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Coronavirus and the EU Vaccines Strategy

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On 17 June, the European Commission presented a European strategy to accelerate the development, manufacturing and deployment of vaccines against COVID-19. The EU Vaccines Strategy intends to ensure the production in Europe of qualitative, safe and efficacious vaccines, and to secure swift access to them for Member States and their populations. Moreover, the Strategy  reflects the global solidarity effort and ensures equitable access to an affordable vaccine as early as possible.

Joint action  at  EU  level  is  the  surest,  quickest  and  most  efficient  way  of achieving  these objectives. No Member State on its own has the capacity to secure the investment in developing and producing a sufficient number of vaccines. It is only through swift and unified action by the EU and its Member States that sufficient and speedy supplies of a safe and effective vaccine can be ensured. A common strategy allows better hedging of bets, sharing of risks and pooling investments to achieve economies of scale, scope and speed.

The Commission has signed two first contracts to allow the purchase of a vaccine, once proven safe and efficient, with AstraZeneca and Sanofi-GSK. Successful exploratory talks were concluded with Johnson & Johnson on 13 August, CureVac on 18 August, Moderna on 24 August and BioNTech on 9 September.*

NEGOTIATION PROCESS

Are all Member States represented in the Steering Committee and in the Negotiation Team?

All Member States have endorsed the approach set out by the Vaccines Strategy and signed up to an agreement for its implementation. As a result, all Member States are represented at the Steering Committee which discusses and reviews all  aspects of  the  Advanced Purchase Agreement (APA) contracts before signature. The Committee appoints the members of the Joint Negotiation Team, which negotiates the APAs with the vaccines developers and reports to the Committee.  All participants in these instances have been appointed by their Governments and have signed declarations of absence of conflict of interest and confidentiality.

What is the difference between concluding an Advanced Purchase Agreement (APA) and signing a contract with a pharmaceutical company?

Before an Advanced Purchase Agreement (APA) is negotiated, the Negotiation Team holds exploratory talks with the company to find out whether proceeding into detailed contractual negotiations is reasonable. If this is the case and a common understanding is reached on a terms sheet, a tender invitation is sent to the company, which then has to propose an offer.

An APA is concluded when both sides have finalised the contractual work. This is discussed and agreed with the Steering Committee. The conclusion of an APA requires the approval of the Commission.

If the APA provides for an obligation for the Member States to purchase vaccine doses (even if there might also be additional optional doses in the APA), Member States have 5 working days to notify if they wish to opt-out. The contract is only signed if at least four Member States are ready to be bound by it.

If the APA provides only for an option for Member States to purchase vaccine doses at a later date, the Commission can approve and sign the APA directly with the company concerned. Member States can decide later whether to exercise the option. It are the Member States that are responsible for purchasing the vaccines when they become available.

Will the Commission publish the contracts signed with pharmaceutical companies?

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.

Finally, the Commission is accountable towards the other European institutions and the European citizen. The Commission is acting in full compliance with all applicable rules regarding financial management, which can be subject to audit at a later stage.

LIABILITY & INDEMNIFICATION

Has the Commission made concessions on liability to the industry, in particular on indemnification for certain liabilities?

The Commission ensures that any agreement made to secure vaccines through the Vaccines Strategy will be fully compliant with EU law. The contracts the Commission is negotiating fully respect and protect citizens’ rights, in line with the Product Liability Directive. 

In line with EU product liability rules, liability remains with the company. However, in order to compensate for potential risks taken by manufacturers due to the unusually shorter timespan for vaccines development, the APAs provide for Member States to indemnify the manufacturer for possible liabilities incurred only under specific conditions set out in the APAs.

The Commission has made clear throughout the implementation of the Vaccines strategy that it is not prepared to make compromises on the application of the existing rules that apply to bringing a pharmaceutical product into the market. These principles are equally valid for any indemnification clause the Commission negotiates.

Thus, the provisions on liability and indemnification do not alter in any way the regulatory burden of proof borne by the companies to demonstrate the safety and efficacy of their products. Any vaccine put on the market will have to meet the necessary safety requirements and undergo the independent scientific assessment by the European Medicines Agency as part of the EU market authorisation procedure.

