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EAPM: Medical access, medical devices, jabs for kids

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Welcome, health colleagues, to the European Alliance for Personalised Medicine (EAPM) update – there is controversy afoot concerning access to new medicines across Europe, doubts expressed over sufficiency of COVID testing alone for foreign travel, and the end of the Medical Device Regulation’s transition period, writes EAPM Executive Director Dr. Denis Horgan.

Stark divide on access to new medicines globally and in Europe

The coronavirus pandemic is far from over, WHO Director-General Tedros Adhanom Ghebreyesus stressed this week, as he lamented new variants, vaccines shortages, and a global disparity in access to inoculations.

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"There is a huge disconnect growing, where in some countries with the highest vaccination rates, there appears to be a mindset that the pandemic is over, while others are experiencing huge waves of infection," Tedros said. He expressed further concern about areas experiencing a continued high number of COVID-19 cases and places that had previously made progress are facing a new wave of cases and hospitalization. "The pandemic is a long way from over," he said, "and it will not be over anywhere until it's over everywhere."In the fight against the coronavirus, some countries are faring better than others. In the United States, for example, cases have been dropping as more and more people get vaccinated.

President Joe Biden has set a goal to have at least 160 million Americans fully vaccinated by the July Fourth holiday. But in India, a second wave of COVID-19 has been devastating, killing thousands of people a day and setting world records for daily infections. Medical facilities have started to run out of oxygen, ventilators and beds, and workers have been stretched thin.

Countries in Northern and Western Europe access new medicines much more quickly than their Southern and Eastern European neighbors, with patients in some countries waiting more than seven times longer, according to research.

Access is the fastest in Germany, with an average of 120 days between marketing authorization and availability in the country, while in oncology, several countries — Poland, Lithuania, Romania, Slovakia Bosnia, Latvia, Iceland, Macedonia and Serbia — have no availability to new cancer medicines that were approved in 2019.

Meanwhile, while there was a much smaller number of orphan medicines approved in 2019, over half of the countries in the study hadn’t made any of these medicines available in 2020.

ECDC warns EU: Testing alone not enough to ensure safe travel

The European Centre for Disease Prevention and Control (ECDC) doesn’t think that only testing for COVID-19 to avoid entry restrictions for travellers in the EU is enough to prevent the possible spread of COVID-19 from incoming travellers. Speaking on the matter, ECDC Director Andrea Amon explained that only a portion of the EU’s population has received COVID-19 vaccines, meaning that the virus is still active and “testing alone doesn’t do the trick” for Europeans to travel freely, SchengenVisaInfo.com reports.

“We should keep in mind that the proof of a full-course vaccination, prior infection or lack of current infection as defined by a PCR [test], which are the three elements that are included in the certificate, have very different levels of certainty regarding the risk of the individual,” Ammon added.

The European Council and Parliament recently reached the agreement to establish the EU Digital COVID-19 Certificate, which will serve as evidence to prove if the holder has been vaccinated against the virus, has recovered from the disease in the recent months or tested negative for COVID-19 within the timeframe set by the EU destination country. These three are expected to be individual certificates and ease citizens movement across Europe.

MDR transition period ends

As of 26 May — after being delayed from 2020 — the Medical Device Regulation’s (MDR) transition period ended. Serge Bernasconi, MedTech Europe’s CEO, said he planned to open a half bottle of champagne to mark the occasion. “You will not see the full effect of the new regulation on May 26,” Bernasconi said, underscoring the fact that many legacy devices were recertified so as to remain on the market until 2024. “It’s only half a bottle of champagne,” Bernassconi said, “because I continue to believe there is still a lot to be done to make the system really operational.”

“Please don’t believe or think that this critical date is like an end — that’s what worries me the most,” Bernasconi said. “Please do not divert resources away from [the MDR], while at the same time, please pay enormous attention to what’s happening for IVDs. People might not see it, because there’s this huge medical device thing in front — but this thing is coming.”

Parliament committee endorses COVID certificates deal

The Civil Liberties Committee has endorsed the EU digital Covid Certificate package with 52 votes in favour, 13 votes against and 3 abstentions (EU citizens) and with 53 votes in favour, 10 votes against and five abstentions (third country nationals). The EU Digital Covid Certificate will be issued by national authorities and be available in either digital or paper format.

A common EU framework will allow member states to issue certificates that will be interoperable, compatible, secure and verifiable across the EU. More information here. LIBE Chairman of the Civil Liberties Committee and rapporteur Juan Fernando López Aguilar (S&D, ES) said:

“The Parliament started negotiations with very ambitious objectives in mind and has managed to achieve a good compromise through painstaking negotiations. The text voted today will ensure that freedom of movement will be safely restored across the EU as we continue to fight this pandemic, with due respect for the right of our citizens to non-discrimination and data protection.”

