[Pharm-policy] federal agencies that address competition policy

[James Love]

This is a note posted to a US American Bar Association list regarding
the use of administrative proceedures in US competition policy.

Jamie

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Subject: federal agencies that address competition policy
       Date: Thu, 16 Nov 2000 13:49:49 -0500
      From: James Love <love@cptech.org>
 Organization: http://www.cptech.org
        To: ABA Antrtrust List <AT-MEMBERS@ABANET.ORG>

I am engaged in discussions with WTO/WIPO and EU trade officials, over
the use compulsory licensing of patents under Article 31.k of the TRIPS
agreement, which reads:

http://www.wto.org/english/tratop_e/trips_e/t_agm3_e.htm#5

      31(k)    Members are not obliged to apply the conditions set
      forth in subparagraphs (b) and (f) where such use is permitted 
      to remedy a practice determined after judicial or
      administrative process to be anti-competitive. The need to 
      correct anti-competitive practices may be taken into account 
      in determining the amount of remuneration in such
      cases. Competent authorities shall have the authority to 
      refuse termination of authorization if and when the conditions 
      which led to such authorization are likely to recur; 

This paragraph waives the general restriction in the TRIPS that
compulsory licenses require prior negotiation on reasonable commercial
terms, and that licenses restrict use predominately to the domestic
market.  The most important issue being that of exports of products. 
Our discussions are in the context of compulsory licenses for patents on
medicines in developing countries, where local production is often
impractical, given economies of scale and limited know how.  

One of the issues in this debate concerns how liberally a developing
country can use this provision in the TRIPS.  In particular, there is a
question of whether or not an administrative procedure, by for example,
a health ministry, would satisfy the TRIPS requirements.

What I am interested in is information about US government agencies that
have responsibilities in the competition policy area.  For example, how
many federal agencies are involved in various merger reviews, and do
they have administrative powers to approve or review mergers, or set
conditions on mergers, for example.  Or, like the US Department of the
Interior, examples where agencies look at competition issues in setting
policy for oil and gas leasing.  Examples in the health care area would
of course be very interesting, including, for example, the US Bayh Dole
Act.   I'll be talking about this in Geneva, Bangladesh and India
shortly, and would appreciate some pointers.  This is a pretty important
trade issue.  

 Jamie


PS... we have lots of info on these disputes here:  
 http://www.cptech.org/ip/health


-- 
James Love  mailto:love@cptech.org http://www.cptech.org
Consumer Project on Technology, P.O. Box 19367, Washington, DC 20036
voice 1.202.387.8030  fax  1.202.234.5176