EU Institutions Press for Early Adoption of Advanced Therapies Regulation
The European biotechnology industry, represented by EuropaBio, is calling for the smooth adoption of the "Advanced Therapies" Regulation and is encouraging the European Parliament to support the position of the Environment (ENVI) Committee to achieve this, when they vote in Plenary on 13th March. The proposed EU Regulation will allow a new generation of treatments to be made available to patients, while safeguarding the highest European-wide standards of safety and quality.
Following an overwhelmingly positive vote at the end of January, the ENVI Committee position is very much aligned with the thinking of the Council. This opens up the possibility for an early adoption and to make up for lost time following the Committee's original rejection of the report back in September due to the introduction of amendments proposing to leave some products unregulated. This time round, the ENVI Committee voted to endorse the Commission's approach to have a single evaluation but to allow Member States to opt out of receiving the treatment if it contravenes their ethical standards. This approach, supported by the Legal Service of the Parliament, is similar to that taken with contraceptives.
The position adopted by the ENVI Committee on the draft Regulation will provide the highest level of patient safety by requiring rigorous testing by the best European experts gathered into an expert Committee at the EMEA. It will unify the bewildering patchwork of guidelines, regulations and procedures relating to advanced therapies, which are currently different in each Member State. Some countries have no specific regulatory framework at all for these products.
The Regulation will create a single EU Marketing Authorisation, which will ensure that patients can have confidence in the safety of their treatment, no matter where it was made. Member States will retain the right enshrined in the Treaty to opt not to have certain treatments if they object on ethical grounds. Nevertheless, countries or individuals that do choose to accept such treatments can be sure that they have been evaluated to the same, uniformly high levels by the best European expertise.
"We've been waiting a long time for a harmonized framework to ensure that patients across Europe have access to high-quality, safe and effective products in this breakthrough field," says Andrea Rappagliosi, Chair of EuropaBio's Healthcare Council. He urged legislators to adopt the Regulation, which is "good for European patients, good for Europe's competitiveness and will help the European Union catch up with the United States in this high technology and promising area."
"Advanced Therapies" is an umbrella term that covers the three new techniques that are revolutionising modern medicine: cell-therapy, gene-therapy and tissue-engineering. These techniques are already producing new treatments, and in the future are likely to produce many more. Research and development in this sector is growing rapidly in areas such as cancer, Parkinson's and heart disease.
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Topic world Gene therapy
Genetic diseases once considered untreatable are now at the center of innovative therapeutic approaches. Research and development of gene therapies in biotech and pharma aim to directly correct or replace defective or missing genes to combat disease at the molecular level. This revolutionary approach promises not only to treat symptoms, but to eliminate the cause of the disease itself.
Topic world Gene therapy
Genetic diseases once considered untreatable are now at the center of innovative therapeutic approaches. Research and development of gene therapies in biotech and pharma aim to directly correct or replace defective or missing genes to combat disease at the molecular level. This revolutionary approach promises not only to treat symptoms, but to eliminate the cause of the disease itself.
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