[Pharm-policy] Six public health groups write Lamy/Nielson on access to medicines

[James Love]

The following letter was sent to the European Commission, on
behalf of the European Public Health Alliance, Health Action 
International, the Consumer Project on Technology, Oxfam UK, 
the Wemos Foundation, and Act Up Paris.   The letter is
part of a dialogue between NGOs and the European Commission
on changes in European trade policy, that relate to access
to medicines.  For more on this issue, see 
http://www.cptech.org/ip/health

   Jamie Love <love@cptech.org> 


http://www.cptech.org/ip/health/eu/lamynielson27092000.html
  
                                          27 September 2000
  
  
  
  Dear Commissioner Lamy and Commissioner Nielson,
  
       On behalf of the following organizations, we would like
  to express our views on the consultations regarding European
  Union trade policy and access to medicines in developing
  countries.  In particular, this letter will address several
  specific points that have been discussed in the
  consultations, relating to intellectual property matters.
  
        We will preface these comments by first agreeing with
  all those who correctly point out that the issues of access
  to medicines are complex, and involve many issues other than
  intellectual property issues.  For example, everyone is in
  agreement that issues concerning medical infrastructure,
  funding for health care, cultural attitudes and education
  are of course very important issues that should be
  addressed.  However, we do not agree with those who suggest
  that intellectual property concerns are not important.
  Policies and practices on intellectual property protection
  have huge influences on the prices of many medicines, and
  the pricing of medicines is an important and indeed critical
  issue for millions of persons who currently suffer from a
  lack of access to medicines.  We cannot accept a trade
  policy that ignores this reality.
  
       With respect to intellectual property concerns, we are
  asking the European Union to address several issues, some of
  them quite technical, that have important consequences
  regarding the pricing of medicines in development countries.
  
  
  1.  It is morally repugnant for the European Union to oppose
  production of medicines for export markets.
  
  The large brand name pharmaceutical companies have made it
  clear that they are hesitant to provide deeply discounted
  priced drugs to the poor in developing countries, and that
  concessions in this area will be limited in terms of price
  discounts, selection of products and the restrictions on the
  availability of medicines. In those case where branded
  companies will not provide affordable drugs, the only
  alternative sources are from generic manufacturers.
  
  There are non-trivial economies of scale in terms of
  manufacturing drugs.  Most African, Latin American and Asian
  countries are do not have a large enough domestic market to
  justify national production of all of the needed products,
  and even those that do have large domestic markets may lack
  the know how and facilities to do so for particular
  products.
  
  It is very important for countries to obtain medicines by
  imports, if they are going to be able to get the best prices
  and the best quality drugs.
  
  The European Union is itself seeking to benefit from the
  free movement of goods, and economies of scale.
  
  Under Article 31 of the WTO TRIPS accord, compulsory
  licenses for medicines may be issued for a variety of
  purposes.  Article 31.f of the TRIPS normally limits the
  compulsory license so that  use shall be authorized
  predominantly for the supply of the domestic market." 
  However, under Article 31.k, countries are not obliged to
  apply the restrictions in (f),  where such use is permitted
  to remedy a practice determined . . . to be
  anti-competitive."  In fact, many compulsory licenses in the
  United States and in Europe are issued pursuant to Article
  31.k, and subject to export. Also, according to WTO and WIPO
  official, a country could waive certain Article 28 patent
  rights, under the general Article 30 exception clause, if
  the WTO determined that such a waiver was reasonable. For
  example, the WTO could decide that the exception was
  reasonable in cases where the production was for export to
  markets where the product was sold under a TRIPS compliant
  compulsory license.
  
  When the European Commission was asked by the Trans Atlantic
  Consumer Dialogue to address the issue of complusory
  licenses on the BRAC1 and BRAC2 breast cancer screening
  patents, to address public health concerns of European
  consumers, the Commission wrote:
  
       2.1. Limitations on patent rights.
  
       A patent is essentially a contract between the inventor
  and the state. In return for fully disclosing his invention
  to the public, the inventor is provided with a limited
  monopoly. This monopoly, which typically extends for a
  maximum of 20 years, provides the     inventor with the
  right to prevent  others from  making or using his
  invention. It does not provide a positive right of use. The
  use of the invention will remain  subject to other laws
  including those for example to protect fundamental human
  rights.
  
