Although the number of transplantations each year has grown rapidly over the past two decades, the demand for transplantation using human cells, tissues and organs has increased significantly, resulting in a continuing shortage of human material, particularly organs. Few countries are near to being self-sufficient in the provision of cells, tissues and organs for transplantation.
Efforts should be made to increase the donation of human material, to achieve national self-sufficiency, and to prevent ‘transplant tourism’ and the ‘trafficking’ of human cells, tissues and organs.
Success in increasing donations of cells, tissues and organs in order to meet global needs depends on public acceptance of safe, legal donation and transplantation, together with public awareness of the dangers of commercial trade and ‘trafficking’.
With the growing global circulation of transplantable material, traceability is a major concern for transplant professionals and surveillance systems. There would be significant advantages in developing a common basis for a global system for coding transplantable material, especially cells and tissues. The use of a global coding system could also offer benefits in combating commercial trade.
The allocation of organs, cells and tissues should be guided by clinical criteria and ethical norms, not financial or other considerations. Allocation rules, defined by appropriately constituted committees, should be equitable, externally justified, and transparent.
1. Member States shall take all necessary measures to ensure that all imports of tissues and cells from third countries are undertaken by tissue establishments accredited, designated, authorised or licensed for the purpose of those activities, and that imported tissues and cells can be traced from the donor to the recipient and vice versa in accordance with the procedures referred to in Article 8. Member States and tissue establishments that receive such imports from third countries shall ensure that they meet standards of quality and safety equivalent to the ones laid down in this Directive.
2. Member States shall take all necessary measures to ensure that all exports of tissues and cells to third countries are undertaken by tissue establishments accredited, designated, authorised or licensed for the purpose of those activities. Those Member States that send such exports to third countries shall ensure that the exports comply with the requirements of this Directive.
3. (a) The import or export of tissues and cells referred to in Article 6(5) may be authorised directly by the competent authority or authorities.
(b) In case of emergency, the import or export of certain tissues and cells may be authorised directly by the competent authority or authorities.
(c) The competent authority or authorities shall take all necessary measures to ensure that imports and exports of tissues and cells referred to in subparagraphs (a) and (b) meet quality and safety standards equivalent to those laid down in this Directive.
4. The procedures for verifying the equivalent standards of quality and safety in accordance with paragraph 1 shall be established by the Commission, in accordance with the procedure referred to in Article 29(2).
5. The tissues and cells Directives (EUTCD) (transposed into EU Member State laws, regulations and standards) should ensure that, within the EU, human tissues and cells, whatever their intended use, are of comparable safety and quality even if procured in another Member State, particularly in order to prevent the transmission of diseases and therefore to protect the health of EU citizens who receive human tissue cells and treatments.
6. In addition, wherever tissues and cells for human application enter or leave the EU, they should have met the standards or equivalent to those laid down in the EU Member State laws, regulations and standards, which may be more stringent than the EUTCD.
7. The terms ‘import’ and ‘export’ relate to the exchange of goods (human tissues in this case) respectively from or to countries outside of the EU.
8. The transit of tissues (the import of tissues only for transfer to another EU Member State or for export to a non-EU country) should be considered as an import followed, possibly after a processing and/or storage step, by a transfer or an export.
9. A fair balance in the exchange of human tissue must be sought in order not to undermine the legitimate public health interests in the importing and exporting countries.
10. The import and export of tissues should not be guided by financial considerations (i.e profit-maximizing practices).
11. TEs wishing to import or export tissues should be able to demonstrate that the purposes for which they wish to import or export such material cannot be adequately met by comparable material available from sources within those countries, or is for a particular justifiable purpose. TEs should be able to document the need for importing or exporting in terms of accessibility, quality, timeliness of supply, risk of infection, or quality of service. Such documentation should be available for inspection by the CA.
12. Imports and exports of tissues may only be undertaken by TEs accredited, designated, authorised or licensed for the purpose of those activities.
13. The transport conditions should maintain the quality and safety of the tissues.
14. TEs that import and export tissues should ensure that they comply with the requirements of:
a) The relevant national laws, regulations and standards of the importing and exporting countries.
b) The WHO Guiding Principles on Human Cell, Tissue and Organ Transplantation (provide an orderly, ethical and acceptable framework for the acquisition and transplantation of human cells, tissues and organs for therapeutic purposes).
c) The Declaration of Helsinki (reinforces consent and ethics issues)
15. The importing or exporting TE should have in place procedures for verifying that the tiues comply with the above-mentioned requirements. It is recommended that TEs perform audits of the TEs from and to which they regularly import or export considerable amounts of tissues. Such an audit should include a review of compliance with the above-mentioned requirements.
16. Approval of imported tissues and approval for exportation of tissues are done under the responsibility of the responsible person of the importing or exporting TE.
17. The terms of import and export of tissues must be described in a document detailing the responsibilities and commitments of each party.
18. Important points of concern are:
a) Importing TEs should satisfy themselves, with due assurance from their collaborators abroad, that any material intended for import is sourced consistently with the legal and ethical requirements in both the importing and exporting countries;
b) If the importing TE cannot ensure that ethical standards have been put in place, the tissues should not be imported.
a) Importing TEs should satisfy themselves that, in the countries from which they seek to import tissue, the gaining of consent for the purpose to which the tissue is subsequently put is part of the process by which the material is obtained (including providing donors, their legal representatives or their family with the information that their tissues may be exported for use abroad).
b) The importing TE should have in place reliable procedures which clearly set out the evidence indicating how informed consent was obtained, including safeguarding the confidentiality of all information relating to consent.
a) Relevant data concerning the import and export of tissues should be retained in a safe place in the TE and should be available for inspection by the CA. This import/export register should include details of the reason why the decision was made to import or export the tissues, of when the tissues were imported or exported and where from or to, the uses to which they were put, when the tissues were transferred elsewhere and to whom.
a) Imported tissues must be traceable from the donor to the recipient and vice versa. This traceability should also apply to all relevant data relating to products and materials coming into contact with these tissues.
b) A unique code must be assigned to each donation and to each of the products associated with it.
c) All imported and exported tissues must be uniquely identified with a label that contains the information or references allowing a link to the information regarding tissue procurement, reception, processing, storage and distribution or disposal. The label should at all times mention the name and address of the facility where the tissue was procured and the TE that performed the procurement.
TEs should keep the data necessary to ensure traceability at all stages. Data required for full traceability (see Annex VI of Commission Directive 2006/86/EC of 24 October 2006), including the import/export register, should be kept for a minimum of 30 years after clinical use or the expiry date, in an appropriate and readable storage medium acceptable to the CA. Data storage may also be in electronic form.
WHO. Human organ and tissue transplantation. Report by the Secretariat. Sixty-Second World Health Assembly. March 26, 2009.