Update from the 74th World Health Assembly

A new resolution urges member states to raise the priority given to the prevention, diagnosis and control of diabetes as well as prevention and management of risk factors such as obesity. It recommends action in a number of areas including: the development of pathways for achieving targets for the prevention and control of diabetes, including access to insulin; the promotion of convergence and harmonization of regulatory requirements for insulin and other medicines and health products for the treatment of diabetes; and assessment of the feasibility and potential value of establishing a web-based tool to share information relevant to the transparency of markets for diabetes medicines and health products. Delegates asked WHO to develop recommendations and provide support for strengthening diabetes monitoring and surveillance within national noncommunicable disease programmes and to consider potential targets. WHO was also asked to make recommendations on the prevention and management of obesity and on policies for diabetes prevention and control More than 420 million people are living with diabetes, a number that is expected to rise to 578 million by 2030. One in two adults living with diabetes type 2 are undiagnosed. Globally, 100 years after the discovery of insulin, half of the people with type 2 diabetes who need insulin are not receiving it.

Vaccine for children aged 12 to 15 expected to get green light from European Medicines Agency

The first COVID-19 vaccine for children aged 12 to 15 is expected to be given approval by the European Medicines Agency (EMA) today (28 May). The vaccine, made by Pfizer BioNTech, has already been given the green light by the FDA in the United States. The EMA will hold a top-committee meeting tomorrow to give its final assessment on the vaccine. The National Immunisation Advisory Committee (Niac) will examine evidence around the vaccine before recommending whether or not it should be rolled out here.

It could mean the jab is offered to secondary school students before the start of the next academic year. Read More Fishing crews stage port protest to highlight problems facing industry It comes as it emerged the cyber attack on the HSE has delayed vaccination appointments for some people at high risk of COVID-19 due to underlying illness.

Those aged 16 to 64, whose GP is not involved in administering the vaccine, were due to be referred by their doctors instead of registering for their vaccination jab on an online portal. However, because of the cyber attack this has been put on hold and the current portal is only open to people over 45. The HSE is attempting to put an alternative system in place for this group.

And that is all from EAPM – stay safe and well and have an excellent weekend, see you next week.

Belgium

Cars and pavements washed away as Belgian town hit by worst floods in decades

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The southern Belgian town of Dinant was hit by the heaviest floods in decades on Saturday (24 July) after a two-hour thunderstorm turned streets into torrential streams that washed away cars and pavements but did not kill anyone, writes Jan Strupczewski, Reuters.

Dinant was spared the deadly floods 10 days ago that killed 37 people in southeast Belgium and many more in Germany, but the violence of Saturday's storm surprised many.

"I have been living in Dinant for 57 years, and I've never seen anything like that," Richard Fournaux, the former mayor of the town on the Meuse river and birthplace of the 19th century inventor of the saxophone, Adolphe Sax, said on social media.

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A woman works to recover her belongings following heavy rainfall in Dinant, Belgium July 25, 2021. REUTERS/Johanna Geron
A woman walks in an area affected by heavy rainfall in Dinant, Belgium July 25, 2021. REUTERS/Johanna Geron

Rainwater gushing down steep streets swept away dozens of cars, piling them in a heap at a crossing, and washed away cobbles stones, pavements and whole sections of tarmac as inhabitants watched in horror from windows.

There was no precise estimate of the damage, with town authorities predicting only that it would be "significant", according to Belgian RTL TV.

The storm wreaked similar havoc, also with no loss of life, in the small town of Anhee a few kilometres north of Dinant.

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Czech Republic

NextGenerationEU: European Commission endorses Czechia's €7 billion recovery and resilience plan

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The European Commission has today (19 July) adopted a positive assessment of Czechia's recovery and resilience plan. This is an important step towards the EU disbursing €7 billion in grants under the Recovery and Resilience Facility (RRF). This financing will support the implementation of the crucial investment and reform measures outlined in Czechia's recovery and resilience plan. It will play a key role in helping Czechia emerge stronger from the COVID-19 pandemic.

The RRF is at the heart of NextGenerationEU which will provide €800bn (in current prices) to support investments and reforms across the EU. The Czech plan forms part of an unprecedented co-ordinated EU response to the COVID-19 crisis, to address common European challenges by embracing the green and digital transitions, to strengthen economic and social resilience and the cohesion of the Single Market.

The Commission assessed Czechia's plan based on the criteria set out in the RRF Regulation. The Commission's analysis considered, in particular, whether the investments and reforms set out in Czechia's plan support the green and digital transitions; contribute to effectively addressing challenges identified in the European Semester; and strengthen its growth potential, job creation and economic and social resilience.

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Securing Czechia's green and digital transition  

The Commission's assessment of Czechia's plan finds that it devotes 42% of its total allocation to measures that support climate objectives. The plan includes investments in renewable energy, the modernisation of district heating distribution networks, the replacement of coal-fired boilers and improving the energy efficiency of residential and public buildings. The plan also includes measures for nature protection and water management as well as investment in sustainable mobility.

