Pharma sector report: a first view

Today's Pharmaceutical Sector Report by the European Commission's DG Competition has been published here (press release here). The Introduction makes it plain that SPCs fall within the report's remit:

"(3) The sector inquiry dealt with the alleged obstacles to market entry for prescription medicines for human use. It focused on obstacles for generic products, i.e. products that can enter the market upon loss of exclusivity of the original product (i.e. upon patent expiry, possibly extended by SPC, or expiry of the exclusivity period pursuant to pharmaceutical law). It also concerned obstacles for innovative products, i.e. obstacles to competition between originator companies. As it is a competition inquiry, it focused on the behaviour of companies. However it is acknowledged that behaviour of companies always takes place against the background of the regulatory environment ...

(9) Intellectual property rights are a key element in the promotion of innovation. The protection of intellectual property rights is important for all sectors of economic life and is paramount to Europe’s competitiveness. However, it is particularly important for the pharmaceutical sector because of the necessity to address current and emerging health problems and the long life cycle of products (including long development periods). The pharmaceutical sector in the EU indeed has one of the highest investments in R&D in Europe and relies significantly on intellectual property rights to protect innovation. The exclusivity periods granted through patent law and other mechanisms (SPC, data exclusivity) provide incentives to originator companies to continue innovating".

A swift and immediate perusal of the main document, which runs to 533 pages, suggests that SPCs are not singled out for attention and that the report does not treat them as playing any role other than that of enabling patent term to be extended. There does not to be any specific criticism of paediatric extensions either.