[A2k] Terry Fisher comments on Second draft of Paris Accord, Access-to-Medicine section

[James Love]

--
[ Picked text/plain from multipart/alternative ]
I am not sure why this did not get through the list when Terry posted
it (the software sometimes blocks posts from some servers for reasons
I don't understand), but here it is:

Begin forwarded message:

From: William Fisher <tfisher@law.harvard.edu>
Date: June 17, 2006 8:02:00 AM EDT
To: a2k@lists.essential.org
Cc: James Love <james.love@cptech.org>
Subject: Second draft of Paris Accord, Access-to-Medicine section

Jamie's second draft of the Access-to-Medicine section of the Paris
Accord is very promising, but I have a few questions and suggestions
-- which I'll intersperse [in brackets] in the draft below:

Proposals for the section in the Paris Accord on Medical research and
development, June 16, 2006.

1.	Research and development is a necessary and valued component of
the health care system.

2.	A number of different institutions are essential for the support
of medical R&D, including government, intergovernmental, non-
government not-for-profit and for-profit organizations.

3.	The systems for supporting research and development of new drugs
should ensure sustainable sources of finance that support employment
in R&D organizations, but also should not undermine the goal of
access for all for new medical inventions.

[I'm not sure why we should be "supporting employment in R&D
organizations."  Suppose, for instance, that we concluded that
malaria research could be conducted more effectively and efficiently
by university labs than by private drug companies.  Should we be
troubled by the fact that, shifting funding from the latter to the
former would put some research scientists out of work?]

4.	Systems for stimulating R&D should address areas of greatest
health need and public interest.

[When does "the public interest" diverge from the "areas of greatest
health need"?  Perhaps when pursuit of a pure utilitarian criterion
would neglect the victims of rare diseases (the orphan drug
problem)?  If that's the only circumstance, I suggest that we spell
it out.  Are there others?]

5.	Separation of markets for innovation and products that incorporate
those innovations.  When possible and appropriate, the elements of
the current systems of stimulating R&D through high prices for
[essential] medical products (through such measures as market
exclusivity for innovators), should be replaced with new systems that
reward developers of new products directly for improved health care
outcomes.   This can be easily accomplished when systems of public or
private insurance exist for medicine, and when it is feasible to
estimate the impact of new medicines on health outcomes.

6.	There is also a need to expand methods of funding projects that
support open research, the development of databases and other
research tools, as well as high-risk R&D projects that are likely to
be useful for follow-on innovation.

7.	Science depends upon access to knowledge.  Hoarding of data and
materials must be discouraged.

8.	Intellectual property rules should not prevent experimental use of
inventions or materials, nor should they discourage or prevent
investments in any field of invention.

9.	National governments should eliminate visa restrictions that limit
the ability of students to study at universities in another nation,
or restrict the ability of scientists or engineers to participate in
conferences or gain experience at firms in another nation.

10.	Methods of protecting investments in clinical trials for new
medicines should not prevent governments from making medicines
available at affordable prices or require unethical or unnecessary
replication of human experiments.

11.	Individuals and communities that collaborate in scientific
research should receive appropriate recognition for contributions to
new scientific discoveries.

12.	Governments must support global agreements to share in the costs
of evaluating new medicines.  Such testing should be transparent, and
funded by sources that do not have incentives to distort or
misrepresent findings, and which address the most useful scientific
and medical questions.

[Could we add that governments should assert and exercise the power
to select the drugs that merit testing and the diseases for which
they should be tested?  The purpose of such a provision would be to
avoid outrages like that discussed in The Guardian today, in which
the British version of the FDA is powerless to determine whether
small doses of Avastin are effective in dealing with a common source
of blindness, because the maker and patent holder (Genentech) refuses
to apply for a license to use Avastin on blindness.  Why?  Because
Genentech hopes to make much more money by licensing a closely
related drug, Lucentis, for blindness.]

13.	Patients should freely share biological materials, and consider
participation in clinical trials to test new medicines, with the
expectation that new scientific advancements will be accessible to
all, that clinical trials and other experiments follow appropriate
ethical standards, and that the trials are reported to public
databases, in order to provide for greater transparency of the
scientific evidence, subject to appropriate protections of personal
privacy.



Terry Fisher
http://www.tfisher.org/