[e-drug] Health TRIPS Issues group

[EHOEN@paris.msf.org (Ellen T HOEN)]

E-drug: Health  TRIPS Issues group
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On Monday 28 June the European Commission DG Trade held a special meeting 
of the health and trips issues group on the preparations for the TRIPS 
Council on health in June. I attach below the text of the MSF briefing 
document prepared for this meeting. For details on the MSF Campaign see: 
www.accessmed-msf.org.

The following NGOS were present: Act Up Paris, OXFAM, Essential Drugs 
Project, Voluntary Sevices Oversees (VSO), WEMOS Foundation, Africa - 
Europe Faith and Justice Network, Médecins Sans Frontières (MSF). There was 
only one pharmaceutical company present GlaxoSmithKline. European 
Federation of Pharmaceutical Manufacturers EFPIA was there for part of the 
meeting. The generic industry was not represented.

The lack of interest from the drug company side was surprising since most 
comapnies have always been well represented at these meetings in the past. 
 Some explained this because it was a bank holiday in the UK others thought 
it was more likely linked to the fact that there is increasing pressure to 
make the tiered pricing system a reality. Now we move from talk to action 
enthusiasm fails?

Commissioner Nielson in a recent speech made it clear that "the global fund 
cannot succeed and will not get our support without a commitment by 
industry to a global tiered pricing system". GSK and EFPIA objected at the 
meeting to the use of the term "system". GSK stated that tiered pricing is 
something companies need to set.
Oxfam stressed that what companies are doing now is not a tiered pricing 
system and proposed a high level meeting. NGOs also asked the Commission to 
study the existing mechanisms such as packaging and labelling regulatory 
measures to deal with the industry's fear of reimportation of low prices 
medicines.

The main part of the meeting was devoted to the preparations of the 
upcoming TRIPS Council on health.
DG Trade is in the process of preparing for the TRIPS Council on health. 
This is part of the Plan for Action on infectious diseases. The European 
Union's General Affairs Council has adopted a resolution endorsing the 
Action plan. In this resolution the Council asks the Commission to report 
on what needs to be done to ensure consistency between the TRIPS Agreement 
and health concerns, which gives the Commission the possibility to monitor 
the effects of TRIPS implementation on health. All of this is definetely 
encouraging and comparing the Commissions statements with their position a 
year ago a lot of progress has been made.

Representatives of DG Trade gave the following overview on  TRIPS Council 
preparations:
- Commission supports a debate concerning the interpretation of the 
Agreement recognizing the balance between the interests of consumers and 
the right holders. At the TRIPS Council the Commission wants to get down to 
the technical level and not stay with general statements. Commission will 
restate believe in IPR stimulus for innovation ( I always find these 
religioius terms that are used in relation to IPR amusing. A similar 
statement was made by the representative of the German Association for 
Industrial property and copyright who stated the association believed in 
IPR and defended it as a human right! EtH)
- Using article 31 for public health reasons. WTO members are free to 
determine the grounds for issuing a compulsory license. Article 7 and 8 are 
important for the interpretation of the provisions of the TRIPS. Article 7 
refers to the objectives of the agreement and 8 to the principles including 
the protection of public health. The Commission considers procedural 
safeguards important but referred to the flexibility (meaning no need to 
consult the patent holder) in cases of emergency and/or public 
non-commercial use.
- The Commission is willing to discuss a permissive reading of the TRIPS 
that would allow compulsory licensing for export to enable countries with 
no production capacity to make use of the art. 31 provisions. The 
Commission does not support the proposals NGOs made to use article 31 k to 
overcome this problem. Under article 31k -compulsory licensing to remedy 
 anticompetitive practices - the requirement that the production is 
"predominantly for the supply of the domestic market" is waived under 
article 31k. See also: 
http://www.cptech.org/ip/health/cl/recommendedstatepractice.html
See for the full text of the TRIPS: 
http://www.wto.org/english/docs_e/legal_e/27-trips.wpf
- The Commission considers that Article 30 exceptions to patent rights can 
be made and should be read in the light of article 7 and 8. So this would 
mean that exceptions for public health reasons are allowed. The Commission 
referred specifically to research. And stressed that article 30 cannot be 
used to allow substantial or unjustified curtailment of patent rights.
- On 39.3 the Commission stated that data protection should be available - 
this prohibits a regulatory agency to use the first applicants data used to 
obtain a marketing authorization to register a generic. This practice 
avoids the need to repeat costly and risky and unnecessary research such as 
clinical trials to show effectiveness for example. The Commission also said 
that 39.3 should not be interpreted to nullify countries rights under 
article 31.
See for a more detailed overview of the Commission's position their 
document "Compulsory Licensing and data protection: 
      http://europa.eu.int/comm/trade/pdf/med_lic.pdf

