Transplantation Act

By Steph2
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In The Matter OfTransplantation Act
Exhibit A
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English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.

Section 1 Confederation

Art. 50 Principle

1 The Confederation shall enforce this Act unless it declares this to be the responsibility of the cantons. 2 The Federal Council shall issue the implementing regulations.

Art. 51 Monitoring

1 The Confederation shall monitor the enforcement of this Act by the cantons. 2 It shall coordinate their enforcement activities if it has an interest in enforcement being standardised throughout Switzerland. To this end it may, in particular: a. oblige the cantons to inform it about their enforcement activities; b. prescribe activities for the cantons to ensure standardised enforcement.

Art. 52 International cooperation

The Confederation shall employ measures to facilitate the exchange of information and the rapid and safe exchange of organs, tissues or cells and to fight illegal trade in organs.

Art. 53 Continuing education and training of medical personnel

The Confederation may carry out or support continuing education and training programmes that enable medical personnel to provide appropriate care for donors and their families.

Art. 53 — Amended by Annex No 29 of the Federal Act of 20 June 2014 on Continuing Education and Training, in force since 1 Jan. 2017 (AS 2016 689; BBl 2013 3729).

Art. 54 Delegation of enforcement duties

1 The Federal Council may delegate enforcement duties to organisations and persons under public or private law. 2 This applies in particular to: a. monitoring the health of organ and blood stem cell donors in accordance with Article 15c; abis. the allocation of organs in accordance with Article 19; b. the keeping of a stem cell register in accordance with Article 62; c. monitoring in accordance with Article 63. 3 The Federal Council shall ensure that the delegated duties are remunerated.

Para. 2 let. a — Amended by No I of the FA of 19 June 2015, in force since 15 Nov. 2017 (AS 2016 1163, 2017 5629; BBl 2013 2317). Para. 2 let. abis — Inserted by No I of the FA of 19 June 2015, in force since 15 Nov. 2017 (AS 2016 1163, 2017 5629; BBl 2013 2317).

Art. 55 Evaluation

1 The FOPH shall ensure that the enforcement and impact of this Act are evaluated scientifically. 2 These evaluations shall focus on: a. the influence of the Act on the situation, attitude and behaviour of the population and medical personnel; b. the practice of allocating organs, the quality of transplantations, and the availability of organs, tissues and cells for transplantation. 3 The Federal Department of Home Affairs shall report the results of completed evaluations to the Federal Council and shall make a recommendation on the next course of action to the Federal Council.

Section 2 The Cantons

Art. 56 Organisation and coordination

1 The cantons shall organise and coordinate activities relating to transplantation in: a. hospitals that care for donors; b. transplant centres. 2 In particular, they shall ensure that at each of these hospitals and at the transplant centres: a. one person is responsible for local coordination; b. the necessary continuing education and training programmes for the medical staff are provided. 3 The person responsible for local coordination shall ensure in particular that: a. donors and their families receive appropriate care; b. donors are reported to the national organ allocation office (Art. 22).

Para. 2 let. b — Amended by Annex No 29 of the Federal Act of 20 June 2014 on Continuing Education and Training, in force since 1 Jan. 2017 (AS 2016 689; BBl 2013 3729).

Section 3 Duty of Confidentiality and Provision of

Art. 57 Duty of confidentiality

All persons charged with enforcing this Act shall be bound to maintain confidentiality.

Art. 58 Confidentiality of data

The confidentiality of the data compiled as a result of this Act merits protection, and the data must accordingly be treated confidentially.

Art. 59 Disclosure of data

1 Where no overriding and conflicting private interest exists, data may, in individual cases and following a written, justified request, be provided to: a. civil courts if the data is required to judge a court case; b. criminal courts and criminal investigation authorities if the data is required to investigate a felony or misdemeanour. 2 Where no overriding and conflicting private interest exists, data may be provided to: a. the offices within the Confederation and cantons responsible for enforcing this Act and organisations or persons under public or private law if they require the data to fulfil the duties assigned to them under this Act; b. criminal investigation authorities if required to prosecute or prevent a felony or an offence under this Act. 3 Data which is of general interest and relates to the application of this Act may be published. The individuals concerned must not be identifiable. 4 In other cases, data may be provided to third parties as follows: a. data not relating

Art. 60 Exchange of data with foreign authorities and international organisations

1 The Federal Council shall regulate responsibilities and the procedures for exchanging data with foreign authorities and institutions and with international organisations. 2 Confidential data may only be provided to foreign authorities and institutions or to international organisations if: a. required by agreements under international law or resolutions passed by international organisations; b. necessary to avert an imminent danger to life or health; or c. this would enable illegal trade or other serious offences under this Act to be exposed.

