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.

Sneaky: European Free Trade Talks can also affect prices of drugs in Canada

Yup. Apparently, our previous post on data exclusivity and the like, will also effect prices in places like Canada as well.

Specifically:

Provisions in a new trade deal being negotiated between Canada and the European Union could add about $2.8-billion a year in costs to Canadian drug plans if implemented, a new report warns.

The estimate includes $1.3-billion more for public drug plans and $1.5-billion for private drug plans.

This is because the EU is asking for a number of things, including lengthening the terms of data exclusivity. Given that in Canada, “Generics account for 54 per cent of prescription drugs and brand-name drugs 46 per cent,” moves such as this will obviously prevent or at least greatly delay the existence of generics in the market. Crucially, and what is a bit dodgy about this whole thing, is that such moves will do these things even if a patent has already expired. It’s just another sneaky way for the pharmaceutical industry to keep control.

Anyway, read the whole Globe and Mail article at the link below.

LINK; EU trade deal could cost Canadian drug plans billions

Why do Data Exclusivity and Investment Rules suck?

O.K. First the tough part: bringing yourself to want to read about “Data Exclusivity” and “Investment Rules.” Granted, not the most common buzz words you hear about in media, but it’s actually very interesting. More so, if you have even a peripheral interest in what all the fuss is with regards to the EU-India Free Trade Agreement talks.

Anyway, there’s a great piece from MSF that does a pretty good job of outlining the problems with granting Data Exclusivity and tweaking Investment Rules when it comes to generic drug production.

Here’s the part on Data Exclusivity, if you’re more keen to just get on with reading it than clicking through to the whole article:

Data exclusivity (DE) is a backdoor way for multinational pharmaceutical companies to get a monopoly and charge high drug prices, even when their drug has been found to not deserve a patent, or the patent has expired – DE would apply to all drugs.

If India accepts DE, the agency in charge of approving medicines for use in the country would not be allowed to register a generic version of a medicine for a period of time – usually 5 to 10 years. To register a generic, producers rely on the clinical trial data provided by the originator company to show the drug is safe and effective. All the generic has to prove is that it is identical to the originator product. But if DE were in place, the originator company’s clinical trial data would be protected by ‘exclusivity’ and generic producers would therefore have to submit their own safety & efficacy data to register the generic medicines. This would oblige them to repeat clinical trials—something that would take years and be incredibly expensive, not to mention unethical, as it would involve withholding a drug that has already proven to be effective from some of the participants in the trial.

LINK: Briefing Note: Data Exclusivity & Investment Rules in EU-India FTA

O.K. You want coverage of Tony Clement being sneaky? Here you go.

Probably not his favourite picture of himself.

So at the bottom of this post is a quick round-up of the various news articles that went up (just before Bill C-393 died), that basically showed how the Bill was delayed and ultimately killed…

But for those who want the truncated version, here (in a nutshell) is what basically transpired. You can get a fuller version of the events of that one week of Senate activities by checking out this megafacepalm post at Boingboing.

1. We have someone who would like to say some stuff, but, hang on, he’s stepped out so let’s delay it until tomorrow…

2. And then there was stuff about “Well if you want it passed, you should try to make sure this election call doesn’t happen, but oh wait, let’s delay it for a day anyway…”

3. And then the next day, it was delayed again…

4. And then again, except “Oh, here’s an interesting leaked email, which happened to be full of spun misinformation, going around…” Hmmm… maybe we should delay it another day?

5. And then, well, it essentially died because you know the election call thingy happened (oh what a shock! If we had known, maybe we would have dealt with this earlier!).

So what happened: Well, by and large it seemed to be that certain folks preferred to not have to vote on Bill C-393 (knowing how popular it was and all), especially since there is always the need to maintain good relationships with your pharmaceutical friends.

All to say that this doesn’t strike me as either being very a rational way to examine a potentially invaluable law, or a very democratic way to do things.

Tory senators determined to delay bill giving medical aid to Africa (Ottawa Citizen, 23 March, 2011)

Tony Clement behind Senate delay, leaked document shows (Xtra!, 24 March 2011)

Clement attempts to block AIDS drug bill (Toronto Star, 24 March 2011)

Tony Clement urges senators to block generic-drug legislation (The Globe & Mail, 24 March 2011)