E-drug: Venezuela Proposal on ED and TRIPS Article 27.3
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I think it is good that Pierre Chirac has begun a discussion of the
Venezuela proposal to the WTO, regarding expanding the permitted
exceptions to patenting to include the WHO list of essential drugs.
I personally am not that worried about making the WHO
"uncomfortable" with putting drugs on the list, in part because the
WHO's list is already pretty cautious. What are they going to do?
Eliminate all patented drugs? They don't have many now. As Pierre
points out, the exception will be fairly unimportant if the WHO never
puts drugs on the list too. Of course, if the prices of the drugs will
predictably fall if they are put on the list, the WHO may be more
inclined to put drugs on the list.
I think the more interesting questions are those concerning the impact
of the exception on the dynamic market for new drugs. Would this
adversely harm R&D funding for products that would be candidates
for the list? I think these qualitative answer is yes, but the quantitative
answer may be -- yes, but not much.
If the TRIPS Article 27.3 includes an exception to obligations, it will
still be up to national governments to decide if they want to exclude
WHO EDs from patentability. And, even if a country decided to do
this, there might be differences in approaches and procedures. I
certainly would not expect every country on earth to use these
exceptions.
The obvious alternative to a patent exception would be government
use or compulsory licensing under Article 31. I think there is a good
case to be made that Article 31 procedures would be a better
approach if countries were confident that they could (a) set
compensation for patents that are reasonable, (b) get the licenses
actually issued without major legal hassles, and (c) import the
products when it isn't economically feasible or desirable to have local
production.
While I think that Article 31 provides room for (a) reasonable
compensation, taking into account a country's (a patients) ability to
pay, (b) fast track procedures -- look at the US rules for government
use, and (c) we think Article 30 can be used to provide patent
exceptions for production for export. But one should acknowledge that
there is some uncertainly on at least some of these three issues. If a
CL strategy failed for any of these reasons, the ED exception would
be another approach.
I might add that I think that a system that requires compensation to
inventors is good, even though I might have issues with the amount of
compensation that a patent owner might want. I also think that
"compulsory research" obligations are a good idea, for the same
reason -- it is important to invest in R&D. But society also has to
address concerns about access and fairness.
In general, I think discussions of the ED proposal at the WTO is quite
helpful, because it focuses attention on the access issues. I personally
hope some country will table a proposal to create a working group on
access to medicines, where the ED exception and several other
proposals and issues can be discussed.
Jamie Love
James Love / Director, Consumer Project on Technology
http://www.cptech.org / love@cptech.org
P.O. Box 19367, Washington, DC 20036
voice 202.387.8030 / fax 202.234.5176
Communication from Venezuela
3. Extend the list of exceptions to patentability in Article 27.3(b) of
the TRIPS Agreement to include the list of essential drugs of the
World Health Organization, in order to develop the principles
established in Article 8 of the Agreement.
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