Abstract
In Switzerland, gene/cell therapies using genome edited iPSCs for somatic differentiation are generally permitted. Although Swiss Law does not contain specific regulations regarding iPSCs or genome editing in human cells, several norms apply. According to the Transplantation Ordinance, human iPSCs, as well as any gene/cell therapy using them, qualify as transplant products. Therefore, their handling needs to be authorised as described in the present contribution. Whenever genome edited iPSCs are used for somatic differentiation, this work argues that their differentiation into gamete cells is currently not permitted as it is, at present, highly possible that their creation may lead to unintended genetic modifications. Swiss Law, however, strictly prohibits genetic modification of germ cells or embryos (including their precursor cells)—this work presents the effect of this prohibition on different forms of germ line interventions. As all such procedures require personal data, Swiss data protection requirements are analysed. Genetic data qualifies as sensitive data that calls for a higher level of protection. Despite the fact that several norms apply to questions of iPSCs and genome editing, de lege lata a clear regulation and suitable definitions for the current state of research are missing. The present contribution favours an inclusion of, among others, iPSCs in existing definitions and aims to fuel the discussion on a specific research privilege for genome editing and artificial gametes subject to strict limitations.
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Notes
- 1.
Pluripotency describes the ability of cells to differentiate into several (in latin plures = several) cell types (cf. Denker 2002, p. 21).
- 2.
- 3.
Yamanaka (2012), pp. 680 et seq.
- 4.
- 5.
- 6.
- 7.
E.g. chimeric antigen receptor tumor cells (also known as CAR T cells) are T-cells that have been genetically engineered to produce an artificial T-cell receptor for use in immunotherapy (cf. Jensen et al. 2019).
- 8.
- 9.
See e.g. Kang et al. (2016).
- 10.
Cf. disease modelling of Parkinson patients by the research group headed by Hans Schöler, Max Plank Institut for Molecular Biomedicine, and Thomas Gasser, Hertie-Institut for Clinical Neuroscience.
- 11.
Pane et al. (2016), Chapter 3.6.
- 12.
Federal Office of Public Health (2018a).
- 13.
Federal Office of Public Health (2018c).
- 14.
Hüsing et al. (2003).
- 15.
Cf. Feki et al. (2008).
- 16.
Swiss National Science Foundation (2016).
- 17.
For an overview of the research projects see Swiss National Science Foundation (2015).
- 18.
Another fascinating project by Knoblich includes genetically engineered cerebral organoids (Bian et al. 2018, pp. 631–639).
- 19.
Caiazzo et al. (2016).
- 20.
Cf. Re et al. (2018).
- 21.
Find stem cell research via https://hpscreg.eu/search?q=human iPSCs, search result for “human iPSCs”.
- 22.
Roche (2020), p. 2.
- 23.
Roche (2020), p. 3.
- 24.
Cf. Kneller (2015).
- 25.
- 26.
Sprecher (2020), pp. 288 et seq.
- 27.
- 28.
Further see Raposo (2019b), pp. 249–257. Raposo elaborates on the concept of human dignity and the effect of gene editing, arguing She states that criticism of genome editing cannot be based on the argument of human dignity.
- 29.
Cf. Belser and Molinari (2015a), par. 46.
- 30.
Gächter and Rütsche (2018), par. 161.
- 31.
Schweizer (2014); BGE 145 V 97 cons. 8, 101 et seq.; 145 v 116 cons. 6.3, 127; 142 V 58 cons. 5, 64 et seq.; 138 II 513 cons. 8.4, 523; 130 I 16 cons. 5.2, 20; European Court of Human Rights (ECtHR) Reynolds v. Royaume-Uni, 2694/08 [2012], para. 60 et seq.; Panaitescu v. Roumanie, 30909/06 [2012], para. 30; Dodov v. Bulgarie, 59548/00 [2008], points 80 et seq.; Tarariyeva v. Russie, 4353/03 [2006], para. 73–88; Mehmet Sentürk and Bekir Sentürk v. Turquie, 13423/09 [2013], No. 81; Arskaya v. Ukraine, 45076/05 [2013], No. 63; Bajic v. Croatie, 41108/10 [2012], para. 87 et seq., according to which Art. 2 ECHR implies a positive obligation of the state to create a legal regulation that forces public and private hospitals to take appropriate measures to protect patients; cf. comm. on Art. 41, para. 39 et seq.
- 32.
- 33.
BGE 119 Ia 460, 502 cons. 12e (translated): “Dignity of the human being, which already belongs to the embryo in vitro”.
- 34.
For more information regarding the protection of embryos and foetuses see Savioz-Viaccoz (2021); Tschentscher (n.d.), par. 11; Schweizer (2014), par. 10, 23; Schweizer (2002), pp. 41 et seqq., especially pp. 56 et seq.; Rütsche (2009), pp. 230 et seqq.; Manaï (2013), pp. 348 et seqq.; cf. Manaï (2009).
- 35.
Tschentscher (n.d.), par. 11; see e.g. ECtHR Asiye Genç v. Turkey, 24109/07 [2015], para. 80.
- 36.
Art. 36 para. 1 FedCst.
- 37.
BGE 130 I 16, cons. 3; 130 I 65, E. 3.3, 68; 127 I 6, cons. 5g; 126 I 112, cons. 3a et seqq.; 115 et seq.
- 38.
BGE 124 I 80, cons. 2d, 82; 128 II 259 concerning cheeks-mucosa smear test.
- 39.
BGE 136 V 117, cons. 4.2.2.1, 126.
- 40.
BGE 115 Ia 234 (on the then St. Gallen Reproductive Medicine Act) and BGE 119 Ia 460 (on the then Basel Reproductive Medicine Act).
- 41.
BGE 146 IV 297 cons. 2.2, 303 et seq.; 131 I 166 cons. 8.2, 182; Amstutz (2002), pp. 212 et seq.; Gächter and Rütsche (2018), par. 168, concerning the emergency case see BGE 138 V 310 cons. 4, 315; Kanton Zürich § 38 Gesundheitsgesetz vom 2. April 2007: Beistands- und Aufnahmepflicht der Institutionen des Gesundheitswesens in dringenden Fällen.
- 42.
BGE 122 I 153, cons. 6b.
- 43.
E.g. Art. 2 para. 1 lit. a Transplantation Ordinance.
- 44.
Cf. Errass (2018), p. 117, who, carefully and highly informatively, elaborates on regulations of plant breeding methods.
- 45.
- 46.
- 47.
- 48.
BGE 115 Ia 234, 169 et seqq.
- 49.
- 50.
Schweizer (2014), pp. 39 and 56; cf. Häfelin et al. (2020), Chapter 1, § 9; Kiener et al. (2018), p. 125 with further remarks; Hottelier (2007), par. 43; Martin (2007), pp. 224 et seqq.; Federal Supreme Court (FSCt) 1C_74/2015 [02.02.2015], cons. 4.2; BGE 140 III 616 cons. 3.6.6, 633 et seq.; 132 I 181, cons. 4.5, 193 f.; 130 I 16, cons. 5, 19 ff.; 129 I 173, cons. 5.1, 181; 119 Ia 460; ECtHR Gillberg v. Sweden, 41723/06 [2012]. para. 82–97.
- 51.
Reusser and Schweizer (2014b), par. 1.
- 52.
SÄZ 1982, 623.
- 53.
SÄZ 1985, 1127.
- 54.
SÄZ 1993, 1449.
- 55.
Cf. Sprecher (2020).
- 56.
While one group of cantons only declared the SAMS guidelines to be applicable (AR, BL, GE, OW, TG and TI), other cantons created independent solutions (e.g. AG, NE), some of them very restrictive (BS, GL, SG).
- 57.
BGE 115 Ia 234, BGE 119 Ia 460.
- 58.
BBl 1987 II 1208 ff. and Federal Council’s Dispatch on this initiative BBl 1989 III 989 et seq.
- 59.
Former Federal Constitution of 1874, valid until the end of 1999.
- 60.
Reusser and Schweizer (2014b), par. 3.
- 61.
Reusser and Schweizer (2014a), par. 2–6, see the same contribution for further details on Art. 118.
- 62.
Convention on the counterfeiting of medical products and similar crimes involving threats to the public health of 28 November 2011 (CETS no. 211), Ratified by Switzerland in 2018 (SR 0.812.41); Federal Office of Public Health (2020a).
