Innovation in Genomics Services and a Global Framework to Achieve It – EAPM Presidency Conference on October 27 – Register Now!

Good afternoon and welcome to the first update of the European Alliance for Personalized Medicine (EAPM) after the successful 9th ​​Annual EU Presidency Conference of the EAPM. writes Denis Horgan, CEO of EAPM.

To begin with, the full report of the conference on September 17 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 at the meeting. After each section, recommendations are included, and EAPM will follow up on these recommendations in the coming weeks and months, with the various institutions at the EU and country level.

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It was heard at the conference that as Europe begins to emerge from the pandemic and looks to the future, some of the prospects are good for improving healthcare with a clearer understanding of the value of innovation. The European Health Data Space initiative aims to take full advantage of the potential of data and digitization to improve treatment, healthcare delivery and quality of life outcomes, by enabling health data to flow seamlessly to where necessary: ​​between hospitals within a country, but also between countries.

Genomic data can be invaluable in helping diagnose rare diseases in patients, and large warehouses of anonymous patient data can also be used to help drive disease research using machine learning tools. For patients and clinicians there are more options, long-lasting clinical benefit, reduced exposure to ineffective drugs, and the potential to take advantage of current scientific and technological advances. For the private sector, the potential to address core challenges in more effective drug discovery and development, to reduce attrition rates in drug development, and to reduce associated rising costs that are critical to a more sustainable future and provision of services for health care needs.

And for health systems and payers, greater efficiency through the provision of effective and cost-effective care while avoiding ineffective and redundant interventions is again key to a plus. sustainable and deliverable future system. For institutions and member states, it could mean a more deliberate discussion, taking more into account the input of stakeholders, avoiding repetition and translating decisions into actions …

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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, provided that the process is based on trust between all parties. concerned parties. The most obvious need, given the current level of fragmentation of policy and practice, is, as was often argued throughout the conference, a new degree of coherence.

And this time around, the conference captured the mood of the moment particularly well with its focus on “how to make it happen.” It was generally recognized that the fragmentation that still hampers European healthcare must be replaced by a new degree of coherence.

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

Public consultation in preparation of the review of pharmaceutical legislation

Starting today (September 29), the Commission wants to hear from citizens and stakeholders about the loopholes in the bloc’s drug regulation.

Contributions from all interested parties and interested parties are welcome. This includes, for example, associations representing patients, healthcare professionals, industry, as well as academic bodies. Citizens can also contribute to this consultation. Objective of the consultation These measures refer to: Manufacture, marketing of drugs and related inspections.

Import, export, transit (transshipment) of medicines. Manufacture, commercialization of active substances and related inspections.

For the purposes of this public consultation, which focuses on EU pharmaceutical sector legislation, the Commission has identified three areas of drug regulation where improvements in the regulatory framework could make a real contribution to protection against counterfeiting of medications. The Directorate-General for Enterprise and Industry is consulting all stakeholders and interested parties on key ideas for changing the regulatory framework for medicines.

The EU plans to reform pharmaceutical legislation to address some of the most pressing problems in pharmaceuticals, many of which have been exposed by the coronavirus pandemic. These include drug supply problems, the need for medical treatments where they do not exist, and the diminishing efficacy of antibiotics.

Feedback on plans to update EU pharmaceutical legislation, which has not changed in 20 years, begins with a questionnaire that seeks opinions from across the industry.

“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 facing this sector,” said the Health Commissioner. Stella kyriakides it said in a statement.

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

Kyriakides defends his HERA

Health Commissioner Stella Kyriakides tried to sell HERA, the emergency response agency that bypasses Parliament, to the health committee on Monday (September 27).

The COVID-19 pandemic revealed deep-seated deficiencies in the EU’s ability 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 to get out of the health crisis as a rationale for accelerating the creation of a new EU-wide health body, HERA, by excluding the European Parliament from the legislative process.

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

HERA will not be a qualified EU agency per se, but rather a part of the commission’s internal services, governed by representatives from each member state. However, the European Parliament could only participate in the executive board as an “observer”, a move that has provoked outrage from MEPs demanding more power beyond budget control.

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

“This was never about foreclosure, but about moving quickly so that HERA is up and running immediately,” Health Commissioner Stella Kyriakides told MEPs in the health committee on Monday (September 27).

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

But MEPs rejected this argument, claiming that they have shown during the pandemic how quickly parliament can react to take action in times of crisis.

“We have demonstrated in parliament the ability to produce quick results in the past, and we need that to build for the long term, so why doesn’t the European Parliament have a full seat on the HERA board?”, Socialist. MEP Jytte GutelanI asked for.

Echoing the same message, liberal MEP Véronique Trillet-Lenoir reiterated her “disappointment and frustration” with the proposal. He said reducing parliament to an observer in the new authority was not aligned with “the spirit of unity and cooperation.”

Europe’s cancer plan under scrutiny

The European plan against cancer was widely welcomed Monday by EU countries, from MEPs to national legislators, but several key concerns were repeatedly raised during a meeting organized by the BECA cancer committee. The European Cancer Plan is intended to be supported by actions that span policy areas, from employment, education, social policy and equality, through marketing, agriculture, energy, environment and climate, transport, cohesion policy and taxes. .

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 full range of Commission funding instruments, with a total of € 4 billion earmarked for actions tackling cancer, including the EU4Health program, Horizon Europe and the Digital Europe program.

Additionally, a new ‘Cancer Diagnosis and Treatment for All’ initiative will be launched in late 2021 to help improve access to innovative cancer diagnostics and treatments, and a European Initiative to Understand Cancer (UNCAN.eu) will help to identify those most at risk for common cancers.

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

EU leaders aim for an agreement on technology regulation by next spring

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

The goal of finalizing both bills in the first half of 2022, when France assumes the rotating presidency of the Council, has been articulated previously by MEPs and Commission officials, but the bills were not mentioned during the State of the Presidency of the Commission, Ursula Von der Leyen. Speech by the European Union earlier this month.

The next European Council summit is scheduled for October 21.

Good news to finish: France will double the doses of the COVID vaccine for the poorest countries

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

“We have to go faster, stronger. “France is committed to doubling the number of doses it is administering,” he added. “We will go from 60 million to 120 million doses offered.” That amounted to more than the doses given so far in France, he said.

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

President Joe Biden described the pandemic as a “hands-on crisis” and added that “we need other high-income countries to fulfill their own ambitions.” The European Union has pledged to distribute 500 million doses.

That’s it, have a nice week and the full report of the September 17 conference is available. here.

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