EGA Press Release

Monday, 08 September 2003

EGA Supports Milan Declaration by Accession Country Health Ministers warning of negative consequences of blocking low-priced generic medicines by increasing data exclusivity periods

The European Generics medicines Association (EGA) strongly supports the attached Milan Declaration on Generic Medicines made by the 10 EU Acceding Member States on Friday 5th September.

The European Generics medicines Association (EGA) strongly supports the attached Milan Declaration on Generic Medicines made by the 10 EU Acceding Member States on Friday 5th September.

This unprecedented declaration, signed by all 10 Accession Country Ministers of Health, warns of the serious negative consequences that the EU’s proposal to increase the periods of regulatory data exclusivity for branded original pharmaceuticals will have on their public healthcare systems. The declaration calls for maintaining data exclusivity at 6 years for the 10 New Member States.

Data exclusivity provisions effectively block the registration of generic medicines. This period of protection is independent of any patent and/or patent extensions. The length of the data exclusivity period is crucial to determining when a generic application can start and at what point after patent expiry a generic can enter the market. If data exclusivity provisions are too long then lower-priced generics can only enter the market several months or even yeas after patent expiry, thus extending the monopoly of the originator product and costing patients and healthcare systems millions of euro in lost savings. It should be recalled that:

• All 10 Acceding Member States have agreed under their Treaties to operate 6 years data exclusivity.
• 7 current EU Member States along with EFTA countries Iceland and Norway also operate 6 years data exclusivity.
• Only 8 Member States operate 10 years data exclusivity.
• The proposal on the pharmaceutical law agreed by the Council of Ministers in June provides up to 11 years data exclusivity for all products approved by EMEA in London and 10 years for all products in Member States. However, in the latter case generic applications can start in year 8.
• The USA only operates a 5-year data exclusivity period.

Attached you will find the EGA Fact Sheet on Generic Medicines and Accession which underscores the importance of generic medicines to Accession Country economies and healthcare budgets.

The European Generic medicines Association strongly supports the Milan Declaration and will be urging the European Parliament and the EU Member States to take the Accession Countries’ position into account during Second Reading of the proposed pharmaceutical legislation.

Milan Declaration

Fact Sheet “Generic Medicines & Accession”

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