Internal Market & Regulation: Priorities for real progress in the pharmaceutical sector Bruges, 27 March 2014 Adrian van den Hoven Director General European Generic medicines Association (EGA) 2
Generic Medicines Industry: - Healthcare Sustainability - Essential for Growth and Jobs Generic Medicines account Every year Generic for Medicines bring savings of 54% 21% €35 Bn in the EU of dispensed of pharmaceutical One of the medicines expenditure Most Competitive Sectors in 7 % of turnover to R&D 150,000 Europe (e.g. new formulations, Direct employees in dosage regimes, delivery Europe systems) Exporting to more than 100 countries outside the EU 3
A Pro-Competitive Pharmaceutical Market in Europe 4
Removal of Anti-Competitive Barriers Accelerate P+R Misinformation status after MA campaigns Patent Pay-back linkage (claw-back) No double assessment after MA 5
Foster Sustainable Competition S ustainable pricing Patients Pharmacists education incentives and for information substitution Physicians Pro-generic prescription campaigns of generics on quality, (guidelines + efficacy and e- safety prescription) 6
Better Enforcement of Public Procurement Directive Inclusion of quality, availability, service standards Tougher provision on abnormal low tendering Predictable market conditions 7
An EU Pharmaceuticals Export Base 8
The Export Potential of the Pharmaceutical Sector EU generic and biosimilar EU-28 Pharma Export medicines exported to more €113.3bn (2013) than 100 countries Global Generic Market: Global biopharmaceuticals $172bn (2012) market: $199.7bn (2013) expected 10% expected 13.5% annual net annual growth growth 9
Regulatory Convergence with Key Partners (US, Japan, etc.) Mutual Recognition of Good Manufacturing Practice (GMP) Inspections • Reduce duplication of inspections • Focus resources on higher-risk areas Single Development Programmes of Generic and Biosimilar Medicines • Reduce inefficiencies, development costs & unethical duplication of studies • Boost EU industry competitiveness • Promote higher global standards 10
Regulatory Approximation with EU in Developing and Emerging Countries Approximation of regulatory standards Regulatory collaboration (regulators & Efficient industry) regulatory between EU and systems 3 rd countries (e.g. to African countries) Strengthened quality standards 11
Supplementary Protection Certificate (SPC) Pharma specific regulation Extends patent-like protection for market delay Should be a market exclusivity Major contributor to delocalisation 12
Export Exception under SPC Regulation • New Only for the 5 main EU MSs Investments • Excluding Biosimilars & API in EU 61.585 EU Growth New Jobs S PC Export Exception Manufacturing and R&D 45 New (107.162 Mio Companies Units) 13
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