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Promoting the Off–label Use of Medicines: Where to Draw the Line?
Published online by Cambridge University Press: 20 January 2017
Extract
In Europe, medicines can only be marketed once they have passed through a strict regulatory process, designed primarily to protect patient safety. It is only after in–depth testing on the targeted disease population, including three phases of clinical assessment and clinical trials, that a medicine will obtain a ‘marketing authorisation’. Given its primary goal of ensuring patient safety, EU law only allows a few narrow exceptions to the requirement of amarketing authorisation. Adrug can only be used “off–label”, meaning outside the limits of its marketing authorization, in authorised clinical trials or under one of the strictly defined exceptions, such as severe public health risk, compassionate use for groups of patients or for individual patients on a named patient basis.
However, in recent years, a trend has emerged Among Member States to push the boundaries of the existing regulatory system, and actively promote the off–label use of medicines on the ground that they are cheaper than the alternative, authorised medicine. It is questionable whether this trend is in line with EU law.
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References
1 See for example, Killick, James and Berghe, Pascal, Should cost prevail over safety? The risks of promoting unauthorised pharmaceuticals and off–label use for budgetary considerations, [2014] 13 (5)Google Scholar Bio–Science Law Review 172, March 2014.
2 KCE Report 252, “Towards a better managed off-label use of drugs”, 29 September 2015, available on the Internet at https://kce.fgov.be/publication/report/towards-a-better-managed-off-label-use-of-drugs#.VgrNYGZXeJI (last accessed on 21 October 2015).
3 Health Technology Assessment (“HTA”) is an important part of evidence–based health decision–making in most EU countries. It provides policy–makers with objective information, so they can formulate health policies that are safe, effective, patient–focused and cost–effective.
4 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.
5 Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004, laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, OJ [2004] L 136/3.
6 See Report, p. 22 and the articles cited therein.
7 Between protection of public health and freedom of undertakings to market such product.
8 See Case C-185/10, Commission v Poland, EU:C:2012:181.
9 See, e.g. Case C–180/96R, UK v Commission (BSE), §§ 91-93 (“paramount importance to be accorded to the protection of health”) and Case T–13/99, Pfizer v Council, at § 456 (“The protection of public health, which the contested regulation is intended to guarantee, must take precedence over economic considerations”).
10 Based on Article 5(1) of Directive 2001/83/EC.
11 Case T-452/14 CTRS v Commission, EU:T:2015:373, § 82.
12 Case C-535/11, Novartis Pharma GmbH v Apozyt GmbH, EU:C:2013:226, § 48.
13 Case C-185/10, Commission v Poland, § 34.
14 Case C-185/10, Commission v Poland, § 35. (emphasis added)
15 Regulation 141/2000 of 16 December 1999 on orphan medicinal products, OJ L 18, 22.1.2000, p. 1.
16 Case T-452/14 CTRS v Commission, § 80. (emphasis added)
17 Report, p. 22. (emphasis added)
18 See Report, p. 95.
19 Case T-452/14 CTRS v Commission, § 82
20 Case C-185/10, Commission v Poland.
21 Report, p. 41.
22 Report, p. 42.
23 See https://en.wikipedia.org/wiki/Battle_of_Copenhagen_(1801) (last accessed on 21 October 2015).
24 Case C-185/10, Commission v Poland, §§ 46-50.
25 Case C-62/09, Association of the British Pharmaceutical Industry (“ABPI”) v Medicines and Helathcare Products Regulatory Agency, EU:C:2010:219.
26 ABPI case, § 17.
27 Report, p. 42, referring to the Doc Morris and Asturias cases.
28 Report, p. 42.
29 Cases C-570/07 and C-571/07, Asturias, ECLI:EU:C:2010:300, notably at § 78.
30 See, e.g., Case C-180/96R, UK v Commission (BSE), §§ 91-93, where the CJEU stressed the “paramount importance to be accorded to the protection of health”.
31 These systems already balance the needs of individual patients with the financial resources available to treat the entire population (see Report, p. 44), so there is no need for authorities to have recourse to off–label use for the same purpose.
32 The CJEU in Joined Cases C-267/91 and C-268/91 Keck and Mithouard (EU:C:1993:905) held that national price controls which apply to all relevant traders operating within the national territory and affecting in the same manner, in law and in fact, the marketing of domestic products and those from other Member States, constitute “selling arrangements” falling outside the scope of the free movement rules. Keck clearly applies to the scenario contemplated by the Report, i.e. general encouragement of offlabel prescribing for budgetary reasons applying to all actors and affecting them in the same manner.
33 Case 174/82, Sandoz, EU:C:1983:213.
34 See to this effect Case C-143/06, Ludwigs – Apotheke München Internationale Apotheke v Juers Pharma Import–Export GmbH, EU:C:2007:656, §§ 32 – 33.
35 Report, p. 44.
36 Report, pp. 90-96.
37 Report, p. 94.(emphasis added)
38 Report, p. 9-10.
39 See, for instance, recital 7 of Directive 2001/83: “The concepts of harmfulness ond therapeutic efficacy can only be examined in relation to each other and have only a relative significance depending on the progress of scientific knowledge and the use for which the medicinal product is intended. The particulars and documents which must accompany an application for marketing authorisation for a medicinal product demonstrate that potential risks are outweighed by the therapeutic efficacy of the product.”
40 For more information on the role of HTA in the EU, please refer to http://ec.europa.eu/health/technology_assessment/policy/index_en.htm.
41 It is noteworthy that no competition authority anywhere has taken issue with the contractual arrangements between Genentech, Roche, and Novartis that resulted in Roche having the rights over Avastin and Novartis having the rights over Lucentis in Europe. Indeed, many of the passing references to competition law in the report are inaccurate, notably the idea that a compulsory licensing could be ordered as a matter of competition law (e.g., Report, p. 83), something that would be manifestly inconsistent with the CJEU's case law – see e.g. C-418/01, IMS Health, ECLI:EU:C:2004:257. For a fuller analysis of the competition issues, see Killick and Berghe “Pharmaceutical sector: can nonauthorised products be considered included in the relevant market for the assessment of alleged anticompetitive conduct? A short analysis of the recent Italian Avastin–Lucentis decision,” Journal of European Competition Law & Practice (2015) 6(2) pp. 102-109. The one point on which the Report is correct is that competition law would not impose any obligation on any undertaking to apply for an MA for an off–label use (Report, p. 94).
42 Report, p. 12.
43 Report, p. 17.
44 Report, p. 81.
45 Report, p. 81.
46 Report, p. 15.
47 Report, pp. 90-91.
48 Report, p. 8.
49 Report, p. 8.
50 Report, p. 96.
51 Report, p. 96.