Policy recommendations

  • In its trade and industrial policies, the EU should take account of its development and public health commitments. Possible impact on developing countries of actions in the trade and industry domains should be assessed thoroughly and impact studies of civil society should be taken into account in a serious manner. The current belief in IPR as a tool for development and the policy coherence in this field should be reassessed objectively and discussed with civil society in a transparent manner.
  • The European Union should refrain from pursuing the inclusion of TRIPS+, WTO+ and even EU+ provisions designed to protect intellectual property rights in any bilateral or multilateral trade agreements with developing countries (including those not defined as LDCs).
  • The EU should not limit, and instead encourage, the efforts of developing countries to use (TRIPS) flexibilities as a public health strategy. In addition it should lobby for the compulsory licence for developing countries without production facilities to be made valid for all similar countries at once (including non-LDC developing countries) and (considering the limits) for other initiatives to be developed, such as patent pools. The EU should actively stand up to European pharmaceutical companies that try to limit the use of compulsory licensing in developing countries.
  • The EU should ensure its interests in enforcement and developments in ACTA will not hamper trade in generic medicine or lead to any more seizures of these. In particular it should not demand adoption of current EU or EU+ enforcement rules, such as border measures, to be introduced in developing countries. 
  • The European Parliament should adopt a Resolution on these recommendations with a view to affirming the ECs commitments to Health and Development, as well as demand  its right of access to all negotiation documents (such as ACTA) and the use of co-decision power to prevent the EU from pursuing agreements that can damage public health.

 

Case: TRIPs & Access to Medicines

26-05-2010 MEPs bring IPR to the Attention of the Commission this Spring

Thijs Berman (S&D), Maria Eleni Koppa (S&D), Ilda Figueiredo (GUE/NGL) and Joao Ferreira (GUE/NGL) all separately asked parliamentary questions concerning Intellectual Property Rights (IPR) and access to affordable medicines.

Access to affordable pharmaceuticals in developing countries is of vital importance for the achievement of development goals and efforts to safeguard human health, but this is extremely difficult due to patents on generic medicine.

Figueiredo and Ferreira especially express their concern for the availability of antiretroviral treatment against HIV/AIDS and suggest a voluntary patent pool to make the medicines more affordable. Koppa asks what the Commission is doing to make medicine more affordable but also to encourage research, technology transfer and establish the necessary legal framework to develop the pharmaceutical production by the developing countries themselves.

Berman focuses more specifically on the free trade agreement between the EU and India that is currently being negotiated. India is the worlds leading manufacturer and exporter of non-branded medicines and therefore also the leading supplier of generic medicines to developing countries. The negotiations concerning IPR in the free trade agreement (FTA) will therefore have a large effect on the access and affordability of medicines for the poorer. Currently the EU is going beyond TRIPs and creating stricter IPR rules for India. Furthermore shipments of generic medicines are blocked in transit in European ports further enhancing the problem. Therefore Berman asks the Commission how the EU will guarantee that the FTA does not undermine Indias export of generic medicines to developing countries.

The European Union has committed itself to attaining the Millennium Development Goals and its own Development Policy with the aim of eradicating poverty. Despite this, they continue to harm development through TRIPs agreements that make it extremely difficult for the poor to access medicines.

For their efforts to bring such issues to the Commission, the Fair Politics team recognizes Figueiredo, Ferreira, Koppa and Berman as Fair Politicians.

Monitor fair: S&D(2), GUE/NGL(2)

Parliamentary questions
6 May 2010
P-3358/10
WRITTEN QUESTION by Thijs Berman (S&D) to the Commission

Subject: EU India free trade agreement generic medicines and IPRs

India is the world's leading manufacturer and exporter of non-branded medicines. In this role India is the leading supplier of generic medicines to developing countries which, with their limited purchasing power, benefit greatly from access to these low-cost pharmaceuticals.

Currently the negotiations for the free trade agreement between the EU and India are taking place. During these negotiations the rules regarding Intellectual Property Rights (IPRs) are also being set. Warnings are being issued that the EU is going beyond TRIPS and creating stricter IPRs rules for India to comply with. This means that the EU is imposing clauses such as a data exclusivity regime whereby an Indian company making generic medicines could be prohibited from using formulae used to develop patented medicine for a period of five to nine years, and the introduction of border protection measures into Indian law.

In 2008 and 2009, 18 shipments of generic medicines from India to other countries were blocked while in transit in Europe on charges of patent infringement. In reaction to this, India and Brazil stated that these actions violated the freedom of transit and ran counter to the spirit of the TRIPS agreement. Afterwards the Commission announced that a re-examination of the effectiveness of the existing custom rules, dating from 2003, would take place.


When will this re-examination be concluded?
Will the conclusions be taken into account in drawing up the FTA with India?
How will the EU guarantee that the FTA does not undermine India's exports of generic medicines to developing countries?
Will the EU include data exclusivity regime in the FTA with India?
Will the EU include border protection measures in the FTA with India?

Parliamentary questions
6 May 2010
E-3120/10
WRITTEN QUESTION by Maria Eleni Koppa (S&D) to the Commission

Subject: TRIPS agreement and access to medicines

Having Regard to:
 the Agreement on Trade-Related Aspects of Intellectual Property Rights
and in view of the fact that:
 access to affordable pharmaceuticals in developing countries is of vital importance for the achievement of development goals and efforts to safeguard human health;
 over 95 % of HIV/AIDS sufferers live in developing countries, principally in Africa;
 the WTO (and EU) member countries have undertaken to produce generic medicines for export to all countries unable to meet the high costs resulting from the TRIPS agreement;
 the average annual cost to an HIV carrier for the purchase of generic medicines is EUR 300, as opposed to EUR 12000 for products covered by intellectual property rights;
 no country is in a position to inform the WTO sufficiently well in advance of its pharmaceutical requirements, being unable to predict HIV resistance levels, the side-effects of drugs or virus transmission rates;

1. What measures has the Commission taken to encourage research, technology transfer and, more generally, the establishment of the necessary legal framework to facilitate and step up pharmaceutical production by the developing countries themselves?
2. Does EU development aid offset any increases in the cost of antiretroviral drugs arising from the adoption of intellectual property agreements?
3. Have the alternative pricing strategies adopted by a number of pharmaceutical companies made medicines more affordable?
4. Finally, does the Commission consider that the modification of the TRIPS agreement has effectively facilitated access to generic medicines for the populations of poor developing countries?

Parliamentary questions
16 February 2010
E-0677/10
WRITTEN QUESTION by Ilda Figueiredo (GUE/NGL) and João Ferreira (GUE/NGL) to the Commission

Subject: Patent pool for HIV drugs proposed by Unitaid

It is calculated that only a third of the 10 million people who need antiretroviral treatment have access to it, and the rise in the price of drugs clearly hinders the treatment of people who are infected. The figures for children are particularly worrying, since it is calculated that less than 10 % of the 2 million children living with HIV have access to drugs.

1. What is the Commission's position on Unitaid's proposal for the creation of a voluntary patent pool for Aids drugs destined for developing countries in order to guarantee that such drugs are available and affordable?
2. What measures are planned to provide active support for this patent pool?