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Pharmaceuticals Policy in the EU

Latest news on the pharmaceutical policies of the European Union.

10 years of the EU Paediatric Regulation 26 October 2017, 23:08 CET
The European Commission presented a report on 26 October to the European Parliament and the EU Council on progress made in children's medicines since the Paediatric Regulation came into force 10 years ago.

European Banking Authority and European Medicines Agency after Brexit - Commission assessment of country offers 03 October 2017, 18:26 CET
European Commission publishes assessment of Member State offers to host European Banking Authority and European Medicines Agency after Brexit

Synthetic opioids a growing health threat: EU report 07 June 2017, 18:38 CET
Highly potent synthetic opioids pose a growing health threat, according to an EU report Tuesday which highlights rising overdose deaths and continued availability of new psychoactive substances.

EU probes Aspen price hikes for cancer drugs 17 May 2017, 17:38 CET
The European Commission opened Monday a formal investigation into concerns that Aspen Pharma has engaged in excessive pricing concerning five life-saving cancer medicines.

Brussels acts against drug use and trafficking 16 March 2017, 00:02 CET
The EU Commission proposed Wednesday a new action plan on drugs to strengthen the EU's response to the newly-emerging health and security challenges in the area of illicit drug use and trafficking.

Brussels mulls new initiative on antimicrobial resistance 27 January 2017, 17:38 CET
The EU Commission launched a public consultation Friday on possible activities to include in a new action plan to combat antimicrobial resistance (AMR) it plans to adopt this summer.

EU proposes ban on new psychoactive substance 01 September 2016, 00:15 CET
The European Commission proposed Wednesday to subject the new psychoactive substance MDMB-CHMICA, sometimes referred to as 'Black Mamba', to control measures across the European Union.

Fees for Pharmacovigilance activities 16 April 2014, 22:50 CET
The European Parliament voted on 16 April in favour of an EU Regulation on fees payable to the European Medicines Agency (EMA) for the conduct of pharmacovigilance activities for medicinal products for human use, which lays down the level and structure of these fees. This Memo explains the meaning and importance of pharmacovigilance in the EU, and why this legislation is necessary.

Joint purchasing of vaccines and medicines 10 April 2014, 22:07 CET
The European Commission has approved a Joint Procurement Agreement, which will enable all EU countries to procure pandemic vaccines and other medical countermeasures as a group, rather than individually.

Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human, CMDh 30 May 2013, 15:40 CET
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 31 January 2013, 17:56 CET
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 04 October 2012, 19:59 CET
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 17 November 2011, 17:57 CET
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 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.

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.

European Medicines Agency 23 September 2010, 22:06 CET
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 08 July 2010, 16:39 CET
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 06 May 2010, 12:44 CET
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 24 April 2010, 00:30 CET
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 03 February 2010, 17:38 CET
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) 06 January 2010, 00:35 CET
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.

Pharmaceuticals 19 August 2009, 16:24 CET
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) 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.

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.