Europabio's Reasons for Supporting the Proposed Advanced Therapies Regulation (link)

Brussels, 16 Jun 2006

EuropaBio Policy Brief
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The Proposed European "Advanced Therapies Regulation" Creating a European Framework for Cell-Therapy, Gene-Therapy & Tissue Engineered Products is an important initiative and should be supported:

• It will benefit European patients by giving them access to new treatments across the EU;

• It will ensure that treatments made available to European patients fulfill high standards of safety, efficacy and quality; and

• It will support competitiveness and jobs in the European biotechnology sector – comprised mostly of Small & Medium-sized Enterprises – by laying down clear rules for advanced therapy products.

What will the Regulation do?

The draft "Advanced Therapies Regulation" will create a single, European marketing authorisation for the next generation of high-technology medical treatments – "Advanced Therapies". This will allow these products to be placed on the European market only after rigorous review and approval. "Advanced Therapies" comprise three different kinds of biotechnology treatments made possible by scientific advances: somatic cell-therapy, genetherapy and tissue-engineered products. They offer the ability to treat diseases in new ways, and the future possibility to cure, rather than merely treat some diseases.

European patients need access to these breakthrough products because of the potential that they offer. It is also important to ensure that the products are safe and that they work. That is what the "Advanced Therapy Regulation" seeks to do.

Why do we need a European framework now?

Currently, there are no cell and gene-therapy products authorised for use in patients in Europe. This is mainly because the products are still at an early stage of development. But it makes sense for the European Union to ensure that the detailed rules for these products are ready in time for the first products to come to market.

In the case of the Tissue Engineered Products – the need is even more urgent. Some products are already available to patients in some Member States.

But because there are no European rules for these products, this creates a patchwork of 25 different systems, and leads to an unfair situation, where some patients have access to products while others do not. Industry cannot afford to put their products on the market in all Member States at the same time because of the financial and administrative burden of meeting the 25 different legal requirements. Investment and growth in the European Biotech Industry sector (in particular SME's) will be encouraged by removing these barriers and creating clarity and certainty of requirement

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