What is EU4Health?
EU4Health is the fourth EU health programme, which will run from 2021-2027. It is the EU’s ambitious health response to the COVID-19 pandemic and the EUs overall health challenges. EU4Health will make €5.1 billion available over the next seven years to improve and foster health in the Union to reduce the burden of communicable and non-communicable diseases by:
- protecting people from serious cross-border health threats;
- improving the availability, accessibility and affordability of medicines, medical devices and other crisis relevant products in the EU;
- strengthening national health systems.
The EU4Health programme will go beyond the COVID-19 crisis, supporting amongst others actions on disease prevention, notably on cancer, the digital transformation of health systems, the reinforcement of the health system and the healthcare workforce. It will pave the way to a strong European Health Union that will improve and safeguard the health of all EU citizens.
What makes EU4Health different from previous health programmes?
Never before has Europe invested more in health. According to a recent EU survey, 66% of EU citizens would like to see the EU given more say over health-related matters. The pandemic has shown that the EU needs greater coordination during health crises and health-systems that are more resilient.
EU4Health is a stand-alone programme with a budget more than ten times that of previous health programmes. Actions like tackling cross-border health threats, making medicines available and affordable, and strengthening and digitalising health systems will be financially supported.
What are the main objectives of the EU4Health Programme?
The EU4Health programme has the following objectives:
- Improve and foster health in the Union by:
- Supporting actions for disease prevention, health promotion and addressing health determinants;
- Supporting global commitments and health initiatives.
- Protect people in the Union from serious cross-border threats to health by:
- Strengthening the capability of the Union for prevention, preparedness and response to cross-border health threats, including through a new bio-preparedness authority, the European Health Emergency Preparedness and Response Authority (HERA);
- Supporting actions complementing national stockpiling on essential crisis relevant products;
- Establishing a structure and training resources for a reserve of medical, healthcare and support staff.
- Enhance the availability, accessibility and affordability of medicinal products, medical devices and crisis-relevant products by:
- Encouraging sustainable production and supply chains and innovation in the Union, while supporting efficient use of medicinal products.
- Strengthening health systems resilience and resource efficiency though:
- Strengthening health data, the uptake of digital tools and services and the digital transformation of healthcare systems, including by supporting the creation of a European Health Data Space;
- Promoting the implementation of best practices and promoting data sharing;
- Enhancing access to quality, patient-centred, outcome-based healthcare and related care services;
- Supporting integrated work among Member States, and in particular their health systems.
How will non-communicable diseases, such as cancer, be addressed in the new programme?
Non-communicable and life style related diseases are among the biggest challenges facing EU health systems. Non-communicable diseases such as cardiovascular diseases, cancer, chronic respiratory diseases, and diabetes, represent major causes of disability, health-related retirement, and premature death in the Union, resulting in considerable social and economic costs. It is key to focus on prevention, combined with efforts to strengthen health systems in order to decrease the impact of non-communicable diseases on individuals and society and to reduce premature mortality towards reaching the Sustainable Development Goals by one third by 2030.
EU4Health will support disease prevention (including screening and early diagnosis for cancer) and health promotion programmes in Member States among others. EU4Health will contribute to the upscaling of the networking through the European Reference Networks, which are virtual networks and aim to facilitate discussion on complex, rare and non-communicable diseases, improving access to diagnosis and the provision of high-quality healthcare.
Will the programme contribute to the EU Beating Cancer Plan?
The pandemic has had a severe effect on cancer care, disrupting treatment, delaying diagnosis and vaccination, and affecting access to medicines. Even before the onset of COVID-19, cancer cases were estimated to increase by almost 25% by 2035, which will make it the leading cause of death in the EU. To reverse this worrying trend, the EU4Health Programme will also finance actions to fight cancer, which is one of the Commission’s main priorities. It will do so by providing funding to eligible legal entities established in Member States, such as health organisations and NGOs. Cancer will already be a strong priority in the first annual work programme for 2021, which will is expected to be adopted soon.
How will EU4Health address cross-border health threats?
The Commission is working to improve prevention, preparedness, surveillance and response to cross-border health threats. EU4Health can finance an EU reserve of medical, healthcare and support staff, and stockpiles of medical equipment.
Cross-border health threats require cross-border cooperation and the EU will play a larger role in supporting capacity and response. Beyond our own borders, the EU will support global cooperation on health challenges to improve health, reduce inequalities and increase protection against global health threats.
Will it also address shortages of medicines and personnel?
