james love sbarca su plos:

The future of drug development

In this month's essay, Tim Hubbard and Jamie Love argue that we need a
better way to research and develop new drugs. They contend that the
existing system for drug development--rooted within the pharmaceutical
industry--is inefficient and unsustainable.  Drugs are too expensive and
are beyond the reach of many people in the developed as well as the
developing world.

The inadequacies in the current system, suggest Hubbard and Love, are a
consequence of a business model that uses a single payment to cover both
the costs of manufacture, marketing and sales of a drug and the cost of
the research and development (R&D) carried out by manufacturers to
discover it. The current system is supported by a vigorously-enforced
intellectual property regime, which protects the financial interests of
companies and reaches across borders so that poorer countries cannot
develop cheaper versions of the drug.

Aside from the inadequate availability and high price of drugs, other
unwelcome side-effects of the existing business model are a lack of
information sharing amongst researchers, and a consequent reduction in
the pace of discovery.  There are also strong incentives to develop
drugs that have little if any increase in efficacy over existing
drugs--so-called me-too drugs.  And it is not surprising that many of
the major global health challenges, which tend to affect poorer nations,
receive short shrift from companies that focus their attention on more
lucrative health markets.

So what's to be done?  Hubbard and Love propose that the markets for R&D
and the markets for products should be separated.  Researchers and drug
developers would be compensated, but not through a marketing monopoly.
Large cash prizes to successful firms or non-profit drug developers,
direct public sector involvement in drug development, new open
collaborative development models, or government imposed research
mandates would be possible economic models for funding drug development.
   Money could be raised and managed through taxes and traditional
government institutions like the NIH, or through "bottom up" mechanisms
such as employee contributions to competitive intermediates that fund
R&D--analogous to pension funds--or through other approaches.

Such a system would reduce the influence of intellectual property
rights, and lead to much greater openness in the area of drug research.
  Competition would still exist for the manufacture and distribution of
drugs, but prices would inevitably drop.  There are many obstacles and
challenges to the development of the new drug R&D market, but Hubbard
and Love believe that the economics can be worked out and will "change
the world," by greatly expanding access to new medicines and promoting a
more efficient system of drug development that addresses real health
priorities.

citation: Hubbard T, Love J (2004) A New Trade Framework for Global
Healthcare R&D. PLoS Biol 2(2): e52 DOI: 10.1371/journal.pbio.0020052.

link:
http://www.plosbiology.org/plosonline/?request=get-document&doi=10.1371/journal.pbio.0020052

press-only preview: http://www.plos.org/downloads/plbi-02-02-hubbard.pdf


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