The 10/90 Gap in International Health Research and Drug Research and Development Whose Moral Responsibility is it?

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The 10/90 Gap in International Health Research
and Drug Research and DevelopmentWhose Moral
Responsibility is it?

• Udo Schuklenk
• www.udo-schuklenk.org

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The Issues

• 10 percent of the worlds health research
  expenditure addresses diseases that account for
  about 90 percent of the global burden of diseases
  afflicting mostly the developing world. GFHR
• From 1975-2004, for instance, 1,446 new drugs
  were made publicly available but only 20 of these
  were for tropical diseases and tuberculosis
  diseases that affect the developing more than the
  developed world. AWSJ
• Communicable diseases kill app. 14 million people
  p/a WHO
• Eliminating these diseases would level the
  mortality gap between developed and developing
  countries World Bank
• Between 2/3rd and 9/10th of new medicines
  coming to the market are me-too drugs.

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The Issues

• Markets not health needs dictate commercial
  research agendas.
• The patent regime arguably fails to stimulate
  innovation in the field of neglected diseases
  MSF/Ford
• Those medicines that do exist more often than not
  are unavailable to the developing worlds poor
  due to patents designed to guarantee the IPR
  owner a substantial return on their investment
  (eg HAART drugs).
• We could, spending the same resources, prevent
  almost immediately millions of preventable deaths
  by immunising newborns with existing (but
  unaffordable vaccines), instead of waiting for
  the outcomes of various (AIDS and other) vaccine
  initiatives.

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(At Least)Three Problems

• Drug RD ie inventing and producing the needed
  medication
• Access ensuring affordable access for those in
  need
• How should we decide which diseases to research
  (and who should decide)?

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Ethical Responses

• HR Human Right to Health
• Utilitarianism Avoidable suffering
• Kantianism Respect for persons
• Contractarianism Support for attainment of
  normal species functioning as pre-condition of
  living a good life. GSK
• Egalitarianism All human lives count equally,
  regardless of where they are located.
• Virtue ethics Living a flourishing life requires
  to behave decently toward those in need.

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Which begs the question

• Who should be responsible for delivering the
  goods?
• Various potential actors have been suggested
• Industry
• Philanthropy
• States (on behalf of their citizens)
• Individuals

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Industry

• Two takes
• Industry is a moral player capable of preventing
  avoidable deaths
• Might have agent-relative duties due to specific
  RD competencies/capacities that are unavailable
  elsewhere
• Our pharmaceutical industry related finger
  pointing seems inconsistent. We do not require
  other commercial organisations to assist the
  developing world (say Daimler-Chrysler supplying
  vehicles to transport the sick to clinics, for
  instance).
• Private enterprises have no societal mandate to
  provide health care to the sick.
• Publicly listed companies exist to generate
  maximum returns to their owners. They deliver
  value by being innovative, employing people and
  pay taxes that the state may use as it sees fit.

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Philanthropy

• Philanthropic giving is usually meant to give
  something back to society that permitted someone
  to become very wealthy.
• As Carnegie argued, business should pursue
  profit, but the wealth created should be utilised
  philanthropically by individual owners for the
  benefit of the community.
• Eg Ford Foundation, Wellcome Trust, Gates
  Foundation
• Nice as such usually very public giving might
  be, it seems doubtful that the called-for
  solution to our problems should have to rely on
  rich volunteers such as Mr Gates.
• Its also disconcerting that unaccountable
  individuals should make decisions affecting
  millions of people re drug RD research
  priorities.

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States

• Developed countries have long since accepted some
  responsibilities toward the worlds poor.
  Rationales for this remain sketchy but often
  include the suggestion of a kind of reparation
  for past colonial exploitation of developing
  nations peoples, self-interest (instability
  over there might eventually affect me here), but
  rarely include any of the ethical rationales
  suggested initially.
• Others have suggested that the State acts on
  behalf of its citizens. Citizens are moral agents
  and should act to assist those in dire need. The
  State could be seen as the instrument deployed to
  achieve this objective. (see also Individuals)

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Individuals

• Main rationale private citizens can, by pooling
  their resources (eg donation to MSF, GAVI)
  resource drug RD. They are moral agents and
  therefore responsible for their decision not to
  contribute personally toward preventing
  preventable suffering and premature death in the
  developing world. (See also States)

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Proposed Solutions to the Access Problem

• Drug Donations by Industry
• Price Reductions by Industry
• PPP
• Compulsory Licensing
• Only CL has so far managed to deliver the goods
  in appreciable quantities.

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Proposed Solutions to the RD Problem

• Pull Mechanisms
• PPP
• Problem Has not delivered the goods.
• Push Mechanisms
• AMCs/APCs
• Problem Has not delivered the goods, seems an
  inefficient, high-risk means to push private
  players into funding drug RD.

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So, Whose Responsibility

• Much of the current rhetoric on a proposed human
  right to health doesnt address the question of
  whose responsibility.
• Private sector will never have sufficient
  capacity and/or the will to deliver the required
  medicines in a timely and reliable fashion.
• Even the Gates Foundation admits that it wont be
  able to develop medicines (to market) for most
  tropical diseases due to budget constraints.
• Equally, it seems unreasonable to entrust the
  survival needs of millions of impoverished people
  into the hands of commercial operators and
  unaccountable do-gooders.

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Whats Needed Opportunities for Research ?

• It is necessary to find a persuasive answer to
  the question of who ought to finance drug RD for
  neglected diseases.
• It is necessary to find a persuasive answer to
  the question of who ought to finance the
  production and delivery of drugs developed to
  fight neglected diseases.
• Relatedly, we should probably consider which
  international institution should manage that
  process, and which international regulatory
  frameworks should be put in place to ensure
  subsequent availability of the developed
  medicines.
• Should we aim for the international equivalent of
  the Manhattan Project?