European Commission Publishes Roadmap Towards Pharmaceutical Strategy for Europe
The European Commission (the Commission) published on 2 June 2020 its roadmap towards a Pharmaceutical Strategy for Europe (PSE) which it plans to publish in the fourth quarter of 2020 (see, attachment). The roadmap defines the steps which the Commission will take prior to adopting the PSE and the data which it will assemble to inform its PSE. While the Commission will consult a range of stakeholders, it has already announced a public consultation which will run until 7 July 2020.
The challenges which the Commission intends to tackle through the PSE include (i) the unequal access to medicines; (ii) medicine shortages; (iii) the occasional mismatch between innovation efforts and public health needs; (iv) the periodic inability to convert the fruits of European pharmaceutical research in commercial success; (v) regulatory barriers to innovation connected with genetic research, personalised therapies, smart health applications and artificial intelligence; and (vi) environmental risks associated with the production, use and disposal of medicines.
The Commission will pursue both non-legislative and legislative avenues and the latter may include changes to existing rules in areas such as orphan medicines and pediatric applications. The Commission also expressly wishes to take on board lessons learned from the COVID-19 pandemic with regard to crisis-preparedness and functioning supply chains.
The public consultation will be opened here.
Related insightsSign up for updates