Article
Advanced therapy: MEPs debate report Monday
Research and innovation - 24-04-2007 - 10:17
Gene and cell therapy are dramatic scientific breakthroughs that offer hope to sufferers of cancer, bone diseases and degenerative organ conditions. However, they also raise questions about how far research should be taken. With different countries allowing different techniques, a proposed new regulation aims to establish European guidelines on the limits of research. Ahead of the vote on Wednesday MEPs debated the issue on Monday. See the full debate by clicking on the first link below.
What is advanced therapy?
Broadly speaking there are three main areas: gene therapy, adult stem cell therapy and tissue engineering.
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Gene therapy: disease-creating abnormal genes can be replaced by healthy ones. This could help treat genetic diseases such as muscular dystrophy, haemophilia (uncontrolled bleeding) and other blood diseases.
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Adult stem cell therapy: corrupt cells can be replaced by regenerating diving cells. This can be used in the treatment of blindness, spinal cord injury, Alzheimer's and Parkinson's diseases.
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Tissue engineering: recreating human tissue or organs by growing organs in laboratories.
Regarding embryonic stem cell research, there is no consensus in the EU. The practice is banned in Italy and Poland whilst countries like the UK and Ireland allow research.
Regulating science?
Many commentators say that the lack of common rules are obstructing research, denying patients access to the most advanced treatment. In addition uncontrolled experiments can pose a danger to patients.
The European Commission has proposed an attempt to codify rules and guidelines in the area. The Parliament's Environment Committee adopted a report on the matter on 31 January - a report authored by Slovak MEP Miroslav Mikolášik. Speaking last week Mr Mikolášik said "the advanced medicinal products represent big hope in treatment of diseases like cancer, damages after the heart attack, tissue damages of skin, muscles, cartilage or neurological diseases. The main goal of this proposal is to remove the barriers on European market and facilitate the access of patients to existing treatments through single European permission for placing these products on the market".
The report recommends the following:
- Creating of common rules for advanced therapy.
- Establishing a new Committee in the European Medicines Agency to allow centralised evaluation, authorisation, supervision and monitoring.
- Ensuring a high level of health and safety.
The vote will take place at 1130 CET on Wednesday 25 April.
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