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Pharmaceuticals Policy in the EU

Latest news on the pharmaceutical policies of the European Union.

Strengthening pharmacovigilance to reduce adverse effects of medicines - briefing
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.

Information to patients on prescription-only medicinal products - briefing
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.

Protecting the legal supply chain against counterfeited medicines - briefing
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.

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

Preliminary EU report on pharmaceutical sector inquiry - briefing
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.

Forum assesses competitiveness of Europe's pharmaceutical industry
Europe's Pharmaceutical Forum has concluded its three-year process and, on 2 October, put forward several recommendations addressing the many challenges facing the pharmaceutical industry, public health interests and national healthcare systems.

Access to essential medicines
Infectious diseases are responsible for almost half of all deaths in developing countries, and half of these diseases are caused by HIV (AIDS), tuberculosis and malaria. More than 2 billion inhabitants of the world do not have regular access to adequate treatment and cure. AIDS, tuberculosis and malaria alone kill 5 million people each year mostly in developing countries.

WTO deal on generic medicines - guide
The European Union on 19 November 2007 adopted a WTO initiative to improve access to medicines for developing countries.

2007 Annual report from the EU drugs agency
Drug facts, figures and analyses: across Europe and by country - Latest trends and legal, political, social and health responses - Selected issues: Drugs and driving; drug use among the under 15s; cocaine

Innovative Medicines Initiative Online
The Innovative Medicines Initiative is a proposed partnership between the European Commission and the European Federation of Pharmaceutical Industry and Associations (EFPIA). The vision of IMI is to create Biomedical Research & Development leadership for Europe to benefit patients and society.

Faster access to better medicines: the Innovative Medicines Initiative
Proposed on 15 May 2007 by the European Commission, the Innovative Medicines Initiative (IMI) seeks to overcome research bottlenecks in the drug development process. Its vision is to create real European leadership in biomedical research and development and thereby reinvigorate the European biopharmaceuticals sector as well as benefiting patients and society in general. IMI will embody a new approach to research financing at the European level, bringing together public and private funds, involving industry, SMEs, and non-profit research institutions. IMI was identified as a candidate Joint Technology Initiative when the EU's 7th Research Framework programme was launched at the beginning of 2007.

Pharmaceuticals in the EU
European Union action in the pharmaceutical products sector is basically composed of two types of measures relating to industrial policy and the smooth operation of the internal market. These involve the harmonisation of technical requirements and strengthening the competitiveness of the European pharmaceutical industry.

EU Pharmaceuticals portal
Since 1985, a score of European Community directives have been adopted with the aim of achieving a single, EU-wide market for pharmaceuticals.

European cosmetics industry
The European cosmetics industry has a value of output of more than EUR 35 billion; is highly innovative, with major cosmetic companies replacing or reformulating around 25% of their products every year; and employs over 150.000 Europeans directly, with a further 350.000 jobs created indirectly in retail, distribution and transport. The main regulatory framework which aims at ensuring the free circulation of cosmetic products in the internal market and safeguarding the safety of cosmetic products placed on the EU-market is the Council Directive 76/768 of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products ("Cosmetics Directive").

Medicinal products register
European Community register of medicinal products for human use

EU Directive on Dangerous Substances
Ehe EU Directive on Dangerous Substances was a response to a need to ensure the protection of public health, in particular the health of workers handling dangerous substances.

European Agency for the Evaluation of Medicinal Products - EMEA
The European Agency for the Evaluation of Medicinal Products (EMEA) is a decentralised body of the European Union. It has its headquarters in London since January 1995. 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 trade - access to essential medecines
Infectious diseases are responsible for almost half of all deaths in developing countries, and half of these diseases are caused by HIV (AIDS), tuberculosis and malaria. More than 2 billion inhabitants of the world do not have regular access to adequate treatment and cure. AIDS, tuberculosis and malaria alone kill 5 million people each year mostly in developing countries. European Union initiatives

EU Influenza Research
As news reaches the public about the spread of H5N1 'avian' influenza virus from Asia to Europe and Africa, it raises some questions. What is the difference between seasonal, avian and pandemic influenza? Is Europe prepared for a pandemic? What are scientists and, especially, EU-funded projects doing to help? This website presents current EU-funded flu and virus research – both human and pandemic strains and animal strains – and future initiatives. It also features profiles of some key personnel engaged in the battle against this deadly opponent.