For the half-year to 30 June 2014, the IPKat's regular team is supplemented by contributions from guest bloggers Alberto Bellan, Darren Meale and Nadia Zegze.

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Thursday, 10 October 2013

Balancing IP and human rights: the case of medicines

What is the correct balance between human rights and IP when it comes to medicines? This is the question posed by Suleman Ali (Holly IP) in this guest post. He reflects as follows:

"A recent paper from the Yale Law School and Yale School of Public health discusses how human rights relate to IP and medicines, and in particular describes how human rights laws are increasingly being used to challenge IP rights in order to gain access to medicines in the developing world. The paper sees itself as a resource for activists, as well as policymakers, and sets out strategies for deploying human rights arguments against IP rights in court cases: it provides specific examples of cases in Thailand, India, South Africa and Peru where such arguments have succeeded.

Essentially, patents mean that medicines are more expensive, and in the developing world that means they will be unaffordable and unattainable for many people. The paper supports the idea of creating human rights norms that would allow patent rights to be overridden when providing medicines. One aspect of this is to establish the principle that corporations, such as pharmaceutical companies, have a human rights obligation to provide medicines at affordable prices. However, the Human Rights Council of the UN has not yet accepted that principle, and one wonders whether making human rights stronger is the way to resolve the issue.

A trilateral report by the World Health Organization, the World Intellectual Property Organization and the World Trade Organization (WTO) published last year also discusses the topic of access to medicines. The purpose of the report is to bring together information as a resource for policy-makers and to offer paper's findings as a platform for debate. That means unfortunately that the report does not aim to propose solutions to the problem, and one wonders how many more years it will take before practical solutions are proposed and implemented. A central part of the debate revolves around whether developing countries should resort to compulsory licensing to bring down the price of patented medicines. Several have already done so, including Brazil, Ecuador, India and Thailand. The Doha Declaration of 2001 supports the right of WTO member states to grant compulsory licences on public health grounds. Generic versions of medicines produced under compulsory licencing are often around 60% cheaper. Other approaches include having an international exhaustion policy, so that patent rights cannot prevent importation, as well as imposing drug pricing.

The present debate comes at a time when pharmaceutical companies are under increasing pressures. Many of their patents on blockbuster drugs are expiring (the so called ‘patent cliff’), the cost of developing drugs is increasing ($5bn per drug according to a recent estimate) and regulation of drugs is becoming stricter. In addition, governments in the developed world are negotiating ever harder over drug prices as they try to keep their health budgets under control.

It must also be accepted that the world continues to need new drugs, and that the developing world still has huge problems with infectious diseases. Ultimately large pharmaceutical companies are best at developing new drugs. Few other organisations have the expertise and resources that are needed. It seems therefore that the preferred solution would be for the developing world learning to work with pharmaceutical companies, rather than resorting to undermining IP rights. The developing world must accept that the research that led to present day drugs was not funded by them, and that pharmaceutical companies do deserve to be financially rewarded for developing them. Perhaps the wealthier people in developing countries should continue to pay higher prices for drugs, while they are made cheaper for the poor. At the same time, pharmaceutical companies must accept there may be conditions for being allowed to enter the markets of the developing world, which still remain lucrative. They should therefore be open to resolving the issue, rather than stubbornly insisting on selling drugs at high prices, perhaps accepting some form of preferential treatment in return for lowering drug prices. That certainly seems preferable to the prospect of an increasing number of countries turning to compulsory licencing to provide cheaper medicines".
This blog, which has many readers from the proprietary and generic sectors of the pharmaceutical industry as well as from medicinal regulatory bodies -- and even more readers from the developing world -- is happy to let this space be a forum for serious and constructive discussion.  It cannot be expected that any consensus will be achieved but, if nothing else, it would be good of issues could be clarified, misconceptions destroyed, assertions supported by reliable data and so on.

23 comments:

Pablo Salazar said...

I guess it is way more complicated. Pharmaceuticals often develop their products from natural resources from developing countries. Don´t we deserve better prices or special conditions?
In a country like this, Costa Rica, with a public health system, drug prices put a lot of pressure on the country budget.

Yes, any entrepreneur should be rewarded for its effort, but there´s also a social responsibility expected from every person.

Greetings from Costa Rica.

Ashley Roughton said...

