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Interview with Eric Bossan, Head of Europe Viatris

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Martin Banks talks with Eric Bossan.

Can you tell us something about Viatris, your own personal role and also what the company is doing, and will do, in terms of environmental sustainability?

Viatris is a global health-care company formed in November 2020 with a workforce of more than 40,000. Viatris aims to deliver increased access to affordable, quality medicines for patients worldwide, regardless of geography or circumstance.

I oversee our commercial operations. In Europe, we are one of the leading pharmaceutical companies. We have a presence in 38 countries and employ approx. 11,000 individuals. We are, for example, a key player in thrombosis, and in driving access to biosimilars, which can offer important, and often more affordable, treatment alternatives – with one of the industry’s largest and most diverse biosimilar portfolios.

Sustainability for us refers to the long-term durability of our overall performance, powered by our mission and operating model. This assumes respect for the natural resources we rely on and the societal contributions we make through our work.

Pollution is one of the themes of EU Green Week this year. How big a health problem is pollution and what do you hope the event will achieve in terms of tackling this global issue?

As stated also in the Zero Pollution action plan launched by the EC mid-May, pollution is the largest environmental cause of multiple mental and physical diseases and of premature deaths.

As part of our commitment, we are upholding sustainable and responsible operations, and work diligently to reduce our environmental impact. We have an integrated approach focused on managing our water use, air emissions, waste, climate change and energy impact; some examples of our efforts are: we grew the use of renewable energy by 485% in the past five years and all sites from our legacy company Mylan in Ireland – a country where we have the highest number of sites in Europe - are using 100% renewable energy.

That being said, EU Green Week 2021 has been and continues to be an opportunity to exchange knowledge and engage with stakeholders and interested citizens on how we can work together to make the ambition for a zero pollution and toxic-free environment a reality.

We cannot do it alone – therefore, we partner with industry and academia to promote risk- and science-based policies and practices.

For example, we are advocating established industry initiatives on good environmental practices including responsible manufacturing and effluent management, as well as partnering with pharmaceutical industry to scale up application.

What specifically is your company’s engagement with Green Week 2021 and, more generally, with the EU? How realistic is the EU’s Zero Pollution Ambition? Could the EU be doing more in this field?

As it was a very insightful week, my call is to use EUGreenWeek energy to take on the environmental challenges ahead and be inspired by the determination and commitment the pharmaceutical industry has put behind COVID-19. The pharmaceutical industry needs to play a part in leading these efforts, as we look to ensure the supply of high-quality medicine and upholding responsible environmental conduct.

Our work at the Brussels level combines advocating for established good practices including responsible manufacturing and effluent management. We believe this is the best way to scale the application of good environmental practices and to facilitate effectiveness across the value chain, to help reduce administrative burden and contain cost – all of which serve the two overarching objectives of stable and timely access to high quality and affordable medicine and responsible conduct.

For example, we are working together with the European pharmaceutical industry associations -  Medicines for Europe, the Association of the European Self-Care Industry (AESGP) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) - and developed a holistic framework for prediction and prioritization of pharmaceuticals to support evaluations of their potential risks in water systems and a spatially explicit environmental exposure tool which enables users to predict API (active pharmaceutical ingredient) concentrations in water systems. The follow-up project, PREMIER, public-private partnership, co-funded by the European Commission and started in September 2020, will make the available environmental data more visible and accessible to all stakeholders.

Can you explain, briefly, how your company tries to balance between addressing pressing health needs and tackling environmental challenges?

Environmental and human health are interconnected, a relationship underscored by climate change, pollution and water stress. The European Commission has set ambitious targets in the European Climate Law - to include the 2030 emissions reduction target of at least 55% as a steppingstone to the 2050 climate neutrality goal; it will most certainly help to drive a greener Europe and contribute to improve public health.

As regards to pharmaceuticals, the ambitious Zero Pollution Action Plan aims to solve pollution from pharmaceuticals in water, in addition to the EU one Health Action Plan against antimicrobial resistance (AMR). Additionally, EU citizens, and our customers and business partners, are more environmentally conscious and demand that companies take a position and show commitment to this topic.

