Regulation of Genome Editing in Human iPS Cells: Germany

Frenken, Gregor; Lüttge, Hannah

doi:10.1007/978-3-030-93023-3_3

Gregor Frenken³ &
Hannah Lüttge³

300 Accesses

Abstract

Until 2021, ten GTMPs and one CTMP have been authorised in the EU and fifteen further are expected to become available by 2023—an augmentation that underlines the relevance of the regulatory framework for combined gene/cell therapy in the EU and, in particular, in Germany as one of its Member States. The present chapter aims at describing the regulation of genome-edited human iPS cells to be differentiated into somatic cells for autologous re-transplantation. Departing from Germany’s constitution as a federal state and its being a Member State of the EU, the key actors in the field of pharmaceutical regulation (EMA, PEI) are presented and their interplay in the multi-level system is analysed. The regulatory processes governing the development, manufacture, marketing and application of ATMPs is scrutinised. Special attention is paid to the EU’s schemes aimed at fostering innovation and guaranteeing the availability of medicinal products required for public health as well as to the possibilities of making available medicinal products without marketing authorisation. The analysis shows that, integrated into the European system, the German regulatory framework strives for maintaining high standards, while at the same time securing scientific and economic competitiveness and best treatment for the individual patient.

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Notes

1.
Verband Forschender Arzneimittelhersteller e.V. (2020).
2.
Alliance for Regenerative Medicine (2019), p. 3.
3.
Freund (2017), Vorbemerkung vor § 1, par. 1–2.
4.
Deutsch and Spickhoff (2014), p. 968; Freund (2017), Vorbemerkung vor § 1, par. 4; Kügel (2016a), par. 9–10; Pfohl (2020), Vorbemerkung, par. 1.
5.
In Germany known as the Contergan-Skandal.
6.
Freund (2017), Vorbemerkung vor § 1, par. 5; Kügel (2016a), par. 10–14, 16–17, 20; Pfohl (2020), Vorbemerkung, par. 2.
7.
Kügel (2016a), par. 18.
8.
Alliance for Regenerative Medicine (2019), p. 1.
9.
Basic Law for the Federal Republic of Germany (Grundgesetz für die Bundesrepublik Deutschland) in the revised version published in the Federal Law Gazette Part III, classification number 100-1, last amended by Article 1 of the Act of 28 March 2019 (Federal Law Gazette I p. 404). An English translation is available at https://www.gesetze-im-internet.de/englisch_gg/englisch_gg.pdf (accessed 25 Feb 2021).
10.
Basic Law, Art. 30.
11.
Basic Law, Art. 70(1), 83, 92.
12.
Basic Law, Art. 74(1) No. 19.
13.
Basic Law, Art. 74(1) No. 26.
14.
Basic Law, Art. 72(1).
15.
Medicinal Products Act (Arzneimittelgesetz) in the version published on 12 December 2005 (Federal Law Gazette Part I p. 3394), last amended by Article 11 of the Act of 6 May 2019 (Federal Law Gazette I p. 646). An English translation is available at https://www.gesetze-im-internet.de/englisch_amg/englisch_amg.pdf (accessed 25 Feb 2021).
16.
Genetic Engineering Act (Gentechnikgesetz) in the version published on 16 December 1993 (Federal Law Gazette Part I p. 2066), last amended by Article 21 of the Act of 20 November 2019 (Federal Law Gazette I p. 1626). Regrettably, only an unauthorised English translation of the version of 2003 is available at http://web.uni-frankfurt.de/si/gentech/GenTGengl10-95c.pdf (accessed 25 Feb 2021).
17.
Cf. Basic Law, Art. 83.
18.
Cf. Basic Law, Art. 87(3).
19.
Medicinal Products Act, § 77(1).
20.
Medicinal Products Act, § 77(2).
21.
Cf. Genetic Engineering Act, § 31.
22.
Basic Law, Art. 23(1).
23.
Consolidated Version of the Treaty on European Union [2016], OJ C 202, 7.6.2016, p. 13 (TEU), available at https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:12016M/TXT&from=EN (accessed 25 Feb 2021).
24.
Consolidated Version of the Treaty on the Functioning of the European Union [2016], OJ C 202, 7.6.2016, p. 47 (TFEU), available at https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:12016E/TXT&from=EN (accessed 25 Feb 2021).
25.
TFEU, Art. 4(2)(k).
26.
TFEU, Art. 168(4)(c).
27.
Schmidt am Busch B (2016), par. 62.
28.
TFEU, Art. 2(2).
29.
Lurger (2018), par. 52; Schmidt am Busch (2016), par. 65; Niggemeier (2015), par. 51; Schmidt and Sule (2012) p. 369. — Kingreen (2016), par. 22, defends the opposite view by analogy with TFEU, Art. 168(4)(a). This is not convincing: whereas lit. (a) states explicitly that “[the EU’s] measures shall not prevent any Member State from maintaining or introducing more stringent protective measures”, such a clause is missing in lit. (c). As there is no evidence for it having been overlooked by the Union legislator, it must be assumed, argumentum e contrario, that a Member State’s right to adopt stricter standards should be excluded for lit. (c).
30.
TFEU, Art. 4(2)(a).
31.
TFEU, Art. 114(1).
32.
Lurger (2018) par. 52; Faltus (2016), p. 600; Kingreen (2016), par. 22; Niggemeier (2015) par. 46.
33.
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67). A consolidated version of 26.07.2019 is available at https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02001L0083-20190726&qid=1613345686360&from=EN (accessed 25 Feb 2021).
34.
Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Union procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1). A consolidated version of 30.03.2019 is available at https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02004R0726-20190330&qid=1613345878480&from=EN (accessed 25 Feb 2021).
35.
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 (OJ L 324, 10.12.2007, p. 121). A consolidated version of 26.07.2019 is available at https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02007R1394-20190726&qid=1613345959831&from=EN (accessed 25 Feb 2021).
36.
Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (OJ L 121, 1.6.2001, p. 34). A consolidated version of 07.08.2009 is available at https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02001L0020-20090807&qid=1613346052970&from=EN (accessed 25 Feb 2021).
37.
Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (OJ L 158, 27.5.2014, p. 1). A consolidated version of 27.05.2014 is available at https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02014R0536-20140527&qid=1613346140633&from=EN (accessed 25 Feb 2021).
38.
Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (OJ L 106, 17.4.2001, p. 1). A consolidated version of 26.07.2019 is available at https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02001L0018-20190726&qid=1613346223811&from=EN (accessed 25 Feb 2021).
39.
Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms (OJ L 125, 21.5.2009, p. 75), available at https://eur-lex.europa.eu/legal-content/DE/TXT/PDF/?uri=CELEX:32009L0041&qid=1613346290811&from=EN (accessed 25 Feb 2021).
40.
TFEU, Art. 288[2].
41.
European Court of Justice (ECJ), Judgement of 14 December 1971, Politi, C-43/71, EU:C:1971:122, par. 9.
42.
ECJ, Judgement of 15 July 1964, Costa v E.N.E.L., C-6/64, EU:C:1964:66.
43.
TFEU, Art. 288[3].
44.
Streinz (2016), par. 485.
45.
Cf. Twelfth Act amending the Medicinal Products Act of 30 July 2004 (Federal Law Gazette Part I p. 2031).
46.
Fenger (2018), § 1 par. 1.
47.
Frenz (2010), pp. 524–525.
48.
Cf. TEU, Art. 17; TFEU, Art. 244–250.
49.
Cf. Regulation (EC) No 726/2004, Art. 55–80.
50.
Regulation (EC) No 726/2004, Art. 61.
51.
Cf. Regulation (EC) No 726/2004, Art. 56(1)(a).
52.
Cf. Regulation (EC) No 726/2004, Art. 56(1)(da); Regulation (EC) 1394/2007, Art. 20–23.
53.
ECJ, Judgement of 15 January 2009, Hecht-Pharma, C-140/07, EU:C:2009:5, par. 25; cf. ECJ, Judgement of 15 November 2007, Commission v Germany, C-319/05, EU:C:2007:678, par. 61.
54.
The German version of the Directive 2001/83/EC tries to resolve the tautology by translating the first alternative (prepared industrially) with gewerblich hergestellt (prepared commercially). Nevertheless, as far as the authors could prove, none of the other official language versions has gone this path, what might be the reason for the German version of Regulation (EC) No 1394/2007 returning to industriell hergestellt (prepared industrially) in its recital 6 (though Bock (2012a), p. 109 assumes a drafting error or translation error).
55.
ECJ, Judgement of 22 April 2010, The Queen v Medicines and Healthcare Products Regulatory Agency, C-62/09, EU:C:2010:219, par. 32.
56.
Bock (2012a), p. 116.
57.
Cf. TFEU, Art. 4(3).
58.
Bock (2012a), p. 126.
59.
Medicinal Products Act, § 4 No. 17.
60.
Cf. Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 031 1.2.2002, p. 1), Art. 3 No. 8: “‘placing on the market’ means the holding of food or feed for the purpose of sale, including offering for sale or any other form of transfer, whether free of charge or not, and the sale, distribution, and other forms of transfer themselves”;
cf. Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (OJ L 268, 18.10.2003, p. 1), Art. 2 No. 14: “‘placing on the market’ means the holding of food or feed for the purpose of sale, including offering for sale, or any other form of transfer, whether free of charge or not, and the sale, distribution and other forms of transfer themselves”;
cf. Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1), Art. 3 No. 9: “‘placing on the market’ means the holding for the purpose of sale within the Community, including offering for sale or any other form of transfer, whether free of charge or not, and the sale, distribution, and other forms of transfer themselves […]”;
cf. Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1), Art. 3 No. 12: “placing on the market: means supplying or making available, whether in return for payment or free of charge, to a third party […]”.
61.
Cf. Bock (2012a), p. 99.
62.
Cf. Bock (2012a), p. 102.
63.
Cf. Pfohl (2020), par. 30–33; Krüger (2016), par. 140, 142; Rehmann (2014), § 4 No. 19; Bock (2012a), p. 105; Pabel (1989), p. 760.—The Courts have adopted this definition, cf. inter alia German Federal Court of Justice (BGH), Judgement of 18 September 2013, 2 StR 535/12, NJW 2014:326, par. 14; German Federal Administrative Court (BVerwG), Judgement of 2 December 1993, 3 C 42.01, BVerwGE 93:341, No. 2.2.
64.
Such structures are hardly considered in legal literature; cf. Rehmann (2014), par. 19, who just remarks that division of labour constellations ought to be scrutinised thoroughly.
65.
European Commission (2005), p. 3.
66.
Regulation (EC) No 1394/2007, Art. 1, 2(1), recital 6.
67.
This result is built on various indications: First, the EMA Regulation refers back to the definitions of the Directive 2001/83/EC (Art. 2[1]). Second, the criteria for granting a marketing authorisation under the EMA Regulation are the same as under Directive 2001/83/EC (Art. 6(1), 7(a), recital 14). Third, the marketing authorisation granted by the EU in accordance with the provisions of the EMA Regulation has the same effects as a marketing authorisation granted by the Member States in accordance with the Directive 2001/83/EC (Art. 13(1), recital 6).
68.
See Sect. 3.3.4.3.
69.
Regulation (EC) No 1394/2007, Art. 2(1)(a).
70.
Regulation (EC) No 1394/2007, Art. 2(1)(c).—Annex I to Regulation (EC) No 1394/2007 contains a negative list of manipulations that are not considered as substantial (cutting, grinding, shaping, centrifugation, soaking in antibiotic or antimicrobial solutions, sterilization, irradiation, cell separation, concentration or purification, filtering, lyophilization, freezing, cryopreservation and vitrification).
71.
Cf. the definitions for tissue engineered products in Regulation (EC) No 1394/2007, Art. 2(1)(b), and for CTMPs in Regulation (EC) No 1394/2007, Annex I, Part IV, par. 2.2.
72.
Cf. Regulation (EC) No 1394/2007, Annex I, Part IV, par. 2.1.
73.
Cf. Faltus (2016), p. 698, for iPS cells.
74.
Cf. Anliker et al. (2015), p. 1274.
75.
Regulation (EC) No 1394/2007, Art. 2(4) and (5).
76.
Cf. Directive 2001/17/EC, Art. 1.
77.
Cf. Directive 2009/41/EC, Art. 1. Admittedly, Directive 2009/41/EC applies to genetically modified micro-organisms (GMMs) only. However, this Directive on the contained use of GMMs has been implemented by most EU Member States in such a way that the respective national rules extend to all GMOs.
78.
Genetic Engineering Act, § 2(1).
79.
Directive 2001/18/EC, Art. 2(2); cf. Directive 2009/41/EC, Art. 2(b); Genetic Engineering Act, § 3 No. 3.
80.
