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EGA Press Release

Tuesday, 22 April 2003

EU Member States Must Tackle the EC Commission's Failure to Promote Pharmaceutical Competition and Affordability

“Member States must significantly change the European Commission's modified proposal for EU pharmaceutical law(1) if they wish to stimulate pharmaceutical competition and ensure affordability of medicines for EU consumers”. This is the message given today by the EGA – the association of pharmaceutical companies supplying affordable generic medicines to patients in Europe.(2)

The European Commission’s proposal, still to be formally released, has four major obstacles for pharmaceutical affordability and competition in Europe.

  • The proposal maintains the controversial “10+1 data exclusivity” measure that substantially increases the delay on generic applications in order to protect branded originals. This was maintained despite a vast majority of MEPs (495 to 55) voting against this increase.(3)
  • It fails to provide a real “Bolar provision” to encourage European production of generics and immediate post-patent competition. In fact, the Commission's provision could even result in a reduction of generic competition.(4)
  • It has not seriously tackled disharmonisation of product information of originator products—one of the biggest obstacles to generic registrations.(5)
  • The proposal still lacks definitions for “innovation” or “significant clinical benefit” etc.—terms, which are important for defining periods of additional market protection. In contrast, definitions of generic medicines and bio-similar medicinal products remain too restrictive.

The proposal also fails to allow generic versions of patented medicines to be manufactured for export to least developed countries facing a healthcare emergency.(6)

The EGA acknowledges that some progress will be made by the introduction of a European Reference Product, which could help the continued marketing of certain affordable generic medicines in candidate countries after EU accession.(7)

“Generic medicines keep the EU’s healthcare systems affordable by bringing savings worth over €18 billion a year, whilst at the same time creating competition and stimulating innovation. EU Member States — who are responsible for healthcare provision — must now work hard to ensure a more balanced Directive is applied to a future medicines policy in the EU,” states Greg Perry, Director General of the EGA.

MEP Support for 8-year Data Exclusivity

Yes: 495 - No: 55 - Abs: 3 = Total: 553

Overwhelming MEP support for 8 year data exclusivity.

(1) The European Commission’s revised proposal for a Directive on Medicinal Products for Human Use (amending 2001/83/EC) follows the European Parliament's First Reading in October 2002, and is now being reviewed by the 15 EU Member States in the Council of Ministers.

(2) EGA represents over 500 companies — excluding subsidiaries — manufacturing and supplying generic medicines in Europe. Over 85,000 people are employed in the manufacturing and supply of generic medicines in Europe.

(3) European Parliamentary Amendment 34 sought to limit the proposed delay on generic applications by allowing generics to start registration procedures 8 years after the first market authorisation of the original product but preventing actual marketing of the product until 10 to11 years after the first authorisation.

(4) The European Commission claims that the Bolar provision should a) ensure that generic competition can begin as quickly as possible after patent expiry and b) attract development and production of generic medicines to the EU. However, whilst the “Bolar” provision they propose would allow generic development work during the patent period, it would not cover the registration process and approval of the generic itself during the patent period, despite the fact that this is already allowed in all EU Member States.

(5) The European Commission has maintained the right of original branded products — authorised before compulsory harmonisation in 1998 — to maintain different uses and information in different EU Member States even where generic equivalents of such products must be approved with identical information throughout the EU. This disharmony between the information on equivalent generic and brand originator products undermines the single market and creates confusion for patients and healthcare professionals. This problem will increase with the increasing number of use/indication patents.

(6) Failure to include Amendment 196 of the European Parliament into the new proposal will be particularly disappointing for healthcare activists and developing countries which had seen this provision as one way to improve access to medicines for the Third World.

(7) The European Reference Product would allow generic medicines to obtain market approval in an EU Member State where the original product (i.e. reference product) has been withdrawn for commercial reasons, so long as the originator exists in at least one other country in the EU. This is especially helpful for new EU Member States in Central and Eastern Europe, where originators either fail to market products or withdraw products from these countries because these markets are not profitable or are simply too small.

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