[e-drug] a new essential health R&D treaty

["E-Drug" <e-drug@healthnet.org>]

E-DRUG: a new essential health R&D treaty
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[An article from MSF about a new way to finance research in this world. From PLOS Med, an open source journal. Copied as fair use. WB]

http://www.plosmedicine.org/archive/1549-1676/2/2/pdf/10.1371_journal.pmed.0020014-L.pdf

The Courage to Change the Rules: A Proposal for an Essential Health R&D
Treaty

Nicoletta Dentico, Nathan Ford (MSF Neglected Disease Group)
Feruary 22, 2005
PLoS Medicine

[Citation: Dentico N, Ford N (2005) The Courage to Change the Rules: A
Proposal for an Essential Health R&D Treaty. PLoS Med 2(2): e14.]

Biomedical science and technology are developing at a more rapid pace
than ever. Investments in health research and development (R&D) have
never been higherglobal spending on health research increased from
US$30 billion in 1990 to US$105.9 billion in 2001. But despite advances
in technology and unparalleled research spending, the medical needs of
many of the world's population go unmet. For example, only 1% of new
drugs approved between 1975 and 1999 were specifically developed for
tropical diseases and tuberculosisdiseases that account for over 10% of
the global disease burden [1].

In recent years, some important steps have been taken to improve access
to existing treatments in the developing world by increasing generic
competition. Yet there continues to be a tension between promoting
access to lifesaving medicines as a human right and maintaining a global
trade regime that seeks to finance health R&D by allowing monopolies to
charge high prices [2].

There is a growing demand from many quarters for a new international
policy framework [3]. A new international treaty on essential health R&D
could provide a binding framework to redirect today's knowledge and
scientific expertise to priority health needs. The treaty could help to
cement new political commitments and coordinate complementary
partnerships aimed at generating and rewarding health innovation as a
global public good.

The Patent System: An Unhealthy Motive for Medical Innovation?

Until recently, providing patent protection for pharmaceuticals was a
choice made by individual governments according to their level of
industrial development. Today, pharmaceutical patents are globalized
through the World Trade Organization's Agreement on Trade-Related
Aspects of Intellectual Property Rights (TRIPS Agreement) [4], and then
further reinforced through bilateral and regional arrangements (the
so-called TRIPS-Plus agreements [5]). But the patent system stimulates
innovation only where industry sees the opportunity for increasing sales
and market share; much of the resulting innovation is in fact
imitation, producing me-too drugs that offer little, if anything, in
the way of therapeutic benefit over existing drugs (Box 1).

The poorest are hardest hit. While R&D of new therapies against tropical
diseases has ground to a standstill, 14 million people die from
infectious diseases each year, predominantly in developing countries
[1]. Most of the world's 40 million people with HIV/AIDS, including 2.2
million children under 15, live in the developing world
(www.unaids.org). The poor also dominate non-communicable disease
tables, accounting for 59% of the 56.5 million annual global deaths [6].

The patent system is also promoting new inequalities in high-income
countries. Americans now spend a staggering $200 billion a year on
prescription drugs. This figure is growing at a rate of about 12% per
year [7]. The average price of the fifty drugs most used by senior
citizens in America was nearly $1,500 for a year's supply in 2002.
Prescription drugs have become inaccessible even to many people in the
rich world.

Patents, with their focus on maximizing profits, have at least three
negative consequences. First, it has been argued that the patent system
causes substantial welfare losses because consumers who would buy the
product if it were priced at somewhere nearer production cost do not buy
it at the monopoly price [8]. Second, the system encourages
counterfeitingcounterfeit drugs may represent up to 10% of the global
market for pharmaceuticals [9]. Third, patented drugs are promoted
through excessive marketingon average, twice as much is spent on
marketing a drug as on its R&D [10]. Across industries, it is becoming
increasingly apparent that the patent system isn't working well [11],
leading some in industry to express public concern that the blockbuster
business model is irreparably broken [12]. A new approach is needed,
for all our sakes.

Prescriptions for an Innovative Approach: A New Treaty for Essential
Health R&D

The only major international policy instrument that exists today to
stimulate and finance health R&D is the TRIPS Agreement [4]. The TRIPS
Agreement provides 20 years of patent protection on pharmaceuticals in
the hope of stimulating the development of new medicines. Beyond that,
governments try to stimulate R&D in neglected areas by providing
industry with incentives such as tax breaks and patent extensions.
However, the effectiveness of these policies is hardly known.

In 2001, the Doha Declaration on TRIPS and Public Health affirmed the
sovereign right of WTO members to take measures to protect public health
by overcoming patents whenever needed [4]. The last few years have seen
increased attention to the fact that patents keep drug costs high and
limit access to medicines. However, there has been no movement in
international policy to address the crisis in pharmaceutical innovation.

Health R&D must be treated as an international problem that requires an
international solution. It should be treated like other strategic
sectors, as happens today for defense and space discoverysectors that
both benefit from very strong government support for innovation. When
global public goods do correspond to national needs, governments should
step in to mobilize and enforce the collective action required. For
example, global cooperation in the sharing of infectious disease
monitoring from 1890 onwards set a valuable precedent [13].

The recent epidemic of severe acute respiratory syndromeSARSclearly
shows that biomedical knowledge and the pharmaceutical sciences can be
mobilized to achieve rapid advances relevant to social needs if
sufficient resources and political will can be mustered. The SARS virus
was completely sequenced in just six days, and a diagnostic test was
developed in only three months. The public-sector funded, collaborative
public-goods model used for the Human Genome Project shows that public
collaborative research can be more efficient than the closed,
monopolistic, private sector approach.

