Internal Market & Regulation: Priorities for real progress in - - PowerPoint PPT Presentation

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)

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Generic Medicines Industry:

• Healthcare Sustainability
• Essential for Growth and Jobs

Every year Generic Medicines bring savings of

€35 Bn in the EU

Generic Medicines account for

54% 21%

• f dispensed
• f pharmaceutical

medicines expenditure

150,000

Direct employees in Europe

7 % of turnover to R&D

(e.g. new formulations, dosage regimes, delivery systems)

One of the Most Competitive Sectors in Europe

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Exporting to more than 100 countries outside the EU

A Pro-Competitive Pharmaceutical Market in Europe

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Removal of Anti-Competitive Barriers

Patent linkage Accelerate P+R status after MA No double assessment after MA Pay-back (claw-back) Misinformation campaigns

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Foster Sustainable Competition

S ustainable pricing Pharmacists incentives for substitution Physicians prescription

• f generics

(guidelines + e- prescription) Pro-generic campaigns

• n quality,

efficacy and safety Patients education and information

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Better Enforcement of Public Procurement Directive

Inclusion of quality, availability, service standards Tougher provision on abnormal low tendering Predictable market conditions

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An EU Pharmaceuticals Export Base

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The Export Potential of the Pharmaceutical Sector

EU-28 Pharma Export €113.3bn (2013) EU generic and biosimilar medicines exported to more than 100 countries Global Generic Market: $172bn (2012)

 expected 10%

annual net growth Global biopharmaceuticals market: $199.7bn (2013)

 expected 13.5%

annual growth

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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

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Regulatory Approximation with EU in Developing and Emerging Countries

Approximation

• f regulatory

standards Efficient regulatory systems Strengthened quality standards

Regulatory collaboration (regulators & industry) between EU and 3rd countries (e.g. to African countries) 11

Supplementary Protection Certificate (SPC)

Pharma specific regulation Extends patent-like protection for market delay Should be a market exclusivity

Major contributor to delocalisation

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Export Exception under SPC Regulation

S PC Export Exception

New Investments in EU

Manufacturing and R&D (107.162 Mio Units)

45 New Companies

61.585 New Jobs

EU Growth

• Only for the 5 main EU MSs
• Excluding Biosimilars & API

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