Transplantation Act
English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.
Art. 43 Mandatory authorisation
1 Any person who wishes to transplant organs, tissues or cells of animal origin or transplant products obtained therefrom into humans shall require authorisation from the FOPH. 2 Authorisation shall be granted for a clinical trial if: a. a risk of infection for the population can be excluded with a high degree of probability; b. a therapeutic benefit can be expected; c. the necessary technical and operative requirements have been fulfilled; d. a suitable quality assurance system is in place. 3 Authorisation shall be granted for standard treatment if: a. a risk of infection for the population can be excluded; b. a therapeutic benefit has been demonstrated; c. the requirements stipulated in paragraph 2 letters c and d have been fulfilled.
Art. 44 Duties of the holder of the authorisation
The holder of the authorisation has a duty: a. to examine the recipient regularly and on a long-term basis for pathogenic agents or markers thereof; b. on the death of the recipient, to examine the cadaver for any signs of infection; c. to record all information and transactions relevant in terms of protecting the health of the population; d. to maintain the records in such a way that the data can be traced back to the donor animal, the recipient and the biological samples that were taken; e. to retain the records and the biological samples and to make them available to the responsible authorities on request; f. should information come to light which could be relevant in terms of protecting the health of the population, to implement all necessary measures without delay and to inform the competent authorities immediately.
Art. 45 Mandatory testing
Any person who removes organs, tissues or cells from an animal or transplants these or transplant products obtained from them must make certain that they have been tested for pathogenic agents or markers thereof.
Art. 46 Indemnification
In order to protect harmed individuals, the Federal Council may: a. require any person who places on the market or transplants animal organs, tissues or cells to obtain insurance coverage for the costs for which he is liable or to make provision for another form of indemnification; b. determine the scope and duration of this indemnification; c. oblige the indemnifier to notify the FOPH of the existence, interruption or cessation of the indemnification.
Art. 47 Costs for measures required by the authorities
The perpetrator shall bear the costs of measures implemented by the competent authorities to: a. prevent or reduce a risk of infection for the population; b. determine or eliminate harm caused by infections.
Art. 48 Regulations of the Federal Council
1 The Federal Council shall issue regulations concerning the handling of organs, tissues and cells of animal origin. In particular, it shall specify: a. requirements concerning the handling of donor animals; b. requirements concerning the quality of the animal organs, tissues or cells; c. the requirements concerning tests to monitor the health of recipients and donor animals; d. the preconditions for authorisation and the authorisation procedure; e. the duration and nature of retention of recorded data and transactions and biological samples that have been taken; f. the pathogenic agents or markers for which tests must be carried out; g. the circumstances in which organs, tissues and cells of animal origin for which the test results are reactive may be transplanted; h. the labelling of organs, tissues or cells of animal origin which have been obtained from genetically modified animals; i. the requirements concerning: 1. information of and consent by the recipient, 2. information of med