The EU and Member States will continue taking all necessary measures to protect citizens, ensuring that:

  • a strict, independent scientific assessment (looking at quality, safety and efficacy) must be carried out before a vaccine is approved;
  • citizens’ rights remain fully protected;
  • Member States are ready to financially cover certain of the companies risks to ensure that vaccines are actually available for EU citizens to protect public health.

AUTHORISATION PROCESS

How can a COVID-19 vaccine be developed and authorised within a 12-18 months timeframe when the normal process takes around 10 years? What are the roles of the European Medicines Agency (EMA) and the European Commission in this context and how can the process of marketing authorisation be speeded up in emergency situations?

We are currently in the middle of the most severe public health crisis in modern times. Finding a safe and effective vaccine will be a key element of the exit strategy from the pandemic. Europe and the world need to act swiftly and teams around the world are working with the ambition of delivering a successful vaccine within a timeframe  of  12 -18  months. Delivering a successful vaccine within a compressed timeframe does however not mean compromising on safety, on the contrary, the safety and effectiveness of vaccines is non-negotiable and a fundamental requirement for any vaccine to reach the EU and other markets.

It is indeed true that vaccine development can take time and this is why we created our Vaccines Strategy to come together and work on all fronts, around the clock, with all Member States, global partners, researchers and scientists to develop a safe and efficacious vaccine in a short time frame. The often-quoted 10 year timeframe refers to the time from concept to authorisation, including gathering the necessary evidence through clinical trials. Reducing this timeline to 12-18 months means both accelerating development and manufacturing timelines as well as the marketing authorisation.

The regulatory processes will be flexible but will remain as rigorous as always. Together with the Member States and the European Medicines Agency, the Commission will use existing flexibilities in the EU’s regulatory framework to accelerate the authorisation and availability of successful vaccines against COVID-19, while maintaining the standards for vaccine quality, safety and efficacy.

Market authorisation process

The vaccine producers will decide if and when to submit an application for a marketing authorisation for a vaccine. The role of the EMA in this context is to carry out an independent scientific assessment of the application and submit its scientific opinion to the European Commission which is responsible for issuing a marketing authorisation that is valid for the entire EU. The marketing authorisation will only be granted if the benefit-risk balance is positive following an assessment of the quality, safety and efficacy of the product.

Variations to usual development plans are possible in the emergency context and developers can reduce timelines, for example, by conducting some studies in parallel, instead of carrying them out sequentially, and by using a variety of trial designs and endpoints to determine efficacy. Developers are advised to discuss development plans with regulators to clarify requirements for marketing approval.

Clinical trials for COVID-19 vaccines are being carried out more quickly than usual because the effort being put into their organisation and conduct has been significantly increased by the sponsors, researchers and regulators. The widespread nature of the pandemic means that large numbers of trial participants can be recruited in a relatively short time, without compromising the quality of the trials themselves.

The EU regulatory system is dedicating significant resources to supporting the rapid development and authorisation of safe, effective and high-quality COVID-19 vaccines. EMA’s pandemic Task Force (COVID-ETF), which brings together in one group the best scientific experts from the EU regulatory network, will work closely with EMA’s human medicines committee (CHMP) for optimal and fast coordination of activities related to the development, authorisation and safety monitoring of vaccines against COVID-19.

Can a vaccine be approved before completion of phase 3 of clinical trials?

A core objective of the Commission and the European Medicines Agency, through the EU Vaccines Strategy, is to ensure the quality, safety and efficacy of vaccines. As such, any vaccine can only be granted a marketing authorisation in the EU after a thorough evaluation. To recommend the authorisation of a vaccine, EMA needs to have sufficient information on its safety, efficacy and pharmaceutical quality. Marketing authorisation is only granted when the evidence shows that the benefits of the vaccine outweigh any risks.

In principle, large-scale Phase 3 efficacy trials involving thousands of participants are required to support the marketing authorisation of a COVID-19 vaccine. These trials should be designed to measure the vaccine’s efficacy in protecting against COVID-19 (efficacy endpoints) and its safety. This is because there are no known indicators (such as the levels of antibodies in the blood) that can predict protection and could be used instead of efficacy endpoints. In addition, we are currently in a situation where the virus is circulating, which makes it feasible to establish the efficacy of a vaccine in large-scale clinical trials.