EU4Health can finance additional emergency reserves of medicines, medical devices and other health supplies to complement national reserves.
One way to make sure we have enough medical supplies is to use what we have more efficiently, in particular antimicrobials. Another way is to encourage European pharmaceutical production and innovation. EU4health will support the EU’s AMR Action Plan and the Pharmaceutical Strategy.
It will not be enough to have sufficient medicine and medical supplies. We also need a strong healthcare workforce, equipped with the necessary skills to face cross-border health threats. That is why EU4Health will also support healthcare workforce training in specific areas.
How will it improve health systems?
By making health systems more resilient, EU4Health will not only help prepare the EU to face future health crisis, but will also get Member States ready to face long-term challenges like an ageing population and health inequalities. Vulnerable groups need to have access to health services and healthcare, and inequalities between Member States and between regions in those Member States must be addressed.
When will the programme start?
Now adopted by the co-legislators, the EU4Health regulation will enter into force on the day of its publication in the Official Journal of the European Union and will apply retroactively from 1 January 2021. Next up is the preparation and adoption of the 2021 annual work programme, which is expected to prioritise crisis preparedness, disease prevention, health systems and digitalisation, as well as cancer as a transversal priority.
How much funding will be available under the EU4Health Programme and how will it be spent?
EU4Health will invest €5.1 billion over seven years to address health challenges. About €316 million are allocated to the first annual budget. Over its 7 year-lifetime, the programme will respect a number of provisions on total expenditure:
- a minimum of 20% for health promotion and disease prevention;
- a maximum of 12.5% for stockpiling crisis-relevant products at Union level;
- a maximum of 12.5% for supporting global commitments and health initiatives;
- a maximum of 8% for administrative expenses.
The programme should also contribute to mainstreaming climate action in the Union’s policies and the achievement of an overall expenditure target of at least 30% of the total amount of the Union budget and the EU Recovery Instrument on climate action.
How will EU4Health be implemented?
EU4Health will be implemented mainly by the Commission through direct management, including delegation to the executive agency. It will be implemented with eligible legal entities from Member States and third countries who will receive EU funding in the form of grants, prizes and procurement as well as indirect management by the relevant EU agencies such as European Medicines Agency or European Centre for Disease Control.
The new Health and Digital Executive Agency (HaDEA), that will be operational from 1 April, will be tasked with the roll-out and management of the annual work programmes.
The EU agencies – the European Centre for Disease Prevention and Control, and the European Medicines Agency – have a key role to play in Europe’s defence against serious cross-border health threats and pandemics, both on the prevention and on the crisis management front. The programme’s actions will enhance the work of these EU Agencies as well as of the European Food Safety Authority and the European Chemicals Agency.
To prepare the annual work programmes and monitor results, the EU4Health Regulation also sets up the consultative EU4Health Steering Group bringing together the European Commission and Member States. The Steering Group will be consulted on the annual priorities, contribute to ensure consistency and complementarity with Member States’ health policies, follow up the implementation of EU4Health and propose any necessary adjustments based on evaluations.
In addition, the Commission will consult with relevant stakeholders, including representatives of civil society and patient organisations, to seek their views on the needs to be addressed through the annual work programme, annual priorities and results.
The results of the stakeholder consultation and steering group discussions will be presented once a year to the European Parliament before the last Steering Group meeting.
Will the Commission continue to provide health funding through the European Social Fund + and other EU funds?
Whilst the EU4Health is the most ambitious health programme ever, important investments in health in the next long-term budget will also be made through other funding instruments working in synergy with EU4Health:
- the European Social Fund Plus (ESF+) to support vulnerable groups in accessing healthcare;
- the European Regional and Development Fund to improve regional health infrastructure;
- Horizon Europe for health research and innovation;
- rescEU to create emergency medical supplies;
- the Digital Europe Programme for creating the digital infrastructure needed for digital health tools;
- the Recovery and Resilience Facility for a stronger and more resilient EU from the current crisis.
Working across programmes and having shared objectives between policies will be key.
With the adoption of the EU4Health programme, the health strand of the proposal for the European Social Fund Plus (ESF+) is fully integrated into the EU4Health Programme.
How will the programme support research and innovation?
The EU4Health programme is an implementation tool for EU health policy and may support and encourage innovation regarding medicinal products and medical devices, and crisis-relevant products in the Union.
