EAPM: successful IVDR meeting paves way for future collaborations


Good afternoon healthcare colleagues, and welcome to the second weekly update of the European Alliance for Personalized Medicine (EAPM), in which we discuss the successful meeting on the regulation of in vitro diagnostics ( IVDR) conducted by the EAPM yesterday (July 22), and other health issues, writes EAPM Executive Director Dr Denis Horgan.

RDIV issues raised

Yesterday, the EAPM was pleased to have organized a successful meeting on the regulation of in vitro diagnostics (IVDR), with more than 73 representatives from 15 participating countries as well as the European Medicines Agency (EMA) and representatives of states members.

The IVDR will enter into force on May 26, 2022. There are a number of areas where there is a lack of awareness or clear direction to support implementation at Member State level. The main areas of concern relate to two issues, namely the limited ability of notified bodies to grant CE marking in a timely manner, with a bottleneck arising in the approval of certain IVDs which are likely to be used for selection. patients for use with precision drugs. . The Commission’s Medical Devices Coordination Group (MDCG) working group is examining this issue.

In addition, a significant proportion of predictive testing in Europe to support access to precision medicines in oncology is performed through the use of laboratory-developed tests (LDT), and there will be a new legal requirement for laboratories to ” use commercially approved tests (CE-IVD) in place of their current LDTs. If there is no commercial CE-IVD test available, public laboratories may be able to use an LDT, subject to certain provisions of the IVDR. The laboratory shall meet all relevant safety and performance requirements, while carrying out manufacturing under an appropriate quality management system.

Although healthcare facilities are widely informed of the IVDR, additional guidance for laboratories on compliance with its key provisions would be welcome, in particular on regulatory exemptions granted under Article 5. A group of MDCG work was created very recently to develop such guidance although there is little time for laboratories to prepare for the regulation.

Another key question was whether Member States expected cost impacts due to IVDR (incurred either by moving from LDTs ​​to CE-IVDs or by the need to improve quality processes and their laboratory performance), and whether they have engaged with their health authority or other relevant stakeholders on this issue.

Finally, one of the main outcomes of the meeting was the question of how the Regulation can facilitate some of the solutions proposed by the representatives of the Member States, and a meeting will be organized with the Commission and the Member States at a later date.

Let’s move on to other European health news …

Making Europe fit for the digital age

The EU continues to lag behind China and the United States on investments in key technologies such as artificial intelligence and quantum computing, warned European Commission President Ursula von der Leyen. “Europe is still hitting well below its weight. I think this is due to two main reasons. The first obvious is a lack of investment, ”she said.

While European companies invest heavily in research and development in sectors such as automotive or pharma, “our investment in other areas is still lagging behind the United States and China”, she added. “Artificial intelligence and quantum computing are two good examples of this, and for this reason far too many European tech startups have had to leave the continent to expand. “

Bulgaria creates patient rights body

The Bulgarian Council of Ministers has given the green light to the creation of a new directorate of patients’ rights within the Ministry of Health. The new body will help the Department of Health ensure that patients’ rights are protected and work to create programs and guidelines to improve patient protection. In general, in Bulgaria the rights provided for in the European legislative framework have been regulated.

The rights of a person, including in sickness (when a person is in the position of “patient”) are part of the human rights regulated by the United Nations convention ratified in Bulgaria in 1992.

Citizens of the Republic of Bulgaria have the right to accessible health care and health insurance (art. 52 of the Constitution, art. 33, 35 of the Health Insurance Act (HIA)), an environment and healthy working conditions, guaranteed food quality. and protection against abuse of their personality. Every patient has the right to obtain the best health care in accordance with the law.

Cyber ​​health concerns

Plans to set up an EU Rapid Response Cyber ​​Unit that could respond quickly to attacks such as the recent ransomware hack by Ireland’s Health Service Executive (HSE) have been unveiled. Across Europe, cyber attacks increased by 75% last year, with 756 incidents recorded, including a growing number of attacks on healthcare systems, representing a growing risk to society with critical infrastructure at stake, according to the European Commission. “We have a lot of cyber enemies around us”,

European Commissioner Thierry Breton noted. “The Irish public healthcare system has suffered a pretty powerful ransomware attack. I believe it affected a system with over 80,000 computers, so it was something that was strong enough, strong enough. It could have been a very important plus, if we could have sent dedicated experts very quickly to react even faster, because we know that, of course, the longer you wait, the worse it is.

The HSE expects it to take up to six months to recover from the attack, with many hospital and patient data systems still affected. The cyber attack was part of a growing trend of attacks on critical systems, most notably on the Colonial Pipeline in the United States.

Spain offers to test EU AI regulation

Spain has presented itself to the European Commission as a laboratory to test the law on artificial intelligence – with more than 117 AI ethics initiatives around the world, initiatives to regulate artificial intelligence (IA) have sprung up around the world, led by figures such as Spain, OECD and UNESCO. It’s time to harmonize and consolidate, this week heard a conference on the ethics of AI organized under the auspices of the Slovenian Presidency of the Council of the EU. “We are clearly at a stage of development where many actors are currently contributing to this movement from principles to practice, and we just need to work together in a multi-stakeholder manner to harmonize these approaches,” said David Leslie, of the Ad Hoc Committee of the Council of Europe on Artificial Intelligence (CAHAI).

WTO and WHO call for more vaccines

The World Trade Organization (WTO) and the World Health Organization (WHO) The World Trade Organization (WTO) has mapped critical inputs for the production of COVID-19 vaccines, with the aim of clarifying the chains supply chain for the supply of raw materials and components. Organizations this week released an indicative list of 83 inputs, most of which cover the manufacture of coronavirus vaccines, but also those related to storage, distribution and administration. It covers vaccines produced by AstraZeneca, Janssen, Moderna, and Pfizer-BioNTech, including product details and their likely HS codes upon export. The list was produced jointly with the Asian Development Bank, the OECD and the World Customs Organization, as well as representatives from the pharmaceutical industry, academia and logistics. It is subject to other modifications and improvements based on expert opinion, according to the WTO. The exercise was conducted amid concerns about the rate of vaccine production.

MEPs call for mutual recognition of resuscitators

As Europe prepares to spend a second summer in the shadow of COVID-19, European policymakers are pushing forward an ambitious agenda and preparing to build a more resilient and sustainable European Health Union. To make the most of the hard-learned lessons from the pandemic, policymakers are now joining the call of the heroes of this unprecedented health crisis: the caregivers in intensive care units (resuscitators) who have come under enormous pressure and have been forced to fight back surpassed. constantly to save lives. Pandemics do not stop at our borders and MEPs recognize the need for European solutions to a European problem. In a letter to European Commission President Ursula von der Leyen, MEPs urge intensive care medicine to be recognized as a main pillar of the new European Health Union. According to MEPs, there is a lack of mutual recognition for training in intensive care medicine between many EU countries, which prevents a swift and effective European response in times of pandemic and other cross-border health threats.

Good news in conclusion: EU countries double their vaccine-sharing pledge to 200 million doses

EU countries have pledged to share 200 million doses of coronavirus vaccines to low- and middle-income countries by the end of 2021, doubling a previous commitment.

The Commission also today highlighted its other efforts to increase access to vaccines in Africa in particular, but the EU remains firmly opposed to a waiver of intellectual property rights for coronavirus vaccines.

That’s all EAPM for now – make sure you stay safe and healthy and have a great weekend, see you next week.

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