Leaked EU Document Lays Out Major Evaluation Of EU Drug Pricing

The 28 European Union member governments are preparing to request the European Commission to conduct an in-depth evaluation of the availability and affordability of EU medicinal products that could possibly lead to changes in R&D and pricing models. An apparent first-of-its-kind, the assessment would look at market and data exclusivity, supplementary protection certificates, and intellectual property issues, according to an alleged copy of the draft Council conclusions document obtained by Intellectual Property Watch.

The draft European Council conclusions on strengthening the checks-and-balances in the EU pharmaceutical system, dated 24 May, is available here [pdf].

It appears to be on the agenda for a 27 May meeting of the Working Party on Pharmaceuticals and Medical Devices. It states that the text was proposed by the Council presidency, the Netherlands, which had made medicines access a top priority.

The document shows changes made from an earlier version, seemingly reflecting member state comments from the first version.

The proposal could potentially lead to changes in EU policy. The final provision, Article 41, includes the action to: “Based on the above, discuss the outcome and possible remedies proposed by the Commission in the Working Party on Pharmaceuticals and Medical Devices.”

It invites the European Commission to work to streamline implementation of legislation on orphan medicinal products and, “if necessary consider revision of the legal framework on orphan medicinal products.”

And it calls for, by early 2018, an “in-depth evaluation” that scrutinises the system of incentives and marketing in relation to medicinal products, working with EU competition authorities to take aim at market abuse, excessive pricing and other market restrictions.

The text stresses the importance of innovation but seeks to tighten abuse of the system. EU countries have been hit by cases of excessively high drug prices in recent months.

The text includes a recently added clause reinforcing the importance of IP rights:

“6a. RECOGNISES that a balanced and strong, functioning and effective intellectual property environment is an essential element in supporting and promoting access to innovative, safe, effective and quality medicinal products in the European Union;”

But it also notes ongoing problems of market failure for some medicines:

“15. NOTES WITH CONCERN that market failure occurs in an increasing number of examples of market failure in a number of Member States, in particular in those situations where patients access to effective and affordable essential medicines is endangered by very high and unsustainable or excessive price levels, market withdrawal of products that are out-of-patent, or when new products are not introduced to national markets for business economic reasons, such as low volumes or portfolio rationalisation, and that cannot be influence by individual governments have limited influence in such circumstances;”

The document also reinforces member states’ authority and offers some suggestions for the national level in relation to the EU.