Directive 2001/18/EC, Art. 2(1); cf. Directive 2009/41/EC, Art. 2(a); Genetic Engineering Act, § 3 No. 1.
81.
Cf. Directive 2009/41/EC, Art. 2(a), which explicitly names “cells in culture”.
82.
Directive 2001/18/EC, Annex I A, part 1; Directive 2009/41/EC, Annex I, part A; cf. Genetic Engineering Act, § 3 No. 3a. These are non-exhaustive lists.
83.
Directive 2001/18/EC, Annex I A, part 2; Directive 2009/41/EC, Annex I, part B; cf. Genetic Engineering Act, § 3 No. 3b. These are exhaustive lists.
84.
Directive 2001/18/EC, Art. 3(1), Annex I B; cf. Directive 2009/41/EC, Art. 3(1)(a), Annex II, part A; Genetic Engineering Act, § 3 No. 3b.
85.
ECJ, Judgement of 25 July 2018, Confédération paysanne et al., C-538/16, EU:C:2018:583, par. 29 et seq.
86.
Cf. Leopoldina et al. (2019), p. 31.
87.
ECJ, Judgement of 25 July 2018, Confédération paysanne et al., C-538/16, EU:C:2018:583, par. 30.
88.
ECJ, Judgement of 25 July 2018, Confédération paysanne et al., C-538/16, EU:C:2018:583, par. 51.
89.
Voigt (2020), p. 61; Spranger (2019), p. 12; Kahrmann and Leggewie (2018), p. 764.
90.
Cf. Dederer and Frenken (2021), p. 5.
91.
Directive 2001/18/EC, Art. 2(2); cf. Directive 2009/41/EC, Art. 2(b); Genetic Engineering Act, § 3 No. 3.
92.
Dederer and Herdegen (2020), par. 95.
93.
Cf. Gromitsaris (1997), p. 402; Preusche (1980), p. 49.
94.
Directive 2004/23/EC, Art. 2(1)[1].
95.
Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells (OJ L 102, 7.4.2004, p. 48). A consolidated version of 07.08.2009 is available at https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02004L0023-20090807&qid=1613851286698&from=DE (accessed 25 Feb 2021).
96.
Directive 2004/23/EC, Art. 2(1)[2]; Regulation (EC) No 1394/2004, Art. 3.
97.
Directive 2004/23/EC, Art. 2(2)(a); cf. Medicinal Products Act, § 4a No. 3.
98.
Cf. Faltus (2016), pp. 631–635.
99.
Cf. Directive 2004/23/EC, Art. 16(1).
100.
Directive 2004/23/EC, Art. 5(1), cf. Art. 17, 18.
101.
Directive 2004/23/EC, Art. 5(2).
102.
Directive 2004/23/EC, Art. 28, 29.—Based on these provisions, the European Commission has adopted various implementing acts. Of particular relevance is the 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 (OJ L 38, 9.2.2006, p. 40). A consolidated version of 17.12.2018 is available at https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02006L0017-20121217&qid=1613948054572&from=EN (accessed 25 Feb 2021).
103.
See Guidelines of the German Society of Surgery (DGCH) on Good Professional Practice (GPP) on the Removal of Human Tissues and Cells for Manufacturing a Medicinal Product (Leitfaden der Deutschen Gesellschaft für Chirurgie zur Guten Fachlichen Praxis (GFP) für die Entnahme von menschlichen Geweben und Zellen zur Herstellung eines Arzneimittels). Regrettably, there is no English translation available.
104.
Cf. Faltus (2016), pp. 677–678.—For the GMP standards see Sect. 3.3.2.
105.
Medicinal Products Act, § 20b.
106.
Medicinal Products Act, § 20b(1) No. 1, 2.
107.
Medicinal Products Act, § 20b(1) No. 3.
108.
Medicinal Products Act, § 20b(1) No. 4.
109.
Medicinal Products Act, § 20b(1).
110.
Faltus (2016), p. 638.—This is the result of an exception to § 20b of the Medicinal Products Act (established in Medicinal Products Act, § 20d). § 20b of the Medicinal Products Act is inapplicable. Therefore, § 13 of the Medicinal Products Act becomes applicable.
111.
See Sect. 3.3.2.
112.
Renner et al. (2016), p. 92.
113.
Directive 2001/83/EC, Art. 40(1).
114.
Directive 2001/83/EC, recital 2; cf. recital 35.
115.
Faltus (2016), p. 657, reaches the same conclusion (but referring to the incorporation of the manufacturing authorisation requirement into the Medicinal Product Act); cf. Kügel (2016b), par. 4.
116.
Directive 2001/83/EC, Art. 41(a); cf. Medicinal Products Act, § 16.
117.
Directive 2001/83/EC, Art. 41(b); cf. Medicinal Products Act, § 14(1) No. 6.
118.
Directive 2001/83/EC, Art. 41(c), 48, 51; cf. Medicinal Products Act, § 14(1) No. 1.
119.
Directive 2001/83/EC, Art. 49(1), (2), (3); Medicinal Products Act, § 15.—There are some exceptions to these requirements for the personal qualifications; Directive 2001/83/EC, Art. 49(2) and (3) lists other forms of theoretical and practical education which are regarded as equivalent.
120.
Directive 2001/83/EC, Art. 43, cf. Medicinal Products Act, § 17.
121.
Directive 2001/83/EC, Art. 42(1); cf. Medicinal Products Act, § 64(3a).
122.
Directive 2001/83/EC, Art. 42(3); cf. Medicinal Products Act, § 16.
123.
Directive 2001/83/EC, Art. 125[1].
124.
Directive 2001/83/EC, Art. 46(f); cf. Medicinal Products Act, § 14(1) No. 6a in conjunction with Ordinance on Manufacture of Medicinal Products and Active Substances, § 3(1), (2).
125.
Directive 2001/83/EC, Art. 47[1].
126.
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 (OJ L 262, 14.10.2003, p. 22), available at https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32003L0094&qid=1614032711809&from=EN (accessed 25 Feb 2021).
127.
Commission Directive (EU) 2017/1572 of 15 September 2017 supplementing Directive 2001/83/EC of the European Parliament and of the Council as regards the principles and guidelines of good manufacturing practice for medicinal products for human use (OJ L 238, 16.9.2017, p. 44), available at https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017L1572&from=EN (accessed 25 Feb 2021).
128.
Commission Delegated Regulation (EU) No 1252/2014 of 28 May 2014 supplementing Directive 2001/83/EC of the European Parliament and of the Council with regard to principles and guidelines of good manufacturing practice for active substances for medicinal products for human use (OJ L 337, 25.11.2014, p. 1), available at https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32014R1252&from=EN (accessed 25 Feb 2021).
129.
Commission Delegated Regulation (EU) 2017/1569 of 23 May 2017 supplementing Regulation (EU) No 536/2014 of the European Parliament and of the Council by specifying principles of and guidelines for good manufacturing practice for investigational medicinal products for human use and arrangements for inspections (OJ L 238, 16.9.2017, p. 12), available at https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R1569&from=EN (accessed 25 Feb 2021).
