Peter LIESE,
Christel SCHALDEMOSE,
Alda SOUSA,
Margrete AUKEN,
Paolo BARTOLOZZI,
Anne DELVAUX,
Anna ROSBACH,
Thomas ULMER,
Zofija MAZEJ KUKOVIČ,
Renate SOMMER,
Mairead McGUINNESS,
Richard SEEBER,
Miroslav MIKOLÁŠIK
Proposal for a regulation
Article 4 a (new)
Article 4a 1. A device may only be used for the purpose of a genetic test if the indication is given by persons admitted to the medical profession under the applicable national legislation after a personal consultation. 2. A device may be used for purposes of a genetic test only in a way that the rights, safety and well-being of the subjects are protected and that the clinical data generated in the course of the genetic testing are going to be reliable and robust. 3. Information. Before using a device for the purpose of a genetic test the person mentioned in paragraph 1 shall provide the person concerned with appropriate information on the nature, the significance and the implications of the genetic test. 4. Genetic counselling. Appropriate genetic counselling is mandatory before using a device for the purpose of predictive and prenatal testing and after a genetic condition has been diagnosed. It shall include medical, ethical, social, psychological and legal aspects and has to be addressed by physicians qualified in genetic counselling. The form and extent of this genetic counselling shall be defined according to the implications of the results of the test and their significance for the person or the members of his or her family, including possible implications concerning procreation choices. 5. Consent. A device may only be used for the purpose of a genetic test after the person concerned has given free and informed consent to it. The consent has to be given explicitly and in writing. It can be revoked at any time in writing or orally. 6. Testing of minors. In case of minors the informed consent of the parents or legal representative shall be obtained; consent must represent the minor’s presumed will and may be revoked at any time, without detriment to the minor. In case of incapacitated adults not able to give informed legal consent, the informed consent of the legal representative shall be obtained; consent must represent the presumed will and may be revoked at any time, without detriment to the person. Devices predicting a genetic condition that has implications for diseases in adulthood or for family planning shall not be used in minors unless preventive means are available before reaching the age when the person tested is able to give consent. 7. A device may only be used for the determination of sex in connection with prenatal diagnosis, if the determination fulfils a medical purpose and if there is a risk of serious gender specific hereditary diseases. By way of derogation of Article 2(1) and (2) this also applies to products which are not intended to fulfil a specific medical purpose. 8. The provisions of this Article on the use of devices for the purpose of genetic tests do not prevent the Member States from maintaining or introducing for reasons of health protection or public order more stringent national legislation in this field.