The protocols of such clinical trials, including any plans for interim analyses, are subject to regulatory approval.

What does the scientific assessment by the European Medicines Agency consist of? What is the process of approval?

To obtain a marketing approval for a vaccine in the EU, a vaccine developer needs to submit the results of all testing/investigations to the medicines regulatory authorities in Europe as part of a ‘marketing authorisation’ application.

Applications for marketing authorisation submitted to EMA undergo a comprehensive, independent scientific assessment carried out by EMA’s expert scientific committees on human medicines and on safety (the “CHMP” and “PRAC”), made up of experts working in national medicines’ regulatory agencies. As for all medicines, EU legislation requires that the initial evaluations are carried out separately by two different assessment teams (led by a so-called Rapporteur and Co-Rapporteur) and reviewed by the Committee as a whole.

For COVID-19, EMA has put in place rapid review procedures to deliver assessments of applications quickly while ensuring robust scientific opinions. Key to this shortening of timescales are ‘rolling reviews’. In a public health emergency, EMA assesses data for promising medicines or vaccines as they become available. Through these rolling reviews, EMA can therefore start evaluating data while the development is still ongoing. When the medicine’s development is progressed enough for a marketing authorisation application, the formal assessment procedure can take place in a shorter than usual timeframe, because the data have already been scrutinised during the rolling review.

The CHMP, once it has concluded its scientific evaluation of the data and after assessing the quality, safety and efficacy of the medicinal product in question, makes a recommendation on whether the medicine should be given a marketing authorisation in the EU.

However, if comprehensive data would not be available at the time of the marketing authorisation application, the EU regulatory system is designed to potentially accommodate this situation by providing for a conditional authorisation system. This means that the initial (“conditional”) authorisation granted by the Commission is based on less comprehensive data than would normally be the case (nonetheless with a positive benefit-risk balance), and with obligations on the marketing authorisation holders for the data to be completed afterwards and to be submitted for assessment. Conditional marketing authorisations are closely monitored and are subject to annual review.

The European Commission takes a decision on whether or not to issue the marketing authorisation on the basis of the recommendation from the EMA. The decision-making timeframe will also be reduced by shortening the period for consulting Member States, and allowing translation of the documents into the full set of languages after the authorisation, rather than before.

What safety requirements need to be met?

In order to authorise any medicinal product, EMA needs to have and assess robust information on its safety, efficacy and pharmaceutical quality, with safety being of the utmost importance. The safety requirements for COVID-19 vaccines remain as high as for any other vaccine in the EU, the context of a pandemic will not change this. 

Before a vaccine is approved for use, the main body of evidence for its safety and efficacy comes from the results of clinical trials, where participants are selected carefully and followed up under controlled conditions.

In addition, after authorisation, EU law requires that the safety of the vaccine – as is the requirement all medicinal products – will be monitored while in use. In addition to safety, the vaccine’s effectiveness should also be monitored. As part of such monitoring, studies are carried out after marketing. Some of these studies may be imposed on companies as part of the conditions for maintaining their marketing authorisation; other studies will be conducted by public authorities responsible for vaccination programmes.

The EU has a comprehensive safety monitoring (pharmacovigilance) system that allows measures to be put in place to minimise risk, to ensure reporting of suspected side effects, to detect any potential adverse effects, and introduce any necessary mitigating actions early.

Specifically for COVID-19 vaccines, EMA in close collaboration with the Commission, Member States, European and international partners, is establishing  enhanced safety monitoring activities. These activities are aimed at making sure that any new information collected post-marketing will be identified and evaluated as quickly as possible, and appropriate regulatory actions are taken in a timely manner to protect patients and safeguard public health. These activities include the collection of exposure data, enhanced safety signal detection and management, enhanced transparency and setting a European infrastructure for vaccines monitoring, including multicentre observational studies on COVID-19 patients. Prompt and clear communication of the outcomes of these evaluations will be ensured.

ONCE A VACCINE IS AVAILABLE

What actually happens when the vaccine is available?

A vaccine will only become available after meeting the established safety requirements, having first undergone the robust scientific assessment by the European Medicines Agency and completed the EU market authorisation procedure.

The Member States will then be able to benefit from those doses by purchasing them, according to the APA concluded.

Where will the doses be stored?

