Gilead to license several HIV/AIDS drugs to the Medicines Patent Pool

On July 12th Gilead, a US-based pharmaceutical company, announced their plans to license four HIV drugs and one fixed-dose combination to the Medicines Patent Pool. This marks the first agreement between the Medicines Patent Pool and a pharmaceutical company. (woohoo!) Although this is a significant step toward increasing global access to affordable meds, a few concerns remain. The agreement limits manufacturing to one country – India – which in turn limits competition (an important mechanism to drive costs down) and people living in middle-income countries – including China and Brazil – are excluded. You can find a more detailed explanation here.

Wondering what a patent pool is? This animation explains it nicely.

Contributor Bio: Stephanie Gatto

Stephanie is an access to medicines junkie armed with research tools and a penchant for social justice. She has a background in global public health and is a researcher in Vancouver BC.

James Cowan: Not all senators against bill C-393

Liberal Senator James Cowan and Leader of the Opposition shares his opinion on the state of Bill C-393 this weekend at the Toronto Star:

I am writing to correct a point made in this otherwise excellent article. Craig and Marc Kielburger made a strong case that Bill C-393 could have gone a long way to save potentially millions of lives. They went on to say that “Canada’s unelected Senate” stalled the bill that had passed in the House of Commons.

Canadians should know that it was not the whole of the Senate, but rather the Conservative majority that insisted on delaying action on the bill until the government fell on the no-confidence motion in the House of Commons. In fact, it was a Liberal senator, Yoine Goldstein, who introduced the first bill in Parliament in March 2009 to fix the problem with Canada’s Access to Medicines Regime, and help make it possible for people in developing countries to access affordable life-saving medicines. That bill unfortunately died on the order paper when Stephen Harper prorogued Parliament. Bill C-393, the NDP bill referred to by the Kielburgers, was virtually identical to Goldstein’s bill.

My Liberal colleagues and I — joined by both a Conservative and a Progressive Conservative senator — spoke strongly about the importance of this bill, and urged that it be considered promptly and passed into law before the expected election. To our disappointment, with their new majority in the Senate, the Conservatives were able to repeatedly adjourn debate on the bill, and effectively stalled it until the government fell.

The issue has not gone away. The need for affordable drugs in developing countries is as great as ever.My colleagues and I are already discussing the best way to move forward with this important initiative.

James S. Cowan, Leader of the Opposition in the Senate

Roche Wins as High Court Limits University Patent Rights

The United States Supreme Court recently announced their decision on a landmark case revolving around university patent rights on life-saving medical technologies. The technology in question, quantitative polymerase chain reaction (real-time PCR), is a highly effective tool in diagnosing infectious diseases and detecting new and emerging threats.

Originally developed by Stanford scientist Mark Holodniy, advancements in real-time PCR were claimed to be owned by the university, under the conditions of the 1980 Bayh-Dole Act that outlines universities’ legal rights for research funded by the federal government. Holodniy later signed agreements that transferred ownership of his PCR work to Cetus Corp, now owned by Roche Pharmaceuticals. Stanford argued that the Bayh-Dole Act superseded any agreement made afterwards by Holodniy and Cetus.

However, in the ruling led by Chief Justice John Roberts, it’s said that the 1980 law doesn’t displace the historical principle that inventors are allowed to have first claim on their work. This decision will certainly affect future cases of patent ownership and potentially all technologies that were jointly developed through federal funding, university research and industry collaboration.

The patent for real-time PCR will be held by Roche until 2021.

For more coverage on this case, the full article by Bloomberg News is available here.

A press release by Roche on the court’s ruling can be read here.

Passing drug bill imperative: AIDS in Africa could be stopped in its tracks if medications were available

Here is a recent op-ed written by Craig and Marc Kielburger of the non-profit Free the Children. Reprinted from the Edmonton Journal. Definitely worth a read…

– – –

We build schools in Kenyan villages where teachers die, but their students refuse to name the cause because of its potent stigma, even as coffins are lowered into graves.

We’ve seen husbands, mothers, and then their children, wither away from a mysterious illness rather than be ostracized with a diagnosis.

In North America, access to treatment makes it possible for people with HIV/AIDS to lead relatively comfortable lives. In developing countries, where antiretroviral drugs (ARVs) are prohibitively expensive, AIDS is a curse.

There’s still no cure, but Canada has a chance to save potentially millions of lives with a single legislation. Bill C-393 would reform Canada’s Access to Medicines Regime, a system so flawed it’s only been used to ship a single drug to Rwanda since it was first introduced six years ago.