EU4Health will work closely with the European Commission’s main research programme, Horizon Europe, which includes a health cluster. Horizon Europe will finance research and innovation on topics such as life-long good health; environmental and social health determinants; non-communicable and rare diseases; infectious diseases; tools, technologies and digital solutions for health and care and healthcare systems. It will also include a Horizon Europe research & innovation mission on cancer, one of the Commission’s top priorities in health policy. The EU4Health Programme will help to ensure best use of research results and facilitate the uptake, scale-up and deployment of health innovation in healthcare systems and clinical practice.
Commission proposes draft mandate for negotiations on Gibraltar
The European Commission has today adopted a Recommendation for a Council decision authorising the opening of negotiations for an EU-UK agreement on Gibraltar. The Commission also presented its proposal for negotiating guidelines.
It is now for the Council to adopt this draft mandate, after which the Commission can begin formal negotiations with the United Kingdom.
Vice-President Maroš Šefčovič, the EU’s co-chair of the Joint Committee and Partnership Council, said: “By putting forward this draft mandate, we are honouring the political commitment we made to Spain to start the negotiations of a separate agreement between the EU and the UK on Gibraltar. This is a detailed mandate, which aims to have a positive impact for those living and working on either side of the border between Spain and Gibraltar, while protecting the integrity of the Schengen Area and the Single Market.”
Gibraltar was not included in the scope of the EU-UK Trade and Cooperation Agreement agreed between the EU and UK at the end of 2020. The Commission committed to begin the negotiation of a separate agreement on Gibraltar, should Spain request so. That is why the Commission is now recommending that the Council authorises the launch of specific negotiations on Gibraltar.
Today’s Recommendation builds upon the political understanding reached between Spain and the UK on 31 December last year. It is without prejudice to the issues of sovereignty and jurisdiction, and focuses on cooperation in the region.
The proposed negotiating directives put forward solutions to remove physical checks and controls on persons and goods at the land border between Spain and Gibraltar, while ensuring the integrity of the Schengen area and the Single Market. The proposals include rules establishing responsibility for asylum, returns, visas, residence permits, and operational police cooperation and information exchange.
Other measures are included in different areas, such as land and air transport, the rights of cross border workers, the environment, financial support, and establishing a level playing field. It envisages a robust governance mechanism, including a review of the implementation of the agreement after four years, the possibility for both parties to terminate the agreement at any time and the possibility of unilateral suspension of the application of the agreement under certain circumstances.
Spain, as the neighbouring Schengen Member State and as the Member State to be entrusted with the application and implementation of certain provisions of the future agreement, will be particularly affected by the agreement. The Commission will therefore maintain close contacts with the Spanish authorities throughout the negotiations and afterwards, taking their views duly into account.
With regard to external border control, in circumstances requiring increased technical and operational support, any Member State, including Spain, may request Frontex assistance in implementing its obligations. The Commission acknowledges that Spain has already expressed its full intention to ask Frontex for assistance.
The UK-EU Trade and Cooperation Agreement excluded Gibraltar from its territorial scope (Article 774(3)). On 31 December 2020, the Commission received a note of the proposed framework for a UK-EU legal instrument setting out Gibraltar’s future relationship with the EU. The relevant services in the Commission have examined this in close consultation with Spain. Building upon the proposed framework and in line with Union rules and interests, the Commission has today adopted a Recommendation for a Council decision authorising the opening of negotiations for an EU-UK agreement on Gibraltar and presented its proposal for negotiating guidelines.
Commission overhauls anti-money laundering and countering the financing of terrorism rules
The European Commission has today presented an ambitious package of legislative proposals to strengthen the EU’s anti-money laundering and countering terrorism financing (AML/CFT) rules. The package also includes the proposal for the creation of a new EU authority to fight money laundering. This package is part of the Commission’s commitment to protect EU citizens and the EU’s financial system from money laundering and terrorist financing. The aim of this package is to improve the detection of suspicious transactions and activities, and to close loopholes used by criminals to launder illicit proceeds or finance terrorist activities through the financial system. As recalled in the EU’s Security Union Strategy for 2020-2025, enhancing the EU’s framework for anti-money laundering and countering terrorist financing will also help to protect Europeans from terrorism and organised crime.
Today’s measures greatly enhance the existing EU framework by taking into account new and emerging challenges linked to technological innovation. These include virtual currencies, more integrated financial flows in the Single Market and the global nature of terrorist organisations. These proposals will help to create a much more consistent framework to ease compliance for operators subject to AML/CFT rules, especially for those active cross-border.
