Focus on IVDR for EAPM by engaging with stakeholders



Hello and welcome to the first update from the European Alliance for Personalized Medicine (EAPM) after the successful 9th ​​annual EAPM EU Presidency conference, writes Denis Horgan, executive director of EAPM.

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


The conference learned that as Europe begins to emerge from the pandemic and look to the future, some of the prospects are good for improving healthcare with a better understanding of the value of innovation. . The European Health Data Space initiative aims to make the most of the potential of data and digitization to improve treatment, healthcare and quality of life, by enabling health data to flow seamlessly where it is needed. are necessary: ​​between hospitals in a country, but also between countries.

Genomic data can be invaluable in helping diagnose rare diseases in patients, and massive stocks of anonymized patient data can also be used to help drive disease research using learning tools. Automatique. For patients and physicians, there are more options, lasting clinical benefits, 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 key challenges in the discovery and development of more effective drugs, to reduce attrition rates in drug development, and to reduce the associated rising costs that are critical to a future and more sustainable health care delivery.

And for health systems and payers, improved efficiency through the delivery of efficient and cost-effective care by avoiding ineffective and redundant interventions is again the key to a plus. future sustainable and deliverable system. For institutions and Member States, this could mean a more focused discussion – taking more account of stakeholder contributions, avoiding duplication and translating decisions into action …


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

And on this occasion, the conference particularly captured the mood of the moment by emphasizing “how to get there”. It was generally recognized that the fragmentation which still hampered healthcare in Europe needed to 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 for the overhaul of pharmaceutical legislation

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

Contributions from all stakeholders and interested parties are welcome. This includes, for example, associations representing patients, healthcare professionals, industry, as well as academic bodies. Citizens are also invited to contribute to this consultation. Objective of the consultation These measures concern: The manufacture, placing on the market of medicinal products and the related controls.

Import, export, transit (transhipment) of medicines. Manufacture, placing on the market of active substances and associated controls.

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

The EU plans to revise pharmaceutical legislation to tackle some of the most pressing pharmaceutical issues, many of which have been laid bare by the coronavirus pandemic. These include problems with the supply of drugs, the need for medical treatment where there is none, and the decrease in the effectiveness of antibiotics.

Comments on plans to update EU pharmaceutical legislation, which has remained unchanged for 20 years, begins with a questionnaire soliciting views from across the industry.

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

The public questionnaire is open until December 21, after which the Commission will finalize legislative proposals to adopt 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 not bypassing parliament – to the health committee on Monday, September 27.

The COVID-19 pandemic has exposed deeply rooted weaknesses in the EU’s ability to respond to a health crisis – in large part because its expertise is limited in this area. But the European Commission is now using the sense of urgency to emerge from the health crisis as a justification to speed up 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 purchases and facilitate coordination between Member States.

HERA will not be a competent European agency per se, but rather part of the commission’s internal services, headed by representatives from each member state. The European Parliament, however, could only participate in the board as an “observer” – a move that has sparked outrage from MEPs who are demanding more power beyond budgetary control.

For the commission, the use of this legal formula (formerly known as a Council Regulation) was the only possibility to respond quickly to existing threats posed by the pandemic and other diseases.

“It was never a question of exclusion, but of acting quickly so that HERA could work immediately” Health Commissioner Stella Kyriakides told members of the health committee on Monday (September 27).

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

But MPs rejected this argument, saying they demonstrated during the pandemic how quickly parliament can react to adopt measures in times of crisis.

“We have shown Parliament the ability to deliver quick results in the past, and we need it to build for the long term, so why doesn’t the European Parliament have a full seat on the Council of Europe? administration of HERA? “said the socialist MEP Jytte Guteland asked.

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

The European plan to fight cancer under review

The European cancer plan was widely praised on Monday by EU countries, from MEPs to national lawmakers, but several key concerns were repeatedly pointed out at a meeting hosted by the BECA cancer committee . The European Cancer Plan is intended to be supported by actions covering policy areas ranging from employment, education, social policy and equality, including marketing, agriculture, energy, environment and climate, transport, cohesion policy and taxation.

As mentioned in previous updates, the Cancer Plan is structured around four key areas of action with 10 flagship initiatives and multiple support actions. It will be implemented using all the Commission’s funding instruments, with a total of € 4 billion allocated to actions to fight cancer, in particular under the EU4Health program, Horizon Europe and the Digital Europe program.

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

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

EU leaders aim for tech regulation deal by next spring

The European Council “invites the co-legislators to continue work on the draft laws on digital services and on the law on the digital market with a view to reaching an agreement by spring 2022”, indicates the first draft regulation.

The goal of concluding the two bills in the first half of 2022, when France takes over the rotating presidency of the Council, was formulated earlier by MEPs and Commission officials, but the bills have failed. been mentioned during the State of the State Commission President 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 COVID vaccine doses for the poorest countries

France will double the number of doses of vaccines it will send to the poorest countries to 120 million, promised President Emmanuel Macron on Saturday, September 25, 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 is committed to doubling the number of doses it administers,” he added. “We will go from 60 million to 120 million doses offered.” This was more than the doses administered so far in France, he said.

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

President Joe Biden described the pandemic as a “crisis at all levels”, adding “we need other high income countries to achieve their own ambitions”. The European Union has pledged to distribute 500 million doses.

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



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