A summary of the Lucentis-Avastin saga

Avastin (Roche) is a medicine authorised for use in treating certain types of cancer. It is also used “off-label” for the treatment of a widespread retinal disease, age-related macular degeneration. Such usage, referred to as “off-label”, is prescribed by a doctor and involves the Avastin being taken out of its original bottle and repackaged in single-use syringes.

Lucentis (Novartis) appeared on the market after Avastin. It is a medicine approved for use on the market in treating age-related macular degeneration. Its unit cost is far higher than that of Avastin used off-label to treat the same condition.

This situation has led to three landmark cases before the Court of Justice:

• In 2013 (judgment of 11.04.2013 - C-535/11), the CJEU made an initial judgment on the “pharmaceutical regulation” aspect of this issue. In this case, the Court allowed that a German company might repackage Avastin (off-label) in syringes and subsequently deliver it to pharmacies, as long as these activities did not lead to a modification of the medicinal product concerned and were conducted solely on the basis of individual prescriptions.
• In 2013 (judgment of 23.01.2018 - C-179/16), the Court ruled on the “competition law” aspect of the issue. In this case, the Italian authorities imposed penalties on the firms Roche and Novartis for concluding an agreement designed to discourage off-label use of Avastin. The Court confirmed that the “relevant market” that was supposed to evaluate the agreement could include, in addition to the medicinal products authorised for the treatment of the diseases concerned, another medicinal product used off-label to treat the same diseases.
• The “social security” aspect (conclusions of the Advocate General, 25 July 2018 - C-29/17), on which the Advocate General recently presented his opinion, concerned the decisions made by the Italian authorities to include Avastin, repackaged by pharmacies and used off-label, in the list of medicines refunded by social security. At the end of his analysis, the Advocate General expressed the opinion that the European rules on placing medicines on the market do not oppose the application of national legislation that, with the sole aim of alleviating the health insurance system’s budget, allows this system to cover a medicine used for a therapeutic indication that is not included in the medicine’s authorisation, notwithstanding the availability on the market of medicines whose authorisation does include this therapeutic indication, as long as this medicine has been marketed and manufactured in accordance with the European rules concerning the marketing of medicinal products.

What these three cases have in common is that they have permitted (or will permit) the Court of Justice to provide considerable clarification on the scope of the rules for placing medicinal products on the market by distinguishing between different types of medicine: those that are fully or partly subject to Directive 2001/83 (medicinal products with a marketing authorisation, medicinal products that have a marketing authorisation but are repackaged or split, medicinal products without a marketing authorisation but which are intended to fulfil special needs), and those which are not subject to this Directive (magistral or officinal formulae).