Mapping of More Stringent Tissues and Cells Donor Testing Requirements - Mapping Exercise 2015
Directive 2004/23/EC defines the mandatory tests that must be performed on tissues and cells donors each time they donate. The legal basis of this legislation allows Member States to adopt more stringent measures on a national basis. Implementation surveys have indicated that many Member States have done this, in some cases in response to local epidemiological risks and in some other cases because they consider that a higher level of safety can be ensured with these more stringent provisions. The more stringent measures are either adopted in national legislation and/or they are defined by national standards organisations to be taken into consideration by authorities in their regular inspections.
Many stakeholders have suggested that these more stringent measures might create barriers for the sharing of tissues and cells between Member States. Additionally, manufacturers and developers of medicinal products derived from tissues and cells (e.g. advanced therapy medicinal products) comment that more stringent measures create a complex and unclear situation that makes distribution of these substances between Member States very challenging.
To address this issue, the Member State competent authorities and the European Commission, DG SANTE agreed to map the more stringent donor testing measures and to make the results of this mapping publicly available. The objective is not to evaluate or comment on the requirements in place at a national level but to provide greater clarity and transparency on this topic.
The exercise was conducted during 2015 by means of a survey that was completed by all Member State competent authorities. The preliminary findings were presented to the authorities during their regular meeting in December 2015. This was followed by a process of clarification and verification with the authorities. The data has been organised in individual country sheets with separate tables for non-reproductive and reproductive tissues and cells. The information from each country has been aggregated into one overview sheet with separate tables for non-reproductive and reproductive tissues and cells to enable a comparison between the different countries.
In each EU country :