[Ip-health] US proposed resolution on IPR, Innovation and Public Health

[James Love]

The 56th World Health Assembly
Draft Resolution
Intellectual Property Rights, Innovation and Public Health
s/
Tommy Thompson

United States of America

Recognising that innovation has fuelled much of the substantial progress
in health care achieved during the last century,

Recognizing that innovative medicines, vaccines and diagnostics account
for 40 percent of the increase in life expectancy achieved between 1986
and 2000

Further recognizing and affirming the important link between the
progress of biomedical innovation and protection of intellectual
property rights,

Understanding that intellectual property rights provide a critical
incentive for innovation,

Further understanding that patents disclose new and useful inventions to
the world that provide the basis for new research and development in the
field of public health,

Acknowledging that the process of research, development and clinical
testing  required to bring safe and effective medicines to market is
both expensive and lengthy,

Aware of the urgent need for increased and continued efforts to prevent
the marketing, sales and use of substandard and counterfeit drugs in
many countries,

Nothing that basic science spurs innovation and that private enterprises
are the principal entities developing and brining innovative health
technologies to market,

Mindful of the need to secure future development of medicines for
HIV/AIDS, tuberculosis and malaria and other diseases of developing and
developed countries by ensuring that a legal and regulatory environment
conducive to successful innovation is created, fostered and maintained
through the protection of patents and clinical test data within the
rramework of TRIPS=97including the dlexibilites containied therein.

Concerned about the rapid reducndancy of existing antimicrobial products
through durg resistance, especially products for treating HIV/AIDS,
tuberculosis, and malaria,

Nothing the need to rapidly develop medicines, vaccines, and diagnostics
for re-emerging and emerging diseases such as Severe Acute Respiratory
Syndrome (SARS),

Deeply concerned that medicines for infectious diseases affecting the
developing world are not being developed at an acceptable pace,

1.=09URGES Member States:

To take all appropriate measures, nationally and through cooperation, to
promote the development of new and more effective preventative and
therapeutic medications, including through implementation of patnet and
data protection, in accordance with applicable international law,
including international agreements acceded to;

To cooperate with non governmental organizations and private enterprises
to strengthen infrastructures and share best practices to enhance
biomedical research, innovation and product development in developing
countries;

To take appropriate surveillance and enforcement action to prevent
substandard and counterfeit drugs from entering the market;

To adopt appropriate measure to protect against the diversion to other
countries of medicines, whether donated or provided under differential
pricing mechanisms;

To establish conditions conducive to research and development through
legislative, fiscal and regulator incentives to spur development of new
medicines for diseases affecting developing countries such as tax and
orphan medicines type incentives, examining possibilities for innovative
approaches such transferable market exclusivity;

To work with developing counties to increase their ability to contribute
to such research and development, including helping to create a climate
of incentive and to develop the necessary regulatory incentives to spur
development of new medicines for diseases affecting developing countries
such as tax and orphan medicines type incentives, examining
possibilities for innovative approaches sucha s transferable market
exlisivity;

To work with developing countries to increase their ability to
contribute to such research and development , including helping to
create a climate of incentive and to develop the necessary regulatory
systems to support ethical and safe clinical trials

To take steps to eliminate tarrifs and internal taxes that constrain
effective access to pharmaceutical product or other goods.

REQUEST the Director General

To ensure that WHO policy remains supportive of biomedical innovation
for both developing and developed countries;

To refer Member States to the the WTO and WIPO to obtain assistance on
how best to develop a national technology and innovation strategy
including effective IPR systems tohat respond to public policy
objectives including compliance with TRIPS requirements and
flexibilities therein;

To encourage Member States in their efforts to remove tariffs and taxes
and to eliminate excessive mark ups at thewhoesale and retail levels in
their countries for medicines, especially for HIV/AIDS, tuberculosis and
malaria;

To develop, jointly with Members States, non governmental organizations,
public funded research centers, and private sector innovators,
strategies to stimulate the research and development of medicines wiher
eresearch gaps have been identified and to best match the health needs
of developing countries;

To promote innovation in the field of public health, through
encourageing respect for strong intellectual property rights,

To enhance public private parnershipts that include private sector
innovators as well as non governmental organizsations with recognized
field experience in order to benefit from the unique expertise of these
entities in rsearch and development, as wella s supply and delivery, of
innovative medicines.