Public Policy Dynamics EU #4

by RPP colleagues

Health and Politics in the European Union

  • The European Parliament’s industry, research and energy committee (ITRE) responded to the European Commission's European Strategy for Data in a report adopted on 24 February. They call for legislation to be based on European values of privacy and transparency to allow the EU to benefit from the potential of industrial and public data.
  • The new draft compromise on the Health Technology Assessment (HTA) proposal developed during the Portuguese Presidency of the Council of the EU of 16 February has been leaked. The new text confirms the efforts of the Portuguese Presidency to reach a common approach ahead of the EU Health Council on 16 March.
  • The Commission on 17 February proposed a new European bio-defence preparedness plan against COVID-19 variants called “HERA Incubator”, which will coordinate researchers, biotech companies, manufacturers and public authorities to detect new variants, provide incentives to develop new and adapted vaccines, speed up the approval process for these vaccines, and ensure scaling up of manufacturing capacities. The European Commission has also published a factsheet, a Q&A, as well President von der Leyen’s speech on the topic.

Politics

  • The European Parliament’s industry, research and energy committee (ITRE) responded to the European Commission's European Strategy for Data in a report adopted on 24 February. They call for legislation to be based on European values of privacy and transparency to allow the EU to benefit from the potential of industrial and public data.
  • Members of the European Parliament state the current crisis highlights the need for efficient data legislation that will support research and innovation. The rules should be based on privacy, transparency and respect for fundamental rights. The committee called on the European Commission and Member States to work globally to promote EU values and principles and ensure the EU market remains competitive. Sectoral data spaces must be developed to enable data sharing while following common guidelines. In light of the pandemic, special attention should be given to the Common European Health Data Space. The Commission presented a European strategy for data in February 2020. The strategy and the White paper on artificial intelligence are the first pillars of the Commission's digital strategy.

 

Health

  • The new draft compromise on the Health Technology Assessment (HTA) proposal developed during the Portuguese Presidency of the Council of the EU of 16 February has been leaked. The new compromise prepared by the Portuguese Presidency takes up the main lines of the proposal submitted during the previous German Presidency, though it does include some new items such as the removal of penalties, the specification that first joint assessments will apply to oncology treatments using new active substances, and references to artificial intelligence.
  • The new text confirms the efforts of the Portuguese Presidency to reach a common approach ahead of the EU Health Council on 16 March. The effort to find a compromise among Member States can explain the decision to remove the provision concerning penalties for violations of the HTA Regulation which further waters down the Commission’s 2018 proposal.

 

Covid-19

  • The Commission on 17 February proposed a new European bio-defence preparedness plan against COVID-19 variants called “HERA Incubator”, which will coordinate researchers, biotech companies, manufacturers and public authorities to detect new variants, provide incentives to develop new and adapted vaccines, speed up the approval process for these vaccines, and ensure scaling up of manufacturing capacities. This Incubator will also be the basis for the EU's long‑term preparedness for health emergencies.
  • These items are aligned with global cooperation via the World Health Organisation and vaccines global initiatives. They will also precede the European Health Emergency Preparedness and Response Authority (HERA), which will provide a permanent structure for risk modelling, global surveillance, technology transfers, manufacturing capacity, supply chain risk mapping, flexible manufacturing capacity and vaccine and medicine research and development.
  • The European Commission has also published a factsheet, a Q&A, as well President von der Leyen’s speech on the topic.

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