The CJEU’s ruling in the Novartis Farma case: Money, health and medicines
| Published date | 01 April 2020 |
| Date | 01 April 2020 |
| DOI | http://doi.org/10.1177/1023263X20904228 |
| Subject Matter | Articles |
Article
The CJEU’s ruling in the
Novartis Farma case:
Money, health and medicines
Vera L ´
ucia Raposo*
Abstract
In the Novartis Farma SpA case (Case C-29/17), the Court of Justice of the European Union (CJEU)
held that the decision of a Member State (Italy) to reimburse a drug used off-label (Avastin), and for
that purpose submitted to repacking procedures, is not in violation of European law, even if there
is a duly approved therapeutic alternative (Lucentis) on the market and the procedure is solely to
reduce health care expenditures.
This was not the CJEU’s first ruling on off-label drug use. The novelty of the Novartis Farma SpA
case is the economic element attached to the assessment of off-label prescriptions, even though
the Court failed to consider this essential feature of the case.
This paper analyses the Court’s ruling in light of two main principles of European pharmaceutical
law: the imposition of marketing authorization for drugs used in the European market; and the
predominance of public health concerns over economic considerations. The paper concludes that
the Court failed to identify a major issue in the Italian policy – the reimbursement of off-label drug
used when there is a properly approved therapeutic alternative on the market – at the risk of
undermining the entire European pharmaceutical framework and endangering public health.
Keywords
Court of Justice of the European Union, marketing authorization, off-label prescription,
reimbursement, public health
*Faculty of Law, Macao University, Macao, China
Corresponding author:
Vera L´
ucia Raposo, Faculty of Law, University of Macau, Room 2043, E32, Avenida da Universidade, Taipa, Macau, China /
Faculty of Law, University of Coimbra, P´
atio da Universidade, Coimbra, Portugal.
E-mails: vraposo@um.edu.mo, vera@fd.uc.pt
Maastricht Journal of European and
Comparative Law
2020, Vol. 27(2) 178–198
ªThe Author(s) 2020
Article reuse guidelines:
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DOI: 10.1177/1023263X20904228
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1. The problem under discussion
The use of a drug outside the scope of its marketing authorization (MA)
1
is known as an off-label
prescription.
2
In such circumstances, the drug is used for a different group of patients, a different
medical condition, following a different dosage, a different posology and/or a different method of
administration than originally intended.
The existing regulations on off-label prescription are almost inexistent. Scholars’ opinions in
this regard are based on norms not directly aimed to regulate off-label prescription, so there is
space for different interpretations from authors and from courts. Due to the lack of specific
regulation we must resort to the case law of the Court of Justice of the European Union (CJEU)
to understand the legal framework for this practice. However, the last ruling of the Court in this
decisions but also with some EU law rules or, at least, their interpretation.
In particular, the paper discusses the complex relation between public health and financial
concerns, how both elements are featured in European case law and which one is gaining
predominance.
This paper begins by exposing the features of the European pharmaceutical framework most
relevant to this particular case, and subsequently clarifies the practice known as off-label prescrip-
tion, in particular the so-called ‘economically motivated’ off-label prescription. The paper then
provides an excursus on the Court’s reasoning on this matter by revisiting the two previous
decisions of the CJEU on off-label drug uses. Thereafter, the paper describes the events that led
to the Novartis Farma SpA decision and examines the Court’s decision from two perspectives: i)
economically motivated off-label prescription in relation to the institutionalised mechanism for
drug approval and subsequent mandatory granting of the MA; and ii) the perils raised by off-label
prescriptions to public health, which is a value protected by EU law.
3
Finally, the paper provides a
critical assessment of the decision in the Novartis Farma SpA case.
2. The EU pharmaceutical framework on drug authorization
The European drugs regulatory system
4
is based on a network composed of regulatory authorities
from each European Economic Area (EEA) country. It includes the 27 European Union (EU)
1. The MA is a licence that allows a medicinal product to get into the market, granted after the authority in charge (in
Europe this authority is either the European Medicines Agency or the national drug authorities of each Member State)
has assessed all evidence presented by the manufacturer attesting to the drug’s safety and efficiency.
2. About off-label prescription, see N. Ghinea et al., ‘Challenges to the Validity of Using Medicine Labels to Categorize
Clinical Behavior: An Empirical and Normative Critique of ‘‘Off-Label’’ Prescribing’, 23 Journal of Evaluation in
Clinical Practice (2017), p. 574-581; C. Lenk and G. Duttge, ‘Ethical and Legal Framework and Regulation for Off-
Label Use: European Perspective’, 10 Therapeutics and Clinical Risk Management (2014), p. 537-546; V.L. Raposo,
‘Prescric¸a
˜o Off-Label de Medicamentos e de Dispositivos M´edicos’, 11 Lex Medicinae (2014), p. 35-77.
3. The Novartis Farma SpA decision raises other issues, such as variations of MA and which entity is in charge of
pharmacovigilance, but they are not addressed in this paper, except en passant.
4. ‘European Regulatory System for Medicines’, European Medicines Agency (2016), EMA/437313/2016, http://www.
ema.europa.eu/docs/en_GB/document_library/Leaflet/2014/08/WC500171674.pdf, p. 2; S. Chakraborty and S.
Macleod, Pharmaceutical and Medical Device Safety: A Study in Public and Private Regulation (Hart, 2019), p. 1-16;
T.K. Hervey and J.V. McHale, European Union Health Law: Themes and Implications (Cambridge University Press,
2015), p. 327-324.
Raposo 179
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