[Ip-health] Essential Meds, Patents & NCDs: Abbott Explains

Krista Cox krista.cox at keionline.org
Mon Sep 26 05:35:12 PDT 2011


Essential Meds, Patents & NCDs: Abbott Explains

By Ed Silverman // September 23rd, 2011 // 9:38 am

Earlier this week, the United Nations held a special two-day meeting to find
a way to combat non-communicable diseases, specifically, cancer, diabetes,
lung disease and cardiovascular disease. The gathering, which was the first
such effort to address any widespread illness since a similar meeting was
held a decade ago about AIDS, had a contentious run-up. The debate centered
on language that would be adopted to allow countries, particularly the
poorest nations, to use compulsory licenses to override patents and secure
supplies of needed medicines. The issue revolved around intellectual
property rights and access to drugs among the poor (here is the
declaration). We spoke with Frederick Abbott, the Edward Ball Eminent
Scholar and a professor of international law at the Florida State University
College of Law, who has written extensively on the topic, about the outcome
and the implications…

Pharmalot: The run-up to the meeting caused quite a stir. Why was that?

Abbott: If you read through the documents, including statements by the
ministers and UN secretary general, it’s apparent this particular discussion
was broadly based in terms of addressing NCDs, but also addressed health
problems arising from tobacco, alcohol and inadequate exercise…But there was
a question of how governments provide affordable access to treatments,
especially in large countries with poor populations and limited means. This
question of access to more advanced medicines is certainly a major issue in
developed countries, as well, such as the US. It’s actually not a problem
limited to developing countries.

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

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

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.

Krista Cox
Staff Attorney
Knowledge Ecology International
(202) 332-2670

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