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Focus on Regulation

The European Commission adopts two new Directives concerning human tissues and cells

On 8 April 2015, the European Commission adopted Directive (EU) 2015/565 amending Directive 2006/86/EC as regards certain technical requirements for the coding of human tissues and cells (“Directive 2015/565”) and Directive (EU) 2015/566 implementing Directive 2004/23/EC as regards the procedures for verifying the equivalent standards of quality and safety of imported tissues and cells (“Directive 2015/566”).

Commission Directive (EU) 2015/565

The purpose of Directive 2015/565 is to improve the traceability of human tissues and cells in the European Union (“EU”) from procurement to human application or disposal. In such circumstances, Directive 2015/565 requires the traceability of human tissues and cells used for Advanced Therapy Medicinal Products (“ATMP”) until the point where such tissues and cells have been transferred to the manufacturer of the ATMP.

A unique identifier will be applied to all tissues and cells distributed within the EU for human application. This unique identifier will be known as the Single European Code. Tissue establishments are required to ensure that all tissues and cells are allocated a Single European Code prior to their distribution for human application. This requirement also extends to establishments importing tissues into the EU.

The European Commission is required to host and maintain an IT platform (the “EU Coding Platform”) which contains:

  • the EU Tissue Establishment Compendium; and
  • the EU Tissue and Cell Product Compendium.

Tissue establishments accredited, designated, authorised or licensed by the competent authorities of the EU Member State will be assigned a unique tissue establishment number. The European Commission will include information concerning the tissue establishment and its unique identification number in the EU Tissue Establishment Compendium.

Furthermore, information concerning the tissues and cells circulating within the EU will be included in the EU Tissue and Cell Product Compendium. This will include the relevant product codes approved as part of the existing coding systems, EUTC, ISBT128 and Eurocode.

The European Commission is required to ensure that the information contained in the EU Coding Platform is publicly accessible before 29 October 2019.

Commission Directive (EU) 2015/566

The purpose of Directive 2015/566 is to ensure that tissues and cells imported into the EU from third countries meet quality and safety standards equivalent to those tissues and cells procured, processed and distributed in the EU.

The importation of human tissues and cells shall be undertaken by an accredited, designated, authorised or licensed tissue establishment authorised by the relevant competent authority in an EU Member State for such purposes.

As part of the application for authorisation as an accredited tissue establishment, the establishment must submit certain information to the competent authority. This information includes:

  • general contact information concerning the tissue establishment;
  • a list of the types of imported tissues and cells, including once-off imports of specific types of tissues or cells;
  • the name(s) of the third country supplier(s) for each type of imported tissue and cell;
  • detailed information concerning the third country suppliers, including the activities carried out by the third country suppliers;
  • a copy of the written agreement between the tissue establishment and the third country supplier(s); and
  • a detailed description of the flow of imported tissues and cells from their procurement to their reception at the importing tissue establishment.

The competent authorities may conduct inspections to ensure that the imported tissues and cells meet the applicable quality and safety standards. This includes on-site inspections at the facilities of the importing tissue establishment.

Directive 2015/566 requires importing tissue establishments to have in place written agreements with a third party supplier if any processing of the tissues and cells is conducted outside of the EU. Such written agreements must specify the quality and safety standards applicable to the imported tissues and cells. EU Member States can, however, provide an exception to this requirement for certain once-off imports.

EU Member States will have until 29 October 2016 to transpose both Directive 2015/565 and Directive 2015/566 into the national laws of the EU Member States. The national implementing measures will apply from 29 April 2017.