Council wrapping up the 2023 health agenda

Editorial word: Council wrapping up the 2023 health agenda

By Marta Iraola

Last Thursday, EU health ministers celebrated their last Council of the year. New Spanish Health Minister Mónica García chaired her first and last meeting under the Spanish EU Council presidency, an encounter where lawmakers reviewed the current legislative files and passed the baton to the Belgian presidency, which takes over in January. 

The agenda of this last meeting was full of critical issues to discuss – all packed in a one-day meeting – that ranged from the medical evacuation of wounded citizens from Gaza to the effects of long COVID. 

EU health ministers talked about the ongoing negotiations on the international pandemic treaty. The Commission informed them on the latest text by the World Health Assembly, where they still see concerns on some aspects such as prevention and preparedness. Despite the slow negotiations, the current deadline for an agreement is still set for May 2024.

Climate change also had a place in the Council, as health lawmakers called for concrete actions to address the public health effects that already impact health systems across Europe. 

There was also time to report on the 2023-2027 implementation roadmap of the  1+Million Genomes project by the Estonian delegation. This initiative aims to make personal genomic datasets accessible in a secure manner for collective diagnostic purposes and prevention as well as research and innovation. 

In the meantime, France raised the issue of hampering the implementation of medical devices and in vitro diagnostic medical device regulations, sounding the alarm over unavoidable shortages if the transitional periods are not extended.

Finally, the Spanish presidency updated health ministers on the current state of the main legislative files. 

Some of them, like the European Medicines Agency fees regulation and the regulation on substances of human origin (SoHO), are expected to be adopted by the end of the year. 

García said the next trilogue with Parliament and Commission on SoHO will be on 14 December, stating that she was optimistic about reaching an agreement then. 

Other files like the European Health Data Space are still being discussed inside the Council without a formal position agreed on. García said she expects to hold the first trilogue in December, with the idea of finishing before the next European elections next June. 

Finally, the new proposal for pharmaceutical legislation presented in April by the European Commission will most likely be passed to the next mandate as the conversations are still in the early stages. 

The baton will be passed to Belgians, who will chair the Council from January and will see the end of the current European legislative mandate before a new Parliament and Commission are in place.

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EU News

• • EU health ministers seek coordinated approach to climate change health threats
  • No sign of EPP at the presentation of the pharma access and innovation study
  • Upcoming Belgian presidency encourages head start on tackling medicine shortages
  • The European Commission adopted the 2024 EU4Health Work Programm
    
