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"National Healthcare Insurance Systems Are Allowed To Reimburse Off-Label Use of Medicine" Says ECJ

  • 22/11/2018
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The Court of Justice of the European Union (“ECJ”) held this morning that under EU law national healthcare insurance systems are allowed to reimburse a medicine for a use not covered by that product’s marketing authorisation (see attached – Case C-29/17, Novartis and others v. Agenzia Italiana del Farmaco and others, judgment of 21 November 2018). The ECJ’s judgment came at the request of the Italian Council of State which had been asked to handle litigation between Novartis and various Italian health authorities over the reimbursement of Avastin for off-label use in the management of the eye-condition wet age-related macular degeneration (“AMD”). Avastin functions in that case as a replacement for Roche’s significantly more expensive Lucentis. For its part, Avastin has a marketing authorisation for a range of unrelated oncology indications.
As is the case in a number of other Member States, Italian law provides for a mechanism that allows for the reimbursement of a non-authorised indication for financial reasons, even if there is an alternative authorised therapy on the market. In its challenge of the reimbursement of the off-label use of Avastin, Novartis relied in part on EU medicines law. Today’s ruling of the ECJ dooms that effort.
The ECJ’s verdict would seem to be predicated on the fundamental principle that the “organisation and management of health services and the allocation of resources assigned to them are the responsibility of the Member States” (Novartis, §49). The ECJ added that Member States thus have the power to regulate the consumption of medicines in order to “promote the financial stability of their healthcare insurance schemes” (Id., §48).
On that basis, the ECJ maintained that Italy was in its right to reimburse the off-label use of Avastin despite the availability of more expensive alternatives. The ECJ went on to state that, in the process, Italy duly observed the EU medicine rules. For example, the ECJ found that the repackaging of Avastin to accommodate the use not contemplated by its marketing authorisation does not require a new authorisation because that process (i) does not modify the medicine; (ii) is prescribed by a physician (who under most national laws bears the ultimate responsibility for off-label prescriptions); and (ii) is undertaken by pharmacies authorised to have that product administered in hospitals.
Similarly, the ECJ considered that the pharmacovigilance system provided for by EU law also applies to off-label use.
The ECJ thus sided with its Advocate General who, at the end of July 2018, had already reached a similar conclusion (see, VBB Life Sciences Newsflash of 30 August 2018).     


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