MSF Recommendations to the European Commission for discussions at the June 
2001 TRIPS Council on Health and Access to Medicines:
Médecins Sans Frontières (MSF) asks the European Commission to support an 
interpretation of the TRIPS Agreement that favours public health needs. The 
main objective of the deliberations at the TRIPS Council should be to 
encourage a more equitable sharing of the benefits of medical technological 
development and advances between the populations of developed and 
developing countries and to seek ways to correct the present imbalance 
between the unbridled exercise of private property rights and public 
interest. The discussions should also address the failures of the present 
intellectual property system (IPR) system to provide incentives for 
research and development (R&D) for neglected diseases.

Discussions in the TRIPS Council should not take place in isolation from 
debates elsewhere such as at the UN Commission on Human Rights, the World 
Health Assembly and multiple regional fora.
Specific recommendations:
1.  The European Commission should go beyond general statements and give 
the widely acknowledged "flexibility" of the TRIPS Agreement "hands and 
feet" by supporting practical implementation options. The European 
Commission should:

a.  Allow for and advocate a wide scope of interpretation of Article 31 and 
support fast track administrative compulsory licensing procedures, 
especially when they relate to public health.
b.  Support compulsory licensing for export to address public health needs.
c.  Advocate humanitarian and health exceptions to patent rights under 
article 30 for:
        i.  globally procured goods or goods purchased with financing of a 
global health fund;
        ii. to allow developing countries to ensure that the poor obtain 
access to essential medicines.
d.  Support the principle of international exhaustion of rights (parallel 
import).
e. Support  "Bolar exemptions" to avoid delays in the introduction of 
generic products.
f.  Avoid restrictive and anti-competitive interpretations of country 
obligations under article 39 of the TRIPS, concerning health registration 
data.

2.  The European Commission should seek alterative ways to increase R&D 
financing for neglected diseases. Replace the current emphasis on private 
commercial rights with a system obligating countries to support essential 
medical research and development that addresses public health needs. Public 
sector commitment to R&D for neglected diseases when the market fails to 
address those needs should be increased.

3.  The European Commission should enhance measures to encourage and 
improve pharmaceutical technology transfer with the aim to build or 
strengthen infrastructure and encourage local and regional production of 
essential medicines. Encouraging technology transfer to the least 
developing countries is an obligation under the TRIPS Agreement (see 
article 66.1), however pharmaceutical technology transfer should be 
specifically targeted to developing countries with production capacity or 
potential production capacity that would allow a regional function.

4. The European Commission should support an extension of the 
implementation deadlines for the least developed countries until mechanisms 
to remedy the effects on access to essential health technologies are in 
place.

5. The European Commission should declare that bilateral pressure to 
prevent countries from making maximum use of the TRIPS flexibility should 
not be exercised and is counter to the nature of the multilateral trade 
system.

6. The European Commission should support a moratorium on dispute 
settlement procedures that may affect access to health care products.

7. The European Commission should encourage full and active involvement of 
the WHO in the discussions and preparations of discussions related to 
health and medicines at the TRIPS Council and encourage WHO's involvement 
in any dispute settlement procedures that affect health.

8. The European Commission should encourage ongoing assessment of the 
effects of TRIPS on access to essential health commodities and R&D for 
neglected diseases.

9. The Assessment of the TRIPS Agreement should take place in cooperation 
with the WHO and WIPO. The European Commission could:

a. Ask that WIPO or WHO examine the costs and capacity of maintaining a 
patent system on medicines, in terms of (a) examining patents and (b) 
litigating claims.

b. Ask that WHO or WIPO address the consequences of poor countries not 
having the capacity to avoid overly broad, non-novel or anticompetitive 
patents.

c. Ask that WIPO address the issue of administrative models for examining 
the validity of patents and for compulsory licensing that would be workable 
in poor country settings.

===============================================
Ellen 't Hoen, LL.M.
MSF- Access to Essential Medicines Campaign
8, rue Saint-Sabin, 75544 Paris Cedex 11
tel: + 33 (0) 1 40212836
fax: + 33 (0) 1 48066868
e-mail: ellen.t.hoen@paris.msf.org
Web-site: www.accessmed-msf.org

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