- 63.
Federal Office of Public Health (2020b).
- 64.
Schroeder de Castro Lopes and Schallnau (2019), p. 33.
- 65.
- 66.
Schroeder de Castro Lopes and Schallnau (2019), p. 47.
- 67.
- 68.
Reusser and Schweizer (2014b), par. 8.
- 69.
Sprecher (2020), p. 298.
- 70.
Belser and Molinari (2015c); cf. BGE 119 Ia 460, E. 5b; Federal Council’s Dispatch Reproductive Medicine and Gene Technology.
- 71.
Reusser and Schweizer (2014b), par. 11.
- 72.
- 73.
When mentioning “Art. […] HGTA”, this contribution refers to the HGTA which was passed by the parliament in 2018 as revision of the law of 2004 (“HGTA 2004”). The HGTA is planned to come into force in 2021. It will newly and explicitly cover genetic examinations inside and outside the medical field. In addition, the scope of the HGTA 2004 has been extended by providing a more open definition of the term “genetic examination”. In the future, genetic testing will include all types of tests on the human genome (Art. 3 lit. a HGTA). In addition, data protection principles such as the right not to know genetic data will be applicable in areas of reproductive medicine, too.
- 74.
- 75.
Belser and Molinari (2015c), par. 15.
- 76.
For further information see: Schweizer (1996), par. 14 et seqq., 39 et seqq., 42.
- 77.
Belser and Molinari (2015c), par. 29.
- 78.
See e.g. Subbaraman (2021).
- 79.
Reusser and Schweizer (2014b), par. 31.
- 80.
For further elaborations see Staub (2019).
- 81.
Federal Council’s Dispatch Art. 119 and PGD, p. 5942.
- 82.
Compare Art. 119 para. 2 lit. f. FedCst, Art. 17 para. 1 RMA: in maximum 12 embryos.
- 83.
Compare ECtHR, Parrillo v. Italy, 46470/11 [2015; GC], para. 167–180.
- 84.
Cf. Art. 5 lit. c chif. 3 revFADP; Art. 3 lit. c para. 2 FADP.
- 85.
Gallegos López (2011) passim.
- 86.
Cf. Art. 4-9 HGTA (applicable accordingly in relation to the RMA, HRA).
- 87.
- 88.
A moratorium on genetically modified plants, plant parts, seeds and animals has been in force since 2005. It was last extended by federal decree on 29 August 2016 and a second time in 2021 (see Federal Council’s Dispatch 19.4225). The moratorium is now valid until 31 December 2025 [Art. 37a GTG; Biaggini (2017b), par. 7; Waldmann (2015), par. 2; Schweizer and Errass (2014), par. 2].
- 89.
Cf. against the application Errass (2006), p. 137.
- 90.
Federal Council’s Dispatch Environment Protection Law, BBl 1993 II, p. 1468.
- 91.
Federal Council’s Dispatch Environment Protection Law, BBl 1993 II, p. 1468.
- 92.
Schott and Schweizer (2014), par. 8 et seq.
- 93.
The Additional Protocol to the Convention on Human Rights and Biomedicine concerning Transplantation of Organs and Tissues of Human Origin (ratified by Switzerland on 10 November 2009; SR 0.810.22) also excludes reproductive organs and tissues, as well as embryonic or fetal organs and tissues, from its application in Art. 2 para. 2 lit. a and b.
- 94.
Note that the ordinance is only available in German. The original title is “Verordnung über die Transplantation von menschlichen Organen, Geweben und Zellen (Transplantationsverordnung)”.
- 95.
Schott and Schweizer (2014), par. 13.
- 96.
Marti (2015), p. 134.
- 97.
- 98.
Also see Chumrec (2018), p. 59.
- 99.
Mumme et al. (2020), p. 89.
- 100.
Belser and Molinari (2015c), par. 29.
- 101.
With further information Reusser and Schweizer (2014b), par. 31.
- 102.
Constantin and Andorno (2020).
- 103.
- 104.
Federal Council’s Dispatch Biomedicine Convention and Cloning, 283.
- 105.
It is important to note that Art. 2 explicitly mentions “human beings” and not, for example, “human life”. Thus, unborn human life seems to be covered by the Ovideo Convention; cf. Radau (2006), p. 213. Comparable, outside the medical context of abortion, is the view of the ECtHR, Vo v. France, 53924/00 [2004], para. 87.
- 106.
Tschannen (2016), par. 4 et seq.
- 107.
Federal Council’s Dispatch Biomedicine Convention and Cloning, p. 285.
- 108.
Federal Office of Public Health (2018f).
- 109.
Art. 25, Art. 27, Art. 36, Art. 38, 43, 65 Transplantation Act; Federal Office of Public Health (n.d.).
- 110.
As the FOPH, the agency is attached to the Federal Department of Home Affairs.
- 111.
Cf. Art. 5, Art. 9 set seqq.; Art. 18 et seqq.; Art. 28; Art. 34 et seq., Art. 54; Art. 64 TPA; Art. 49 Transplantation Ordinance in conjunction with the TPA; Swissmedic (2019c).
- 112.
Berne, Northwest and central Switzerland (EKNZ), East Switzerland (EKOS), Geneva (CCER), Ticino as well as Valais and Fribourg; Art. 47 HRA; see a list of the cantonal ethic commissions on the website of Swissethics, a joint association: https://swissethics.ch/en/ethikkommissionen.
- 113.
Cf. Art. 45 et seqq., Art. 51 et seqq. HRA.
- 114.
Koordinationsstelle Forschung am Menschen (2018), p. 8; the report offers further insights into the work of the ethics commissions in 2018, including statistics e.g. about the number of approved research projects.
- 115.
Schroeder de Castro Lopes and Schallnau (2019), p. 1. The authors provide a highly significant and very useful practical guide on the regulations of life science law in Switzerland, as well as meaningful considerations on the current cutting-edge questions. The present section is organised following their structure.
- 116.
For an insightful discussion on the degree of autonomy that the individual has with regard to genetic analyses and the HGTA, see Junod and Romagnoli (2016), pp. 227–245.
- 117.
Closely related to the principle of informed consent for medical measures, is the principle of necessary consent to disclose personal data. (Cf. Art. 27 revFADP, Art. 13 para. 1, Art. 4 para. 5 FADP; Art. 16 et seq., 32–34 HRA; Art. 5 HGTA; Art. 8, 57–60 Transplantation Act; Art. 321bis para. 1 Criminal Code).
- 118.
For biomedical research, the principle is concretised in Art. 13 et seq. Additional Protocol Biomedicine Convention on Biomedical Research.
- 119.
Art. 6, 7 16 et seqq., 26 and 32 para. 1 HRA; Art. 5 para. 1, 6 HGTA; Art. 5 para. 6 revFADP, Art. 4 para. 5 FADP; van Spyk (2011), pp. 106 et seq. Note that the HRA is not applicable to anonymised genetic and biological data (Art. 2 para. 2 HRA).
- 120.
- 121.
Sprecher and van Spyk (2015), pp. 270–289.
- 122.
- 123.
ISSCR Guidelines (2021), para 2.3 Procurement and Informed Consent of Human Biological Materials, Appendix A3. Informed Consent Considerations for Procurement of Cells and Tissues for Stem Cell Research and Translation.
- 124.
Schweizer RJ (2020b), pp. 210 et seqq.
- 125.
- 126.
Manaï (2013), pp. 65 et seqq.
- 127.
Aebi-Müller (2020), p. 6.
- 128.
- 129.
Cf. e.g. ECtHR, Fernandes de Oliveira v. Portugal, 78103/14 [2019], para. 104–115.
- 130.
See Aebi-Müller (2014) for further detail on the patient, uncapable of judgment; Radau (2006), pp. 55 et seqq. See then van Spyk (2011), pp. 253 et seqq. on the exceptional admissibility of research without “informed consent” and pp. 291 et seqq. on the possible infeasibility of research despite “informed consent”.
- 131.
Mumme et al. (2020), p. 93.
- 132.
For a comprehensive and cross-disciplinary contribution on the clinical application of human IPSCs, see Gerke et al. (2020).
- 133.
