Biotechnology

A new report on consent and confidentiality in genetic practices

The Royal College of Physicians and the British Society of Human Genetics have joined forces to publish a new report on Consent and confidentiality in genetic practices.
It aims to develop guidance on:
genetic testing ans sharing information,
obtaining consent prior to genetic tests,
regulations for giving and sharing genetic information with family members and between professionals,
genetic investigations on stored human tissues.
It comes timely with the highly sensitive debates on (...)

"Stay healthy, Stop mercury" Campaign Launched

Health Care Without Harm and the Health and Environment Alliance have launched a European anti-mercury campaign with a series of fact sheets for citizens and health professionals.
The ultimate objective of the "Stay Healthy Stop Mercury" campaign is to phase out mercury from health care and a total ban in international trade.
In order to do so, the campaign proposes, as a first step to raise awareness of the immediate health threats of mercury, and to propose alternatives and solutions for (...)

Commission consultation on nanotechnology

The Commission is launching a wide consultation on its Communication Towards a European Strategy for Nanotechnology in which it proposed an integrated and responsible approach for developing nanosciences and nanotechnologies in Europe.
Nanotechnology is a new approach to research and development for controlling the fundamental structure and behaviour of matter at the level of atoms and molecules. Applications are emerging in many different areas such as health care, information (...)

European Agency for Health and Safety at Work: review of progress made in 2006

The European Agency for Safety and Health at Work (OSHA) has published its annual report for 2006. The report outlines three main areas of progress: reinforcement of the agency’s tripartite governance structure; communication on occupational safety and health; and scientific research on emerging risks.
In 2006, the European Agency for Safety and Health at Work (OSHA) strengthened its tripartite governance structure and network by involving workers, employers and governments more closely (...)

**Updated** Current EU research policy

The European Commission’s Directorate General on Research publicly launched the 7th European Research Programme (FP7) at a conference held by the German Presidency in Bonn on January 15-16, 2007. The 7th Research Framework Programme will run from 2007-2013. The first calls for proposals under FP7 were issued on 22 December 2006.
Information days for potential applicants were held across the EU during February 2007 (including one in Brussels on the 7-8 February attended by Silvia Marcos (...)

**Updated** Advising the European Commission on Ethics and Science

The European Group on Ethics in Science and New Technologies (EGE) has just issued the general report of their activities 2000-2005.
The EGE was established in December 1997 to succeed to the Group of Advisers on the Ethical Implications of Biotechnology. The role of the EGE is to give advice to the European Commission (EC) on ethical aspects of science and new technologies. It also exchanges views with NGOs and national bodies.
During the second mandate (2000-2005), the Group issued (...)

**UPDATED** EFSA’s consultation and opinion on animal cloning

EFSA has a published draft opinion on the implications of animal cloning on food safety, animal health and welfare and the environment.
This article has been updated with news concerning the European Parliament motion for resolution on the cloning of animals for food supply and with news on the delay of EFSA’s final opinion
EFSA’s public consultation on animal cloning
EFSA has held a public consultation on its draft scientific opinion on the implications of animal cloning on food safety, (...)

The European Food Safety Agency (EFSA) sits on the fence in final scientific opinion on animal cloning.

EFSA published its final scientific opinion on the implications of animal cloning on food safety, animal health and welfare and the environment. Prof. Vittorio Silano, chair of EFSA’s Scientific Committee presented the opinion of EFSA on 24 July 2008. Prof. Silano stated that for some animals there is no clear safety risk from cloned animals but went on to say that more data needs to be accumulated on the subject before it could make any serious judgment on the safety of cloned animals.
The (...)

*Update* Agreement on GMO approval overhaul

The EU environment ministers have supported a proposal from France to overhaul EU’s approval process for genetically modified organisms (GMOs).
On the 5th of June 2008, the EU environment ministers decided that risk assessment procedures within the GMO evaluation and authorisation system needed to be improved. They also agreed on the need of a longer-term discussion on GMOs’ effects on the environment.
The European Food Safety Authority (EFSA) has provided scientific advice in this area. It (...)

An international informal debate on ethics and science

Members of national forums and the European Group in Ethics (EGE) met last February during the 11th Forum of National Ethics Council (NEC) at Brdo, Slovenia. The Forum was organized by the European Commission and the Slovenian National Medical Ethics committee, and provided for an international informal debate in the field of ethics and science.
The leading theme of the NEC Forum-> was the Freedoms and Rights of the individuals in competition with the interests of the society. The meeting (...)

***Updated*** A European database on medicinal products: EudraPharm

EudraPharm is the name of the public database launched by the European Medicines Agency (EMEA) to facilitate access to information about medicines available in the European Union. This article was updated to include information about new languages.
The EudraPharm database is designed to give on-line access to information about all medicinal products for human or veterinary use that have been authorised in the European Union (EU).
It includes the summary of product characteristics, package (...)

Clinical Trials: has the EU directive helped to reduce red tape?

A report from Cancer Research UK (an EPHA member) published recently argues that the EU Clinical trials directive has had a counter-productive effect on clinical trials.
The 2004 European Union Clinical Trials Directive (2004/23/EC) was thought to harmonise standards across the EU, hence cutting red tape for international groups to work together.
Unfortunately, the report shows that the directive is implemented slightly differently in each Member States, which implies that red tape is not (...)

Biotechnology in Europe - no definitive answer on patentability

A new European Commission report on biotechnology inventions refuses to take a clear position on the patenting of human stem cells.
This highly controversial issue covers the protection of biotechnology inventions and a potentially lucrative and large market, but also the ethical aspects of patenting.
These ethical concerns have been at the heart of a 10 year stand-off between EU governments and MEPs that was ended by the adoption of a Directive and a European Court of Justice ruling (...)

Bioethics at stake in the new FP7

The European Commission encounters a sound opposition from the European Parliament to introducing European funding for research on human embryo and embryonic stem cells in the next 7th Research Framework Programme (FP7).
On the 20 September 2005, a group of 73 MEPs have signed a letter to the European Commission President, Manuel Barroso, calling the Commission to respect the principle of subsidiarity in the matter: Member States should decide if they want to fund research on the human (...)

EMEA launches consultation on guidelines for registering biosimilar medicines

The European Medecines Agency (EMEA) has issued draft guidelines on the development of "similar biological medicinal products", the so-called biosimilar medecines.
The draft guideline follows two existing EMEA documents adopted in 2003 and aims at describing the EMEA approach to the development and approval of these products.
The final guidelines will define what is a biosimilar medicine and will be a "user guide" for applicants that claim biosimilarity of their products.
The aim of this (...)

EU industry ministers call for less red tape and regulation

On 17 May 2004, the EU Competitiveness Council approved a timetable to identify priority areas for lighter European regulation on industry and business "with a view to agreement before the end of 2004".
The Council has also asked the European Commission to develop a method to assess administrative burdens on industry and report to the Ministers in November.
The trade and industry Ministers called for reduced regulation, new policies to stimulate private investment in scientific research, (...)