Euro Roundup: Commissioner-designate vows MDR action on orphan, pediatric devices in Q1 2025

The Commissioner-designate for Health and Animal Welfare vowed that we would address “a major bottleneck” created by the Medical Devices Regulation (MDR) in the first quarter of next year if he is confirmed.

Speaking at his confirmation hearing, Olivér Várhelyi received a question about how quickly the new European Commission will try to fix problems with MDR and the In Vitro Diagnostic Regulation (IVDR). The European Parliament has recently pushed the Commission to go faster, calling for officials to publish acts that “address the most pressing challenges and bottlenecks” in the first quarter of 2025.

Várhelyi expressed a willingness to work to the Parliament’s timeline. The Commissioner-designate said there is a problem with the accessibility and availability of pediatric and orphan medical devices.

“We are convinced that we can move ahead with implementing acts, it doesn't require a legislative amendment, and this is going to happen once I'm in office. It would be a priority, and, yes, I can confirm that we can deliver this already in the first quarter of next year,” Várhelyi said.

The measures will aim to “reduce burden(s) and simplify procedures,” Várhelyi added. As the Commission works toward the near-term fixes, officials will advance a broader legislative proposal to solve other problems with MDR and IVDR. Várhelyi said the Commission will consider competitiveness and efficient innovation processes when reviewing the legislation.

The hearing allowed Várhelyi to share more information on the Critical Medicines Act. Várhelyi said the next Commission would propose the law to “address the severe shortages of medicines and medical devices” and reduce dependencies related to critical products and ingredients in his mission letter in September.

Várhelyi said he would propose the Act within the first 100 days as a priority action of this new mandate. The Act is “a key initiative to enhance the availability and European manufacturing of medicines and boost the EU's economic security in health,” he said, adding that it will complement the existing pharmaceutical reforms.

“We should not only create incentives for the pharmaceutical companies to produce these products for us, but also to create a market, a market on the basis of which they can foresee production longer term, meaning that through, for example, joint procurements of member states we can create markets that are also economically interesting and viable for companies to supply,” Várhelyi said.

It is unclear if Várhelyi will be confirmed. A loyal supporter of Hungarian Prime Minister Viktor Orbán, Várhelyi was a controversial pick for the role and politicians grilled him on his stance on abortion and women’s rights at the hearing. Rather than back him, Parliament sent a second round of questions and then deferred a decision.

Hearing Recording

MedTech Europe calls for removal of regulatory barriers to more sustainable healthcare

MedTech Europe has recommended the Commission removes “regulatory, financial, administrative and other barriers to sustainability” to support a patient-centric implementation of the EU Green Deal.

The trade group issued the recommendation in response to the Commission's plan for the sustainable prosperity and competitiveness of Europe. MedTech Europe said it “envisions a future where healthcare systems are environmentally and financially sustainable” but sees barriers including a fragmented regulatory framework, inconsistent definitions and standards, and a lack of harmonized tools and methodologies.

MedTech Europe proposed 10 actions to clear the barriers and ensure the patient-centric implementation of the initiative. The recommendations include a call to remove regulatory barriers in existing legislation.

MedTech Europe cited the rules on electronic instructions for use (e-IFU) as one area where it wants reform. The trade group called for the expansion of the rules to allow e-IFUs for all professional use medical devices two years ago. MedTech Europe’s 10 recommendations also cover the requirements for regulatory reporting.

“Reporting requirements should be streamlined so that they are workable and fit for purpose,” the trade group said. “In particular, ensure that future environmental legislation is consistent with sector-specific regulatory requirements and enhances the sustainability performance of medical technologies both, from a life cycle and care continuum perspective.”

Press Release

MHRA posts guidance on drug advertising and promotion under revised Brexit deal

The Medicines and Healthcare products Regulatory Agency (MHRA) has posted guidance on advertising and promoting medicines authorized in the UK under the revised Brexit rules.

Under the Windsor Framework, which takes effect on 1 January, all medicines in the UK will be licensed by MHRA. Marketing authorization holders will still be able to have a license, granted by MHRA, that only covers Northern Ireland and the agency will retain the right to issue licenses that only cover England, Scotland and Wales in exceptional circumstances.

Most licenses will cover the UK, though, and as such companies will be able to advertise in all four countries. However, MHRA will only allow advertising of medicines with licenses that just cover Northern Ireland or Great Britain in the territory where they are licensed. The guidance also covers the rules on producing promotional materials that will run across Europe.

MHRA Guidance

EMA task force supports use of mpox vaccine in at-risk children below age 12 years

A European Medicines Agency (EMA) task force has ruled Imvanex could be used for the prevention of mpox in children below 12 years of age who are at risk of catching the disease.

Bavarian Nordic won European approval to provide the vaccine, which is known as Jynneos in the US, for use in people aged 12 years and older this year. However, no vaccine is approved in younger children and no clinical data are available in the population. Trials in children aged 2-12 years and below 2 years are scheduled to start but the current mpox outbreak drove EMA to consider the existing evidence.

EMA’s Emergency Task Force (ETF) said “the available surveillance data on the use of Imvanex in children from birth during the 2022-2023 mpox outbreak show a reassuring reactogenicity and safety profile.” The data and other evidence informed ETF’s conclusion about the use of Imvanex in children. National health authorities are responsible for deciding whether to use the vaccine in the patient population.

ETF Statement

EFPIA tracks ‘growing gap’ in R&D investment between Europe, US and China

Investment in pharmaceutical R&D grew more slowly in Europe than in the US and China from 2010 to 2022, according to a report published by EFPIA.

The report, which PwC wrote for EFPIA, found pharma R&D spending grew 4.4% a year in Europe, rising from €27.8 billion ($29.3 billion) in 2010 to €46.2 billion in 2022. R&D spending grew 5.5% a year in the US over the same period. China, a less established pharma R&D market, grew 20.7% a year.

EFPIA said the “growing gap” in R&D investment correlates with a “relative decline” in the number of European new molecular entities (NMEs). In 2023, China overtook Europe as an originator of NMEs, with the regions respectively launching 25 and 17 new substances on the world market for the first time.

Press Release

Euro Roundup: Commissioner-designate vows MDR action on orphan, pediatric devices in Q1 2025

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