E-DRUG: FTAA - Health Care and IP (contd)

[James Love <love@cptech.org>]

E-DRUG: FTAA - Health Care and IP (contd)
-----------------------------------------
E-druggers:

The FTAA stands for the Free Trade Area for the Americas. The following 
are recommendations on health care and IP (Intellectual Property) that 
we have drafted, to submit the to FTAA Business Forum working group on 
IP, which has a meeting March 16-18 in Costa Rica.  More info about this 
is at: http://www.cptech.org/ip/draftipwg98.html  Basically, the FTAA is 
a proposed trade agreement involving 34 nations in the Western
Hemisphere. We are hoping that other groups could endorse these
positions, or at least, some subset of the positions.  The deadline for
submissions to the FTAA Business Forum Working Group on IPR is Feb 15,
1998.

I. Selected Recommendations for Health care and IP 

   1.Intellectual property regimes for healthcare should achieve public
health goals. It is not appropriate to treat healthcare is a matter of
commerce only. 

   2.In the area of healthcare, the focus of trade agreements on
intellectual property should be the equitable and reasonable sharing of
the costs of research and development, rather than the particular
mechanisms for R&D support, such as patents or exclusivity marketing
provisions.

   3.An important measure of equitable sharing is per capita
expenditures on healthcare R&D. Countries with higher per capita incomes
should assume higher burdens for R&D expenditures. 

   4.Countries should have discretion to choose mechanisms that raise
per capita R&D expenditures. R&D by commercial firms is important, but
so is R&D spending by governments, non-profit entities and other public
health entities. 

   5.Policies should encourage R&D for pharmaceuticals and other new
therapies and medical devices, as well as items less likely to attract
private investment. There are important market failures in R&D. Research
on basic medical science, adverse reactions to pharmaceuticals, dietary
practices, appropriate technologies for rural healthcare, epidemiology,
therapies for low income patient groups, and more generally, research
which is not likely to lead to profitable inventions, is also important.
Public health goals reflect research priorities which differ in
important respects from investor priorities. 

   6.Countries should have discretion to limit or eliminate patent
protections for areas of public interest, such as healthcare or life
forms. 

   7.Countries should have discretion to use compulsory licenses to
achieve public interest goals. This is particularly important in complex
fields of technology, where inventions are essential inputs for other
inventions. 

   8.Countries should have discretion to require minimum levels of
reinvestment in healthcare R&D. A program of minimum reinvestment in
R&D, or a required contribution to a national R&D program (as has been
proposed by the U.S. Senate) may achieve fair burden sharing for R&D. 

   9.Countries should avoid overbroad patents and other approaches which
discourage innovation and lead to anitcompetitive practices. 

  10.Protection of trademarks should not be interpreted a limitation on
a government's ability to regulate marketing of products or services. In
the area of healthcare, governments clearly have the power to require
plain paper packaging of cigarettes, bar billboard ads for cigarettes or
alcoholic beverages, require standardized packaging of infant formula,
promote generic drug use, and other matters which protect the public's
health. 

  11."Sweat of the brow" protections for health care research should not
be excessive, or create inappropriate anticompetitive barriers to entry.
Protections based upon investment, rather than genius, should be limited
to avoid anticompetitve effects, and subject to compulsory licenses,
where licensing fees are related to the costs (and risks) of the
unpatented research. Firms seeking sui generis marketing exclusivity for
unpatented investments in research should be required to make financial
disclosures about investments which receive exclusivity marketing
privileges. Such disclosures are needed to evaluate the reasonableness
of the exclusivity privileges. 

  12.A blanket five year period of exclusivity for reliance upon health
registration data is excessive. 

  13.Health registration data should be disclosed to the public,
following the principles presented by the International Working Group on
transparency and accountability in drug regulation. 

  14.Patent, copyright and trademark provisions of the FTAA should not
create barriers to parallel imports. Parallel imports of pharmaceuticals
are particularly important for smaller economies which suffer from
inadequate competition. (See CPT's October 16, 1997 comments to the
Portfolio Committee on Health, Parliament, Cape Town, South Africa, on
the Medicines and Related Substances Control Amendment Bill and South
African Reform of Pharmaceutical Policies, on the web at:
http://www.cptech.org/pharm/sa/sa-10-97.html).

  15.Patent or other IP rights should not be used to prevent persons
from engaging in health care research. When necessary, governments
should provide for policies on material transfers or compulsory licenses
which expand opportunities for medical researchers. 

  16.Patents should not be issued for surgical procedures or doses of
medications. 

If interested, please contact me.  

James Love
Consumer Project on Technology
P.O. Box 19367, Washington, DC 20036
Email:love@cptech.org | http://www.cptech.org
Phone: 202.387.8030, fax 202.234.5176

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