Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Review 2001: The future of the Mutual Recognition Procedure including special aspects of the EU-enlargement ***

Dr. Karin Heidenreich (Abschlußjahr: 2001)

With effect of 1 January 1995 the new EU regulatory system for the registration of medicinal products via Mutual Recognition Procedure or Centralized Procedure was implemented with a transition period until 31 December 1997. A survey with the European health authorities and the pharmaceutical industry evaluated the efficiency of this regulatory system and was conceived to provide the opportunity to suggest improvements. The results of this survey and proposals for changes are published in a report, which has been called "Review 2001".

Positive aspects of the Mutual Recognition Procedure (MRP) presented in the review include its high flexibility with regard to co-promotion arrangements, trademarks, labelling and legal classification as well as the speed of the first launch of the medicinal product in the Reference Member State (RMS). Despite the general acceptance and support for the aims of the MRP, the basic problem seen by all parties involved in the survey is that no real mutual recognition is practiced. The repeated assessment of dossiers by the Concerned Member States (CMS`s) may lead to non-acceptance of the first approval of the RMS, which results in withdrawals of applications in these CMS`s or to arbitration procedures. Reasons for this situation are seen in the CMS`s misusing the concept of "risk to public health" as a tool for not recognising the assessment made by the RMS. Furthermore, the Mutual Recognition Facilitation Group (MRFG) has no legal basis and therefore, decisions made in that group during breakout sessions, where different opinions about the first assessments are discussed, have only limited value.

The results of the Review 2001 and the proposals for changes and improvement for MRP are extensively discussed within several EU bodies (such as the EU commission and the Joint human and veterinary pharmaceutical committee) and pharmaceutical industry association (such as the EFPIA), and are finally integrated into the draft directive. This draft directive contains as the most important changes compared to the present legislation:

the legalisation of the MRFG, now called "Coordination Group";
the division of the MRP into two procedures, the MRP for a medicinal product which is already authorized in at least one EU country and the Decentralized Procedure for a medicinal product not authorized within the EU yet;
the possibility of RMS and recognising CMS`s to launch the product while an arbitration is running;
the exclusion of the assessment of new active substances via MRP, but only via Centralized Procedure.
The Review 2001 was a great opportunity for a discussion of the present regulatory procedures for gaining the marketing authorization of medicinal products and for bringing up suggestions for their improvement. Nevertheless, the results should be critically assessed due to the limited number of participants in the survey and its unbalanced presentation of the negative aspects of MRP. The review neglected the fact that MRP`s deal not only with new active substances found in the Centralized Procedures but also with generics and some special products, such as herbals. The MRP can therefore be seen as a truly successful procedure after considering the facts that the high number of withdrawals associated with the MRP concern generics, and the number of successful MRP`s dealing with new active substances is comparable or exceeding the number of centralized List B products.

In my view the exclusion of assessment of new active substances via MRP in the new legislation can be regarded as an unjustified debasement of MRP, which will result in a monopoly and overload of the Centralized Procedure for new active substances and in a reduction of the influence of the national health authorities.

With the anticipated EU-enlargement within the next few years, the Mutual Recognition Procedure will come under additional pressure due to the increasing number of products and procedures. This means that the new MRP or Decentralized Procedure respectively, need a simplified system for the decision making process. In addition, the process of the EU-enlargement must enable the implementation of the high EU-standards of pharmaceutical legislation and the efficient integration of the health authorities of the candidate countries into the EU-system. In order to achieve the main healthcare aims of the EU - to create a single market in medicinal products and to ensure the protection of public health - the accession countries have been organised as CADREAC and are supported by the PERF programme.

Pages: 35