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European Alliance for Personalised Medicine

EAPM: A packed schedule, with treaty changes and biomarker testing

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Good morning, and welcome one and all to the European Alliance for Personalised Medicine (EAPM) update. The Alliance is set for a packed schedule in the weeks and months ahead, and thankfully it is not just concerning COVID-19. A proposed change to the EU’s health powers is aiming to ensure that the EU can do more, health-wise, during emergencies, and biomarker testing is also high on the EU’s priorities, writes EAPM Executive Director Denis Horgan.

Commission aspires for treaty change on health

The European Commission is hoping for a treaty change so that it has more say on health. "If the moment is right, it will happen," Margaritis Schinas, the vice president of the European Commission has said. This echoes similar sentiments expressed by outgoing German Chancellor Angela Merkel, who said Wednesday (21 April) that the European Union needs more power to coordinate the bloc’s response to health crises like the coronavirus pandemic, and did not rule out a treaty change to secure them. Her comments to an online meeting on the Future of Europe of fellow European conservatives raised eyebrows in Brussels, where the start of a large-scale public debate on the future of the EU has revived talk of reopening the bloc’s governing structure.

And Health Commissioner Stella Kyriakides made a push to look at the EU’s health powers on Thursday (22 April) in the Parliament’s health committee, telling MEPs that the Conference on the Future of Europe is a “unique opportunity” to discuss health competences. When asked about doing this for medicines, Kyriakides said the EU is “ready to work in all areas for this where there is a clear EU added-value”, she said. “But ultimately, this is a decision also in discussion to be having with member states.”

MEP Cristian-Silviu Buşoi, rapporteur for the EU4Health program, said: “The COVID-19 crisis has clearly proven European Union’s need for well-defined and adequately financed policy instruments.”

And Chancellor Merkel added that she is open to making changes to the EU’s founding treaties, particularly in the area of health policy, and urged the bloc to find ways to make its foreign policy more efficient.

Merkel said the World Health Organization had told the EU that it should not only see itself as a single market in economic terms but also when it comes to health policy. “Ideally, we should always have had a uniform European approach to lockdowns, shutdowns and other measures,” she said. “And that’s why I think it’s right that the president of the Commission, Ursula von der Leyen, says we need a health policy that is more strongly coordinated, at least for such supra-regional health hazards — be it at intergovernmental or at European level.

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“If we do not speak with one voice, we will not be able to speak strongly,” Merkel said. “That is not how Europe achieves strength.”

Take-up in health systems needs to match advances in biomarker testing and it should be a priority in the implementation of the EU Beating Cancer Plan

Rapid and continuing advances in biomarker testing are not being matched by take-up in health systems, and this is hampering both patient care and innovation. It also risks costing health systems the opportunity to make their services more efficient and, over time, more economical. The potential that genomics has brought to biomarker testing in diagnosis, prediction and research is being realised, pre-eminently in many cancers, but also in an ever-wider range of conditions. But development is impeded by data deficiencies, and lack of policy alignment on standards, approval and reimbursement.

Europe should already have in place a guarantee of universal access to a minimum suite of biomarker tests, and should be planning for an optimum testing scenario with a wider range of biomarker tests integrated into a more sophisticated health system articulated around personalised medicine. Improving health care and winning advantages for Europe's industrial competitiveness and innovation require an appropriate policy framework – starting with an update to outdated recommendations.

The list of deficiencies and barriers to exploiting the potential of biomarkers is long, but so too is the list of solutions that are already available – or should be.

Many of the issues relating to funding can be solved with only marginal adjustments to healthcare funding. European health authorities should put in place a policy framework to support diagnostics in the EU by 2022, with a ring-fenced budget allowance for biomarker testing development and clinical validation. 

Research on biomarkers discovery and early testing should benefit from policies that promote investment and funding. What is currently missing for innovative diagnostic technologies is a dedicated and specific reimbursement pathway, on the basis of the value of information delivered, implemented consistently across Europe. 

Models of well-evolved HTA mechanisms – if connected to a reimbursement decision - would inspire other countries without relevant structures. In such a system, decision makers, including HTA bodies informed by input from patients, would define evidentiary standards for diagnostics and would commit to pay for products that met them.

