• Contact Us

Drugs Prescribed 'Off Label' Deemed to Be Competing

on Wednesday, 13 June 2018.

The Italian competition regulator was right to consider a drug licensed to treat eye conditions such as glaucoma and macular degeneration (Lucentis) and another to treat tumours (Avastin) as competing, the European Court of Justice has ruled.

This was because Avastin had been found to have beneficial effects on people with the eye conditions and it was prescribed by some 'off label' for that other condition. This was the case of F Hoffmann-La Roche Ltd v Autorita Garante della Concorrenza e de Mercato.

What was really happening here was Avastin was cheaper than Lucentis, hence why it was popular for prescribers; and Roche had involvement in both medicines, and would rather have its official drug, Lucentis, used for the ophthalmic conditions. The Italian regulator had fined Roche and Novartis (Roche's licensee for Avastin) €90m each for what they decided was an anti-competitive arrangement between the two companies, contrary to Article 101 of the Treaty on the Functioning of the European Union. Article 101 outlaws anti-competitive agreements within the EU. The regulator had ruled that Roche and Novartis had provided misleading information around the safety of the off label use of Avastin for ophthalmic purposes.

Since the off label use of a drug was not illegal as long as certain conditions were met, the ECJ ruled that the Italian regulator had been entitled to find that they were substitutable and interchangeable - ie competing - products and therefore on the same market, notwithstanding that Avastin had not been registered to treat ophthalmic conditions.

Comment

The competition regulators are focusing significantly on the pharmaceutical sector. There have been several decisions around 'pay for delay' agreements, where a branded product supplier agrees with the generic supplier to stay off the market for a period of time in return for a payment. There have also been several cases recently brought against suppliers whom the regulators deemed to be charging excessive prices in a market where the regulators considered them to be in a dominant position. This latest case further supports the proposition that the regulators are examining a wide range of agreements, even, in this case, where there is no fixing of prices.


Have you got any questions around the use of competition law in the pharma industry? Please contact Paul Gershlick in our Pharmaceuticals and Life Sciences team on 01923 919 320.

Leave a comment

You are commenting as guest.