Inside EU Health: EMA pilot for 'breakthrough' medical devices; snus; future budget
EMA pilot to fast-track breakthrough medical devices; Snus’s generational impact on asthma and allergies; MEPs adopt position on EU’s long-term budget reinforcing health measures
EMA pilot to fast-track breakthrough medical devices
The European Medicines Agency (EMA) has launched a pilot programme to accelerate the development of “breakthrough” medical devices, where medicines and devices intersect. The initiative will test a dedicated regulatory pathway, giving selected manufacturers early and prioritised access to expert scientific advice from medical device panels.
The first phase targets higher-risk devices that administer or remove medicines from the body. Later phases are expected to expand into additional categories, including in vitro diagnostics.
The pilot aligns with broader reforms proposed by Health Commissioner Olivér Várhelyi, who has stressed that the latest therapies can require dedicated delivery mechanisms that make the medicine and medical device regulation more closely intertwined.
Catherine Feore
Snus’s generational impact on asthma and allergies
“What a boy puts in his mouth at age 14 can affect the health of children he may not have for another 15–20 years.” This is the key finding highlighted by Vivi Schlünssen, Professor and Deputy Head of Research at the Department of Public Health at Aarhus University.
The study examined whether a father’s use of snus -particularly when initiated during puberty - may increase the risk of asthma and allergies in his future children.
"We had already seen this with smoking, but we were surprised to find the same signal from snus. It's an exposure you intuitively think of as more localised - it takes place in the mouth, after all. But our results suggest that it is enough to produce a systemic effect," said Schlünssen.
The study has extra resonance as the EU prepares the groundwork for the revision of the Tobacco Products Directive and the ongoing discussions on the Tobacco Taxation Directive.
Catherine Feore
MEPs adopt position on EU’s long term budget reinforcing health measures
As expected, MEPs supported the Budget Committee's draft report on the future multiannual financial framework for 2028-2034.
The MEPs want to set the budget at 1.27% of EU GNI, but with debt servicing for the NextGenerationEU (NGEU) - created during the pandemic for recovery - kept apart. The Parliament supports ring-fenced funding for the EU4Health programme and increased funding for other areas important for health, especially the Horizon research programme. The report was adopted by 370 votes to 201, with 84 abstentions.
Catherine Feore