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#EAPM - European innovation in a time of #COVID-19



Before we get into what’s been going on of late during these testing times (pun intended) here’s a quick reminder that registration will close very soon for next week’s virtual conference, which takes place on Tuesday 30 June, writes European Alliance for Personalised Medicine (EAPM) Executive Director Denis Horgan.

Entitled Maintaining public trust in the use of Big Data for health science in a COVID and post-COVID world, it acts as a bridging event between the EU Presidencies of Croatia and Germany.

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.

Here is the link to register, but be quick!

In the meantime, if you get the opportunity, it may well be worth taking a look at the European Commission’s Innovation Scoreboard. Innovation is certainly something Europe is generally great at - although it does vary across member states and the implementation could certainly be better. 

Obviously, it’s of key interest to EAPM and its members and partners, not least because innovation in healthcare is something we continuously work hard to promote and encourage.

The link for the site can be found here, but here’s a general idea of what to expect.

So, what is the European Innovation Scoreboard (EIS)?

The annual EIS provides a comparative assessment of research and innovation performance in EU Member States, other European countries, and our regional neighbours.

Its aim is to let policymakers assess relative strengths and weaknesses of national research and innovation systems, track progress, and identify priority areas to boost innovation performance.

The EIS covers the EU-27 plus Iceland, Israel, Montenegro, North Macedonia, Norway, Serbia, Switzerland, Turkey, Ukraine and the UK. It also looks at a limited number of global indicators from, for example, Australia, Brazil, Canada, China, India, Japan, the Russian Federation, South Africa, South Korea, and the US.

Currently, based on scores for 27 separate indicators, including innovation activities in companies, investment in research and innovation, and human resource and employment elements, EU countries fall into four performance groups:

Innovation leaders are Denmark, Finland, Luxembourg, the Netherlands, and Sweden, all of whom perform significantly above the EU average;

Strong innovators are Austria, Belgium, Estonia, France, Germany, Ireland, and Portugal, all of which perform above or close to the EU average.

Moderate innovators are Croatia, Cyprus, Czech Republic, Greece, Hungary, Italy, Latvia, Lithuania, Malta, Poland, Slovakia, Slovenia, and Spain. These countries show an innovation performance below the EU average.

And modest innovators - which is putting it gently - are Bulgaria and Romania. Both countries come in below 50% of the EU average.

The EIS 2020 shows an improved overall innovation performance. For the EU as a whole, it increased by 8.9% between 2012 and 2019. Over the same period, the performance improved for 24 Member States, most notably for Lithuania, Malta, Latvia, Portugal and Greece, where the innovation performance grew by more than 20%.

Compared to the last year's edition, performance has improved for 25 member states, most notably for Cyprus, Spain, and Finland.

There’s plenty of more specific sector information online at the link above, so do take a look if you’ve the opportunity.

Progress - and lessons learned

We mentioned in our last update that the HTA discussions in Council have taken a hit from for the COVID-19 crisis, yet in France at least, this is apparently not the case.

Its Haute Autorité de Santé (HAS) claims that COVID-19 has “hampered neither the arrival of [innovative medicines] on the market, nor their evaluation by the HAS”.

It seems that manufacturers are using the new fast-tracking applications from HAS more often, with 22 applications filed this year so far, compared to 16 in the entirety of last year.

HAS says it is also writing opinions more quickly. Good to know.

Meanwhile, generics lobby Medicines for Europe has brought out a new paper on the lessons learned from the COVID-19 pandemic in Europe.

It seems that many of the shortcomings came from within the EU, with the biggest issue being the countries’ unilateral actions. For example, slamming shut borders within the bloc caused supply issues, and hoarding.

The EMA couldn’t deal with the dramatic increase in demand for ICU medicines, while the ECDC was slow to share epidemic forecasts, which didn’t help medicines producers with predictions.

The upshot is that Medicine for Europe has now called on the Commission to create an EU pandemic preparedness plan so Europe won’t have to face the same obstacles in future.

For example, it has suggested diversifying supply chains and changing reimbursement and procurement policies, more regulatory flexibility, and more digital reporting.

Second wave fears

Much has been said about second waves and local breakouts, not least in the last couple of days after the UK - following in the footsteps of the likes of Germany - saw Prime Minister Boris Johnson announced the rowing back of many restrictions and the re-opening of a wide range of business permissible from 4 July.

Realistically, there will be more local lockdowns and if scientists are to be believed there will certainly be some kind of a second wave. So some governments and, of course, many members of the general public are understandably a little nervous.

Europe’s Health Commissioner Stella Kyriakides this week said that the Commission will publish a communication on the second wave on 15 July.

Worryingly, some member states that didn’t get hit the worst by the coronavirus initially, such as Romania and Bulgaria, are now reporting localized outbreaks. 

At the same time, Greece and Denmark are warning about possible second waves, while Portugal’s Prime Minister António Costa has imposed some stricter rules. 

But as mentioned, Germany’s facing its own new challenges, with numerous localised outbreaks. EAPM’s supporter and German MEP Peter Liese has said he was “shocked” when his constituency was hit. 

Liese thinks some indoor venues should be closed. For example, cinemas and restos. Also, he feels that citizens should be unable to use places such as nonessential shops for longer than 15 minutes,. Masks should be an absolute requirement, he believes.

If were not careful, we will have a general increase,” he said.

