One of the key measures outlined in the document is closer cooperation between member states authorities and payers to explore areas that can contribute to "higher affordability and better access to medicinal products."
It draws attention to what is described as "an increasing number of examples of market failure in a number of member states" for reasons. These include "very high and unsustainable price levels", the market withdrawal of generic products and the decision by some drugmakers not to launch products in national markets for "business economic strategies."
Among the new drugs highlighted by the Council are new antiviral for hepatitis C virus (HCV) infections, such as Gilead Sciences' Harvoni and AbbVie's Viekira Pak, which cost tens of thousands of euros per course.
For the first time, the governments of the 28 EU members signal their intent to tackle pharma competition directly, with an eye on drug pricing, the availability of generic and biosimilar drugs and the activities of health technology assessment (HTA) agencies such as the UK's National Institute for Health and Care Excellence (NICE).
Among the recommendations are that member states should carry out joint 'horizon scanning' to try to anticipate new drugs that could have affordability issues, greater information exchange between national pricing and reimbursement authorities before product launches and collective pricing negotiations.
The Council invites the European Commission to carry out an analysis of incentives offered to companies to encourage the development and registration of new products, including supplementary protection certificates (SPCs) that can be used to extend the patent life of drugs in some circumstances, for example by conducting trials in children.
It would also like an impact assessment of the effect of these incentives on the availability and accessibility of drugs, "including high priced essential medicinal products for conditions that pose a high burden for patients and health systems as well as availability of generic medicinal products."
The document provides plenty of food for thought for pharma and the EC, although the final version of the plan is reported to have been toned down from earlier drafts after lobbying by industry.