[Ip-health] KEI comment on WIPO report on patents landscape for the WHO essential medicines list

Thiru Balasubramaniam thiru at keionline.org
Tue Apr 12 23:26:34 PDT 2016


KEI comment on WIPO report on patents landscape for the WHO essential
medicines list

This is a comment on the WIPO- commissioned report on the patent landscape
for the WHO essential medicines list, published on April 11th, 2016. The
report is titled: Patent-based Analysis of the World Health Organization’s
2013 Model List of Essential Medicines, by Reed F. Beall and Amir Attaran,
both at the University of Ottawa, Canada. This is is the third
collaboration between WIPO's Thomas (Tom) Bombelles (Head, Global Health,
WIPO) and Attaran on the same topic -- the patenting of medicines in
developing countries.

In December 2000, WIPO published a report by the industry and USPTO funded
International Intellectual Property Institute (IIPI), titled "Patent
Protection and Access to HIV/AIDS Pharmaceuticals in Sub-Saharan Africa."
The report was prepared by Bruce Lehman, the former head of the USPTO and
then CEO of IIPI, as well as Lee Gillespie-White, Venus Griffith, Albena
Petrova, and Stetson Sanders of the IIPI staff, and Paul Salmon (then
working for WIPO). This paper was subsequently re-written by Amir Attaran
and Lee White, and re-published in JAMA on October 17th, 2001, a few weeks
before the WTO met in Doha (November 2001) to consider the issue of TRIPS
and access to medicines. The title of the JAMA version was "Do patents for
antiretroviral drugs constrain access to AIDS treatment in Africa?" [JAMA.
2001 Oct 17;286(15):1886-92.] Merck gave IIPI $25,000 grant for its work on
the report. At the time, Tom Bombelles was the Director of International
Government Relations at Merck. Attaran was then working as a researcher for
Jeff Sachs at Harvard. PhRMA, its member company lobbyists and USTR
referred to the paper as the “Harvard report,” and used it to lobby against
the Doha Declaration on TRIPS and Public Health, citing Attaran’s
conclusions that patents were largely irrelevant to access to drugs for HIV
in Africa.

After Attaran wrote the JAMA article, but before it was published, Tom
Bombelles presented an August 2001 PhRMA survey on patents in Africa on
September 30, 2001, at the American Society of Law, Medicine & Ethics
(ASLME) conference on Law and Human Rights, which covered essentially the
same points as the JAMA article, and he also presented data on the paucity
of patents on the WHO essential drugs list, another favorite talking point
for drug companies seeking to deflect criticism of drug patents.

Criticisms of the various Attaran, IIPI, Bombelles/PhRMA papers have
covered several topics.

The October 16, 2001 "Comment on the Attaran/Gillespie-White and PhRMA
surveys of patents on Antiretroviral drugs in Africa," by Consumer Project
on Technology, Essential Action, Oxfam, Treatment Access Campaign, and
HealthGap [
explained that the most useful drugs (from a medical and manufacturing cost
basis) were fairly widely patented in Africa, nearly everything was
patented in South Africa, and patents covered the most important products
in the countries with most purchasing power in Africa (at a time when the
Global Fund did not exist). Because economies of scale were important,
extensive patents in South Africa and patents on key drugs like AZT, 3TC
and Nevirapine in countries with higher than average (for Africa) incomes
were harmful not only for the countries where the patents existed, but
because the smaller markets were associated with less efficient
manufacturing costs.

The lack of patented drugs on the WHO model list of essential drugs had
been for years a standard talking point for pharmaceutical industry
lobbyists, designed to persuade people who knew and cared little about
access to medicine in developing countries that patents were unimportant.

In 2004, Attaran published "How Do Patents And Economic Policies Affect
Access To Essential Medicines In Developing Countries?" in Health Affairs.
[Health Aff May 2004 vol. 23 no. 3 155-166]. The Health Affairs article was
basically an update of the paper that Bombelles had presented earlier as a
PhRMA report, and it was used again, repeatedly, to argue that concerns
about drug patents in developing countries were misguided.

On the issue of patents and the WHO model list, the issues were much more
basic than the more nuanced debate over the HIV/AIDS drug patent patent
landscape. For years, the WHO just excluded patented drugs from its EML,
not because patented drugs were medically unimportant -- but because the
prices were too high, and they were not “cost effective.”

The lack of patents on the WHO model list was not evidence that poor people
would not benefit from patented medicines, it was evidence that patents
lead to high prices, and high priced drugs were systematically excluded
from the list. In other words, the WHO EML was evidence that patents block
access, not that patents were unimportant.

The issue of patented drugs on the EML has been very slowly reformed, first
for drugs for HIV/AIDS, and only recently for drugs for cancer, hepatitis
C, tuberculosis and other illnesses.

In the current WIPO report on patents on drugs on the 2013 WHO Model List
of Essential Medicines, what is lacking is an analysis of the harm that
patent-related access barriers have caused.

It is a shame that for years, new cancer drugs had been systematically
excluded from the EML for several decades. [See: 2011:1. KEI Research Note:
Paul Miano. Cancer: Approval, ownership, market structure, and placement on
WHO Model Essential Medicines List, for 100 new molecular entities (NMEs)
on the NCI alpha list of cancer drugs and vaccines.]

The WIPO report focuses on the 18th edition of the WHO EML, which was
issued in 2013. The newer version of the EML is the 19th edition, which was
published in May 2015, and it focused on adding several new cancer drugs,
including two under patent, trastuzumab and imatini, as well as new
patented drugs for HCV (daclatasvir, sofosbuvir) and TB (bedaquiline,
delaminid) (See:http://keionline.org/node/2222). The WHO is now considering
a much more ambitious effort to expand the number of patented medicines on
the EML, but they still have to deal with the challenges associated with
the very high prices for these medicines.

Tom Bombelles is now an international public servant, and spends his time
working on issues of poverty. In commissioning his long time collaborator
[on this issue] to publish a paper on patents and essential medicines,
Bombelles picked someone who knows the topic, but who has also
systematically sought to downplay patent-related access barriers, and
produce what have often been used as public relations talking points to
harm reforms that will benefit poor people. The current report is not as
misleading or harmful as earlier papers by Attaran on the same topic, but
it also is astonishingly tone deaf to the implications of few patented
drugs on the WHO EML, and makes the inaccurate and puzzling comments that
health groups are not concerned about the transparency of patent
landscapes, particularly given the intensive efforts to address these
issues over the past 15 years, all of which the authors ignore.

We hope that WIPO and Tom Bombelles will continue to focus on this issue,
but in ways that show more sophistication about the relationship between
patents, prices and access, and consider the important reforms to
progressively delink R&D costs from drug prices so that in the future the
WHO can publish lists of essential medicines that do not systematically
exclude drugs that work but are too expensive to be purchased by health
systems with limited resources.

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