Schroeder de Castro Lopes and Schallnau (2019), p. 48.
- 134.
Art. 5 Biomedicine Convention; Art. 13 et seq. Additional Protocol Biomedicine Convention on Biomedical Research; Art. 7 HRA; modifications based on Art. 18, 30 HRA.
- 135.
Art. 16 HRA.
- 136.
Cf. Art. 11 HRA, Art. 16 lit i, 17 para. 1 lit. i Biomedicine Convention; Art. 5, 23 Additional Protocol Biomedicine Convention on Biomedical Research.
- 137.
Art. 12, 15 HRA; already enshrined in Art. 5 para. 2, Art. 36 para. 3 FedCst.
- 138.
Council for International Organizations of Medical Sciences.
- 139.
Art. 8 in conjunction with Art. 1 Additional Protocol Biomedicine Convention on Biomedical Research; CIOMS-Guidelines 19 und 20; GCP-Guideline No. 2.5.
- 140.
Cf. CIOMS-Guideline 10.
- 141.
Cf. GCP-Guidelines No. 2.5, 2.10; Art. 11 Additional Protocol Biomedicine Convention on Biomedical Research.
- 142.
Cf. Art. 28 Biomedicine Convention Protocol on Biomedical Research; Art. 27 Helsinki-Declaration.
- 143.
WHO Expert Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing (2021), point 2.5, p. 12 et seq.
- 144.
Art. 15 para. 3 Additional Protocol Biomedicine Convention on Biomedical Research.
- 145.
Cf. CIOMS-Guideline 7.
- 146.
Art. 119 para. 2 lit. e FedCst.
- 147.
Art. 24 Biomedicine Convention; Art. 31 Additional Protocol Biomedicine Convention on Biomedical Research.
- 148.
Federal Act on Research Involving Embryonic Stem Cells (Stem Cell Research Act, StRA).
- 149.
Federal Act on Medically Assisted Reproduction (Reproductive Medicine Act, RMA).
- 150.
See Schabas WA (2019), Art. 7.
- 151.
Art. 21 et seqq. HRA in conjunction with Art. 3 lit. j and k HRA.
- 152.
Art. 25 et seqq. HRA.
- 153.
Art. 28 et seq. HRA.
- 154.
Art. 30 et seq. HRA.
- 155.
- 156.
Cf. HRA; CIOMS Guideline 2; Art. 9 Additional Protocol Biomedicine Convention on Biomedical Research.
- 157.
The ISSCR Guidelines explain: “Cell-based interventions offer unique challenges for preclinical studies. In some cases, homologous cells in the same species are unavailable. Immunesuppressed animal models, while useful, do not permit an understanding of the effect of the immune system on transplanted cells, or, more often, they may not share all the same biological properties of their human counterparts. Since transplanted cells are considerably more complex and can change after transplantation in unpredictable ways, extrapolating cell therapies in an animal model to humans is even more challenging than for small molecule therapeutic candidates.” Guidelines 2021 § 3.3, p. 27.
- 158.
Jenni (2015), par. 3.
- 159.
The Swiss coordination authority for research on human beings (kofam) provides a useful online categoriser: https://www.kofam.ch/en/categoriser/.
- 160.
The mandatory documentation is described in Annex 3 No. 1 ClinO.
- 161.
The documentation needed for the CEC is set out in Annex 3 No. 2 ClinO, the prerequisites regarding Swissmedic are defined in Annex 4 No. 1.
- 162.
The necessary documentation regarding the CEC is also set out in Annex 3 No. 2 ClinO, the prerequisites regarding Swissmedic are defined in Annex 4 No. 2.
- 163.
For extensive explanation on the application process and the legal requirements for gene therapy and transplant products see Marti (2015), pp. 134 et seqq.; See Annex 2 ClinO.
- 164.
Schroeder de Castro Lopes and Schallnau (2019), pp. 58 et seq.
- 165.
Marti (2015), p. 142.
- 166.
- 167.
Concerning the distinction between transplants (as e.g. cardiovascular tissues) and transplant products (as e.g. an ex vivo or ex vitro gene therapy product with cells that have been genetically modified) see Appendix 1 of the EU Regulation (EC) 1394/2007 of 13 November 2007; Marti (2015), pp. 135 et seqq., and pp. 140 et seqq. concerning transplant products and gene therapy products respectively.
- 168.
Marti (2015), p. 141.
- 169.
For further information Swissmedic publishes an application establishment license for medicinal products or TP/GT/GMO (Swissmedic 2019a).
- 170.
- 171.
Bollag et al. (2016), S. N. 53.
- 172.
Fellmann (2015b), pp. 321 et seq.
- 173.
Bollag et al. (2016), par. 54.
- 174.
Schroeder de Castro Lopes and Schallnau (2019), p. 61.
- 175.
Explanatory Report Pre-Draft HRA, pp. 85, 86.
- 176.
The Swiss Code of Obligations contains the civil law of obligations and contract law. The Code of Obligations is contained in part five of the Swiss Civil Code, also officially called the Federal Act on the Amendment of the Swiss Civil Code.
- 177.
Cf. e.g. Canton de Vaud: Loi sur la responsabilité de l’Etat, des Communes et de leurs agents (LRAECA) du 16 Mai 1961, and: Loi sur la santé publique (LSP) du 29 mai 1985, art. 25 Recherche biomédicale avec des personnes. The CHUV, the main hospital in Lausanne, is one of the central places in biomedicinal research in Switzerland.
- 178.
Schroeder de Castro Lopes and Schallnau (2019), p. 70.
- 179.
For further information see Marti (2015), p. 143 et seq.
- 180.
According to Art. 28. 2 of Regulation EC 1394/2007 of the European Parliament, certain ATMPs which are non-routinely manufactured, but manufactured in healthcare facilities and used under the professional supervision and responsibility of a doctor on a patient, do not require a centralised authorisation. Although in Switzerland no explicit “hospital exemption” exists (Mumme et al. 2020, p. 93), in practice and under certain conditions, medical freedom of therapy can act as a surrogate for a product authorisation in the therapeutic products sector (We thank Dr. iur. et dipl. sc. nat. ETH Stefan Kohler, Partner at VISCHER for his valuable information).
- 181.
There is no English version, the German title is “(Arzneimittelverordnung, VAM)”.
- 182.
Cf. Federal Office of Public Health (2018b), pp. 5 et seq.
- 183.
The ICH aims to achieve greater harmonisation worldwide to ensure that safe, effective and high-quality medicines are developed, registered and maintained in the most resource-efficient manner (ICH n.d.).
- 184.
Schroeder de Castro Lopes and Schallnau (2019), pp. 82–85, see pp. 85 et seq. for further information about the different forms of authorisation procedures.
- 185.
Cf. Kohler (2006), p. 454, including further details on the issue.
- 186.
Motion Leumann.
- 187.
Schweizer (2009), p. 74.
- 188.
- 189.
Calame (2007), p. 771.
- 190.
Cf. Art. 7 FedCst.
- 191.
Thomsen (2019), p. 78.
- 192.
Schweizer (2009), p. 83.
- 193.
- 194.
Heinrich (2018), par. 36.
- 195.
- 196.
Cf. ECJ, C-34/10, 18 October 2011 (Grand Chamber), ECLI:EU:C:2011:669.
- 197.
Federal Council’s Dispatch PatA, p. 66.
- 198.
Process patents protect the respective manufacturing process and the direct products of this process (Art. 8a (1) and 8b PAtA).
- 199.
Federal Council’s Dispatch PatA, pp. 70 et seq.
- 200.
Deuring (2020), p. 13.
- 201.
Cystic fibrosis is a congenital metabolic disease. It is caused by a change in the cystic fibrosis gene, the CFTR gene (Mukoviszidose e.V. [2020]).
- 202.
German Ethics Council (2019), pp. 179 et seqq.
- 203.
- 204.
- 205.
Sprecher (2017), p. 1470.
- 206.
The National Academies of Sciences, Engineering, and Medicine (2015).
- 207.
More information on this experimentation: Lang and Griessler (2019), passim.
- 208.
- 209.
Cf. German Ethics Council (2019), p. 48.
- 210.
- 211.
- 212.
Cf. Schöne-Seifert and Stroop (2015), p. 2.
- 213.
German Ethics Council (2019), p. 65.
