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Pharmaceuticals Policy in the EU

Latest news on the pharmaceutical policies of the European Union.

Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human, CMDh
The Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human, CMDh, has been set up in the revised Pharmaceutical Legislation (Directive 2004/27/EC amending Directive 2001/83/EC) for the examination of any question relating to marketing authorisation of a medicinal product in two or more Member States in accordance with the mutual recognition procedure or the decentralised procedure.

EU drug markets report: key findings
Europe is entering an important new era in the supply and demand for illicit drugs -- a development which is challenging current policies and responses. This is according to the first joint EU drug markets report from the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) and Europol released today in Brussels. The two EU agencies have joined forces to provide the first strategic analysis of the European illicit drug market in its entirety. In the report, they describe a market which is increasingly dynamic, innovative and quick to react to challenges and one which requires an equally dynamic, innovative and agile response across Europe. The report unveils the ‘changing face of organised crime in Europe’: while, historically, the EU drug market has focused on specific drugs trafficked by specialised operators along well-defined routes, the contemporary market is more ‘fluid’, with new routes and multi-substance consignments becoming more common.

EC measures to tackle biopiracy and facilitate nature-based research
Researchers and companies in the EU received a boost today with a new proposal that should provide reliable access to genetic resources from outside the Union. The proposal – a draft Regulation that would implement the 'Nagoya Protocol on Access to Genetic Resources and Benefit-sharing' – is designed to protect the rights of countries and of indigenous and local communities that allow their genetic resources and associated traditional knowledge to be used, while also giving researchers in Europe improved, reliable access to quality samples of genetic resources at low cost with high legal certainty.

Antimicrobial Resistance - guide
With about 25,000 patients dying per year in the EU from infections caused by drug resistant bacteria and related costs of over 1.5 billion euros in healthcare expenses and productivity losses , antimicrobial resistance is a growing health problem in the EU. Today, on the eve of European Antibiotic Awareness Day, the European Commission tabled a comprehensive Action Plan on Antimicrobial resistance (AMR) which unveils12 concrete actions to be implemented in close cooperation with the EU Member States.

Information to patients on prescription-only medicines - guide
The European Commission has adopted revised proposals clarifying the information that industry can supply to the public on prescription-only medicines.

EU Register of Clinical Trials
From 22 March 2011, all EU citizens have access to information on the thousands of authorised pharmaceutical clinical trials that are under way in the EU. The aim of this official public register is to make clinical research on pharmaceuticals more transparent for patients and others and to avoid unnecessary duplication of clinical trials. Every year approximately 4000 clinical trials are authorised in the EU. Since most of them last 2 to 3 years, this means that around 10,000 trials are ongoing at any given time.

European Medicines Agency
The European Medicines Agency is a decentralised body of the European Union, located in London. Its main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use.

EU approves acquisition of Millipore by Merck
The European Commission has cleared under the EU Merger Regulation the acquisition of Millipore, a US-based life science group of companies by the German pharmaceutical and chemical company Merck.

Incentive driven pharmaceutical prescription is lawful, EU Court rules
The European Court of Justice has ruled that public authorities may offer financial incentives to induce doctors to prescribe cheaper medicinal products. However, those authorities are required, first, to ensure that the incentive scheme is based on non-discriminatory objective criteria and, second, to make public, inter alia, the therapeutic evaluations relating to the scheme

Cheaper drugs incentive schemes ruled legal by European court
The European Court of Justice has ruled that public authorities may offer financial incentives to induce doctors to prescribe cheaper medicinal products.

CASELEX:EU:2008:92 - IP Law - Trade marks - Pharmaceutical products
The reference was made by the Oberster Gerichtshof (Austria) in the course of proceedings between The Wellcome Foundation Ltd (‘Wellcome’), proprietor of the Austrian trade mark ZOVIRAX, and Paranova Pharmazeutika Handels GmbH (‘Paranova’), concerning pharmaceutical products under the ZOVIRAX trade mark, marketed in Member States of the European Economic Area (‘EEA’) by Wellcome or by third parties, and the subject of parallel importation by Paranova and marketing by the latter in Austria, after having been repackaged.

