EU Biotechnology Law & Policy News

EU Council Joint Action in the area of laboratory bio-safety and bio-security

noreply@blogger.com (Fina) — Wed, 23 Jul 2008 21:25:00 +0000

Council Joint Action 2008/307/CFSP of 14 April 2008 in support of World Health Organisation activities in the area of laboratory bio-safety and bio-security in the framework of the European Union Strategy against the proliferation of Weapons of Mass Destruction
[[2008] OJ L 106/17]

European Commission launches public consultation on medical devices

noreply@blogger.com (Fina) — Fri, 09 May 2008 14:56:00 +0000

The European Commission launched a public consultation with the aim to modernise and simplify the legislation on medical devices. Since the nineties the safety of medical devices in Europe has been guarded by a series of medical devices Directives. Their introduction also contributed to free trade, innovation and competitiveness within Europe. However, in recent years a number of drivers have come into play that require a revisit of this legislation. Experience indicates that the current system does not always offer a uniform level of protection of public health in the European Union. New and emerging technologies present new challenges to the current framework, highlighting gaps and pointing to a certain scarcity of expertise. In addition, in recognition that the medical devices market is a global one, to keep European industry competitive, the European Community regime needs to further converge on globally applied rules. And finally, the legal framework has been criticised as being too fragmented and difficult to follow and fraught with national variation. This situation has motivated the European Commission to consider a revision of the legal framework in order to meet the growing expectations from European citizens.
[European Commission Press Release]

A public-private research initiative to boost the competitiveness of Europe's pharmaceutical industry

noreply@blogger.com (Fina) — Wed, 30 Apr 2008 15:50:00 +0000

The European Commission and the pharmaceutical industry began work today on implementing the Innovative Medicines Initiative (IMI). IMI aims to remove severe bottlenecks in the drug development process through innovative research projects, hence to accelerate the discovery and development of new medicines. It will launch later this year promising research projects in the areas of brain disorders, metabolic and inflammatory diseases. IMI is a unique public-private partnership between the European Commission and the European Federation of Pharmaceutical Industries and Associations (EFPIA).
[European Commission Press Release]

Smoking genes? European scientists discover the first case of a genetic dependence to nicotine

noreply@blogger.com (Fina) — Thu, 24 Apr 2008 17:09:00 +0000

Scientists from an EU-supported consortium have discovered that a mutation in a human gene confers nicotine dependence. They have shown that a particular variant of a nicotine-receptor gene impacts smoking behaviour and hence confers a 30% increase in risk of lung cancer and a 20% increase in risk of peripheral artery disease (PAD), a common and debilitating constriction of the arteries to the legs. Roughly half of the people of European descent carry at least one copy of this genetic variant, which does not influence smoking initiation, but makes it more difficult to quit. The results stem out from the European project GENADDICT (Genomics, mechanisms and treatment of addiction), which is supported by 8.1 million euros' worth of funding from the EU’s Sixth Framework Programme for research and by the U.S. National Institutes of Health.
[European Commission Press Release]

ECJ: pharmaceutical company which refuses to meet the orders of wholesalers, in order to limit parallel trade, engages in abusive practice

noreply@blogger.com (Fina) — Thu, 24 Apr 2008 16:45:00 +0000

ECJ Advocate General Ruiz-Jarabo maintains that a pharmaceutical company holding a dominant position which refuses to meet the orders of wholesalers, in order to limit parallel trade, engages in abusive practice
[European Court of Justice Press Release]

European Commission authorises GM maize GA21

noreply@blogger.com (Fina) — Wed, 23 Apr 2008 17:19:00 +0000

The European Commission adopted a Decision authorising the GM maize GA21 for feed and food use and for import and processing.
[European Commission Press Release]

Reducing biodiversity loss: a new European Commission tool will help protect Africa's wildlife

noreply@blogger.com (Fina) — Wed, 23 Apr 2008 16:21:00 +0000

Africa is home to some of the most valuable natural ecosystems and species on the planet. Worldwide, more than 16 000 plant and animal species are threatened with extinction. The monitoring of Africa's 741 protected areas (representing over two million square kilometres, i.e. nearly half the total area of the EU) plays a vital role in biodiversity protection, conservation and the sustainable management of natural resources. "The Assessment of African Protected Areas", an online information system based on the latest advances in satellite technology, monitors trends in fire, vegetation, and rainfall. It allows park managers to compare current fire activity, vegetation growth or rainfall against seasonal norms. This information will help African nations to achieve the goal of reducing the rate of biodiversity loss by 2010.
[European Commission Press Release]