While we have the spotlight on Liese, it is rumoured that while his party the EPP will get the chair of the European Parliament’s Cancer Committee, he doesn’t want the job personally.

The Renew Europe party will get the lead rapporteur role on the Cancer Plan - probably in the person of MEP ronique Trillet-Lenoir.

Immunity questions for vaccines

The last item today involves vaccines. And it turns out that vaccine developers dont know the level of immunity needed to protect people against coronavirus. This means that it is difficult to estimate their version of a vaccine’s success chances, with the higher level of immunity needed meaning the fewer number of vaccine efforts will be successful.

This latter observation came from Imperial CollegeRobin Shattock while he was addressing the UK’s House of Lords Science and Technology Committee earlier in the week.

He said: “I think our chances are high, but I think we shouldnt be over hyping the potential success.”

University of Oxford Professor Sarah Gilbert however said that it depends on the purpose of the vaccine. She said: “The aim is to protect the population and that doesnt mean that the vaccination has to be 100% effective. Even with the 50% efficacy, we could actually go a long way to protect the population.”

So that’s all for this week. Look out for our monthly newsletter which is due shortly and, once again, do take this late opportunity to register for Tuesday’s virtual conference, if you haven’t done so already.

All the best for the weekend and here is the link to register.


Commission approves modified Austrian liquidity assistance scheme to support companies affected by the coronavirus outbreak



The European Commission has found certain amendments to a previously approved Austrian liquidity assistance scheme to support Austrian enterprises affected by the coronavirus outbreak to be in line with the State Aid Temporary Framework. The original scheme was approved on 8 April 2020 under case number SA.56840, and provides for temporary limited amounts of aid in the form of (i) direct grants, (ii) guarantees on loans and repayable advances, and (iii) guarantees on loans and subsidized interest rates on loans.

The aim of the original scheme was to enable enterprises affected by the coronavirus outbreak to cover their short-term liabilities, despite the current loss of revenues caused by the pandemic. Austria notified certain modifications to the original scheme, in particular: (i)micro or small enterprises can now benefit from the measure even if they were considered in difficulty on 31 December 2019, under certain conditions; and (ii)an increase of €4 billion in the total budget of the scheme, from €15bn to €19bn.

The Commission concluded that the scheme, as modified, remains 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.

More information on the Temporary Framework and other actions taken by the Commission to address the economic impact of the coronavirus pandemic can be found here. The non-confidential version of the decision will be made available under the case number SA.58640 in the state aid register on the Commission's competition website once any confidentiality issues have been resolved.

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Conservative Party

Johnson to levy £10,000 fine on COVID-19 rule-breakers



People in England who break new rules requiring them to self-isolate if they have been in contact with someone infected with COVID-19 will face a fine of up to £10,000 ($12,914), Prime Minister Boris Johnson said on Saturday (19 September), writes David Milliken.

The rules will apply from 28 September to anyone in England who tests positive for the virus or is notified by public health workers that they have been in contact with someone infectious.

“People who choose to ignore the rules will face significant fines,” Johnson said in a statement.

Fines will start at 1,000 pounds for a first offence, rising to 10,000 pounds for repeat offenders or cases where employers threaten to sack staff who self-isolate rather than go to work.

Some low-income workers who suffer a loss of earnings will receive a £500 support payment, on top of other benefits such as sick pay to which they may be entitled.

Current British government guidance tells people to stay at home for at least 10 days after they start to suffer COVID-19 symptoms, and for other people in their household not to leave the house for 14 days.

Anyone who tests positive is also asked to provide details of people outside their household who they have been in close contact with, who may then also be told to self-isolate.

To date there has been little enforcement of self-isolation rules, except in some cases where people have returned from abroad.

However, Britain is now facing a rapid increase in cases, and the government said police would be involved in checking compliance in areas with the highest infection rates.

Johnson has also faced calls to reintroduce more wide-ranging lockdown rules for the general public.

However, the Sunday Times reported he was poised to reject calls from scientific advisors for an immediate two-week nationwide lockdown to slow the spread of the disease, and instead reconsider it when schools take a late-October break.

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Ireland tightens Dublin COVID-19 restrictions as cases surge




The Irish government on Friday (18 September) announced strict new COVID-19 restrictions for the capital Dublin, banning indoor restaurant dining and advising against all non-essential travel, after a surge in cases in recent days. Ireland, which was one of the slowest countries in Europe to emerge from lockdown, has seen average daily case numbers roughly double in the past two weeks and significant increases in those being treated for the virus in hospitals, writes Conor Humphries.

“Here in the capital, despite people’s best efforts over recent weeks, we are in a very dangerous place,” Prime Minister Micheal Martin said in a televised address to the country, announcing the restrictions.

“Without further urgent and decisive action, there is a very real threat that Dublin could return to the worst days of this crisis.” The measures, which include a ban on indoor events, will last for three weeks, he said. Ireland had the 17th highest COVID-19 infection rate out of 31 European countries monitored by the European Centre for Disease Control on Friday, with 57.4 cases per 100,000 people in the past 14 days.

The government reported three deaths from the virus on Friday, bringing the total toll to 1,792. Countries across Europe, including Britain, Greece and Denmark, on Friday announced new restrictions to curb surging coronavirus infections in some of their largest cities. Ireland on Thursday tightened its COVID-19 travel restrictions by imposing quarantines on travellers from major holiday markets Italy and Greece.

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