Commission Directive 2006/17/EC of 8 February 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells (Text with EEA relevance) (c. 17)

ANNEX III SELECTION CRITERIA AND LABORATORY TESTS REQUIRED FOR DONORS OF REPRODUCTIVE CELLS AS REFERRED TO IN ARTICLE 3(b) AND ARTICLE 4(2)

3. Donations other than by partners

The use of reproductive cells other than for partner donation must meet the following criteria:

3.1.

donors must be selected on the basis of their age, health and medical history, provided on a questionnaire and through a personal interview performed by a qualified and trained healthcare professional. This assessment must include relevant factors that may assist in identifying and screening out persons whose donation could present a health risk to others, such as the possibility of transmitting diseases (such as sexually transmitted infections), or health risks to themselves (e.g. superovulation, sedation or the risks associated with the egg collection procedure or the psychological consequences of being a donor);

3.2.

the donors must be negative for HIV 1 and 2, HCV, HBV and syphilis on a serum or plasma sample, tested in accordance with Annex II, point 1.1, and sperm donors must additionally be negative for chlamydia on a urine sample tested by the nucleic acid amplification technique (NAT);

3.3.

HTLV-I antibody testing must be performed for donors living in or originating from high-incidence areas or with sexual partners originating from those areas or where the donor’s parents originate from those areas;

3.4.

in certain circumstances, additional testing may be required depending on the donor’s history and the characteristics of the tissue or cells donated (e.g. RhD, malaria, CMV, T. cruzi).

3.5.

for autologous donors, Annex I, point 2.1.1 applies;

3.6.

genetic screening for autosomal recessive genes known to be prevalent, according to international scientific evidence, in the donor’s ethnic background and an assessment of the risk of transmission of inherited conditions known to be present in the family must be carried out, after consent is obtained. Complete information must be provided, in accordance with the requirements in force in Member States. Complete information on the associated risk and on the measures undertaken for its mitigation must be communicated and clearly explained to the recipient.