European Commission Decision on emergency measures regarding the non-authorised GM organism ‘LL RICE 601’ in rice products

noreply@blogger.com (Fina) — Wed, 27 Feb 2008 16:16:00 +0000

European Commission Decision 2008/162/EC of 26 February 2008 amending Decision 2006/601/EC on emergency measures regarding the non-authorised genetically modified organism 'LL RICE 601' in rice products
[[2008] OJ L 52/25]

European Commission requires certification for Chinese rice products to stop unauthorised GMO from entering the EU

noreply@blogger.com (Fina) — Wed, 13 Feb 2008 16:34:00 +0000

The European Commission decided today to require compulsory certification for the imports of Chinese rice products that could contain the unauthorised GMO Bt63. The decision has been taken after rice products - originating in, or consigned from, China and containing the unauthorised genetically modified rice "Bt 63" - were discovered in the EU market between 2006 and 2007. Despite measures announced by the Chinese authorities in 2007, alerts concerning the presence of the unauthorised genetically modified rice "Bt 63" were reported until late 2007. The emergency measures adopted by the European Commission today mean that, as of April 15, only consignments of the rice products indicated in a specific Annex of the Decision can enter the EU. These consignments must be tested by an official or accredited laboratory using a specific testing method and accompanied by the analytical report assuring they do not contain Bt63.
[European Commission Press Release]

GMOs: Proposals to authorise soybean A2704-12 and cotton LL25 to be transmitted to the EU Council

noreply@blogger.com (Fina) — Wed, 13 Feb 2008 16:32:00 +0000

The European Commission presented today to the EU Member States proposals for the authorisation of genetically modified soybean A2704-12 and cotton LL25 for import and processing and food and feed use.
[European Commission Press Release]

Joint Undertaking for the implementation of the Joint Technology Initiative on Innovative Medicines

noreply@blogger.com (Fina) — Mon, 04 Feb 2008 09:31:00 +0000

Council Regulation (EC) No 73/2008 of 20 December 2007 setting up the Joint Undertaking for the implementation of the Joint Technology Initiative on Innovative Medicines
[[2008] OJ L 30/38]

European Commission Decision relating to the Polish Draft Act on Genetically Modified Organisms

noreply@blogger.com (Fina) — Mon, 21 Jan 2008 08:04:00 +0000

Commission Decision 2008/62/EC of 12 October 2007 relating to Articles 111 and 172 of the Polish Draft Act on Genetically Modified Organisms, notified by the Republic of Poland pursuant to Article 95(5) of the EC Treaty as derogations from the provisions of Directive 2001/18/EC of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms
[[2008] OJ L 16/17]

Antitrust: European Commission launches sector inquiry into pharmaceuticals with unannounced inspections

noreply@blogger.com (Fina) — Wed, 16 Jan 2008 14:49:00 +0000

The European Commission has launched a sector inquiry into competition in the pharmaceuticals sector (under Article 17 of Regulation 1/2003), and is conducting inspections at the premises of a number of innovative and generic pharmaceutical companies. The inquiry is a response to indications that competition in pharmaceutical markets in Europe may not be working well: fewer new pharmaceuticals are being brought to market, and the entry of generic pharmaceuticals sometimes seems to be delayed. The inquiry will therefore look at the reasons for this. In particular, the inquiry will examine whether agreements between pharmaceutical companies, such as settlements in patent disputes, may infringe the EC Treaty's prohibition on restrictive business practices (Article 81). It will also look into whether companies may have created artificial barriers to entry, whether through the misuse of patent rights, vexatious litigation or other means, and whether such practices may infringe the EC Treaty's ban on abuses of dominant market positions (Article 82). Vigorous competition in this sector is crucial for the public, as it ensures both access by patients to state-of-the-art medicines, and value for money for health spending by individuals, private health schemes and government health services in Europe. An interim report is planned for autumn 2008 and final results are expected in the spring of 2009. The inquiry's findings will allow the European Commission or national competition authorities to focus any future action on the most serious competition concerns, and to identify remedies to resolve the specific competition problems in individual cases.
[European Commission Press Release]

