At the end of July 2018, advocate general Saugmandsgaard Øe (the “AG” ) gave a little noticed opinion on the vexed issue of the compatibility with EU law of Italian rules providing for the reimbursement of an unauthorised indication of a medicine for purely budgetary reasons.

The advice for the Court of Justice of the European Union (“ECJ”) came in litigation between Novartis and various Italian health authorities over the reimbursement of Avastin for off label use in the management of wet age-related macular degeneration (“AMD”), an eye condition.

Avastin functions in that case as a replacement for Roche’s significantly more expensive Lucentis. To be sure, Avastin has a marketing authorisation for a range of unrelated oncology indications.

In what would seem to be a negation of pharmaceutical orthodoxy but would bolster the existing regulatory approach in a number of Member States, the AG formed the view that EU law does not stand in the way of a national rule that offers reimbursement of an off label indication of a medicine which is registered and commercialised for unrelated therapeutic indications, even if such reimbursement was established for purely budgetary reasons given the presence on the market of a more expensive second medicine with a registered indication that matches the reimbursed off label indication of the first medicine (case C-29/17, Novartis Farma v. AIFA, Roche Italia and others, opinion of advocate general Saugmandsgaard Øe of 25 July 2018).

The opinion is somewhat surprising in the light of an earlier ruling of the ECJ which in case C-185/10, Commission v. Poland, held that an application for the unauthorised use of a medicine “must remain exceptional in order to preserve the practical effect of the marketing authorisation procedure” and should be used only if that is necessary, taking account of the special needs of patients.

The concept of “special needs” “applies only to individual situations justified by medical considerations and presupposes that the medicinal product is necessary to meet the needs of the patient.”

By contrast, financial considerations cannot give rise to such special needs. The ECJ thus pointed out that special needs cannot arise “where medicinal products having the same active substances, the same dosage and the same form as those which the doctor providing treatment considers that he must prescribe to treat his patients are already authorised and available on the national market.”

Admittedly, the situation that gave rise to case C-185/10 differs from the off label use of Avastin which has an active substance, dosage and form that are different from those of Lucentis. Still, the rationale for avoiding the circumvention of an established marketing authorisation regime designed to protect and safeguard public health would appear to apply to the AMD case as well.

Deferring to established pharmaceutical rules seems all the more important because the Italian competition authority had already tackled private anticompetitive conduct of Novartis and Roche in relation to AMD.

The case ended up before the ECJ which, on 23 January 2018 and again based on the advice of Advocate General Saugmandsgaard Øe, held (i) that the content of a marketing authorisation does not determine the scope of the relevant product market so long as other specific conditions are satisfied; (ii) that a licensing agreement between non-competitors may fall within EU competition rules; and (iii) that the coordinated dissemination of misleading safety claims may constitute a serious violation of competition rules.

It is now for the ECJ to decide whether or not it will espouse the AG’s opinion in the most recent, “regulatory” case involving these same parties.