Index of Legal Sources
International
Cartagena Protocol on Biosafety to the Convention on Biological Diversity (adopted on 29 January 2000 EXCOP 1 Decision EM-I/3)
168, 169
Universal Declaration of Human Rights (adopted 10 December 1948 UNGA Res 217 A(III) (UDHR) art 5
39
Article 1
140
Art 25
39, 92
Article 27
39
United Nations, International Covenant on Civil and Political Rights (adopted 16 December 1966, entered into force 23 March 1976) 999 UNTS 171 (ICCPR)
37, 140
Article 2(1)
54
Article 4
204
Article 12
37, 38, 44, 92
Article 15 (1)(b)
170, 204
UN General Assembly, Convention on the Rights of Persons with Disabilities (adopted by the General Assembly, entered into force 24 January 2007) A/RES/61/106), and UN General Assembly, Optional Protocol to the Convention on the Rights of Persons with Disabilities (13 December 2006, A/RES/61/106, Annex II)
9, 87, 97
Article 10
99
Article 25
92, 94, 102
Article 26
87, 94, 99, 102–103
UN General Assembly, Constitution of the World Health Organization (entry into force 17 November 1947, A/RES/131)
91
UNESCO International Declaration on Human Genetic Data (adopted by the UNESCO General Conference on 16 October 2003)
258
Universal Declaration on the Human Genome and Human Rights, adopted by the UNESCO General Conference on Nov. 11, 1997 and endorsed by the United Nations General Assembly, 53rd session, resolution AIRES/53/152, 9 December
6, 19, 53, 86, 100, 115, 141, 258
Article 1
100–101, 115, 140
Article 10
101
Article 11
115
Article 24
115
Article 25
141
Universal Declaration on Bioethics and Human Rights, adopted by the UNESCO General Conference, 19 October 2005
86, 100, 258
Article 2
101
Article 14
39
Vienna Convention on the Law of Treaties (United Nations (UN)) 1155 UNTS 331 VCLT, 1969
Articles 31
48
Article 32
48
Article 39
213
World Health organization, Constitution of the World Health Organization, adopted by the International Health Conference held in New York from 19 June to 22 July 1946, signed on 22 July 1946 (Off. Rec. Wld Hlth Org., 2, 100), and entered into force on 7 April 1948
91
World Medical Association (WMA) Declaration of Helsinki — Ethical Principles for Medical Research Involving Human Subjects (Helsinki Declaration) Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964, last amended by the 64th WMA General Assembly, Fortaleza, Brazil, October 2013
32, 41
Article 8
44
Article 28
41
World Trade Organization, Agreement on Trade-Related Aspects of Intellectual Property Rights (as amended on 23 January 2017), Annex 1C of the Marrakesh Agreement Establishing the World Trade Organization, signed in Marrakesh, Morocco on 15 April 1994
Article 8
250
Article 27(2) and (3)
249, 254, 255
Article 30
250
Article 31
250
Regional
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, ETS 164 (Biomedicine Convention or Oviedo convention)
4, 5, 6, 19, 86, 100, 115, 201, 205, 268
Article 1
214
Article 2
214
Article 3
100
Article 4
214, 216
Article 13
29, 37, 47, 100, 115, 141, 153, 167, 169, 184, 200, 205, 206, 207, 209, 213, 259
Article 14
30
Article 17 (2) (i)
41
Article 18
208
Article 32
209, 214
Steering Committee on Bioethics (CDBI) Convention on 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 (Ets No. 164), Preparatory Work on the Convention, CDBI/INF (2000)
208
Explanatory Report to the Convention on Human Rights and Biomedicine, European Treaty Series, no. 164
116, 209
Council of Europe, European Convention for the Protection of Human Rights and Fundamental Freedoms of 4 November 1950, as amended by Protocols Nos. 11 and 14 (entry into force 3 September 1953, ETS 5)
36, 86, 134, 169
Article 2
36, 38, 44, 55, 128, 134, 136, 142, 148, 149, 150, 151, 197
Article 3
141
Article 8
134, 136, 142, 143, 144, 145, 146, 148, 151, 152, 153, 155, 197
Article 12
55
Article 15
148
Convention on the Grant of European Patents (European Patent Convention) of 5 October 1973 as revised by the Act revising Article 63 EPC of 17 December 1991 and the Act revising the EPC of 29 November 2000
173
Article 52
253
Article 53 (a)
251, 255
Implementing regulations to the Convention on the Grant of European Patents (European Patent Convention) of 5 October 1973, Administrative Council Decision, OJ EPO 7/1999