130.
An overview of the guidelines on good manufacturing practice is available at https://ec.europa.eu/health/documents/eudralex/vol-4_en (accessed 25 Feb 2021).
131.
Medicinal Products Act, § 13(1).
132.
Medicinal Products Act, § 13(4).
133.
Medicinal Products Act, § 13(4) in conjunction with § 77 (1) and (2).
134.
Cf. Weber K (2019), entry “Einvernehmen”.
135.
Ordinance on Manufacture of Medicinal Products and Active Substances (Arzneimittel- und Wirkstoffherstellungsverordnung) of 3 November 2006 (Federal Law Gazette Part I p. 2523), last amended by Article 3 of the Ordinance of 2 July 2018 (Federal Law Gazette I p. 1080). Regrettably, there is no English translation available.
136.
See Sect. 3.3.3.1.
137.
See Sect. 3.3.3.3.
138.
See Sect. 3.3.4.2.
139.
See Sect. 3.3.4.4.
140.
Directive 2001/83/EC, Art. 6(1); Medicinal Products Act, § 21.
141.
Directive 2001/83/EC, Art. 8(1), 28(2); cf. Medicinal Products Act, §§ 21, 22.
142.
Directive 2001/83/EC, Art. 28(2); cf. Medicinal Products Act, § 25b(2).
143.
Directive 2001/83/EC, Art. 28(1), (3); cf. Medicinal Products Act, § 25b(1), (3).
144.
Regulation (EC) No 726/2004, Art. 3(1) in conjunction with Annex I No. 1a.
145.
Regulation (EC) No 726/2004, Art. 4(1).
146.
Regulation (EC) No 726/2004, Art. 6(1).
147.
Directive 2001/83/EC, Art. 8(3)(ca).
148.
Directive 2001/83/EC, Art. 8(3)(i); see Sect. 3.3.3.3.
149.
Directive 2001/83/EC, Art. 8(3)(k).
150.
Regulation (EC) No 726/2004, Art. 6(2)(a)-(c).
151.
See Sect. 3.2.5.
152.
Regulation (EC) No 1394/2007, Art. 23(a).
153.
Regulation (EC) No 726/2004, Art. 6(3)[4].
154.
Regulation (EC) No 726/2004, Art. 5(2), 6(3)[1]; Regulation (EC) No 1394/2007, Art. 23(a).
155.
Regulation (EC) No 726/2004, Art. 7(c).
156.
Regulation (EC) No 726/2004, Art. 6(3)[2].
157.
An overview of the guidelines relevant for ATMPs in general and GTMPs in particular is available at https://www.ema.europa.eu/en/human-regulatory/research-development/advanced-therapies/guidelines-relevant-advanced-therapy-medicinal-products and at https://www.ema.europa.eu/en/human-regulatory/research-development/scientific-guidelines/multidisciplinary/multidisciplinary-gene-therapy (both accessed 25 Feb 2021).
158.
EMA, Guideline on the quality, non-clinical and clinical aspects of gene therapy medicinal products, 22 March 2018, EMA/CAT/80183/2014, available at https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-quality-non-clinical-clinical-aspects-gene-therapy-medicinal-products_en.pdf (accessed 25 Feb 2021).
159.
EMA, Guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells, 13 April 2012, EMA/CAT/GTWP/671639/2008, available at https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-quality-non-clinical-clinical-aspects-medicinal-products-containing-genetically-modified_en.pdf (accessed 25 Feb 2021).
160.
EMA, Guideline on the risk-based approach according to annex I, part IV of Directive 2001/83/EC applied to Advanced therapy medicinal products, 11 February 2013, EMA/CAT/CPWP/686637/2011, available at https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-risk-based-approach-according-annex-i-part-iv-directive-2001/83/ec-applied-advanced-therapy-medicinal-products_en.pdf (accessed 25 Feb 2021).
161.
EMA, Guideline on scientific requirements for the environmental risk assessment of gene therapy medicinal products, 30 May 2008, EMEA/CHMP/GTWP/125491/2006, available at https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-scientific-requirements-environmental-risk-assessment-gene-therapy-medicinal-products_en.pdf (accessed 25 Feb 2021).
162.
Regulation (EC) No 726/2004, Art. 9(1).
163.
Regulation (EC) No 726/2004, Art. 9(2).
164.
Regulation (EC) No 726/2004, Art. 9(3).
165.
Regulation (EC) No 726/2004, Art. 10(1)[1], [5].
166.
Regulation (EC) No 726/2004, Art. 10(1)[4].
167.
Regulation (EC) No 726/2004, Art. 10(4).
168.
Regulation (EC) No 726/2004, Art. 10(2), 87(1), (3); Regulation (EU) No 182/2011, Art. 3, 5, 10, 11, 13(1)(b), (e).
169.
Cf. Regulation (EU) No 182/2011, Art. 3(3).
170.
Regulation (EC) No 726/2004, Art. 10(2), 87(3); Regulation (EU) No 182/2011, Art. 13(1)(b), 5(2).—Since 2013, the Standing Committee on Medicinal Products for Human Use has given a positive opinion on all drafts submitted by the European Commission (cf. the annual reports from the Commission on the working of the comitology committees available at https://ec.europa.eu/transparency/regcomitology/index.cfm?do=Report.Report, accessed 25 Feb 2021).
171.
Regulation (EC) No 726/2004, Art. 81(1).
172.
Regulation (EC) No 726/2004, Art. 14(1), 13(1).
173.
Regulation (EC) No 726/2004, Art. 14(2).
174.
Regulation (EC) No 726/2004, Art. 14(3).
175.
Cf. Dederer and Frenken (2021), pp. 33–35.
176.
Regulation (EC) No 726/2004, Art. 57(1)[2](n).
177.
PRIME is an acronym for priority medicines.
178.
EMA, European Medicines Agency Guidance for applicants seeking access to PRIME scheme, 7 May 2018, EMA/191104/2015, available at https://www.ema.europa.eu/en/documents/other/european-medicines-agency-guidance-applicants-seeking-access-prime-scheme_en.pdf (accessed 25 Feb 2021), p. 4.
179.
Ibid., p. 4.
180.
Ibid., p. 6–8.
181.
EMA (2020a), pp. 3–4.
182.
EMA (2020c).
183.
EMA (2020d).
184.
EMA (2021c).
185.
Regulation (EC) No 2004/726, Art. 14(9)[1]; see EMA, Guideline on the scientific application and the practical arrangements necessary to implement the procedure for accelerated assessment pursuant to Article 14(9) of Regulation (EC) No 726/2004, 25 February 2016, EMA/CHMP/671361/2015 Rev. 1, available at https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-scientific-application-practical-arrangements-necessary-implement-procedure-accelerated/2004_en.pdf (accessed 25 Feb 2021).
186.
Regulation (EC) No 2004/726, Art. 14(9)[2].
187.
Regulation (EC) No 2004/726, Art. 14-1(1); see EMA, Guideline on the scientific application and the practical arrangements necessary to implement Commission Regulation (EC) No 507/2006 on the conditional marketing authorisation for medicinal products for human use falling within the scope of Regulation (EC) No 726/2004, 25 February 2016, EMA/CHMP/509951/2006, Rev.1, available at https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-scientific-application-practical-arrangements-necessary-implement-commission-regulation-ec/2006-conditional-marketing-authorisation-medicinal-products-human-use-falling_en.pdf (accessed 25 Feb 2021).
