Inside EU Health: Rare diseases; UK COVID inquiry; PRIME improves; UK meningitis outbreak

Casares says people suffering from rare diseases ‘deserve hope’

MEP Nicolas Casares (S&D, Spain), presented his own initiative opinion for an EU action plan on rare diseases to the European Parliament’s public health committee.

Rare diseases affect more than 30 million Europeans, yet care, diagnosis and research remain uneven across member states. Casares argued the core problem is not only scientific gaps but systemic disorganisation, calling for a “structured framework” and a “technical European ecosystem” to coordinate national efforts.

Casares stressed the need for cross-border tools and interoperable data systems. The report calls for a strengthened, structurally reinforced legal basis for the European Reference Networks (ERNs), as well as sustainable financing.

Lawmakers across political groups broadly backed the initiative, highlighting persistent inequalities in access to care and the need for increased funding and research incentives. Several supported moving towards binding EU legislation rather than a loose directive.

MEP Billy Kelleher (Renew, Ireland) said the current situation, in which national competent authorities oversee rare diseases, results in a disparate, fragmented, and disjointed ecosystem.

Closing the debate, Casares urged colleagues to back a European regulation on rare diseases, “There are 30 million people living with rare diseases across Europe, they deserve hope.”

UK COVID-19 Inquiry says healthcare system was close to collapse

The UK’s healthcare system came close to collapse during the COVID-19 pandemic, according to the latest report from the UK COVID-19 inquiry led by Baroness Hallett. Hallett said that collapse was only narrowly avoided thanks to the extraordinary efforts of all those working in healthcare across the United Kingdom. She said that when the pandemic arrived, “our healthcare systems were already overstretched and understaffed. This fragility had profound consequences when the numbers of people seeking treatment for COVID-19 started to increase dramatically.”

The report describes how healthcare workers were obliged to work under intolerable pressure for months on end, which had a “significant and long-lasting impact on their mental health and well-being”. One of the ten recommendations from the inquiry is to provide greater support for healthcare workers.

It is also critical of early infection control guidance, which failed to fully account for airborne transmission of the virus. The inquiry recommends that, in future, public health guidance should assume all plausible routes of transmission until evidence allows them to be ruled out.

Beyond COVID-19 itself, the report examines the broader consequences for patients with other conditions. Confusing government messaging - particularly the ‘Stay at Home' directive - discouraged many people from seeking urgent medical care. As a result, serious conditions such as heart attacks and strokes often went untreated or were treated too late, leading to worse outcomes.

Overall, the report offers a sobering assessment of how bad the situation was. The Inquiry’s ten recommendations aim to ensure the UK’s healthcare system is better prepared for future pandemics.

EMA upgrades PRIME with three tools to support developers

The European Medicines Agency PRIME scheme aims to accelerate the development and availability of medicines that address unmet medical needs. By providing early and enhanced regulatory support.

After a two-year pilot of additional tools to support scientific dialogue, give developers faster answers and provide better support for the submission of marketing authorisation, EMA has decided to integrate these tools as standard practice.

"Over the ten years since its launch, PRIME has continued to evolve to keep pace with scientific innovation and accelerate the development and assessment of innovative medicines,” said Head of Scientific Evidence Generation at EMA, Michael Berntgen. “The new features we are now rolling out following the pilot enhance our ability to identify and address critical issues early in the development process through continuous scientific dialogue with the developer."

EMA surveyed the contact points for the PRIME scheme between 2023 and 2025, including academic, SME and non-SME industry developers. The three news tools are:

A regulatory roadmap and product development tracker, which helps chart a medicine’s progress and flag potential issues early, making it easier for developers and EMA to stay aligned throughout development.

Expedited scientific advice is a fast‑track route for developers to receive timely, focused regulatory input on questions critical to the development process.

A submission readiness meeting as a dedicated check-in, about a year before submission, where EMA and developers discuss the progress of the programme against the plan and identify any remaining evidence gaps to ensure that a comprehensive data package is available for a thorough evaluation by the Committee for Medicines for Human Use (CHMP).

ECDC: MenB outbreak in UK poses low risk to EU/EEA

The European Centre for Disease Prevention and Control (ECDC) has assessed the risk to the general population from the recent outbreak of invasive meningococcal disease (IMD type B) as low, outside the cluster linked to the outbreak.

Since 13 March, 20 cases have been reported in Kent, including two fatalities. Investigations by UK authorities suggest that some individuals may have been exposed at the ‘Club Chemistry’ nightclub in Canterbury between 5 - 7 March. One case has been reported in France, it is thought to be connected to the club.

In 2023, EU/EEA countries reported 1,895 cases of IMD, including 200 deaths. In 2024, reported cases increased to 2,263, with 202 fatalities. Serogroup B (MenB) accounted for the majority of infections 57% in 2023 and 55% in 2024.

Vaccination programmes across the EU/EEA primarily target infants and adolescents, with vaccines available for several meningococcal serogroups, including B. However, vaccination may also be recommended for other age groups, particularly in specific risk situations or as catch-up immunisation. The EU agency says that updates will be provided if the risk level changes.