Comments on: The Commission’s innovation confusion EU news and policy debates across languages Tue, 09 Apr 2019 14:09:21 +0000 hourly 1 By: Adrian van den Hoven Thu, 16 Mar 2017 15:58:51 +0000 For an expert on innovation, trade and health policy, Philip Steven’s commentary on the innovation gap with China falls short of the mark.

Clearly Mr Stevens understands very little about the Commission’s Single Market Strategy which includes numerous proposals to strengthen IP protection for, among others, the pharmaceutical industry. The extensive proposals to adapt EU legislation to the anticipated establishment of the Unified Patent Court (which will have a specialised court devoted entirely to life sciences cases) are clearly favourable to patent right holders. However, we suspect that Mr Stevens is less interested in the Single Market Strategy than in discrediting the SPC manufacturing waiver. Contrary to the title of his commentary, the manufacturing waiver is proposed specifically to bolster the competitiveness of the European pharmaceutical industry relative to China and to India. Contrary to his claim, the proposal will in no way harm the originator pharmaceutical industry because it will maintain their monopoly position on the EU market under as revised SPC just as it does today. The amendment only serves to stop the delocalisation of generic and biosimilar medicine manufacturing to Asian countries without SPCs which is the unintended side effect of the current SPC. Again contrary to his claims, the SPC Manufacturing Waiver would certainly not allow generic or biosimilar manufacturers to produce patent protected drugs for export since, by definition, the SPC is a regulatory compensation which is only granted after the expiry of the original patent and, as any expert knows, the WTO ruling on the Bolar provision (DISPUTE DS114 Canada — Patent Protection of Pharmaceutical Products: ) specifically prohibits this. Mr Stevens seems to be unaware that it would be a breach of EU law for the Commission to make a legal proposal deliberately disregarding its WTO obligations.

Mr Stevens also clearly knows very little about the European pharmaceutical industry. Generic manufacturers are among the leading industries investing in R&D in Europe – well above the industry average relative to sales. In fact, the European manufacturers that I represent are so innovative that they have developed – against all odds – the world’s leading biosimilar medicines industry. Our industry is one of the last ones in Europe still building new factories – mainly in high technology and complex pharmaceutical production like biological, respiratory or sterile injectable plants. Over the last two years, new such plants have been built in Spain, Hungary, Poland and Ireland – to name but a few.

This is important because the study Mr Stevens cites to discredit the Manufacturing Waiver was sponsored by Abbvie which markets and manufacturers (but did not invent according to does that make it an innovator Mr Stevens?) the world’s best-selling drug Humira™ whose scientific name or INN is adalimumab. According to news reports(, this drug has a staggering $14 billion in sales/year and its SPC protection is expected to expire at some time in 2018 in Europe. It is also important to note that adalimumab is the number one target of the biosimilar medicines industry with many biosimilar versions currently under development or under review for approval by the EMA. Abbvie, which manufactures biologics in the US and Puerto Rico, knows all too well that the Manufacturing Waiver would create more competition from EU manufacturers to its mega-blockbuster in countries where patents or SPCs have expired. Because the approval of a biosimilar medicine is closely associated with a review of its manufacturing quality, the current way the SPC is applied could delay competition by an additional six months or one year after all IP protections have expired and thus artificially extend the monopoly on the world’s most expensive drug.

The manufacturing waiver seeks to put European generic and biosimilar manufacturers on a level playing field with competitors from China and India. No more, no less.
Summarising its effect incorrectly based on the arguments of a single American/Puerto Rican manufacturer whose drug – the best-selling in the world – is about to face competition from an innovative European industry is hardly a balanced commentary.