EU Health Ministers to Consider Policies Fostering Cooperation to Improve Access to Medicines and Reduce Medicine Shortages
The Finnish Presidency of the European Council has invited Member States to a policy debate that will consider avenues towards strengthened cooperation in order to improve access to medicines (see, attached note of 22 November 2019 – the “Note”). The debate should take place during the employment, social policy, health and consumer affairs Council of 9 December 2019.
The Note takes stock of the many initiatives that have been taken in recent years at various levels of government and on a wide range of subjects. At the same time, guided by what it describes as the “four phases of a medicine’s lifecycle”, the Note also identifies a number of possible regulatory gaps. It specifically welcomes Member State comments on the requirement to maintain medicines on the market, reduce “uncontrolled market withdrawals” and curb shortages. On this basis, it requests the Member States to take a position on the following issues:
- Concrete measures to be taken by both Member States and the European Commission to ensure access to medicines and avoid medicine shortages.
- Possible EU rules to (i) make EU-based back-up manufacturing capacity mandatory; (ii) create earlier warnings of supply interruptions; and (iii) ensure continuity of supply.
- Strengthened Member State cooperation in areas as diverse as sustainability of budgets and shortages of medicines.
While a parting shot for the Finnish Presidency of the Council (In 2020, first Croatia and then Germany will succeed Finland), the Note sets the tone for an ambitious medicines policy to be adopted by the new European Commission which is now expected to become operational on 1 December 2019.