In July 2001 the European Commission announced proposals for major changes to the regulatory system for pharmaceuticals, following the Review of the system carried out in 2000 by CMS Cameron McKenna and Andersen Consulting (available at http://pharmacos.eudra.org), which have considerable relevance for industry. The most important points are as follows:
Policy objectives
Overall, the Commission comments that the system, that last underwent major change in 1995, has worked well and has contributed to achieving the policy goal of the EC Treaty of providing a high level of public health protection as well as progressing the internal market in pharmaceuticals, so there is no need to fundamentally change the current system with its dual structure of centralised and decentralised procedures.
The Commission has stated four principal objectives in pursuing its review, on which we comment in brackets:
1. To ensure a high level of public health protection for the European citizen, in particular by allowing rapid access to innovative and safe products and by rigorous market surveillance, based on reinforced procedures of control and pharmacovigilance. [This objective highlights the politically necessary policy of stating that safety is paramount, but also lays the foundations for various regulatory changes designed to speed up access to the market by manufacturers where acceptable quality and safety will not be compromised.]
2. To complete the internal market in pharmaceuticals and to establish a regulatory framework favourable to the competitiveness of European pharmaceutical industry, to "meet the challenges" of globalisation. [The Commission has justified proposals to further expand the centralised procedure and tighten up the decentralised (formerly mutual recognition) procedure on the basis of the demonstrated need to meet the recent trend in global competitiveness in pharmaceuticals, in which growth in US?based companies outstrips that of EU industry.] 3. To meet the challenges of an enlarged European Union. [The proposals for 15 further states to join the EU over the next few years require rationalisation in the procedures of both regulatory mechanisms.
4. To rationalise and to simplify, as far as possible, the regulatory system and to improve its global coherence, its visibility and the transparency of the procedures. [Global harmonisation and its effect on competitiveness are powerful drivers of simplification and transparency.]
PROPOSALS
Centralised procedure
1. The list of products for which the centralised system is mandatory is expanded to all new active substances.
2. The centralised procedure is to be opened, on an optional basis, to
- any other product which the applicant shows constitutes a significant therapeutic or technical innovation or that granting a centralised authorisation is of interest at Community level to patients or the matters of animal health,
- immunological veterinary products subject to Community prophylactic measures, and
- generic products of centrally authorised products may be approved nationally.
3. Some deadlines in the procedure are shortened. In particular, the time taken by the Commission decision-making process is to be reduced.
4. Accelerated assessment procedures for products of major interest for public health or therapeutic evaluation. The Commission wants the EMEA to be seen as the fastest and scientifically rigorous world regulatory agency.
5. Introduction of conditional annually reviewable authorisations, subject to further surveillance.
6. Regulation of compassionate use of medicinal products subject to Guidance/ Recommendations prepared by the CHMP (formerly CPMP) which are to be implemented by national authorities.
7. Abolition of the time limits on duration of authorisations, but requirement of more frequent safety reports of pharmacovigilance data.
The EMEA
8. Revision of the form and composition of the scientific committees and the Management Board, with formation of an Advisory Board.
9. Expansion of the role of the EMEA in the provision of scientific advice.
10. Supervision of the conditions of parallel distribution of centrally authorised products.
11. Power to impose financial sanctions for breach of obligations pursuant to marketing authorisations issued centrally.
Decentralised procedure
Several changes are proposed aimed at limiting delays experienced with this procedure.
12. Reduction in the timetable for granting a marketing authorisation from 210 days to 150 days.
13. Preventing parallel assessment of medicinal products in more than one member state, and preventing national assessment of products already authorised in another member state.
14. Defining more precisely the concept of serious "public health" concerns on the basis of which member states may object to mutual recognition and trigger arbitration.
15. Giving formal and legal status to the MRFG and VMRFG committees, which have achieved success in gaining agreement between dissenting member states, so that this preliminary "arbitration" mechanism is formalised and binding.
16. Providing that urgent pharmacovigilance measures taken by a member state are thoroughly evaluated at European level and consistent action is taken by all states.
17. Permitting scientific tests and clinical trials to be carried out within the Community and an application for a marketing authorisation filed on a product during the validity of patent and its supplementary protection certificate: this is a significant benefit to generics.
18. Standardisation of the data protection periods applying to application dossiers at 10 years: an advantage for research-based companies. Extension of one year of the data protection period for a product with a new therapeutic indication with important benefit for patients.
19. Abandoning the strict prohibition of advertising of prescription-only medicines by permitting, on a trial basis, response to direct request by patients or patient groups for information on three long-term/chronic diseases: diabetes, AIDS and asthma. Industry will be expected to adopt principles of good conduct and self-regulatory procedures.
For further information please contact Christopher Hodges on +44 (0)20 7367 2738 or by e-mail at [email protected] Or contact Christine Bendall on +44(0)20 7367 2043 or by e-mail at [email protected].
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