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#EAPM – Vaccine confidence, preventing cancer, second waves

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Hello to all our health correspondents, and welcome to the latest update from the European Alliance for Personalised Medicine (EAPM). There is news today about improving vaccine confidence in the UK and Europe and how preventing cancer is a priority, so forwards we go, writes EAPM Executive Director Denis Horgan.  

First, a quick word about EAPM’s upcoming events –  regarding our ESMO event, please see the agenda here, register here, and there is of course the upcoming participation of EAPM at the German Presidency conference in October, register by clicking here, and see the agenda by clicking here.

Vaccine confidence boost in UK and Europe, doubts globally

Public confidence in vaccines may be improving in the UK and other parts of Europe but many countries worldwide are seeing growing doubts over immunizations, a new study suggests.  Nations experiencing political instability and religious extremism are seeing increasing scepticism over the safety of inoculations, the researchers said, adding that the spread of misinformation is also posing a global threat to vaccination programmes. The study is based on data from more than 284,000 adults across 149 countries in what is thought to be the largest global vaccine confidence survey identifying “hesitancy hotspots”.  In the UK, confidence in vaccine safety rose from 47% in May 2018 to around 52% in November 2019.  In contrast, the researchers said, countries such as Azerbaijan, Afghanistan, Indonesia, Nigeria, and Pakistan showed a fall in confidence in the importance, safety, and effectiveness of vaccines.  

The findings, published in the journal The Lancet, also raise questions over people’s willingness to be given a COVID-19 vaccination should any of the candidates currently undergoing trials prove successful.  In 2019, the World Health Organization (WHO) declared vaccine hesitancy as one of the top 10 threats to global health.  As the race to find a COVID-19 vaccine continues, the authors said assessing public attitudes on a regular basis and taking swift action when confidence is declining “must be top priority to give the best chance to ensure uptake of new life-saving vaccines”.  Poland was one of the countries in Europe which showed “significant losses” in confidence in vaccine safety – a dip from 64% strongly agreeing that vaccines are safe in November 2018 to 53% by December 2019.  The researchers attribute the fall in confidence to “the growing impact of a highly organized local anti-vaccine movement”.

Cancer prevention ‘like Mrs Columbo’

Concerning the effect that COVID-19 has had and continues to have on the EU and Europe as a whole, and on the incidence of cancer, Health and Food Safety Commissioner Stella Kyriakides said: “COVID-19 has been yet another wake-up call, making us acutely aware of the relationship between our ecosystems and our health and the need to face the facts – the way we live, consume and produce is detrimental to the climate and impacts negatively on our health, and with Europe's future Beating Cancer Plan, we have made a strong commitment to protect the health of our citizens and our planet.”

And preventing cancer appears to be emerging as the most popular point of emphasis for Europe’s Beating Cancer Plan, with a wry observation on a never-seen character from a 1970s TV detective show. “Prevention is like Mrs Columbo from the 1970s detective show Columbo, joked the Commission’s Hana Horka. “Mrs Columbo was frequently invoked, but viewers never saw her. 

"Likewise, governments have stressed in every single meeting the importance of prevention, but only an average of 3% of the budgets go towards that imperative,” she said. “We will probably not see amazing results of the prevention activities over the next two years,” she added, but said that 30 years “is a more realistic time frame”. SANTE’s Matthias Schuppe said a dashboard is being considered as a way to track the Cancer Plan’s results. “The cancer plan is a political priority for the entire Commission, it’s not just a SANTE priority,” Schuppe said. 

HTA ‘missed opportunity’

The rolling reviews of evidence of a substantial list of potential COVID-19 therapies is the “perfect example of what can be done” when EU countries collaborate on health technology assessment, said EUnetHTA’s Marcus Guardian. In the face of an unprecedented situation, it is essential that researched, timely and reliable information be made available to inform all stakeholders, whether they be healthcare professionals or the general public, to help develop a coordinated response to the Covid-19 pandemic. 

However, shortcomings of the majority of the HTAs have been found, according to reports – although most have supported the adoption of biosimilars, these statements have often been based on reports lacking a systematic literature review and not considering economic issues. 

The authors evaluated each report based on whether they covered safety and effectiveness; economic analysis; financial impact; clinical evidence; quality of evidence; organizational considerations; and ethical, social, and legal considerations. The two full HTAs met all criteria. All full and mini-HTAs included a systematic review of the clinical evidence, compared with just 3% of the rapid reviews. Almost half of rapid reviews failed to evaluate the risk of bias of studies, and this has represented a missed opportunity for an HTA to lead to cost savings, argue experts.

