Sun. Oct 6th, 2024

Luxembourg, 21 June 2024

European Health Union

The Council approved conclusions entitled The Future of the European Health Union: a Europe that cares, prepares and protects, in which it set out key areas of focus for EU health policy and encouraged the incoming Commission to keep health as a priority.

European health systems are set to face ten difficult years, with the growing needs of an ageing population, rising chronic diseases, shortages of medicines and medical devices, and retiring health workers straining our resources. The climate crisis and the rise of artificial intelligence further complicate the situation. To manage these challenges, Europe must step up. Over the past half year, EU health ministers have outlined an ambitious programme, aiming to reshape the European Health Union and ensure resilient, high-quality healthcare in all member states.

Frank Vandenbroucke, Belgian Deputy Prime Minister and Minister of Health and Social Affairs

Pharmaceutical package

Ministers held a policy debate on the incentives system in the pharmaceutical package, a regulation and directive proposed by the Commission in April 2023. They discussed ways forward on the modulation of regulatory data protection periods, the market access incentive, and the unmet medical needs incentive. The Belgian presidency also updated ministers on the broader state of play of the package.

During the discussion:

  • most ministers expressed support for modulation, provided the framework was clear, predictable and respected the need for innovation, while a notable minority supported the current framework
  • several ministers stressed that access should not be linked to pricing and reimbursement, taking into account differences between national systems
  • all ministers agreed that a solution was needed for access, yet there were mixed views on how this should be achieved, with some expressing support for an approach that incentivised companies to facilitate access, while others preferred to impose an obligation on companies
  • ministers expressed support for an unmet medical need (UMN) incentive, but felt that the definition and criteria of this incentive should be further discussed, specifically regarding achieving legal certainty and objectivity in its application
Vaccine-preventable cancers

The Council adopted a recommendation setting out new measures on vaccine-preventable cancers, as part of Europe’s Beating Cancer Plan. The recommendation aims to encourage the uptake and monitoring of vaccinations against human papillomaviruses (HPV) and Hepatitis B virus (HBV), both of which can cause cancer. It proposes measures to help member states increase vaccination against non-preventable diseases.

Other business

Under other business, EU health ministers received information on the 10th Conference of the Parties to the WHO Framework Convention on Tobacco Control, the pandemic agreement, the marketing of tobacco and nicotine to children, novel tobacco and nicotine products, the health situation in Gaza, national stockpiling of medicines, efforts to end HIV/AIDS, events organised by the Belgian presidency, and the work programme of the upcoming Hungarian presidency.

Informal lunch debate

Over lunch, ministers took part in an informal debate on equitable access to healthcare in EU member states.

Preparatory documents
Outcome documents
Press releases

 


European Health Union: Council calls on Commission to keep health as a priority

The Council is calling on the European Commission to keep health as a priority in its upcoming five-year term. In conclusions approved today, member states acknowledge the work already carried out to improve health policy coordination at EU level, highlight the ongoing challenges facing the EU’s health system, and set out the key areas of focus for strengthening the European Health Union.

European health systems are set to face ten difficult years, with the growing needs of an ageing population, rising chronic diseases, shortages of medicines and medical devices, and retiring health workers straining our resources. The climate crisis and the rise of artificial intelligence further complicate the situation. To manage these challenges, Europe must step up. Over the past half year, EU health ministers have outlined an ambitious programme, aiming to reshape the European Health Union and ensure resilient, high-quality healthcare in all member states.

Frank Vandenbroucke, Belgian Deputy Prime Minister and Minister of Health and Social Affairs

Tacking ongoing challenges

In its conclusions, the Council notes that the EU’s health system faces significant challenges. These include health workforce shortages, which member states and the Commission are encouraged to address through investment, digital tools, knowledge sharing, cooperation at EU level and adapted regulatory frameworks.

Another key challenge is improving the security of supply of medicines and medical devices. The Council calls on member states and the Commission to continue work on mitigating shortages of critical medicines, including via the Critical Medicines Alliance, and invites the Commission to consider proposing a critical medicines act, which would provide a legal framework for addressing supply-chain vulnerabilities.

Addressing priority needs

The Council notes that priority needs in healthcare should be addressed.  Setting up an independent, needs-evidenced database can help to identify unmet health-related patient and societal needs. As next steps, the establishment of a voluntary, member-state driven mechanism for evaluating and prioritising such needs and the EU level coordination of public support to address the most pressing health-related unmet needs could be considered.

The Council also calls on member states and the Commission to strengthen action in priority areas by improving the EU’s implementation tools, including EU4Health, and developing new ones such as an EU health investment hub.

Disease prevention

The Council’s conclusions also point to areas where further action needs to be taken. These include prevention of non-communicable diseases, which are responsible for nearly 90% of all deaths in the EU. The Council calls on member states and the Commission to promote healthy lifestyles and environments, including  through adopting the legislative proposals announced under Europe’s Beating Cancer plan and strengthening the work on the ‘Healthier Together’ initiative.

Likewise, action in the area of preparedness and communicable diseases should include keeping cross-border health threats high on the EU’s agenda, strengthening the fight against mis- and disinformation, and improving security of supply of relevant medicines and medical devices.

Background

In a communication published in November 2020, the European Commission announced the establishment of a European Health Union (EHU). The aim of the EHU is to facilitate closer cooperation among member states at EU level on matters relating to health care, including:

  • a collective response to health crises at EU level
  • available, affordable and innovative medical supplies
  • better prevention, treatment and aftercare for diseases such as cancer

Visit the meeting page

 


Speech by Commissioner Stella Kyriakides at the Health Council – The Future of the European Health Union

“Check against delivery”

Chair, Ministers,

Health is at the top of the political agenda, and this is where it rightly should be.