Today’s package consists of four legislative proposals:
- A Regulation establishing a new EU AML/CFT Authority;
- A Regulation on AML/CFT, containing directly-applicable rules, including in the areas of Customer Due Diligence and Beneficial Ownership;
- A sixth Directive on AML/CFT (“AMLD6”), replacing the existing Directive 2015/849/EU (the fourth AML directive as amended by the fifth AML directive), containing provisions that will be transposed into national law, such as rules on national supervisors and Financial Intelligence Units in Member States;
- A revision of the 2015 Regulation on Transfers of Funds to trace transfers of crypto-assets (Regulation 2015/847/EU).
Members of the College said:
Valdis Dombrovskis, Executive Vice-President for an Economy that works for people, said: “Every fresh money laundering scandal is one scandal too many – and a wake-up call that our work to close the gaps in our financial system is not yet done. We have made huge strides in recent years and our EU AML rules are now among the toughest in the world. But they now need to be applied consistently and closely supervised to make sure they really bite. This is why we are today taking these bold steps to close the door on money laundering and stop criminals from lining their pockets with ill-gotten gains.”
Mairead McGuinness, Commissioner responsible for financial services, financial stability and Capital Markets Union said: “Money laundering poses aclear and present threat to citizens, democratic institutions, and the financial system. The scale of the problem cannot be underestimated and the loopholes that criminals can exploit need to be closed. Today’s package significantly ramps up our efforts to stop dirty money being washed through the financial system. We are increasing coordination and cooperation between authorities in member states, and creating a new EU AML authority. These measures will help us protect the integrity of the financial system and the single market.”
A new EU AML Authority (AMLA)
At the heart of today’s legislative package is the creation of a new EU Authority which will transform AML/CFT supervision in the EU and enhance cooperation among Financial Intelligence Units (FIUs). The new EU-level Anti-Money Laundering Authority (AMLA) will be the central authority coordinating national authorities to ensure the private sector correctly and consistently applies EU rules. AMLA will also support FIUs to improve their analytical capacity around illicit flows and make financial intelligence a key source for law enforcement agencies.
In particular, AMLA will:
- establish a single integrated system of AML/CFT supervision across the EU, based on common supervisory methods and convergence of high supervisory standards;
- directly supervise some of the riskiest financial institutions that operate in a large number of Member States or require immediate action to address imminent risks;
- monitor and coordinate national supervisors responsible for other financial entities, as well as coordinate supervisors of non-financial entities;
- support cooperation among national Financial Intelligence Units and facilitate coordination and joint analyses between them, to better detect illicit financial flows of a cross-border nature.
A Single EU Rulebook for AML/CFT
The Single EU Rulebook for AML/CFT will harmonise AML/CFT rules across the EU, including, for example, more detailed rules on Customer Due Diligence, Beneficial Ownership and the powers and task of supervisors and Financial Intelligence Units (FIUs). Existing national registers of bank accounts will be connected, providing faster access for FIUs to information on bank accounts and safe deposit boxes. The Commission will also provide law enforcement authorities with access to this system, speeding up financial investigations and the recovery of criminal assets in cross-border cases. Access to financial information will be subject to robust safeguards in Directive (EU) 2019/1153 on exchange of financial information.
Full application of the EU AML/CFT rules to the crypto sector
At present, only certain categories of crypto-asset service providers are included in the scope of EU AML/CFT rules. The proposed reform will extend these rules to the entire crypto sector, obliging all service providers to conduct due diligence on their customers. Today’s amendments will ensure full traceability of crypto-asset transfers, such as Bitcoin, and will allow for prevention and detection of their possible use for money laundering or terrorism financing. In addition, anonymous crypto asset wallets will be prohibited, fully applying EU AML/CFT rules to the crypto sector.
EU-wide limit of €10,000 on large cash payments
Large cash payments are an easy way for criminals to launder money, since it is very difficult to detect transactions. That is why the Commission has today proposed an EU-wide limit of €10,000 on large cash payments. This EU-wide limit is high enough not to put into question the euro as legal tender and recognises the vital role of cash. Limits already exist in about two-thirds of Member States, but amounts vary. National limits under €10,000 can remain in place. Limiting large cash payments makes it harder for criminals to launder dirty money. In addition, providing anonymous crypto-asset wallets will be prohibited, just as anonymous bank accounts are already prohibited by EU AML/CFT rules.
