[Ip-health] KEI Intervention at UN HLM on AIDS: De-Linking R&D costs from drug prices and the sustainability of treatments for persons living with HIV

Jamie Love james.love at keionline.org
Thu Jun 9 08:25:27 PDT 2011


These are the notes from my intervention today at the UN's High Level
Meeting on HIV/AIDS in New York. The persons making statements from
the floor were asked to keep their comments to two minutes, so the
actual intervention was somewhat shorter. Jamie

2011 High-Level Meeting on
the comprehensive review of the progress achieved in realizing
the Declaration of Commitment on HIV/AIDS and
the Political Declaration on HIV/AIDS

Panel 3: Innovation and new technologies

Intervention by James Love of Knowledge Ecology International

June 9, 2011

De-Linking R&D costs from drug prices and the sustainability of
treatments for persons living with HIV

With regard to new medicines for HIV, policymakers need a strategy for
making both innovation and universal access feasible. Such a strategy
will necessarily involve de-linking R&D costs from drug prices.
Newer HIV drugs are needed to deal with the adverse effects of older
drugs and drug resistance, or to achieve better compliance.[1] The
system of granting legal monopolies to make and sell HIV medicines in
order to stimulate investments in R&D is flawed, and predictably leads
to barriers to access.[2]

High prices for medicines are the enemy of universal access. High drug
prices not only limit the drugs you can buy with a limited budget, but
they call into question the entire rationale for funding HIV treatment
in developing countries.
High drug prices will weaken donor enthusiasm, and undermine efforts
to transfer funding of treatment programs from Northern donors to
developing country governments.

Under the de-linkage approach, new HIV drugs would be available from
competitive generic suppliers at low prices, allowing more patients to
participate in treatment programs, and to receive the best drugs.

Rewards for successful investments in R&D would be a separate element
of treatment budgets, not linked to the prices of medicines.[3]
De-linkage of R&D costs and product prices is endorsed in the WHO
Global Strategy for Public Health, Innovation and Intellectual
Property, [4] and is at the center of the Donor Prize Fund proposal
being reviewed by WHO experts on R&D,[5] and a US legislative proposal
for a Prize Fund for HIV/AIDS.[6]

In the past two years, Gilead, Johnson and Johnson and Novartis have
indicated it may be appropriate to use innovation prize funds as an
incentive to openly license drug patents in developing countries,
effectively de-linking R&D cost and drug prices for diseases like HIV
or TB.
These are four questions that the WHO, UNAIDS, donors, member states,
and persons living with HIV need to answer, with data and economic
Is it possible to de-link R&D incentives from drug prices?

    1.  How much would this cost?

    2.  What would be the benefits to persons living with HIV?

    3.  Is it possible to obtain and sustain universal access to
treatment in the absence of a de-linkage strategy?

    4.  De-linkage is a new idea when new thinking is needed.[7]

Embracing de-linkage will show that policymakers are serious about
achieving universal access.


1 Sarah Zaidi, “Differential Treatment: Restricted Access to Newer
Antiretrovirals,” UN Chronicle, Vol. XLVII No. 1, 2011 (15.05.2011)

2 2011. James Love, “The production of generic drugs in India: A new
trade agreement with the EU would hinder access to drugs in developing
countries,” BMJ 2011; 342:d1694.

3 Joseph Stiglitz, “Scrooge and Intellectual Property Rights: A
medical prize fund could improve the financing of drug innovations,”
British Medical Journal, 333:1279-80, December 23, 2006. James Love
and Tim Hubbard, “Prizes for Innovation of New Medicines and
Vaccines,” Annals of Health Law, Vol. 18, No 2, pages 155-186, Summer

4 Sixty-First World Health Assembly, WHA61.21, May 24, 2008. The Annex
is the Global strategy on public health, innovation and intellectual
property. In Element 5, on the “Application and management of
intellectual property to contribute to innovation,” paragraph 5.3 (a)
calls upon member states and the WHO to “explore and, where
appropriate, promote a range of incentive schemes for research and
development including addressing, where appropriate, the de-linkage of
the costs of research and development and the price of health
products, for example through the award of prizes, with the objective
of addressing diseases which disproportionately affect developing

5 Proposal by Barbados, Bolivia, Suriname and Bangladesh, A Prize Fund
to Support Innovation and Access for Donor Supported Markets Linking
Rewards for Innovation to the Competitive Supply of Products for
HIV-AIDS, TB, Malaria and Other Diseases for Humanitarian Uses, Date:
09.04.15, http://www.who.int/phi/Bangladesh_Barbados_Bolivia_Suriname_DonorPrize.pdf.

6 “Senator Sanders introduces two medical innovation prize bills in
U.S. Senate to de-link R&D costs from drug prices,” Knowledge Ecology
International Blog, May 27, 2011. http://keionline.org/node/1147. The
Prize Fund for HIV/AIDS: A New Paradigm for Supporting Sustainable
Innovation and Access to New Drugs for AIDS: De-Linking Markets for
Products from Markets for Innovation, May 26, 2011,
S. 1138, 112th Congress.

7 Recognizing the shortcoming of the existing frameworks to support
innovation, the official “aim” of the WHO Global strategy on public
health, innovation and intellectual property is “to promote new
thinking on innovation and access to medicines.”

James Love.  Knowledge Ecology International
http://www.keionline.org, +1.202.332.2670, US Mobile: +1.202.361.3040,
Geneva Mobile: +41.76.413.6584, efax: +1.888.245.3140.

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