Legal frameworks

The European Union, on the basis of its competency in Public Health, decided to supervise the cells and tissues banking activities when these samples were used for a therapeutic target (Directive 2004/23/EC). This Directive has a limited scope, as it covers the use of only certain types of cells and only for certain purposes. Indeed, some cells are specifically excluded from the scope of the Directive as the cells used as an autologous graft within the same surgical procedure. In contrast, stem cells from cord blood and embryonic stem cells (among others) should be covered by this Directive (when these cells are subject to a lawful use in a Member State).

These requirements have been primarily drafted to

  • offer a high level of safety and quality for cells in transplantation by providing harmonized standards across the European territory for their collection, storage and distribution, and
  • guarantee recipients’ safety in transplantation, specifically concerning the risks of transmissible diseases.

Measures for the accreditation of the establishments storing, preparing and distributing Tissues and cells are required by the Directive and have been implemented in the various Members States’ Jurisdictions, and adequate training is required for the personnel directly involved in such activities.

 

Despite this legislation, the EU legal framework for cells cannot be seen as totally harmonized. This lack of harmonization results

  • from the use of the legislative vehicle of Directives which offsets out the objectives to be achieved but leaves the Members States free in the means chosen for their implementation, and
  • because other pieces of legislation have to be referred to when the whole development pipeline of cells is addressed.

 

When researchers perform research-development activities in Europe they face two levels of complexity :

  • First, they have to identify the correct legal instrument to apply to their activity.
  • Second, they have to deal either with EU law or with national laws, or with both, depending on the qualification of their activities and products.

 

Thus, the translational pipeline from basic research to the delivery of innovative stem-cell based therapies is covered by a variety of European legal instruments [Migliacco and Pintus, 2012] ranging from regulations on marketing authorization (Regulation (EC) n°1394/2007), to directives about clinical trials (Directive 2001/20/EC) and guidelines of good clinical practice (Directive 2001/83/EC, Directive 2009/120/EC). In this respect the legal regulation is far from being totally homogeneous in European national frameworks [Ancans 2012; Mahalatchimy, Rial-Sebbag and al. 2012] and furthermore not all the steps in the translational pipeline are equally addressed from a legal point of view (Favale. and Plomer, 2009). This leads to heterogeneity of the legal requirements to be fulfilled in the various Members States and, as a consequence, heterogeneity can be seen as one factor which can slow down the innovation process.