Brussels, 29 January 2007 - The EU legislator should exclude from the scope of the Advanced Therapy Medicinal Products Regulation any product whose principal mode of action is that of a medical device. This is the key message from Eucomed to the European Parliament ENVI Committee, ahead of its vote tomorrow on the Commission's proposed text. Eucomed, which represents some 4500 mostly small medical technology manufacturers in Europe, also calls for an appropriate transition period to adapt to the new legislation.
"Eucomed welcomes the proposal for an Advanced Therapy Medicinal Products Regulation. The aim is to create a harmonized EU legal framework for marketing cell and gene therapies and human tissue engineered products. This is a great opportunity for European patients, who will benefit from improved access to a wide range of these highly innovative medical technologies. The proposed Regulation is based on the medicinal products regulatory model. For Eucomed, however, certain types of human tissue engineered products should rather be regulated as medical devices", commented Eucomed Director-General, Maurice Wagner.
The fundamental criterion to make the distinction between a medical device and a medicinal product is the principal mode of action. The principal action of medical devices is typically mechanical, whilst medicinal products have a pharmacologic, immunologic or metabolic action. Only medicinal products are absorbed by the body, and distributed, metabolized and excreted.
Demineralized bone powder, which is used to repair small defects in bones, is a typical example of a medical device-like tissue engineered product (mechanical action). This type of product should not fall within the scope of the Advanced Therapy Medicinal Products Regulation.
This should also be the case for products combining a medical device such as a hip or dental implant, with an autologous human tissue or cell coating ( patient's own tissue or cells added for biocompatibility and/or better osteo-integration), as long as an appropriate authorization mechanism is enforced for the tissue and cell components. Such "combination" products will become increasingly widespread in the future. The overall "therapeutic tool" is clearly a medical device (hip joint or dental implant) and should be regulated as such.
Several other types of products falling under the scope of the Advanced Therapy Medicinal Products Regulation are marketed today under national regimes that do not require a medicinal products-style evaluation procedure.
Manufacturers of such products - mostly small companies and start-ups - will need to adapt to meet the new data requirements for marketing authorization. Eucomed estimates this could take up to five years. The text currently proposes an unworkably short transition period of two years.
Mark Grossien
Communications Director
mark.grossien(at)eucomed(dot)be
+32 (0)2.775.92.24
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