One answer to some of these problems, from a pharmaceutical standpoint, is that a number of conditions can be treated by what the World Health Organization refers to as essential medicines. Many of these are off patent. Some may have questions of affordability, but nothing to do with patents, just production and distribution costs. But then you get into questions of which conditions require treatment by newer, more advanced medicines where patents would be an issue and what might need to be done with intellectual property and access barriers.
Which drugs are needed to treat which conditions? Which areas do we need newer patented drugs to provide effective treatment and to what extent are patents a problem? The second level problem is if you’re going to allow countries to overcome patent obstacles, for example using a compulsory license under the TRIPS flexibility, the question has been whether a limit on what levels of income in countries is appropriate…
There’s been a long process associated with this going back from through 2001 to 2003. And there’s no limitation on what diseases might be addressed through use of a CL. And second, there was no limitation on what level of income governments would be at in order to use these flexibilities. In that regard I have to add a qualification because in the 2003 decision on compulsory licensing for export, there were a couple of limitations...
Pharmalot: You’re referring to the TRIPS agreement and the subsequent Doha declaration and how that was applied to AIDS drugs. [EDITOR’S NOTE: The Trade Related Aspects of Intellectual Property Rights is an international agreement reached in 1994 and administered by the World Trade Organization. In 2001, a new round of talks were begun to clarify TRIPS and affirmed that the goal should be to “promote access to medicines for all."] What happened this year? Abbott: Well, fast forward to 2010 and 2011, and there’s a renewed discussion and this time it’s about NCDs. The context was the HIV epidemic in South Africa years back and how that would be addressed. Now, it’s a different kind of widespread disease… The purpose this time was to make a high-level political commitment to direct global public health and financial resources toward addressing NCDs. That type of high-level political commitment needs to be translated into practical action. Typically, there is a pretty significant distance between statements by heads of governments that we should seriously tackle this and set milestones and the parameters that are set and actually having them carried out…And so a statement was issued that was similar to an earlier UN declaration with respect to the AIDS pandemic… Pharmalot: There was some dickering about different terms – whether NCDs constitute an epidemic or public health emergency. To what extent did this matter? Abbott: The reason the term emergency came up as a topic of discussion was the issue of compulsory licensing. The TRIPS agreement article 31 is the legal rule at the international level that governs compulsory licensing…and there is no limitation. Governments can issue these on the grounds of its own choosing and there’s no limitation or restriction that says you can only do this in the case of a public health emergency…I don’t see the word emergency…. They didn’t want to say it was an epidemic, which implicated something more immediate needed to be done…Instead, the problem is of epidemic proportions… I think the term epidemic would cover any such need (read the statement here).
From a political standpoint, an urgency standpoint, public health emergency sounds more like an immediate crisis than an epidemic, which I suppose takes a bit longer to spread… But I think you’re splitting hairs in one’s own way. An epidemic is a pretty serious matter. I don’t myself see that as a significant thing.
Pharmalot: This pitted the pharmaceutical industry against non-governmental organizations, though. Abbott: Industry has said compulsory licensing is only for emergencies and we agreed that AIDS, for example, is an emergency, but that statement is incorrect as a matter of law and the industry knows that. But the industry is trying to promote the belief, including among government officials in developing countries, that there is some international rule that says you can only issue a compulsory license under an emergency. The belief appears to be that if you say it enough, particularly in the media, it will become true…
The industry approaches a meeting such as this wanting to avoid a reinforcement of the principle acknowledgement among countries that developing countries are free to issue a compulsory license of their own choosing - and avoiding reference to the DOHA declaration that specifically says that. That initial right doesn’t flow from DOHA. It was an agreed interpretation of TRIPS. That rule is already in the basic TRIPs agreement governing international property and trade.
Some NGOs wanted this new NCD declaration to specifically refer to the Doha declaration as a way of reinforcing some of the things in there, including that the objective is to protect public health and promote access to medicines for all, and that countries can use compulsory licensing of their own choosing. The NGOs were arguing the US was pressuring other government to keep mention of DOHA out of the NCD declaration. That’s what the debate was about…
Pharmalot: What do you think? Abbott: I think it’s very important that the TRIPS agreement is interpreted properly as it’s reflected in the Doha declaration – compulsory licensing may be issued on the grounds of a government’s choosing and promote access to medicines for all…
Pharmalot: The pharmaceutical industry, though, has seemed opposed. Abbott: To think HIV and AIDS is the beginning and end of Africa’s public health problem is to not see the whole picture… In general, we cannot limit these solutions to HIV and AIDS, as important as it is. You have to look at public health in a more holistic way. I believe compulsory licensing is an important tool in the arsenal of governments that are addressing public health problems. I don’t believe the fact that compulsory licensing is available means that governments will automatically begin a wholesale process (of issuing licenses).
Those rules have been on the books since the inception of the Paris Convention and were codified in the 1930s. It’s always been available and it’s tended to have been used relatively scarcely. But it always serves as a background. It’s a control mechanism in negotiations and over a pricing issue if a company will not ameliorate their practices. Then compulsory licensing serves as a check. Some may be useful and necessary, but I don’t view it as something that will suddenly overtake the industry because there are political, economic and trade constraints. So I think it will be used reasonably in any foreseeable circumstance.
Pharmalot: And so what was the upshot this week? Abbott: The final document contains language that makes clear countries can make use of the TRIPS agreement. Paragraph 45 talks about promoting access..that’s an affirmative statement about using TRIPS flexibility to the fullest… Paragraph 52 says international organizations should provide technical assistance and capacity to developing countries in areas of NCD prevention and control, and promoting access to medicines…
These were contained in the Doha declaration. So from my own standpoint, while I might have preferred to see a reference to Doha as a matter of continuity, I think this declaration makes clear governments can and should make use of all flexibility in the TRIPS agreement. It’s not in any way limiting. To my mind, I would not focus on what didn’t happen. I would say this confirms the position that developing countries and public health-access oriented groups have sought.
I prefer not to characterize this as a victory or loss for anybody. The NGO side can be pleased with reaffirmation and the industry side presumably is saying to itself that they prefer not to have the Doha declaration in there. But to my mind, the language is supportive.