- 214.
The German Ethics Council explained these forms in great detail and examined their implications in their valuable statement “Intervening in the Human Germ Line” of 2019.
- 215.
- 216.
- 217.
- 218.
German Ethics Council (2019), p. 68.
- 219.
- 220.
German Ethics Council (2019), p. 68.
- 221.
German Ethics Council (2019), pp. 68 et seq.
- 222.
- 223.
- 224.
See e.g. Tyser et al. (2021).
- 225.
- 226.
ISSCR Guidelines (2021), page Embryo Models <https://www.isscr.org/policy/guidelines-for-stem-cell-research-and-clinicaltranslation/key-topics/embryo-models>.
- 227.
The U.S. NAS guidelines prohibit the mixing of cells of any nature with the pre-streak embryo. This restriction excludes a number of experiments considered standard in animal embryology, including cell aggregation studies to investigate the segregation of primitive embryonic blastomeres into inner cell mass and trophectoderm.
- 228.
ISSCR Guidelines (2021), page Culture of Human Embryos <https://www.isscr.org/policy/guidelines-for-stem-cellresearch-and-clinical-translation/key-topics/culture-of-human-embryos>
- 229.
- 230.
Pro memoria, all methods are prohibited which are not aimed at the health and integrity of the child, but at a positive eugenic selection of embryos or germ material, Rütsche (2009), pp. 274 et seqq., 427 et seqq.; cf. Art. 33 RMA e contrario.
- 231.
Federal Council Dispatch RMA, p. 283.
- 232.
Sprecher (2017), p. 1471.
- 233.
Reusser and Schweizer (2014b), par. 23.
- 234.
Cf. Sect. 5.2.1.1.
- 235.
Belser and Molinari (2015c), par. 29.
- 236.
- 237.
- 238.
Reusser and Schweizer (2014b), par. 25.
- 239.
Cf. Explanatory Report Biomedicine Convention; Radau (2006), pp. 213 et seqq.
- 240.
Cf. Explanatory Report Biomedicine Convention; The Council of Europe’s Committee on Bioethics examines the practical and legal implications of Art. 13 and whether clarifications or amendments are required (CoE Strategic Action Plan 2020–2025, p. 9).
- 241.
Federal Dispatch RMA, p. 281; cf. Federal Dispatch Biomedicine Convention, pp. 310 et seq.; Rütsche (2010), p. 305; Sprecher (2020), p. 303. For additional informations on the concept and scope of the fundamental right to respect and protect human dignity (Art 7 FedCst) see BGE 142 IV 77 cons. 4.1, 82 et seqq.; 119 Ia 460 cons. 12c-12e, 501 et seqq.
- 242.
- 243.
Reich et al. (2015), p. 12.
- 244.
- 245.
Rütsche (2010), p. 305.
- 246.
- 247.
Cf. Federal Dispatch RMA.
- 248.
Federal Council’s Dispatch EFG, p. 1187; cf. Nationale Ethikkommission im Bereich der Humanmedizin (2016), pp. 2 et seq.; Hertig Randall and Marquis (2021), Art. 10 para. 15 FedCst; Reusser and Schweizer (2014b), par. 16 with further information; Rütsche (2009), p. 230 et seqq.; Augustin (2001), p. 174.
- 249.
Federal Dispatch RMA, pp. 5946 et seq.; Federal Council’s Dispatch EFG, pp. 1186 et seqq.
- 250.
Sprecher (2017), p. 1478.
- 251.
- 252.
- 253.
Nationale Ethikkommission im Bereich der Humanmedizin (2016), p. 4.
- 254.
Gruber and Sommer (2019), p. 287 et seqq.
- 255.
This was also made clear by the Federal Supreme Court in BGE 119 Ia 500, E. 12e, 502.; as already mentioned in Sect. 5.3, today’s allowance to create 12 surplus embryos during PID seems inconsistent with this strict set of prohibitions. In addition, the prohibition on research on embryos in vitro stands in contrast to the permission to research on ESCs, as in the latter case embryos are destroyed.
- 256.
- 257.
Federal Council Dispatch RMA, p. 283.
- 258.
In 2013/2014 there were several attempts to revise Art. 4 RMA arguing that the provision violates the fundamental right to personal liberty (Art. 10 FedCst) and discriminates against women. For further elaborations, see the expert report Büchler (2013).
- 259.
While deriving ESCs from an embryo, the embryo is destroyed.
- 260.
Note that the Biomedicine Convention implicitly allows cloning for therapeutic, preventive and diagnostical reasons in Art. 13; see also Reusser and Schweizer (2014b), par. 28 et seq. For technical details on cloning see: National Human Genome Research Institute, Cloning Fact Sheet (August 15, 2020).
- 261.
- 262.
Augustin (2001), p. 176.
- 263.
Augustin (2001), p. 175.
- 264.
Federal Office of Public Health (2018e).
- 265.
Cf. Art. 119 para. 2 lit. c FedCst; Art. 17 para. 1 RMA.
- 266.
Embryo donation is prohibited (cf. Belser and Molinari 2015b, c, par. 42). However, cells and tissues derived from embryos might be transplanted after complete information and agreement of both parents (cf. Art. 37 et seqq. Transplantation Act). Concerning the use of surplus embryos for research purposes see Savioz-Viaccoz (2021), pp. 498 et seqq.
- 267.
- 268.
For further information and the required documentation see Federal Office of Public Health (2018c).
- 269.
Federal Office of Public Health (2018d).
- 270.
Translated from German to English from Federal Dispatch StRA, p. 1243.
- 271.
- 272.
Federal Dispatch RMA, pp. 281 et seq.; Sprecher (2020), p. 318.
- 273.
Nuffield Council on Bioethics (2018), par. 2.19.
- 274.
Hayashi et al. (2011).
- 275.
- 276.
- 277.
- 278.
Advena-Regenry et al. (2018), p. 315.
- 279.
Reusser and Schweizer (2014b), par. 23.
- 280.
Which is allowed according to Swiss law, as we saw above.
- 281.
- 282.
In the same sense cf. ISSCR Guidelines (2021), para 3.3 Preclinical Studies: 3.3.4 Transparency and Publication (p. 32), and para 3.4 Clinical Studies: 3.4.3 Transparency and Reporting of Research Results (p. 37).
- 283.
- 284.
Federal Council’s Dispatch RMA 1996, p. 247.
- 285.
- 286.
Cf. Sect. 5.2.1.1.
- 287.
Cf. Federal Dispatch RMA, pp. 281 et seqq.; Art. 35 RMA, Art. 3 lit. b StRA, Art. 13 Biomedicine Convention.
- 288.
ISSCR Guidelines (2021), page: Culture of Human Embryos.
- 289.
However, as shown above (Sect. 5.4.3.1) using genetically modified human iPSCs as a basis for the creation of artificial gametes and thus modifying the human germ line is prohibited.
- 290.
Cf. Easley et al. (2012), p. 440.
- 291.
Advena-Regnery et al. (2018), p. 293.
- 292.
Likewise, Sprecher (2020), p. 288.
- 293.
- 294.
Advena-Regenry et al. (2018), p. 318.
- 295.
- 296.
Cf. Sprecher (2020), p. 289.
- 297.
Reusser and Schweizer (2014b), par. 32; Art. 2 lit. a RMA.
- 298.
Seen above (Art. 2 lit. a RMA).
- 299.
Advena-Regnery et al. (2018), p. 286.
- 300.
For an alluring contribution on the constitutional assessment of human iPSC-based gametes see Deuring (2019), pp. 350 et seqq.
- 301.
Note that these prohibitions do questionably not include human iPSCs; Art. 24 StRA seems further not prohibit the development of iPSCs into gametes.
- 302.
Note that Art. 119 para. 2 FedCst does not cover ovum donation. Originally, it was thought to lift the ban stated in Art. 4 RMA in the revision in 2017.
- 303.
For more details see Wettlaufer (2018), pp. 337 et seqq.
- 304.
- 305.
I.e. because they open up new and prior unexpected possibilities of assisted reproduction, including selection procedures which are currently prohibited.
- 306.
Cf. Advena-Regnery et al. (2018).
- 307.
In contrast, the discussion on “green genetic engineering” is already very advanced, cf. e.g. Errass (2018).
