EU Issues Tracking Sheet - EFPIA Patient Think-Tank

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					                                                                                                                EU Issues Tracking Sheet
                                                                                                                                    November 2009

PHARMACEUTICAL PACKAGE

             European Parliament: appointed MEPs


COMMITTEE                 APPOINTMENTS              ANTI-COUNTERFEITING    INFORMATION TO PATIENTS        PHARMACOVIGILANCE
       ENVI




                                                       Marisa Matias          Christofer Fjellner            Linda McAvan
                           Rapporteur
                                                        (PT, GUE)                (SW, EPP)                     (UK, S&D)
       IMCO




                                                                          Antonio Correia de Campos
                                                      Regina Bastos
                          Draftsperson                                             (PT, S-D)          Claude Turmes (LUX, Greens)
                                                        (PT, EPP)
                                                                          Cristian Busoi (RO, ALDE)
       ITRE




                                                       Amalia Sartori     Jorgo Chatzimarkakis (DE,          Michèle Rivasi
                          Draftsperson
                                                        (IT, EPP)                  ALDE)                     (FR, Greens)



             European Parliament: timetable of the lead committee


COMMITTEE                    STATUS                 ANTI-COUNTERFEITING    INFORMATION TO PATIENTS        PHARMACOVIGILANCE

                                                     1 September 2009                                      1 September 2009
                       Exchange of views                                      1 September 2009
                                                     2 December 2009                                       5 November 2009
                    Text sent to translation                                 11 November 2009              3 December 2009
                   Consideration draft report                               30 Nov. – 1 Dec. 2009
   ENVI




                                                      25 January 2010                                    25-26-27 January 2010
                     Deadline amendments              3 February 2010         8 December 2009               3 February 2010
                      Exchange of views                                        26 January 2010
                   Discussions amendments                                     10 February 2010
                      Vote in Committee                6 March 2010              6 April 2010               16 March 2010
                         Plenary vote                  20 April 2010             18 May 2010                 20 April 2010




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                                                                                                                         EU Issues Tracking Sheet
                                                                                                                                                    November 2009

   Council of Ministers: working party


            DATE                                                                       AGENDA

           13 July                  Anti-counterfeiting (definitions and scope)
                                    Pharmacovigilance (Continued examination, in particular concentrating on: - the Opinion of the European
           20 July:                 Data Protection Supervisor, - the EudraVigilance database, - the composition and role of the
                                    Pharmacovigilance Risk Assessment Advisory Committee)
                                    Pharmacovigilance (Continued examination, in particular concentrating on: - the composition and role of the
         3 September                Pharmacovigilance Risk Assessment Advisory Committee; - data protection; - the "Pharmacovigilance
                                    Chapter" (Title II, Chapter 5) of the proposed regulation)
                                    Anti-counterfeiting (continued examination, in particular concentrating on accreditation, definitions and
        25 September
                                    scope)
                                    Pharmacovigilance (Continued examination, in particular concentrating on: - the transitional provision, - the
          2 October:                role of CMD(h), - Community procedures, - transparency and communications, - recording and reporting of
                                    adverse reactions (poss.), - PSUR reporting (poss.), - PASS reporting (poss.)
                                    Anti-counterfeiting (Continued examination, in particular concentrating on accreditation, definitions and
          9 October
                                    scope).
                                    Anti-counterfeiting (Continued examination, in particular concentrating on accreditation, definitions and
        22-23 October
                                    scope).
                                    Pharmacovigilance (Continued examination, in particular concentrating on: - Community procedures and
                                    referrals; - Recording and Reporting of adverse reactions; -PSUR reporting; - PASS reporting; - (possible)
        5-6 November
                                    Summary of Essential Information and Definitions; Preparation of progress report) - Anti-counterfeiting
                                    (Preparation of progress report).
                                    Pharmacovigilance of medicinal products for human use (Preparation of progress report based on a
        12 November                 Presidency document to follow); Falsified medicines-(Preparation of progress report; Continued
                                    examination, in particular concentrating on excipients)
        23 November                 Pharmacovigilance

         8 December                 Anti-counterfeiting




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                                                                                                                                      EU Issues Tracking Sheet
                                                                                                                                                                   November 2009

