Shortly before becoming the new home of the EMA, the Netherlands piqued the interest of the pharma industry with a controversial move on drug pricing. The move consisted of a recommendation by the Dutch Council for Public Health and Society (“RVS”) that the government should use compulsory licences when a medicine is priced too high, or in RVS’s words, does not have a “socially acceptable price”. In this article, we touch upon the significance of such a proposition in the regulatory sphere, as in our regulatory colleagues’ eyes this could result in a violation of the established IP regulatory rights enacted in EU legislation. However, for now our focus is on the significance of the move from a competition law standpoint.
Readers of this blog will be more used to thinking about price reduction measures and compulsory licensing issues through the lens of competition law. However, the RVS bases its recommendation in part on Article 8 of the TRIPs Agreement, which allows measures that protect public health or prevent the (anti-competitive) abuse of intellectual property rights resulting in the unreasonable restraint of trade or of international transfer of technology. Further provisions relevant to compulsory licensing are covered in Article 31 of TRIPs, which provides for certain rights to use the subject matter of a patent without the rights holder’s authorisation, provided rights holders are remunerated for the licence based on the “economic value of the authorisation”.
In recent years, considerable attention has been given by competition authorities to possible instances of excessive pricing. To date, those cases (such as Pfizer/Flynn, currently on appeal before the UK’s Competition Appeal Tribunal, or the latest Statements of Objections issued by the Competition and Markets Authority (“CMA”) to Actavis and Concordia) have focussed on prices of legacy generic products. By contrast, the RVS’s proposal is firmly focussed on cost containment measures for new, patent-protected, medicines, but is not limited to potential blockbusters.
The RVS’s criticism of current prices and consequently its recommendations extend to orphan drugs (medicines for very rare diseases affecting less than five out of 10,000 people in the EU population), which by definition benefit only a very small part of the population. The relatively high cost of R&D and production for orphan drugs, juxtaposed against the narrower reach/ patient pool and thus lower profit margin, has resulted in the EMA providing additional incentives for the development and commercialisation of those products. The Dutch authority’s recommendations therefore appear somewhat contrary to the spirit of the EMA’s policies aiming at encouraging investment by innovators in these areas, but is perhaps motivated by concerns expressed by some around the increasing use of orphan drug status (the concept of ‘orphanizing’, alluded to here).
There is an absence of any definition of or set of criteria to determine what might constitute ‘high’ or ‘socially unacceptable’ pricing. The RVS proposal is not a new concept and in fact the subject of high or ‘excessive’ pricing in the pharma industry has occupied European stakeholders and has been the subject of investigations on a national and European level over the past few years. In June 2015, in response to a European Parliament member’s (MEP) suggestion of compulsory licensing as a means to lower drug prices, the Commission stated that this is a matter to be dealt with at national level and that neither the Commission nor the EMA are competent to take such action.
The UK’s approach to compulsory licensing differs significantly from the Dutch proposal. Compulsory licensing is a rare breed in the UK, as it is only a measure to be taken for an abuse of monopoly stemming from patent rights – and it is very often the case that the relevant authorities prefer alternative means. Where new drugs are concerned, the question of cost effectiveness of medical treatments lies primarily in the hands of NICE. As noted above, the CMA has been particularly active over the past year in pursuing practices which result in elevated prices for generic pharmaceuticals But rather than automatically holding that very high prices are inherently anticompetitive, the CMA appears to draw a distinction between abusive ‘excessive pricing’, which is artificially and unjustifiably inflated pricing or increased pricing once a gap in competition on the market is identified, and high pricing which properly reflects the cost of development and production of a new drug.
Our (not excessively priced) two pennies’ worth on this proposal is that imposing a compulsory licensing system for drugs which are not priced in a ‘socially acceptable way’ is, at best, a vague proposition which is likely to alarm and be met with adamant opposition by the industry. With much uncertainty as to what may constitute ‘excessive pricing’ or the ‘appropriate remuneration’ for the rights holder, there will be great scope for dispute. From a regulatory perspective, the fact that this measure might make it possible for governments to bypass rights such as the regulatory data protection (RDP) is a concerning prospect. More generally, this proposal strikes at the heart of the delicate balance between long-run innovation incentives in a high risk/high reward sector, and short-term costs considerations around access to existing medicines. The struggle between both sides of this debate looks set to continue.