Good afternoon, health colleagues, and welcome to the European Alliance for Personalised Medicine (EAPM) update – with just three days left, your last chance is here to register for the upcoming EAPM event this Friday, 17 September, ‘The need for change: Defining the health-care ecosystem to determine value’ that will take place during the ESMO Congress, details below, writes EAPM Executive Director Denis Horgan.

Responsibility for policy formation

The event will take place from 8h30–16h CET on Friday; here is the link to register and here is the link to the agenda. 

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The conference will take into account the fact that new discoveries – generated from a deeper understanding of the human genome – is driving a paradigm shift in medicine from a one-size-fits-all approach to one which is personalised and targeted to the individual.

This shift is rapidly progressing in oncology but is slower in other areas. And, while there are many barriers to innovation in clinical practice – including market access, scientific, and/or regulatory challenges – the biggest challenge across the healthcare system is the issues related to early diagnosis, value and data.

The differing ideas about what constitutes ‘value’ in modern medicine is a hot topic for debate in Europe and beyond. 

How do we define it? How do we measure a human life – or quality of life – against the cost of a treatment? Do we judge the individual’s contribution, fiscally and otherwise, to society and weigh it against a price? And what about the moral issues involved in such judgments? And who would want to make them?

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Most of us would find that shocking, unfair and inhumane. Yet it happens in a broad sense.

Unfortunately, with an aging population of 500 million citizens, healthcare in the EU has never been more expensive. People are living longer and will, in most cases, be treated for not just one but several ailments during their lifetime. It’s a dilemma, and it won’t go away.

To understand ‘value’ one must first, of course, understand a treatment, plus any other treatment options, and consider what it (or they) can provide.

Patients, when they understand their options, will have their own views on what constitutes value, depending on their circumstances – “Will I get better? Will I live longer? Will my quality of life improve? What are the side effects?”. `

Payers, not surprisingly, when they weigh, as they do, benefits against cost and other considerations, may take a different approach. 

Meanwhile, manufacturers and innovators must operate within limits of ‘value’ that are as yet unclear. 

There is a solid argument that value should always be defined in respect of the customer, Value in healthcare depends on results and outcomes – vital to the patient –  regardless of the volume of services delivered, yet the value is always going to be seen as relative to cost.

All this will be addressed at our conference.  Here is the link to register and here is the link to the agenda.

Among the many speakers present will be Cristian Busoi MEP, ENVI Committee, European Parliament, Szymon Bielecki, DG CONNECT, European Commission and Stefan Schreck, Adviser for Stakeholders relations in DG SANTE, DG SANTE, European Commission.

On to other news….

Health Emergency Preparedness and Response Authority and the Parliament back in Strasbourg...

The European Health Emergency Preparedness and Response Authority (HERA) is intended to be 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. But, according to Peter Liese, the EPP’s health spokesperson in the European Parliament, it doesn’t matter that HERA won’t be an EU agency, he told reporters on Monday morning (13 September). Establishing a completely new agency takes time, Liese acknowledged. “We need to act fast,” Liese said. The authority will instead be housed within the Commission. 

But an even bigger problem for many MEPs is the fact that they are unlikely to get to debate the proposals before they become law. According to the draft proposals, the Commission is proposing a Council regulation based on Article 122 of the EU treaties. This means the proposal would move through without MEPs’ sign-off. 

“HERA will build on EU funding,” which is taxpayer money, and thus has “EP competence to oversight it!” Green MEP Tilly Metz tweeted. 

MEPs have expressed anger after it emerged the European Parliament may not be consulted on the plans.

The backlash comes after the EU executive downgraded the authority to a “dedicated central structure” housed in the Commission, rather than a standalone EU agency.

Under the draft proposals, the emergency biomedical authority will be created using Article 122 as a legal basis — a provision under EU law that does not involve sign-off by the European Parliament.

That legal basis has been used during the pandemic to send emergency funds to EU countries, as well as for other regulations such as the creation of SURE, a program that provided unemployment assistance.

In its HERA draft proposal, the Commission justified its legal choice to “ensure the supply and the timely availability and accessibility of crisis-relevant medical countermeasures.”

One Commission official noted that HERA will be an internal Commission structure, thus “the Parliament isn’t involved”.

MEPs are not happy: “It is unacceptable that under the pretext of crisis emergency, the @EU_Commission and the @EUCouncil break again the spirit of the Lisbon Treaty and exclude the only democratically elected EU institution from the decision-making process,” French MEP Michèle Rivasi tweeted.

In addition, the results of the Parliament’s plenary vote on the proposals to strengthen the European Centre for Disease Prevention and Control (ECDC) and the regulation on serious cross-border health threats are imminent – MEPs discussed the proposal in the plenary Monday afternoon, with most showing support for the proposals.  

As to whether the ECDC should cover noncommunicable diseases (NCDs) in addition to infectious ones, Health Commissioner Stella Kyriakides is against the idea, arguing it could duplicate work done in the member countries and “it would substantially stretch resources within the agency, therefore weakening its focus rather than strengthening it”.

France wants to curb US access to EU data

France’s top cybersecurity official is pushing Europe to stop US law enforcement from accessing critical data stored within Europe by US cloud companies.

European cybersecurity authorities are developing rules for cloud providers like Amazon, Microsoft, Google and others that would impose tougher cybersecurity rules under a new certification scheme, including on data management.

Under an American law known as the CLOUD Act, US companies are obliged to provide foreign data to U.S. authorities if asked. But if Poupard has his way, new EU rules would prevent critical data from ending up with US authorities.

The rule “would exclude the standard American and Chinese services” from offering services in critical sectors in Europe, said Poupard. “This is not about turning our backs on partners. But it’s about having the courage to say that we don’t want non-European law to apply to these services.”

European governments are trying to grow less dependent on US cloud services as part of their drive toward “strategic autonomy,” the idea that Europe needs to keep control over technology policy, in part due to fears of spying and surveillance from the U.S.

The new cloud cybersecurity rule “will be a real test, a real objective for the political will to achieve strategic autonomy in the digital field,” Poupard said. “If we’re not capable to say this, the notion of European sovereignty doesn’t make sense.”

Poupard’s statements come two weeks before US and EU officials meet to discuss cybersecurity, data privacy and other issues at the first meeting of a newly-formed Trade and Tech Council, in Pittsburgh on 29 September.

At a gathering of digital leaders last week in Tallinn, Estonia, US Secretary of Commerce Gina Raimondo lamented Europe’s increasing tendency to impose laws and efforts to keep EU data from being shipped to the US.

“I hope that we can all agree that requirements to keep data localized in country hurt all of our businesses, all of our economies, and all of our citizens,” Raimondo said, adding that data flows were key for avoiding “very expensive threats and attacks” as well as commercial gains.

Good news to finish: Italy to start administering booster vaccine jabs

Italy will start administering a third shot of Covid-19 vaccines to the most vulnerable parts of its population this month, the country’s health minister said.

“There will be a third dose, we will start as early as September,” Roberto Speranza said on Monday at a press conference in Rome.

Last week Mario Draghi, Italian prime minister, said that his government was considering making COVID-19 vaccines mandatory for all people of eligible age. Italy has already made vaccines compulsory for medical workers.

The country has vaccinated just over 70% of all people aged over 12, and Draghi has said he hopes that will rise to over 80% by the end of September.

And that is all from EAPM – don’t forget, here is the link to register for EAPM’s conference on Friday, and here is the link to the agenda. Stay safe and well, see you soon!