- 308.
ISSCR Guidelines (2021), page: “Heritable Genome Editing”. And idem: “This is described in more detail in the recent report, Heritable Human Genome Editing, from the International Commission on the Clinical Use of Human Genome Editing (National Academy of Medicine, National Academy of Sciences, and the Royal Society, 2020)”.
- 309.
Sprecher (2017), pp. 1484 et seq.
- 310.
- 311.
Likewise, cf. Taupitz and Deuring (2019), p. 83.
- 312.
ISSCR Guidelines (2021), page: “Heritable Genome Editing”. (for “consequences”).
- 313.
- 314.
One might think of an exemption similar to the amendment to the British Human Fertilisation and Embryology Act of 2008 (HFEA) and the Human Fertilisation and Embryology (Research Purposes) Regulations 2001. With a special licence an embryo can be kept and used for research purposes, but according to HFEA section (3) subsection (3) a licence cannot authorize “(a) keeping or using an embryo after the appearance of the primitive streak.” Subsection (4) concretises for research: “For the purposes of subsection (3)(a) above, the primitive streak is to be taken to have appeared in an embryo not later than the end of the period of 14 days beginning with [the day on which the process of creating the embryo began], not counting any time during which the embryo is stored.”
- 315.
Art. 119 para. 2 lit. a and c. Lit. c might require an amendment, as additional questions could be relevant (e.g. the age of the iPSCs donor).
- 316.
Speaking of the ethical debate, it seems worthy to note the difference between the different aspects of the discussions on genome editing in the extra-human and human sphere in Switzerland. Whereas in the extra-human area, the question of admissibility is rather a matter of positive law (cf. Art. 5 para 2 GTA, and the decision C-528/16 of the ECJ in 2018, defining genome editing on plants as gen-technology), here, ethical-legal considerations prevail (Cf. Taupitz and Deuring 2019, p. 76).
- 317.
- 318.
The National Academies of Sciences, Engineering, and Medicine (n.d.).
- 319.
Comité Consultatif National d’Éthique pour les sciences de la vie et de la santé, German Ethics Council, Nuffield Council on Bioethics (2020).
- 320.
German Ethics Council (2019), p. 35.
- 321.
Cf. Pommering (2014), p. 60.
- 322.
Cf. Higher Education Funding Council for England et al. (2016).
- 323.
Schläpfer (2016), p. 137.
- 324.
- 325.
Cf. Uttinger (2015), par. 10.93.
- 326.
Cf. Do Canto (2020), p. 178.
- 327.
Do Canto and Steiner (2019), p. 6.
- 328.
Pommering (2014), pp. 62 et seq.
- 329.
Uttinger (2015), par. 10.93.
- 330.
- 331.
Uttinger (2015), par. 10.47.
- 332.
German abbreviation; there is no English version available.
- 333.
Art. 1 para. 1 EPDG.
- 334.
The introduction of the national electronic patient dossier (EPD) was planned for April 2020, however, works on certifications have taken longer than expected. Currently (as of July 2020), it is becoming apparent that the certification procedures could be completed between autumn 2020 and spring 2021 (Konferenz der kantonalen Gesundheitsdiretorinnen und -direktoren 2020); for further information about the EPD see the website www.patientendossier.ch by e-healthsuisse, the coordination authority of the federal government and cantons, the Swiss Confederation and the conference of the cantonal health directors.
- 335.
“Spitex” is the abbreviation of hospital external help and care and is used in Switzerland to describe care at home. Spitex organisations provide services to people in need of every age group in order to support and enable life at home. For further information see https://www.spitex.ch.
- 336.
Especially the European Data Protection Convention 108 (“Convention 108”) and its additional protocols.
- 337.
FOPH-working group “Personalised Medicine” (2017), p. 4.
- 338.
Art. 6 Convention 108 Special categories of data “1. The processing of: (a) genetic data; (b) personal data relating to offences, criminal proceedings and convictions, and related security measures; (c) biometric data uniquely identifying a person; (d) personal data for the information they reveal relating to racial or ethnic origin, political opinions, trade-union membership, reli-gious or other beliefs, health or sexual life, shall only be allowed where appropriate safeguards are enshrined in law, complementing those of this Convention. 2. Such safeguards shall guard against the risks that the processing of sensitive data may present for the interests, rights and fundamental free-doms of the data subject, notably a risk of discrimination” (Letters (a)-(d) in sentence 1 added by the authors.).
- 339.
Finished on 25 September 2020.
- 340.
- 341.
According to the common principle lex specialis derogat legi generali.
- 342.
However, according to the prevailing view of the cantonal data protection commissioners, cantonal data protection law is also applicable in private medical care institutions if they fulfill an assignment based on the cantonal list of hospitals (Cf. Rütsche (2012); according to a report written by the author).
- 343.
Cf. Brunner (2015), par. 10–12; Germany has similar regulations.
- 344.
For further elaborations on data processing by cantonal organs see Waldmann and Oeschger (2011).
- 345.
Disclosing data includes making personal data accessible, for instance, by permitting access, transmission or publication (Art. 4 lit. d revFADP, [Art. 3 lit. f FADP]).
- 346.
Art. 16 et seq., 32–34 HRA; Art. 5 HGTA; Art. 8, 57–60 Transplantation Act; Art. 321bis para. 1 Criminal Code; and already resulting generally from Art. 27 Civil Code.
- 347.
Cf. Brunner (2015), par. 22.
- 348.
Cf. Hofstetter (2014).
- 349.
- 350.
Schroeder de Castro Lopes and Schallnau (2019), p. 284.
- 351.
Cf. Art. 5 revFADP, Art. 4 FADP.
- 352.
FSCt 1C_597/2020, cons. 6.3; ECtHR, Catt v. The United Kingdom, 43514/15 [2019], para. 127).
- 353.
The “data controller” is any private person or federal body that decides on the purpose and content of a data file (Art. 3 lit. i FADP). In the drafted revFADP, the term describes the private person or federal body who, alone or together with others, decides on the purpose and the means of the processing (Art. 4 lit. i revFADP). The data protection legislation of the Cantons is using the term “person responsible” or “data controller”.
- 354.
ECtHR, Roche v. United Kingdom, 32555/96 [2005], para. 157-168; Joanna Szulc v. Poland, 43932/08 [2012], para. 93; Segerstedt-Wiberg and others v. Sweden, 62332/00 [2006], para. 99; BGE 122 I 153 cons. 6b/aa, 162; 127 V 219 cons. 1a/aa, 222; 138 I cons. 4.1, 23, ns cons. 7.5.2, 38; 144 II 126 cons. 8.3.7, 153.
- 355.
- 356.
In Switzerland, the Federal Data Protection and Information Commissioner (Commissioner) supervises the application of federal data protection legislation. He supervises federal bodies as well as private bodies, assists federal and cantonal authorities in the field of data protection and gives his opinion on draft Confederation legislation. Further, he cooperates with data protection authorities in the Cantons and abroad in other states. He informs the public about his findings and recommendations. Additionally, he maintains and publishes the Register for Data Files. For more information about the the Commissioner see Art. 43-59 revFADP, and cocerning the crossborder disclosere of personal data see Art. 16 and 17 revFADP.
- 357.
Art. 31 para. 2 lit. e revFADP: “e. The controller processes personal data for purposes not relating to a specific person, in particular for the purposes of research, planning and statistics, provided that the following requirements are fulfilled:
-
1
The controller shall anonymize the data as soon as the purpose of the processing allows for it or shall take reasonable measures to prevent the identification of the data subjects if anonymization is impossible or requires a disproportionate effort.
-
2
Sensitive personal data is disclosed to third parties in such a manner that the data subjects may not be identified. If this is not possible, measures must be taken to ensure that third parties only process the data for non-personal related purposes.
-
3
Results are published in such a manner that the data subjects may not be identified.”
-
1
- 358.
The natural person whose personal data is processed (Art. 5 lit. b revFADP).
- 359.
Art. 19 para. 3 revFADP.
- 360.
Cf. Art. 5 lit. c revFADP; including genetic data (Art. 5 lit. c. para. 3 revFADP).
- 361.
