Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

New Pharmaceutical Legislation (Review 2004) - The Impact on the Generic Industry

Katharina Neumann (Abschlußjahr: 2005)

Language: English
 
This thesis discusses the key provisions in the new pharmaceutical legislation affecting the generic industry. The issue is examined by focusing on regulatory and intellectual property rights provisions. Considering that there is no experience with central abridged applications yet, the discussion is mainly based on the Mutual Recognition Procedure.

In the first part of this thesis, measures adopted to improve the efficiency of the EU regulatory framework, and thus improve the international competitiveness of both generic and innovative industry, are examined. In particular, the Mutual Recognition Procedure is facilitated. In the course of this process, a new Decentralised Procedure for medicinal products not yet authorised in the Community is introduced. Also, the referral procedures are simplified and shortened.
Other regulatory provisions affecting all sides of industry equally include the removal of the five year renewal procedure and an increased frequency of the submission of periodic safety update reports (PSURs). In addition, a “sunset clause” is introduced, which provides that a marketing authorisation ceases to be valid if it is not placed on the market for three consecutive years.

Striking the balance between innovation and generic competition was one of the most contentious issues in the development of the new EU pharmaceutical legislation. The second part of the thesis outlines the provisions affecting the balance between the innovative and generic industry. The discussion includes intellectual property rights issues, in particular the European Bolar provision and the harmonisation and extension of the regulatory data protection period through an "8+2+1 formula".
In addition, regulatory issues and their relevance to the generic industry are examined. Provisions include the definition of a generic medicinal product and the definition of a biosimilar medicinal product, as well as the introduction of the global marketing authorisation concept and the European reference product. Moreover, the possibility to exclude usage patents from the SmPC and a legal basis for the harmonisation of the originators SmPCs are established.

In the conclusion of this thesis, the regulatory and intellectual property rights provisions of the new pharmaceutical legislation are summarised and their relevance to the generic market is discussed. The balance between innovation and generic competition has been shifted in favour of the generic industry.

Pages:35