France at ‘worrisome’ point in its second coronavirus wave

According to Scientific Council President Jean-François Delfraissy, speaking on Wednesday (9 September) this week, the ‘worrisome’ situation in France is “much more severe” than Italy, but not yet as bad as in Spain, adding that politicians will need to make “difficult decisions” over the next eight to 10 days to protect the health system in certain regions. However, he suggested measures like closing bars would not be a solution.

UK research funding knocked back by COVID-19

UK university leaders on Wednesday warned MPs that the sector’s high tuition fee model needs an urgent re-think, following the huge loss of revenues caused by the COVID-19 pandemic.  “This pandemic has highlighted a long standing issue,” Nancy Rothwell, chair of the Russell Group of research-led universities, and vice chancellor of Manchester University, told the Science and Technology Committee.  “Our research is only funded to 72% of the full cost. That’s been okay, so long as we’ve had international fees, residency [fees], commercial activities coming in. But the pandemic has opened up the Pandora’s box that we’ve all managed to keep the lid on for a while,” said Rothwell. International students are a “very significant cross-subsidy” for research in the UK, the committee heard.  With both domestic student tuition fees and research funding below many universities’ operating costs, overseas student fees are a vital money-maker.  

“They’re worth £2 billion a year to research activities,” said Julia Buckingham, president and chair of the Universities UK lobby group.  The UK, which operates a commercially-oriented university system like in the US, Australia and Canada, has become increasingly dependent on often-exorbitant tuition fees from international students. As a result, its universities are particularly vulnerable during the crisis compared with continental European universities.

And that is all for this week – do check out the information on the ESMO and German EU Presidency conferences, stay safe, and have an excellent weekend.

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Commission approves €1.46 billion UK scheme to distribute free medical grade personal protective equipment in the context of coronavirus outbreak

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The European Commission has approved under EU State aid rules a £1.3 billion (approximately €1.46bn) UK scheme to distribute free medical grade personal protective equipment (PPE) to health and social care services, community pharmacies and public sector organisations in the context of coronavirus outbreak. The public support will take the form of free medical grade PPE and will be accessible to eligible health and social care providers, community pharmacies and public sector organizations.

The purpose of the measure is to ensure that beneficiaries continue to provide their services, while limiting the spread of the coronavirus through preventing cross-infection and other forms of contamination. The Commission assessed the measure under Article 107(3)(c), which enables member states to facilitate the development of certain economic activities, subject to certain conditions.

The Commission concluded that the measure is necessary, appropriate and proportionate to fight the health crisis, in line with Article 107(3)(c) TFEU. On this basis, the Commission approved the measure under EU state aid rules. The non-confidential version of the decision will be made available under the case number SA.58477 in the state aid register on the Commission's competition website once any confidentiality issues have been resolved.

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Commission approves €44 billion Italian recapitalization scheme to support large companies affected by #Coronavirus outbreak

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The European Commission has approved an Italian scheme, with an overall budget of €44 billion, to support large enterprises affected by the coronavirus outbreak. The scheme consist of four measures that were approved under the state aid Temporary Framework.

Executive Vice President Margrethe Vestager, in charge of competition policy, said: “This Italian recapitalization scheme will support large companies affected by the coronavirus outbreak by strengthening their capital base and facilitating their access to finance in these difficult times. Together with other previously approved measures, the scheme will ultimately be instrumental in supporting the Italian economy and labour market. We continue to work in close co-operation with member states to find workable solutions to mitigate the economic impact of the coronavirus outbreak, in line with EU rules.”

The Italian support measures

Italy notified to the Commission, under the Temporary Framework, a scheme consisting of four complementary measures to support large companies particularly affected by the coronavirus outbreak, through recapitalisation instruments, in particular equity, and hybrid capital instruments (convertible bonds and subordinated debt). Together with the Italian scheme intended for small and medium-sized enterprises, approved by the Commission on 31 July 2020, the Italian measures aim to support the solvency of a large spectrum of companies that have suffered from the coronavirus outbreak, thus helping them to ensure the continuation of their activities and supporting employment.

The scheme targets large companies that have faced a severe reduction of revenues in 2020. To be eligible, among other criteria, the companies should be considered strategic for the economy and for the labour markets.

The measures under the scheme consists of:

(1)  Equity injections;

(2)  mandatory convertible bonds;

(3)  convertible bonds, upon request of either the beneficiary or the bondholder, and;

(4)  subordinated debt.

The four measures are administrated by an ad-hoc special purpose vehicle, Patrimonio Rilancio.

