From mental health to medical devices: a lookahead into 2023

Since the COVID pandemic, the European Commission has presented a steady stream of health files to answer the many health issues in the EU and globally, work that is expected to continue in 2023.

2022 was pretty generous in terms of the EU’s health policy, particularly regarding the European health union puzzle pieces which finally came into place.

This important framework covers severe, cross-border health threats, provides new skins for the European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA), and extra powers to the European Health Emergency Preparedness and Response Authority (HERA)

In the annual State of the European Union (SOTEU) speech last September, European Commission President Ursula von der Leyen also announced “a new health preparedness and resilience mission for the whole of the European Union”, which will be backed up by a ‘Team Europe’ investment of €50 billion by 2027.

But not all is perfect with healthcare systems, as it was pointed out in WHO’s report, which found that medical staff are ageing and exhausted and suggested that without immediate action, health and care workforce gaps in Europe could spell disaster.

Meanwhile, more voices advocate addressing health burdens together, eventually asking for treaty change – which is easier said than done, especially when even getting health ministers to meet in Brussels is challenging.

And things are not getting any more accessible with the ongoing COVID pandemic, unexpected monkeypox outbreaks and increasing threat of anti-microbial resistance (AMR).  

With 2022 behind us, it is time to see what awaits in the 2023 pipeline.

Mental health strategy

Mental health issues have increased in prevalence across Europe for many years, but this accelerated during the COVID-19 pandemic.

The Commission is expected to address this topic next year, with a mental health strategy pencilled in the second quarter of 2023, as was announced in von der Leyen’s SOTEU speech in mid-September. 

“We should take better care of each other. And for many who feel anxious and lost, appropriate, accessible and affordable support can make all the difference,” von der Leyen said.

The new initiative was called  “a comprehensive approach to mental health” in the president’s letter of intent, addressed to European Parliament President Roberta Metsola and Czech Prime Minister Petr Fiala. 

The EU’s health chief Stella Kyriakides had more on this, saying that the commission is supporting member states to reform mental health systems and has allocated more than €28 million to mental health actions under the EU4health programme over the last three years.

“We have to improve access to mental health care, one of the principles of the European Pillar of Social Rights,” she said.

New mental health strategy must involve everyone, EU Commissioner

A strategy in mental health, first announced by European Commission President Ursula von der Leyen, is on next year’s agenda, Commission Vice-President Maroš Šefčovič told a Parliamentary plenary debate on Tuesday (18 October).

Council to decide on the medical devices transition timeline

At the end of 2022, the Commission came to the Council with a proposal:  extending the deadline of the transition period of medical devices regulation (MDR) from 2024 to 2027 following warnings that delays in the implementation of the regulation are creating shortages.

The health ministers will have to formally vote on this proposal in the near future.

“Provided that you agree, this targeted amendment will be on your table beginning of the transitional medical device regulation period ending next year. I believe that this targeted amendment would allow us to address the short-term difficulties we face,” Kyriakides told ministers on 9 December. 

Commission to suggest ways out of medical device shortage

With the medical device regulation transitional period set to end in May 2024, stakeholders and politicians warning of potential shortages.

A year closer to health digitalisation 

The Commissioner is hopeful that the European Health Data Space (EHDS), one of the central building blocks of the European Health Union, will be finalised by June 2024. The aim is to have the EHDS up and running in 2025. 

The goal is “quite ambitious”, in Iveta Nagyova, president of the European Public Health Association (EUPHA)’s words. 

Making data fair, findable, accessible, interoperable and reusable across the EU is not easy when Europe’s health information systems are diverse and countries are at different stages of digitalisation, not forgetting loopholes in digital literacy.

The EHDS, presented by the Commission in May 2022, aims to regulate the transmission and sharing of health data across the EU for private individuals, researchers, and policymakers.

Stakeholders doubtful EU health data space will launch on schedule

Stakeholders expressed concern that the European Health Data Space (EDHS), aimed at reforming the sharing of health data across hospitals around the EU, will launch as planned in 2025 due to a large number of issues still to be addressed.

The year of orphan products legislation?

After many postponements, the Commission promised European lawmakers to finally adopt the proposal for revising the orphan medicinal products legislation in the coming months. 

Orphan medicinal products are for diagnosing, preventing or treating rare conditions, meaning those affecting five in 10,000 people or less. The term can also refer to medicines unlikely to be the source of enough profit to make up for research and development costs.

In November, Anna-Eva Ampelas, head of the Commission’s health service’s (DG SANTE) unit for medical products, attempted to reassure the sceptical MEPs that the proposal would come in the following months, while originally it was already promised for last spring. 

The current legislation was introduced in 2000 to create better incentives for developing orphan medicinal products.

The revision of the legislation is often considered alongside the EU regulation for paediatric medicines, as diseases found in children are mostly considered rare diseases too. The Commission jointly evaluated the two in 2020.

Proposal to revise EU orphan medicines legislation expected in next months, says Commission

Without providing a specific date, a Commission representative told MEPs in the European Parliament’s health committee (ENVI) that they expect to adopt the proposal for a revision of the orphan medicinal products legislation next month.

Pharmaceutical legislation and smoke-free environments

According to the Commission’s provisional work programme, the overarching Pharmaceutical legislation revision should have been presented in December 2022 but is following the same path as orphan drugs legislation. The same delay is also expected for legislation on paediatric medicines.

The new legal framework for pharmaceuticals is expected to ensure access to quality and affordable medicines, make the pharmaceutical system more resilient to crises and increase the security of supply. Most importantly, it should be adapted to new scientific and technological developments.

In 2023, the Commission is to put forward an update of the 2009 Council’s smoke-free environments recommendation, tentatively scheduled for the third quarter of 2023.

Innovation or stagnation? EU pharma industry at a crossroads ahead of rules revision

War, COVID-19 pandemic and vulnerability of supply chains are pushing the EU to be more resilient and self-sufficient in pharmaceutics production. The revision of existing legislation offers the possibility to unlock investments and research in this area.

[Edited by Alice Taylor]

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