At present, the additional requirements of Art. 6 para. 7 revFADP regarding explicit informational consent do not apply in cantonal and communal hospitals and nursing homes and other cantonal health care facilities, unless a canton follows the concept of the federal legislature. At best, one could argue that a graduated form of consent corresponds to a general legal principle of Swiss data protection law.
- 362.
Federal Council’s Dispatch HRA, p. 8106; Art. 16 para. 1 HRA.
- 363.
Rudin (2015b), par. 4.
- 364.
Cf. Schläpfer (2016), p. 140.
- 365.
Rudin (2015b), par. 5.
- 366.
Cf. Art. 118b, para. 1 FedCst “The Confederation shall legislate on research on human beings where this is required in order to protect their dignity and privacy. […]” (highlighting added); Federal Council’s Dispatch HRA; Rütsche and D’Amico (2015), par. 21 et seqq.; Van Spyk (2015), par. 28 et seqq.
- 367.
- 368.
Federal Council’s Dispatch HRA, p. 8095.
- 369.
Cf. Federal Council’s Dispatch HRA, pp. 8083, 8121.
- 370.
As Rudin (2015b), N 11 highlights, the terms used in the HRA are misleading. This is why Rudin introduces further descriptions which are given in parentheses in this text.
- 371.
- 372.
Sprecher (2018), p. 527.
- 373.
In 2017, the Swiss Academy of Medical Science and the Swiss Ethics Committees for Human Research published a legally-non-binding proposal regarding the general agreement. The proposal was broadly discussed, developed and unified in 2018 and is available via the following link https://www.unimedsuisse.ch/de/projekte/generalkonsent. The template is complemented by the work of the Swiss Biobanking Platform, as well as by the Swiss Personalized Health Network (see Sprecher 2018, p. 528).
- 374.
Baeriswyl (2015), par. 74.
- 375.
Rudin (2015a), par. 23; the HRA is not applicable to research with anonymised biological material and health-related data that was collected in anonymised form (Art. 2 para. 2 lit. b, c HRA).
- 376.
Rudin (2015a), par. 26.
- 377.
- 378.
Equally critical Belser and Molinari (2015b), par. 33–37.
- 379.
Nationale Ethikkommission im Bereich der Humanmedizin (2015), par. 2.
- 380.
- 381.
Nationale Ethikkommission im Bereich der Humanmedizin (2015), par. 5.
- 382.
Art. 31 para. 2 lit. e revFADP is indefinite in this regard.
- 383.
Nationale Ethikkommission im Bereich der Humanmedizin (2015), par. 28.
- 384.
- 385.
Art. 26 para. 2 Health Law Berne in conjunction with Art. 6 para. 1 Patients Right Ordinance Canton Berne; § 18 para. 1 Patient Act Zurich; § 16 para. 1 Ordinances to the hospital law Canton of Basel City, Art. 57 Loi de la santé Canton of Genf; Art. 87 Abs. 5 Loi sur la santé publique Canton Vaud.
- 386.
Eidgenössischer Datenschutz- und Öffentlichkeitsbeauftragter (n.d.).
- 387.
Importantly, the Code of Obligations was revised in 2018 and by January 2020 the revised Art. 128a was introduced which stipulates that claims for damages or satisfaction arising from an injury or death in breach of contract are prescribed in absolute terms after 20 years. One can expect relevant changes in the cantonal health laws.
- 388.
There is no English version available, the German title is “Verordnung über genetische Untersuchungen beim Menschen”. It is to be expected that the ordinance will be adapted to the revised HGTA (cf. Art. 28 et seqq., 30, 31 et seqq., 34 et seqq.).
- 389.
Federal Council’s Dispatch HGTA 2002, p. 7398.
- 390.
Federal Council’s Dispatch HGTA 2017, p. 5666.
- 391.
Not only the person examined, but everybody (e.g. in the case of diseases which are transferred to the offspring). This is especially valuable for blood relatives; Cf. Rieder (2016).
- 392.
Errass (2021), Chapter 3, § 7 V.
- 393.
Cf. Büchler and Michel (2014), pp. 303 et seq.; on the right not to know in the context of genetic examinations, including the different positions in literature as to the question whether the patient needs to be informed of his or her right not to know after the genetic examination and prior to communication of the results, see Hollenstein (2014).
- 394.
A reservation to the right not to know seems appropriate for medical applications, i.e. when the doctor has a duty to act.
- 395.
On the limited use of random finds in the secret surveillance of private communications in criminal proceedings: cf. Art. 272 para. 2 Swiss Code of Criminal Procedure, BGE 144 IV 254, E. 1.3, 157.
- 396.
Cf. Sprecher (2020), p. 323.
- 397.
- 398.
ISSCR Guidelines (2021), page: “Heritable Genome Editing”; Lang et al. (2019), p. 177.
- 399.
A “Federal Council’s Dispatch” is a report to the Federal Assembly in which the Federal Council provides justification for a bill that it is submitting to the Assembly for consideration. If necessary, it includes comments on the individual provisions and provides information on certain aspects (legal background, points of view debated in the preliminary stages of the legislative process, planned implementation of the enactment, consequences of the enactment, etc.). Descriptions of the requirements in Art. 141 para. 2 Parliament Act (SR 171.10) BK, TERMDAT-Leitfaden, 2016, Appendix 4.1.
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Appendices
Legal Acts
Additional Protocol Biomedicine Convention on Biomedical Research | CETS No. 195; Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research of 25 January 2005; https://www.coe.int/en/web/conventions/full-list/-/conventions/treaty/195 |
Additional Protocol Biomedicine Convention on Cloning | CETS No. 168; Additional Protocol to the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, on the Prohibition of Cloning Human Beings of 11 January 1998; https://rm.coe.int/168007f2ca |
Additional Protocol Biomedicine Convention on Transplantation | CETS No. 186; Additional Protocol to the Convention on Human Rights and Biomedicine concerning Transplantation of Organs and Tissues of Human Origin of 24 January 2002 (ratified by Switzerland on 10 November 2009); https://rm.coe.int/1680081562 |
AO EPÜ 2000 | SR 0.232.142.21; Ausführungsordnung zum Europäischen Patentübereinkommen (AO EPÜ 2000), Angenommen vom Verwaltungsrat am 7. Dezember 2006, in Kraft getreten für die Schweiz am 13. Dezember 2007, no English version; https://www.admin.ch/opc/de/classified-compilation/20072183/index.html# |
Charter of Fundamental Rights of the European Union | 2000/C 364/01; Charter of Fundamental Rights of the European Union; https://www.europarl.europa.eu/charter/pdf/text_en.pdf |
Clinical Trial Ordinance (ClinO) | SR 810.305; Verordnung über klinische Versuche in der Humanforschung (Verordnung über klinische Versuche; KlinV) vom 20. September 2013; Ordinance on Clinical Trials in Human Research (Clinical Trials Ordinance, ClinO) of 20 September 2013; https://www.admin.ch/opc/en/classified-compilation/20121176/index.html |
EU-Directive 1998 | 98/44/EC; Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998on the legal protection of biotechnological inventions, https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:31998L0044&from=EN |
European Convention for Data Protection, Convention 108 | CETS No. 108; European Convention for the Protection of Individuals with regard to Automatic Processing of Personal Data of 198; https://www.coe.int/en/web/data-protection/convention108-and-protocol |
European Convention of Human Rights (ECHR) | European Convention of Human Rights of 4 November 1950; https://www.echr.coe.int/Documents/Convention_ENG.pdf |
European Patent Convention | SR 0.232.142.2; Convention on the Grant of European Patents of 5 October 1973; https://www.epo.org/law-practice/legal-texts/html/epc/2016/e/ma1.html |
European Regulation (EC) No. 1394/2007 | (EC) No 1394/2007; Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004; https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2007:324:0121:0137:en:PDF |
