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A calm before the storm

8 months ago 33

Editorial word: A calm before the storm

By Giedrė Peseckytė

After an eventful last week, this one has been rather calm. Even the main policy development, which came from the Council – an agreed position on the revision of safety and quality standards of substances of human origin (SoHO) – is promising smooth trialogues as all institutions seem to be taking similar stands.

But the current situation is more of a calm before the storm.

Voices in the Parliament warn about bumpy progress in forming its position on the European Health Data Space (EHDS), which was hoped to be voted on in the first part of November.

Another super file – the pharmaceutical strategy – awaits amendments from the rapporteur for the regulation, Tiemo Wölken (S&D), and the rapporteur for the directive, Pernille Weiss (EPP). They will be tabled to Parliament’s Environment and Health Committee (ENVI) next week.

The file is also shrouded in the mysterious disappearance of a study by the Panel for the Future of Science and Technology (STOA) on improving access to medicines and promoting pharmaceutical innovation.

“The publication of the study is currently postponed, as it is under review at the request of STOA panel members,” the STOA secretariat told Euractiv, even though the study was published on Friday (27 October) with this link [which currently shows error].

Last but not least, the negotiations on the directive on violence against women, which is currently in the trialogue phase, are becoming stagnant regarding the question of rape inclusion.

France and Germany, among other countries, stand against the inclusion of rape, meaning that the upcoming third trialogue might not be as fruitful as wanted.

EU News 

    • EU Council has reached a negotiating position on substances of human origin.
    • EU’s campaign aims to support healthy work environments in the digital age.
    • Bumpy negotiations on violence against women directive.
    • Countries are discussing the extension of the COVID-19 vaccine waiver – again.
    • EU action to address medicine shortages.
  • EU Council has reached a negotiating position on substances of human origin. The Council of the EU approved on Wednesday (25 October) its position on the revision of safety and quality standards of substances of human origin (SoHO), which has been welcomed by patients’ associations and parliamentarians. The Council’s position is in line with Parliament’s position, which was agreed on in September, indicating likely smooth negotiations in trialogues that will start on November 6. The Spanish EU Council Presidency hopes to find a provisional deal before the presidency ends on 31 December.
    More on this from Clara Bauer-Babef here.
  • EU’s campaign aims to support healthy work environments in the digital age. The European Commission, the Spanish presidency of the EU Council, and the European Agency for Safety and Health at Work (EU-OSHA) jointly presented on Wednesday (25 October) the campaign “Safe and Healthy Work in the Digital Age”. European Commissioner for Jobs and Social Rights Nicolas Schmit explained that the campaign will help raise awareness and understanding about these issues, promote risk assessments by employers, and facilitate the exchange of best practices. This initiative comes after the European Commission started its new overarching approach to mental health in June in a Communication calling on the Parliament and Council to take mental wellbeing into consideration across all policies – not only in the health sector.
    Read more from Marta Iraola on this here
  • Bumpy negotiations on violence against women directive. Two trilogues down, reaching a compromise does not appear easy, even though Ignacio Álvarez Peralta, Spain’s secretary of state for social rights, said the negotiations are happening in “a positive environment”. The Parliament’s optimism voiced in the summer that an agreement can be found during the Spanish presidency, which ends on 31 December, is starting to fade. “We were hoping that we might conclude and have a proposal before the end of the year. Right now, it looks like we might need at least some part of the Belgian presidency also, to be able to conclude it,” Evin Incir, Swedish social democrat MEP and co-rapporteur of the file, told Euractiv. The main struggle is to find an agreement regarding the inclusion of rape but this is not the only clash.
    Kjeld Neubert has more on this here.  
  • Countries are discussing the extension of the COVID-19 vaccine waiver – again. On Monday and Tuesday, the World Trade Organisation (WTO) Council on Trade-Related aspects of Intellectual Property Rights (TRIPS) met to discuss whether the waiver should be extended to include COVID-19 diagnostics and treatments, as well as vaccines. It was brought up again after the almost 500-page US International Trade Commission (USITC) report on COVID-19 diagnostics and therapeutics was published on 17 October. The report did not draw any conclusions but touched upon many sensitive issues. It will be clear later this week how countries in the TRIPS Council received the findings.
    Amalie Holmgaard Mersh reports on this here
  • EU action to address medicine shortages. “It is really unthinkable that in the Europe of 2023 and in a health union that we’re trying to build, that all patients don’t have access to the medicines that they need,” Health Commissioner Stella Kyriakides said last week. While it might be “unthinkable”, it was a harsh reality for many Europeans last winter, in the face of a surge of respiratory viruses combined with continued COVID-19 infections, insufficient production capacity, shortages of raw materials, distribution problems, labour disruptions and natural disasters. To prevent the same scenario, the Commission now proposed an “operational response” because the actions set out in the pharmaceutical strategy are unavailable as the file is still going through the Council and Parliament. The proposed response includes elements from the pharmaceutical reform, such as earlier notification of shortages by companies, shortage prevention plans for all medicines, and increased information for sharing medicine shortages at the EU level. The actions include the launch of a European Voluntary Solidarity Mechanism for medicines, a list of critical medicines, regulatory flexibilities and EU guidance on procurement.
    Giedrė Peseckytė reports on the actions here.

The debate over the EU pharmaceutical package is currently in full swing in the Czech Republic, with discussions among lawmakers revealing that the proposed changes to data and marketing protection are raising remarkable concerns. Read more.

Czech government bows to young doctors’ demands to rest after 24-hour shifts. Young doctors in the Czech Republic have challenged the existing system, which forces them to work overtime without adequate pay and rest with the government, after weeks of negotiations, finally bowing to pressure and preparing new legislation. Read more.


German pharma urges for EU-member states coordination in fresh health push.
The problem of medicine shortages in Europe is not a recent concern, but national bodies like the German Health Ministry and European decision-makers are intensifying their legislative output, leaving a question of how much these will work together. Read more.


Personal Doctors without specialty drafted to carry Greek primary health care. Greece plans to abolish the institution of “rural doctors”, utilising young physicians as “personal physicians” to boost the numbers and increase population coverage, but doctors warn about the implications, foreseeing further downgrading of the health services provided to the public. Read more.


Inaccurate data steering Bulgarian children’s health strategy, doctors warn.
Bulgaria’s strategy for children’s health care is based on wrong data on obesity, which means that the state has no way to foresee adequate measures to solve the problem, doctors have signalled to Euractiv. Read more.


Experts call for revamp of pharma policies to ensure drug security
. Healthcare experts in Poland have issued recommendations to the government calling for specific measures to both increase drug security and give domestic production a boost. Read more.


Ireland’s medical technology drives country’s competitive advantage.
Global healthcare technology giant Medtronic plc, headquartered in Dublin, Ireland, is discussing with development agency IDA Ireland to expand the company’s presence in the country, citing the country’s strategic focus on research and manufacturing. Read more.


Amsterdam start-up receives funding to develop revolutionary type 1 diabetes treatment.
Advanced Microbiome Interventions (AMI) start-up has received funding to help it research whether the key to helping type 1 diabetes patients avoid regular insulin shots lies within the body’s microorganisms. Read more.

[Edited by Zoran Radosavljevic]

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