It is together that we have built a strong European Health Union, protecting citizens’ health with more resilient health systems.

The recent Commission Communication on the European Health Union highlights some of our key achievements.

We have a reinforced health security framework. We have already discussed the pharmaceutical reform. We have the European Health Data Space.

We have the initiatives under Europe’s Beating Cancer Plan, which aim to  improve, detection, equal access to treatment and quality of life for people living with cancer.

We are addressing mental health, offering over 1.2 billion euros to support Member States and stakeholders for prevention and treatment.

And we have the Healthier Together Initiative, which is bringing Member States together to address the burden of major non-communicable diseases and to take action on health determinants.

This action at EU level cannot stop here.

Much more needs to be done. For this we all need to commit to more  political support.

We welcome the Council Conclusions on the future of the European Health Union.

They show Member States’ continued commitment to work in this direction.

And they will guide our reflection on possible future priorities in the area of health.

When doing so, we need to factor in the recent redeployment of 1 billion euros from the EU4Health budget, and look at how this will impact the ongoing work to rationalise reporting obligations and the need to ensure full implementation of legislative and non-legislative initiatives already in place.

Let us continue working together to keep health high on the political agenda, and I would like to thank you again for the support you have given in the last months on the European Health Union.

Source – EU Commission

 


Speech by Commissioner Stella Kyriakides at the Health Council – Pharmaceutical Package

“Check against delivery”

Chair, Ministers,

From the very beginning, we had two main political objectives through the EU pharmaceutical reform proposals.

First, to create a single market for medicines where all patients across the EU have timely and equal access to safe, effective and affordable medicines.

Second, to continue to ensure the EU is an attractive place for innovation and to foster the competitiveness of our pharmamaceutical industry.

Today, we know that not all patients in the EU have equal access to innovative medicines.

We cannot have first- and second-class citizens or patients in the EU.

Access to newly approved medicines ranges from 90%  in some Western and bigger Member States compared to 10% in Eastern and smaller EU countries.

This Council has stressed, time and time again, the need to make sure medicines are available, accessible and affordable.

We as a Commission answered this call.

Our reform proposals provide for:

  • Wider access to medicines, through a modulation system for incentives that reward innovation and supply in all Member States;
  • Affordable medicines, through earlier availability of generics and biosimilars;
  • A globally competitive regulatory framework with tools that will accommodate cutting-edge therapies, faster authorisations and simplification.

As a result of what we have put forward, this would  mean new medicines reaching an estimated 60-70 million more patients in the EU.

Ministers,

I would like to welcome the progress made under the Belgian Presidency on incentives, which I thank.

The Presidency paper on incentives clearly highlights that access to medicines is a key part of the reform, and proposes four options in this respect.

I want to emphasise that our access incentive is meant to achieve an objective that we all agree to: equal and more timely patient access to medicines in all Member States.

This needs to remain the key objective of the pharmaceutical reform, which we as a Commission will continue to defend.

Let us work together to advance the discussions quickly and to deliver what EU patients expect from us.

Source – EU Commission

 


Press statement by Commissioner Stella Kyriakides following the EPSCO Council

“Check against delivery”

Ladies and gentlemen,

First, I want to thank Minister Vandenbroucke for the important progress of the Belgian Presidency in the area of health over the last six months.

The adoption of Council Conclusions on the future of the European Health Union is a clear signal of how far we have come in the last five years, as well as what we are trying to build in the area of health;

Today, we have a European Health Union that citizens believe in and which provides a foundation for a healthier and more equitable future for each and every of our citizens and health systems.

This has been made possible by the strong support of our Member States in the last years.

Another very positive outcome of today’s meeting was the adoption of the Council recommendation on vaccine-preventable cancers.

This is one of our flagship actions on prevention under the Cancer Plan – with the potential to save thousands of lives each year.

We need to work with Member States to increase vaccination levels and fight misinformation to ensure that citizens have the necessary protection to deal with cervical cancer and other cancers caused by HPV and Hepatitis B.

We will help Member States in every way possible by  launching a joint action funded with 20 million euros from the EU4Health programme to support its implementation.

When it comes to the Pharmaceutical Strategy, we have taken significant steps under the Belgian Presidency.

We launched a Critical Medicines Alliance in April, which has started is work towards more coordinated action at EU level to prevent shortages of medicines.

We now have new rules on Substances of Human Origin to increase the safety and quality of these lifesaving substances, and improve the protection of both donors and recipients.

We have the European Health Data Space, which was concluded under this Presidency, to harness the full potential of digitalisation in our health systems.

Last but certainly not least, discussions are ongoing on the pharmaceutical reform. We still have a way to go, but I felt that there were positive feeling towards finding solutions together.

Ultimately, equal access to medicines needs to be our priority. We cannot live in a European Union in which not all patients and citizens have access to the medicines they need. It cannot depend on where citizens live.

We have the opportunity through the reform to maintain the level of ambition, while promoting innovation and the competitiveness of our industry, to create a Single Market for medicines.

Ladies and gentlemen,

In ending, I would like to once again thank the Belgian Presidency for the excellent results they have delivered, and keeping health at the top of the political agenda, where it should be.

Thank you.

Source – EU Commission

 

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