The EU drugs action plan (2009-2012)
This action plan establishes five priorities to be implemented in the fight against drugs: coordination at European and national levels, reduction of demand for drugs, reduction of supply of drugs, international cooperation and information on the drugs phenomenon.

The role of the European Commission is to ensure that all players on the pharmaceuticals market (EU Member States, national health services and pharmaceutical companies) respect the Treaty rules on free competition and the free movement of goods and services within the internal market.

Information Communication Technologies Policy Support Programme (ICT PSP)
The ICT Policy Support Programme (or ICT PSP) aims at stimulating innovation and competitiveness through the wider uptake and best use of ICT by citizens, governments and businesses.

EU pharmaceutical sector inquiry - briefing
Market entry of generic drugs is delayed and there is a decline in the number of novel medicines reaching the market, according to the European Commission's final report on competition in the pharmaceutical sector. The sector inquiry suggests that company practices are among the causes, but does not exclude other factors such as shortcomings in the regulatory framework. As a follow up, the Commission intends to intensify its scrutiny of the pharmaceutical sector under EC antitrust law, including continued monitoring of settlements between originator and generic drug companies. The first antitrust investigations are already under way. The report also calls on Member States to introduce legislation to facilitate the uptake of generic drugs. The report notes near universal support amongst stakeholders for a Community Patent and specialised patent litigation system in Europe.

ICT Policy Support Programme
The ICT Policy Support Programme (or ICT PSP) aims at stimulating innovation and competitiveness through the wider uptake and best use of ICT by citizens, governments and businesses.

Pharmaceuticals Unit: Contacts

Funding opportunities in the EU pharmaceutical industry
Expand your business in the pharmaceutical industry through the Entrepreneurship and Innovation Programme developed by the European Commission to support innovation and SMEs in the EU.

Priorities for the Pharmaceutical sector in the EU
The pharmaceutical sector is extensively regulated by the European Union in the dual interest of protecting public health while completing the single market for pharmaceuticals.

The Rules Governing Medicinal Products in the European Union
The body of European Union legislation in the pharmaceutical sector is compiled in Volume 1 and Volume 5 of the publication “The rules governing medicinal products in the European Union”. The basic legislation is supported by a series of guidelines that are also published in the “The rules governing medicinal products in the European Union”.

The EU and International Cooperation in Pharmaceuticals
The European Commission is an active member of the World Health Organisation’s International Medical Products Task Force (IMPACT). IMPACT counts all the major anti-counterfeiting players including international organizations, non–governmental organisations, enforcement agencies, pharmaceutical manufacturers associations and drug regulatory authorities.

Future direction of EU policy: innovation
Research and development (R&D) in life sciences is a precondition to pharmaceutical innovation. The Commission recognises the key role pharmaceutical R&D plays. Consequently, it is currently implementing various sector-specific initiatives to restore Europe's leading role as the natural home for pharmaceutical innovation.

Key directives: The EU Transparency Directive in the Pharmaceuticals sector
The EU Transparency Directive lays down harmonised provisions to ensure the transparency of measures adopted by national authorities to regulate the pricing and reimbursement of medicinal products.

European Medicines Agency Committee for Medicinal Products for Human Use (CHMP)
The Committee for Medicinal Products for Human Use (CHMP) is responsible for preparing the European Medicines Agency's opinions on all questions concerning medicinal products for human use, in accordance with Regulation (EC) No 726/2004. The CHMP plays a vital role in the marketing procedures for medicines in the European Union.

Action against Cancer: A European Partnership - briefing
The European Commission on 24 June set up a European Partnership for Action against Cancer, reinforcing its long-term commitment to the fight against cancer. The partnership will focus on actions that can be taken at EU level to more effectively prevent and control cancer across Europe. In Europe, one in three people will develop cancer in their lifetime. This translates to 3.2 million people being diagnosed with the disease every year. Cancer is not equally distributed in Europe and the chances of surviving cancer differ greatly between countries. By bringing together all relevant organisations working on cancer, the intention is to identify gaps, address needs and learn from each other.