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Synthetic Marijuana Not a “Medicinal Product”

Published online by Cambridge University Press:  20 January 2017

Joasia Luzak
Joasia Luzak*
Affiliation:
Centre for the Study of European Contract Law, University of Amsterdam, the Netherlands, j.a.luzak@uva.nl
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Abstract

Joined Cases C-358/13 and C-181/14, Markus D. and G.

Substances which produce effects that merely modify physiological functions but which are not such as to have any beneficial effects, either immediately or in the long term, on human health, are consumed solely to induce a state of intoxication and are, as such, harmful to human health do not fall within the scope of the definition of a “medicinal product” in the Directive 2001/83 (official headnote).

Consumer safety and medicines control legislation is not suitable to penalise the introduction of new psychoactive substances on European markets (author's headnote).

Art 1(2)(b) Directive 2001/83

Type
Case Notes
Information
European Journal of Risk Regulation , Volume 5 , Issue 4 , December 2014 , pp. 548 - 552
Copyright
Copyright © Cambridge University Press 2014

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References

1 European Monitoring Centre for Drugs and Drug Addiction (EMCDDA), “European Drug Report: Trends and developments”, 2014, available on the Internet at: <http://www.emcdda.europa.eu/publications/edr/trends-developments/2014> (last accessed on 5 November 2014).

2 EMCDDA, “European Drug Report out today – Europe's drugs problem ‘increasingly complex’”, New Release No 3/2014, available on the Internet at: <http://www.emcdda.europa.eu/news/2014/3> (last accessed on 5 November 2014).

3 United Nations Single Convention on Narcotic Drugs, 30 March 1961, in force 13 December 1964, UN Treaty Series, vol. 520, p. 151.

4 United Nations Convention on Psychotropic Substances, 21 February 1971, in force 16 August 1976, UN Treaty Series, vol. 1019, p. 175.

5 The European institutions are currently in the process of adopting new measures that could provide the EU with a quicker and smarter system to protect consumers from potentially harmful substances being sold to them. In 2011 the European Commission published a report on the functioning of the Decision 2005/387/JHA calling for the revision of this measure (COM(2011)430 final). The resulting thereof two legislative proposals have been endorsed by the European Parliament in April 2014 and await approval by the Council: Regulation on new psychoactive substances (COM(2013)619 final) and Directive amending Council Framework Decision 2004/757/JHA of 25 October 2004 laying down minimum provisions on the constituent elements of criminal acts and penalties in the field of illicit drug trafficking, as regards the definition of drugs (COM(2013)618 final).

6 EMCDDA, “European Drug Report out today…”, supra note 2.

7 EMCDDA, “Perspectives on Drugs: Synthetic cannabinoids in Europe”, last update 27 May 2014, available on the Internet at <http://www.emcdda.europa.eu/topics/pods/synthetic-cannabinoids> (last accessed on 5 November 2014); Andrea Rael, “What Is Synthetic Marijuana And How Does It Compare To Traditional Marijuana?”, Huffington Post, 9 November 2013, available on the Internet at <http://www.huffingtonpost.com/2013/09/11/synthetic-marijuana_n_3908171.html> (last accessed on 5 November 2014); Alice G. Walton, “Why Synthetic Marijuana Is More Toxic To The Brain Than Pot”, Forbes, 28 August 2014, available on the Internet at <http://www.forbes.com/sites/alicegwalton/2014/08/28/6-reasons-synthetic-marijuana-spice-k2-is-so-toxic-to-the-brain/> (last accessed on 5 November 2014). See also: EMCDDA, “European Drug Report: Trends and developments”, supra note 1, p. 36.

8 Michelle Hunter, “Clemson University professor created synthetic marijuana for abuse research”, 29 July 2012, available on the Internet at <http://www.nola.com/crime/index.ssf/2012/07/clemson_university_professor_c.html> (last accessed on 5 November 2014); Mark Schone and Anna Schecter, “Legalize Marijuana, Says Inventor of ‘Spice’ Chemicals”, ABC News, 7 June 2011, available on the Internet at <http://abcnews.go.com/Blotter/legalize-marijuana-inventor-spice-chemicals/story?id=13782613> (last accessed on 5 November 2014).

9 EMCDDA, “Analysis: synthetic cannabinoids in Europe”, last update 27 May 2014, available on the Internet at < http://www.emcdda.europa.eu/topics/pods/synthetic-cannabinoids> (last accessed on 5 November 2014).

10 Case C-358/13 and C-181/14, Markus D. and G., ECLI:EU:C:2014:2060, at para. 13. See also: EMCDDA, “Perspectives on Drugs…”, supra note 7, p. 3.

11 Opinion AG Bot, Case C-358/13 and C-181/14, Markus D. and G., ECLI:EU:C:2014:1927, para. 23. See also: Andrea Rael, “What Is Synthetic Marijuana…”, supra note 7; Alice G. Walton, “Why Synthetic Marijuana Is More Toxic…”, supra note 7.

12 European Commission, “Responding to new drugs”, available on the Internet at <http://ec.europa.eu/justice/anti-drugs/new-drugs/index_en.htm> (last accessed on 5 November 2014). See also note 5.

13 Council Decision 2005/387/JHA of 10 May 2005 on the information exchange, risk-assessment and control of new psychoactive substances, OJ 2005 L 127/32.

14 EMCDDA, “European Drug Report: Trends and developments”, supra note 1, p. 69.

15 Case C-358/13 and C-181/14, supra note 10, para. 16.

16 Ibid., supra note 10, para. 11.

17 Ibid., supra note 10, para. 12.

18 Ibid., supra note 10, para. 15.

19 Ibid., supra note 10, para. 21.

20 Ibid., supra note 10, para. 19.

21 European Parliament and the Council Directive 2001/83/EC of 6 November 2001 on the Community code relating to medicinal products for human use, OJ 2001 L 311/67.

22 Opinion AG Bot, supra note 11, para. 33.

23 Case C-358/13 and C-181/14, supra note 10, paras. 29, 32. Contrary to often applied separate interpretation of these notions, see e.g.: Müller, Rolf-Georg, “Arzneimittelrecht: Synthetische Cannabinoide keine Arzneimittel”, 19 Europäische Zeitschrift für Wirtschaftsrecht (2014), p. 745 Google Scholar.

24 Case C-358/13 and C-181/14, supra note 10, para. 34.

25 Ibid., supra note 10, paras. 31, 35-36.

26 Opinion AG Bot, supra note 10, para. 43. See also: Case C-319/05, Commission v. Germany, ECLI:EU:C:2007:678, para. 64.

27 Case C-358/13 and C-181/14, supra note 10, para. 38. See also recital 2 preamble of the Directive 2001/83.

28 Case C-358/13 and C-181/14, supra note 10, paras. 48-49.

29 Opinion AG Bot, supra note 11, para. 47.

30 EMCDDA, “European Drug Report: Trends and developments”, supra note 1, p. 69.

31 Case C-358/13 and C-181/14, supra note 10, para. 46.

32 Opinion AG Bot, supra note 11, paras. 29, 48.

33 Opinion AG Bot, supra note 11, para. 43. See also: Case C-319/05, Commission v. Germany, ECLI:EU:C:2007:678, para. 64. See also: Rolf-Georg Müller, “Arzneimittelrecht…”, supra note 23, p. 744-745.

34 See also: Patzak, Jörn, Volkmer, Mathias und Ewald, Andreas, “Neue psychoaktive Substanzen sind keine Funktionsarzneimittel”, 8 Neue Zeitschrift für Strafrecht, (2014), p. 464 Google Scholar.

35 Opinion AG Bot, supra note 11, paras. 53-56.