Priorities contained in European Commission’s Management Plans for 2021

By analysing the different Management Plans, we have identified the priorities conducted by several DGs in order to be able to engage with the European Commission according to their agenda and have leverage in conveying the VPHi & Alliance’s key messages.

Key highlights:

• DG SANTE’s plan

Within its management plan for 2021, DG SANTE (Directorate-General for Health and Food Safety) focuses on building a strong European Health Union. The main pillars contributing to this objective are the Pharmaceutical Strategy, Europe´s Beating Cancer Plan, and the foreseen launch of the European Health Data Space. The Plan also references the upcoming EU4HealthProgramme whose actions will be implemented under the “One Health” approach. Its four sub-objectives are listed as follows:

Diminishing the impact of cancer in Europe by improving prevention and care.

Ensuring patients’ access to safe, innovative, and affordable medicines and medical devices. Activities include, among others:

• An evaluation of basic legislation on medicines for human use will occur in Q2 2021;
• A public consultation of the Pharmaceutical strategy will happen in Q4 2021;
• A public consultation for the impact assessment of the review of the legislation on medicines for rare diseases and children in Q2 2021;
• The Commission will revise EMA fees during this year;
• The Clinical Trial Regulation will enter into force in Q2 2021;
• A public consultation of the Pharmaceutical strategy in Q4 2021;

• DG SANTE together with co-legislators will continue working for securing the adoption of the Commission proposal on Health Technology Assessment;
• The Medical Device Regulation will enter into application on 26 May this year; and
• The in vitro Diagnostics Regulation (IVDR) will be applicable from 26 May 2022 and it will include setting up the necessary infrastructures, ensuring appropriate standards and guidance, and identifying and addressing potential bottlenecks.

Ensuring effective response coordination of serious cross-border health threats, including:

• Proposal for cross-border health regulation to reinforce the EU framework;
• The mandates of the European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA) will be revised;
• A preparatory action and a Consultation on establishing the EU Health Emergency Response Authority (HERA) will be launched in Q2 2021;
• An Impact Assessment and proposal to Establish HERA will follow in Q4 2021;
• Joint EMA / ECDC platform for post-marketing authorisation studies assessing the safety and the effectiveness of vaccines/urgent studies of COVID-19 vaccines.

Ensuring more effective, accessible, and resilient health systems. The following activities, inter alia, will be carried out.

• The Directive 2011/24/EU on cross-border healthcare (CBHC) will be revised in Q2 2021;
• An impact assessment and a proposal will be published in Q4 2021 to revise the EU legislation on blood, tissues, and cells;
• A Joint Action supporting the development of the European Health Data Space will be launched in Q1 2021 with a legislative proposal will be presented later this year.

• DG CONNECT’s plan

DG CONNECT (Directorate-General for Communications Networks, Content and Technology) will implement a substantial part of Horizon Europe, setting the strategy for research and innovation related to digital technologies.

As such, its Management Plan puts forward the following activities of relevance to Avicenna:

The launch of the calls for funding of the Digital Europe programme - which aims to establish essential digital capacities in key digital technology areas among which High Performance Computing and AI - is to be expected in Q4 2021.

A proposal a Regulation on a Horizontal Regulatory Framework on Artificial Intelligence, relating to aspects of fundamental rights and safety in Q1 2021.

As to the European Health Data Space, DG CONNECT will support the deployment of secure infrastructures that will make genomic data and cancer images securely accessible across borders and the exploration of new tools, technologies and digital solutions including health data.

Launch of the next phrase of the Brain Project Flagship that provides an infrastructure for researchers to advance in neuroscience, computing, including neuromorphic computing, and brain-related medicine in Q1 2021.

The launch of the Public-Private Partnership in AI, Data and Robotics in Q1 2021.

• Joint Research Centre Plan

The JRC will remain supporting the fight against COVID-19. Correspondingly, its activities will focus on six strategic priorities, among which: epidemiological monitoring, modelling and reporting, use of alternative data and digital technologies, diagnostics and health, as well as socio-economic modelling and analysis.

For the European Health Data Space, the JRC will provide evidence related to heath data in terms of data quality, standardisation, interoperability, governance and analysis (including the use of AI). Both the JRC’s cancer and rare diseases registries will serve as a pilot of the EU Data Space:

• Enhancement of the European Cancer Information System as a common interactive space for European population-based cancer registries in Q4 2021.
• Development of a common space for European rare disease registries in Q4 2021.

• Directorate-General for Research and Innovation (RTD)’s plan

Activities put forward by DG RTD plan‘s include, among others:

Contributing to the implementation of the Communication on enabling the digital transformation of health and care in the Digital Single Market in Q4 2021.

Connecting the European Health Data Space to the European Open Science Cloud (EOSC) in Q2 2021.

Introduction of an EIC Accelerator challenge to support game-changing innovations and technologies in strategic digital and health technologies by end of 2021.

Launch of the Innovative Health Initiative partnership following the adoption of the legal base in Q4.

A report by Renée Frijns, Avicenna Alliance Secretariat.