An international treaty (Box 2) would promote a health-needs-driven
approach to drug discovery. The elaboration of such a treaty would have
to meet the two crucial requirements for an effective system of funding
innovation in pharmaceuticals. First, the reward for innovation should
be proportional to the social (that is, therapeutic) value. Second,
prices should be near average production cost.

The idea is to shift the discourse from trade to health. The
treatyfocussed directly on R&D rather than patent rights or drug
priceswould address the global management of publicly funded health
R&D. Priorities for R&D would be defined through public-sector
leadership and based on public health needs. R&D opportunities would be
aimed at new lead compounds, new types of health tools (Figure 2) and
new treatment approaches. As the only legally mandated international
government agency responsible for global health, the World Health
Organization should work toward establishing this essential R&D agenda.
Individual states would need to periodically evaluate targets for
priority research and make adequate recommendations toward needs-driven R&D.

How Will the Treaty Work?

One of the main objectives of the treaty would be to encourage the broad
dissemination of information and knowledge-sharing, and to support
diversity, competition, and collaboration among researchers from
developed and developing countries.

There are already precedents for the free, public sharing of innovations
with the aim of developing new drugs. The Tropical Diseases Initiative
(www.tropicaldisease.org), for example, is a new, Internet-based,
community-wide effort to develop new drugs for tropical diseases [14].
The BioBricks project (http://parts.mit.edu/) at the Massachusetts
Institute of Technology is exploring standardized tools and processes
for DNA work, largely by computer. The Bios Initiative (Biological
Innovation for Open Society), launched by the Australian non-profit
organization Cambia (the Center for the Application of Molecular Biology
to International Agriculture; www.cambia.org), is an effort to develop
new innovation systems for market failures and for neglected priorities
[15].

Among other incentives, technology exchange frameworks could include
licensing agreements with developing countries, or affirmative
commitments of research funds for collaborative projects with these
countries. Such collaboration is currently being implemented in Europe,
for example, through the European and Developing Countries Clinical
Trial Partnership (www.edctp.org) [16]. The partnership is a new funding
body established to fund research in developing countries, particularly
in Africa, which contributes to the development of affordable
prophylactics and drugs for HIV/AIDS, tuberculosis, and malaria. The
treaty on health R&D should also promote partnerships between countries
in the developing world and encourage the creation of regional
technology networks in developing countries.

Much of today's drug development know-how exists within the private
sector. Further work is needed to define obligations and incentives in
the treaty that maximize industry contributions to publicly funded R&D
by providing in-kind contributions in areas where industry has the
skills that public groups need. The treaty should also provide an
expanded use of government rights against patent abuse on drugs
developed with public support. This would include the right of a
government to intervene if an invention is not made available to the
public on reasonable terms, such as is included in the march-in rights
clause of the United States's 1980 Bayh-Dole Act (which enabled public
universities to license inventions for commercial development [17]).
Making the Treaty Happen

There are a number of obvious difficulties in moving the treaty forward,
and these should not be underestimated. A delicate issue is the treaty's
relation with other binding agreements, particularly the TRIPS
Agreement. Governments that join the treaty should be granted patent
exceptions and should not be accused of free-riding, since they would
be contributing to R&D through a different juridical avenue.

Substantial government resources would need to be mobilized to finance
the highest priority medical research. All governments should
participate according to their means. Countries already contribute
significantly to global R&D through the purchase of costly patented
drugs. Among other measures, not-for-profit initiatives working to
develop new drugs, vaccines, and diagnostic tools for neglected diseases
should be funded at levels that enable them to reach their objectives.
Recent examples clearly show that when political will is mobilized,
resources are rapidly made available to generate R&D in a particular
area. In 2001, the anthrax scare in the US led to increases in
biodefense research spending at the US National Institutes of Health
from US$53 million in 2001 to US$1.6 billion in 2004.

A treaty on health R&D is certainly a feasible proposalthe successful
adoption of a treaty on plant genetic resources shows that it can be
done. After seven years of negotiations, the Food and Agriculture
Organization of the United Nations adopted the International Treaty on
Plant Genetic Resources for Food and Agriculture in November 2001 [18].
This legally binding treaty covers all plant genetic resources relevant
for food and agriculture. Through the treaty, countries agree to
establish an efficient, effective, and transparent multilateral system
to facilitate access to plant genetic resources for food and
agriculture, and to share the benefits in a fair and equitable way.
While there has been a growing consensus in development circles that
more international public goods need to be supplied as part of the
development strategy, increasing their provision will be influenced by
the extent to which inspirational groups of individuals step in to play
a leadership role to meet the collective need.

The Ottawa Convention to Ban Anti-Personnel Landmines and the 2003
Framework Convention on Tobacco Control show that international
frameworks are essential to the regulation of the private sector for the
good of global health. The World Health Organization, together with
other relevant United Nations agencies, has full legitimacy to work with
member states toward crafting challenging proposals, and provoking
policy action. One lesson from these treaties is that support will have
to be built from a strong coalition of like-minded countries that would
steer the process internationally.

While the development of the treaty is still at an early stage of
discussion, the concept is already being aggressively opposed. As with
tobacco, landmines, and more recently, sugar, the involvement of civil
society will be crucial to defend these health improvement strategies
where these may conflict with powerful vested interests in the private
sector [19].

It takes courage to change the rules. If governments are indeed
persuaded to face up to their responsibilities in the coming years, it
may very well be because of the many voluntary organisations that seek
to promote the global public interest.

Acknowledgments

This paper draws on the work of many people who have dedicated their
time to confronting the issue of neglected diseases over the past five
years. We would like to thank all members of the Neglected Diseases
Group, some of whom have given extensive time to developing a much
longer version of this proposal.

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