1 Addressing the challenges: Variations: timing key upcoming - PDF document

Commission Communication on a strategy Initiative of the EU Commission: for the sector Follow up to the Public consultation on the future of the � Identifying and addressing the challenges: Safe, pharmaceutical sector Innovative and Accessible Medicines. A Renewed Vision for the Pharmaceutical Sector � A comprehensive overview of the challenges EU Regulatory Network and the Commission’s proposals for action, Rijeka, 13 November 2008 Martin TERBERGER across a wide range of areas (access to Head of Unit - Pharmaceuticals medicines, internal market, competitive EU industry, safety of medicines, globalisation, innovation and research, etc) European Commission European Commission Title of the presentation | Date | 1 Title of the presentation | Date | 2 Enterprise and Industry Enterprise and Industry EU legal framework for Outline pharmaceuticals � The EU legal framework for pharmaceuticals: � Placing on the market of medicinal products evolution and current regulatory challenges subject to the granting of a marketing authorisation (MA) � Key upcoming initiatives: agenda for 2008 � Progressive harmonisation of requirements for onwards MA since 1960s, implemented across the EEA � Overall system dependent also on the proper � The issue of availability in small markets: functioning of the network of competent reflections from a regulatory perspective authorities European Commission European Commission Title of the presentation | Date | 3 Title of the presentation | Date | 4 Enterprise and Industry Enterprise and Industry Regulatory challenges: current trends Regulatory challenges � Ensuring availability of authorised medicines � Ensuring a high level of protection of public and affordability health: legal framework in constant evolution as � Competitiveness and innovation in Europe a result of scientific and technical progress � Evaluating the procedures for marketing � Addressing market fragmentation: a true single authorisation and the functioning of the network market in medicines � Several layers of rules (Community and of competent authorities � Globalisation national legislation, guidelines, international harmonisation) � Simplification and better regulation European Commission European Commission Title of the presentation | Date | 5 Title of the presentation | Date | 6 Enterprise and Industry Enterprise and Industry 1

Addressing the challenges: Variations: timing key upcoming initiatives New legal basis applies BUT no change until EC Adoption Co-decision Codecision 1 has exercised � On-going: Revision of the variations framework EC proposal its new power � “ Pharma package ” for adoption in October 2008: 2008 2009 2010 2011 • Commission Communication on a renewed strategy EC adoption Transitional Application of 2 (MRP/CP for the pharmaceutical sector period the new rules only) (MRP/CP only) Fully • Legal proposal on Safety of the supply chain harmonised Comitology system • Legal proposal on Information to patients applies • Legal proposal on Pharmacovigilance Inclusion of Transitional 3 purely national period variations European Commission European Commission (3rd step comitology Title of the presentation | Date | 7 Title of the presentation | Date | 8 Enterprise and Industry Enterprise and Industry proposal) Variations: next steps Globalisation poses new challenges for Guidelines regulator and internal market • Different technical/scientific groups contribute to drafting • EMEA coordinates this drafting Example: • Commission to finalise the first draft Counterfeit medicines and API • Broad consultation of Member States and stakeholders • Legal scrutiny and adoption Fees – Regulation to be amended European Commission European Commission Title of the presentation | Date | 9 Title of the presentation | Date | 10 Enterprise and Industry Enterprise and Industry Counterfeit medicines: looking a different aspects: Information to patients 3. 2. 1. Manufacture, • Clarify the legal framework how the Manufacture, Actors Placing on the industry can provide information on Placing on the in Market of prescription-only-medicines to patients Market of the Medicinal Active • Keep the ban for advertisement for supply chain Substances Products these medecines & & • Keep in general the rules for OTC Inspections Inspections medicines European Commission European Commission Title of the presentation | Date | 11 Title of the presentation | Date | 12 Enterprise and Industry Enterprise and Industry 2

Conclusions � Commission launching debate on the future Pharmacovigilance strategy for the pharmaceutical sector, to ensure safe, innovative and accessible • Need to strengthen and rationalise the medicines EU-system widely accepted by � Imminent adoption of a legislative package stakeholders addressing certain of the current regulatory challenges � Availability of medicines gaining visibility in the political debate and one of the challenges for the coming years European Commission European Commission Title of the presentation | Date | 13 Title of the presentation | Date | 14 Enterprise and Industry Enterprise and Industry 3