188.
Regulation (EC) No 2004/726, Art. 14-1(1). — The unmet medical need is defined as “a condition for which there exists no satisfactory method of diagnosis, prevention or treatment authorised in the Union or, even if such a method exists, in relation to which the medicinal product concerned will be of major therapeutic advantage to those affected” (Regulation (EC) No 2004/726, Art. 14-1(2)).
189.
Regulation (EC) No 2004/726, Art. 14-1(3).
190.
Regulation (EC) No 2004/726, Art. 14-1(7).
191.
Regulation (EC) No 2004/726, Art. 14-1(4), (5).
192.
Regulation (EC) No 2004/726, Art. 14-1(8).
193.
EMA (2021b).
194.
EMA (2020b).
195.
EASAC, FEAM (2020), p. 10; see Banzi et al. (2017); MacPherson and Kimmelman (2019).
196.
Directive 2001/20/EC, Art. 1(4), recital 15; Medicinal Products Act, § 40(1).
197.
Based on Directive 2001/20/EC, Art. 1(3), the European Commission has issued the Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products (OJ L 91, 9.4.2005, p. 13), available at https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32005L0028&qid=1627475770435&from=EN (accessed 25 Feb 2021).
198.
Directive 2001/20/EC, Art. 9(1).
199.
GCP Ordinance (GCP-Verordnung) in the version published on 9 August 2004 (Federal Law Gazette Part I p. 2081), last amended by Article 8 of the Act of 19 October 2012 (Federal Law Gazette I p. 2192). Regrettably, there is no English translation available.
200.
Directive 2001/20/EC, Art. 2(e); Medicinal Products Act. § 4(24).
201.
Directive 2001/20/EC, Art. 9(6); Medicinal Products Act, § 42(2).
202.
Medicinal Products Act, § 40(1) in conjunction with § 77 (1) and (2).
203.
Directive 2001/20/EC, Art. 9(1); Medicinal Products Act, § 40(1).
204.
Directive 2001/20/EC, Art. 9(1).
205.
Cf. Directive 2001/20/EC, Art. 9(7).
206.
Directive 2001/18/EC, Art. 2(3); Genetic Engineering Act, § 3 No. 5.
207.
Directive 2001/18/EC, Art. 6(1), (8); Genetic Engineering Act, § 14(1) No. 1.
208.
Genetic Engineering Act, §§ 14(1) No. 1, 31.
209.
For an overview on the incorporation of EU legislation on GMO into the Member States’ domestic law with regard to investigational medicinal products, cf. https://ec.europa.eu/health/human-use/advanced-therapies/gmo_investiganional_de (accessed 25 Feb 2021). Only Estonia, Greece, Lithuania and Sweden have adopted a similar approach to Germany.
210.
GCP Ordinance, § 9(4); cf. Genetic Engineering Act, §§ 14(1), 31.
211.
Cf. Weber K (2019), entry “Einvernehmen”.
212.
GCP Ordinance, § 9(4).
213.
Directive 2001/20/EC, Art. 9(2); Medicinal Products Act, § 42(2).
214.
European Commission, Communication from the Commission—Detailed guidance on the request to the competent authorities for authorisation of a clinical trial on a medicinal product for human use, the notification of substantial amendments and the declaration of the end of the trial (CT-1) (2010/C 82/01), available at https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2010:082:0001:0019:en:PDF (accessed 25 Feb 2021); which is based on Directive 2001/20/EC, Art. 9(8). The GCP Ordinance lists the information and documents that must accompany the application in § 7(2), (3) and (4).
215.
Annex 1 to CT-1: Clinical trial Application Form, available at https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/application-form_en.pdf (accessed 25 Feb 2021).
216.
GCP Ordinance, § 7(2) No. 9.
217.
GCP Ordinance, § 7(2) No. 3.
218.
Medicinal Products Act, § 42(2).
219.
GCP Ordinance, § 7(4) No. 3.
220.
Directive 2001/20/EC, Art. 13(3)(a); GCP Ordinance, § 7(4) No. 1d.
221.
Directive 2001/20/EC, Art. 13(3)(b); GCP Ordinance, § 7(4) No. 1e.
222.
See Sect. 3.3.2; cf. Directive 2001/20/EC, recital 12.
223.
GCP Ordinance, § 9(1).
224.
Directive 2001/20/EC, Art. 9(4); Medicinal Products Act, § 42(2), GCP Ordinance, § 9(4).
225.
Directive 2001/20/EC, Art. 9(3); Medicinal Products Act, § 42(2), GCP Ordinance, § 9(2).
226.
An overview of the guidelines relevant for ATMPs in general and GTMPs in particular is available at https://www.ema.europa.eu/en/human-regulatory/research-development/advanced-therapies/guidelines-relevant-advanced-therapy-medicinal-products and at https://www.ema.europa.eu/en/human-regulatory/research-development/scientific-guidelines/multidisciplinary/multidisciplinary-gene-therapy (both accessed 25 Feb 2021).
227.
EMA, Guideline on the non-clinical studies required before first clinical use of gene therapy medicinal products, 30 May 2008, EMEA/CHMP/GTWP/125459/2006, available at https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-non-clinical-studies-required-first-clinical-use-gene-therapy-medicinal-products_en.pdf (accessed 25 Feb 2021).
228.
EMA, Guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials, Draft, 31 January 2019, EMA/CAT/852602/2018, available at https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-quality-non-clinical-clinical-requirements-investigational-advanced-therapy_en.pdf (accessed 25 Feb 2021).
229.
See Sect. 3.3.3.1.
230.
Renner et al. (2016), p. 95.
231.
Renner et al. (2016), p. 95.
232.
EMA, Guideline on scientific requirements for the environmental risk assessment of gene therapy medicinal products, 30 May 2008, EMEA/CHMP/GTWP/125491/2006, available at https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-scientific-requirements-environmental-risk-assessment-gene-therapy-medicinal-products_en.pdf (accessed 25 Feb 2021).
233.
GCP Ordinance, § 9(4); cf. Genetic Engineering Act, §§ 14(1), 31.
234.
Renner et al. (2016), p. 97.
235.
Cf. Bundesinstitut für Arzneimittel und Medizinprodukte (2019).
236.
Medicinal Products Act, § 41a(1), (3).
237.
Directive 2001/20/EC, Art. 3(2)(a), 6(3)(b); GCP Ordinance, § 7(3) No. 2.
238.
Directive 2001/20/EC, Art. 6(3)(g); GCP Ordinance, § 7(3) No. 9.
239.
Directive 2001/20/EC, Art. 6(7); Medicinal Products Act, § 42(1); GCP Ordinance, § 8(4).
240.
Directive 2001/20/EC, Art. 6(6); GCP Ordinance, § 8(2).
241.
Directive 2001/20/EC, Art. 7[1]; Medicinal Products Act, § 42(1); GCP Ordinance, § 8(5).