As pharmaceuticals are a highly regulated industry, manufacturing effluent only marginally contributes to the presence of pharmaceuticals in the environment. Most of the impact comes from human excretion. For effective results, municipalities should be putting in place wastewater treatment plants.

We are committed to doing our part as we work to fulfil our mission of addressing the environmental impact of our industry while delivering access to patients regardless of geography or circumstance.

Conserving water and proactive wastewater management are core components to managing sustainable operations as well as in promoting access to medicine and good health. For example, in 2020, we implemented measures at several of our sites in India to reduce our water use, enhance efficiency and ensure that no untreated wastewater enters the environment. These initiatives testify to our commitment to conserving water and proactive wastewater management globally.

Another area which we find to be critical to partner on is fighting antimicrobial resistance (AMR), which occurs when bacteria evolve to withstand the effects of antibiotics. Many factors contribute to AMR, including poor infection control, over-prescribing of antibiotics and antibiotics in the environment. Most antibiotics in the environment are the result of human and animal excretions while a significantly smaller amount is from the manufacturing of active pharmaceutical ingredients (API) and their formulation into drugs. We are a signatory to the Davos Declaration on combating AMR and a founding board member of the AMR Industry Alliance. We have adopted the AMR Industry Alliance Common Antibiotic Manufacturing Framework and are an active member of its manufacturing working group. The Common Antibiotic Manufacturing Framework provides a common methodology to assess potential risk from antibiotic discharges and to take appropriate action when necessary.

As a newly formed company, we look forward to setting science-based performance targets, initially focused on climate, water and waste. Also, Viatris has recently endorsed the UN Global Compact CEO Water Mandate. It is an important, global initiative committed to reducing water stress by identifying and reducing critical water risks, seizing water-related opportunities, and contributing to the UN Sustainable Development Goals.

What, if any, are the lessons to be learned from the pandemic in terms of environmental sustainability and tackling pollution? Will the world be better equipped to tackle another pandemic like this?

The pandemic has underlined urgent issues of global health solidarity, security and equity, and the economic impacts of it will have long-ranging ramifications. As a company, in 2020, we focused our policy efforts related to COVID-19 on ensuring continuity of access to medicines for patients around the world, overcoming an ever-changing landscape of border restrictions, government requirements and health system disruptions.

The efforts made by hundreds of thousands of healthcare workers worldwide can’t be underscored enough. Their tireless efforts and the collaboration between public and private partners, including the global pharmaceutical industry, proves that when we align on a common objective, we can make it happen.

Looking to the future, what do you see as the main issues/challenges ahead for policymakers and your sector?

To overcome any challenges or issues, we must keep an open and constructive dialogue with stakeholders around Europe, aim to find solutions that guarantee access to medicines and respond to the health and environmental challenges. It is my strong belief that business can be a force for good. We are ready to partner for a greener and more just Europe.

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EAPM: 2nd Bridging Presidency Conference on 'Innovation, Public Trust and Evidence' beckons: Register now!

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Good morning, health colleagues, and a warm welcome to the European Alliance for Personalised Medicine (EAPM) update. We have exciting news this morning as an upcoming 2nd Bridging Presidency conference during the Slovenian Presidency of the EU will take place on 1 July, writes EAPM Executive Director Dr. Denis Horgan.

Bridging Conference: Innovation, Public Trust and Evidence: Generating Alignment to facilitate personalized Innovation in Health Care Systems – Registration Open

The theme of EAPM’s 2nd Bridging Presidency conference, which will be held on Thursday,  1 July, during the auspices of the Slovenia Presidency of the EU, will be ‘Innovation, Public Trust and Evidence: Generating Alignment to facilitate personalized Innovation in Health Care’

The conference is divided into five sessions which cover the follows areas: 

  • Session 1: Generating alignment in the regulation of Personalized Medicine: RWE and Citizen Trust
  • Session 2: Beating Prostate Cancer and Lung Cancer - The Role of the EU Beating Cancer: Updating EU Council Conclusions on Screening
  • Session 3: Health Literacy - Understanding Ownership and Privacy of Genetic Data
  •  Session 4: Securing patient Access to Advanced Molecular Diagnostics

Each session will comprise panel discussions as well as Q&A sessions to allow the best possible involvement of all participants, so now is the time to register, here, and download your agenda here!

