EGA Press Release

Monday, 27 May 2002

The EU’s Accession Plans Could Undermine Affordability and the Single Market

Mismanagement of EU Accession in the area of pharmaceuticals will seriously undermine access to affordable medicines in Central and Eastern European Countries as well as undermine the EU’s own single market policy. This was the warning given today in Bratislava by the EGA, the pan-European association representing manufacturers of non-patented generic medicines from EU and Candidate Countries.

According to the EGA’s Director General, Greg Perry, public health interests in these countries are seriously undermined by the following two developments:

• The European Commission’s demand that existing local generic products in these countries be withdrawn from their national markets unless they can fit exactly into the various EU procedural categories used to approve medical products.
• The European Commission’s current proposal to increase the overall EU protection period for branded pharmaceuticals by extending the period during which no generic application can be made in the EU.

Withdrawal of many local well established generic medicines could take place not because of a lack of quality, safety or efficacy but because the equivalent brand products are not authorised for the national market itself, a condition that is currently required in the EU for gaining market approval of a generic. However, according to Mr Perry, only quality, safety and efficacy should be used to decide the fate of these local products when used only for the national market. The EGA believes that this could be done by demonstrating a product’s own “well established use” in the country. More helpful would be to apply the principles of the “EU Single Market” in the current proposal to amend EU pharmaceutical law and allow a generic medicine to be authorised in any EU Member State or Candidate Country as long as the equivalent brand had been authorised in any of one of the EU Member States.

Mr Perry also highlighted the problem of allowing, after accession, recently approved originator brand products to have different product information and use in the Candidate Countries than in the EU. This would undermine the harmonisation process, which has since 1998 required all products authorised in the EU to have harmonised use and information. According to Mr Perry, EU Accession would require the same products authorised since 1998 in Candidate Countries to adopt the harmonised EU information and use but the European Commission is reluctant to force big companies to do this.

This latest development is also bad news for European generic applications since the lack of harmonisation of nationally approved originator products can severely block their approvals This is because EU Member States will often require identical information and use between originator and generic as a criteria for market approval or reimbursement.

“The continued lack of harmony underlines the EGA’s long standing case that where there is no originator harmonisation then generic applications in the mutual recognition procedure must be allowed to have product indication and use approved on national lines. This is another issue that can be resolved in the new pharmaceutical legislation,” said Mr Perry.

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