242.
Cf. Dederer and Frenken (2021), pp. 47–52.
243.
Regulation (EC) No 726/2004, Art. 83(1).
244.
Regulation (EC) No 726/2004, Art. 83(2).
245.
Medicinal Products Act, § 21(2) No. 6.
246.
Medicinal Products Act, § 21(2) No. 6, cf. Deutscher Bundestag (2009), p. 47.
247.
Ordinance on the placement on the market of medicinal products without license or without marketing authorisation in cases of hardship (Arzneimittel-Härtefall-Verordnung) of 14 July 2010 (Federal Law Gazette Part I p. 935). Regrettably, there is no English translation available.
248.
Cases of Hardship Ordinance, § 3(1).
249.
Cases of Hardship Ordinance, § 3(2) No. 8.
250.
Cases of Hardship Ordinance, § 3(2) No. 11.
251.
Cases of Hardship Ordinance, § 3(2) No. 6.
252.
Cases of Hardship Ordinance, § 4(1).
253.
Cases of Hardship Ordinance, § 4(3).
254.
Cases of Hardship Ordinance, § 4(2).
255.
Directive 2001/83/EC, Art. 3 No. 7.
256.
Bock (2012a), p. 133; cf. Medicinal Products Act, § 4b(1) No. 1.
257.
Cf. Directive 2001/83/EC, Art. 2(1); for details see Sect. 3.2.3.
258.
Cf. Bock (2012a), p. 134.
259.
Cf. Bock (2012a), p. 135.
260.
Medicinal Products Act, § 4b(2) No. 1, 2.
261.
Cf. Medicinal Products Act, § 4b(1) No. 2.
262.
Directive 2001/83/EC, Art. 3 No. 7.
263.
Cf. Bock (2012a), p. 181; Faltus (2016), pp. 716–717.
264.
Cf. Directive 2001/83/EC, Art. 71(3), Annex I Part I par. 5.2. c), Part IV par. 3.1.; Regulation (EC) No 1394/2007, Art. 15(1), (2), (3).
265.
Regulation (EU) No 536/2014, Art. 61(5)(a), (b), (c).
266.
Cf. Hornby (2010), entry “hospital”.
267.
Cf. Bock (2012a), p. 193; Bock (2012b) p. 794.
268.
Transfusion Act (Transfusionsgesetz) in the version published on 28 August 2007 (Federal Law Gazette Part I p. 2169), last amended by Article 20 of the Act of 20 November 2019 (Federal Law Gazette I p. 1626). Regrettably, there is no English translation available.
269.
Transfusion Act, § 14(2).
270.
ECJ, Judgement of 10 April 1984, von Colson and Kamann v Land Nordrhein-Westfalen, C-14/83, EU:C:1984:153, par. 26, par. 3 of the operative part; ECJ, Judgement of 10 April 1984, Harz v Deutsche Tradax GmbH, C-79/83, EU:C:1984:155, par. 26, par. 3 of the operative part.
271.
Cf. Kühling (2014), p. 482.
272.
TEU, Art. 4(3); cf. ECJ, Judgement of 4 December 1974, van Duyn v Home Office, C-41/74, EU:C:1974:133, par 12.
273.
Cf. Kühling (2014), p. 485.
274.
The same conclusion—but based on the opposite reasoning—is drawn by Gasser and Spranger (2020), pp. 131–132, who stick to the definition of the “facility of health care” as “hospital or other medical facility that treats persons”—which they then equate with the meaning of “hospital” in EU law, as this term is not legally defined.
275.
Cf. Medicinal Products Act, § 4b(1) No. 3.
276.
Directive 2001/83/EC, Art. 5(1).
277.
See Sect. 3.3.4.3.
278.
Cf. Bock (2012a), p. 188.
279.
Directive 2001/83/EC, Art. 3 No. 7[2].
280.
Cf. Medicinal Products Act, § 13(1), which does not exempt ATMPs falling under the hospital exemption from the general requirement of a manufacture authorisation—see Sect. 3.3.2.
281.
Medicinal Products Act, §§ 4b(3), 77(2).
282.
Medicinal Products Act, §§ 4b(3), 21a(2) No. 11.
283.
Medicinal Products Act, §§ 4b(3), 21a(2) No. 9.
284.
Medicinal Products Act, §§ 4b(3), 21a(2) No. 10.
285.
Medicinal Products Act, § 4b(3) No. 5.
286.
This results from an argumentum e contrario with §§ 4b(3), 21a(2) No. 9 and 10 of the Medicinal Products Act.
287.
Medicinal Products Act, §§ 4b(3), 21a(4).
288.
Medicinal Products Act, §§ 4b(3), 21a(4).
289.
Cf. Medicinal Products Act, §§ 4b(3), 21a(6).
290.
Medicinal Products Act, § 4b(4).
291.
Cf. Weber (2019), entry “Einvernehmen”.
292.
Directive 2001/83/EC, Art. 5(1).
293.
See Sect. 3.2.3; cf. Faltus (2020), pp. 69–70.
294.
See Sects. 3.3.1 and 3.3.2, Faltus (2020), p. 69.
295.
Directive 2001/17/EC, Art. 6(1); Genetic Engineering Act, § 14(1) No. 1.
296.
Medicinal Products Act, § 67(9).
297.
Medicinal Products Act, § 63j(1), (3).
298.
Cf. Sato et al. (2019).
299.
Cf. Linoh and Rosenau (2020), p. 1; Vossenkuhl (2013), pp. 93–97; Heyers (2008), p. 508; Deutscher Bundestag (2008), p. 16; Damm and König (2008), p. 65; Lindner (2007), p. 287; cf. UNESCO International Declaration on Human Genetic Data of 16 October 2003, Art. 4.
300.
Cf. Eberbach (2010), p. 162; Kiehntopf and Pagel (2008).
301.
Deutscher Bundestag (2008), p. 16.
302.
Cf. Weichert (2017), p. 538, see Sect. 3.4.1.2.
303.
Linoh and Rosenau (2020), p. 1; Vossenkuhl (2013), pp. 93–97; Heyers (2008), p. 508; Deutscher Bundestag (2002), p. 131; Damm and König (2008), p. 65; Lindner (2007), p. 287.
304.
Heyers (2008), p. 508; Deutscher Bundestag (2008), p. 16; Lindner (2007), p. 287; Deutscher Bundestag (2002), p. 131.
305.
Hübner and Pühler (2010), p. 678; Heyers (2008), p. 508; Deutscher Bundestag (2002), p. 131.
306.
Heyers (2008), p. 508; Deutscher Bundestag (2002), p. 131.
307.
Deutscher Bundestag (2008), p. 16; Lindner (2007), p. 287; Deutscher Bundestag (2002), pp. 131–132.
308.
Weichert (2017), p. 540; Vossenkuhl (2013), pp. 94, 97.—On the contrary, Marnau et al. (2018), p. 87, defend that the anonymisation of genetic data is possible because, from a legal point, it must only be effective, but not absolute.
309.
Heyers (2008), p. 508; Lindner (2007), p. 287; cf. Weichert (2017), pp. 539–540.
310.
German Federal Constitutional Court (BVerfG), Chamber Order of 14.12.2000, 2 BvR 1741/99, 276/00, 2061/00, BVerfGE 103:21–41, par. 49; Deutscher Bundestag (2008), p. 16, cf. Lindner (2007), p. 290; Kluth (2003), pp. 89–92; Deutscher Bundestag (2002), p. 137; cf. Scherrer (2012), pp. 320–344.—As genetic data are biological data, it could be assumed that they were protected by a fundamental right to ‘bio-informational self-determination’ (cf. Duttge (2011), p. 2). However, the correct designation for the fundamental right as it was developed by the Federal Constitutional Court is ‘informational self-determination’. Genetic data merely represent a particular form of data protected under this fundamental right.—On the contrary, the terms ‘gene-informational self-determination’ (Begemann (2015), pp. 103 et seq.), ‘genetic self-determination’ (Halàsz (2004), p. 86) or ‘right to one’s own genetic code’ (Fisahn (2001), p. 52–53) refer to broader concepts which often encompass the relation between the individual and its own genetic data (e.g. a right to know and/or not to know).