Each Member State will decide on the best way to store the vaccines. The technical storage conditions are defined by each manufacturer based on specific requirements of each type of vaccine so as to ensure they quality.

Who will receive  the first doses?

All Member States will have equal access to the available doses. The Member States will then decide whom they will offer the vaccines to among their population.

COVID-19 VACCINE GLOBAL ACCESS FACILITY (COVAX)

What is the Commissions involvement with COVAX?

The COVAX Facility, co-led by Gavi, the Vaccine Alliance, the Coalition for Epidemic Preparedness Innovations (CEPI) and WHO, aims to accelerate the development and manufacture of COVID-19 vaccines and to guarantee fair and equitable access for every country in the world.

Supporting equal and global access to a safe and efficient vaccine for everyone in the world is a priority for the Commission. No region of the world is safe until we are all safe. That is why, on 31 August, the Commission’s expressed its interest to participate in COVAX. The 31 August announcement included a support of €400 million in guarantees for the COVAX Facility. The vaccines purchased in this context are for Low and Medium Income Countries.

The Commission and Member States joining the COVAX Facility reaffirm that they are supporting COVAX’s objectives and interest as a group, in order to make the EU Vaccines Strategy and the COVAX Facility complementary and thus mutually reinforcing.

The Commission and Member States are currently pursuing a joint approach for their participation in COVAX, and the 31 August expression of interest is part of this process. Talks are ongoing with Gavi and CEPI to reach an agreement in September on terms and conditions for the EU’s participation in the COVAX Facility. .

Will the Commission procure vaccines through the COVAX facility?

The Commission is only purchasing vaccines on behalf of EU Member States via the mechanism set up in the EU Vaccines Strategy and finances it through the Emergency Support Instrument (ESI). The Commission’s participation in COVAX supports a global effort to produce and distribute vaccines to all in need, in particular for low and middle income countries. The detailed terms and conditions for the EU’s and Member States’ participation and contribution is under discussion and will be worked out in the coming days and weeks.

Can Member States buy vaccines through COVAX?  

Member States have committed, as part of the EU Vaccines Strategy, not to enter into parallel negotiations with the same vaccine manufacturers with which talks are on-going at EU level.  This does not exclude the possibility to take part in negotiations with other vaccine companies through COVAX.

What will the guarantees be used for and why not give cash?          

The Commission is providing financial guarantees backing COVAX negotiations on advanced purchase agreements of vaccines. These guarantees will enable COVAX to lower the risk and conclude advanced purchase agreements with a larger portfolio of vaccine producers.

Contracts under negotiation by COVAX require a strong financial backing which the EU guarantees will provide.

How does the Commission ensure complementarity between the EU Vaccines Strategy and COVAX?

The EU Vaccines Strategy goes hand in hand with the EU’s commitment to global solidarity. This applies at different levels: support to companies in their capacity expansion, advancing research and support development for the benefit of the world population. Investing upfront in the accelerated development and manufacturing of vaccines to the benefit of the rest of the world. By providing financial resources to the international institutions, such as WHO, CEPI, GAVI, the EU is also supporting access to vaccines for the whole world.

Manufacturers with whom the EU negotiates are also committed to supply future doses to other countries in the world, there is no exclusivity for delivery to Europe only and no export restriction.

What Europe is doing is making important and risky investments so that together with the regulatory authorisation procedures that we have in place, we accelerate the development of safe and efficacious vaccines, which will also be to the benefit of the rest of the world.

What we do in Europe is complementary and mutually reinforcing with our action for global solidarity. That is also why the Commission and the EU Member States have decided to join the COVAX facility.

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EU Politics

EU Cohesion policy: Commission announces the winners of the REGIOSTARS Awards 2021

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Today, the European Commission has announced the winners of the 2021 edition of the REGIOSTARS Awards that reward the best Cohesion policy projects in the whole EU. This year’s REGIOSTARS competition received a record 214 applications and 14,156 people voted in the public choice’s category.

Commissioner for Cohesion and Reforms, Elisa Ferreira, commented: “My warm congratulations to the 10 winners of the EU Cohesion policy projects of 2021. They are role models for everyone who wishes to better the life of people with the use of EU funds. I hope they will inspire many others across the continent. For sure, with REGIOSTARS we have learnt that excellence and innovation are everywhere in Europe. You just need to look for them and highlight them as they deserve. We will keep looking for them and we will keep supporting them.”

