Good afternoon, and welcome to the first European Alliance for Personalised Medicine (EAPM) update after EAPM’s successful 9th annual EU Presidency Conference, writes EAPM Executive Director Denis Horgan. 

To begin, the full report from the 17 September conference is available here.  The conference, EAPM’s ninth annual event during the ESMO Congress, brought together some 160 registered participants.

The report presents the key issues that were addressed in the meeting. After each section, the recommendations are included, and EAPM will be following up on these recommendations in the weeks and months ahead, with the various institutions at the EU and country level. 

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The conference heard that as Europe begins to emerge from the pandemic and look ahead, some of the prospects are good for improved healthcare with a clearer understanding of the value of innovation. The European Health Data Space initiative aims to make the most of the potential of data and digitalisation to improve treatment, healthcare delivery and quality of life outcomes, by allowing health data to flow seamlessly to wherever it’s needed: between hospitals inside a country, but also between countries. 

Genomic data can be invaluable to help diagnose rare diseases in patients, and massive stores of anonymized patient data can also be used to help drive disease research using machine learning tools. For patients and physicians there are more options, durable clinical benefit, reduced exposure to non-effective drugs and potential to leverage current scientific and technological advances. For the private sector, the potential to tackle core challenges in discovering and developing more effective medicines, to reduce rates of attrition in drug development, and to reduce the associated escalating costs which are central to a more sustainable future and delivery for healthcare needs.

And for healthcare systems and payers, improved efficiency through the provision of efficacious and cost-effective care through the avoidance of ineffective and redundant interventions, are again key to a more. sustainable and deliverable future system. For institutions and member states it could mean more purposeful discussion – taking more account of input from stakeholders, avoiding repetition, and translating decisions into action… 

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At the level that matters most to everyone, their own personal interest, a recalibration of policy towards the patient could not only improve health, but restore faith in Europe itself, providing that the process is based on trust among all stakeholders. The most obvious need, given the current level of fragmentation of policy and practice, is – as was frequently argued throughout the conference – for a new degree of coherence.

And on this occasion, the conference caught the mood of the moment particularly aptly with its focus on “how to make it happen”.  There was a general recognition that the fragmentation still hampering Europe’s health-care needed to be replaced with a new degree of coherence.

Once again, the full report from the 17 September conference is available here.

Public consultation in preparation of pharma legislation overhaul

From today (29 September), the Commission wants to hear from citizens and interested parties regarding gaps in the bloc’s medicines regulation.

Contributions from all stakeholders and interested parties are welcome. This includes, for example, associations representing patients, health care professionals, the industry, as well as academic bodies. Citizens are also welcome to contribute to this consultation. Objective of the consultation These measures relate to: Manufacture, placing on the market of medicinal products and related inspections. 

Import, export, transit (transhipment) of medicinal products. Manufacture, placing on the market of active substances and related inspections. 

For the purpose of this public consultation, which concentrates on sectoral pharmaceutical EU-legislation, the Commission has identified three areas of regulation of medicinal products where improvements to the regulatory framework could make a real contribution to protecting against counterfeit medicinal products. The Directorate-General Enterprise and Industry is consulting all stakeholders and interested parties on key ideas for amending the regulatory framework for medicinal products.

The EU plans to overhaul pharmaceutical legislation to tackle some of the most pressing issues in pharmaceuticals — many of which have been laid bare by the coronavirus pandemic. These include drug-supply issues, the need for medical treatments where none exist, and the dwindling efficacy of antibiotics.

Feedback on plans to update the EU’s pharmaceutical legislation, which has not been changed in 20 years, begins with a questionnaire seeking views from across the sector.

“A regulatory framework for pharmaceuticals, which is modernized and fit for purpose, is a key element of a strong European Health Union and crucial to addressing the many challenges this sector is facing,” Health Commissioner Stella Kyriakides said in a statement.

The public questionnaire is open until 21 December, after which the Commission will finalize the legislative proposals with a view to adopting proposed new legislation in the fourth quarter of 2022.

Kyriakides defends her HERA

Health Commissioner Stella Kyriakides tried to sell HERA — the emergency response non agency bypassing the Parliament — to the health committee on Monday (27 September). 

