EU Politics
Explainer: COVID-19 vaccination in the EU
With which companies have you concluded COVID-19 vaccine agreements?
The Commission is negotiating intensely to build a diversified portfolio of vaccines for EU citizens at fair prices. Contracts have been concluded with AstraZeneca (400 million doses), Sanofi-GSK (300 million doses), Johnson and Johnson (400 million doses ), BioNTech-Pfizer 300 million doses, CureVac (405 million doses) and Moderna (160 million doses). The Commission has concluded exploratory talks with the pharmaceutical company Novavax with a view to purchasing up to 200 million doses.
This means that the Commission has secured a portfolio of more than 2 billion doses. For the Commission it was important from the beginning to build a diversified portfolio of vaccines based on different technologies, to increase the chances that one or more of the vaccine candidates are approved by EMA. Should all vaccines candidates turn out to be safe and effective, Member States have the possibility to donate part of their doses to lower and middle income countries.
Which vaccine is now authorised?
The Commission has given on 21 December the conditional marketing authorisation for the vaccine developed by BioNTech and Pfizer, following EMA positive assessment of its safety and efficacy. It is now waiting for EMA’s opinion on the possible conditional marketing authorisation for the vaccine by Moderna, which should be provided by 6 January at the latest.
No other vaccine producer has formally applied for a marketing authorisation to EMA. In order to accelerate the process, EMA has started rolling reviews on the vaccines produced by Johnson and Johnson and AstraZeneca.
How will vaccines be monitored post authorisation under the Conditional Marketing Authorisation (CMA)?
The monitoring of the safety and effectiveness of vaccines after authorisation is a requirement under EU law and a cornerstone of the EU’s pharmacovigilance system relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem. The system is exactly the same than for a normal market authorisation.
The safety and effectiveness of vaccines which have received conditional marketing authorisations are rigorously monitored, as for all medicines, through the EU’s established medicines monitoring system.
In addition, special measures are in place to quickly collect and evaluate new information. For example, manufacturers must usually send a safety report to the European Medicines Agency every six months. For COVID-19 vaccines, safety reports must be sent every month.
The European Medicines Agency will set up additional large-scale safety monitoring given the exceptionally high numbers of people expected to receive the vaccines.
Once authorised, when will vaccines be available in the EU?
In line with the EU vaccine strategy agreed with Member States, once authorised and produced, each vaccine will be available to Member States at the same time and at the same conditions.
The distribution will start progressively. This means that in the first few months, there will not be enough doses available to vaccinate all adults. The first doses will go to the priority groups identified by Member States (e.g. healthcare professionals, persons over 60 years of age). Supplies will increase over time, and all adults should be able to get vaccinated during the course of 2021.
For most contracts concluded, the majority of delivery is foreseen to be completed in 2021. Under some contracts, first deliveries are expected to already start in the first quarter of 2021.
First deliveries of the BioNTech and Pfizer vaccine are expected within days of authorisation and first vaccinations would take place in the context of the EU vaccination days of 27-29 December.
The Commission has been asking national authorities to prepare as early as possible for organising the fast and accessible deployment of vaccines, according to national vaccination plans and has issued guidance on the large-scale vaccination deployment.
The Commission is following the developments of national vaccination plans very closely and provides support notably by organising joint procurement for vaccination supplies, such as syringes and needles, and running a stress test of the national vaccination plans ahead of deployment together with the ECDC.
Will the EU have enough capacity to manufacture the COVID vaccines?
There is already substantial vaccine production capacity in the EU – and the Commission is working intensively to increase it. In addition, and in order to ensure that vaccine developers have the necessary capacity to scale up the production of COVID-19 vaccines as soon as they have been approved by the EMA, the Commission supports the necessary investment in the development of such production capacities.
How will logistics work? How will vaccines be distributed?
Logistics and transportation is a key aspect on which all Member States have to work, as emphasised in the Communication on preparedness for COVID-19 vaccination strategies and vaccine deployment of 15 October.
Delivery to national distribution hub(s) will be ensured by the manufacturers.
Further distribution to vaccination centres will be ensured by Member States, who will also be responsible for the vaccination of their population.
Who should be vaccinated first?
All Member States will have access to COVID-19 vaccines at the same time on the basis of the size of their population. The overall number of vaccine doses will however be limited during the initial stages of deployment and before production can be ramped up. The Commission has therefore provided examples of unranked priority groups to be considered by countries once COVID-19 vaccines become available.
Most countries have defined priority groups and are further refining who should get priority in these priority groups e.g. older person over 80 years of age. The ECDC published an overview of where EU/EEA countries and the UK are with the development of their vaccination plans/strategies. ECDC is also working on a modelling exercise on prioritisation to support Member States. This report should be published before Christmas.
Will citizens know which vaccine they will be getting?
Yes.
When vaccines receive conditional marketing authorisation, the package leaflet with details on the specific vaccine will be translated into all languages and published in electronic form by the Commission.
All health care professionals and all patients would therefore have access to a leaflet in electronic form in their own languages.
The vaccine companies are responsible for putting in place the necessary mechanisms to ensure that each patient receives the package leaflet in print form in his/her language upon request without burdening healthcare professionals administering the vaccine.
What labelling and packaging information will citizens and health care professionals get with the COVID-19 vaccines?