  • Implementing regulations on medical devices and in vitro diagnostic medical devices is failing. 
• EU health ministers seek coordinated approach to climate change health threats. EU health ministers called during the EU Health Council on Thursday (30 November) for specific bloc-wide measures to address climate threats that are already impacting European healthcare systems. Responding to major consequences of climate change that can be seen across Europe such as heatwaves, wildfires, rising sea levels and increased presence of mosquito-borne diseases EU ministers stressed the need to look at surveillance and preparedness for new cross-border threats and to focus on preparedness and medical countermeasure. “It is important for the EU to be prepared through overall coordination and exchange of best practices to take on these challenges, which are not challenges for the future. There are challenges of the present,” said Spanish health minister Mónica García.
  Marta Iraola has more on this here.
• No sign of EPP at presentation of pharma access and innovation study. No members of the conservative EPP party were in the room when the authors of the study “Improving public access to medicines and promoting pharmaceutical innovation” from the Panel for the Future of Science and Technology (STOA) presented it to lawmakers on the European Parliament’s environment and public health committee (ENVI) on Monday. The absence was noticeable, as the circumstances around the publishing, subsequent withdrawal, and re-publishing of the study have been highly criticised and remain untransparent, which has raised suspicion around the involvement of two EPP MEPs – STOA chair Christian Ehler and pharma revision rapporteur Pernille Weiss – as well as the major pharmaceutical lobby, the European Federation of Pharmaceutical Industries and Associations (EFPIA).
  The STOA study feeds into some of the most fierce debates about the revision of the EU pharmaceutical legislation and is largely unfavourable to the pharmaceutical industry’s arguments.
  Watch the presentation in ENVI here. You can also read the study here or catch up on the controversy here.
• Upcoming Belgian presidency encourages head start on tackling medicine shortages. Despite the short- and long-term initiatives already in the pipeline, health ministers are eager to further expedite action on medicines shortages across the continent following last winter’s critical increase. One of the key tasks for Belgium ahead of its EU Council presidency starting 1 January is to address medicine shortages – through the proposed EU pharmaceutical legislation – as soon as possible, Belgian Health Minister Frank Vandenbroucke told the EPSCO Council on Thursday (30 November). He wants to do this by cracking open the negotiations with Chapter 10 of the revision’s proposed regulation.
  In October, the European Commission published a communication with a set of actions aiming to prevent and mitigate critical medicine shortages. While health ministers generally supported the Commission’s initiatives, the vast majority argued for further action.
  Amalie Holmgaard Mersh has more.
• The European Commission adopted the 2024 EU4Health Work Programme. The work programme was adopted on Tuesday and has a total budget of €752.4 million. It will support a wide range of policy initiatives such as strengthening the EU’s preparedness for crises, the roll-out of digital intiatives, the implementation of the EU pharmaceutical strategy. The programme will also provide operating grants of €9 million in 2024.
  Read more in the Commission decision here.
• Implementation of two regulations on medical devices and in vitro diagnostic medical devices is failing, despite the tweaks made earlier this year, posing shortage risks on one hand and outdated certification rules on the other. “We do have a problem six years after the publication of the regulations and years after the transitional measures. It’s really not working,” Manuel Pizarro, Portuguese health minister, told his European colleagues who gathered in Brussels on Thursday (30 November) for the Health (EPSCO) Council meeting. Supported by the Austrian, Belgian, Czech, Finnish, German, Irish, Italian, Luxembourgish, and Dutch ministers, France submitted an information note to the Council that raises concerns about supply disruptions and the disappearance from the European market of medical devices and IVD medical devices.  The submitted note said that issues were due to “on the one hand, the system’s ramp-up and the requirements and timeframes necessary to designate NBs within this new framework and, on the other hand, to a lack of foresight on the part of some manufacturers”. Health Commissioner Stella Kyriakides, present at EPSCO, shared the shortage concerns and asked to look for solutions together.
  Giedre Peseckyte reports on this here.

News from the Capitals

WARSAW
New registered HIV infections in Poland reach record high. Poland has seen an increase in HIV infections during 2023, as revealed by the latest data from the National Institute of Public Health – National Research Institute. Read more.

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BRUSSELS
Pharma boss: EU’s open strategic autonomy needs a European health security act. A comprehensive strategy to build a European health security framework with a broad perspective for action should be at the heart of any efforts regarding EU’s Open Strategic Autonomy from the view of health, Olivier Charmeil, executive vice president of General Medicines of Sanofi told Euractiv in an interview. Read more.

Belgium: Six hospitals collaborate on ‘extra layer of care’ for young cancer patients. A network comprised of six hospitals located across Belgium is aiming to carry out age-specific care dedicated to adolescents and young adults (AYAs) diagnosed with cancer, that is young adults between the ages of 16 and 35 years. Read more.

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THE HAGUE
Dutch survey finds redispensing cancer pills can save millions. Re-issuing a cancer patient’s unused medication to a fellow patient can save up to €50 million annually in the Netherlands, a study conducted at four Dutch hospitals and published in JAMA Oncology has found. However, the EU-wide Falsified Medicines Directive is preventing a wider roll-out of this environment- and cost-friendly programme. Read more.

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PRAGUE
Czechia initiates prostate cancer screening programme. Czechia will launch a new prostate cancer screening program in January 2024 to ensure early detection and treatment of the disease. Read more.

Czech MPs approve law to tackle drug shortages, pharma industry unconvinced. Czech Parliament has approved a law amendment setting out new obligations for suppliers and distributors of medicines, pharmacies and state authorities in what the Health Ministry hopes will tackle medicine shortages, but the pharmaceutical sector is unconvinced. Read more.

[Edited by Zoran Radosavljevic]

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