Much of this can be achieved by more effective collaboration. The EU should agree by 2023 a business model for public-private cooperation for optimal biomarker testing available across the EU, based on a recognition of the business and value case to provide infrastructure to meet testing requirements. This would make it possible to build the evidence base on biomarker testing, and define how this is accessed.  This is a key focus of work in the next few months. 

Since data collection, data quality, data standards and data interoperability are notoriously deficient in many of Europe’s health and research systems, with frequently incomplete, non-standardised, retrospective, non-accessible and siloed methods, health authorities should provide guidelines on how clinically-relevant biomarkers should be measured and reported. 

Member states should agree on a federated structure  of national databases, and regulatory barriers to data transmission and the transport of human samples should be eased to permit large international multi-centre clinical validation studies of biomarkers (especially early diagnostic and prognostic biomarkers), which require large and long-lasting cohorts.

The EU should establish a framework for quality of testing and value of diagnostics information. Testing data should come from standardised laboratories where samples are collected, transported stabilised and stored under standardised conditions and include sample metadata on the complete preanalytical phase. 

This way the data can be compared and analyzed as it is not polluted with irreproducible and or unusable data for further analysis. This would facilitate centralised and standardised registries of diagnosis including sequence and biomarker data, pre- analytical sample metadata, and treatment and outcome data. It would feed into a fast track approval mechanism for biomarker validation, accompanied by guidance on minimal testing standards and resource allocation. 

Clarity for clinicians on where and when tests should be performed should be provided, within a system capable of allowing for evolving testing needs and permitting new tests to be rapidly made available to patients. In a virtuous feedback loop, the captured testing data would inform service improvement, benchmarking and research.  The clinical infrastructure would turn fit-for-purpose real world data into real world evidence to help close evidence gaps, overcoming the deficiencies of existing datasets, Global or even pan European pan-cancer registry could demonstrate the insights possible from a large data set of high quality and provide valuable learning on what is needed to share data across borders. 

Collaboration also would have to be systemized to provide for the engagement of multiple specialties in shifting testing objectives from risk assessment to informing treatment decisions, with drug and diagnostic developers, clinicians, biologists, biostatisticians and digital technology groups routinely cooperating on studies. Member states should promote engagement between payer organizations, biomarker developers and the wider healthcare stakeholder community, through vertical and horizontal integration, and member states should ensure that new validated biomarker tests are rapidly made available to patients without unrealistic evidentiary burdens being imposed by regulators.

There are opportunities still to be explored – such as providing simpler testing kits for complex conditions, and notably the development of blood biopsy, or the convergence of complex test offerings with predictive protein-, genetic-, epigenetic-based biomarkers or NGS panels, or the development of predictive potential of prognostic tests (effectively as companion diagnostics) with emerging drugs.

Parliament and Council to begin HTA negotiations on Monday

Proposed joint Health Technology Assessment legislation will enter negotiations between the European Parliament and the Council on Monday (26 April), said an EU diplomat today (23 April). 

The proposal seeks to establish EU-level assessments of pharmaceuticals and medical devices. The piece of legislation had been stalled for years in the Council as countries debated how much of their own powers to give up, but the capitals agreed to a proposal in March clearing the way for discussions with the Parliament to begin.

Facebook 'fails to clamp down on COVID-19 misinformation in Europe'

Facebook leaves European users exposed to dangerous conspiracy theories about the pandemic and COVID-19 vaccines with an “America First” policy that fails to clamp down on misinformation in Europe, according to a report by US campaign group Avaaz. The report says that most of the false content posted in French and Italian was not acted on by Facebook moderators and that the social media platform is typically nearly a week slower to flag misleading content posted in languages other than English.

Responding to the report, a Facebook representative said that it did not reflect the company's “aggressive steps to fight harmful COVID-19 misinformation in dozens of languages”. Action taken by Facebook included adding warning labels to some misleading posts, and removing others altogether, it said. But the Avaaz report said 69% of false posts in Italian and 58% of those in French lacked any kind of visible red flag from Facebook. The same was true of 50%of Portuguese content and 33% of that in Spanish, according to the study. By contrast, only 29% of English language posts were similarly unmarked, the report said.

And that is everything for this week from EAPM, stay well, and have an enjoyable, safe weekend, see you next week.

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