So, what are among the topics on the table?

The current COVID-19 crisis has thrown many European, and indeed global, healthcare issues into sharp relief.  It has also raised important questions, not necessarily new ones, but ones that have shifted more into focus during the pandemic.

One such question is whether the EU should have a bigger role in public health – and particularly in the provision of health technology. This, of course, would impinge upon the closely guarded member state competence in healthcare so, if this were to happen, how would that be?

Another question is how can the now very evident gaps be bridged in order to better protect Europe’s health ahead of another crisis and how do we identify potential patients? What are the priorities?  Should the EU develop Lung and Prostate Cancer Screening Guidelines?  The broader question, as mentioned above, is whether it’s time to give the EU a bigger role in Europe’s health protection.

Meanwhile, at the heart of personalised medicine, is the hugely expanding use of health data. This is a sensitive topic. There’s certainly a need for the health-science community to talk more openly about using personal health data in research to enhance human health and eradicate diseases such as cancer and the public has to be at the centre of any and all discussion.

Many national and international initiatives rely on comprehensive data analytics to drive evidence-based solutions to improve health outcomes.

Alongside our many great speakers, attendees will be drawn from leading experts in the personalised medicine arena – including patients, payers, healthcare professionals, plus industry, science, academia and the research field. We’ll be discussing, at some point during the day, most or all of what we’ll be talking about below.

You can register, here, and download our agenda here!

In other news…

500million BioNTech/Pfizer doses set for global distribution from US

The Biden administration plans to purchase 500 million doses of Pfizer coronavirus vaccine to distribute to other nations, significantly adding to its ongoing efforts to inoculate populations around the world, according to three people familiar with the plans. The move by the U.S. government could lead to 200 million Pfizer doses being sent worldwide this year, followed by another 300 million across the first half of 2022, according to the individuals familiar with the plan. President Joe Biden will announce the plan ahead of the G-7 meeting in the United Kingdom. 

Pfizer and its development partner BioNTech have boasted in recent weeks that they are vastly expanding manufacturing capabilities and expect to deliver billions of doses within the next few years.

EU Digital COVID Certificate

MEPs see the EU Digital COVID Certificate as a tool to restore freedom and urge EU countries to implement it by 1 July. The certificate aims to enable easier and safer travel by proving someone has been vaccinated, had a negative COVID test or recovered from the disease. The infrastructure for it is in place and 23 countries are technically ready, with nine already issuing and verifying at least one type of certificate. 

In a plenary debate on 8 June, Juan Fernando López Aguilar (S&D, Spain), the lead MEP regarding the certificate, said that freedom of movement is highly prized by EU citizens and that the negotiations on the COVID Certificate "have been completed in record time”. 

“We want to send out the message to European citizens that we are doing everything we can to restore freedom of movement.” 

Justice Commissioner Didier Reynders said: "The certificate, which will be free of charge, will be issued by all member states and will have to be accepted across Europe. It will contribute to a gradual lifting of restrictions." Member states have to apply the rules The COVID certificate is “the first step towards getting rid of restrictions and that is good news for many people in Europe - people who travel for work, families that live in border areas, and for tourism,” said MEP Birgit Sippel (S&D, Germany). 

She said it is now up to EU countries to harmonise the rules on travel. “All citizens in the European Union rightfully expect to be able to use this system by the start of summer and member states must deliver,” said Jeroen Lenaers (EPP, the Netherlands). He said that this means not only the technical implementation of the certificate, but much more: “European citizens want to finally have some co-ordination and predictability on our internal borders.”

Plenary vote on waiver

MEPs will today (10 June) vote on a resolution on the TRIPS waiver discussions — the European Parliament endorsed a resolution on Wednesday (9 June) calling for a temporary waiver of COVID-19 vaccine patents, while the Commission remained firm in its opposition to such measures and said it has different plans to speed up the global vaccine rollout. 

The Parliament voted in support of waiving COVID-19 vaccine intellectual property (IP) rights with 355 to 263 and 71 abstentions. The vote came after a debate on whether the EU should join other countries such as South Africa and India in demanding a waiver of IP rights in the context of the World Trade Organisation (WTO). MEPs were largely split: while some called on the Commission to support the waiver, others, particularly from the centre-right European People’s Party (EPP), argued that this would not accelerate the provision of vaccines and would harm innovation. 

