Source: EURLEX
Language: en
Format: md

[**Important legal notice**](http://europa.eu.int/eur-lex/lex/en/editorial/legal_notice.htm)

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# 92002E3196

**WRITTEN QUESTION E-3196/02 by Ria Oomen-Ruijten (PPE-DE) to the Commission. Illegal parallel imports of cheaper pharmaceuticals from developing countries.** 
  
*Official Journal 011 E , 15/01/2004 P. 0037 - 0038*

  

WRITTEN QUESTION E-3196/02

by Ria Oomen-Ruijten (PPE-DE) to the Commission

(8 November 2002)

Subject: Illegal parallel imports of cheaper pharmaceuticals from developing countries

As developing countries do not have sufficient financial resources and facilities for the safe and effective use of pharmaceuticals, they receive cheaper pharmaceuticals. At present, these cheaper pharmaceuticals are being sold at a higher price in the European Union by means of illegal parallel imports. This product differentiation reduces the scope for supplying cheaper medicines to developing countries. The health of the inhabitants of those countries suffers as a result.

1. What measures will the Commission take to prevent cheaper pharmaceuticals from being diverted from developing countries to countries where pharmaceuticals are more expensive?

2. At present EU patent law provides for the system of exhaustion of Community rights. For how long does the Commission expect that it will be possible to retain this system? Could this system be replaced so that EU countries can protect their markets against parallel imports of cheaper pharmaceuticals from developing countries?

Answer given by Mr Lamy on behalf of the Commission

(23 December 2002)

In accordance with the Commission Communication to the Council and the Parliament on accelerated action targeted at major communicable diseases within the context of poverty reduction(1), measures to prevent trade diversion of tiered priced products should be reinforced. To this end, the Commission therefore, on 30 October 2002, adopted a proposal for a Council Regulation to avoid trade diversion into the Union of certain key medicines(2).

This initiative, once adopted by the Council, will enable the customs authorities to suspend the release of or detain tiered priced products at Union borders until the national competent authority has decided whether the products are tiered priced products or not. It is important that segmentation between developed country markets and developing country markets can be upheld in order to secure sustainable offers of low priced medicines to developing countries.

The proposed Regulation does not interfere with intellectual property rights. Both protected and non-protected products may be listed as tiered priced products provided the conditions set out in the draft Regulation are fulfilled. A right holder might indeed choose to exercise his intellectual property rights in the event protected tiered priced products have entered the Community market despite efforts to intercept them at the border.

While exhaustion of intellectual property rights does apply to products placed on the market by or with the consent of the right holder within the European single market, right holders are free to take civil action for infringement in the national courts against the unauthorised parallel importation or commercialisation of protected goods which have entered the Union from third counties. This position has been confirmed by the European Court of Justice. There are no plans within the Community to change this policy.

(1) COM(2001) 96 final.

(2) COM(2002) 592 final.

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