Access 101: Introduction to Compulsory Licensing

If you’re new to the issue of access to medicines, you’ll see us talk often of intellectual property and how these laws and rules affect people’s ability to obtain life-saving medicines. Today I’ll discuss compulsory licensing but before I do, I need to talk a bit about intellectual property.

What is intellectual property? Well, intellectual property is a branch of law that deals with the rights and ownership of ideas–properties of the mind, so to speak. It’s grounded in the belief that individuals should be able to protect their ideas and profit off of them and in turn, the financial returns will also drive economic development. We usually see intellectual property in the form of:

• Copyright (the expression of ideas say in a textbook or journal article)
• Trademarks (think of Microsoft’s floating window logo and McDonald’s golden arches) or
• Patents (which applies to inventions like cameras or chemical compounds)

So this is all very well and good we might say–if I come up with some original work, I ought to be able to take ownership and make money to recoup the time and resources I spent coming up with that valuable idea. For the most part I would agree with that. But what about when this idea means the difference between life or death, sickness and health? What happens when people don’t have the means to afford the prices someone else sets? That’s where compulsory licenses (CL) come into light. CL’s are a legal means to force a patent-holder to grant use of a patent to the government or another party. Historically, CL’s are used in extraordinary situations to protect health and human safety, situations like:

• World War II, where the allies needed to manufacture a large number of specific engines in airplanes for minimum cost.
• 2001, where the Anthrax bacteria scare in the U.S. led their government to issue a compulsory license to maximize production of the antibiotic ciprofloxacin.
• The HIV/AIDS pandemic, where the cost to treat one patient for one year in the early 1990’s was well over $10,000.

So we see that there are very good reasons to use compulsory licensing when human safety is threatened and there is a clear precedent of its use and value. When faced with the rising problem of access to medicines in the developing world, the World Trade Organization incorporated means to address these imbalances by implementing mechanisms to use CL in the international trade agreement, TRIPS. Critics of the WTO have argued however that these measures are insufficient and do not allow CL to be effectively used by populations in need (read more in the links below).

Initially TRIPS only allowed a country to obtain a compulsory license for domestic markets, that meant if you’re a country like Rwanda that has no pharmaceutical industry, you will need someone industrialized (like Canada) to export medicine to you. TRIPS was updated to reflect this gap in something called the ‘August 30th Decision’–it allowed member countries to develop a legal mechanism for manufacturers to obtain a CL so they could export a life-saving medicine to developing countries. Canada was the first to do so by creating Canada’s Access to Medicines Regime; however, this is far from a functional solution which Dave Ng writes more about here.

Compulsory licensing is but one solution for a variety of problems that constitute the challenging in providing medicines for the 1-in-3 people around the world who still lack access. We have much to talk about the limitations of compulsory licensing, other mechanisms for improving access in terms of IP management and other logistical problems that prevent medicines reaching points of care from points of manufacturing.

For more readings on compulsory licensing in general and in practice, visit:

• “Compulsory licensing of pharmaceuticals and TRIPS” WTO.
• “Overcoming Patent Barriers” Doctors Without Borders.
• “Delivering on the Pledge: Global Access to Medicines, WTO Rules, and Reforming Canada’s Law on Compulsory Licensing for Export” — article in McGill International Journal of Sustainable Development Law & Policy, Volume 3, Issue 1

Comments are always welcome below.

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.

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