Lawmakers in the European Parliament’s trade committee expressed their pro-waiver position on 25 May, after adopting a report on the trade-related aspects and implications of COVID-19. The report urged the EU to engage in constructive talks with the WTO for a temporary waiver from the IPR protection on COVID-19 vaccines, to ensure that countries do not face retaliation over COVID-19-related patent infringements. According to the Greens leader, one tool to bring this forward and boost global vaccine production is the temporary waiver of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), as well as compulsory licensing and knowledge sharing for countries of the south of the world.

And that is all for this week from EAPM – don’t forget to register for the upcoming EAPM/Slovenian EU Presidency here and see the agenda here, and have a safe and very enjoyable weekend.

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COVID-19

Mainstream media risks becoming a threat to public health

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In recent weeks the controversial claim that the pandemic might have leaked from a Chinese laboratory - once dismissed by many as a fringe conspiracy theory - has been gaining traction. Now, US President Joe Biden has announced an urgent investigation that will look into the theory as a possible origin of the disease, writes Henry St.George.

Suspicion first arose in early 2020 for obvious reasons, the virus having emerged in the same Chinese city as the Wuhan Institute of Virology (WIV), which has been studying coronaviruses in bats for over a decade. The laboratory is located just a few kilometres from the Huanan wet market where the first cluster of infections emerged in Wuhan.

Despite the glaring coincidence, many in the media and politics dismissed the idea outright as a conspiracy theory and refused to consider it seriously throughout the past year. But this week it has emerged that a report prepared in May 2020 by the Lawrence Livermore National Laboratory in California had concluded that the hypothesis claiming the virus leaked from a Chinese lab in Wuhan was plausible and deserved further investigation.

So why was the Lab Leak Theory overwhelmingly dismissed from the get go? There is no question that from the mainstream media’s perspective the idea was tarnished by association with President Donald Trump. Granted, skepticism of the President’s claims surrounding any given aspect of the pandemic would have been warranted at almost any stage. To put it euphemistically, Trump had shown himself to be something of an unreliable narrator.

During the course of the pandemic Trump dismissed the seriousness of COVID-19 repeatedly, pushed unproven, potentially dangerous remedies like hydroxychloroquine, and even suggested at one memorable press briefing that injecting bleach might help.

Journalists also reasonably feared similarities with the narrative of weapons of mass destruction in Iraq, whereby vast threats were cited and assumptions granted to an antagonistic theory with too little evidence to back it up.

However, it’s impossible to ignore the fact that a general animus felt towards Trump by large swathes of the media brought about a large-scale dereliction of duty and failure to uphold objective standards of journalism as well as science. In reality the Lab Leak was never a conspiracy theory but a valid hypothesis all along.

Suggestions to the contrary by anti-establishment figures in China were also summarily quashed. As early as September 2020, the ‘Rule of Law Foundation’, connected with prominent Chinese dissident Miles Kwok, appeared on the title page a study that alleged the coronavirus was an artificial pathogen. Mr. Kwok’s long-standing opposition to the CCP was sufficient to ensure the idea was not taken seriously.

Under the pretense that they were combatting misinformation, the social media monopolies even censored posts about the lab-leak hypothesis. Only now – after almost every major media outlet as well as the British and American security services have confirmed that it is a feasible possibility – have they been forced to backtrack.

“In light of ongoing investigations into the origin of COVID-19 and in consultation with public health experts,” a Facebook spokesman said, “we will no longer remove the claim that COVID-19 is man-made or manufactured from our apps.” In other words, Facebook now believes that its censorship of millions of posts in the preceding months had been in error.

The consequences of the idea not having been taken seriously are profound. There is evidence that the lab in question may have been conducting what is called “gain of function” research, a dangerous innovation in which diseases are deliberately made more virulent as part of scientific research.

As such, if the lab theory is in fact true, the world has been deliberately kept in the dark about the genetic origins of a virus that has killed over 3.7m people to date. Hundreds of thousands of lives could have been saved if the key properties of the virus and its propensity to mutate had been understood sooner and better.

