EU Health Policy Briefing. 15 th January pm - 5 pm Vienna, Austria

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1 EU Health Policy Briefing 15 th January pm - 5 pm Vienna, Austria

2 8. IMS presentation on wholesaling remuneration systems

3 9. Reports on European Union health policy developments

4 Content 1. European Commission changes 2. Update on the European Commission anti-counterfeit proposal 3. European Medicines Agency (EMEA) proposal for a revision of the Good Distribution Practice Guidelines (GDP) revision 4. World Health Organisation (WHO) Good Distribution Practice (GDP) guidelines revision 5. European Federation of Pharmaceutical industries and Associations (EFPIA) pilot project on coding and authentification

5 European Commission: major changes [1] Barroso II: The new face of the European Commission has been announced by second term President Mr. José Manuel Barroso. Portfolios of the nominated Commissioners unveiled. Changes for a new five year term?"

6 European Commission: major changes [2] Most important changes of European Commissioners from GIRP s perspective: Mr. Günter Verheugen (Germany) Mr. Antonio Tajani (Italy) Enterprise & Industry (Vice President) Ms. Androulla Vassiliou (Cyprus) Mr. John Dalli (Malta) Health and Consumer Policy Mr. Charlies McCreevy (Ireland) Mr. Michel Barnier (France) Internal Market and Service Ms. Neelie Kroes (Netherlands) Mr. Joaquín Almunia (Spain) Competition (Vice President)

7 European Commission: major changes [3] Ms. Androulla Vassiliou (Cyprus) hands over Health and Consumer Policy (Directorate General Health and Consumer Protection) to Mr. John Dalli (Malta) who will take on significant additional responsibilities in the new Commission: Changes for Directorate General Health and Consumer Protection The Cosmetics and Pharmaceutical Products Units move to Directorate General Enterprise and Industry to Directorate General Health and Consumer Protection, consequently the European Medicines Agency (EMEA) comes under the Health and Consumer portfolio

8 European Commission: major changes [4] Mr. Günter Verheugen (Germany) retires and Mr. Antonio Tajani (Italy) is designated to BUT loses responsibilities in the new Commission: Changes for Directorate General Enterprise and Industry The Cosmetics Pharmaceutical Products Units move from Directorate General Enterprise and Industry to Directorate General Health and Consumer Protection, consequently the European Medicines Agency (EMEA) moves to the Health and Consumer Policy portfolio

9 European Commission: major changes [5] Procedure: All candidates will appear in individual hearings before European Parliamentary committees from 11 th -19 th January 2010 Mr. John Dalli, Commissioner designate for Health 14 th Jan Mr. Antionio Tajani, Commissioner designate for Enterprise and Industry 18 th Jan The entire College of Commissioners will be subject to a vote of approval by the European Parliament before its mandate can start (until 2014). The vote of consent on the new Commission is foreseen for 9 th February On the basis of this vote of consent, the Commission shall be appointed by the European Council and can then start work.

10 European Parliament: hearing Commissionerdesignate John Dalli (Malta) Underlying theme of his term will be: Patients First, Consumers First Patients first, but strong commitment to competitive pharmaceutical industry win-win situation possible Pharmaceutical package: Wants to move forward quickly with two non-controversial parts of package (pharmacovigilance and falsified medicines) Detach the information to patients proposal Latter needs to be reassessed to bring in more patient perspective Counterfeit medicines: Counterfeits are danger to consumers but also innovation Internet trade: same controls should apply on-line and off-line Patients' rights in cross-border healthcare needs to move forward

11 Update on European Commission anti-counterfeit proposal Proposal for a Directive amending Directive 2001/83/EC as regards the prevention of the entry into the legal supply chain of medicinal products which are falsified in relation to their identity, history or source The distribution chain has become very complex and is only as strong as its weakest link"

