Pharmaceuticals Guides

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EU pharmaceutical sector inquiry - briefing by EUbusiness — last modified 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.

Pharmaceuticals Unit: Contacts by Ina Dimireva — last modified 09 July 2009, 15:54 CET

 

Funding opportunities in the EU pharmaceutical industry by Ina Dimireva — last modified 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.

Priorities for the Pharmaceutical sector in the EU by Ina Dimireva — last modified 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.

The Rules Governing Medicinal Products in the European Union by Ina Dimireva — last modified 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”.

The EU and International Cooperation in Pharmaceuticals by Ina Dimireva — last modified 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.

Future direction of EU policy: innovation by Ina Dimireva — last modified 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 by Ina Dimireva — last modified 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.

Action against Cancer: A European Partnership - briefing by EUbusiness — last modified 24 June 2009, 22:25 CET

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.

Strengthening pharmacovigilance to reduce adverse effects of medicines - briefing by EUbusiness — last modified 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.

Information to patients on prescription-only medicinal products - briefing by EUbusiness — last modified 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.

Protecting the legal supply chain against counterfeited medicines - briefing by EUbusiness — last modified 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 by EUbusiness — last modified 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.

WTO deal on generic medicines - guide by EUbusiness — last modified 19 November 2007, 17:17 CET

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

Faster access to better medicines: the Innovative Medicines Initiative by EUbusiness — last modified 16 May 2007, 13:48 CET

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 by EUbusiness — last modified 25 August 2006, 12:35 CET

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.