EU Biotechnology Law & Policy News: January 2008

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

[posted @ 1/21/2008 12:04:00 AM] #

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

[posted @ 1/16/2008 06:49:00 AM] #

Questions and Answers on Novel Foods in Europe
Questions and Answers on Novel Foods
[European Commission Memo]

[posted @ 1/15/2008 05:10:00 AM] #

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

[posted @ 1/15/2008 05:03:00 AM] #