12 European Commission anti-counterfeit proposal: issues to achieve & avoid Issues to achieve: + Identification, definition, licensing, inspection and transparency of traders and brokers + Harmonised coding and identification system + Wholesaler interface for product verification tracability + Auditing only to complement inspections + Security of supply by manufacturers Issues to avoid: Full Track & Trace Batch and expiry date tracking at dispatch Mandatory auditing of suppliers (other wholesalers)

13 European Commission anticounterfeit proposal Overview of Parliament activities: Committee on Internal Market & Consumer Protection (IMCO) Draft Opinion: Delivered, 8 th January 2009 Committee on Industry, Research & Energy (ITRE) Draft Opinion: Delivered, 23 rd November 2009 Committee on the Environment, Public Health & Food Safety (ENVI) Draft Report: Delivered 7 th January 2010 Adoption Environment, Public Health & Food Safety (ENVI) Committee: 6 th 7 th April 2010 Adoption likely at European Parliament Plenary Session: 17 th 21 st May 2010

14 European Commission anti-counterfeit proposal: European Parliament Environment, Public Health & Food Safety committee actions [1] Environment, Public Health & Food Safety committee Rapporteur: Member of European Parliament Ms. Marisa Matias (Portugal), draft report issued 7 th January 2010: You can find the draft Report through the following link: //EP//NONSGML+COMPARL+PE DOC+PDF+V0//EN&language=EN Refers to traders and brokers. (Amendment. 7) Amends the definition for trading. (Am. 19) Introduction a definition for brokering. (Am. 20) Legal base is expanded to include the scope of Article 95 & 152 EC Treaty. (Am. 1) Takes account of the work of Council of Europe. (Am. 4) Internet pharmacy is addressed introduces awareness rising needs. (Am. 6)

15 European Commission anti-counterfeit proposal: European Parliament Environment, Public Health & Food Safety committee actions [2] Introduces definition of Falisified medicinal products. (Am. 16) Risk based approach for safety features for generics. (Am. 27) Keep costs for safety features low. (Am. 29) Introduces provisions on Internet sales. (Am. 39)

16 European Commission anti-counterfeit proposal: European Parliament Environment, Public Health & Food Safety committee actions [3] GIRP concerns: Draft report does not properly cover the responsibilities, liabilities, licenses, visibility (database), etc of traders and brokers. Wholesalers must check whether the medicinal products they have purchased are not falsified by authenticating the safety feature on the outer packaging;. (Am. 34) Wholesalers (e) must keep records. giving for any transaction. at least the following information. batch number;. registration number of the marketing authorization;. (Am. 35)

17 European Commission anti-counterfeit proposal: European Parliament Environment, Public Health & Food Safety committee actions [4] Next steps for European Parliament: Deadline for amendments to draft report: 9 th February 2010 Vote in European Parliament Environment, Public Health & Food Safety Committee on draft & amendments in 6 th 7 th April 2010 Vote in European Parliament Plenary Session 17 th 21 st May 2010 Next steps for GIRP Lobby members of the Environment, Public Health & Food Safety Committee for amendments: to cover responsibilities, liabilities, licenses, visibility arrangements (database), etc of brokers and traders to change Am. 34 for wholesalers to randomly check to change Am. 35 so that wholesalers do not have to keep records of the batch number, but ok with them keeping the national identification number as appropriate.

18 GIRP proposed amendment for Environment, Public Health & Food Safety Committee Rapporteur Report Amendment 34 by GIRP proposed Amendment 8: European Commission anti-counterfeit proposal: European Parliament Environment, Public Health & Food Safety committee actions [5]

19 GIRP proposed amendment for Environment, Public Health & Food Safety Committee Rapporteur Report Amendment 35 by GIRP proposed Amendment 9: European Commission anti-counterfeit proposal: European Parliament Environment, Public Health & Food Safety committee actions [6]

