A dispute … [with] unusual characteristics …[1] is how AG Saugmandsgaard described this case. It relates to the decision of the Italian Antitrust Authority (the AGCM) that certain conduct affecting the off-label use of Avastin in competition with Lucentis in the field of ophthalmology was anti‑competitive. In most CJEU cases the final judgment tends to reflect the Opinion of the Advocate General, so this Opinion provides a useful indicator of the likely outcome and also throws up a number of fascinating issues. We will write about the case in more detail on our competition law blog, The CLIP Board but some of the key issues which are particularly relevant to the pharmaceutical sector are summarised below.

The case relates to the interplay between EU competition law and the pharmaceutical regulatory regime, and the key issue was summarised by the Advocate General as follows: “… to clarify to what extent and on what basis the legal uncertainty regarding the lawfulness of prescribing and marketing a medicine with a view to its off-label use and the scientific uncertainty surrounding the risks associated with such use come into play in the application of Article 101 TFEU”.

The Opinion contains a lengthy discussion on whether a ‘market’ for competition law purposes may include medicinal products which cannot legally be prescribed for a particular indication. The Advocate General concluded that, as market definition depends on the objective characteristics of the product, and the actual competitive conditions, the fact that legislative hurdles may make substitutability more difficult does not mean that two products cannot compete – it is a matter of looking at what is actually happening in the market. The Advocate General concluded that the definition of the relevant product market for competition law purposes, and the assessment of whether two products compete, is not limited by the content of Marketing Authorisations.

Equally, even if there is uncertainty about the lawfulness of supplying particular medicinal products for particular uses (including off-label use) that does not mean that those products cannot compete with products that have been authorised. The Advocate General was quite clear: “EU competition law pursues independent objectives distinct from those which pharmaceutical legislation seeks to achieve.

By way of introduction to the discussion of the main issue, the Opinion deals with a number of technical competition law points. This is the most complex part of the Opinion which reviews concepts such as such as how the relationship between licensors and licensees may affect the competitive dynamic between them; the meaning of the doctrine of ancillary restraints; when a restriction of competition arises in the context of a licensing agreement; the application of the exception in Article 101(3) TFEU; and the distinction between ‘by object’ and ‘by effects’ restrictions of competition.

Of immediate interest to pharmaceutical companies, these concepts are then applied to the question whether “… collusive conduct concerning the dissemination of allegations of the lesser safety of one medicinal product by comparison with another … reveal[s] a sufficient degree of harm to competition [to infringe the competition rules] where those allegations are misleading …”.

The Advocate General considers a number of potential scenarios in which misleading information might be communicated, including where the information provided is accurate but incomplete. He concludes that an agreement to provide information about the relative safety of two medicines which, in itself, is “correct but … presented selectively or incompletely” so that it is likely to mislead, amounts to a restriction of competition by object. The Opinion suggests that when companies agree to communicate information about the comparative safety of two medicines, they should provide only information which is “precise and objective” having regard to “scientific knowledge at the material time” if they wish to avoid potential risks under competition law.

The fact of continuing scientific uncertainty about the safety of products is not an excuse for providing objectively misleading information. The Advocate General refers to the obligation under Article 49(5) of Regulation 726/2004 that the holder of a Marketing Authorisation must ensure that information about pharmacovigilance concerns is “presented objectively and … not misleading”. He imports a similar obligation into the competition law analysis, commenting that “… omitting to state that the risks created by using the medicine are uncertain, or exaggerating such risks with a lack of objectivity with regard to the available evidence, may render the concerted communication of those risks misleading.

If the CJEU follows the Advocate General, this is likely to be a very significant judgment for the pharmaceutical sector. Its implications may well extend beyond Article 101 TFEU, into unilateral conduct. It echoes observations in the AstraZeneca[2] case about the obligation on dominant companies to act transparently in their dealings with the authorities – for example, when applying for an SPC. Given the very narrow markets that are often defined in the pharmaceutical sector, the implications of such an obligation when commenting on product safety should be considered carefully by anyone active in the sector.