After a restful, and restorative summer break, the Brussels Bubble is buzzing again. And the buzz is palpable. There is a lot deserving attention, from the looming recession to the lingering pandemic and the critical energy crisis, and amongst it all, there is a packed healthcare agenda.
It could be argued that this is the most significant period for European healthcare reform since the formation of the Union. For a long time, healthcare sat firmly as a national interest but both the events of the last few years and endemic healthcare challenges have thrust it into the spotlight.
In this article we have highlighted the key files, giving an overview of how developed they are and what we are likely to see in the coming months to the close of the year.
The long-awaited review of the general pharmaceutical legislation has received a justifiable amount of attention as it promises to challenge business as usual for healthcare companies operating in Europe.
Whatever the specifics, we should expect the proposals to feed into a broader debate on affordability and access. With budgets being universally stretched, this will likely place significant pressure on industry to play its part in reducing prices and leveling health inequalities across EU Member States.
A reduction to the existing regulatory data protection (RDP) period is anticipated, with a potential extension being granted to products introduced in all EU markets within a specified timeframe and drugs developed for unmet medical needs. Time will tell if these proposed changes address or overlook the regulatory barriers which also hinder patient access.
Furthermore, the package will give the Commission an opportunity to outline its ambition on environmental sustainability for the sector, with a more transparent supply chain likely.
However, we shouldn’t plan on seeing the package later this year as the European Commission’s Regulatory Scrutiny Board has issued the package a negative opinion, delaying the initiative until positive opinion is received. This is predicted to be in February or March next year, raising questions about the likelihood of this legislation being concluded in the current Commission mandate at all. The reason behind the negative opinion is to be determined, but it is speculated there may be concerns over the impact of changes to RDP on Europe’s competitiveness.
European Health Data Space
The European Health Data Space (EHDS) is designed to provide a stable legal framework to facilitate the exchange of health data within the Union and form a cornerstone of the European Health Union.
Before summer, the EPSCO council had a first discussion on the proposal which was, generally, well received. However, while we believe that EHDS is still firmly on the Commission’s agenda, the heavy legislative pipeline has caused the uptake of the file to be slower than anticipated.
We don’t expect to see much progress in 2022 but hope to see the first discussions in Parliament. Starting with the appointment of the rapporteur in the LIBE committee and the rapporteur for opinion in the ENVI committee, as well as more clarity on the positions of the different stakeholders.
The EU’s Non-Communicable Diseases (NCD) Initiative was released in June and the onus is now on Member State governments to roll this out in their own strategies.
With the EU having limited authority to improve collaboration on the treatment of diseases, the Commission drafted the NCD initiative alongside Member States and third-party organisations, including patient groups. They put together a list of best practices detailing how EU governments have addressed the four types of NCDs to be tackled in priority order: cardiovascular diseases, diabetes, chronic respiratory diseases, mental health and neurological disorders, and health determinants.
The COVID-19 crisis has laid bare the issues facing European healthcare systems over long-term sustainability and the NCD Initiative seeks to shift Member State focus towards detection and prevention of NCDs. Member States wishing to implement these best practices nationally will benefit from EU funding.
We will be sure to keep a close eye on how successful this is taken-up in national governments, with cardiovascular disease and diabetes expected to be addressed first, as it could have massive implications for the future success of both the NCD initiative and others which are heavily reliant on uptake at Member State level.
European Care Strategy
While the three initiatives mentioned above have been at the forefront of all health-related discussions in Brussels, other texts such as the European Care Strategy have garnered less attention. This non-legislative initiative, however, will be key to improving both childcare and long-term care.
The Strategy, adopted by the Commission on 7 September 2022, comes in a package including a Communication on a European Care Strategy and two proposals for Council Recommendations to be discussed in upcoming months: a revision of the Barcelona targets on childcare, and a proposal on long-term care. This will likely boost and guide Member States into implementing national policies on these topics.
The uptake of these recommendations will be closely monitored by the Commission which will publish an in-depth report for each within five years, to give an overview of the state of play.
We see the text on long-term care as being key to support the United Nations’ 2021-2030 Decade of Healthy Ageing. The demand for long-term care is rising as our populations are ageing, especially in Europe. This is an opportunity for the Commission to call Member States for action to improve the quality of life of the elderly, focusing on providing them with choice, dignity, and affordable care.
Global Health Strategy
In May 2022, during the G7 Development and Health Ministerial meeting, Commissioners Kyriakides and Urpilainen announced the launch of work on a new EU Global Health Strategy.
EU Ministers welcomed this decision and stressed its importance in redefining the EU’s global health priorities. There is a clear focus on strengthening health systems, preparing for and responding to health crises, and promoting the One Health approach. Ministers also called for this strategy to strengthen the EU’s influence on health on the international scene and the coordination between relevant EU actors.
The proposal is expected to be presented by the Commission in mid-November 2022.
We now wait for the publication of the Commission Work Programme 2023 (expected 18 October 2022) and the EU4Health 2023 programme (expected in January 2023) to confirm, or at least indicate, what the 2023 priorities.
Get in touch if you need any further information
It is certainly as busy time for European Healthcare, but it’s set to be monumental. Our team is excited for the remainder or 2022 and what 2023 has in store. We will remain ‘plugged in’ to all the key developments across the full agenda and would be delighted to go into more depth on any of the issues presented, so please feel free to get in touch.
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July 13, 2023