In order to allow for a rapid deployment of COVID-19 vaccines at large scale, the Commission has developed, with Member States and the European Medicines Agency, labelling and packaging flexibilities for a temporary period. Flexibility in the labelling and packaging requirements is expected to reduce transport costs and storage space, improving the distribution of the doses between Member States and limit possible impact on the production of other routine vaccines. Despite these flexibilities, anyone vaccinated and health care professionals will have access to all the information on the vaccine used.
An example of such flexibilities is the fact that the outer and immediate packaging may only be printed in English. Also, the package leaflet does not have to be included inside the package of the medicinal product, but will be provided separately by the vaccine company, who will be responsible for the distribution of the printed package leaflet locally in the national language(s).
Some Member States do not require the package leaflet to be printed in their national language(s). The leaflet may be printed in English only, but the information contained in the leaflet should still be available in the national language(s), for instance via a QR code printed in the package leaflet and also available in the EMA website in all languages.
How will the Commission support Member States in the rolling-out of vaccines?
The Commission stands ready to support Member States to ensure the smooth deployment of COVID-19 vaccines. A number of EU instruments in the programming period 2021-2027 can offer financial support in this regard.
For instance, investments to support health reforms and resilient, effective and accessible health systems are eligible under the Recovery and Resilience Facility (RRF), and can be included in the national Recovery and Resilience Plans. Furthermore, the Cohesion Policy funds (European Regional Development Fund – ERDF and European Social Fund Plus – ESF+) as well as the REACT-EU programme can provide financing to Member States and their regions to strengthen their health systems, both in terms of managing and recovering from the current health crisis and as well as ensuring their resilience in the longer term.
Collectively, these programmes can support a range of investment needs, for example, in health infrastructure, training of health professionals, health promotion, disease prevention, integrated care models, digital transformation of healthcare, and equipment, including critical medical products and supplies to strengthen the resilience of health systems.
In this context, investments to prepare health systems for the roll out COVID-19 vaccines are eligible under these programme, especially given the direct link to the resilience of health systems, the availability of critical medical products and disease prevention. However, it will be up to each Member State to decide on the priorities and content of their Recovery and Resilience Plan and also their Programmes for the Cohesion Policy funds.
How will vaccination certificates work?
A common approach to pharmacovigilance, and to trusted, reliable and verifiable vaccination certificates across the EU could reinforce the success of vaccination programmes in Member States and the trust of citizens.
Registering data on vaccination is important both at individual and population levels. For an individual, it is a means to know and demonstrate their vaccination status. Proof of vaccination should be available from the moment vaccination starts. Vaccination certificates could for example be useful in the context of travel, showing that a person has been vaccinated and therefore may not need testing and quarantine upon arrival in another country.
The Commission and Member States, together with WHO, are working on vaccination certificates. This work includes a minimum dataset, including a unique identifier, for each individual vaccination which will ease the issuance of certificates and vaccination monitoring on a Europe-wide basis from the moment that the COVID-19 vaccines are authorised.
The development of the common specifications framework will take account of and contribute to the work of WHO. EU funds, such as RRF, ERDF, InvestEU can support the setting up of the Immunisation Information Systems (IIS), Electronic Health Records and secondary use of health data on immunisation.
How much does the vaccine cost? What is the price of the vaccine?
The Commission negotiated advantageous deals with vaccine manufacturers to secure access to almost 2 billion doses so far.
At this stage the specific pricing per dose is covered by confidentiality obligations. However, a significant part of the overall costs are funded by a contribution from the overall EU funding for vaccines.
Will the vaccine be free in all EU Member States?
While this is a Member State responsibility, the large majority of the Member States intend to offer vaccination free of charge.
Are the contracts with the companies publicly available?
The focus for the Commission is the protection of public health and securing the best possible agreements with companies so that vaccines are affordable, safe and efficacious.
Contracts are protected for confidentiality reasons, which is warranted by the highly competitive nature of this global market. This is in order to protect sensitive negotiations as well as business related information, such as financial information and development and production plans.
Disclosing sensitive business information would also undermine the tendering process and have potentially far-reaching consequences for the ability of the Commission to carry out its tasks as set out in the legal instruments that form the basis of the negotiations. All companies require that such sensitive business information remains confidential between the signatories of the contract. The Commission therefore has to respect the contracts it concludes with the companies.
When will the vaccine allow the control of the pandemic?
For some known communicable diseases, it is understood that herd immunity allowing to control a pandemic and eventually eradicate a disease requires around 70% of the population to have protection either from vaccination or previous infection.
Depending on the pace of vaccination and natural infections, the pandemic might be controlled by the end 2021 in Europe.
Can we still spread the disease once vaccinated?
We do not yet know. Additional evaluations will be needed to assess the effect of the vaccine in preventing asymptomatic infection, including data from clinical trials and from the vaccine’s use post-authorization.
Therefore, and for the time being, even vaccinated people will need to wear masks, avoid indoor crowds, and respect social distance, so on. Other factors, including how many people get vaccinated and how the virus is spreading in communities may also prompt revision of this guidance.
If I have already had COVID-19 and recovered, do I still need to get the vaccine?
There is not enough information currently available to say if or for how long after infection someone is protected from getting COVID-19 again; this is called natural immunity. Early evidence suggests natural immunity from COVID-19 may not last very long, but more studies are needed to better understand this.
EU Politics
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.
Draft mandate
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.
Background
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.
EU Politics
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.
Third countries
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.
Next steps
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.
Background
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.
EU Politics
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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