AHD/APHA SEMINAR 18/9/02

1. AHD/APHA SEMINAR 18/9/02 EU REVIEW OF MEDICINES LEGISLATION

2. EU REVIEW OF MEDICINES LEGISLATION Summary of key developments to date: • Summer 2001 – Commission adopts proposals; • November 2001 – Commission formally submits proposals to Council and Parliament.

3. EU REVIEW OF MEDICINES LEGISLATION What has happened to proposals since? • Detailed discussions within Council framework - Belgian Presidency began process Dec. ’01 -Spanish Presidency several meetings 1st half 2002 - Danish Presidency taking process forward to end 2002

4. EU REVIEW OF MEDICINES LEGISLATION Spanish Presidency concluded with ‘Orientation Debate’ by Health Ministers June ‘02; • Debate focussed on two issues: Scope of Centralised Procedure & Composition of EMEA Management Board

5. EU REVIEW OF MEDICINES LEGISLATION Danish Presidency July – December ‘02: • Stated policy to focus on centralised regime • Human and veterinary Directives to be left to Greek Presidency

6. REVIEW OF EU MEDICINES LEGISLATION • REMEMBER, CO-DECISION APPLIES: • FIRST FORMAL RESPONSE FROM EP IN OCTOBER ’02: • IF NO AGREEMENT EP/COUNCIL 2ND AND 3RD READING: • IF STILL NO AGREEMENT, CONCILIATION

7. EU REVIEW OF MEDICINES LEGISLATION • CURRENT SATE OF PLAY ON MAIN ISSUES DISCUSSED: LEGAL BASIS FOR PROPOSALS - ISSUE EMERGING BETWEEN COUNCIL AND COMMISSION;

8. MAIN ISSUES – CURRENT SITUATION EXTENSION OF CENTRALSIED PROCEDURE; • SIGNIFICANT OPPOSITION FROM MEMBER STATES; • STRATEGY TO SEPARATE VET FROM HUMAN

9. MAIN ISSUES (contd.) EMEA MANAGEMENT BOARD; COMMISSION WANTS 4X4X4X4 MODEL; • MEMBER STATES WANT GREATER INPUT; • VARIOUS MODELS DISCUSSED

10. MAIN ISSUES (contd.) UNLIMITED LICENSE TERM/ 2 YEAR MARKETING REQUIREMENT: • SIGNIFICANT UNEASE FROM MEMBER STATES; • COMMISSION OFFERING ADDITIONAL SAFEGUARDS;

11. MAIN ISSUES (contd.) CASCADE; • COMMISSION PROPOSALS GENERALLY WELCOMED; • SUGGESTIONS; • THAT CASCADE BE ALLOWED WHERE LESS EFFECTIVE MEDICINE IS AVAILABLE; • THAT VETS. CAN IMPORT MEDICINES FROM OTHER COUNTRIES; • SOME PRESSURE TO REMOVE ‘6 MONTH RULE’ FOR HORSES

12. MAIN ISSUES (contd.) DATA PROTECTION: • GOOD SUPPORT FOR STANDARD 10 YEARS; • + 3 - FEELING THAT 3YEAR PERIOD ALLOWED FOR ADDITIONAL SPECIES TOO SHORT; • REQUEST TO EXTEND 13Y STANDARD (FISH AND BEES) TO ALL MINOR SPECIES; • REQUEST TO BE ABLE TO SUBMIT DOSSIERS DURING DATA PROTECTION

13. MAIN ISSUES (contd.) ‘POM’ FOR ALL FOOD-PRODUCING ANIMALS; • NOT YET DISCUSSED IN DETAIL; • WE WILL NEED TO BE CONVINCED OF PUBLIC HEALTH GAIN; • DIFFERENT APPLICATIONS OF ‘POM’ RULE AND DEFINITION OF MEDICINE ALSO RELEVANT.

14. AHD/APHA SEMINAR 18/9/02 EU REVIEW OF MEDICINES LEGISLATION