20 European Commission anti-counterfeit proposal: European Parliament Industry, Research & Energy Committee Draft Opinion actions [1] Industry, Research & Energy Committee Draft Opinion Rapporteur: MEP Amalia SARTORI (Italy) draft Opinion issued 23 rd November 2009: You can find the draft Opinion through the following link: //EP//NONSGML+COMPARL+PE DOC+PDF+V0//EN&language=EN Refers to need to address internet. (Amendment 1) Refers to traders and brokers. (Am. 3) Introduces definition of Falisified medicinal products. (Am. 8) Intro. def. for brokering. (Am. 9) Sunset clause. (Am. 19) Covers the responsibilities, liabilities, licenses, visibility (database), etc. of traders and brokers. (Am. 18, 20, 21, 22, 23, 24, 26, 27, 30, 31, 32, 33, 34 and 38)

21 European Commission anti-counterfeit proposal: European Parliament Industry, Research & Energy Committee Draft Opinion actions [2] GIRP concerns: Draft Opinion does not amend definition for trading, but GIRP has been in contact with the Rapportuer and this will be amended. Draft Opinion introduces an exemption to the safety features based on their channel of distributions (Amendment 4 and 14). Amendments 4 and 14 state that products directly delivered by producers to clinical establishments in which they are directly administered to patients should be exempted from the safety features requirements.

22 European Commission anti-counterfeit proposal: European Parliament Industry, Research & Energy Committee Draft Opinion actions [3] Next steps for European Parliament: Deadline for amendments to Industry, Research & Energy Committee draft Opinion: 21 st January 2010 Vote in Industry, Research & Energy Committee on draft Opinion 23 rd February 2010 Next steps for GIRP Lobby members of the Industry, Research & Energy Committee to: Reject amendments 4 and 14 of Opinion of Mrs. Sartori Support an alternative amendment to 14 as proposed by MEP s sympathetic to GIRP s concern Make editorial amendments Introduce a definition of persons authorised to supply.

23 Article 81 paragraph 2 Directive 2001/83/EC: The holder of a marketing authorisation for a medicinal product and the distributors of the said medicinal product actually placed on the market in a Member State shall, within the limits of their responsibilities, ensure appropriate and continued supplies of that medicinal product to pharmacies and PERSONS AUTHORISED TO SUPPLY medicinal products so that the needs of patients in the Member State in question are covered.

24 While it is not mentioned Industry, Research & Energy Committee Draft Opinion GIRP has proposed amendment for persons authorised to supply: European Commission anti-counterfeit proposal: European Parliament Industry, Research & Energy Committee Draft Opinion actions [4]

25 European Commission anti-counterfeit proposal: European Parliament Internal Market Commitee actions [1] Internal Market Committee Rapporteur: Member of European Parliament Ms. Regina Bastos (Spain) draft opinion Delivered, 8 th January 2010 You can find the draft Report through the following link: //EP//NONSGML+COMPARL+PE DOC+PDF+V0//EN&language=EN GIRP concerns: GIRP has a concern with Amendment 6 of the draft Opinion possible ban on commercial use of data on distribution channels Next steps for European Parliament: Deadline for amendments to draft Internal Market Committee draft Opinion: 2 nd February, TBC Vote in Internal Market committee on draft IMCO Opinion: 17 th March 2010 Next steps for GIRP Eventually monitor that there is no risk to members interests with regard to data use

26 European Commission anti-counterfeit proposal: Council of the European Union actions [1] Health Council meeting on 30 th November 2009 European Union Swedish Presidency: Reached tentative agreement on a number of technical aspects, including: The definition of "falsified medicinal products The proposed definition of ''trading of medicinal products'' has been changed to ''brokering of medicinal products'' and amended, thereby clarifying which actors in the supply chain should be subject to the responsibilities of brokers No revision of the request for batch number recording for deliveries

27 European Commission anti-counterfeit proposal: Council of the European Union actions [2] 11 MS s (AT, BE, EE, ES, DE, FR, LV, NL, AT, PL, PT, SI & UK) still propose the introduction of the need for wholesalers to keep records of the BATCH NUMBER for the dispatches of medicines to pharmacies Other elements: Majority of Member States oppose accreditation, since they maintain that such a system could result in a transfer of responsibility from manufacturers and importers as well as make enforcement by national competent authorities more difficult.

