Following the recent announcements of a new EU4Health Programme, and publication of a Roadmap on timely patient access to affordable medicines, the EU Commission has now launched a far-reaching consultation on its plans for a Pharmaceutical Strategy for Europe. Some of the challenges brought into sharp focus by the COVID-19 crisis will be addressed in these initiatives, particularly ensuring that health systems are resilient in the face of future health threats, and medicines remain available under all circumstances. Changes to medicines legislation are likely as a result of implementation of the new policy.
The public consultation will last for three months (to 15 September 2020) and will focus on the following themes:
- strategic autonomy and manufacturing of medicines
- access to affordable medicines
- innovation
- environmental sustainability and health challenges.
Among the objectives of the new strategy is a reduction on the EU’s dependency on imports from non-EU states (“third countries”). The will include the development of a stronger EU manufacturing capability for active ingredients and other necessary supplies.
The consultation itself invites contributions from all who may wish to express an opinion. The Commission will also hold technical discussions with stakeholders such as national regulators and industry representatives in parallel.
Of course, the UK has left the EU and is on track to move out of the current transition period at the end of 2020. It is likely that the UK will be a “third country” by the time this policy is rolled out. Current negotiations on the future relationship between the EU and the UK are likely to shape the degree of involvement for UK industry in the new approach.
This article was written by Medilink EM Patron, Mills and Reeve LLP.