Bill C-393 allows Canadian companies to manufacture generic versions of patented drugs, like ARVs, making it easier to deliver affordable medicine to developing countries. It passed the House of Commons on March 9, but stalled in the Senate, and then died on the order paper when the government fell.

When Parliament resumes June 2 there will be numerous pleas for the attention of Stephen Harper’s majority government. But this is more than a plea. Finally passing this bill is a moral imperative, and research released since its initial passing has made it an urgent one.

A few weeks ago, a major clinical trial found that treating HIV-positive people with ARVs led to 96 per cent reduction of transmission for the 1,763 participating couples in 13 sites all over the world, including Kenya.

The breakthrough was so great that results were released four years earlier than scheduled.

“We have a new vaccine and it’s called treatment,” Dr. Jennifer Cohn from Medecins sans frontieres, a medical relief organization with offices in Kenya, recently told the Nairobi Star. Advocacy organizations also predicted the virus could be eradicated in Kenya in just a few years.

Kenya is our second home -we’ve spent the past 15 summers there. We love the untouched beauty of its landscapes and the warmth of its people, but we’re sick with the knowledge that AIDS devastates the country.

Mary was a nurse in Kenya’s Rift Valley. She knew her husband had been unfaithful, and that she was in danger. But he refused to wear condoms -he’d paid her dowry, she was his property. When Mary was diagnosed with HIV, her husband abandoned her while she was pregnant with their second child. Women are more likely to be identified as carriers because of prenatal testing. Her child, who we will call Abby, was born HIV-positive.

Mary couldn’t afford proper treatment. When she died, none of her close relatives would adopt Abby for fear of “catching” the virus. The now two-year-old has little hope of receiving the medicine she desperately needs to survive.

Canadian pharmaceutical company Apotex Inc. has promised to make a generic duplicate of a pediatric ARV should bill C-393 pass. Dr. James Orbinski, founder of the medical humanitarian organization Dignitas International and staunch supporter of C-393, has said this alone would save millions of lives, since generic drugs reduce treatment costs from $10,000 to $100 a year -even less for children, like Abby.

We wonder how many people were infected while Canada’s unelected Senate stalled a bill that passed in the House of Commons with a vote 172 to 111 -including support from the Bloc and NDP, all but two Liberals and a handful of Conservatives.

But not a single Conservative cabinet minister supported the bill, and brand-name drug companies, threatened by the prospect of lost business, lobbied against it.

Ideally, competition on the global market would increase with added competition from generic companies better able to compete on price, driving costs down for poor people dying preventable deaths. This is a humanitarian aid bill meant to save lives, not money.
After years battling opposition and regulatory quirks in the House, only to be stalled to death in the Senate, Bill C-393 isn’t guaranteed a swift pass through this Parliament.

Canada’s political landscape has changed. The NDP say they will reintroduce the private member’s bill that was first passed in the minority Parliament.

Canada has two choices.

The Conservative government could bolster the country’s reputation on the world stage at no cost to taxpayers. In fact, passing the bill would make Canada’s foreign aid dollars go further because we, and developing countries, could purchase more medicine for less.

Or, our government could fail to act, leaving countless people to die needless deaths.

CIHR Reverses Drug Trial Policy

Canada’s national funding agency for health sciences, CIHR, made a controversial move to cancel a policy that required full public disclosure on results from drug trials. Without full disclosure of study results, the public may not be privy to important early details about drugs that may be ineffective or worse, significantly toxic. Transparency, a necessity for gathering evidence and truth in making healthcare related decisions, is believed to have been further undermined by the lobbying efforts of Canada’s pharmaceutical corporations. CIHR has increasingly drawn fire for its closeness with industry, having appointed last year an executive from Pfizer to their national board. Quoting Sir Iain Chalmers, co-founder of the U.K.’s respected Cochrane Collaboration research body: “It seems to me that CIHR has decided that it’s going to put my interests and the interests of other patients behind those of industry…. I think that’s tragic.”

The full article by the National Post is available here.

UNICEF Begins to List Prices Paid for Vaccines

UNICEF recently announced that it would list the prices paid for vaccines to pharmaceutical corporations and it’s now available online. The decision to withhold this information until recently came out of a concern to avoid confrontation with pharmaceutical organizations. This is not a surprising demand by the industry, considering that increased transparency on the true costs of treating illnesses has protected them from a level of scrutiny and competition that would undoubtedly lead to calls for lower prices.

For more details on UNICEF’s announcement, visit the New York Times article here.