Key Issues Regarding the EU Enlargement

Transcription

1 Key Issues Regarding the EU Enlargement Prof. Dr. rer. nat. habil. Harald G. Schweim Präsident des Bundesinstituts für Arzneimittel (BfArM), Bonn

2 1. HoA East Meeting Visit of Heads of Agencies from Candidate Countries to BfArM on Monday, Topic Review 2001: As CADREAC colleagues have expressed their impression that current Member States and/or European Commission may not very much interested in the views of their Central/Eastern European counterparts, Prof. Schweim has suggested that BfArM offers a platform for discussion results can then be transported into existing official fora as requested by HoA from CC. 2. Presentation DGRA stipend programme, K.W. Glombitza,, University of Bonn As follow up we had about 5 stipends (3 months, in cooperation with PEI), 1 full (female) student (incl. examination), 1 stipend for a dissertation sertation (ongoing) and prof.. M. Smid (cz cz) as lecturer

3 2. HoA East Meeting Communications Plans How to communicate issues and offer direction to Applicants and MA holders How to ensure common understanding between EU 15 Candidate Country Authorities and MA Holders - Plenary - Break-outs: Discussion Phasing in Discussion EUDRA projects ** EudraTrack ** Safe transfer of data (live demonstration) ** BfArM approach to ADR-Reporting - requirements (electronic)

4 3. HoA East Meeting 11 June 2003 Phasing In (Presentation Anthony Humphreys ) Phasing in with EFPIA representatives (Presentation Anu Tummavuori) CP, Mutual Recognition and Referrals: ongoing procedures at time of Accession + NCE Applications in EU/Candidate Countries Variations to existing MR products + Candidate Countries with MA achieved through Simplified Procedure + National MAs in Candidate Countries. + Line extensions to existing MR products + Candidate Countries with MA achieved through Simplified Procedure + National MAs in Candidate Countries How to manage short time window until January 2005 for submission of non-ctd Applications? Use of Repeat-use Mutual Recognition Procedures (MRP) in post-accession phase How best to manage potential workload Differentiation between CADREAC MAs and simple national MAs? Potential resource/time constraints for RMSs? Procedures for CADREAC Simplified MRP at and around Accession Timings for acceptable Applications approaching accession What will happen following accession amendments to procedure for remaining Candidate Countries? Electronic Transmission of Pharmacovigilance-Information How does BfArM cope with that requirement? (Presentation) Secure transaction method for Eudratrack/CTS via TCP-IP network (Presentation)

5 ..und das 4.te Treffen more meetings are planned

6 January 2004 DIA HoA Bonn PERFIII Producers Conference Ljubljana PERF III Vets Conference Warsaw PERF III Users Conference November Prague MRP/CAP Industry Info Day Ifis / DIA Paris 30 April 2004 Euro DIA Prague 1 st May 2004 Commission Framework Act J J A S O N D J F M A M J J A S O N D J F M A QRD Meeting QRD Training Submission Linguistic elements QRD Meeting Checking Linguistic elements Administrative Procedure (Early Process) 1 st May 2004 Variation Life - cycle Administrative Procedure (clean-up)

7 Where are the Problems to be found? Potentially everywhere: Centralised Procedure Article Procedures Mutual Recognition (less for the new Decentralised Procedure) National Procedure Full Applications, Generics,, WEU, Herbal Pharmaceuticals Any Old and New Member State Potentially at any time: Before Accession (transitional observation) During Transition (transitional behaviour) After Accession (transitional arrangement?)