The cultural ramifications of such a discovery cannot be overstated. If the hypothesis is true - the realization will soon set in that the world’s fundamental mistake was not insufficient reverence for scientists, or inadequate respect for expertise, but not enough scrutiny of mainstream media and too much censorship on Facebook. Our main failure will have been the inability to think critically and acknowledge that there is no such thing as absolute expertise.

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Commission approves €800 million Italian scheme to support companies in context of coronavirus outbreak

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The European Commission has approved a €800 million Italian scheme to support companies affected by the coronavirus outbreak, active in Italy under “Development Contracts” for the implementation of priority projects. The scheme was approved under several sections of the State Aid Temporary Framework.

Executive Vice President Margrethe Vestager (pictured), in charge of competition policy, said: “This €800 million Italian scheme will ensure liquidity support to companies affected by the coronavirus outbreak. At the same time, it will contribute to much needed research activities and products to respond to the coronavirus outbreak. We continue working in close cooperation with member states to find workable solutions to mitigate the economic impact of the coronavirus outbreak, in line with EU rules.”

The Italian measures

Italy notified to the Commission a €800 scheme addressed to companies performing priority projects under so-called “Development Contracts under the COVID-19 Temporary Framework” (mainly COVID-related projects). The scheme supports companies affected by the coronavirus outbreak and provides incentives to companies for directing their activities to research and/or production of certain products that are crucial to address the coronavirus outbreak.

These “Development Contracts” will be administered by the National Agency for Inward Investment and Economic Development S.p.A. (Invitalia) and will be open to companies of all sizes, active in all sectors, except the financial, primary production of agricultural products, fishery and aquaculture, construction, insurance and real estate ones.

The aid will take the form of:

  • Direct grants and loans up to a maximum of €1.8m per company and with an overall maximum nominal value equal to 45% of the eligible costs;
  • direct grants for coronavirus-related research and development (R&D) projects, with a maximum allowable aid intensity equal to 80% of the eligible costs;
  • direct grants and repayable advances for testing and upscaling infrastructures that contribute to the development of coronavirus relevant products, with a maximum allowable aid intensity equal to 75% of the eligible costs, and;
  • direct grants and repayable advances for the production of coronavirus-relevant products, with a maximum allowable aid intensity equal to 80% of the eligible costs.

The Commission found that the Italian scheme is in line with the conditions set out in the Temporary Framework. In particular, (i) the aid granted under the first measure will not exceed €1.8 million per company, (ii) the aid granted under the other measures will cover a significant share of the necessary R&D and investment costs, iii) for the second measure in particular, any result of the research activities will be made available to third parties in the European Economic Area at non-discriminatory market conditions through non-exclusive licences, and (iv) all aid will be granted no later than 31 December 2021.

The Commission therefore concluded that all the measures are necessary, appropriate and proportionate to remedy a serious disturbance in the economy of a member state, in line with Article 107(3)(b) TFEU or to fight the health crisis, in line with Article 107(3)(c). On this basis, the Commission approved the aid measures under EU state aid rules.

Background

The Commission has adopted a Temporary Framework to enable member states to use the full flexibility foreseen under state aid rules to support the economy in the context of the coronavirus outbreak. The Temporary Framework, as amended on 3 April, 8 May, 29 June, 13 October 2020 and 28 January 2021, provides for the following types of aid, which can be granted by member states:

(i) Direct grants, equity injections, selective tax advantages and advance payments of up to €225,000 to a company active in the primary agricultural sector, €270,000 to a company active in the fishery and aquaculture sector and €1.8m to a company active in all other sectors to address its urgent liquidity needs. Member states can also give, up to the nominal value of €1.8m per company zero-interest loans or guarantees on loans covering 100% of the risk, except in the primary agriculture sector and in the fishery and aquaculture sector, where the limits of €225,000 and €270,000 per company respectively, apply.

(ii) State guarantees for loans taken by companies to ensure banks keep providing loans to the customers who need them. These state guarantees can cover up to 90% of risk on loans to help businesses cover immediate working capital and investment needs.

(iii) Subsidized public loans to companies (senior and subordinated debt) with favourable interest rates to companies. These loans can help businesses cover immediate working capital and investment needs.

