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EAPM holds sway over next generation sequencing

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Good morning, health colleagues, and welcome to the European Alliance for Personalised Medicine (EAPM) update. A ground-breaking new oncology report from EAPM greets the new year, writes EAPM Executive Director Dr. Denis Horgan.

Rest in peace, David Sassoli

European Parliament President David Sassoli died overnight at a hospital in Italy, his spokesperson Roberto Cuillo announced. The 65-year-old had been in hospital since 26 December, according to a press statement issued by his office on Monday. The details of his funeral will be announced soon, Cuillo said. We’ll have more details as they emerge here. Our condolences to his loved ones.

Sassoli began his professional career as a newspaper journalist, before moving to television. He was first elected to the European Parliament in 2009 as a member of Italy’s center-left Democratic Party — part of the wider Socialists and Democrats group in the European Parliament.

Next generation sequencing in oncology – EAPM Academic Publication available!

In a ground-breaking report from EAPM, Identifying the Steps Required to Effectively Implement Next-Generation Sequencing in Oncology at a National Level in Europe’, an international group of authors has produced a paper, published in Cancers, that links into EAPM’s work for the implementation of the EU Beating Cancer Plan.

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Next-generation sequencing (NGS) may enable more focused and highly personalized cancer treatment, with the National Comprehensive Cancer Network and European Society for Medical Oncology guidelines now recommending NGS for daily clinical practice for several tumor types. However, NGS implementation, and therefore patient access, varies across Europe; a multi-stakeholder collaboration is needed to establish the conditions required to improve this discrepancy. In that regard, EAPM-led expert panels were set up during the first half of 2021, including key stakeholders from across 10 European countries covering medical, economic, patient, industry, and governmental expertise.

The outcomes of these panels have been described in order to define and explore the necessary conditions for NGS implementation into routine clinical care to enable patient access, identify specific challenges in achieving them, and make short- and long-term recommendations. Europe, and its individual member states, are at a pivotal moment in the evolution of health-care policy, driven in part by a determination to recover from the recent COVID-19 pandemic and to prepare for future crises.

It is also driven by an ever-sharper awareness of the underlying crisis in health care, where demographics and chronic disease are on a collision course with health-care financing, unless there are radical changes to the current approach and better use is made of innovative methods. In this context, the importance of NGS-driven, high-tech screening and diagnostics have been given new prominence by the exigencies of the COVID-19 pandemic; the continually rising burden of cancer in Europe has also lent new significance to technologies that can deliver more selective and effective treatments, with benefits for health budgets as well as for patients. For example, in advanced non-small cell lung cancer, NGS has been shown to have a modest budget impact for payers, with the potential to better enable selection for targeted therapy and clinical trial enrollment. The full report is available here.

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Health policies to watch as France takes helm of EU

As France takes over the rotating Council presidency, the nation that is gripped by soaring COVID-19 cases — and has a big election looming — has an ambitious lineup of health files and events on its books. A legislative proposal governing health care data is pegged to land early in 2022. Digital is a key priority for the French presidency and discussions on a digital package, including the European health data space, are planned for late February. The Commission will set out its plan for how the Health Data Space will be regulated and then the fun and games will begin as countries weigh in. And France wants to explore further possibilities under the EU Health Union and is creating a high-level expert committee to work on ideas - there’s also a movement spurred by the centre-right European People’s Party group, calling for a new EU health committee, extracting health care from the ENVI committee, which also covers the environment and food policy. The committee already separates the two broad topics, so if it gets consensus, this could be a key change early this year. 

Helsinki moves away from mass testing

It’s a move increasingly being considered and debated by experts as Omicron rips through countries — abandoning most contact tracing and dialing back testing. The Finnish capital, Helsinki, said on Monday that contact tracing could no longer control the epidemic and that it had “lost its effectiveness due to delays in testing and contacting.” In addition to stopping contact tracing except in places where there is a risk of severe disease such as health care units, people with mild symptoms are being advised not to take a PCR test. This capacity should be targeted at those most at risk, says the city. Instead, people with mild symptoms should stay home and inform their close contacts. 

Global regulators to mull next-generation COVID-19 vaccines

Drugs regulators from around the world are meeting to debate whether a vaccine tailored to the Omicron variant should be produced next as the highly transmissible coronavirus variant races across the EU and beyond.

The composition of next-generation COVID-19 vaccines will be high on the agenda of the International Coalition of Medicine Regulatory Authorities (ICMRA) at a meeting on Wednesday.

But Europe’s medicines regulator is not yet convinced that an Omicron-targeted vaccine should be developed. That’s because it wants to see more data on how well existing vaccines protect against Omicron, as well as better understand the epidemiological evolution of the current wave, which could have peaked and passed by the time such vaccines are developed.

This data is vital “to define how urgently an adaptive vaccine with a different composition is warranted,” said Marco Cavaleri, head of vaccines strategy at the European Medicines Agency.

Booster limitations

The EMA is meanwhile reviewing booster data in 16- and 17-year-olds with the BioNTech/Pfizer jab, which would expand the existing license which allows boosting from age 18. The companies will also soon file to expand the booster license to 12- to 15-year-olds too, he said.

Second boosters are also an area of uncertainty. “Data have not yet been generated to support this approach,” pointed out Cavaleri.

He said that while an additional booster shot could be considered as part of a contingency plan, repeated vaccinations within short intervals “will not represent a sustainable long-term strategy.”

If you give boosters every four months, “we will end up potentially having a problem with immune response and the immune response may end up not being as good as we would like it to be,” he warned.

He also cautioned there could be fatigue among citizens to get boosted so frequently.

The best approach was to administer boosters with a bigger interval and ideally, in moving to endemicity, countries should be thinking about boosters that coincide with the cold season, much like for influenza. “We need to think about how to transition to this,” he said.

European Parliament reprimanded over US data transfers

Following a complaint by six MEPs, including Patrick Breyer of the Pirate Party, the European Data Protection Supervisor (EDPS) has confirmed that the European Parliament‘s COVID test website violated data protection rules. The EDPS highlights that the use of Google Analytics and the payment provider Stripe (both US companies) violated the European Court of Justice's (CJEU) "Schrems II" ruling on data transfers between the EU and the US. The ruling is one of the first decisions to implement "Schrems II" in practice and could be groundbreaking for many other cases currently being considered by regulators. On behalf of six MEPs, the data protection organisation noyb filed a data protection complaint against the European Parliament in January 2021.

Digital Markets Act negotiators plan for March agreement

Negotiators from the European Parliament and the French presidency of the Council of the EU have earmarked March 29 as a possible date for finalizing talks on the bloc’s draft gatekeeper rules, the Digital Markets Act, according to three EU officials.

Also, in a list of provisional dates seen by POLITICO, which are subject to change, monthly trilogue negotiations have been penciled in, with the first round of talks set for January 11 at the European Parliament.

A second round of talks is due to take place on 15 February in Strasbourg, before a “possible agreement” on 29 March.

“The goal is to work hard and hopefully achieve a deal by the end of March if everything goes well,” one EU official said.

Should they be required, additional negotiations have been slated for early April and early May, both in Strasbourg.

And that is everything from EAPM for now – do stay safe and well, enjoy the rest of the week.

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