Questions and Answers on Novel Foods in Europe

noreply@blogger.com (Fina) — Tue, 15 Jan 2008 13:10:00 +0000

Questions and Answers on Novel Foods
[European Commission Memo]

European Commission proposes measures to encourage safe novel foods in the EU

noreply@blogger.com (Fina) — Tue, 15 Jan 2008 13:03:00 +0000

The European Commission has adopted a proposal to revise the European Novel Foods Regulation with a view to improving the access of new and innovative foods to the EU market, while still maintaining a high level of consumer protection. Under the draft Regulation, novel foods would be subject to a simpler and more efficient authorisation procedure, which should enable safe, innovative foods to reach the EU market faster. Moreover, special provisions are made for foods which have not been traditionally sold in the EU but which have a safe history of use in third countries, in order to create a more proportionate system and positive environment for trade. The proposal also sets out certain data protection rules, which aim to protect newly developed foodstuffs once authorised, and encourage companies to invest in developing new types of foods and food production techniques.
[European Commission Press Release]

Parents need better information on genetic testing of IVF embryos in Europe

noreply@blogger.com (Fina) — Mon, 10 Dec 2007 12:48:00 +0000

A new report by European Commission scientists shows that urgent guidelines are needed for the counselling of patients that opt to screen their embryos created by in vitro fertilisation (IVF) for serious genetic disorders, and there is a need for specific quality assurance schemes. Preimplantation genetic diagnosis (PGD) is the practice of testing embryos for conditions such as Huntington's, haemophilia and cystic fibrosis before they are implanted in the mother. As the first report to give a full picture of this practice at European level, it shows that PGD is a well-established practice in many EU Member States, but regulations, standards and accreditation requirements can differ widely. The report, drawn up by the European Commission's in-house scientific service, the Joint Research Centre, in co-operation with a number of European research centres, will help provide more knowledge and information about current PGD services.
[European Commission Press Release]

EU strengthens cooperation with U.S. on cosmetics and medical devices

noreply@blogger.com (Fina) — Mon, 23 Jul 2007 22:02:00 +0000

The European Commission and the U.S. government will from now on be able to exchange confidential information about the safety of cosmetics and medical devices. The European Commission and U.S. Food and Drug Administration agreed confidentiality arrangements at a bilateral meeting in Brussels, enabling better health protection and easier trade between EU and U.S. Closer economic cooperation is the main aim of the new Transatlantic Economic Council (TEC). The TEC's work program covers cooperation initiatives to harmonize standards and improve trade in the areas of Regulatory Cooperation, Intellectual Property Rights, Secure Trade, Financial Markets, Innovation and Technology and Investment.
[European Commission Press Release]

European Commission welcomes European Parliament's report on Halting the Loss of Biodiversity

noreply@blogger.com (Fina) — Wed, 04 Jul 2007 20:40:00 +0000

The European Commission welcomes the report adopted by the European Parliament on the European Commission's Communication on 'Halting the Loss of Biodiversity by 2010 – and Beyond: Sustaining Ecosystem Services for Human Well-being'. The European Commission shares the European Parliament's strong concern at financial constraints to implementation and at the continuing loss of biodiversity and related decline of ecosystem services. It supports Parliament's position that the maintenance of ecosystem services should become a fundamental goal of all EU horizontal and sectoral policies.
[European Commission Press Release]

