Euro Roundup: Kyriakides defends EHDS but warns €1B budget cut will force ‘difficult’ decisions

The European Commissioner for Health and Food Safety has reaffirmed her commitment to the planned data space in the face of a 1 billion euro ($1.1 billion) budget cut that she warned will force “difficult political decisions” in other areas.

With the European Union seeking to free up cash to support Ukraine, leaders recently decided to move money allocated to a range of programs under the 2021 to 2027 budget. The 5.3 billion euro EU4Health program is one of the areas affected. Stella Kyriakides, the EU health commissioner, publicly addressed the impact of the roughly 20% budget cut for the first time this week at a meeting of the European Parliament’s health committee.

Kyriakides told the meeting that “we are going to be soon faced with difficult political decisions” related to EU4Health, a program that the EU adopted in response to the COVID-19 pandemic. The goals of the program include complementing national stockpiling of essential crisis-relevant products and reinforcing health data, digital tools and services.

The budget for 2024 is unaffected by the cuts and the work program will continue as planned. Beyond that, “the Commission will operationalize the budget cut over the remaining period of the [2021 to 2027 budget] in the best possible way to limit its impact,” Kyriakides said. The Commission is still working on what that will mean in practice.

“It's going to be premature to quantify the exact effects of this budget cut across the different strands of work,” Kyriakides said. “We need to be very meticulous. We need to prioritize initiatives that address immediate health concerns. But we also need to, at the same time, make sure that we're laying down the groundwork for the future ... [and] building up on the resilience that we have started.”

Facing questions from politicians, Kyriakides clarified a few details, confirming that the European Health Data Space (EHDS) “is an obligation that we will be upholding.” The Commissioner made the comment the day before pharma trade group EFPIA put out another statement about EHDS.

In the statement, EFPIA said it believes in “the undeniable value of creating a common European space to share and access health data” but does not want the initiative to be pursued “at any cost.” Negotiators from the three main bodies of the EU were unable to reach an agreement at a meeting on 7 March, a development that EFPIA sees as evidence of areas where there is little to no consensus.

Electoral timelines could put pressure on policymakers to close the gaps between their positions quickly, but EFPIA has warned against letting those forces interfere with the ambition to create an EHDS that meets the original objectives and supports the competitiveness of EU research.

EHDS was one of several initiatives that politicians pushed Kyriakides to comment on at the meeting. The politicians also questioned the future of efforts to tackle drug shortages, drawing the following response from the Commissioner.

“We are going to be launching the Critical Medicines Alliance at the next EPSCO in April. There is a strong political commitment to the critical medicines, and this includes the Alliance. There are several actions which are foreseen for 2024 for the shortages. These are not impacted in any way and we will see how we will be able to move forward in the future,” Kyriakides said.

Debate Recording, EFPIA Statement

MDCG shares guidance on content of medical device clinical investigation plans

The Medical Device Coordination Group (MDCG) has released guidance on the content of clinical investigation plans (CIPs) for studies of medical devices.

Under the EU Medical Device Regulation (MDR), clinical investigations “shall be performed on the basis of an appropriate plan of investigation reflecting the latest scientific and technical knowledge,” MDCG wrote in the guidance. MDR describes the content that sponsors are legally required to include in their CIPs, which are documents that set out the rationale, objectives and other aspects of the study.

The MDCG guidance describes the information that companies should include in their CIPs and provides a clinical investigation plan synopsis template. Referring to the requirements set out in MDR, the coordination group explains the information sponsors should provide about their investigational devices, the benefits and risks, the objectives and design of the study, and the statistical analysis.

MDCG primarily focuses on devices but includes some details about combination studies. When a drug and device are involved, additional details such as the name and description of the investigational medicinal product may be needed. Responsibilities and qualifications “need to be clearly described for the various investigators involved” in combination studies, MDCG wrote.

MDCG Guidance

EMA finds insufficient evidence of causal link between COVID-19 vaccines and postmenopausal bleeding

The European Medicines Agency’s (EMA) safety committee has found insufficient evidence to establish a causal association between the COVID-19 vaccines Comirnaty and Spikevax and cases of postmenopausal bleeding.

Women who have vaginal bleeding one year or more after their last menstrual period are classed as having postmenopausal bleeding. Such bleeding is always considered abnormal and can be a sign of a serious medical condition. Reports in the medical literature and post-authorization data led EMA to look if there is a link between the mRNA vaccines Comirnaty and Spikevax and postmenopausal bleeding.

EMA’s Pharmacovigilance Risk Assessment Committee concluded that “the available data do not support a causal association and an update of the product information for either vaccine is not warranted.” The conclusion is based on an assessment of findings from literature, postmarketing spontaneous reports of suspected adverse reactions and other sources of data.

The committee will continue to monitor for cases of postmenopausal bleeding in recipients of the two vaccines.

Meeting Highlights

European Commission adopts harmonized standards for medical device sterilization

The European Commission has adopted implementing decisions on harmonized standards for sterilized medical devices.

Under the EU medical device and in vitro diagnostic (IVDs) regulations, products that conform to harmonized standards are presumed to meet the relevant regulatory requirements. The Commission asked other EU bodies to draft new harmonized standards to support the regulations, resulting in documents about the sterilization of a range of medical devices and diagnostics.

Officials have ruled that the proposed standards satisfy the requirements, leading the Commission to create two implementing decisions. One decision adds three standards related to sterilization to an annex of an existing document about IVDs. The other document adds the sterilization standards, plus other texts about medical gloves and more, to the annex of an existing decision on medical devices.

Implementing Decision, More

Other News:

The European Commission has shared updated data from its notified body surveys, showing that the number of certificates issued under the device and diagnostic regulations increased by 43% and 40%, respectively, from June to October 2023. Despite the progress, most notified bodies said their clients are still part way through the transition to the new regulations. Survey Report

European Free Trade Association (EFTA) countries have formed an agreement with India. The medical technology trade group in Switzerland, which is part of EFTA, welcomed the free trade deal. India will abolish customs duties, which are currently 11% to 13.75%, for “a substantial proportion of medtech products” within 10 years or halve the rates within five years. Press Release, More

Euro Roundup: Kyriakides defends EHDS but warns €1B budget cut will force ‘difficult’ decisions

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