The awards cover five categories and a public choice prize:

For ‘SMART Europe: Increasing the competitiveness of local businesses in a digital world’ (1st category) the award went to Integration 3D metal printing from Belgium. The project supports the implementation of the 3D metal printing technology in small and medium-sized companies (SMEs) through a very innovative integrated approach to knowledge and technology. The idea is easily transferable to other contexts with industrial tradition.

For ‘GREEN Europe: Green and resilient communities in urban and rural setting’ (2nd category) the award was given to ICCARUS (Gent knapt op) for providing a unique housing renovation financial scheme for 100 vulnerable homeowners in Ghent, Belgium. This project has a strong social component and is easily transferable, both to other places, including to less developed regions, and other sectors.

The award for ‘FAIR Europe: Fostering inclusion and anti-discrimination’ (3rd category) went to TREE – Training for integrating Refugees in the Euregion, which facilitates the integration of refugees through the  development of a needs-based training programme for practitioners working with refugees and migrants, and a qualification programme for social interpreters. The winners are from the Netherlands, Germany, and Belgium.

Travelling Solidary Cannery received the award in the 4th category, ‘URBAN Europe: Promoting green, sustainable and circular food systems in functional urban areas’. The project provides the disadvantaged access to healthy and fair food at affordable prices all year round. At the same time, it develops a new range of professions centred on the production, valorisation, logistics and marketing of local products, but also of unsold products from supermarkets or surplus harvests. The winner is from Belgium.

Under the topic of the year: ‘Enhancing green mobility in the regions – European Year of Rail 2021’ (5th category) the winner is North-West Multimodal Transport Hub from the United Kingdom and Ireland. This project provides an increased rail capacity, a strong balance of services for cycling, public transport and active travel users in Londonderry and an encouraging modal shift from car to public transport.

Finally, the ‘Public Choice Award’ goes to BEGIN, a project that unites cities, citizens, and stakeholders through the co-creation of blue and green infrastructure projects in 10 EU cities in the Netherlands, the United Kingdom, Sweden, Belgium, Norway and Germany. The project aims at reducing flood risk by up to 30% and improving livability. Other public favorites were Balkan Road (under the 1st category), Baltazar (3rd category), Digital Farming Specialist (4th category) and Transporte A Pedido (5th category).

Background

The REGIOSTARS Awards are the yearly competition organised by the Commission since 2008: it has become Europe’s label of excellence for EU-funded projects under Cohesion policy that demonstrate innovative and inclusive approaches to regional development.

Each year, hundreds of projects compete in five categories: ‘Smart Europe’, ‘Green Europe’, ‘Fair Europe’, ‘Urban Europe’, and the topic of the year. The public can participate by voting for their favourite project among all finalists for the public choice award.

By bringing about solutions to common challenges and tapping into the biggest opportunities, the REGIOSTARS have inspired regions to deliver evermore-impactful EU Cohesion policy.

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Commission proposes to strengthen coordination of safe travel in the EU

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European Commission has proposed to update the rules on coordination of safe and free movement in the EU, which were put in place in response to the COVID-19 pandemic.

Since the summer, vaccine uptake has increased significantly and the EU Digital COVID Certificate has been rolled out successfully, with more than 650 million certificates issued to date. At the same time, the epidemiological situation in the EU continues to develop with some Member States taking additional public health measures, including administering booster vaccines. Taking into account all those factors, the Commission is proposing a stronger focus on a ‘person-based’ approach to travel measures and a standard acceptance period for vaccination certificates of 9 months since the primary vaccination series. The 9 month period takes into account the guidance of the European Centre for Disease Prevention and Control (ECDC) on the administration of booster doses as of 6 months, and provides for an additional period of 3 months to ensure that national vaccination campaigns can adjust and citizens can have access to boosters.

The Commission is also proposing updates to the EU traffic light map; as well as a simplified ‘emergency brake’ procedure. 

The Commission is also proposing today to update the rules on external travel to the EU [press release available as of 14:15].