The Commission found that the scheme notified by Italy is in line with the conditions set out in the Temporary Framework. In particular, with respect to recapitalisation measures, (i) the support is available to companies if it is needed to maintain operations, no other appropriate solution is available, and it is in the common interest to intervene; (ii) support is limited to the amount necessary to ensure the viability of beneficiaries and does not go beyond restoring their capital structure before the coronavirus outbreak; (iii) the scheme provides an adequate remuneration for the state; (iv) the conditions of the measures incentivise beneficiaries and/or their owners to repay the support as early as possible (inter alia through progressive increases in remuneration, a dividend ban as well as a cap on the remuneration of and a ban of bonus payments to management); (v) safeguards are in place to make sure that beneficiaries do not unduly benefit from the recapitalisation aid by the state to the detriment of fair competition in the internal markets, such as an acquisition ban to avoid aggressive commercial expansion; and (vi) aid to a company above the threshold of €250m has to be notified separately for individual assessment.

With respect to aid in the form of subordinated debt instruments, (i) aid will not exceed the relevant limits on turnover and wage bill of the beneficiaries set out in the Temporary Framework and (ii) support can only be granted until the end of 2020.

Finally, only companies that were not considered to be in difficulty already on 31 December 2019 are eligible for aid under this scheme.

The Commission concluded that the scheme is necessary, appropriate and proportionate to remedy a serious disturbance in the economy of a member state, in line with Article 107(3)(b) TFEU and the conditions set out in the Temporary Framework.

On this basis, the Commission approved the measure under EU state aid rules.

Background

In case of particularly severe economic situations, such as the one currently faced by all Member States and the UK due the coronavirus outbreak, EU State aid rules allow Member States to grant support to remedy a serious disturbance to their economy. This is foreseen by Article 107(3)(b) TFEU of the Treaty on the Functioning of the European Union.

On 19 March 2020, the Commission has adopted a state aid 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 2020 and 8 May and 29 June 2020, 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 €100,000 to a company active in the primary agricultural sector, €120,000 to a company active in the fishery and aquaculture sector and €800,000 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 €800,000 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 €100,000 and €120,000 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)        Subsidised 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 recapitalization 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.

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 Coordinated 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 2020. As solvency issues may materialise only at a later stage as this crisis evolves, for recapitalization measures only the Commission has extended this period until the end of June 2021. With a view to ensuring legal certainty, the Commission will assess before those dates if it needs to be extended.

The non-confidential version of the decision will be made available under the case number SA.57612 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 State Aid 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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#EAPM - State of the Union: Health in the spotlight and the question of translation into health-care system

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Good morning, good morning, and welcome to the second European Alliance for Personalised Medicine (EAPM) update of the week – plenty of news today concerning health matters in Commission President Ursula von der Leyen’s State of the Union speech earlier this week and, as ever, updates on coronavirus testing. On with the show, writes EAPM Executive Director Denis Horgan...

First, a brief reminder that EAPM is hosting the ESMO event tomorrow (18 September), agenda here, register here, and the Alliance is very much looking forward to taking its seat at the round table during the German EU Presidency conference on 12 October, agenda here, register here.

State of the Union

Lest we forget, EU citizens have always highlighted in responses to the Eurobarometer poll that health care should be a priority at a pan EU level, a sentiment that has undoubtedly been echoed in the work that EAPM has done, encouraging policymakers in the area of cancer, particularly lung cancer for pan EU action and the EU health data space.

So, it is always encouraging when health policy is mentioned in an EU State of the Union address, as Commission President Ursula von der Leyen most certainly did this week.

Addressing MEPs in the European Parliament on Wednesday (16 September), von der Leyen said her commission would try to reinforce the European Medicines Agency and European Centre for Disease Prevention and Control. The president of the European Commission urged EU members to build a stronger health union, promising a biomedical research agency and a global summit. 

In her first annual State of the European Union address, Ursula von der Leyen said the coronavirus pandemic had underlined the need for closer cooperation, stressing that people were “still suffering”. “For me, it is crystal clear – we need to build a stronger European Health Union,” she said. “And we need to strengthen our crisis preparedness and management of cross-border health threats.” 

Von der Leyen said her Commission would try to reinforce the European Medicines Agency and European Centre for Disease Prevention and Control. And she announced the creation of a new agency for biomedical advanced research and development dubbed BARDA. 

She said she would work with Italy during its presidency of the G20 - a grouping of the world’s richest countries - to convene a global health summit next year to share the lessons of the coronavirus crisis. “This will show Europeans that our Union is there to protect all,” she said. Health policy remains the responsibility of EU member states and, while Brussels has tried to coordinate the bloc’s response to the epidemic, national lockdowns and border rules have varied widely. Von der Leyen, a doctor by training, also warned countries not to act selfishly when on vaccines, which are widely seen as the solution to end the crisis.