Federal Act on Data Protection (FADP) of 1992 | SR 235.1; Bundesgesetz über den Datenschutz (DSG) vom 19. Juni 1992; Federal Act on Data Protection (FADP) of 19 June 1992; https://www.admin.ch/opc/en/classified-compilation/19920153/index.html; The final text of the parliamentary discussion on the revision of the Federal Data Protection Act (revFADP) is available via https://www.admin.ch/opc/de/federal-gazette/2020/7639.pdf, the consultation period ends on 14 January 2021; BBl 220 7639 |
Federal Act on the Electronic Patient Dossier | SR 816.1; Bundesgesetz über das elektronische Patientendossier (EPDG) vom 19. Juni 2015; no English version; https://www.admin.ch/opc/de/classified-compilation/20111795/index.html |
Former Swiss Federal Constitution (fFedCst) | SR 101; Bundesverfassung der Schweizerischen Eidgenossenschaft vom 29. Mai 1874; no English version; no online version |
Gene Technology Act (GTA) | SR 814.91; Bundesgesetz über die Gentechnik im Ausserhumanbereich (Gentechnikgesetz, GTG) vom 21. März 2003; Federal Act on Non-Human Gene Technology (Gene Technology Act, GTA) 21 March 2003; https://www.admin.ch/opc/de/classified-compilation/19996136/index.html |
GMP Directive | Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use; https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32003L0094&qid=1648149876388&from=EN |
Helsinki Declaration | World Medical Association Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subject; https://www.who.int/bulletin/archives/79(4)373.pdf |
Human Fertilisation and Embryology Act (HFEA) | 1990 c. 37; Human Fertilisation and Embryology Act of 1990; https://www.legislation.gov.uk/ukpga/1990/37 |
Human Fertilisation and Embryology (Research Purposes) Regulations | 2001 No. 188; The Human Fertilisation and Embryology (Research Purposes) Regulations of 2001; https://www.legislation.gov.uk/uksi/2001/188/regulation/1/made |
Human Genetic Testing Act (HGTA) | SR 810.12; Bundesgesetz über genetische Untersuchungen beim Menschen (GUMG) vom 8. Oktober 2004; Federal Act on Human Genetic Testing (HGTA 2004) of 8 October 2004; https://www.admin.ch/opc/en/classified-compilation/20011087/index.html; the revised and by the parliament approved text (HGTA) is available via https://www.bag.admin.ch/bag/de/home/medizin-und-forschung/genetische-untersuchungen/aktuelle-rechtsetzungsprojekte1.html; The revised text will probably come into force beginning of January. |
Human Research Act (HRA) | SR 810.30; Bundesgesetz über die Forschung am Menschen (Humanforschungsgesetz, HFG) vom 30. September 201; Federal Act on Research involving Human Beings (Human Research Act, HRA) of 30 September 2011; https://www.admin.ch/opc/en/classified-compilation/20061313/index.html |
Human Research Ordinance (HRO) | SR 810.301; Verordnung über die Humanforschung mit Ausnahme der klinischen Versuche (Humanforschungsverordnung, HFV) vom 20. September 2013; Ordinance on Human Research with the Exception of Clinical Trials (Human Research Ordinance, HRO) of 20 September 2013; https://www.admin.ch/opc/en/classified-compilation/20121177/index.html |
Loi sur la santé Canton Geneva | K 1 03; Loi sur la santé du 7 avril 2006; no English version; https://www.ge.ch/legislation/rsg/f/s/rsg_K1_03.html |
Loi sur la santé publique Canton of Vaud | LOI 800.01, Loi sur la santé publique du canton de Vaud du 29 mai 1985 (LSP); no English version; http://www.drrybisarvandyke.ch/wp-content/uploads/LSP.pdf |
Medcrime Convention | SR 0.812.41; CETS No. 211; Council of Europe Convention on the counterfeiting of medical products and similar crimes involving threats to public health of 28 October 2011; https://www.coe.int/en/web/conventions/full-list/-/conventions/treaty/211 |
Medical Products Licencing Ordinance (MPLO) | SR 812.212.1; Verordnung über die Bewilligungen im Arzneimittelbereich (Arzneimittel-Bewilligungsverordnung; AMBV) vom 14. November 2018; Ordinance on Licensing in the Medicinal Products Sector (Medicinal Products Licensing Ordinance, MPLO) of 14 November 2018; https://www.admin.ch/opc/en/classified-compilation/20180857/index.html |
Ordinance on Human Genetic Testing | SR 810.122.1; Verordnung über genetische Untersuchungen beim Menschen (GUMV) vom 14. Februar 2007; no English version; https://www.admin.ch/opc/de/classified-compilation/20051790/index.html |
Ordinance on Organisational Aspects of the HRA (OrgO-HRA) | SR 810.308; Organisationsverordnung zum Humanforschungsgesetz (Organisationsverordnung HFG, OV-HFG) vom 20. September 2013; Ordinance on Organisational Aspects of the Human Research Act (HRA Organisation Ordinance, OrgO-HRA) of 20 September 2013; https://www.admin.ch/opc/en/classified-compilation/20121179/index.html |
Ordinance to the Federal Act on Data Protection | SR 235.11; Verordnung zum Bundesgesetz über den Datenschutz, vom 14. Juni 1993; Ordinance to the Federal Act on Data Protection of 14. June 1993 (Status as of 16 October 2012); https://www.admin.ch/opc/en/classified-compilation/19930159/index.html |
Patents Act (PatA) | SR 232.14; Bundesgesetz über die Erfindungspatente (Patentgesetz, PatG) vom 25. Juni 1954; Federal Act on Patents for Inventions (Patent Act, PatA) of 25 June 1954; https://www.admin.ch/opc/en/classified-compilation/19540108/index.html |
Patient Act Zurich | 813.13; Patientinnen- und Patientengesetz vom 5. April 2004; no English version; http://www2.zhlex.zh.ch |
Patient Rights Ordinance Berne | BSG 811.011; Verordnung über die Rechte und Pflichten der Patientinnen und Patienten und der Gesundheitsfachpersonen (Patientenrechtsverordnung, PatV) vom 23.10.2002; no English version; https://www.belex.sites.be.ch/frontend/versions/346/embedded_version_content |
Reproductive Medicine Act (RMA) | SR 810.11; Bundesgesetz über die medizinisch unterstützte Fortpflanzung (Fortpflanzungsmedizingesetz, FMedG) vom 18. Dezember 1998; The Federal Act on Medically Assisted Reproduction (Reproductive Medicine Act, RMA) of 18 December 1998; https://www.admin.ch/opc/en/classified-compilation/20001938/index.html |
Stem Cell Research Act (StRA) | SR 810.31; Bundesgesetz über die Forschung an embryonalen Stammzellen (Stammzellenforschungsgesetz, StFG) vom 19. Dezember 2003; Federal Act on Research Involving Embryonic Stem Cells (Stem Cell Research Act, StRA) of 19 December 2003; https://www.admin.ch/opc/en/classified-compilation/20022165/index.html |
Swiss Code of Criminal Procedure | SR 312.0; Schweizerische Strafprozessordnung (Strafprozessordnung, StPO) vom 5. Oktober 2007; Swiss Criminal Procedure Code (Criminal Procedure Code, CrimPC) of 5 October 2007; https://www.admin.ch/opc/en/classified-compilation/20052319/index.html |
Swiss Code of Obligations | SR 220, Bundesgesetz betreffend die Ergänzung des Schweizerischen Zivilgesetzbuches (Fünfter Teil: Obligationenrecht) vom 30. März 1911 (Stand am 1. April 2020); Federal Act on the Amendment of the Swiss Civil Code (Part Five: The Code of Obligations) of 30 March 1911; https://www.admin.ch/opc/de/classified-compilation/19110009/index.html |
Swiss Criminal Code | CC 311.0; Schweizerische Strafgesetzbuch vom 21. Dezember 1937; Swiss Criminal Code of 21 December 1937; https://www.admin.ch/opc/en/classified-compilation/19370083/index.html |
Swiss Federal Constitution (FedCst) | SR 101; Bundesverfassung der Schweizerischen Eidgenossenschaft vom 18. April 1999; Federal Constitution of the Swiss Confederation of 18 April 1999; https://www.admin.ch/opc/en/classified-compilation/19995395/index.html |
The Biomedicine Convention; Oviedo Convention | SR 0.810.2; CETS 164; The Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine (The Biomedicine Convention, Oviedo Convention) of 1997; https://rm.coe.int/168007cf98 |
Therapeutics Products Act (TPA) | SR 812.21; Bundesgesetz über Arzneimittel und Medizinprodukte (Heilmittelgesetz, HMG) vom 15. Dezember 2000; Federal Act on Medicinal Products and Medical Devices (Therapeutics Products Act, TPA) of 15 December 2000; https://www.admin.ch/opc/en/classified-compilation/20002716/index.html |