(iv) Safeguards for banks that channel State aid to the real economy that such aid is considered as direct aid to the banks' customers, not to the banks themselves, and gives guidance on how to ensure minimal distortion of competition between banks.

(v) Public short-term export credit insurance for all countries, without the need for the member state in question to demonstrate that the respective country is temporarily “non-marketable”.

(vi) Support for coronavirus related research and development (R&D) to address the current health crisis in the form of direct grants, repayable advances or tax advantages. A bonus may be granted for cross-border cooperation projects between member states.

(vii) Support for the construction and upscaling of testing facilities to develop and test products (including vaccines, ventilators and protective clothing) useful to tackle the coronavirus outbreak, up to first industrial deployment. This can take the form of direct grants, tax advantages, repayable advances and no-loss guarantees. Companies may benefit from a bonus when their investment is supported by more than one member state and when the investment is concluded within two months after the granting of the aid.

(viii) Support for the production of products relevant to tackle the coronavirus outbreak in the form of direct grants, tax advantages, repayable advances and no-loss guarantees. Companies may benefit from a bonus when their investment is supported by more than one member state and when the investment is concluded within two months after the granting of the aid.

(ix) Targeted support in the form of deferral of tax payments and/or suspensions of social security contributions for those sectors, regions or for types of companies that are hit the hardest by the outbreak.

(x) Targeted support in the form of wage subsidies for employees for those companies in sectors or regions that have suffered most from the coronavirus outbreak, and would otherwise have had to lay off personnel.

(xi) Targeted recapitalisation aid to non-financial companies, if no other appropriate solution is available. Safeguards are in place to avoid undue distortions of competition in the Single Market: conditions on the necessity, appropriateness and size of intervention; conditions on the state's entry in the capital of companies and remuneration; conditions regarding the exit of the State from the capital of the companies concerned; conditions regarding governance including dividend ban and remuneration caps for senior management; prohibition of cross-subsidisation and acquisition ban and additional measures to limit competition distortions; transparency and reporting requirements.

(xii) Support for uncovered fixed costs for companies facing a decline in turnover during the eligible period of at least 30% compared to the same period of 2019 in the context of the coronavirus outbreak. The support will contribute to a part of the beneficiaries' fixed costs that are not covered by their revenues, up to a maximum amount of €10m per undertaking.

The Commission will also enable member states to convert until 31 December 2022 repayable instruments (e.g. guarantees, loans, repayable advances) granted under the Temporary Framework into other forms of aid, such as direct grants, provided the conditions of the Temporary Framework are met.

The Temporary Framework enables member states to combine all support measures with each other, except for loans and guarantees for the same loan and exceeding the thresholds foreseen by the Temporary Framework. It also enables member states to combine all support measures granted under the Temporary Framework with existing possibilities to grant de minimis to a company of up to €25,000 over three fiscal years for companies active in the primary agricultural sector, €30,000 over three fiscal years for companies active in the fishery and aquaculture sector and €200,000 over three fiscal years for companies active in all other sectors. At the same time, member states have to commit to avoid undue cumulation of support measures for the same companies to limit support to meet their actual needs.

Furthermore, the Temporary Framework complements the many other possibilities already available to Member States to mitigate the socio-economic impact of the coronavirus outbreak, in line with EU State aid rules. On 13 March 2020, the Commission adopted a Communication on a co-ordinated economic response to the COVID-19 outbreak setting out these possibilities. For example, member states can make generally applicable changes in favour of businesses (e.g. deferring taxes, or subsidising short-time work across all sectors), which fall outside State Aid rules. They can also grant compensation to companies for damage suffered due to and directly caused by the coronavirus outbreak.

The Temporary Framework will be in place until the end of December 2021. With a view to ensuring legal certainty, the Commission will assess before this date if it needs to be extended.

The non-confidential version of the decision will be made available under the case number SA.62576 in the state aid register on the Commission's competition website once any confidentiality issues have been resolved. New publications of State aid decisions on the internet and in the Official Journal are listed in the Competition Weekly e-News.

More information on the Temporary Framework and other action the Commission has taken to address the economic impact of the coronavirus pandemic can be found here.

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