedural technicality and the unwillingness of a few MPs to respect the spirit of parliamentary democracy.   
Herein lies the rub: Because the MP who originally introduced Bill C-393 is no longer in the House, the bill will need a new sponsor in order to be brought to a final vote. Incredibly, making this minor procedural change requires unanimous support in the House. The NDP, Liberals and Bloc Québécois have all committed to consent to a new sponsor. But the Conservatives have not. This procedure has been done on numerous occasions before -- and Prime Minister Harper was once extended this very same courtesy. Given statements by some Conservative MPs, there are real concerns that the government will block a motion to accept a new sponsor for Bill C-393.
Eighty percent of Canadians support fixing CAMR, as do dozens of civil society groups and an ever-growing list of prominent Canadians. Parliamentarians deserve a vote on this important bill and Canadians deserve to see this issue resolved democratically. MPs must do the honourable thing and give unanimous consent. Lives are hanging in the balance.
For more information please visit www.letparliamentvote.ca. 
Richard Elliott
Executive Director
Canadian HIV/ AIDS Legal Network



Fight to get cheap drugs to Africa at critical stage
January 28, 2011
Tanya Talaga 

The eight-year fight between big pharma, generic drug makers, AIDS lobbyists and international humanitarian organizations over Canada's ability to send life-saving medicine to Africa could be days from the finish line.

As Parliament resumes Monday, among the first items up for debate are fixes to Canada's Access to Medicines Regime (CAMR) - legislation enabling generic makers to send life-saving drugs to needy countries.

The legislation was enshrined in 2003 by the Liberal government and at the time it was hailed by the international community as a trail-blazing Canadian effort to save lives in poor countries with no ability to make or purchase medication for AIDS, malaria and tuberculosis.

But the private member's bill aimed at fixing CAMR's flaws might die after its sponsor, New Democratic Party MP Judy Wasylycia-Leis, quit last year to run for mayor of Winnipeg. She lost.

Her exit leaves bill C-393 in limbo. It can't move to third reading unless all parties allow for a new sponsor to come forward.

NDP MP Brian Masse (Windsor West) wants to take C-393 over.

Supporters are hoping Prime Minister Stephen Harper - whose government has been less than supportive of the amendments - doesn't stand in the way by letting Conservative MPs vote against the change in sponsorship.

"Let this go to a vote - respect democracy," said Richard Elliott, executive director of the Canadian HIV/AIDS Legal Network. 

The bill needs to be democratically debated and improved, critics say.

Only one generic drug maker, Apotex Inc., has managed to use the legislation to make one drug, a triple combination anti-AIDS medication.

In 2009, Apotex shipped enough medication to treat 21,000 Rwandan AIDS patients for two years.

But Apotex said the process to make the pills was so bureaucratically cumbersome - it involved talks with the patent holding brand-name pharmaceutical firms, Health Canada and dealing with countries interested in getting the drugs - that if the bill is not made easier to use they won't use it again.

Wasylycia-Leis put forward a private members bill on May 25, 2009 which proposed a one-license solution.

It allows for a generic drug maker to only apply for one drug-making license and that license would let them supply to any of the eligible countries in need, which are already listed in the current law. It also covers repeats.

However, last October, Liberal industry critic MP Marc Garneau introduced amendments at committee to effectively get rid of the one-license proposal. His vote, added to that of the Conservative MPs on the committee, meant these changes were made and now the bill, in its weaker form, will be debated in the House Monday.

The bill's supporters hope they'll be able to reverse Garneau's changes and say his position is that of a small minority within the Liberal caucus.

Masse feels Canada owes it to the world to improve bill C-393, especially after trumpeting the legislation to Third World nations as a means to help them fight public health epidemics.

"If we don't live (up to) our responsibilities we'll have misled the world," Masse said in an interview. "We promise to make sure affordable, low cost drugs to address suffering and dying were available but we never lived up to that."

Masse said he was stunned when the Commons industry science and technology committee "gutted the bill". 

"It is shocking. Given the global circumstances we've had - floods, earthquakes, natural disasters - there has never been a more opportune time," he said. 

The Liberals, the NDP and the Bloc are expected not to block Masse's sponsorship, said Elliott.

Apotex sent a letter on January 19 to all MPs urging them to reconsider Bill C-393's pledge to Africa. If a one-license solution is adopted, Apotex said it will manufacture a triple-combination anti-AIDS medication for children - something the developing world desperately needs.

No one knows if the Tories will support Masse's move, said Elliott.

But Elliott hopes the prime minister will look kindly on the sponsorship change because he was once in a similar position.

In 1997, a then back-bench Reform Party MP Stephen Harper put forward a private member's bill that he had to drop when he resigned his seat. The act was to establish terms that must apply to a referendum relating to the separation of Quebec from Canada. Reform Party Leader Preston Manning took over as the bill's sponsor.

"It would be beyond irresponsible that a bill addressing a critical issue - the global AIDS crisis - and one of great importance to many Canadians, be allowed to die because of a procedural technicality," Elliott said.


TORONTO STAR (editorial)


Africa's Hope: Save AIDS drugs bill
January 30, 2011

When Bongani Masalaza was diagnosed with the AIDS virus, he braced for the worst. "You would surely die," recalls the resident of Cape Town, South Africa. He could barely eat, couldn't wash himself and weighed just 86 pounds.

But he's a fighter. He lived with the virus for years, South Africa's Health-e news service reports. Still, tuberculosis dragged him down, twice, until he was put on an antiretroviral treatment program. He credits the AIDS drugs with saving his life. Today he's a scrawny but thriving 136 pounds, with a good blood count.

"I think I would be dead by now, had I not started treatment."

That's just one person's story. But it is a tale of survival that Prime Minister Stephen Harper and Parliament should ponder on Monday, when MPs reconvene. In one of their first bits of business they must decide whether to keep Bill C-393 alive. That's the proposed law to make it easier for generic drug firms to get approval to make cheap copies of brand-name drugs for poor countries. It's a worthy cause.

The war on AIDS is faltering, the World Health Organization warns. Some 15 million people need drugs. But only 5 million get them. 
Canada can help. But keeping C-393 alive requires unanimous consent. The Conservatives haven't yet agreed. All opposition parties have. If the bill dies, the Tories may have to bear the blame.

Even if C-393 lives, another battle looms. Last fall a Commons committee narrowly, and wrongly, voted to gut it of an essential provision, the so-called "one-licence solution." Parliament must decide at a later stage whether to reverse that move. It should.

The original bill would do away with obtuse Canadian rules that make it hard for generic firms to supply drugs. Currently they must get separate licences for each sale, country by country and order by order, and for limited periods of time only. Designed to protect brand-name firms, these rules have resulted in only Rwanda getting drugs in the past five years.

Bogus arguments have been floated that the AIDS crisis is well in hand, that China and India now supply all the generics that are needed, and that price isn't a problem. The facts, as reported by the WHO, refute such claims.

Even today, 15 million people are in need. Canada vowed in 2005, with unanimous Commons assent, to ensure "universal access" for all. We should be worthy of our word, stand by C-393 and offer the help that so many require.

Richard Elliott
Executive Director | Directeur général
Canadian HIV/AIDS Legal Network | Réseau juridique canadien VIH/sida 
+1 416 595-1666 (ext./poste 229) | relliott_aidslaw
www.aidslaw.ca | www.twitter.com/aidslaw  

Access to Medicines Campaign: www.aidslaw.ca/camr | www.aidslaw.ca/facebook 
Campagne pour accès aux médicaments : www.aidslaw.ca/rcam | www.aidslaw.ca/facebook 

More information about the Ip-health mailing list