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Data Exclusivity

Regulatory Affairs - General Guidelines

Written by Zdravko Mauko

Thursday, 29 December 2005

New legal framework for harmonisation of the data exclusivity

The new periods of data exclusivity will only take effect for reference products applying for marketing authorisation after the new law is fully in effect (around November 2005). Therefore, the first generics applications under the 8+2+1-year data exclusivity period will not occur until late 2013.

The New EU Pharmaceutical Legislation adopted in 2004 has created a harmonised EU eight-year data exclusivity provision with an additional two-year market exclusivity provision. This effective 10-year market exclusivity can be extended by an additional one year maximum if, during the first eight years of those ten years, the marketing authorisation holder obtains an authorisation for one or more new therapeutic indications which, during the scientific evaluation prior to their authorisation, are held to bring a significant clinical benefit in comparison with existing therapies. This so called 8+2+1 formula applies to new chemical entities (NCE)s in all procedures and to all Member States (unless certain new Member States are awarded derogations, which they can request following publication of the new law).

In practical terms, this means that a generic application for marketing authorisation can be submitted after Year 8, but that the product cannot be marketed until after Year 10 — or 11.

The revised legislation also provides a one-year data exclusivity provision for products switching from “prescription-only” to “over the counter” (OTC) status, on the basis of new pre-clinical or clinical data. The law also grants one-year data exclusivity for any new indication for a product which can demonstrate well-established use. This latter provision is non-cumulative ie, it covers only the use of the new indication, and can only be used once.

Because of the adamant opposition to this overall increase in data exclusivity from the current six-year countries — especially from the Accession countries, who had not agreed to this law in their accession agreements, were not yet entitled to vote on it during the legislative process, and who felt it would have a significant effect on their government medicines bill — an additional clause was inserted at the last minute making the law prospective. As a result, the new periods of data exclusivity will only take effect for reference products applying for marketing authorisation after the new law is fully in effect (around November 2005). Therefore, the first generics applications under the 8+2+1-year data exclusivity period will not occur until late 2013.

Source: EGA

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