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Scientists Edit Genes, Courts Edit Directives. Is the Court of Justice Fighting Uncertain Scientific Risk with Certain Constitutional Risk?

Published online by Cambridge University Press:  26 March 2019

Han SOMSEN
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Abstract

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Type
Case Commentaries
Information
European Journal of Risk Regulation , Volume 9 , Issue 4 , December 2018 , pp. 701 - 718
Copyright
© Cambridge University Press 

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Footnotes

*

Professor of EU Law, Tilburg Law School. I wish to thank the anonymous reviewer and Dr Francisco Alves Da Costa-Cabral for invaluable comments. Any remaining errors are mine.

References

1 Case C-528/16, Confédération paysanne, Réseau Semences Paysannes, Les Amis de la Terre Frane, Collectif Vigilance OGM et pesticides 16, Vigilance OG2M, CSFV49, OGM dangers, Vigilance OGM 33, Fédération Nature et Progrès t. Premier ministre, Ministre de l’Agriculture, Agroalimentaire et de la Forêt, ECLI:EU:C:2018:583. For some authoritative desriptions of future applications of CRISPR/CAS technologies, see for example Knott, GJ and Doudna, JA, “CRISPR/CAS Guides the Future of Genetic Engineering” (2018) 361 Science 866 CrossRefGoogle Scholar ; Vora, S et al, “Next stop for the CRISPR revolution: RNA‐guided epigenetic regulators” (2016) 283(17) The FEBS Journal 3181 Google Scholar ; R Cross, “CRISPR’S Breakthrough Problem” (2017) C&EN 28.

2 See Rath, J, “Safety and Security Risks of CRISPR/CAS9” in D Schroeder et al (eds), Ethics Dumping (Springer 2018) p 107 CrossRefGoogle Scholar .

3 Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC, OJ [2001] No L 106/1.

4 See S Micholopoulos, “Industry shocked by EU Court decision to put gene editing technique under GM law”, Euractive 9 August 2018, published at <www.euractiv.com/section/agriculture-food/news/industry-shocked-by-eu-court-decision-to-put-gene-editing-technique-under-gm-law/>; E Calloway, “EU Law Deals Blow to CRISPR Crops” (2018) 560 Nature 16.

5 See Leczykiewicz, D, “Why do the European Court of Justice Judges Need Legal Concepts?” (2008) 14 European Law Journal 773 Google Scholar .

6 Case C-34/10, Oliver Brüstle, ECLI:EU:C:2011:669.

7 Directive 2015/412/EC as regards the possibility for the Member States to restrict or prohibit the cultivation of genetically modified organisms (GMOs) in their territory, OJ [2015] No L 68/1.

8 ibid.

9 Case C-528/16, supra, note 1, point 21.

10 ibid, point 24.

11 ibid, point 23.

12 Purnhagen, KP et al, “EU Casts New Plant Breeding Techniques into Regulatory Limbo” (2018) 36 Nature Biotechnology 799–800 Google Scholar .

13 Opinion AG Bobek of 18 January 2018, ECLI:EU:C:2018:20, point 94.

14 See O Renn and A Sterling, “The precautionary principle: A new paradigm for risk management and participation” 3 (2004) Entreprises et Biens Publics, available at <pdfs.semanticscholar.org/bc69/5cbcfe1b4e7face8c929ab48ba7d5bccea54.pdf>.

15 See Communication of the Commission on the precautionary principle, COM (2001) 1 fin; Reports of the Panel, European Communities—Measures Affecting the Approval and Marketing of Biotech Products, at 1, WT/DS291/R (US), WT/DS292/R (Can.), WT/DS293/R (Arg) (29 September 2006) available at < www.wto.org/english/tratop_e/dispu_e/cases_e/ds291_e.htm>.

16 Issues of “regulatory connection” are explored in Brownsword, R, Rights, Regulation and the Technological Revolution (Oxford University Press 2008)CrossRefGoogle Scholar ch 4.

17 Art 1 reads: “In accordance with the precautionary principle, the objective of this Directive is to approximate the laws, regulations and administrative provisions of the Member States and to protect human health and the environment when: carrying out the deliberate release into the environment of genetically modified organisms for any other purposes than placing on the market within the Community; or placing on the market genetically modified organisms as or in products within the Community”.

18 Art 2(2) defines GMOs as follows: “‘genetically modified organism (GMO)’ means an organism, with the exception of human beings, in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination. Within the terms of this definition:

(a) genetic modification occurs at least through the use of the techniques listed in Annex I A, part 1;

(b) the techniques listed in Annex I A, part 2, are not considered to result in genetic modification”.

