European pharmaceutical strategy goes through data science

On 25 November 2020, the European Commission published its Pharmaceutical Strategy for Europe, which aims to create a futureproof regulatory framework and to support industry in promoting research and new technologies.

This strategy will be based on 4 pillars:

· Ensuring access to affordable drugs for patients, and addressing unmet medical needs.

· Supporting the competitiveness, innovation and sustainability of the EU pharmaceutical industry and the development of high quality, safe, effective and greener medicines.

· Enhancing crisis preparedness and response mechanisms, diversified and secure supply chains, addressing medicine shortages.

· Ensuring a strong EU voice in the world, by promoting a high level of quality, efficacy and safety standards.

Secure and efficient access to health data is key to fully exploiting the huge potential of new technologies and digitalisation. Industry and regulators require access to data through robust EU-wide data infrastructure to support innovation. An interlinked system that gives access to comparable and interoperable health data from across the EU would be a real multiplier in terms of research, regulation and evidence generation.

In the coming years, the Commission will build a European health data space and establish interoperable data access infrastructure, which will improve exchange, federated access and cross-border analysis of health data in the EU. This will support better healthcare delivery and health research, policymaking and regulation, while protecting individuals’ fundamental rights, notably their rights to privacy and data protection.

The Commission will propose revising the pharmaceutical legislation to consider how to make the best use of this transformation.

Legislative proposal on a European Health Data Space, enabling better healthcare, health research, innovation and evidence-based decisions – 2021.

· Establish by 2025 interoperable data access infrastructure for the European Health Data Space in order to facilitate secure cross-border analysis of health data; tested in 2021 with a pilot project involving EMA and national authorities – 2021 – 2025.

· Propose revising the pharmaceutical legislation, to adapt to cutting-edge products, scientific developments (e.g. genomics or personalised medicine) and technological transformation (e.g. data analytics and digital tools) and provide tailored incentives for innovation – 2022.

· Enhance dialogue among regulatory and other relevant authorities in the area of drugs and medical devices to increase cooperation on evidence generation within their respective fields – 2021.

· Support collaborative projects bringing together stakeholders to take forward the use of high-performance computing and artificial intelligence in combination with EU health data for pharmaceutical innovation – 2021-2022.

Francesc Arcas Ruscalleda

Links:

Pharmaceutical Strategy for Europe