Transplantation Act | SR 810.21; Bundesgesetz über die Transplantation von Organen, Geweben und Zellen (Transplantationsgesetz) vom 8. Oktober 2004; Federal Act on the Transplantation of Organs, Tissues and Cells (Transplantation Act) of 8 October 2004; https://www.admin.ch/opc/en/classified-compilation/20010918/index.html |
Transplantation Ordinance | SR 810.211, Verordnung über die Transplantation von menschlichen Organen, Geweben und Zellen (Transplantationsverordnung) vom 16. März 2007 (Stand am 15. November 2017); no English version; https://www.admin.ch/opc/de/classified-compilation/20051806/index.html |
Material
CoE Strategic Action Plan 2020–2025 | Strategic Action Plan on Human Rights and Technologies in Biomedicine (2020–2025), Adopted by the Committee on Bioethics (DH-BIO) at its 16th meeting (19–21 November 2019) |
Differenzen Datenschutzgesetz | Ständerat Sommersession 2020 Differenzen Datenschutzgesetz. Totalrevision und Änderung weiterer Erlasse zum Datenschutz (SR 17.059), e-parl 02.06.2020 |
Explanatory Report Biomedicine Convention | Oviedo, 4.IV.1997; Explanatory Report to the Convention for the protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine |
Explanatory Report Pre-Draft HRA | Erläuternder Bericht des Eidgenössischen Departement des Inneren (Departement of Federal Affairs) zum Vorentwurf Bundesgesetz über die Forschung am Menschen (Humanforschungsgesetz, HFG) von Februar 2006 |
Federal Council’s DispatchFootnote 399 Biomedicine Convention and Additional Protocol on Cloning | Curia 01.056; Botschaft betreffend das Europäische Übereinkommen vom 4. April 1997 zum Schutz der Menschenrechte und der Menschen-wÜrde im Hinblick auf die Anwendung von Biologie und Medizin und das Zusatzprotokoll vom 12. Januar 1998 über das Verbot des Klonens menschlicher Lebewesen; BBI 2002 271 ff. |
Federal Council’s Dispatch Additional Protocol Biomedicine Convention Transplantation | Curia 08.064; Botschaft Über die Genehmigung des Zusatzprotokolls Über die Transplantation menschlicher Organe und Gewebe zum Übereinkommen Über Menschenrechte und Biomedizin; BBl 2008 7951 (-7960) |
Federal Council’s Dispatch Art. 119 and PGD | Curia 13.051; Botschaft zur Änderung der Verfassungsbestimmung zur Fortpflanzungsmedizin und Gentechnologie im Humanbereich (Art. 119 BV) sowie des Fortpflanzungsmedizingesetzes (Präimplantationsdiagnostik) vom 7. Juni 2013; BBl 2013 5853 (-5964) |
Federal Council’s Dispatch Biomedicine Convention and Cloning | Curia 01.065; Botschaft betreffend das Europäische Übereinkommen vom 4. April 1997 zum Schutz der Menschenrechte und der MenschenwÜrde im Hinblick auf die Anwendung von Biologie und Medizin (Übereinkommen Über Menschenrechte und Biomedizin) und das Zusatzprotokoll vom 12. Januar 1998 Über das Verbot des Klonens menschlicher Lebewesen vom 11. September 2002; BBl 2002 271 (-336) |
Federal Council’s Dispatch StRA | Curia 02.083; Botschaft zum Bundesgesetz Über die Forschung an Überzähligen Embryonen und embryonalen Stammzellen (Embryonenforschungsgesetz, EFG) vom 20. November 2002; BBl 2003 1163 (-1277) |
Federal Council’s Dispatch Environment Protection Law | Curia 93.053; Botschaft zu einer Änderung des Bundesgesetzes Über den Umweltschutz (USG) vom 7. Juni 1993; BBI 1993 II 1445 |
Federal Council’s Dispatch HGTA 2002 | Curia 02.065; Botschaft zum Bundesgesetz Über genetische Untersuchungen beim Menschen vom 11. September 2002; BBI 2002 7361 |
Federal Council’s Dispatch HGTA 2017 | Curia 17.048; Botschaft zum Bundesgesetz über genetische Untersuchungen beim Menschen vom 5. Juli 2017, BBI 2017 5757 |
Federal Council’s Dispatch HRA | Curia 09.079; Botschaft zum Bundesgesetz Über die Forschung am Menschen vom 21. Oktober 2009; BBl 2009 8045 (-8162) |
Federal Council’s Dispatch PatA | Curia 05.082; Botschaft zur Änderung des Patentgesetzes und zum Bundesbeschluss über die Genehmigung des Patentrechtsvertrags und der Ausführungsordnung vom 23. November 2005; BBl 2006 155 (-186) |
Federal Council’s Dispatch Reproductive Medicine and Gene Technology | Curia 89.067; Botschaft zur Volksinitiative “gegen Missbräuche der Fortpflanzungs- und Gentechnologie beim Menschen” vom 18. September 1989; BBl 1989 III 989 (-1211) |
Federal Council’s Dispatch RMA 1996 | Curia 96.058; Botschaft Über die Volksinitiative “zum Schutz des Menschen vor Manipulationen in der Fortpflanzungstechnologie (Initiative fÜr menschenwÜrdige Fortpflanzung, FMF)” und zu einem Bundesgesetz Über die medizinisch unterstÜtzte Fortpflanzung (Fortpflanzungsmedizingesetz, FMedG) vom 26. Juni 1996; BBl 1996 III 205 (-305) |
Federal Council’s Dispatch Transplantation Act | Curia 01.057; Botschaft zum Bundesgesetz Über die Transplantation von Organen, Geweben und Zellen (Transplantationsgesetz) vom 12. September 2001; BBl 2002 29 (-246) |
Interpellation Michaud Gigon | Interpellation Michaud Gigon (Curia 19.4448) “Biobanken. Wie werden sie kontrolliert, und welche Garantien können den Kundinnen und Kunden zugesichert werden?” vom 02. Dezember 2019 |
ISSCR Guidelines | International Society for Stem Cell Research (2021). ISSCR Guidelines for Stem Cell Research and Clinical Translation. Version 1.0, May 2021 |
Motion Leumann | Motion Leumann (Curia 98.3243) “Revision Bundesgesetz über die Erfindungspatente” vom 10. Juli 1998 |
Motion Ruiz | Motion Ruiz (Curia 17.3170) “Biobanken. Ein gesetzlicher Rahmen zur Sicherung der biomedizinischen Forschung und des Patientenschutzes” vom 16. März 2017 |
Votum Piller AB 1990 | Curia 89.067. Gegen Missbräuche der Fortpflanzungs- und Gentechnologie beim Menschen. Volksinitiative. Botschaft und Beschlussentwurf vom 18. September 1989; BBI III, 989, AB S 1990 477 f. |
WHO Recommendations | WHO Expert Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing. Human Genome Editing: Recommendations 12 July 2021 |
Swiss Federal Supreme Court Cases
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BGE 146 V 297
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BGE 145 V 97
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BGE 145 V 116
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BGE 144 IV 254
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BGE 142 V 58
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BGE 138 II 513
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BGE 138 V 310
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BGE 136 V 117
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BGE 132 I 181
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BGE 131 I 166
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BGE 130 I 65
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BGE 130 I 16
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BGE 129 I 173
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BGE 127 I 145
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BGE 127 I 6
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BGE 126 I 112
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BGE 122 I 153
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BGE 119 Ia 460
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BGE 119 Ia 500
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BGE 115 Ia 234
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Not published: FSCt (BGer) 1C_597/2020
European Court of Human Rights Cases
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Catt v. The United Kingdom, 43514/15 [2019]
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Asiye Genç v. Rurkey, 24109/07 [2015]
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Parillon v. Italy, 46470/11 [2015; GC]
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Arskaya v. Ukraine, 45076/05 [2013]
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Schweizer, R.J., Bernhard, H.P., Straden, A.S. (2022). Regulation of Genome Editing in Human iPS Cells: Switzerland. In: Dederer, HG., Frenken, G. (eds) Regulation of Genome Editing in Human iPS Cells. Springer, Cham. https://doi.org/10.1007/978-3-030-93023-3_5
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