EAPM: באמת אַקטיוו זומער פאָרויס פֿאַר אי.יו. געזונט פּאָליטיק

Good afternoon, health colleagues, and welcome to the first European Alliance for Personalised Medicine (EAPM) update of the week, in which we discuss the range of items ahead for the summer months as far as EU health policy is concerned, so it’s a busy time ahead for EAPM, שרייבט EAPM עקסעקוטיווע דירעקטאָר ד"ר דעניס האָרגאַן. 

In-vitro diagnostic expert panel

And it is a busy week for EAPM, with an in-vitro diagnostic expert panel on Thursday (22 July). This deals with legislation that is due to come into force next year on 26 May, 2022 - the question will be how will this legislation have an impact on bringing innovation into health-care systems and being able to diagnose patients earlier? 

At present a significant proportion of predictive testing in Europe to support access to oncology precision medicines is delivered through the use of laboratory developed tests (LDTs), with the following implications under the IVDR, and there will be a new legal requirement for labs to use commercially approved tests (CE-IVD) in place of their current LDTs. If there is no CE-IVD commercial test available, public laboratories may be able to use an LDT, subject to certain provisions in the IVDR. 

The lab will be required to meet all the relevant requirements for safety and performance, whilst carrying out the manufacture under an appropriate quality management system. As a consequence, many laboratories may face additional procurement costs for commercially approved tests and/or the need to improve their safety and performance requirements for any LDT offerings.

All these issues will be discussed in the expert panel this Thursday through various case studies. A policy paper will be the outcome of this meeting so more on this in the months ahead. 

EU Health Union 

אַדווערטייזמאַנט

As discussed in the previous updates, the European Health Union package includes proposals to strengthen the European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC), and a regulation on cross-border health threats. 

Slovenia, who holds the EU Presidency now and its predecessors at the helm of the EU, Portugal and Germany, are working to finalize negotiations on three draft regulations that form the basis of the EU Health Union, Slovenian Health Minister Janez Poklukar has said. 

The desire is to co-ordinate the regulations in trialogue with other EU institutions as soon as possible, the minister added in a statement. The comments came after a high-level conference on implementing innovative solutions for resilient health systems that also featured the health ministers of Portugal and Germany, Marta Temida און דזשענס ספאהן. Spahn said the shared objective of all three countries was to establish a trialogue with the European Parliament and the Commission. 

“We want actual results in practice,” Spahn added. Temida said it was essential that the work done by the German and Portuguese presidencies continues to produce good results and that the transition was smooth. 

She said adoption of the legislative package would mark “a significant milestone in Europe’s preparedness for extraordinary health events”. The Health Union package includes proposals to strengthen the European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC), and a regulation on cross-border health threats.

פאָרשונג און כידעש 

The Commission has adopted its proposal for a Council Recommendation on ‘A Pact for Research and Innovation in Europe' to support the implementation of national European Research Area (ERA) policies.

This is an issue that the EAPM has followed closely. 

The Pact proposal defines shared priority areas for joint action in support of the ERA, sets out the ambition for investments and reforms, and constitutes the basis for a simplified policy coordination and monitoring process at EU and member states' level through an ERA platform where member states can share their reform and investment approaches to enhance exchanges of best practices. Importantly, to ensure an impactful ERA, the Pact foresees the engagement with research and innovation stakeholders. 

A Europe fit for the Digital Age Executive Vice President Margrethe Vestager said: “The pandemic has shown us the importance of uniting research and innovation efforts that swiftly bring results to the market. It has shown us the importance of investment in jointly agreed strategic priorities between Member States and the EU. 

"The Pact for Research and Innovation we propose today, will facilitate better collaboration and join our efforts to tackle research and innovation objectives that matter the most for Europe. And it will allow all of us to learn from each other.” 

נייַע כּללים פֿאַר עפענען דאַטן און רייוס פון אינפֿאָרמאַציע פון ​​עפנטלעך סעקטאָרס אָנהייבן צו צולייגן 

17 July marked the deadline for member states to transpose the revised Directive on open data and reuse of public sector information into national law. The updated rules will stimulate the development of innovative solutions such as mobility apps, increase transparency by opening the access to publicly funded research data, and support new technologies, including artificial intelligence. 

A Europe Fit for the Digital Age יגזעקיאַטיוו וויצע פרעזידענט Margrethe Vestager said: “With our Data Strategy, we are defining a European approach to unlock the benefits of data. The new directive is key to make the vast and valuable pool of resources produced by public bodies available for reuse. Resources that have already been paid by the taxpayer. So the society and the economy can benefit from more transparency in the public sector and innovative products.” 

אינערלעכער מאַרקעט קאָמישאָנער Thierry Breton said: “These rules on open data and reuse of public sector information will enable us to overcome the barriers that prevent the full re-use of public sector data, in particular for SMEs. The total direct economic value of these data is expected to quadruple from €52 billion in 2018 for the EU member states and the UK to €194bn in 2030. Increased business opportunities will benefit all EU citizens thanks to new services.” 

Commission to make HERA proposal on 14 September

The European Commission will present its European Health Emergency Preparedness and Response Authority (HERA) package on 14 September. The COVID-19 pandemic demonstrated the need for co-ordinated EU level action to respond to health emergencies. It revealed gaps in foresight, including demand/supply dimensions, preparedness and response tools. 

A European HERA is a central element for strengthening the European Health Union with better EU preparedness and response to serious cross-border health threats, by enabling rapid availability, access and distribution of needed countermeasures. Last year, the Commission proposed changing the mandates for both the EU’s infectious disease agency and medicines agency, and made a proposal for a regulation on serious cross-border health threats.

Some good news to end: COVID-19 antibodies persist 'at least nine months after infection', study finds 

Antibodies in COVID-19 patients remain high even nine months after infection, according to a landmark study which tested almost the entirety of a small Italian town. The study, published in the journal Nature Communications, focused on the town of Vo which became the centre of the country's coronavirus pandemic in February 2020 when it recorded Italy's first death. 

Now, researchers from the University of Padua and Imperial College London have tested more than 85% of the town's 3,000 residents for antibodies against COVID-19. 

The researchers found that 98.8% of people who had been infected in the first wave of the pandemic were still showing detectable levels of antibodies nine months later, regardless of whether their infection had been symptomatic or not. Residents' antibody levels were tracked using three different "assays", or tests that detected separate kinds of antibodies which respond to different parts of the virus.

That is all from EAPM for now  - make sure you stay safe and well and have an excellent week, see you on Friday.

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