Transcript The 10/90 Gap in International Health Research and Drug Research

The 10/90 Gap in International Health Research
and Drug Research and Development
Whose Moral Responsibility is it?
Udo Schuklenk
www.udo-schuklenk.org
1/
The Issues
• 10 percent of the world’s 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.
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 world’s 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.
(At Least)Three Problems
• Drug R&D – 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)?
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.
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
Industry
• Two takes
– Industry is a moral player capable of preventing avoidable
deaths
• Might have agent-relative duties due to specific R&D
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.
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.
– It’s also disconcerting that unaccountable individuals should
make decisions affecting millions of people re drug R&D
research priorities.
States
• Developed countries have long since accepted some
responsibilities toward the world’s 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)
Individuals
• Main rationale: private citizens can, by
pooling their resources (eg donation to
MSF, GAVI) resource drug R&D. 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)
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.
Proposed Solutions to the R&D
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 R&D.
So, Whose Responsibility
• Much of the current rhetoric on a proposed human right
to health doesn’t 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 won’t 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.
What’s Needed –
Opportunities for Research 
• It is necessary to find a persuasive answer to the
question of who ought to finance drug R&D 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?