311.
Basic Law, Art. 2(1) in conjunction with Art. 1(1).
312.
BVerfG, Judgement of 15 December 1983, 1 BvR 209, 269, 362, 420, 440, 484/83, BVerfGE 65:1–71, par. 147.
313.
BVerfG, Judgement of 15 December 1983, 1 BvR 209, 269, 362, 420, 440, 484/83, BVerfGE 65:1–71, par. 147.
314.
BVerfG, Order of 18 December 2018, 1 BvR 142/15, BVerfGE 150:244–309, par. 45.
315.
Rademacher and Perkowski (2020), p. 719.
316.
Lorenz (2008), par. 339.
317.
Kingreen and Kühling (2015), pp. 215–216.
318.
Lorenz (2008), par. 343.
319.
Kingreen and Kühling (2015), pp. 215–216.
320.
BVerfG, Judgement of 13 February 2007, 1 BvR 421/05, BVerfGE 117:202–244, par. 67; Lindner (2007), p. 292; cf. (restrictive) Kluth (2003), p. 92.
321.
Charter of Fundamental Rights of the European Union [2016], OJ C 202, 7.6.2016, p. 389 (CFR), available at https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:12016P/TXT&from=EN (accessed 25 Feb 2021).
322.
CFR, Art. 8(1); cf. TFEU, Art. 16(1).
323.
TFEU, Art. 16(2), 4(1).—It could be argued, though, that the EU has exclusive competence for, at least, the protection of individuals with regard to the processing of personal data by EU institutions, bodies, offices and agencies by virtue of the nature of this matter as only the EU itself (and not the Member States) can legislate on the action taken by its organs.
324.
Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1). A consolidated version of 04.05.2016 is available at https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02016R0679-20160504&from=EN (accessed 25 Feb 2021).
325.
Regulation (EU) 2016/679, Art. 4 No. 13.
326.
Regulation (EU) 2016/679, heading of Art. 9.
327.
Cf. Weichert (2017).
328.
Regulation (EU) 2016/679, Art. 9(2)(a) as lex specialis to Art. 6(1)(a), 7(1), (2); see Spranger (2017), pp. 864–865.—However, the EU and the Member States may determine circumstances under which it is not possible to consent to the processing of genetic data (Regulation (EU) 2016/679, Art. 9(2)(a)).
329.
Regulation (EU) 2016/679, Art. 9(2)(c) as lex specialis to Art. 6(2), (3).
330.
Regulation (EU) 2016/679, Art. 9(2)(h).—In these cases, the genetic data must be processed “by or under the responsibility of a professional subject to the obligation of professional secrecy” (Regulation (EU) 2016/679, Art. 9(3)).
331.
Regulation (EU) 2016/679, Art. 9(2)(i).
332.
Regulation (EU) 2016/679, Art. 9(2)(j).—In these cases, the processing must comply with the requirements in Art. 89.—Halàsz (2004), pp. 195–196, argues that, in the light of the overall scheme and objectives of EU data protection law, the requirement of consent takes priority over the (exceptional) permission of data processing for research purposes, which therefore can only apply subsidiarily under special circumstances.
333.
Regulation (EU) 2016/679, Art. 9(4).
334.
Federal Data Protection Act (Bundesdatenschutzgesetz) of 30 June 2017 (Federal Law Gazette Part I p. 2097), last amended by Article 12 of the Act of 20 November 2019 (Federal Law Gazette I p. 1626). An English translation is available at https://www.gesetze-im-internet.de/englisch_bdsg/englisch_bdsg.pdf (accessed 25 Feb 2021).
335.
Federal Data Protection Act, § 27(1).
336.
Federal Data Protection Act, § 27(3).
337.
Genetic Diagnostic Act (Gendiagnostikgesetz) in the version published on 31 July 2009 (Federal Law Gazette Part I pp. 2529, 3672), last amended by Article 23 of the Act of 20 November 2019 (Federal Law Gazette I p. 1626). Regrettably, there is no English translation available.
338.
Genetic Diagnostic Act, § 1.
339.
Genetic Diagnostic Act, § 2(1).
340.
Genetic Diagnostic Act, § 3 No. 2.
341.
Genetic Diagnostic Act, § 3 No. 1.
342.
Genetic Diagnostic Act, § 3 No. 6, 7, 8.
343.
Genetic Diagnostic Act, § 2(2).
344.
Gärditz (2020), par. 94 referring to BVerfG, Judgement of 29 May 1973, 1 BvR 424/71, 325/72, BVerfGE 35:79, p. 113.
345.
Linoh and Rosenau (2020), pp. 2–3.
346.
Cf. Gärditz (2020), par. 106–107.
347.
Linoh and Rosenau (2020), p. 5; Zuck (2018), par. 96; Sosnitza and Op den Camp (2011), p. 404. — Häberle (2020), § 2 par. 4, restricts the scope of the exception of genetic examinations for research purposes to “general research which does not involve concrete measures towards specific persons” [English translation by the author], i.e. to basic research; Kern (2012a), par. 14–16, goes even further suggesting an analogous application of certain provisions of the Genetic Diagnostic Act to basic research.
348.
Genetic Diagnostic Act, § 7(1).
349.
Genetic Diagnostic Act, § 7(2).
350.
Genetic Diagnostic Act, § 9(1).
351.
Genetic Diagnostic Act, § 9(2) No. 1, 2, 3.
352.
Genetic Diagnostic Act, § 9(1).
353.
Genetic Diagnostic Act, § 8(1).
354.
Genetic Diagnostic Act, § 8(2).
355.
Genetic Diagnostic Act, § 13(1).—The patient may consent to a longer retention period (Kern (2012b), par. 8; Fenger (2018), § 13 par. 1).
356.
Genetic Diagnostic Act, § 12(1).
357.
Genetic Diagnostic Act, §§ 13(1), 12(1).
358.
Medicinal Products Act, § 40(1) No. 3(c).
359.
Medicinal Products Act, § 40(2a) No. 1.
360.
Medicinal Products Act, § 40(2a) No. 2.
361.
Medicinal Products Act, § 40(2a) No. 3.
362.
GCP Ordinance, § 7(2) No. 15.
363.
GCP Ordinance, §§ 12 (4), (6), 13(1), (2), (3).
364.
Cf. Directive 2001/20/EC, Art. 22(1).
365.
European Commission (2008), p. 8.
366.
Mayor (2017).
367.
Cf. TFEU, Art. 289(1), 294(2).—For scientific advice and expertise on clinical trials, the European Commission has created the Commission Expert Group on Clinical Trials on 14th June 2006, which consists of officials of the Member States’ health ministries and authorities involved in the authorisation of clinical trials; cf. European Commission (n.d.).
368.
Cf. Regulation (EU) No 536/2014, Art. 99[1].
369.
Regulation (EU) No 536/2014, Art. 99[2], 82(3), (2).
370.
Regulation (EU) No 536/2014, Art. 96(1); cf. Regulation (EU) No 536/2014, Art. 98(1), (2) which establishes a transitional period of 3 years.
371.
Cf. ECJ, Judgement of 15 July 1964, Costa v E.N.E.L., C-6/64, EU:C:1964:66.