Money laundering is a global phenomenon that requires strong international cooperation. The Commission already works closely with its international partners to combat the circulation of dirty money around the globe. The Financial Action Task Force (FATF), the global money laundering and terrorist financing watchdog, issues recommendations to countries. A country that is listed by FATF will also be listed by the EU. There will be two EU lists, a “black-list” and a “grey-list, reflecting the FATF listing. Following the listing, the EU will apply measures proportionate to the risks posed by the country. The EU will also be able to list countries which are not listed by FATF, but which pose a threat to the EU’s financial system based on an autonomous assessment.
The diversity of the tools that the Commission and AMLA can use will allow the EU to keep pace with a fast-moving and complex international environment with rapidly evolving risks.
The legislative package will now be discussed by the European Parliament and Council. The Commission looks forward to a speedy legislative process. The future AML Authority should be operational in 2024 and will start its work of direct supervision slightly later, once the Directive has been transposed and the new regulatory framework starts to apply.
The complex issue of tackling dirty money flows is not new. The fight against money laundering and terrorist financing is vital for financial stability and security in Europe. Legislative gaps in one Member State have an impact on the EU as a whole. That is why EU rules must be implemented and supervised efficiently and consistently to combat crime and protect our financial system. Ensuring the efficiency and consistency of the EU AML framework is of the utmost importance. Today’s legislative package implements the commitments in our Action Plan for a comprehensive Union policy on preventing money laundering and terrorism financing which was adopted by the Commission on 7 May 2020.
The EU framework against money laundering also includes the regulation on the mutual recognition of freezing and confiscation orders, the directive on combating money laundering by criminal law, the directive laying down rules on the use of financial and other information to combat serious crimes, the European Public Prosecutor’s Office, and the European system of financial supervision.
New EU guidance helps companies to combat forced labour in supply chains
The Commission and the European External Action Service (EEAS) have published today a Guidance on due diligence to help EU companies to address the risk of forced labour in their operations and supply chains, in line with international standards. The Guidance will enhance companies’ capacity to eradicate forced labour from their value chains by providing concrete, practical advice on how to identify, prevent, mitigate and address its risk.
Executive Vice-President and Commissioner for Trade Valdis Dombrovskis said: “There is no room in the world for forced labour. The Commission is committed to wiping this blight out as part of our broader work to defend human rights. This is why we put strengthening the resilience and sustainability of EU supply chains at the core of our recent trade strategy. Businesses are key to making this happen, because they can make all the difference by acting responsibly. With today’s Guidance, we are supporting EU companies in these efforts. We will ramp up our due diligence work with our upcoming legislation on Sustainable Corporate Governance.”
High Representative/Vice-President Josep Borrell said: “Forced labour is not only a serious violation of human rights but also a leading cause of poverty and an obstacle to economic development. The European Union is a global leader on responsible business conduct and business and human rights. The Guidance we publish today translates our commitment into concrete action. It will help EU companies to ensure their activities do not contribute to forced labour practices in any sector, region or country.”
The Guidance explains the practical aspects of due diligence and provides an overview of EU and international instruments on responsible business conduct that are relevant for combatting forced labour. The EU has already put in place mandatory standards in some sectors and actively promotes the effective implementation of international standards on responsible business conduct.
Promoting responsible and sustainable value chains is one of the pillars of the recent EU trade strategy. The Guidance delivers on the strategy by helping EU businesses already take the appropriate measures, bridging the time until legislation on Sustainable Corporate Governance is in place. This upcoming legislation should introduce a mandatory due diligence duty requiring EU companies to identify, prevent, mitigate and account for sustainability impacts in their operations and supply chains. Subject to the upcoming impact assessment, this will include effective action and enforcement mechanisms to ensure that forced labour does not find a place in the value chains of EU companies.
EU trade policy already contributes to the abolishment of forced labour through its various instruments. EU trade agreements are unique in including binding commitments to ratify and effectively implement all fundamental ILO Conventions, including those on forced labour. Those conventions include an obligation to suppress the use of forced or compulsory labour in all its forms. This commitment extends to the countries benefitting from the special incentive arrangement for sustainable development and good governance (GSP+) under the EU’s General Scheme of Preferences (GSP). All 71 beneficiary countries of the General Scheme of Preferences are obliged to not commit serious and systematic violations of the principles of the fundamental ILO Conventions.
The Guidance also delivers on a number of the priorities of the EU Action Plan on Human Rights and Democracy 2020-2024 in the area of business and human rights. Those priorities include the eradication of forced labour and the promotion of internationally recognised due diligence standards.
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