Didier Reynders, Commissioner for Justice, said: “Since the start of the pandemic, the Commission has been fully active in finding solutions to guarantee the safe free movement of people in a coordinated manner. In light of the latest developments and scientific evidence, we are proposing a new recommendation to be adopted by the Council. Based on our common tool, the EU Digital COVID Certificate, which has become a real standard, we are moving to a ‘person-based’ approach. Our main objective is avoid diverging measures throughout the EU. This also applies to the question of boosters, which will be essential to fight the virus. Among other measures, we propose today that the Council agrees on a standard validity period for vaccination certificates issued following the primary series. Agreeing on this proposal will be crucial for the months ahead and the protection of the safe free movement for citizens.”

Stella Kyriakides, Commissioner for Health and Food Safety added:  “The EU Digital COVID Certificate and our coordinated approach to travel measures have greatly contributed to safe free movement, with the protection of public health as our priority. We have vaccinated over 65% of the total EU population, but this is not enough. There are still too many people who are not protected. For everyone to travel and live as safely as possible, we need to reach significantly higher vaccination rates – urgently. We also need to reinforce our immunity with booster vaccines. Taking into account the guidance from ECDC, and to allow Member States to adjust their vaccination campaigns and for citizens to have access to boosters, we propose a standard acceptance period for vaccination certificates. At the same time, we have to continue to strongly encouraging everyone to continue to respect public health measures. Our masks need to stay on.”

Key updates to the common approach to travel measures within the EU proposed by the Commission are:

Focus on a ‘person-based approach’: a person who has a valid EU Digital COVID Certificate should in principle not be subject to additional restrictions, such as tests or quarantine, regardless of their place of departure in the EU. Persons without an EU Digital COVID Certificate could be required to undergo a test carried out prior to or after arrival.

Standard validity of vaccination certificates: To avoid diverging and disruptive approaches, the Commission proposes a standard acceptance period of 9-month for vaccination certificates issued following the completion of the primary vaccination series. The 9 month period takes into account the guidance of the European Centre for Disease Prevention and Control (ECDC) on the administration of booster doses as of 6 months, and provides for an additional period of 3 months to ensure that national vaccination campaigns can adjust and citizens can have access to boosters. This means that, in the context of travel, Member States should not refuse a vaccination certificate that has been issued less than 9 months since the administration of the last dose of the primary vaccination. Member States should immediately take all necessary steps to ensure access to vaccination for those population groups whose previously issued vaccination certificates approach the 9-month limit.

Booster shots: As of yet, there are no studies expressly addressing the effectiveness of boosters on transmission of COVID-19 and therefore it is not possible to determine an acceptance period for boosters. However, given the emerging data it can be expected that protection from booster vaccinations may last longer than that resulting from the primary vaccination series. The Commission will closely monitor newly emerging scientific evidence on this issue. On the basis of such evidence, the Commission may, if needed, propose an appropriate acceptance period also for vaccination certificates issued following a booster.

The EU traffic light map is adapted: combining new cases with a region’s vaccine uptake. The map would be mainly for information purposes, but would also serve to coordinate measures for areas with particularly low (‘green’) or particularly high level (‘dark red’) of circulation of the virus. For these areas, specific rules would apply by derogation from the ‘persons-based approach’. For travellers from ‘green’ areas, no restrictions should be applied. Travel to and from ‘dark red’ areas should be discouraged, given the high number of new infections there, and persons who are neither vaccinated nor have recovered from the virus should be required to undergo a pre-departure test and quarantine after arrival (with special rules for essential travelers and children under 12 years old).

Exemptions from certain travel measures: should apply for cross-border commuters, children under 12 and essential travellers. The list of essential travellers should be reduced as many travellers included in the current list have had the opportunity to be vaccinated in the meantime.

Simplified ‘emergency brake’ procedure: the emergency procedure intended to delay the spread of possible new COVID-19 variants or address particularly serious situations should be simplified and more operational. It would include a Member State notification to the Commission and the Council and a roundtable at the Council’s Integrated Political Crisis Response (IPCR).

To allow for sufficient time for the coordinated approach to be implemented, the Commission proposes that these updates apply as of 10 January 2022.