28 European Medicines Agency (EMEA) Good Distribution Practice (GDP) guidlines revision [1] European Medicines Agency (EMEA) concept paper published proposing a revision of the European GDP guidelines GIRP submitted a comprehensive response to this consultation 28 th May 2009 Draft GDP proposal expected in 2010 Public consultation on draft proposal GIRP responsible Working Groups: Legal Affairs Committee Technical Committee

29 European Medicines Agency (EMEA) Good Distribution Practice (GDP) guidlines revision [2] GIRP submitted a comprehensive response to this consultation: Clear definitions for all supply chain operators Licensing categorisation to cover all operators not only wholesalers Clear responsibilities and liabilities Harmonised conditions for granting new licenses Harmonised conditions for inspecting existing licenses EMEA database of all license holders and inspection status indicators Mandatory inspection before license reactivation Harmonised inspection reports PART A for wholesale distributors, PART B for traders & brokers

30 World Health Organisation (WHO) Good Distribution Practice (GDP) guidelines [1] Proposal for revising WHO GDP Currently being discussed by a WHO Expert Committee Areas of remaining concern for GIRP: Definition of distribution Language on traceability Requirements for documentation (batch no. & expiry date) Temperature control & cold chain (separate document) WHO expected to adopt revised GDP October 2010

31 Launched in Stockholm in October European Fedieration of Pharmaceutical Industries and Assocaitions (EFPIA) pilot project coding and authentification [1] 23 pharmacies scanning about 110,000 pharmaceutical packs TAMRO and Oriola involved in product labeling and delivery Next Steps The pilot will be finalised at the end of January Evaluation & Reporting of the pilot project: Pharmacist evaluation, online questionnaire has been sent to all 255 pharmacists who took part in the pilot. Meeting 13 or 14 January 2010 in Stockholm on the issues faced by pharmacists. The response of the questionnaire will be shared Project Reporting - draft report being prepared by EFPIA

32 10. Upcoming GIRP events a. 51 st Annual General Meeting, 6 th 8 th June 2010, Cannes, France

33 5 th JUNE 2010 Managing Board 4 pm - 6 pm Martinez Hotel, Cannes 6 th JUNE 2010 Board 1 pm - 3 pm Martinez Hotel, Cannes EU Briefing 3.30 pm 4.30 pm Martinez Hotel, Cannes Annual General Assembly 5 pm - 6 pm Martinez Hotel, Cannes Welcome Dinner 8 pm onwards Palais Stéphanie Hotel, panorama roof top restaurant 7 th JUNE 2010 Annual Conference Spouses Programme 9 am - 6 pm Martinez Hotel, Cannes 9.30 am pm To be determined Gala Dinner 8 pm onwards To be determined 8 th JUNE 2010 Annual Conference Farewell Lunch 10 am - 1 pm Martinez Hotel, Cannes 1 pm onwards Zplage, open air beach restaurant

34 Vienna Meetings 15 th JANUARY 2010 Heurigen 16 th JANUARY 2010 Cocktail Reception 7.30 pm pm 6.30 pm Zimmermann Transport from hotel at 6.30 pm Tranport back to hotel at to Le Méridien Hotel, Vienna Transport to Hofburg at 8 pm Pharmacy Ball 8 pm - 3 pm Hofburg Vienna

Autumn Meeting 2010 9 th November 2010 Managing Board meeting Board meeting

35 Autumn Meeting th November 2010 Managing Board meeting Board meeting Autumn General Assembly 10 th November 2010 Autumn Conference EP Reception BRUSSELS

36 5 th 7 th June TALLINN Annual General Meeting 2011

37 Thank You Full presentation available via the GIRP website:

Therefore the provision of medicines is an area for which a Community regulatory framework should be properly supervised to ensure full and

Therefore the provision of medicines is an area for which a Community regulatory framework should be properly supervised to ensure full and European Association of Pharmaceutical Full-line Wholesalers (GIRP) response to the European Commission Consultation regarding Community action on Health Services Introduction Firstly, GIRP welcomes the