8 European Bodies Executing Medicines Regulation Eur. Commission EMEA Pharmaceutical or CPMP Standing Committee Working Parties ad hoc Groups, TAG s Controlling approx. 10% of Pharmaceuticals via Centralised and Article Procedures Competent Authorities of the Member States Mutual Recognition National Procedures Controlling approx. 20% approx. 70% of Pharmaceuticals on the EU-Member States Markets

9 European Bodies Executing Medicines Regulation: Responsibilities? Eur. Commission Member States Guardian acquis Communautaire hard law / soft law Transitional arrangements EMEA simplification logistic support Pharmaceutical Industry (trade Old generics (without dossier?) Upgrading effort Use of simplified procedures Provision of dosisiers on time Facilitator to Accession - transparency - provision of experience New Member States - responsible for assessment - competent for decisions (throughout the product lifetime) trade associations, MAH s - old old / new new EU)

10 Partnership of National competent Agencies: Current and New Member States Current EU Member State Centrally authorised product (CAP) Mutually recognised authorised Product (MAP) Referral/Arbitration harmonised product (RAP) Solely nationally authorised product (NAP) Originator authorised product Self-Standing Dossier (WEU) Essentially Similar Product (consented) Essentially Similar Product (generic) BE with local product? Module 3 (Part II) to be submitted New EU Member State Simplified procedure available Simplified procedure available Early, on-time or no implementation? Simplified procedure(s) available? Current or Future EU-MS product? Current or Future EU-MS dossier? Consent to a Future EU-MS product Claim to be based on MA of Originator BE with European product? Module 3 (Part II) to be submitted

11 Important Aspects of the Review and Enlargement Streamlining of EU-Committees (number of members; selection process; responsibility) Importance of clear definitions Scope for centralised / decentralised procedures Renewal versus pharmacovigilance

12 Need for Definition: "Serious Risk to Public Health" do national views / definitions differ from case to case and from country to country? are national views always objective? are national views potentially "historical"? are national views applicable to European harmonisation / single market? are national views "for home use" only or a "mission" to other countries? Conclusion: A European definition is highly necessary. Already on Commission agenda

13 Scope for Centralised / Decentralised Procedure centralised Council Regulation (EEC) No. 2309/93 - Annex new drugs for: AIDS, oncology & neurovegetative diseases (e.g. Alzheimer's) obligatorily CENTRALISED. and more? decentralised Generics centralised and decentralised line-extension national FOR ONE MEMBER STATE ONLY; bibliographic approval;

14 European Bodies Executing Medicines Regulation: Where are the Problems to be found? Consequences? Cooperation Collaboration Networking Bilaterally (between Agencies, Twinning) Multilaterally (between Agencies,, PERF) Specific Groups (CPMP, QRD, HoA HoA-East East )

15 Possible Developments I Effect of Centralisation Medium-sized companies' development of innovative products may be inhibited by in-house bundling of capacities for processing of centralised procedures in-house costs for pursuing centralised procedures fees for centralised procedures Choice of access to the market is highly necessary for companies

16 Possible Developments II Shift from national and decentralised procedures to centralised procedures Increase in centralisation of licensing systems Decrease in competition between licensing authorities Shifting of decisions from national to centralised EU authorities

17 Possible Developments II Common market Advantages Quality of supply with medicinal products of a consistently high European standard Uniform regulatory system Transparency Orientation for consumer and patient But Pharmacovigilance always stays a national responsibility!!

18 Agencies Have to Define Their Position for the Future: Team leader and/or opinion leader? Center of excellence or "full provider"? - according to approvals: - MRFG RMS / Centralised - Rapporteur - according to projects / indications (e.g. antibiotics, HIV) - according to topics (Working Parties, Notes for Guidance, Working Parties) Team player in all other cases! (The Network-System!)

19 Role and Tasks of the Agencies in the Future to be clarified : How to survive? Centre of excellence or "full provider"?

20 BfArM s Proposed Solution Cooperation on a network-basis Promotion of research and development via scientific expertise Some agencies as "full providers" Other agencies as centers of excellence Cooperation within the procedures

21 IC Estonia Estland my home country : EUROPE* NO SE FI Latvia Lettland Lithuania Litauen IR UK Thank You for NL Your kind Attention! BE DE Slovak Republic Slowakische Republic LU FR DK AT Poland Polen Hungary Ungarn PT ES IT Romania Rumänien EL Slovenia Slowenien Bulgaria Bulgarien Malta Malta Czech Republic Tschechische Rebublik *Intermediate stage 2004/7 and Turkey?