Masterstudiengang "Drug Regulatory Affairs"
Master-Thesis
The Revision of the European Regulation 2309/93 - Comparison and Assessment of the Draft Version and the Results of the First Reading of the European Parliament ***
Frauke K. Stamm (Abschlußjahr: 2003)
In 2000 the European Commission appointed Cameron McKenna & Andersen Consultant to perform an audit on the performance of the European pharmaceutical legislation. With this audit the EC fulfilled a commitment made with Article 71 of Council Regulation (EEC) No. 2309/93 (RL 2309/93) to conduct a performance appraisal of the new authorisation processes six years after implementation. This audit resulted in the "Review 2001" process, which has been started to revise and improve the EU pharmaceutical legislation in accordance with the finding of the consultants.
In this thesis the revision proposals made within the Review 2001 regarding RL 2309/93 are summarised and discussed. Since 1995 the RL 2309/93, which lays down "Community procedures for the authorisation and supervision and pharmacovigilance of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products", rules the so-called "Centralised Procedure (CP)" for marketing authorisation for medicinal products in the European Union (EU). Using the CP to apply for a marketing licence allows the respective pharmaceutical entrepreneur in case of an approval to market its medicinal product throughout the entire territory of the EU as well as Iceland, Liechtenstein and Norway.
Basing on the results of the Andersen/McKenna audit and the subsequently performed EU co-decision procedure for revision of the RL 2309/93 an evaluative comparison of the present regulation and the proposed changes regarding human medicines was performed. Further, position papers and meeting notes published by industry associations were involved in the evaluation of the results of the review procedure between November 2001 and June 2003. Revision procedure and discussions focused mainly on:
The scope of the procedure;
The structure of the EMEA;
Several procedural steps (e.g., timelines and renewal obligation);
Data protection aspects;
Postmarketing period (e.g., marketing obligations).
These six major aspects of the revision procedure have been intensively discussed in a two-year period by various authority bodies and pharmaceutical industry representatives. The pharmaceutical industry was not prepared to accept all the revision proposals made by the authorities. With view on all the changes made in the course of the review process and on political agreement of the European Health Ministers it is obvious that nearly all objections raised by the industry associations regarding several major changes have been re-considered so far. Compared with the initial Commission proposal of November 2001 only the proposed marketing obligation is left as not being welcomed or at least accepted as a compromise by the companies (see Figure 1, next page).
As the decision procedure on the RL 2309/93 is not finished yet, the changes proposed so far have to be considered as preliminary until the Council of the European Union (CEU) and the European Parliament (EP) provided their final opinion. With the political agreement on the revision proposal by the Council Meeting of the European Health Ministers in June 2003 a further milestone in the decision-making process has been reached. The next step will be the second reading by the European Parliament, which will be followed by the final decision on the proposal by the EP and the CEU. Most of the concerned parties in the European decision process are highly interested to close the review process before the accession date of the candidate countries in May 2004. With regard to the recent status of the discussion it seems that there have not been left any serious hurdles, which may foil a final agreement on the new regulation within 2003.
Figure 1: Recent Legislative Proposals made by the Authorities and the View of the Pharmaceutical Industry
Recent Legislative Proposals The Pharmaceutical Industry's View
1. Scope of the Centralised Procedure
Mandatory:
MPs developed by the means of biotechnological processes
NCEs for AIDS, Neurodegenerative disorders, Cancer or diabetes (list can be modified after four years)
Deliberately:
for all other NCEs
Change of the scope of the centralised procedure as agreed by the health ministers has been welcomed by industry associations.
2. Timelines
210 days for CPMP decisionif negative: 60 days Appeal procedure possible
if positive or Appeal decides positive for applicant: 60 days for final decision by EC
Welcomed, but without appropriate tools to sue the EC if she fails to meet the timelines, the industry does not await a real improvement.
3. Renewal
Once after 5 years after first marketing authorisation approval
Most companies desire a deletion of the renewal, as with respect to the safety of a MP no additional use can bee seen to existing pharmacovigilance systems.
Due to a lack of objective data regarding the usefulness of the renewal, the current proposal seems to be acceptable.
4. Marketing obligations
Launch of products within 3 years after grant of marketing authorisation or the licence will cease
No break in marketing longer then 3 years or the licence will cease
Not welcomed but accepted as compromise
5. Data protection period
10 plus 1 years for the mandatory listed MPs, if a new indication for a given MP should be found, Generics may apply for MA after 10 resp. 11 years
8 plus 2 years for deliberate CP licensed MPs, means that Generics may apply for MA after 8 years for launch of generic product after expiry of the 10-years data protection period
Welcomed by the investigational companies; Criticised by the generic companies
Pages: 61