437 173, 256
Rules 28 & 29
256
Rule 28 (1) (b)
258, 259, 260
Protocol on Patents and Industrial Designs within the framework of the African Regional Intellectual Property Organization (ARIPO), adopted on 10 December 1982, at Harare (Zimbabwe), latest amended by the Administrative Council of ARIPO on 20 November 2019
251
Patent Regulations under the Eurasian Patent Convention Adopted by the Administrative Council of the Eurasian Patent Organization (EAPO AC) at its second (1st ordinary) session on 1 December 1995, with the amendments and addenda adopted by EAPO AC up to its thirty-sixth (27th ordinary) session on 10–11 September 2020
251
Council of Europe Parliamentary Assembly Recommendation 2115 (2017) The use of new genetic technologies in human beings. Parliamentary Assembly Origin — Assembly debate on 12 October 2017 (35th Sitting) Text adopted by the Assembly on 12 October 2017 (35th Sitting)
202
European Union
Charter of Fundamental Rights of the European Union OJ C 326, 26 October 2012, pp. 391–407
178
Preamble
140
Article 1
106, 220
Article 3
49, 141, 154, 220
Article 35
92, 219
Article 51
49, 219
Treaty on European Union and the Treaty on the Functioning of the European Union (consolidated version) C326/15’, Official Journal of the European Union OJ C 326, 26/10/2012 P. 0001 – 0390
Article 2 TEU
106
Article 14 TEU
217, 219
Article 15 TEU
217
Article 17 TEU
217
Article 84 TFEU
219
Article 101 TFEU
275, 280
Article 101(1) TFEU
276, 277, 281, 282, 288
Article 101(3) TFEU
276, 277, 284, 295
Article 102 TFEU
275, 276, 272, 282, 288
Article 114 TFEU
205, 218
Article 168 TFEU
166, 206, 217, 219
Article 294 TFEU
217
Regulation (EC) No1946/2003 of the European Parliament and of the Council of 15 July 2003 on transboundary movements of genetically modified organisms OJ L 287, 5 November 2003, pp. 1–10
168
Regulation (EC) No 1829/2003 on genetically modified food and feed OJ L 268, 18 October 2003, p. 1
168
Regulation (EC) No 1830/2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms OJ L 268, 18 October 2003, p. 24
168
Regulation 726/2004 of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use
66, 80, 166
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 (Text with EEA relevance) OJ L 324, 10 December 2007, pp. 121–137
10, 30, 48, 65, 66, 68, 69, 76, 80, 82, 83, 166 , 172, 185, 206, 212
Recitals 2 and 3
211
Article 28
187
Article 83
187
Regulation (EU) No 1217/2010 of 14 December 2010 on the application of Article 101(3) of the Treaty on the Functioning of the European Union to certain categories of research and development agreements OJ [2010] L 335/36 (RBER)
277, 278, 279, 280, 281, 282, 283, 286, 295, 296
Regulation (EU) No 316/2014 of 21 March 2014 on the application of Article 101(3) of the Treaty on the Functioning of the European Union to categories of technology transfer agreements Text with EEA relevance OJ [2014] L 93/17 (TTBER)
277, 278, 279, 280, 281, 282, 283, 286, 296
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
65, 66, 72, 166, 172, 201, 205
Article 2(2)
211
Article 90
48, 154, 167, 200, 207, 209
Article 94(1)
207
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (OJ L 117)
66, 67, 68, 69, 70, 72, 75, 76, 80, 166, 172, 173
Regulation (EU) No 695/2021 of the European Parliament and of the Council of 28 April 2021 establishing Horizon Europe — the Framework Programme for Research and Innovation, laying down its rules for participation and dissemination, and repealing Regulations (EU) No 1290/2013 and (EU) No 1291/2013 (text with EEA relevance) PE/12/2021/INITOJ L 170, 12.5.2021, pp. 1–68
210
Proposal for a regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (COM(2012)0369—C7-0194/2012—2012/0192(COD)), Amendment 257
210
Proposal for a Regulation of the European Parliament and of the Council Laying Down Harmonized Rules on Artificial Intelligence (Artificial Intelligence Act) and Amending Certain Union Legislative Acts ((COM (2021) 206 final), 21 April 2021)
67, 79, 82, 83
Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions OJ L 213, 30 July 1998, p. 13–21
