EU Biotechnology Law & Policy News

European Commission launches public consultation on medical devices
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]

[posted @ 5/09/2008 07:56:00 AM] #

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

[posted @ 4/30/2008 08:50:00 AM] #

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

[posted @ 4/24/2008 10:09:00 AM] #

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

[posted @ 4/24/2008 09:45:00 AM] #

European Commission authorises GM maize GA21
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]

[posted @ 4/23/2008 10:19:00 AM] #

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

[posted @ 4/23/2008 09:21:00 AM] #

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

[posted @ 2/27/2008 08:16:00 AM] #

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

[posted @ 2/13/2008 08:34:00 AM] #