Category Archives: EU

A Primer on the Subject of Access to Medicines

Here’s a piece I wrote for online reading at Scientific American. It basically tries to cover the main ideas and main challenges in Access to Medicines issues. Not a bad place to start to get into the swing of things. Also, If you’re a reader from Canada, don’t forget to check out aidsaction.ca. Here, you can look up your candidates and send off an email to support the Call to Action to reform Canada’s Access to Medicines Regime and help save lives!

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30 minutes, 70 fates.

You don’t know it, but as I write this piece, there is some serious procrastination going on. My attention span is weak and sidetracked constantly by a variety of diversions, and if you must know, it’s taken me close to half an hour to write these first two sentences. Still, one could argue that none of us are strangers to procrastination, and 30 minutes is relatively short – only a minor instance of time in the grand scheme of things.

But a lot can happen in thirty minutes. Earlier, I had been looking over some 2009 UNAIDS statistics, and noting the numbers issued in the report. They are all very big, big enough certainly to require the pressing of buttons on calculators. More to the point, I learn that during my thirty minutes, approximately 70 people died from HIV/AIDS in Sub-Sahara Africa. That’s 1.3 million victims each year – in Sub-Sahara Africa alone. Many of these were parents leaving orphans, and many were young children just leaving. Most troubling, however, is the fact that all of them suffered their fate with a loss of dignity.

Why do I say this? I say this because people shouldn’t have to die from HIV/AIDS. There are good medicines out there, and they can control the disease. In fact, for those in the developed world, HIV/AIDS is now considered a chronic disorder, not a death sentence. If you are diagnosed, you are no longer forced to take a shortcut to demise. You can still have a long life, you can still be productive, and you can still live with dignity.

Unfortunately, this wasn’t an option for those who passed away. For them, the medicines were out of reach. They were simply too expensive. And from this, you come to realize a cold hard fact in this narrative: that the fate of a person living or dying from HIV/AIDS is determined by their income. This statement is fairly straightforward, with no mincing of words, or confused rhetoric. But for most, it feels fundamentally wrong, and yet, it is a simple reality of how the world works today. Why it works in this way, however, is complicated.
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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

Great primer on “India+EU+screwing up generic production=people dying” situation

O.K. this article was excellent to get up to speed with something that’s worth the time to get literate about. Granted, the subject doesn’t sound that exciting to the folks who aren’t normally interested in such things – buy hey… That’s what this blog is all about: Getting you familiar with these Access to Medicines topics.

The basic idea is as follows: The EU and India are negotiating how they can be buddies in terms of trade. However, a downstream effect of this, is that generics produced in India (which are a LOT), that also happen to revolve around patents held by European pharmaceuticals (also a LOT), will get phased out in the process. The overall consequence is that production of these drugs, which are currently employed by folks like MSF and in places that desperately need them, will be halted.

Here is the link (below) to check out, but just in case the Lancet has a “limited access policy”, I’m going to reprint the text below the fold for all prosperity since it’s a decent overview of the situation.

LINK: India—EU free-trade pact could stifle generics industry
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