Section 4 Informing the Public

Art. 61

1 The FOPH and the cantons shall regularly inform the public about matters concerning transplantation medicine. To this end they shall collaborate with organisations and persons under public or private law. 2 This information shall cover: a. the ways in which an individual can express their wishes concerning the donation of organs, tissues or cells, the preparatory medical measures and the related risks and harm, and the consequences of expressing such wishes; b. the legal situation and practical aspects, i.e. explanation of the preconditions for the removal, allocation and transplantation of organs, tissues and cells in Switzerland; c. the demand for organs, tissue and cells and the benefits of donation for the patients. 3 The Federal Council may determine that a declaration of volition to donate organs, tissues or cells may be recorded on a suitable document or information storage medium.

Para. 1 — Second sentence amended by No I of the FA of 19 June 2015, in force since 15 Nov. 2017 (AS 2016 1163, 2017 5629; BBl 2013 2317). Para. 2 let. a — Amended by No I of the FA of 19 June 2015, in force since 15 Nov. 2017 (AS 2016 1163, 2017 5629; BBl 2013 2317). Para. 2 let. c — Inserted by No I of the FA of 19 June 2015, in force since 15 Nov. 2017 (AS 2016 1163, 2017 5629; BBl 2013 2317).

Section 5 Stem Cell Register

Art. 62

1 The FOPH shall keep a stem cell register. 2 The purpose of the stem cell register is to find suitable stem cells for a specific recipient. The data recorded in this register may only be used for this purpose. 3 The data stored in the stem cell register are those necessary to determine the tissue match of: a. stored stem cells; b. persons who have declared their willingness to donate. 4 Any person who processes data of the type referred to in paragraph 3 must report them to the register. These data should only be reported in conjunction with a person's name if required by the purpose of the register. 5 A person entered in the register may request the deletion of data referring to him or her at any time. 6 The Federal Council shall specify the types of stem cells for which a register will be kept.

Section 6 Monitoring and Measures

Art. 63 Monitoring

1 The Federal Office shall monitor compliance with the provisions of this Act. In particular it shall carry out periodic inspections to this end. 2 It may, free of charge, take the necessary samples, request the necessary information or documents and request any other assistance required. It may instruct the customs authorities to obtain samples. 3 It may enter sites, establishments and premises and search vehicles in pursuit of its duties.

Art. 64 Duty of cooperation

Any person who handles organs, tissues or cells or transplant products obtained therefrom must, without remuneration, assist the FOPH in the pursuit of its duties. In particular they must: a. permit samples to be taken or provide samples on request; b. provide information; c. grant access to documentation and premises.

Art. 65 Measures

1 The FOPH may take any measures necessary to enforce this Act. 2 In particular it may: a. issue notices of non-compliance and set an appropriate deadline for rectification of the situation; b. seize and destroy organs, tissues and cells or transplant products that endanger health or do not comply with the requirements of this Act; c. forbid the use of premises or establishments or close plants; d. suspend or revoke authorisations or approvals. 3 The FOPH may take necessary precautionary measures. In particular it may seize or hold organs, tissues or cells or transplant products which are deemed to be non-compliant or in the event of a reasonable suspicion. 4 Where an infringement of the terms of this Act is suspected, the customs authorities shall be entitled to retain shipments containing organs, tissues, cells or transplant products at the border or in bonded warehouses and to involve the FOPH. The Federal Office shall carry out subsequent investigations and instigate the necessary

Section 7 Funding

Art. 66 Division of tasks

The Confederation and the cantons shall bear the costs of enforcing this Act in their respective jurisdictions.

Art. 67 Fees

1 Fees shall be levied in respect of: a. the granting, suspension or revocation of authorisations; b. the conduct of inspections; c. the ordering and performance of measures. 2 The Federal Council shall set the fees for enforcement by the federal authorities.

Section 8 Right of Appeal

Art. 68

1 Appeals may be filed with the Federal Administrative Court with respect to rulings derived from this Act and its implementing ordinances. 2 If an appeal against a ruling on the allocation of organs is justified, the Federal Administrative Court shall only determine the degree to which federal law has been infringed by the contested ruling. 3 The right of appeal shall otherwise be governed by the general provisions on the Administration of Federal Justice.

Art. 68 — Amended by No I 11 of the Ordinance of the Federal Assembly of 20 Dec. 2006 on the Amendment of Legislation in accordance with the Provisions of the Federal Supreme Court Act and the Administrative Court Act, in force since 1 July 2007 (AS 2006 5599; BBl 2006 7759).