Currently, no cell- or gene-therapy products are authorised for use in Europe. There is some access to tissue-engineered products, but there are no European-wide rules in relation to these. This means that there are currently 27 different legal regimes in relation to advanced therapies, and that these products are, unfairly, available to some patients but not to others. The Advanced Therapies Regulation was agreed on 25th April 2007 and aims to create a centralized approval process for innovative therapies; the therapies covered by the scope of the regulation are "somatic cell therapies" (in which cells are used to replace cells that are diseased, damaged or absent in a patient's body; "gene therapy" (in which healthy and properly functioning genes are inserted into a patient's host cells), and "tissue-engineered products" (in which the product acts within the patient's body to regenerate tissue, such as cartilage). The idea is that the harmonization of the approval process will, in turn, harmonize safety standards and increase patient access to therapies, and provide a single market in which to attract investment into the usually small- or medium-sized entities that develop these innovative technologies.
There was considerable debate over the ethical issues involved, although amendments proposed to carve out the use of human embryonic stem cells from the scope of the regulation were ultimately rejected. However, the overall impact of the regulation is likely to be limited by the wording in Article 28(2) of the regulation, which has a scope broader than merely human embryonic stem cells to encompass adult stem cells as well . This article has the effect of making the regulation subject to any "national legislation prohibiting or restricting the use of any specific type of human or animal cells, or the sale, supply or use of medicinal products containing, consisting or or derived from these cells".
Notwithstanding the introduction of the regulation, then, it is therefore entirely possible for one member state to continue to apply criteria radically different from that of its neighbours, thus compromising the efficacy of what was, after all, designed to be a "harmonizing" regulation. It is true that member states introducing more restrictive provisions at national level are required to notify the Commission of the national rules introduced, in order that a clearer picture of the various regimes in member states can be drawn up and perhaps made available to inform and broaden the options of patients seeking an advanced therapy that is not available in their own member state. However, it is certain that investors will not be attracted by fragmented rules and regulations across the different member states. The usefulness of the regulation to the biotech sector therefore remains to be seen, depending on the degree to which member states chose to opt out of it at the national level.
If you would like to discuss this topic further or have a request for further information, please contact Jenny Beresford-Jones, professional support lawyer to the Mills & Reeve Technology team.