EU puts emphasis on innovation in the field of biotechnology

noreply@blogger.com (Fina) — Sun, 15 Apr 2007 06:48:00 +0000

The European Commission wants to put a special focus on innovation, research, market development and the debate with society on ethical issues in the field of biotechnology. In a mid-term review of the Strategy on Life Sciences and Biotechnology 2002 – 2010, presented today by European Commission President Barroso and European Commissioners Verheugen and Potocnik, a refocus of actions has been proposed to promote a competitive and sustainable European knowledge based Bio-Economy. Competitiveness can be ensured by the promotion of research and market development, innovation programmes, societal debates, sustainable development of agriculture and better implementation of legislation. Life sciences and biotechnology offer the prospects of new and renewable bio resources, lower energy and water consumption, reduction of greenhouse gas emissions and reduced dependence on petroleum. They also play a growing role in the discovery and development of new medicines, advanced therapies, diagnostics and vaccines. Biotechnology as a scientific technique has existed for more than 5000 years. It was first used in foodstuffs, such as bread, cheese, wine and beer. Modern applications of biotechnology include the production of enzymes, used in very practical day to day products like washing powder, or the creation of bio-plastics, which degrade considerably quicker than conventional plastics, thereby reducing waste. Biotechnology is also used to develop new life-saving medicines and medical devices. New applications are being developed all the time and Europe should be at the forefront of these developments. [European Commission Press Release]

Life sciences and biotechnology – a key sector for Europe's competitiveness and sustainability

noreply@blogger.com (Fina) — Sun, 15 Apr 2007 06:41:00 +0000

The European Commission reviewed its strategy on Life Sciences and Biotechnology. This sector has the potential to make a significant contribution to the sustainability and competitiveness of European industry and the quality of life of Europe's inhabitants. This background note gives some key facts and figures about the sector, outlines the revisions proposed to the strategy and highlights some of the on-going and planned support to research in this area. [European Commission Press Release]

EU moves to improve safety of medical devices

noreply@blogger.com (Fina) — Tue, 03 Apr 2007 17:53:00 +0000

The safety of medical devices such as surgical equipment or implants is to be significantly improved after the adoption of a proposal by the European Commission, today by the European Parliament. There will be stricter rules for the use of potentially toxic materials, for which adequate labelling will be required. Furthermore the safe single use of devices is enhanced. A study will be done to see how better reprocessing of devices can be achieved. Apart from this, specialized medical software will fall under the scope of the new Medical Device Directives, which have been updated in the light of new technological developments. The European Parliament vote is based on a compromise, reached with the Council, which is expected to adopt the package shortly. [European Commission Press Release]

European Commission creates registry for human embryonic stem cell lines

noreply@blogger.com (Fina) — Tue, 03 Apr 2007 17:51:00 +0000

The European Commission agreed funding for the creation of a European registry for human embryonic stem cell lines. The main objective of this new initiative, funded through the EU's Research Framework Program, is to provide comprehensive information about all human embryonic stem cells lines available in Europe. A publicly accessible internet site will contain high quality data about the cell lines (e.g. cell characteristics) and will inform on interesting developments, such as clinical trials. There will be details on the sources of the stem cell lines and contact data. The registry will also include information on human embryonic stem cell lines obtained from on-going and future EU-funded projects. 81 different lines are currently used in EU projects. The project has been agreed for 3 years, with EU funding of just over €1m. [European Commission Press Release]

The EU Framework Program for Research and Development and human embryonic stem cell research

noreply@blogger.com (Fina) — Tue, 03 Apr 2007 17:45:00 +0000

The European Commission announced the creation of a European registry providing comprehensive information about all human embryonic stem cell lines in Europe. This background note gives some more information about the project, as well as describing the context for European support of research using human embryonic stem cells. [European Commission Memo]

GMOs: Three oilseed rapes authorised by EU for import and processing in animal feed

noreply@blogger.com (Fina) — Tue, 03 Apr 2007 17:38:00 +0000

The European Commission authorised the placing on the market of three oilseed rapes known as Ms8, Rf3 and Ms8xRf3, genetically modified for tolerance to the herbicide glufosinate-ammonium. This decision is valid for 10 years and covers the use of the oilseed rapes for imports and processing into animal feed or for industrial purposes. It includes measures to be taken by the company who developed the GM oilseed rapes to prevent any damage to health and the environment in the event of accidental spillage. Processed oil derived from these GM oilseed rapes has already been approved for food use in 1999 and 2000 in the EU. [European Commission Press Release]

Questions and Answers on the Regulation of GMOs in the European Union

noreply@blogger.com (Fina) — Tue, 03 Apr 2007 17:26:00 +0000

[European Commission Memo]