The Scope of Global Marketing Authorisations within the EU Legal Framework of Regulatory Data Protection for Reference Medicinal Products

Regulatory Data Protection (“RDP“) shelters research and development investments carried out by pharmaceutical companies, at a point where the term of a patent might be exceeded. During the RDP term the data generated as investment results of pre-clinical tests and of clinical trials of a medicinal product may not be referred to by generic competitors. Thus, it completes the patent protection and provides another incentive for further investments into the improvement and development of innovative medicinal products.

On the other side generics do not merely facilitate, but induce competition and, thereby, relieve national healthcare systems of costs for medicinal products. Furthermore, references to existing data originating from pre-clinical tests and clinical trials prevent unnecessary testing on  humans and animals.1 In the end, it is up to the discretion of the legislator to strike a balance between investment protection and public interest, after a certain period of time. The European legislator has balanced these interests in Article 10(1) of Directive 2001/83:2

“[…] the applicant shall not be required to provide the results of pre-clinical tests and of clinical trials if he can demonstrate that the medicinal product is a generic of a reference medicinal product which is or has been authorised under Article 6 for not less than eight years in a Member State or in the Community. A generic medicinal product authorised pursuant to this provision shall not be placed on the market until ten years have elapsed from the initial authorisation of the reference product” and in Article 14(11) of Regulation 726/2004:3 “Without prejudice to the law on the protection of industrial and commercial property, medicinal products for human use which have been authorised in accordance with the provisions of this Regulation shall benefit from an eight-year period of data protection and a ten-year period of marketing protection, in which connection the latter period shall be extended to a maximum of 11 years 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”.



Copyright: © Lexxion Verlagsgesellschaft mbH
Source: StoffR 04/2013 (September 2013)
Pages: 8
Price: € 20,00
Autor: Prof. Dr. Christian Koenig
Lucyne Ghazarian

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