EU gives go-ahead for stem cell and other 'advanced' therapies

The European Commission has passed rules on new medical treatments, rejecting all ethical amendments after bitter discord, caused primarily by the inclusion of potential treatments involving human embryonic stem cells (ES cell) and human-animal hybrid embryos under the European Union (EU) regulatory banner.

The Advanced Therapies Regulation aims to stimulate innovative medicine and ensure uniform patient access to quality-controlled treatments. It simplifies the 27-member-state mosaic of regulatory schemes into a singular EU marketing approval and monitoring procedure for cutting-edge therapies.

'With this regulation, we unleash the EU potential for innovation, often driven by SMEs [small-medium-size enterprises], while respecting Member States' decisions on ethical concerns', explained Commission Vice-President Gunter Verheugen.

Opposition to the rules came largely from an alliance supported by Italy, Germany and Eastern European countries and led by Miroslav Mikolasik, which fought to attach additional ethical safeguards. Polish MEP Konrad Szymanski admonished that there may be 'serious shortcomings' providing insufficient protection of 'human dignities'. He felt Europe could not be 'passive' as the regional human rights watchdog.

However, a strong majority, 357-269 votes, defeated the proposal to prohibit human ES cell products from EU authorisation; one of two amendments tabled by influential Slovakian Parliament rapporteur Mikolasik.

An EU statement declared its role is to ensure the safety and effectiveness of therapies not their ethical acceptability, which could be addressed by individual member states through national legislation. Whilst the regulation allows the authorisation of all products, it preserves member states' right to reject products access to their markets on ethical grounds. Thus, authorised EU therapies are subject to national approval, respecting members such as Poland and Italy where human ES research is illegal.

Advanced therapies - gene therapy, somatic cell therapy and human tissue engineering - involve the replacement of malfunctioning cells, genesor tissues. They are novel approaches expected, albeit in the distant future, to revolutionise modern medicine and provide treatments for many degenerative conditions and injuries such as Parkinson's and spinal cord damage.

Both patient groups and Europe's biotechnology sector have welcomed the regulation. Most European biotechnology companies are smaller enterprises. The regulation seeks to promote the EU's competitiveness in the key economic area of emerging biotechnology by offering smaller companies a 95 per cent reduction for European Medicines Agency (EMEA) scientific opinion fees and potentially 65 per cent for larger firms.

The EC has proposed to fast-track implementation for mid-2008 and will review the regulation in five years.