I have read this paper and it presents arguments from one side only and in a rather wolly fashion to boot. It does not deal in any real way with the fact that many of the countries crying out for cheap pharmaceuticals already have the means to produce them or licence others to produce them, provided that under GATT it can be proven that there is a relevant emergency - attempts to prove this have, in the past, been lame to say the least. Neither does it in any serious way acknowledge the fact that pharmaceutical companies are not particularly bothered about this - if people cannot afford their products then they have to be sold at lower prices. The question is whether it is can't pay or won't pay. After it is just a pill innit!

No analysis is presented concerning price discrimination or the problem of cross-border leakage. Likewise no analysis is presented that there is anything more special about promoting ideals of health over, say, education or economic development. Why are developed economies not being asked to throw open the doors of their universities for nationals of countries who cannot afford a decent tertiary education system? The answer is because it does not tug on the heart strings like health does - that is the only reason.

I am afraid that I regard this report to be as tendentious and one-sided as many of the pharmaceutical companies are often, wrongly, accused of being.

I am no apologist for pharmaceutical companies, I am not in their pay, indeed I tend to represent more those who they persecute.

This is the wrong way to go about this problem.

Anonymous said...

"Ultimately large pharmaceutical companies are best at developing new drugs." Are they? Really, truly, honestly? These days, many, if not most, originate from universities or, as Pablo said, from the natural resources of developing countries.

I would have thought that there could only be one answer to the question "which comes first, human rights or IP rights?" I have no problem with Big Pharma making a reasonable profit - having worked there, I know how much it costs (and how long it takes) to bring a new drug to market. However, Big Pharma doesn't help itself by being a bunch of greedy rip-off merchants, with its rapacious pricing and "evergreening" policies.

Ultimately, it comes down to the sad fact that, in this day and age, it's only wrong if you get caught doing it. And legislating to cause people to do what they should decently be doing has never worked. There's a shelf-full of Nobel Prizes waiting for whoever solves THAT one!

Anonymous said...

The patent monopoly period is short, in the scale of the struggle of human existance. Twenty years ago this year, Captain Corelli's Mandolin was published, UKIP was formed, the Ford Mondeo was launched, and Wiles proved Fermat's Last Theorem.

Drugs, especially modern drugs, do not invent themselves. Patentable inventions, once made, have the potential to benefit countless generations of humanity after their discovery, such that the relatively limited monopoly period will pale into insignificance over time.

It seems that the anti-patent lobby could do with a dose of perspective and a course of delayed gratification. The inventors have already had the same therapy in their struggle to bring their product to market.

Why the rush?

Darren Smyth said...

Greetings to Pablo Salazar.

You say "Pharmaceuticals often develop their products from natural resources from developing countries." I often hear this allegation. There are even words for it (which I won't repeat here) and entire international treaties dedicated to preventing or controlling it. But rarely do I see any evidence that it occurs to any significant extent. For example I look at the top 100 pharmaceuticals:

http://en.wikipedia.org/wiki/List_of_largest_selling_pharmaceutical_products

and I see a small number coming from natural sources, and I cannot identify any as being from developing countries.

Anonymous said...

I think it's accepted now that blocking HIV treatment for South Africans by using IP in the late 90's was wrong. Around 10 million or more people died as result. The scandal was documented in the film 'Fire in the Blood' if anyone is interested. I hope it does not happen again.

Anonymous said...

One aspect that I never see in stories like this is the fact that 'better' prices is NOT being looked at fully.

I too would like better prices. I live in the US. It is no secret (although it appears to be from only reading these types of articles) that the US prices subsidize the rest of the world.

I am ALREADY being charged more so that the rest of the world pays less.

Any talk about fixing a price had better include making that price the same throughout the world and stopping the location TAX that I have to pay for the very same product. Please do not assume that because I merely live in the US that have the means to carry the costs for anyone else, or that my Rights that you wish to invoke for yourselves somehow should not apply to me too.

Mark Summerfield said...

Anonymous: 'The patent monopoly period is short, in the scale of the struggle of human existance.'

And if, in that 'short' period, 10 million people die unnecessarily, does the end justify the means?

I am not for one moment suggesting that the solutions are simple, or that someone does not need to cover the cost of development. But it is these kinds of heartless, rationalist, arguments that give pharmaceutical companies and the IP profession a bad name among people with souls.

Ashley Roughton said...

