Universities role global access to essential medicines

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Universities role - global access to essential
medicines

• Caroline Gallant
• Universities Allied for Essential Medicine
• McGill University
• April 19th, 2007
• Ottawa, Canada

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Universities Allied for Essential Medicine

• Two-fold mission
• to ensure that biomedical innovations, such as
  drugs, developed in campus labs are accessible in
  developing countries
• to facilitate and promote research on neglected
  diseases, or those diseases predominantly
  affecting people who are too poor to constitute a
  market attractive to private-sector RD
  investment.

www.essentialmedicine.org
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Universities are major contributors to
health-related innovations

• Includes but not limited to
• drugs
• vaccines
• diagnostics
• monitoring tools
• know-how and technical expertise

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The landscape of RD for neglected diseases
Universities are involved in 26/63 current ND
drug projects (2005).
Moran, PLoS Med, 2005
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Universities are major contributors to drug
development

• A recent U.S. report found that 15 of the 21
  drugs with the most therapeutic impact were
  derived from federally funded projects at
  academic centres.

U.S. Senate Joint Economic Committee 2000
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Universities patent rights in key HIV/AIDS drugs
on the market

• Emtricitabine - Emory
• Emtriva, component of Truvada Atripla
• 3TC - Emory
• Epivir, component of Combivir, Epzicom
  Trizivir
• Staduvine - Yale
• Zerit
• Abacavir - Minnesota
• Ziagen, component of Trizivir Epzicom
• T-20 - Duke
• Fuzeon

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Letter from Dr. Deluca, key Zemplar innovator

• I have been receiving mail from nephrologists in
  Thailand who are upset that Zemplar will not
  become a product in their country for use in
  their patients.
• I believe it is unfortunate that patients
  anywhere in the world are denied this wonderful
  drug because of political reasons.
• As the inventor, I would merely like to say that
  I would like this drug to be as widely available
  to renal patients as possible.
• I urge you to do everything you can to see to it
  that this medication is made available in that
  country and any other country where patients are
  suffering.

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WHO Commission on IP, Innovation Public Health
(CIPIH) Report

• 2.12 Public research institutions and
  universities in developed countries should
  seriously consider initiatives designed to ensure
  that access to RD outputs relevant to the health
  concerns of developing countries and to products
  derived therefrom, are facilitated through
  appropriate licensing policies and practices.

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How can universities ensure that their
innovations reach low- and middle- income
populations?
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What can universities do to promote access to
essential medicines?

• Promote equal access to university research
• Require licensing terms in technology transfer
  agreements that ensure low-cost access to
  health-related innovations.
• Equitable Access License (EAL) allows generic
  companies to manufacture and export university
  innovations to eligible countries.
• Include a transparent, case-by-case global access
  strategy.

UAEM Policy Statement
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What can universities do to promote access to
essential medicines?

• Promote research development for neglected
  diseases
• Promote in-house ND research
• Engage with nontraditional partners to create new
  opportunities for ND drug development
• Carve out an ND research exemption for any
  patents held or licenses executed.

UAEM Policy Statement
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What can universities do to promote access to
essential medicines?

• Measure research and technology transfer success
  according to impact on human welfare.

UAEM Policy Statement
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UAEM Projects

• ND policy meeting (Berkeley)
• Funders, universities, public-private product
  development partnerships
• Alternative access-minded licensing policies
  (Harvard)
• Progressive technology transfer metrics
  (Hopkins/McGill)
• Expanding the WHO Essential Medicine List
• April 2007 successful application for a statin
  drug.
• Meeting of University Presidents other
  stakeholders.

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Beyond the August 30th Decision The EAL as a
Simple Self-Enforcing Tool for Access

• Access to Medicines Regime
• GOAL to increase the supply of high-quality
  affordable drugs and medical devices to
  impoverished countries (by implementing the WTO
  August 30th Decision).
• The Regimes failure to-date has
• revealed flaws of the legislation
• the limitations of the underlying TRIPS
  compulsory licensing framework.
• Regime must consider approaches that go beyond
  the WTO Decision.

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Beyond the August 30th Decision The EAL as a
Simple Self-Enforcing Tool for Access

• Pipeline increasing reliance on university
  biomedical discoveries.
• Universities have leverage to set the licensing
  terms for their innovations
• Include provisions that allow generic companies
  to manufacture medicines and export them to
  eligible countries.
• Universities can leverage their rights in
  lifesaving innovations to lift patent, data and
  production barriers to generics.

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Beyond the August 30th Decision The EAL as a
Simple Self-Enforcing Tool for Access

• Requires no prior negotiation between supplier or
  generic manufacturers and the patent holder.
• Requires no stipulation of destination and
  quantity of medicines.
• Creates no onerous notification requirements.
• Minimizes red tape and political contingency.
• Expands the set of potential suppliers.
• Any health-related innovation would be eligible.

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Introduced U.S. legislation Public Research in
the Public Interest Act of 2006

• Conditions federal research funding on an
  institutions adoption of equitable access
  licensing terms.

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