Neglected Diseases: Policy Proposals for Universities

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Neglected DiseasesPolicy Proposals for
Universities

• Basit Khan
• 30 Sept 2006

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What is a neglected disease?

• Primarily affect LMI countries
• Gap in attention from global RD
• Shortage of safe, effective treatments

Yamey, Brit. Med. J. 2002
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Operational definition of neglected diseases

• From the U.S. Orphan Drug Act
• Any disease that either
• affects less than 200,000 persons in the United
  States OR
• for which there is no reasonable expectation that
  the cost of developing and making available in
  the U.S. a treatment...can be recovered from
  sales of the treatment.

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The landscape of RD for neglected diseases

• Push and pull incentives
• Push direct funding or facilitation of research
  and development (grants)
• Public-private partnerships (PPPs)
• Virtual RD management
• Pull promise downstream rewards by organizing a
  market for eventual end products (patents)
• Advanced Purchase Commitments

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The landscape of RD for neglected diseases
Moran, PLoS Med, 2005
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The landscape of RD for neglected diseases
Widdus, IPPPH, 2004
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This is an important milestone in the fight
against Visceral Leishmaniasis, and it
demonstrates the potential for public-private
partnerships to develop new solutions to serious
global health problems, said Dr. Regina
Rabinovich, Program Director of the Gates
Foundations Infectious Diseases Program.
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Case Study Malaria

• 323 million (2004)
• 60 went to PPPs
• 49 NIAID and the Gates Foundation
• Account for 80 of growth in funding (93-04)
• 37 Drugs
• 24 Vaccines
• lt1 Diagnostics
• Were malaria research funded at the average rate
  for all medical conditions, it would receive more
  than 3 billion in annual RD funding.

Malaria RD Alliance
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Where universities fit in

• The preclinical gap
• Source of scientific knowledge
• Intellectual property transaction costs
• Nontraditional partnerships
• Progressive technology transfer metrics

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UAEM policy proposals

• Neglected diseases (ND) research partnering
• ND research exemptions
• ND research promotion

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UAEM policy proposalsND research partnering

• Engage nontraditional partners
• PPPs, nonprofits, and developing-world research
  institutions in ND drug development
• Patent donation
• Dual-market licensing
• Straightforward exclusive/non-exclusive licensing
• Foundation funding for ND research projects

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Is this contentious?

• According to several respondents, negotiations
  with academic institutions were often hard,
  reflecting rigidity and overvaluation.
• 2 cases of protracted negotiation in which the
  university demanded royalties for licenses
  covering developing-world markets.
• Universities are more difficult to deal with than
  pharmaceutical companies.

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Case study patent donation

• UCSB Ca2-channel blockers for schistosomiasis
  treatment (to OneWorld)
• University of Nebraska royalty-free license to
  Medicines for Malaria Venture (MMV) for synthetic
  peroxides allows MMV to take out subsequent
  patents on compounds

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Case study dual-market licensing

• Azole compounds with anti-Chagas activity
• Yale, U. Washington, and OneWorld Health
• Universities reserve the right to partner with
  private companies for antifungal use in
  high-income countries

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Case study licensing to developing-world
institutions
Salicrup et al., IP Strategy Today 2005
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Funding opportunities available

• Real dollars are available for ND research
• The Bill Melinda Gates Foundation spends
  roughly 650M on global health each year, with a
  growing focus on RD
• In 2005, the foundation in partnership with the
  NIH awarded 450M in grants for basic science
  research most went to universities
• 20M to UC Irvine for new Dengue control methods
• 20M to Imperial College London to treat latent
  TB
• 9/14/06 additional 68 million in funding for
  NDs

www.gcgh.org
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Foundation funding

• Upstream problem
• UCSF-DNDi example researcher unable to receive
  grant because of IP issues within the university
• UAEM-UCSF helped to resolve the issue

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UAEM policy proposalsND research exemptions

• Part of the EANDL
• Open access to research innovations for neglected
  disease applications
• If an innovation has not yet been out-licensed,
  universities should allow non-profit institutions
  to use that innovation for ND research as a
  matter of policy
• For any innovations that a university
  out-licenses, the university should retain the
  right to non-exclusively open license use of its
  technology for ND research

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UAEM policy proposalsND research exemptions

• In either case, the university should forego
  royalties on products sold in developing
  countries
• Whats to keep companies from using the ND
  exemption and selling products in high-income
  countries?
• Still actionable infringement
• Cross-licenses required
• PIPRA precedent

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UAEM policy proposalsND research promotion

• Incentives to attract ND researchers and support
  for existing researchers
• Example UCB Center for Neglected Disease
  Research, Malaria Institute (JHU)
• Compound libraries
• Antihistamine Identified as Potential
  Antimalarial Drug (JHU - July 2, 2006)
• Annual review practices (portfolio monitoring)
• Marketing neglected disease capabilities

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Case study Berkeley

• Socially Responsible Licensing Initiative
• Several innovative licensing deals featuring
  royalty-free licenses, no-cost sublicenses,
  profit sharing, and inventor attribution.
• Provides additional backing for technology
  licensing officers to draft licenses that pursue
  non-monetary goals in the future.
• Increased foundation funding to Berkeley for
  research on neglected diseases that will be
  licensed under these principles

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Research and evolution of proposals

• Proposals are not static
• Consultation with stakeholders and data-driven
  improvement
• ND Policy Meeting
• Research projects on non-traditional partnerships

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The bottom line

• Role of our activism to amplify the voices of
  those who are directly affected by the access and
  research gaps
• This changes the decision-making calculus of
  university administrators
• Leads to policies that universities will
  eventually be proud of, but might resist mightily
  in the interim