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What’s to come on health for the Spanish EU presidency

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An editorial word: What’s to come on health for the Spanish EU presidency

By Amalie Holmgaard Mersh

With just over two months left of the Spanish EU Council presidency, Spanish health minister, José Manuel Miñones Conde, visited the members of the European Parliament’s Environment, Public Health and Food Safety (ENVI) committee on Monday (23 October) for the first time – better late than never.

Miñones did, however, bring some updates to the table about what to expect on health until the end of the year. 

Firstly, that the Council expects to give its final go-ahead to the recent trilogue deal on the European Medicines Agency (EMA) fees in December. The ENVI members voted in favour of the deal on Tuesday (24 October), leaving only the final vote in plenary. 

While the agreement on the EMA fees was reached after two trilogues and without any major drama, the European Health Data Space poses a different challenge. Miñones was optimistic that there would be a Council mandate within the Spanish presidency and even floated the possibility of potentially initiating trilogues before the end of the year as the ENVI-LIBE joint Parliament committee is planned to vote on their mandate on 9 November.

Miñones also said that there would hopefully be a Council mandate on the Substances of Human Origin (SoHO) file during the Coreper meeting Wednesday (25 October), paving the way for the trilogues to begin on 6 November as the Parliament agreed on their mandate in September.

The last major legislative file is the overwhelmingly complex reform of the EU’s pharmaceutical legislation. However, since the translations of the Commission’s proposal from April were not available until the end of September, Miñones said that “all our delegations are poring over them in order to move forward”.

In the non-legislative corner, three key priorities for the presidency were brought up, namely: mental health, the negotiations among World Health Organisation (WHO) members on amending the International Health Regulations and a Pandemic Accord, and the meeting in Panama in November about the WHO Framework Convention on Tobacco Control (WHO FCTC).

On mental health, he reassured the committee that the Council will adopt conclusions during the meeting on 30 November. 

He did not mention the still-missing Council conclusions on the EU Global Health Strategy following the Commission’s proposal almost a year ago.

Another thing he did not mention was medicine shortages, to the dismay of many MEPs who expressed their disappointment about this not being top of the list of priorities. 

While Miñones mentioned Tuesday’s announcement from the Commission of a “set of actions to better prevent and mitigate critical medicine shortages in the EU”, he did not go any further into action from the Council’s side of things.

Shortages are very much top of mind for both citizens and lawmakers. Late Monday (23 October) EMA chief Emer Cooke updated the ENVI members on this (and other) matters and on Wednesday (25 October), members of the public health sub-committee (SANT) will hold a hearing on the supply of critical medicines.

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The Commission adopted a set of actions to address critical medicine shortages in the EU.
The health committee (ENVI) approved the final agreement on EMA’s fees.
Final political accords to ensure better protection from asbestos. 
Negotiations for a WHO pandemic treaty come closer.
Commission’s official criticised EU countries for patching up healthcare gaps through migration.

The Commission adopted a set of actions to address critical medicine shortages in the EU. On Tuesday (24 October) the Commission published a Communication set to prevent and mitigate critical medicine shortages at the EU level. The actions include the launch of a European Voluntary Solidarity Mechanism for medicines, a list of critical medicines to be available by the end of 2023, regulatory flexibilities and EU guidance on procurement. Additionally,  the Commission intends to set up a Critical Medicines Alliance to be operational in early 2024 to mitigate risks of shortages. It is hoped that the pharmaceutical strategy, currently in the hands of the Parliament and the Council, will further address the issue. On the same day, EMA published details of the newly created solidarity mechanism for member states to support each other in the face of a critical medicine shortage.
The health committee (ENVI) approved the final agreement on EMA’s fees. On Tuesday (24 October) the Environment and Health Committee (ENVI) gave the green light with a large majority to the final agreement on the regulation of the European Medicines Agency (EMA)’s fee system, paving the way for the endorsement in the plenary. “The new regulation is a way to establish a predictable and cost-based financing system for the EMA that is at the same time flexible and agile”, the parliament’s rapporteur on the file, Romanian Cristian-Silviu Bușoi (EPP) told Euractiv after the vote. “We aim to ensure the fee system is adaptable for the future by safeguarding regulatory flexibility,” Bușoi added. Clara Bauer-Babef has more on this here.
Final political accords to ensure better protection from asbestos. The EU Council on Monday (23 October) formally adopted the directive to step up the protection of workers from health risks related to asbestos, the final stage in the legislative process for the file. The new directive, which both steps up protections and improves the early detection of asbestos fibres based on newly available technologies, will enter into force 20 days after its publication in the Official Journal of the European Union. Member states will have two years to incorporate all provisions of the directive into their national legislation, except for the introduction of electron microscopy as a measuring method, for which they will have six years. Giedrė Peseckytė has more on this here.
Negotiations for a WHO pandemic treaty come closer. A proposal for a negotiating text for a pandemic treaty was circulated to World Health Organisation (WHO) member states and non-state actors on Monday (16 October). The text will not be publicly available until 30 October, but was seen by Euractiv. The 194 WHO member states will vote to accept or reject the proposal at the next Intergovernmental Negotiating Body (INB) meetings on 6-10 November and 4-6 December. If they approve the draft, negotiations can finally begin. The text includes highly controversial topics like intellectual property (IP) and access and benefit sharing. Amalie Holmgaard Mersh writes about this here.
Commission official criticised EU countries for patching up healthcare gaps through migration. Francisco Perez-Canado from the Commission’s Directorate General for Health told German lawmakers during a hearing this week that Europe cannot simply lure skilled workers away from their countries of origin en masse. For him, drawing staff away from low- and middle-income countries struggling to build up their own healthcare workforce is at odds with the EU’s ambition to play a bigger role on the global stage, set out in the Commission’s Global Health Strategy. Julia Dahm has more on this here.

[Edited by Nathalie Weatherald]

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