Venezuela Proposal on ED and TRIPS Article 27.3

[James Love <love@cptech.org>]

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 patenability.  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 <love@cptech.org>
  

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.



Pierre Chirac wrote:
> 
> E-drug: ACT UP Demands Essential Medicines for All (cont'd)
> ---------------------------------------------
> 
> Dear e-druggers,
> 
> The problem with Venezuela's proposal to "exempt the World Health
> Organization's list of essential medicines from the patent system for
> "developing [and] least developed trading partners" is double:
> - WHO will be very uncomfortable with such a pressure and we may
>   be afraid the essential drugs list not to be fully updated as a result
> - the second reason is linked to the first one: some essential drugs
>   are not in the WHO's list.
> 
> So the limitation to the WHO's list may be a dangerous solution.
> 
> Pierre Chirac
> MSF, Paris
> e-mail: pierchir@club-internet.fr
> 
> [I understand that ACT UP is pressuring the US government (USTR);
> not WHO. But it would not hurt if WHO would support developing
> countries in their patent struggle by selecting antiretrovirals for
> inclusion in next updates of the Model List of Essential Drugs. After
> all, selecting essential drugs is a technical act; not a political one. It
> would be interesting to hear WHO's opinion on Venezuela and
> Kenya's step. Hilbrand Haak, E-drug co-moderator].
> 
> --
> Send mail for the `E-Drug' conference to `e-drug@usa.healthnet.org'.
> Mail administrative requests to `majordomo@usa.healthnet.org'.
> For additional assistance, send mail to:  `owner-e-drug@usa.healthnet.org'.

-- 
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