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EU: new laws on political advertising, electoral rights and party funding

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The European Commission has today presented a proposal on transparency and targeting of political advertising, as part of measures aimed at protecting election integrity and open democratic debate.  The proposed rules would require any political advert to be clearly labelled as such and include information such as who paid for it and how much. Political targeting and amplification techniques would need to be explained publicly in unprecedented detail and, would be banned when using sensitive personal data without explicit consent of the individual. The Commission also proposes to update the current EU rules concerning EU “mobile citizens” and their right to vote in European and municipal elections as well as on European political parties and foundations.

Vice-President for Values and Transparency, Vera Jourová said: “Elections must not be a competition of opaque and non-transparent methods. People must know why they are seeing an ad, who paid for it, how much, what micro-targeting criteria were used. New technologies should be tools for emancipation, not for manipulation. This ambitious proposal will bring unprecedented level of transparency to political campaigning and limit the opaque targeting techniques.”

Commissioner for Justice, Didier Reynders, said: “Fair and transparent elections are an integral part of a vibrant and functioning society. That is why we need to support inclusive and equal participation in the 2024 elections to the European Parliament and in municipal elections across the EU. With the proposal on political advertising, we are securing the use of personal data in context of political targeting, protecting the democratic process. Together, we are making progress with our common work for democracy.”

Clear rules on transparency and targeting of political advertising

With the digital transition under way, people must be able to easily distinguish whether they are looking at paid political content – offline and online, and be able to participate in open debates, free from disinformation, interference and manipulation. People should be able to clearly see who sponsored a political advert and why. The main measures set out in the proposed Regulation on transparency and targeting of political adverts include:

Scope: Political ads will cover ads by, for or on behalf of a political actor as well as so called issue-based ads which are liable to influence the outcome of an election or referendum, a legislative or regulatory process or voting behaviour.

Transparency labels: Paid political advertising must be clearly labelled and provide a set of key information. This includes the name of the sponsor prominently displayed and an easily retrievable transparency notice with (1) the amount spent on the political advertisement, (2) the sources of the funds used and (3) a link between the advertisement and the relevant elections or referenda.

Strict conditions for targeting and amplification: Political targeting and amplification techniques, which use or infer sensitive personal data, such as ethnic origin, religious beliefs or sexual orientation, will be banned. Such techniques will be allowed only after an explicit consent from a person concerned. Targeting could also be allowed in the context of legitimate activities of foundations, associations or not-for-profit bodies with a political, philosophical, religious or trade union aim, when it targets their own members. For the first time it will be mandatory to include into the ads’ clear information on what basis the person is targeted and to publish which groups of individuals were targeted, on the basis of which criteria and with what amplification tools or methods, among others. Organisations making use of political targeting and amplification will need to adopt, apply and make public an internal policy on the use of such techniques. If all transparency requirements cannot be met, a political add cannot be published.

Fines for breaches: Member States will be required to introduce effective, proportionate and dissuasive fines when the rules on transparency of political advertising are breached. Under the proposed Regulation, National Data Protection Authorities will monitor specifically the use of personal data in political targeting and have the power to impose fines in line with EU data protection rules.

Update of EU rules on EU political parties and foundations and on electoral rights

The Commission has also proposed to revise the EU rules on funding of European political parties and foundations. The current framework had a number of loopholes, preventing the parties and foundations from operating and fulfilling their mission to represent the voice of EU citizens. The updates to the Regulation seek to facilitate European political parties interactions with their national member parties and across borders, increase transparency, in particular in relation to political advertisement and donations, cut excessive administrative burden and increase the financial viability of European political parties and foundations.

Finally, the Commission has proposed to update the current rules on European elections and municipal for EU citizens who reside in a different Member State to their state of nationality (“mobile EU citizens”). While there are around 13.5 million such citizens, very few exercise their right to vote in European and municipal elections. In order to ensure inclusive participation ahead of European elections in 2024, the Commission proposes targeted amendments to the existing Directives on electoral rights including, among others, obligation to inform such citizens proactively of their electoral rights, use standardised templates for registration as voters or candidates as well as use of language broadly spoken by the mobile EU citizens residing at the territory. The proposal also includes safeguards for EU mobile citizens not to be de-registered from electoral roll in the country of their origin.

Next Steps

The proposals will now be discussed by the European Parliament and the Council. To ensure that the 2024 elections to the European Parliament take place under the highest democratic standards, the aim is for the new rules to enter into force and be fully implemented by Member States by spring 2023, i.e. one year before the elections.

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