About blocking treatment for HIV in South Africa - I agree that IP blocking was a factor but I am not sure that 10 million deaths can be laid at the door of IP enforcement. There were three other factors which I think are important being (1) that HIV is as much about how (and very importantly when) you use the drugs as about the drugs themselves which was not known about well in the 1990s (in other words even if the drugs had been available the outcomes might have been the same), (2) that cross-border leakage was at an all time high (in other words drugs which were destined for the domestic market simply found themselves on higher priced markets elsewhere for the same product) and (3) that the right or wrong - make up your own mind - but understandable attitude of the South African government was seriously anti-colonial and their policy of using more natural cures or treatments (the so called "salad stall" approach) was given precedence over medicines emanating from countries which had previously enslaved, brutally exploited and emasculated the indigenous peoples of South Africa - they were understandably sceptical. Those who don't believe me would do well to listen to the "Whose Science?" interview of Manto Tshabalala-Msimang (a South African Health minister at the time), so well reported by Ben Goldacre.

I would say that I like the quality of this debate - it is interesting.

Anonymous said...

Mark Summerfield @ 13:09,

Do not play the 'high road' card, for without the reward in the first place, many more people would have died.

Engaging in such hindsight is more deplorable in a discussion of this nature, because in essence you are calling the other side 'criminal' for taking advantage of a system put in place to encourage the very activity that you are challenging - and whose accomplishment would not likely exist at all without such a system.

Let's see how much effort is put into such work if you removed the patent system. Where does your 'high road' actually lead to?

Please, let's not pontificate under such falsity.

Anonymous said...

Anonymous 15:31: Yes. As has been pointed out elsewhere, all that needs to happen to prevent Big Pharma from having their temporary monopoly is to invent the drug first and then to publish the research. I see little evidence of this happening in practice.

As to "bioprospecting", developing an anticancer agent from a rare vine is rather more complex than pulling a berry off a tree and feeding it to an ill patient. Where issues of origination come into question, although the original sample may have originated in a species deriving from one (or more) developing country, it is rare that the substantial investment of time and money needed to transform the sample into a safe and effective medicine shares the same origin.

Anonymous said...

Mark: "people with souls"? We may all have one, or none has one, but it is a curious theological position that ascribes souls to some of us, and not others.

I know of few people in the world who take an absolutist view of altruism in their personal life: the number of people who truly only direct their resources into the bare essentials and direct the rest of their productivity into solving the problems of others are very few indeed. And, oddly enough, the positive impact they have on the world, though direct and easily-visible, is minimal. The discovery of a powerful and useful drug, even if subject to a temporary monopoly, might well be argued of great overall benefit to humanity, even if first motivated by profit.

You see, to the hungry, thirsty malaria-stricken family in a developing country, every last one us who lives in a Western society is already guilty of the most unimaginable waste and selfishness. Therefore, once we accept that we are all objectively selfish to some degree, the only thing remaining is to find out how acceptably selfish we are permitted to be: how much of our personal resources we should spend on trivialities and nonessentials, to the betterment of our families rather than those of others, and to the making of our lives more pleasant.

Hence the "rationalist" debate: once it is accepted that, selfish beings that we are, we will not generally throw all of our resources, personal and social, into solving the problems of others, we try to do the most good we have with the resources that are available from ourselves and others, and try to encourage societal activities that on balance, over time, better the lot of humanity as a whole.

The patents system is one means of such encouragement. And it works. The age of the simple remedy is over. Now, if we want a cure for AIDS, or malaria, or any of the other ravages of the developing or developed world, someone has to invest time, money and effort to develop it, and the best way to get someone to do that is to give them a big reward for doing it one they have done it. To make the reward commensurate to the demand for and value to humanity of the developed therapy, a monopoly works surprisingly well.

(Parenthesis: if we value human life so highly, how else should we reward those that procure the means to save it when none existed?)

Of course, there's an argument that says that if only the pharma industry would accept a cut in profits, then the world would be a nicer place. But that applies to everyone, not just the pharma fat cats, and yet most of us still behave objectively selfishly in our private lives. Very few of those who argue that big pharma should drop their monopoly also, as an interim measure, and until the patent system is abolished, plan to direct a substantial proportion of their personal resources, and those of their families, to paying for treatment courses for those who cannot afford it, whether at home or abroad.

Sadly, rational approaches are at least something we can all take final comfort in, when the notion that some of us have souls that are better than those of others is stripped away from our eyes.

Mark Summerfield said...

Being an atheist, and a patent attorney, my intent was ironic. I am neither opposed to patent monopolies, nor do I believe in an immortal soul.

But the point is a serious one: whatever the appropriate balance may be, I simply do not find it acceptable to say, in effect, that everything will be OK in the long run, because the patent term is 'only' 20 years.

Many people, myself included, would regard that view as callous. It serves only to reinforce the worst perceptions about the pharmaceutical industry, and to undermine respect for the patent system.

