CJEU rules on whether the NHS reimbursing off-label medicinal products for cost-cutting purposes conflicts with Directive 2001/83/EC

Novartis Farma S.p.A. v Italian Medicines Agency and Roche Italia S.p.A.

On 21 November 2018, the CJEU issued an important decision in Novartis Farma v Italian Medicines Agency and Roche Italia et al. (C-29/17). The case was referred to the CJEU by the Italian Council of State and regarded an Italian law that allows the national healthcare insurance system (NHS) to reimburse a medicinal product for a use not covered by its marketing authorisation (off-label use) in order to reduce expenditure, notwithstanding the existence and market availability of a valid therapeutic alternative.

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