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.

It’s about control

Imagine yourself an inventor. And you have invented something that many people want. Not only that, but you spent a significant amount of time and money on the way there. Naturally, you want to make sure you protect your innovation. You want to make sure that you are not only compensated for your work, but that you are rewarded accordingly – handsomely even. This is where government can step in: they can protect you, and they can do this by setting rules on intellectual property. They grant patents, which allow you to control your invention, and control how others can or cannot use it. The government sees obvious value in this, because the fact of the matter is that innovation needs help sometimes.

This, basically, is how the pharmaceutical industry works. They are inventors, and their product is medicine. Research and development costs are significant, both in terms of money and in terms of time, mostly because many of the things they invent do not work out in the end. They get patents, and are compensated and rewarded accordingly – relatively speaking, the pharmaceutical industry is rewarded very handsomely.

This is because there is a market for such things: whether we are talking about antiretroviral drugs for HIV or Viagra for life style needs, in the developed world, people want these drugs (and in some cases, need these drugs), and are willing to pay for them. They do this, because they can, often with help from health care providers and government. The supply and demand is there, and the pharmaceutical industry knows how to play this game. You, the reader in the developed world, make the market.
Because things are so handsome, the pharmaceutical industry has a vested interest in maintaining the status quo. They don’t want to lose any semblance of control, even if, apparently, lives are on the line. They are very good at protecting this control – their lobbying influence is very strong indeed, and they do this with zeal although sometimes by misrepresenting facts.

Generics create new markets.

Herein lies the challenge: that for drugs against HIV/AIDS, there is this other market. Furthermore, this is a market that needs the medicine desperately: the aforementioned 70 individuals are included here, although it is too late for them. However, it is also a market that is generally not part of the game. We can say this, because of two points:

1. This market doesn’t count because they cannot afford the drugs.

2. This market doesn’t count because they are not part of the pharmaceutical industry’s bottom line.

Consequently, a lot of very clever people have suggested that a way to get around this challenge, this challenge of access to medicine, is to set up ways to produce generic drugs. This is essentially where outside companies can be granted the right to copy the drug and produce it at much lower costs. Just to clarify, the cost of drug production is generally a very small fraction of the final price tag. Anyway, the argument here, is that these rights would be very specific, in that generics could only be sold under strict circumstances such that the status quo is unaffected in wealthy markets. A good example of this, is to simply say that generics can only go to developing markets, can only go to places like Sub-Sahara Africa, since they already do not factor into the industry’s bottom line. Furthermore, the inventors can stipulate royalties, so that they still get compensated for opening up these markets. In fact, in the best situation, the inventors would even produce their own generics.

For a variety of reasons, the pharmaceutical industry has not been keen on this idea, and has done much to make generic production as laborious and slow as possible. Ideally, they would be a willing participant in discussions with generic producers, and bargain fair terms so that these cheaper drugs can be made. Unfortunately, this rarely happens and when it does, it tends to be on an older palette of medicines, things out of date for rich people like us, which may be less effective for a variety of reasons (side effects, efficacy, convenience).

Because the pharmaceutical industry generally does not want to play, the notion of “compulsory licenses” has been pushed to the forefront. I’ve written about these in the past, and they deserve a repeat mention.

The gist of a compulsory license*.

Compulsory licenses assume that, sometimes, the inventor isn’t the best person to make decisions about control. Sometimes, the inventor doesn’t have the best information to take stock of a situation, or sometimes there might be a moral argument where monetary performance should not take precedent. In other words, sometimes, there are special circumstances where you could say it is reasonable that this control is tweaked.

To illustrate this, here are some hypothetical (and not so hypothetical examples):

1. You are a company that recently received your patent, so that now your drug is being sold for $1500 instead of the previous $10 pricetag.

2. Your country has experienced a series of anthrax scares. The company that holds the patent for the most effective drug against infection from the offending bacterium, sees an opportunity, and decides to jack up the price.

3. Someone has declared war on your country. To defend yourself, you would like to utilize a particular product. Unfortunately, it is under a cost prohibitive patent and therefore out of reach.

4. There is an impending nuclear power plant meltdown, and there is technology that would be incredibly useful to mitigate radiation contamination and poisoning. However, your resources are already stretched because of the utterly horrific effects of a 9.0 Richter Scale earthquake, and this technology is too expensive at the scale that is required in such an emergency.

5. There are markets where your life saving drug is not being sold because no-one can afford them anyway. However, the drug (which could be a matter of life and death for millions) could be made at a cost (i.e. a generic) that makes it accessible in these markets, but if and only if, the patent over them is adjusted.

Here is the point. In all of the above cases, you would like to live in a civil society where the government can step in and forcibly change the patent, because in every case, there is an element of morality involved. And guess what – governments can do this and they do! It’s called a “compulsory license,” and they exist for this very purpose.

In fact, even the WTO is on board with this idea. They recognize that in some circumstances, such as those pertaining to global health, there needs to be an understanding that using such compulsory licenses is both necessary and an obligation. In fact, if you have a hankering for the legalese that outlines this for patents over essential medicines, you need only look up info on the Doha Declaration.

Fighting it: Access to Medicine Regimes.

So at the end of the day, advocates like myself feel that compulsory licenses are a way to save lives. And so we push for laws that enable their existence in the global health front. These are often called “Access to Medicine Regimes” and a few countries already have them in place. In many respects, they are an example of innovation themselves, since there are two challenging criteria they are designed to meet: (1) that cheaper life saving drugs are made available to poorer countries; and (2) that the pharmaceutical industry can still keep their status quo in richer countries. Many, like the law in Canada, don’t seem to be working, and so there is a movement to try and fix it. Like, any good exercise, this has been done under expert review, and the new Canadian law (called Bill C-393) looks pretty good. It meets the two criteria.

Unfortunately, there is some serious push back from the Canadian pharmaceutical industry. They lobby government and do so with counter arguments that have already been addressed by this expert peer review, such that many have been calling the pharmaceutical industry unethical: that their reasons for fighting are based on misinformation. Most of their arguments appeal to those that value ownership, that their properties, inventions, and monopolies are in danger because of careless policy, but that could not be farther from the truth. They simply don’t want to lose any semblance of control. Despite these tweaks being carefully scripted to protect their business interests, the pharmaceutical industry still regards them as a starting point to a “possible” loss of control. Because of this excessive anxiety, they fight and they fight and they fight. For those interested in endings, this one is severe: Bill C-393 was killed.

Sometimes, they fight in other ways. In the case of Free Trade Agreements between the European Union and India, one of the battles over generic drugs concerns the issue of “data exclusivity.” This is a technical term that essentially says that even if a patent is not holding things back, a company still can halt the process. Here, a bulletin recently released by Doctors Without Borders describes it well:

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.

And so things drag, time passes, and minutes, days, and years are wasted. To call this delay an act procrastination sounds too contrite. I can certainly think of stronger words.

To conclude…
In the end, it boils down to the following nugget: Do you think access to life saving medicine is a human right? Or at least, if you think that previous statement is too overreaching, do you think it is something that is worth more than the pharmaceutical industry’s perceived fear of loss. I sincerely hope so: At the very least, maybe more dialogues will be sparked, and a good place to start is down below in the comments.

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You can follow the blog on twitter or better yet, partake in its first Global Health Carnival. If you’re a Canadian reader, I strongly urge you to check out aidsaction.ca particularly the page which asks our candidates to endorse and support the reform of Canada’s Access to Medicines Regime. Timing is crucial here, as a Federal election looms. If nothing else, just make sure you vote.


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