From combatting loneliness to digitalisation – EURACTIV.com

From combatting loneliness to digitalisation – EURACTIV.com

Swedish ministers have laid out their health policy agenda for their six months at the helm of the rotating presidency of the EU Council, from measures to combat loneliness to the realisation of European Health Data Space.

“This will be a very busy six months, and the Swedish presidency is ready for what is on the agenda and to deal with the unexpected,” Swedish Social Affairs and Public Health Minister Jakob Forssmed told the European Parliament’s health committee (ENVI) on Monday (23 January).

Stockholm began its presidency on 1 January with a loaded in-tray: Overstretched healthcare systems, drug shortages, the effects of the ongoing Russian aggression in Ukraine, the COVID-19 pandemic and a packed legislative agenda including the pharmaceutical strategy and European Health Data Space (EHDS). 

Sweden has underlined that a coordinated approach will be key. 

“It is vital to maintain a close dialogue and cooperation at the EU level and with the European Parliament being a natural and I would say crucial partner in this,” Forssmed stressed.

The minister added that this applies too to international negotiations when it comes to the international pandemic treaty and supplementary amendments to international health regulation. 

Health data space

One of the biggest legislative acts is the European Health Data Space (EHDS), one of the central building blocks of the European Health Union, which should be finalised by June 2024. The aim is to have the EHDS up and running in 2025. 

A number of stakeholders have already raised concerns about the timeline, warning that EHDS might not be ready as scheduled. 

It’s very important that the work moves forward,Forssmed said, describing data sharing as a central issue for Europe which, if solved, would help to share health data across the EU for private individuals, researchers, and policymakers.

In this, he stressed the importance of treading the fine line “between what we wish to achieve and data protection so that people feel secure in how their data is being managed”.

This entails aligning EHDS with other pieces of legislation, such as the Data Act, the NIS2 Directive, the AI Act, and the proposal on national provisions on health data.

SoHO

Another piece of legislation on the Swede’s list is the Commission’s proposed new rules on substances of human origin (SoHO), which would replace the current parameters, which are over 20 years old.

For the presidency, it is not only about updating it but also making it “future-proof”.

“We will advance the proposal for a regulation on standards of quality and safety for substances of human origin intended for human application,” said Acko Ankarberg Johansson, Swedish health care minister. 

EMA fees 

European Commission is currently revising the European Medical Agency’s (EMA) fees system, to make it more flexible to adapt to future developments and more sustainable in the long term.

Johansson said that the presidency will advance the EMA fees regulation.

“The system needs to be made as flexible as possible so that it’s aligned with the medicines package that’s coming further down the road. But of course, we need to give member states time to analyze the proposal before we get down to work,” she said. 

Medical devices regulation 

At the beginning of January, the European Commission adopted a proposal to give suppliers an extra four years to re-certify medical devices, to circumvent the risk of shortages. Stella Kyriakides called on European Parliament and the Council to quickly adopt the proposal. 

Johansson assured that this is “a matter of urgency” for the presidency for ensuring patient safety. 

This is crucial that we avoid shortages of life saving medical devices,” the minister said. 

A presidency working party meeting took place to discuss the file last week where the proposal gained strong support from member states, according to Johansson.

Solving the issue of medicine shortages in the EU

The European Commission is pointing to the sharp increase in demand along with insufficient production capacity as the main reasons for medical shortages seen across the EU. Lawmakers are calling for the relocation of medicine manufacturing to Europe.

Pharmaceutical legislation 

The Commission is to present a revision of pharmaceutical legislation, as well as files on orphan drugs and paediatric medicines this year.

Hopefully we’ll get a Commission proposal,Johansson said. 

The need for a new framework is highlighted by the drug shortages seen across the bloc. 

“We have problems with the supply chain and we have lacks because there are certain medicines that have not been developed, and which may be needed in different areas,” Johansson highlighted, adding that these issues have to be addressed jointly. 

Discussion on medicine shortages and pharmaceuticals will take place at the EPSCO informal Council on 4-5 May, according to the Council’s draft agenda.

The presidency has highlighted the importance of orphan drugs and medicines to children

“We need to have strategies and tools to grant access to early detection, care, treatment, lifelong care, and the same facilities that are available for other diseases,” Johansson said.

The Council will consider creating initiatives to get the needed medicines to address antimicrobial resistance (AMR), Alzheimer’s and other diseases, Johansson said. Initiatives include vouchers and incentives. 

“We cannot simply rely on great sales so it’s very important to work with different types of models, as incentives,” Forssmed added, saying that the presidency hopes this will be reflected in the upcoming Commission proposal.

EU Commission plays down antibiotics shortage

The current antibiotic shortage remains a ‘big alarm bell’ for Europe but it does not require special measures as alternatives to cope with are available to member states, the  European Commission’s health policy ‘number-two’ said.

Cancer

As for the previous presidency, cancer remains a priority for the Swedish. “We need to do more to prevent this terrible disease,” Johansson said

Together with the Commission, the presidency will hold a conference on cancer in Stockholm on 1 February, focusing on the implementation of Europe’s beating cancer plan, and ensuring equal cancer care for all. 

Additionally, cancer diagnostics and advanced therapies will be addressed in a presidency conference on the future of life science in June. 

AMR

The presidency is awaiting the Commission’s recommendations on tackling AMR, with hopes to adopt them at the EPSCO Council in June.

“We tried to find ways of using small spectrum antibiotics, but to also supervise the use of antibiotics in humans and animals and make sure that there are sufficient human resources available to do that and to watch the situation at a clinical level and in practice,” Forssmed said.

The member states meeting on AMR is planned for 6-7 March in Stockholm. 

Mental health and loneliness

As the Commission is to present its strategy on mental health by the end of the Swedish presidency’s term, the presidency intends to highlight the issue of loneliness. 

“Loneliness can have a negative impact on public health, on mental health, the welfare of the population, as well as social inclusion and cohesion,” said Forssmed

He explained that the presidency is looking forward to exchanging experiences with other countries on how to approach the issue and which measures work to counteract loneliness. 

COVID-19 

Following the change in China’s COVID policy, member states agreed on a coordinated precautionary approach in early January. Swedish ministers said that a priority will be to ensure a coordinated approach is taken in the future as well. 

“The Swedish presidency stands ready to further facilitate and promote an EU coordinated approach if necessary, and we are following the developments very closely,” Forssmed said. He highlighted that if countries take different measures, “it has very little effect”. 

Global Health

The EU’s Global Health Strategy, which was adopted at the end of November, aims to improve global health security and deliver better health for all in a changing world.

“The EU needs to do more with this strategy, do more for global health,” said Forssmed, adding that while the aim is to promote health, the strategy also has geopolitical importance.

[Edited by Nathalie Weatherald]

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