EPSCO (EMPLOYMENT, SOCIAL POLICY, HEALTH AND CONSUMER AFFAIRS COUNCIL) – SWEDISH EU PRESIDENCY

1 December (prov.): Progress reports on the Pharmacovigilance and Anti-Counterfeiting proposals.
      Information from the Presidency on Information to Patients


       Issue             European Commission                      European Parliament              Council of Ministers                   Summary                        Link

OTHER LEGISLATIONS
                                                            Lead committee: Agriculture (AGRI)
                                                            Rapporteur: Neil Parish (EPP-ED,
                                                            UK)
                                                                                                  Working group on
                                                                                                  animal welfare:
                                                            Opinion committees:
                                                                                                  6-7 July                  The directive contains measures in
                      - European Commission DG:             - Industry and Research (ITRE)
                                                                                                  23-24 July                the field of ethical evaluation,        Environment -
Animal welfare:       Environment                           Draftsperson: Esko Seppanene
                                                                                                  11 September              authorization, promotion of the 3Rs     Chemicals -
review directive      - Date of publication: 5 Nov. 2008    (GUE, FIN)
                                                                                                  25 September              (Refinement, Reduction and              Laboratory
86/609                - Procedure: co-decision              - Environment and Public Health
                                                                                                                            Replacement), primates, severity and    Animals
                                                            (ENVI)
                                                                                                  Adoption foreseen in      reuse, housing and care.
                                                            Draftsperson: Marios Matsakis
                                                                                                  the Agriculture council
                                                            (ALDE, CY)
                                                                                                  on 19 November 2009.
                                                            Timing:
                                                            Plenary vote: 5 May 2009
                                                                                                                            This directive provides a Community
                                                            Lead Committee: Environment and
                                                                                                                            framework for safe, high quality and    http://ec.europa.
Directive on the      - European Commission DG:             Public Health (ENVI)
                                                                                                                            efficient health services, by           eu/health/ph_ov
application of        SANCO                                 Rapporteur: John Bowis (EPP-ED,       1 December 2009:
                                                                  st                                                        reinforcing cooperation between         erview/co_opera
patients’ rights in   - Date of publication: 2 July 2008    UK) 1 reading                         Council: political
                                                                                                                            Member States and providing             tion/mobility/com
cross-border health   - Consultation: ended on 31           Timing:                               agreement
                                                                                                                            certainty over the application of       munity_framewo
care                  January 2007                          ENVI vote: 12 March 2009
                                                                                                                            Community law to health services        rk_en.htm
                                                            Plenary: 23 April 2009
                                                                                                                            and healthcare.

                                                            Lead committee: Environment and                                                                         http://ec.europa.
Communication                                               Public Health (ENVI)                                                                                    eu/health/ph_inf
                      - European Commission DG
Action against                                              Rapporteur: Alojz Peterle (EPP, SL)                                                                     ormation/dissem
                      SANCO
Cancer: European                                                                                                                                                    ination/keydocs_
                      - Date of publication: 24 June 2009
Partnership                                                 Timing :                                                                                                dissemination_e
                                                            Plenary vote : 19 April 2010                                                                            n.htm


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                                                                                                                 EU Issues Tracking Sheet
                                                                                                                                                 November 2009


        Issue           European Commission              European Parliament   Council of Ministers                 Summary                             Link


