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Alianța Europeană pentru personalizată Medicina

EAPM: Conferința de legătură a președinției „un mare succes”, compromisul HTA convenit și date pe ordinea de zi

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The European Alliance for Personalised Medicine (EAPM) today (2 July) hailed its latest virtual conference “a great success”, attended by 164 delegates, after its Bridging Event held between the outgoing and incoming EU Presidencies took place on 1 July, scrie directorul executiv al EAPM Dr. Denis Horgan. 

On the same day, Portugal was handing over the EU Presidency reins to Slovenia and, as that was taking place, EAPM was hosting the 2nd EAPM Bridging Presidency Conference entitled 'Innovation, Public Trust and Evidence: Generating Alignment to facilitate personalized Innovation in Health Care Systems', which acted as a bridging event between the EU Presidencies of Portugal and Slovenia, with the key areas speakers and delegates discussed being RWE and public trust, beating prostate cancer and lung cancer, health literacy, and securing patient access to advanced molecular diagnostics.

The problem, as ever, for both presidencies is the closely guarded member state competence in health care, which was a hot topic during the conference. Indeed, we’ve seen recent battles in this arena regarding the European Commission’s proposed mandatory aspects of HTA, although a compromise was reached on the last day. More on that below.

What is certainly clear, there is the need for Europe to make sure that it is much better coordinated ahead of the next major pandemic as well as ongoing pandemics such as in cancer.  As Președintele Comisiei Europene, Ursula von der Leyen has previously said, the best investment in the EU’s future is in innovators and researchers as the key to competitiveness.  This holds as true in health care as in any other sector, if not more so, which was a key consensus for the conference. 

A report will be issued next week. 

HTA compromise text 

The compromise text of the agreement between negotiators on the health technology assessment (HTA) regulation is a big symbolic win for Portugal, which was able to close a deal that had escaped the previous six Presidencies that worked on joint HTA — including the Germans who were expected to be the ones to get a deal. Besides Portugal, France and Germany got their biggest ask — namely no binding wording to encroach on national powers over scientific assessments of drugs. 

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EU’s COVID-19 Digital Certificate finally live

The EU's Digital COVID certificate officially came into force from 1 July. By Wednesday evening (30 June), 21 EU nations, out of the total 27, were connected to the system's network and six others were technically ready. Some countries already began using the new health certificate in June. 

According to the European Commission, all member states should now be in a position to issue and accept the pass, except for Ireland which has been delayed by cyber attacks. A gradual implementation period is now in place, with a grace period running until 12 August for countries not ready on 1 July. During this period, other states should accept national documents on condition they contain data required at a European level. 

But the launch comes under the cloud of the Delta variant, which is already prompting EU countries to restrict travel from countries where it is prevalent, such as the UK, Portugal and India. 

European region COVID cases jump 10% 

New COVID cases in the World Health Organization’s (WHO) 53-country European region rose 10% last week after falling for 10 straight weeks, the body has said, warning of a possible new surge before autumn and calling for more monitoring of Euro 2020 matches. Infection numbers continue to fall in many parts of the region, including the EU, but Katy Smallwood, WHO Europe’s senior emergencies manager, said some – such as Russia – were recording their highest daily death tolls of the pandemic. Driven by the more contagious Delta variant, combined with “increased mixing, travel, gatherings, and easing of social restrictions”, infections were rising while vaccination levels in the region were not high enough, the regional director, Hans Kluge, said.

Slovenia’s digital agenda 

As mentioned above, the Slovenian Presidency of the EU Council that started on 1 July will focus on cybersecurity, Artificial Intelligence and Digital Services Package, while the long-pending ePrivacy Regulation is set to take a back seat. Ljubljana sees cybersecurity as a way to enhance the resilience of the EU economy by establishing cybersecurity standards, reporting procedures, and information exchange requirements as part of the revised Directive on Security of Network and Information Systems (NIS II).  

Slovenia also backs the recently published Commission plans for an EU Joint Cyber Unit, which aims to co-ordinate responses at the EU level for large-scale cyberattacks on critical infrastructure.

On Artificial Intelligence, the approach is to “create a high level of trust in human-centric AI”, Public Administration Minister Boštjan Koritnik told reporters. The Slovenian authorities aim to lay the groundwork for a general approach to the Artificial Intelligence Act. The Digital Services and Markets Acts are the other main priorities, as the objective is to broker a common position for EU countries by November. The focus here will be on preventing “the exposure of citizens to increasing risks and harmful consequences online”, Koritnik added. 

The ePrivacy Regulation intends to define the privacy framework for electronic communications, following online communications enjoying the same level of privacy protection as more traditional telecommunications. 

The Commission launched the first draft of the proposal in January 2017, while the European Parliament reached a common position in September the same year. The legislative proposal has been stalled in the Council ever since, as the EU governments held different views on how to reconcile the right to privacy with technical requirements that do not hamper innovation. The council finally agreed on a mandate for the negotiations on February 2021, which passed only for the abstention of Austria and Germany. One of the main points of controversy related to the conditions under which metadata could be processed. Metadata refers to all the information related to electronic communications, such as time, place, and people involved. Another controversial point is under which conditions to allow service providers to access the data stored on consumer equipment, for instance in the form of cookies.

UK gets data flows deal from EU — for now 

The UK’s digital businesses can breathe a sigh of relief today as the European Commission has officially signed off on data adequacy for the (now) third country, post-Brexit. It’s a big deal for UK businesses, as it means the country will be treated by Brussels as having essentially equivalent data protection rules as markets within the bloc, despite no longer being a member itself — enabling personal data to continue to flow freely from the EU to the U.K. and avoiding any new legal barriers. The granting of adequacy status has been all but assured in recent weeks, after European Union member states signed off on a draft adequacy arrangement. 

But the Commission’s adoption of the decision marks the final step in the process — at least for now. It’s notable that the Commission’s PR includes a clear warning that if the U.K. seeks to weaken protections afforded to people’s data under the current regime it “will intervene”. In a statement, Commission Values and Transparency Vice President Věra Jourová said: “The UK has left the EU but today its legal regime of protecting personal data is as it was. Because of this, we are adopting these adequacy decisions today. At the same time, we have listened very carefully to the concerns expressed by the Parliament, the member states and the European Data Protection Board, in particular on the possibility of future divergence from our standards in the UK’s privacy framework.

"We are talking here about a fundamental right of EU citizens that we have a duty to protect. This is why we have significant safeguards and if anything changes on the UK side, we will intervene.” 

That is all from EAPM for now – have an excellent weekend, stay safe and well, and do check in with EAPM next week!

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