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Italian Constitutional Court - decision n. 151/2014: off-label drugs
19 Maggio 2014

The Constitutional Court declared inadmissible the constitutional question raised in the judgment between Novartis and the Emilia-Romagna Region, promoted by the Emilia-Romagna Regional Administrative Court (Tribunale amministrativo regionale) and originating from an appeal of a resolution adopted by the Regional Council (Giunta) (October 26, 2009) allowing the medicine Avastin (La Roche) to be distributed as a Regional Health Service expenditure for the off-label treatment of age-related maculopathy (ARM).

Numero
151
Anno
2014

 The constitutional question concerned the distribution rules of medicines to be dispensed for a therapeutic purpose different from the authorized one – so called “off-label” drugs – from National Health Service funds. It also concerned the discipline of marketing authorization. Both violate Arts. 2, 3 (para. 2), 97 (para. 1), 119 (paras. 1, 4) of the Constitution.

According to the remittent judges, the rule was unconstitutional for two reasons:

  1. The Regions, upon which the costs of NHS-dispensed drugs fall concretely (as charged to the Regional Health Service), would not have the power of initiative and participation in the procedure regulated by the state law.
  2. The non-existence of a “valid therapeutic alternative” refers to the market unavailability of an authorized, on-label drug of at least equal therapeutic efficacy, without attributing any importance to the necessary and indispensable economic factor, related to the primary need for control of public expenditures.

The Court declared the question inadmissible because the resolution of the Regional Council (Giunta) represented an exercise of decision-making power based on a regional provision already declared unconstitutional with Decision n. 8 of 2011.

However, the Court recognized that: “The criterion of the ‘valid alternative’ presupposes the comparison by the Agency of the ‘equivalent’ drugs from both a medical-scientific, and economic perspective, since an alternative medicine from a medical-scientific point of view might not be a valid therapeutic alternative ‘when it does not guarantee – from an economic-financial point of view – its efficient use by the NHS in terms of the numerical ratio between purchasable doses of the drug and treatable patients, thus achieving economically unacceptable and discriminatory conditions that limit the access to care and thus harm the protection of the constitutionally guaranteed right to health. The same can be said in the reverse hypothesis”.

Full text of the decision in Italian can be found here.

Derek Van Becelaere, Raffaele Guerini
Pagina pubblicata Lunedì, 19 Maggio 2014 - Ultima modifica: Lunedì, 02 Settembre 2019
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