European Health Ministers Call for More Competition in Pharmaceutical Markets

Medicines for Europe will engage rapidly with Health Ministers across Europe to implement the Health Council Conclusions on “strengthening the balance in the pharmaceutical system in the EU and its Member States”. The Conclusions underline the importance of the timely availability of generics and biosimilar medicines to improve patient access to therapy and to ensure the sustainability of national health systems. Value added medicines should also be included in this process as they can also contribute significantly to the efficiency of health systems while stimulating more competition between pharmaceutical innovation models.

Adrian van den Hoven, Medicines for Europe Director General, commented on the conclusions: “Member States have now understood the importance of stimulating competition in pharmaceuticals after patent expiry to help rebalance a market heavily impacted by the introduction of new highly priced patent protected medicines. Our members are ready to drive this agenda forward to ensure better access for better health”.

Medicines for Europe strategy to deliver better access for better health can contribute significantly to efficient and sustainable pharmaceutical policies. To strengthen the balance of the pharmaceutical market in Europe, Medicines for Europe calls for:

• Member States to stimulate competition at patent expiry through specific uptake measures for generic, biosimilar and value added medicines.
• The EU to include new generic, biosimilar and value added developments in “horizon scanning” to enable Member States to plan for uptake measures in specialty markets immediately after patent or exclusivity expiry.
• The EU to rapidly adopt the SPC manufacturing waiver, improve EPO opposition procedures, remove patent linkage systems and address other unwarranted restrictions to competition after patent or exclusivity expiry.
• EU regulatory agencies to advance the regulatory efficiency agenda to ensure that our industry can rapidly and sustainably deliver more access to medicines.
•  The EU and Member States to engage joint dialogues with Medicines for Europe and EFPIA (or their national members) to develop a sustainable partnerships for better access to medicines respecting the different role and responsibilities of the EU and Member States in this domain.