372.
EMA (2015), p. 4.
373.
EMA (n.d.).
374.
EMA (2021a), p. 2.
375.
Flear (2016), p. 194.
376.
Flear (2016), p. 195.
377.
Cf. Regulation (EU) No 536/2014, recitals 15, 17, 27, 44, 76, 80, Art. 3, 28–35.
378.
Regulation (EU) No 536/2014, Art. 5(1)[1].
379.
Cf. Regulation (EU) No 536/2014, Art. 80, 81.
380.
Regulation (EU) No 536/2014, Art. 81(2), (4).
381.
Regulation (EU) No 536/2014, Art. 80[1].
382.
Cf. Regulation (EU) No 536/2014, recitals 25, 39, 67, 68, Art. 29(2)(b), 37(4)[2], Annex V.
383.
Regulation (EU) No 536/2014, Art. 25(1)[2].
384.
Regulation (EU) No 536/2014, Art. 4[1], [2].
385.
Gross et al. (2017), p. 826.
386.
Regulation (EU) No 536/2014, Art. 6(1)(b)(ii).
387.
Regulation (EU) No 536/2014, Art. 6(1)(b)(i).
388.
Regulation (EU) No 536/2014, Art. 6(1)(c).
389.
Regulation (EU) No 536/2014, Art. 6(1)(d).
390.
Regulation (EU) No 536/2014, Art. 8(2)[1].—There are only three exceptions which allow the Member States to dissent from the joint assessment, Regulation (EU) No 536/2014, Art. 8(2)[2](a)-(c).
391.
Regulation (EU) No 536/2014, Art. 7(1)(a).
392.
Regulation (EU) No 536/2014, Art. 7(1)(b), (c).
393.
Regulation (EU) No 536/2014, Art. 7(1)(d).
394.
Regulation (EU) No 536/2014, Art. 7(2)[1].
395.
Regulation (EU) No 536/2014, Art. 4[2].
396.
Nickel et al. (2017), p. 807.
397.
Regulation (EU) No 536/2014, Art. 6(4), 7(2)[1].
398.
Regulation (EU) No 536/2014, Art. 6(7).
399.
Regulation (EU) No 536/2014, Art. 6(8)[2], [3], 7(3)[1], [2].
400.
See Sect. 3.3.3.3.
401.
Mende et al. (2017), p. 803.
402.
Abou-El-Enein and Schneider (2016), p. 231.
403.
Abou-El-Enein and Schneider (2016), p. 233.
404.
Cf. Deuring (2020), p. 53.—However, it is worth noting that the provisions on clinical trials explicitly rule out any (accidental or deliberate) modifications to the human “germ line genetic identity” (Directive 2001/20/EC, Art. 9(6); Regulation (EU) No 536/2014, Art. 90[2]); cf. Schleidgen et al. (2019), p. 10.
405.
For the terminology see National Academy of Medicine, National Academy of Sciences, Royal Society (2020), p. 18: The term “germ line (genome) editing” refers to heritable human genome editing (HHGE), i.e. “any editing in germline cells that is done in a clinical context, with the intent of transferring any resultant embryos to a woman’s uterus for gestation”, as well as any editing in germline cells for other, especially research purposes.
406.
Cf. Taupitz (2014) pp. 98–99.
407.
Deutscher Bundestag (1989), p. 1.
408.
Bundesminister für Forschung und Technologie (ed) (1985).
409.
Cf. Taupitz (2014), pp. 98–99.
410.
Deutscher Bundestag (1987).
411.
Bundesminister der Justiz (ed) (1989).
412.
See also Deutscher Bundestag (1990), p. 5.
413.
Embryo Protection Act (Embryonenschutzgesetz) of 13 December 1990 (Federal Law Gazette Part I p. 2746), last amended by Article 1 of the Act of 21 November 2011 (Federal Law Gazette I p. 2228).
414.
Embryo Protection Act, § 8(3).
415.
Günther (2014), p. 324 par. 9; argumentum ex Embryo Protection Act, § 5(4) No. 2.
416.
Cf. Dederer and Frenken (2021), pp. 65 et seq.—The Government followed the proposition of the Benda Commission (cf. Bundesminister für Forschung und Technologie (ed) (1985), p. 47) and the parliamentarian inquiry commission (Deutscher Bundestag (1987), p. 190).
417.
Cf. Basic Law, Art. 5(3); see Deutscher Bundestag (1989), p. 11.
418.
Cf. Directive 2001/20/EC, Art. 9(6); Regulation (EU) No 536/2014, Art. 90(2).
419.
Deutscher Bundestag (1989), p. 11.
420.
In 1984, the success rate for hereditary genome editing in mice was still 2%, cf. Hammer et al. (1984); see Deutscher Bundestag (1987), p. 188.
421.
Cf. Basic Law, Art. 2(2).
422.
Cf. Basic Law, Art. 1(1); see Bundesminister für Forschung und Technologie (ed) (1985), p. 46.
423.
Deutscher Bundestag (1989), p. 11; see Bundesminister für Forschung und Technologie (ed) (1985), p. 46.
424.
See Deutscher Bundestag (1987), pp. 187–188.
425.
Cf. Deuring and Taupitz (2020), p. 102; Deutsch and Spickhoff (2014), p. 956.—For a multidisciplinary contribution to the discussion, see Schleidgen et al. (2019).
426.
Cf. Dederer and Frenken (2021), pp. 66 et seq.
427.
Deuring (2020), p. 105; Deuring and Taupitz (2020), p. 103; Enghofer (2018), p. 292; Müller-Terpitz (2018), § 5 par. 5; Faltus (2016), p. 462.
428.
Embryo Protection Act, § 8(3).
429.
See Basic Law, Art. 103(2).
430.
Deuring (2020), p. 106; Deuring and Taupitz (2020), p. 106; Enghofer (2018), p. 299.
431.
Müller-Terpitz (2018), § 5 par. 5; Faltus (2016), pp. 461–462.
432.
Legislation and court cases are only cited in footnotes and not included in the bibliography.

Abbreviations

ATMP:: Advanced Therapy Medicinal Product
CAT:: Committee for Advanced Therapies
CHMP:: Committee for Medicinal Products for Human Use
CTMP:: Somatic Cell Therapy Medicinal Product
EMA:: European Medicines Agency
EU:: European Union
GCP:: Good Clinical Practice
GMO:: Genetically Modified Organism
GMP:: Good Manufacturing Practice
GTMP:: Gene Therapy Medicinal Product
PEI:: Paul Ehrlich Institute

References

Legislation and court cases are only cited in footnotes and not included in the bibliography.

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Faculty of Law, University of Passau, Passau, Germany
Gregor Frenken & Hannah Lüttge

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Hans-Georg Dederer
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Gregor Frenken

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Frenken, G., Lüttge, H. (2022). Regulation of Genome Editing in Human iPS Cells: Germany. 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_3

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Published: 24 May 2022
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Regulation of Genome Editing in Human iPS Cells: Germany

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Challenging the Therapy/Enhancement Distinction in CRISPR Gene Editing

From fiction to science: clinical potentials and regulatory considerations of gene editing

Regulatory Environment and Approvals in Cell and Gene Therapy Products Between Japan, the USA, and the EU

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