The balance between rights-holders interests and the public interest must not only be fair, it must be seen to be fair.

Anonymous said...

Post facto changing the terms of the deal is what is not fair, Mark.

You are missing the point.

By a mile.

If you want a different deal to be struck for any type of lifesaving invention, then you need to establish that up front.

As I posted above, your 'high road' will lead to nowhere.

And it matters not if you are an atheist, your logic here is decrepit. It is the the bait and switch you are attempting that is callous. If your way is pursued and knwon upfront - many many many more people will die because the march-in rights would destroy the very thing you want to have.

Good luck with that.

Ashley Roughton said...

Fair - now there is a word. If it means equality of arms (and even then what potential battle are we talking about?) then what goes into the mix?

I agree with Mark Summerfield that a bit of humanity (and in my case a bit of humility) is no bad thing in any situation. The question is, as ever, how far does it go? If I am making an investment and my investment is subject to a humanity override of some sort (no matter how moral or well intentioned) then is it not fair for me to ask how my investment will be affected and ought I to be in a position to know that before I make the decision to invest? The alternative - like it or not - is to scare money away which means that nobody will do anything. Even the most junior of treasury officials (of whatever country) will tell you that that way depression lies.

If, on the other hand, you were to say to an investor that in certain limited circumstances of genuine human need and in the context of a government certified crisis of some sort the benefits from a particular investment would be limited in the case of returns from sales in a particular country then the investors would be happy - it is not then about expropriation and uncertainty but that the investor knows what he is buying into. But wait a minute! Is that not the system we actually have when it comes to pharmaceutical patents except that governments are very bad at certifying emergencies. Why? The answer is obvious - smooth talking politicians and even smoother talking lobbyists.

Anonymous said...

As a practical point, the question is are all parties at the point of coming to the negotiation table to sort this out? I fear they are not, and we're going to need to have countless court cases all over the world before everyone sees sense.

Asad said...

A superb piece by Suleman. I do wonder, however, if part of the reason that compulsory licensing has spread so rapidly and has such widespread support is that Big Pharma has been comprehensively discredited in the eyes of many. In theory, there should be no better developers of new drugs, but in practice I'm sure not that it necessarily works that way.

Anonymous said...

Hi everybody,
I really appreciate this debate...
I'm not an expert of IPRs (I'm a PhD student of International and European Union law) but I will deal with them because of my PhD thesis (at the very beginning!) about the protection of medicines (from counterfeing also) and the right to health.
Since the question is so debated and discussed between Academics...Lawywers...Politicians...I would like to find something more interesting (and maybe not very explored) to deal with...
Any suggestion?

Anonymous said...

Asad @ 13:37,

I would say that you presume too much.

Compulsory licensing has not spread so rapidly (and especially in the US is viewed in a strongly negative manner).

Whether or not Big Pharma has been "comprehensively discredited" goes to a PC battle, rather than a legal one. Those of us in the legal world SHOULD recognize that the battle of perception is not based in logic and facts, but rather the battle is based on emotions and shifting targets (witness Mark Summerfield's posts).

Grant said...

But Anonymous of Saturday, 12 October 2013 16:43:00 BST hasn't pharma's reputation been tarnished (the fines and settlements in the US over mislabelling etc) and isn't public opinion relevant to government policy-making?

Anonymous of Saturday, 12 October 2013 14:36:00 BST, India seems to be the most active place for this issue. The recent compulsory licences and patent revocations based on their evergreening prohibition, their drug pricing policy, the US response and negotiations with the EU to get their generics into Europe. Their recent proposals to restrict foreign investment etc are also there in the background, combined with intelligent internal debate about all these issues.

Anonymous said...

Grant,

The problem with making public opinion relevant is that you invite the full engagement of propaganda machines which more often than not obfuscate rather than clarify.

"Trying your case in the press" is notoriously bad for reaching objective truth - everyone suffers.

HumanRightsHumanWrongs said...

It is very easy to put "Big Pharma" in the gum sights. There are many millions of people facing starvation and lack of water yet how many of the Anti-pharma crowd would willingly turn away from their Waitrose shopping and M&S finest to submit to rationing to feed the starving instead? Surely food is a human right too and yet I see very few people going without so that others might live. It's very easy to shout about human rights when it comes to pharmaceuticals, it's even easier to turn away from a starving homeless person as you rush into the supermarket to fill your own cupboard. Human rights don't stop at the medicine cabinet.

Anonymous said...

PhD student

Thank you so much for your suggestion, Grant!
It is interesting for me to have different suggestions from other people in the world.

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