  The information disclosed by patent applications  provides
  an extremely useful source of technical information for
  those seeking to design around or further develop patented
  inventions. To enable them to do these things, patent laws
  generally contain    exceptions to patent infringement
  covering basic non-commercial research and also experimental
  use of the patented invention.
  
  Patent laws also include safeguards such as compulsory
  licensing  to prevent the abuse of patent rights. Such abuse
  could comprise for example failing to provide the market on
  reasonable terms, or the denial of licences to another
  patent holder who is dependant on that licence to exploit
  his invention.
  
  Clearly there is an abuse of patent rights if an invention
  is priced so high that it endangers the public health, and
  clearly developing countries have a moral right and indeed a
  public duty to take steps to ensure that their public has
  access to medicines.
  
  If the European Government opposes the use of patent
  exceptions for production for export, it will make it much
  more difficult for developing countries to obtain
  inexpensive medicines, even under a compulsory license.  At
  the present time this is not an impossible problem, because
  there are many products off patent in India, Brazil,
  Thailand and other countries, that could be sources for
  imported products.  But this will change over time as the
  TRIPS is implemented, and even today it is a problem because
  developing countries cannot purchase many products from high
  quality manufacturers in Europe, the United States, Israel,
  Japan and elsewhere.
  
  
  2.   The European Union should not seek to place
  unreasonable restrictions on the use of test data for drug
  approvals.
  
  The big branded companies are seeking a very aggressive
  interpretation of Article 39.9 of the TRIPS accord, with
  respect to the unfair commercial use of test data used for
  drug approvals.  The EU rule in this regard is currently
  restricted to only some regulatory uses, and was adopted
  primarily to compensate for a lack of patent protection on
  pharmaceuticals in Spain and Portugal, a condition that has
  since been remedied.
  
  There is a WTO dispute now involving Article 39.3 and
  Argentina, and the EU's role in the dispute will be
  important.  The EU should not insist on restrictive
  interpretations of this clause in the TRIPS, or more
  generally in its bilateral trade negotiations.
  
  A restrictive interpretation of Article 39.9 would frustrate
  efforts at compulsory licensing of patents, because even if
  a patent was licensed, exclusive rights to the data would be
  a barrier to market entry.  At a very minimum, the EU should
  recognize the need to have a form of compulsory licensing of
  test data, in cases where this is appropriate or needed.
  
  
  3.   The European Union should support the creation of a
  working group on access to medicines in the WTO.
  
  The two points above illustrate only a few of several
  technical areas where the WTO will have to make important
  judgements in terms of the TRIPS.  The WTO is also engaged
  in ongoing reviews of the TRIPS.  We welcome the current WHO
  efforts to monitor trade policies, but this is not a
  substitute for a WTO working group on access to medicines. 
  It should be noted that the WTO has the real power in trade
  negotiations, and that it has a responsibility to protect
  the public health in its policies.  In the Seattle WTO
  meeting, the European Union offered a poorly conceived
  proposal on compulsory licensing of the WHO essential
  medicines list that was ultimately withdrawn because of
  opposition from public health groups.  The confusion over
  this issue illustrated the gap between trade officials and
  public health groups, and a WTO working group on access to
  medicines would begin to bridge that gap.
  
    
  
  The Working Group on Access to Medicines has been endorsed
  by the Trans Atlantic Consumer Dialogue (TACD), MSF, Health
  Action International, Act Up, the Consumer Project on
  Technology and a number of other NGOs working on the access
  to medicines campaign. The failure of the European Union to
  support the creation of such a working group is evidence
  that despite the public relations efforts, there is still no
  real effort to change policy in order to support better
  access to medicines.
  
  
  Sincerely,
  
  Genon Jensen
  European Public Health Alliance
  
  p.p.Bas van der Heide
  Health Action International, European region
  
  p.p. Jamie Love
  Consumer Project on Technology
  
  p.p. Mohga Kamal Smith
  Oxfam UK
  
  p.p. Jaap Kemkes
  Wemos Foundation
  
  p.p. Gaëlle Krikorian
  Act Up-Paris
  
  
  
  Cc Paul Vandoren (DG Trade, Unit  New technologies,
  intellectual property, public procurement)