                                                                                                      In its Communication of 10 December
                                                                                                      2008 to the European Parliament, the
                                                                                                      Council, the European Economic and
                                                                                                      Social Committee and the Committee
                                                                                                      of the Regions on “Safe, Innovative
                                                                                                      and Accessible Medicines: a
                                                                                                      Renewed Vision for the
                     - European Commission DG:                                                        Pharmaceutical Sector”, the                 http://ec.europa.
                     Enterprise                                                                       Commission announced that an                eu/enterprise/ph
                     - Assessment: expected date of                                                   assessment would be made of the             armaceuticals/cli
Clinical Trials
                     publication: 2010                                                                application of the Clinical Trials          nicaltrials/docs/2
Directive
                     - Public consultation paper                                                      Directive.                                  009_10_09_publ
                     published 9 Oct. 2009 (deadline 8                                                                                            ic-consultation-
                     January 2010)                                                                                                                paper.pdf
                                                                                                      This assessment would consider, in
                                                                                                      particular, various options for
                                                                                                      improving the functioning of the
                                                                                                      Clinical Trials Directive with a view to
                                                                                                      making legislative proposals, if
                                                                                                      appropriate, while taking the global
                                                                                                      dimension of clinical trials into
                                                                                                      account.
                                                                                                      The Communication sets out priorities
                                                                                                      to tackle HIV/AIDS across Europe in
                                                                                                      the coming years. The Commission
                                                                                                      strategy aims to contribute:
Communication                                                                                         -    to reduce new HIV infections
Combating HIV/AIDS                                                                                         across all European countries by       http://ec.europa.
                     - European Commission DG
in the European                                                                                            2013,                                  eu/health/ph_thr
                     SANCO
Union and                                                                                                                                         eats/com/aids/c
                     - Date of publication: 26 October                                                -    to improve access to prevention,
neighbouring                                                                                                                                      om_aids_en.htm
                     2009                                                                                  treatment, care and support and
countries, 2009 -
2013                                                                                                  -    to improve the quality of life of
                                                                                                           people living with, affected by or
                                                                                                           most vulnerable to HIV/AIDS in
                                                                                                           the European Union and
                                                                                                           neighbouring countries.



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                                                                                                                    EU Issues Tracking Sheet
                                                                                                                                                  November 2009


        Issue              European Commission              European Parliament   Council of Ministers                Summary                           Link

                                                                                                         The need for further action arises
                                                                                                         because of increasing evidence on
                                                                                                         the size and pervasiveness of health
                                                                                                         inequalities across the EU and
                                                                                                         concerns about the negative
                                                                                                         consequences for health, social
                                                                                                         cohesion and economic development
                                                                                                         if health inequalities are not
                                                                                                         effectively tackled. Existing actions
                                                                                                         appear to have had only limited            http://ec.euro
                                                                                                         impact and there is a risk that these
Communication
                                                                                                         gaps could widen as a result of recent
                                                                                                                                                    pa.eu/health/
                        - European Commission DG
Solidarity in Health:                                                                                                                               ph_determina
                        SANCO                                                                            economic difficulties. Moreover better
Reducing health
inequalities in the
                        - Date of publication: 20 October                                                levels of health across all population     nts/socio_eco
                        2009                                                                             groups are critical in the context of an
EU
                                                                                                         ageing EU population to contribute to
                                                                                                                                                    nomics/cons_
                                                                                                         the sustainability of social protection    inequalities_e
                                                                                                         systems.                                   n.htm
                                                                                                         (…) The European Commission can
                                                                                                         contribute by ensuring that relevant
                                                                                                         EU policies and actions take into
                                                                                                         account the objective of addressing
                                                                                                         the factors which create or contribute
                                                                                                         to health inequalities across the EU
                                                                                                         population.




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                                                                                                             EU Issues Tracking Sheet
                                                                                                                                            November 2009



      Issue            European Commission           European Parliament   Council of Ministers                Summary                           Link

                                                                                                  There are four key issues that
                                                                                                  Community action could help to
                                                                                                  address:
                                                                                                  – There is a lack of awareness of the
                                                                                                  importance of prevention and early
                                                                                                  intervention throughout the EU;
                                                                                                  – There is a clear need for improved
                                                                                                  understanding of dementias. Yet
                                                                                                  there is very limited coordination of
                                                                                                  research, an issue with particular
                                                                                                  potential for European added value,
Communication on                                                                                  and a lack of sufficient
a European          - European Commission DG                                                      epidemiological data to help direct
initiative on       SANCO                                                                         research and action in the future;         COM(2009)38
Alzheimer’s         - Date of publication: 22 July                                                – There are good practices emerging        0
disease and other   2009                                                                          in different places across the EU with
dementias                                                                                         regard to diagnosis, treatment and
                                                                                                  financing of therapies for these
                                                                                                  conditions, but they are not being
                                                                                                  shared throughout the Union. –
                                                                                                  Insufficient attention is being paid to
                                                                                                  rights of people suffering from a
                                                                                                  cognitive deficit. There is also a lack
                                                                                                  of understanding by the general
                                                                                                  public of what Alzheimer's disease is,
                                                                                                  and a stigma associated with
                                                                                                  dementias that can influence the
                                                                                                  health of these patients.




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