Pharmaceuticals

Current priority areas of the Pharmaceutical Industry Policy include competitiveness and innovation, pricing and reimbursement policies, medicines availability and patients’ access to information. These issues are addressed, amongst others, through the implementation of the Transparency Directive 89/105/EEC. News, background information and web links about European Union policies on pharmaceuticals and medicines.

Towards a stronger European response to drugs - EC Communication — 26 October 2011, 14:16 CET

The European Commission has given a fresh impetus to anti-drugs policy by announcing an overhaul of the EU rules to fight illicit drugs.

Information to patients on prescription-only medicines - guide — 11 October 2011, 22:15 CET

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

The Rules Governing Medicinal Products in the European Union — 05 July 2011, 21:50 CET

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”.

Traditional Herbal Medicinal Products — 08 June 2011, 22:55 CET

Directive 2004/24/EC covering 'herbal' products has recently passed its transition period and come into force, meaning even traditional herbal products face a process of registration .

EU Register of Clinical Trials — 22 March 2011, 17:57 CET

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.

Pharmaceuticals companies — 19 October 2010, 23:29 CET

Pharmaceuticals companies in Europe

Search for pharmaceuticals companies in Europe — 19 October 2010, 23:29 CET

Chemicals and pharmaceuticals companies in Europe

Pharmaceuticals Guides — 01 August 2010, 11:04 CET

Guides on the EU Pharmaceuticals policy.

Priorities for the Pharmaceutical sector in the EU — 15 July 2009, 14:40 CET

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.

Information Communication Technologies Policy Support Programme (ICT PSP) — 14 July 2009, 22:17 CET

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.

Funding opportunities in the EU pharmaceutical industry — 09 July 2009, 16:01 CET

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.

The EU and International Cooperation in Pharmaceuticals — 09 July 2009, 15:57 CET

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.

Pharmaceuticals Unit: Contacts — 09 July 2009, 15:54 CET

 

Future direction of EU policy: innovation — 09 July 2009, 15:53 CET

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 — 09 July 2009, 15:51 CET

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.

Pharmaceuticals Policy in the EU — 08 July 2009, 23:40 CET

<p><b>Latest business news about Pharmaceuticals and Medicines Policy in the European Union.</p><p><img src="../drugs.jpg" alt="drugs photo" height="127" width="128" class="image-right" hspace="10" vspace="5" />Current priority areas for the EU's Pharmaceutical Industry Policy include competitiveness and innovation, pricing and reimbursement policies, medicines availability and patients' access to information. These issues are addressed, amongst others, in the framework of the High Level Pharmaceutical Forum and through the implementation of the Transparency Directive 89/105/EEC.</b></p> <p><b>FACT SHEETS</b></p><p><b>General Information</b></p><ul><li><a href="../priorities">Priorities for the Pharmaceutical Sector in the EU</a></li><li><a href="../directives">Key directives: The EU Transparency Directive in the Pharmaceuticals sector </a></li><li><a href="../future-direction">Future direction of EU policy: innovation</a></li><li><a href="../contacts">Pharmaceuticals Unit: Contacts </a></li></ul> <p><b>Expand your business</b></p> <ul> <li><a href="../funding">Funding opportunities in the EU pharmaceutical industry</a></li> </ul> <p><b>Business with third countries</b></p> <ul> <li><a href="../international-cooperation">The EU and International Cooperation in Pharmaceuticals</a></li></ul> <p><b>Legislation</b></p> <ul> <li><a href="../legislation">The Rules Governing Medicinal Products in the European Union</a></li></ul> <hr /> <h2>LATEST NEWS</h2>

EU pharmaceutical sector inquiry - briefing — 08 July 2009, 23:10 CET

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 — 08 July 2009, 18:17 CET

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.

Drugs — 04 July 2009, 11:25 CET

pills

European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) — 25 June 2009, 17:38 CET

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.

Information to patients on prescription-only medicinal products - briefing — 11 December 2008, 00:18 CET

Citizens of the European Union have become more empowered and proactive consumers of healthcare, increasingly seeking information about medicines and treatments. EU citizens want to be able to access information on existing medicines and treatments and at the same time to be more actively involved in making decisions regarding their health, says the European Commission. With the increased Internet use, ensuring the reliability and quality of information, particularly on websites, has become fundamental. Action at EU level is aimed at benefiting EU citizens in many ways. First and foremost, the information provision will be improved and harmonized across the EU. There will be more possibilities to receive high quality objective and non-promotional information. Secondly, European citizens will be able to receive information that is in line with EU legislation. This reduces the risk of receiving misleading and bad quality information.

Strengthening pharmacovigilance to reduce adverse effects of medicines - briefing — 11 December 2008, 00:13 CET

Medicinal products contribute considerably to the health of EU citizens. They can, however, also have adverse effects. It is estimated that 5% of all hospital admissions are due to an adverse drug reaction (ADR), and that ADR is the fifth most common cause of hospital death. In light of experience and following an assessment made of the EU pharmacovigilance system (supervision and monitoring of ADR) made by the European Commission, it has become clear that new measures are necessary to improve how the EU rules operate on the pharmacovigilance of medicinal products. Today’s proposals seek to change the existing EU legislation on pharmacovigilance (provisions in Regulation (EC) No 726/2004 and Directive 2001/83/EC). They aim to strengthen and rationalise the EU pharmacovigilance system, with the overall objectives of better protecting public health, ensuring proper functioning of the internal market and simplifying the current procedures.

Protecting the legal supply chain against counterfeited medicines - briefing — 11 December 2008, 00:07 CET

The European Commission has proposed today to protect the legal distribution chain from the infiltration of fake medicines. This is aimed at helping to ensure confidence of distributors, health care professionals and patients in the medicinal products they trade, prescribe and purchase in the legal supply chain.

Preliminary EU report on pharmaceutical sector inquiry - briefing — 28 November 2008, 13:57 CET

The European Commission has published its preliminary report on the competition inquiry into the pharmaceutical sector, which finds that competition in this industry does not work as well as it should. According to the preliminary findings there is evidence that originator companies have engaged in practices with the objective of delaying or blocking market entry of competing medicines. Practices vis-à-vis generic companies include multiple patent applications for the same medicine (so-called patent clusters), initiation of disputes and litigation, conclusion of patent settlements which constrain market entry of generic companies and interventions before national authorities when generic companies ask for regulatory approvals. Where successful, these practices result in significant additional costs for public health budgets – and ultimately taxpayers and patients – and reduce incentives to innovate. The report takes a sample of medicines that faced loss of exclusivity in the period 2000 to 2007 in 17 EU Member States and estimates that additional savings of around EUR 3 billion would have been possible on that sample over this period if generic medicines had entered the market without delay. The report also finds that companies applied defensive patenting strategies, primarily aimed at blocking competitors in the development of new medicines.

EU Pharmaceuticals Sector Inquiry — 28 November 2008, 13:30 CET

On 15 January 2008 the European Commission launched an inquiry into competition in the pharmaceuticals sector.