4, 30, 255, 256
Recital 42
260, 263
Article 5
256
Article 6 (2)
48, 201, 210, 256, 260
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 April 2001, pp. 1–39
168, 216
Directive 2001/20/EC 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 May 2001, p. 34)
4, 166, 171, 201
Article 9(6)
210
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 November 2001
65, 68, 172, 185, 186, 211
Article 3(7)
187
Article 5
256
Article 6
256
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 May 2009, pp. 75–97
168
European Parliament legislative resolution on the Council common position for adopting a European Parliament and Council directive 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 (8878/1/2000—C5-0424/2000—1997/0197(COD)), Amendment 42
210
Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety (Text with EEA relevance), OJ L 11, 15 January 2002, pp. 4–17
206
Communication from the Commission, Guidelines on the application of Article 101 of the Treaty on the Functioning of the European Union to technology transfer agreements, OJ [2014] C 89/3 (TT Guidelines)
273, 278, 284, 286
Communication from the Commission, Guidelines on the applicability of Article 101 of the Treaty on the Functioning of the European Union to horizontal co-operation agreements OJ [2011] C 11/1 (Horizontal Guidelines)
278, 282
European Medicines Agency, Procedural advice on the evaluation of combined advanced therapy medicinal products and the consultation of Notified Bodies in accordance with Article 9 of Regulation (EC) No. 1394/2007, February 11, 2011, EMA/354785/2010
74
European Medicines Agency, Guideline on the quality, non-clinical and clinical aspects of gene therapy medicinal products’ (EMA/CAT/80183/2014)
172
European Medicines Agency, Guideline on safety and efficacy follow up and risk management of Advanced Therapy Medicinal Products (EMEA/149995/2008)
172
European Medicines Agency, Guideline on the Risk-Based Approach According to Annex I, Part IV of Directive 2001/83/EC Applied to Advanced Therapy Medicinal Products [EMA/CAT/CPWP/686637/2011]
194
National Legal Sources
Italy:
Law 40/2004 on medically assisted reproduction
144, 148
Law 194/1978 on social protection of motherhood and abortion
144
Germany:
German Medicinal Products Act (Arzneimittelgesetz AMG) (2019)
189
Norway:
Biotechnology Act of 5 December 2003 no. 100
49, 50
Patient and User Rights Act of 2 July 1999 no. 63
49, 51
Specialist Health Services Act
51
Portugal:
Article 8 of Law No. 12/2005, from 26 January
184
Spain:
Article 158 of the Criminal Code
184
Article 74 of Law No. 14/2007, from 3 July
184
United Kingdom of Great Britain and Northern Ireland (UK)
The Equality Act 2010
89
Human Fertilisation and Embryology Act of 1990
146
Medicines and Healthcare Products Regulatory Agency, Guidance on “Non Routine” (2021)
189
United States of America:
America Invents Act, HR 1249
253
US Patent Act, 35 U.S.C. para. 101
253, 254
Institutional Reports and Recommendations
American National Academy of Medicine and the Royal Society of Great Britain Report on Heritable Human Genome Editing
32
European Academies (ALLEA), Statement on Patent Related Aspects of CRISPR-Cas Technology (18 July 2016)
261
National Academies of Sciences, Engineering, and Medicine, On Human Gene Editing — International Summit Statement | National Academies (3 December 2015)
202
Nuffield Council’s Report on social and ethical issues related to genome editing
26, 32, 202
The Committee on Bioethics of the Council of Europe, Genome Editing Technologies: Some Clarifications but No Revision of the Oviedo Convention (7 June 2021)
203
UNESCO Human Genome and Human Rights International Bioethics Committee, Report of the IBC on updating its reflection on the Human Genome and Human Rights (2015)
202
World Health Organization (WHO) Expert Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing, Human Genome Editing: A Framework for Governance (2021), available online at www.who.int/publications/i/item/9789240030060
86, 244, 266
World Health Organization (WHO) Recommendations on Human Genome Editing for the Advancement of Public Health
6, 33, 86