The COVID-19 pandemic exposed deep-rooted weaknesses in the EU’s capacity to act in a health crisis – largely because its competencies are limited in this field. But the European Commission is now using the sense of urgency of exiting the health crisis as the rationale to fast-track the creation of a new EU-wide health body, HERA – excluding the European Parliament from the legislative process. 

The new Health Emergency preparedness and Response Authority (HERA) will research and identify potential cross-border health emergencies, ensure the availability of medicines and treatments by increasing EU procurement, and facilitate coordination among member states. 

HERA will not be a skilled EU agency per se, but rather a part of the commission’s internal services, governed by representatives from each member state. The European Parliament, however, would only be able to take part in the executive board as an ‘observer‘ – a move that has triggered outrage from MEPs who demand more power beyond budgetary control.

For the commission, using this legal formula (formally known as a council regulation) was the only possibility to respond quickly to the existing threats posed by the pandemic and other diseases. 

“This was never about exclusion but about moving quickly for HERA to be operating immediately,” Health Commissioner Stella Kyriakides told MEPs in the health committee on Monday (27 September). 

She also justified the commission’s decision, arguing that making HERA an EU agency would have taken up to three years of inter-institutional discussions. 

But MEPs rejected this argument, claiming that they have demonstrated during the pandemic how fast the parliament can react to adopt measures in times of crisis. 

“We have shown in the parliament the capacity to deliver quick results in the past, and we need that to build for the long term, so why is the European Parliament not given a full seat in the HERA board?,” socialist MEP Jytte Guteland asked. 

Echoing the same message, liberal MEP Véronique Trillet–Lenoir reiterated her “disappointment and frustration” with the proposal. She said that reducing the parliament to an observer at the new authority was not aligned with “the spirit of unity and co-operation”.

Europe’s Beating Cancer Plan under scrutiny 

Europe’s cancer plan was broadly welcomed on Monday by EU countries, from MEPs to national lawmakers, but several key concerns were repeatedly flagged during a meeting hosted by the BECA cancer committee. Europe’s Beating Cancer Plan is intended to be supported by actions spanning across policy areas from employment, education, social policy and equality, through marketing, agriculture, energy, the environment and climate, to transport, cohesion policy, and taxation. 

As discussed in previous updates,  the Cancer Plan is structured around four key action areas with 10 flagship initiatives and multiple supporting actions. It will be implemented using the whole range of Commission funding instruments, with a total of €4 billion being earmarked for actions addressing cancer, including from the EU4Health programme, Horizon Europe and the Digital Europe programme. 

In addition, a new ‘Cancer Diagnostic and Treatment for All’ initiative will be launched by the end of 2021 to help improve access to innovative cancer diagnosis and treatments and a European Initiative to Understand Cancer (UNCAN.eu) will help identify individuals at high risk from common cancers. 

A ‘Better Life for Cancer Patients Initiative’ will also be launched, focusing on follow-up care. 

EU leaders aim for deal on tech regulation by next spring

The European Council “invites the co-legislators to continue work on the Digital Services Act and the Digital Market Act proposals with a view to reaching agreement by spring 2022,” the early draft regulation states.

The goal of wrapping up both bills in the first half of 2022, when France takes over the Council’s rotating presidency, has been articulated earlier by MEPs and Commission officials, but the bills weren’t mentioned during Commission President Ursula Von der Leyen’s State of the European Union address earlier this month.

The next European Council summit is scheduled for October 21.

Good news to finish: France to double COVID vaccine doses for poorer countries 

France will double the number of vaccine doses it will send to poorer countries to 120 million, President Emmanuel Macron pledged on Saturday (25 September), in a video broadcast during the Global Citizen concert in Paris. “The injustice is that in other continents, obviously, vaccination is very late,” he said. 

“We have to go faster, stronger. “France pledges to double the number of doses it is giving,” he added. “We will pass from 60 million to 120 million doses offered.” That amounted to more than the doses so far administered in France, he said. 

On Wednesday, the United States announced that it would be doubling its donation of vaccine doses, bringing its total contribution to 1.1 billion. 

President Joe Biden described the pandemic as an “all-hands-on-deck crisis”, adding “we need other high-income countries to deliver on their own ambitions”. The European Union has committed to distributing 500 million doses.

That is it, have a good week and the the full report from the 17 September conference is available here.