Tuesday, August 22, 2017
Project co-funded by the European Commission in the framework of the 2nd Health Programme
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A.7.6. CONTINUITY PLANS / CESSATION OF BANK

1.  Member States shall ensure that TEs have agreements and procedures in place to ensure that, in the event of termination of activities for whatever reason, stored tissues and cells shall be transferred to other tissue establishment or establishments accredited, designated, authorised or licensed in accordance with Article 6 (Directive 2004/23/EC), without prejudice to Member States' legislation concerning the disposal of donated tissues or cells, according to the consent pertaining to them.[1]

2. TEs should have in place a continuity plan (with adopted procedures and concluded agreements) to ensure that, in the event of termination of their banking/servicing activities (partly, temporarily or permanently) for whatever reason, the tissues in their management should be transferred to other TEs.

3. This continuity plan should not undermine legitimate public health interests and should not be guided by financial considerations (profit-maximizing practices).

4. When the continuity plan implies that tissue could be exported (transferred to a country outside the EU), the export should comply with the requirements in section A.6.3. (Import and export).

5. The accepting TEs need to be accredited, designated, authorized or licensed for the purpose of the activities they will need to assume when accepting the tissue.

6. The accepting TEs need to be able to handle the anticipated amounts of transferred tissue (e.g. sufficient stocking capacity).

7. The transferred tissue needs to be accompanied by its relevant documentation (including traceability data) and material concerning the quality and safety of the tissue (including retention samples).

8. The transport conditions should maintain the quality and safety of the tissues.

9. The transfer of tissues, documentation and material are done under the responsibility of the Responsible Persons of the giver and acceptor TEs.

10 The acceptor TEs should have in place procedures for verifying the compliance of the tissues to the ethical and legal requirements.

11. The terms and conditions of the transfer of tissues should be described in an agreement (service level agreement or convention) detailing at least:

a)   Responsibilities and commitments of each party;

b)   Type and anticipated quantities of tissues that will be transferred;

c)   Type and anticipated quantities of documentation that will be transferred;

d)   Type and anticipated quantities of material (e.g. retention samples) that will be transferred;

e)   Transport conditions for tissue, documentation and material.

It is possible, however, that a meaningful transfer of tissues cannot be agreed upon (or is impossible).  In this case, the CA should determine the fate of the tissues.



[1] Directive 2004/23/EC of the European Parliament and of the Council (Art 21)

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