“Vaccine nationalism puts lives at risk. Vaccine cooperation saves them,” she said. She also called for a reformed and strengthened World Health Organization “so that we can better prepare” for future pandemics. The Commission chief also tried to reassure citizens that the EU now has a grip on the coronavirus pandemic and she proclaimed the Commission’s intent to seize the moment, use the money, increase its powers and press EU countries to help “build the world we want to live in”.

She also called for the EU to “lead reforms” at the WHO and World Trade Organization “so they are fit for today’s world.”

Testing times on testing

UK Prime Minister Boris Johnson has defended the coronavirus testing system, saying it is trying to meet a "colossal spike" in demand. It comes as the government said it was drawing up a list setting out who will be prioritised for tests. Care home residents and staff are likely to be near the top of the list, as Johnson acknowledged ministers were concerned about infection rates. The PM told MPs a new "action plan" for care homes will soon be released.

Earlier, Justice Secretary Robert Buckland said schools could be considered for priority testing. On Wednesday (16 September), coronavirus cases in the UK increased by 3,991, taking the total to 378,219, according to figures from the government. A further 20 people had died within 28 days of testing positive for COVID-19. This brings the UK death total by this criteria to 41,684. 

Johnson said 89% of those who have in-person tests get them the next day. He told Prime Minister's Questions on Wednesday: "I think most people looking at the record of this country in delivering tests across this nation will see that it actually compares extremely well with any other European country."

The BBC reports that  the government will publish details of its plan to prioritize coronavirus tests in the next few days, with NHS staff and patients and those in care homes top of the list.

Not how you start, it’s how you’re Finnish...

A new app, intended to stop the spread of the novel coronavirus by tracing contacts, has been downloaded nearly two million times in Finland, a country of 5.5 million. Its neighbours have by contrast either declined to launch a national app or cancelled it due to privacy concerns. 

Nearly one in three Finns have downloaded the new coronavirus contact tracing app, according to the Finnish Institute for Health and Welfare, THL. The Koronavilkku app (“Corona blinker”), released barely a week ago on iOS and Android, has already been downloaded over 1.8 million times. Finland's total population is about 5.5 million people, national broadcaster Yle reported. The THL's initial goal was to reach up to a million users in September. Users of the app send randomly-generated codes via Bluetooth signal to each other when they come into close contact for at least 15 minutes. The smartphones then store anonymous information about the contact.

During the first week, a total of 41 of Koronavilkku's users have entered so-called unlock codes into the app. These unlock codes are given to users diagnosed with the coronavirus infection, THL's director of information services, Aleksi Yrttiaho, explained. The unlock codes thus enable the infected person's phone to alert other app users of exposure risk. 

The number of exposure notifications is not received, Yrttiaho added. “In the first couple of days, the application has been downloaded significantly more than we had anticipated. People want help in preventing the spread of coronavirus,” he mused. 

The app is available in Finnish and Swedish, and an English version is currently in the works. With 8,327 Covid-19 cases, 336 deaths and over 7,300 recoveries, Finland has been the least-hit Nordic nation.

Funding

We’ll never be prepared for the next pandemic if we only invest in R&D targeting diseases grabbing headlines at the time,” said Nick Chapman, CEO of Policy Cures Research. Concerning an earlier epidemic, a G-FINDER report shows that funding to fight Ebola fell as the West African pandemic waned. Similarly, clinical trials and funding for Zika dwindled in 2018. Total funding in this area reached a peak of $886 million in 2018 – a 14% increase on the previous year.

New restrictions in Netherlands' cities

New coronavirus restrictions will be introduced in parts of the Netherlands where coronavirus cases are mounting, and Amsterdam, Rotterdam, The Hague, Delft and Leiden are on the hit list. Health minister Hugo de Jonge said on Wednesday that the rising number of coronavirus infections is ‘not good’, particularly in the big cities in the west of the country. 

On Wednesday, a further 1,500 positive test results were reported to public health institute RIVM, and Germany and Belgium have put Noord and Zuid-Holland provinces on their code red list – which means they should be avoided. De Jonge and prime minister Mark Rutte will hold a press conference on Friday evening (18 September) at 19h to announce what measures are being brought in on a regional basis. “There is no single solution to reduce the number of infections,” De Jonge said. “We want to hit the virus hard, but keep the impact on society and the economy to a minimum.”

And that is everything for this week – do enjoy the ESMO event, agenda here, register here,

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