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Should everyone have access to lifesaving medicines? [Video]

The views expressed are those of the author and are not necessarily those of Scientific American.

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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 30 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 30 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. It’s remarkable actually as the above video can attest. 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 lifestyle 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 $1,500 instead of the previous $10 price tag.

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 lifesaving 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 lifesaving 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 lifesaving 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.

- – -

To get involved there are a number of places I can recommend. Firstly, an informal blog collective has been set up to discuss these issues in a more layman and easy to read manner. This blog is called My Rights versus Yours and includes a cast of students and academics who are involved in various aspects of the Access to Medicine cause. We aim to have posts that deal with the various issues at stake including pieces about both the science and policy involved. This is a new blog, but we are hopeful that many will find it both useful and enjoyable to read. 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 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.

About the Author: David Ng is a science literacy academic and faculty member of the Michael Smith Laboratories at the University of British Columbia. He also encourages you to check out the Phylo project. Follow him on Twitter @dnghub

The views expressed are those of the author and are not necessarily those of Scientific American.

Comments 11 Comments

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  1. 1. glwade 5:49 pm 04/21/2011

    Dear Mr. Ng,

    I think you should get a real job, one involving creation of something tangible, serving a real world purpose. People who’re involved in such production usually develop a different attitude toward government sponsored larceny. BTW, subsaharan Africans have been told the causes of HIV. The numbers you quote indicate willful disregard of that knowledge.

    Link to this
  2. 2. daveng 6:28 pm 04/21/2011

    Dear glwade

    It’s interesting that you accept the model of government sponsored protection, but do not see the value of governments coming in to provide a second look when ethical issues are at stake. That you’ll take the "win," at the expense of others no matter what the consequences is troubling.

    Also, curious to know what your "real" job is – because I’d rather like to keep an eye out for folks like you, who can disregard millions of lives so coldly as well as, frankly, unethically.

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  3. 3. glwade 7:27 pm 04/21/2011

    My secondary suggestion is for you to move to Africa and pitch in. Several of my close relatives spent years doing that. Boy are they disillusioned. Amazingly, with their years of experience, they don’t have your righteous, give everything away, attitude either. I’m all for "ethicals" like yourself moving to other countries to "help". After you’re done fixing Africa, go to South America and see if you can stop the locals from chopping down the rain forest and spreading Hg all over the place.
    Another thought, why should generic drug companies make any money. If you shaft them too, those drugs for Africa would be almost free!

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  4. 4. scientific earthling 7:37 pm 04/21/2011

    In a biosphere saturated with Homo sapiens, causing the extinction of other species, it is wrong to lower the natural death rate. Not only should we not do anything in the poor countries, we must shut down all hospitals and medical research in the advanced nations as well. This is the price we all must pay for the irrational breeding of sects of our species.

    Religion & charity has been the biggest contributor to global population increases. Perhaps this is unthinking natural selection’s way of eliminating species that behave irrationally, while developing intelligence.

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  5. 5. 9:03 pm 04/21/2011

    Hi, David

    Thank you so much for your comprehensive and understandable explanation of the issue around the value of enabling generic pharmaceutical companies to produce affordable drugs to address the AIDS pandemic especially in sub Saharan countries. In the western world, as you rightly comment, HIV/AIDS is now considered a chronic disease and it could be the same way for people around the world if the medicines they had access to the medicines they need to live long and healthy lives

    There is now a three in one pediatric drug which would save the lives of children born HIV positive, 50% of whom die by the age of two and the rest of whom die before they are five. There is a "vertical transmission" drug which can be given to HIV positive pregnant women which will protect the fetus. The lives these two drugs could save are probably uncountable.

    And it was the WTO itself, in the DOHA Declaration, that made provision for the compulsory license. They did this when the patent period was increased from 10 to 20 years in recognition of the health crises that existed in the developing world that would be very adversely affected by the increase in the patent period.

    There is no threat to the markets or profits for the brand name pharmaceutical companies in this provision. They don’t market their drugs in sub Saharan Africa and they will receive royalties from generic companies who do produce and market those drugs. Nonetheless, they, sadly, seem not to be interested in helping save the lives of countless thousands of people in developing countries.

    I was jubilant when Bill C393,which would have amended Canada’s Access to Medicines Regime to include the "one license" solution, passed with a healthy majority in the House and devastated when the Conservative majority in the Senate stalled the Bill until it died on the order paper.

    Tens of thousands of Canadians supported Bill C393 and they will be there again when the Bill is reintroduced when Parliament reconvenes.

    Canada has long had an international reputation as a compassionate nation. The Conservative government’s failure to recognize and support the one license solution can only erode our international reputation and it is, I believe, totally contradictory, to the priority Mr. Harper gave to maternal and child health and the G20.

    The Bill will return to the Parliament and concerned Canadians will once again put their best efforts into trying to save lives and restoring Canada’s international reputation.

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  6. 6. jgrosay 6:08 am 04/23/2011

    Of course, we have a moral command to help suffering others, be it by easing access to medicines or thru other ways.
    But, do medicines save lives ?. We all finish in death, medicines just delay date and relieve some suffering. Divinum est sedare dolorem, but that’s all.

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  7. 7. okwhen 8:15 am 04/24/2011

    Glwase, I have no doubt you are a Christian and do your utmost to live by the words of God. The Pope is probably one step above your religious standards and he condemns people who wear condoms no matter what the reason. As a man of science, I have no use for the supernatural beliefs however, I respect the rights of others as long as they do not infringe on my rights. Africans are basically split between Christianity or Islamic beliefs. Missionaries invaded Africa converting as many as possible to Christianity. Now they are following the Popes directive and you condemn them for this. No matter is you are a Christian or an atheist like me, instructing people to disregard their religious and spiritual beliefs is wrong. Or are you suggesting the people completely stop procreating.

    I personally believe the planet is carrying to large of a burden and a reduction in people is in order. I also believe before Mother Nature takes the necessary actions any farther than she has already to reduce the population, as intelligent beings one might think we could acknowledge the problem and prevent the disastrous conditions we are creating.

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  8. 8. okwhen 10:20 am 04/24/2011

    Jgrosay, I can hardly ingest the vast amount of trite comments. I do not believe I intended any disrespect and from your intimately chosen verbiage it appears we are reading a deeply religious memorandum.

    As a mere atheist, shit happens and then you die would have sufficed. Meaning, I have little to no doubt the majority of people are willing to relieve someones pain if possible and are acutely aware none of us are getting out of here alive. Now, after reading the reenactment of my perception, can you agree using all the trite verbiage is tedious.

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  9. 9. bucketofsquid 9:20 am 04/27/2011

    You are one sick hypocrite. If you think that more people should die then start with yourself. We certainly don’t need you.

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  10. 10. bucketofsquid 9:25 am 04/27/2011

    Americans have been told of the dangers of alcohol, tobbacco, hydrogenated food, mind altering substances and a wide variety of things. I don’t see you commenting that rich Americans should be denied health care because they behave particularly stupidly. Why don’t YOU get a real job? I’m sure there are toilets that need scrubbed.

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  11. 11. Daniel35 4:15 pm 04/27/2011

    YES, people’s fates should be dependent on their income, if the day ever comes when their income is proportionate to their real and potential social contributions, minus their social burdens. (Real and potential contributions will be proportionate when we have a just education system.) Meanwhile, medical care should be proportional to maybe the square root of income. Also, we should have birth taxes proportional to the square of income, and the square of the number of previous children. How better to reduce the population to sustainable, and most socially productive, levels?

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