The Directive combines process and product based elements, see New Techniques Working Group, Final Report, available at <www.seemneliit.ee/wp-content/uploads/2011/11/esa_12.0029.pdf>.

However, it is commonly interpreted as strictly process-based and, as will be seen, the Court in this case amplifies that conclusion. See Sprink, T et al, “Regulatory hurdles for genome editing: process- vs. product-based approaches in different regulatory context” (2016) 36 Plant Cell Rep 1493 Google Scholar .

19 Art 3(1) provides as follows: “This Directive shall not apply to organisms obtained through the techniques of genetic modification listed in Annex IB”. Annex IB provides as follows: “Techniques referred to in Article 3

Techniques/methods of genetic modification yielding organisms to be excluded from the Directive, on the condition that they do not involve the use of recombinant nucleic acid molecules or genetically modified organisms other than those produced by one or more of the techniques/methods listed below are:

(1) mutagenesis

(2) cell fusion (including protoplast fusion) of plant cells of organisms which can exchange genetic material through traditional breeding methods”.

20 Case C-528/16, supra, note 1, point 29.

21 ibid, point 35.

22 ibid, point 37, see also supra, note 11.

23 Supra, note 17.

24 Supra, note 19.

25 Case C-528/16, supra, note 1, point 51.

26 Supra, note 19.

27 Case C-528/16, supra, note 1, point 42.

28 ibid, point 43.

29 ibid, point 41.

30 In addition but much less prominently, the Court relied on recitals 4–6, 8, 44 and 55, which are worded as follows:

“4. Living organisms, whether released into the environment in large or small amounts for experimental purposes or as commercial products, may reproduce in the environment and cross national frontiers, thereby affecting other Member States. The effects of such releases on the environment may be irreversible.

5. The protection of human health and the environment requires that due attention be given to controlling risks from the deliberate release into the environment of genetically modified organisms (GMOs).

6. Under the Treaty, action by the Community relating to the environment should be based on the principle that preventive action should be taken.

8. The precautionary principle has been taken into account in the drafting of this Directive and must be taken into account when implementing it.

44. Member States should be able, in accordance with the Treaty, to take further measures for monitoring and inspection, for example by official services, of the GMOs as or in products placed on the market.

55. It is important to follow closely the development and use of GMOs”.

31 Opinion AG Bobek, supra, note 13, point 94.

32 ibid, point 95.

33 ibid, point 102.

34 ibid, point 94.

35 Case C-528/16, supra, note 1, point 52.

36 Art 1 provides as follows: “In accordance with the precautionary principle, the objective of this Directive is to approximate the laws, regulations and administrative provisions of the Member States and to protect human health and the environment when:

– carrying out the deliberate release into the environment of genetically modified organisms for any other purposes than placing on the market within the Community,

– placing on the market genetically modified organisms as or in products within the Community” (my emphasis).

37 See R Smart, M Blum and J Wesseler, “EU Member States’ Voting for Authorizing Genetically Engineered Crops: a Regulatory Gridlock” (2015) 64 German Journal of Agricultural Economics 244.

38 Regulation (EC) No 1829/2003 on genetically modified food and feed, OJ [2003] No L 268/1.

39 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 and amending Directive 2001/18/EC, OJ [2003] No. L 268/24.

40 Regulation (EC) No 178/2002 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 [2002] No L 31/1.

41 Directive 2004/35/CE on environmental liability with regard to the prevention and remedying of environmental damage, OJ [2004] No L 143/56.

42 Directive 2002/53/EC on the common catalogue of varieties of agricultural plant species, OJ [2002] No L 193/1.

43 Case C-528/16, supra, note 1, point 67.

44 ibid, point 72.

45 ibid, point 74.

46 ibid, point 71.

47 ibid, points 77–79.

48 Art 22 provides: “Without prejudice to Article 23, Member States may not prohibit, restrict or impede the placing on the market of GMOs, as or in products, which comply with the requirements of this Directive”.

49 Supra, note 7.

50 In particular point 48 of the judgment: “As the referring court states in essence, the risks linked to the use of those new techniques/methods of mutagenesis might prove to be similar to those which result from the production and release of a GMO through transgenesis. It thus follows from the material before the Court, first, that the direct modification of the genetic material of an organism through mutagenesis makes it possible to obtain the same effects as the introduction of a foreign gene into that organism and, secondly, that the development of those new techniques/methods makes it possible to produce genetically modified varieties at a rate and in quantities quite unlike those resulting from the application of conventional methods of random mutagenesis”.

51 See Daukšienė, I and Budnikas, Arvydas, “Has the Action for Failure to Act in the European Union Lost its Purpuse?” (2014) 7 Baltic Journal of Law & Politics 209 Google Scholar .