The Commission's assessment of Czechia's plan finds that it devotes 22% of its total allocation to measures that support the digital transition. The plan provides for investments in digital infrastructure, the digitalization of public administration, including the areas of health, justice and the administration of construction permits. It promotes the digitalisation of businesses and digital projects in the cultural and creative sectors. The plan also includes measures to improve digital skills at all levels, as part of the education system and through dedicated upskilling and reskilling programmes.

Reinforcing Czechia's economic and social resilience

The Commission considers that Czechia's plan effectively addresses all or a significant subset of the economic and social challenges outlined in the country-specific recommendations addressed to Czechia by the Council in the European Semester in 2019 and in 2020.

The plan provides for measures to tackle the need for investment in energy efficiency and renewable energy sources, sustainable transport and digital infrastructure. Several measures aim at addressing the need to foster digital skills, improve the quality and inclusiveness of education, and to increase the availability of childcare facilities. The plan also provides for improving the business environment, mainly through extensive e-government measures, a reform of the procedures of granting construction permits and anti-corruption measures. Challenges in the area of R&D shall be improved by investment geared at strengthening public-private cooperation and financial and non-financial support to innovative firms.

The plan represents a comprehensive and adequately balanced response to Czechia's economic and social situation, thereby contributing appropriately to all six pillars referred to in the RRF Regulation.

Supporting flagship investments and reform projects

The Czech plan proposes projects in all seven European flagship areas. These are specific investment projects which address issues that are common to all member states in areas that create jobs and growth and are needed for the twin transition. For instance, Czechia has proposed €1.4bn to support the energy efficiency renovation of buildings and €500 million to boost digital skills through education and investments in upskilling and reskilling programmes for the entire labour force.  

The Commission's assessment finds that no measure included in the plan does any significant harm to the environment, in line with the requirements laid out in the RRF Regulation.

The arrangements proposed in the recovery and resilience plan in relation to control systems are adequate to prevent, detect and correct corruption, fraud and conflicts of interests relating to the use of funds. The arrangements are also expected to effectively avoid double funding under that Regulation and other Union programmes. These control systems are complemented by additional audit and control measures contained in the Commission's proposal for a Council Implementing Decision as milestones. These milestones must be fulfilled before Czechia presents its first payment request to the Commission.

President Ursula von der Leyen said: “Today, the European Commission has decided to give its green light to Czechia's recovery and resilience plan. This plan will play a crucial role in supporting a shift towards a greener and more digital future for Czechia. Measures that improve energy efficiency, digitalize public administration and deter the misuse of public funds are exactly in line with the objectives of NextGenerationEU. I also welcome the strong emphasis the plan places on strengthening the resilience of Czechia's health-care system to prepare it for future challenges. We will stand with you every step of the way to ensure that the plan is fully implemented.

Economy Commissioner Paolo Gentiloni said: “Czechia's recovery and resilience plan will provide a strong boost to the country's efforts to get back its feet after the economic shock caused the pandemic. The €7bn in NextGenerationEU funds that will flow to Czechia over the next five years will support a wide-ranging programme of reforms and investments to build a more sustainable and competitive economy. They include very sizeable investments in building renovation, clean energy and sustainable mobility, as well as measures to boost digital infrastructure and skills and the digitalisation of public services. The business environment will benefit from the promotion of e-government and anti-corruption measures. The plan will also support improvements in healthcare, including reinforced cancer prevention and rehabilitation care.”

Next steps

The Commission has today adopted a proposal for a Council Implementing Decision to provide €7bn in grants to Czechia under the RRF. The Council will now have, as a rule, four weeks to adopt the Commission's proposal.

The Council's approval of the plan would allow for the disbursement of €910m to Czechia in pre-financing. This represents 13% of the total amount allocated to Czechia.

An Economy that Works for People Executive Vice President Valdis Dombrovskis said: “This plan will put Czechia on the path to recovery and boost its economic growth as Europe gears up for the green and digital transitions. Czechia intends to invest in renewable energy and sustainable transport, while improving the energy efficiency of buildings. It aims to roll out greater digital connectivity across the country, promote digital education and skills, and digitalize many of its public services. And it places a welcome focus on improving the business environment and justice system, backed by measures to fight corruption and promote e-government – all in a balanced response to the Czech economic and social situation. Once put properly into practice, this plan will help to put Czechia on a sound footing for the future.”

The Commission will authorize further disbursements based on the satisfactory fulfilment of the milestones and targets outlined in the Council Implementing Decision, reflecting progress on the implementation of the investments and reforms. 

More information

Questions and answers: European Commission endorses Czechia's recovery and resilience plan

Recovery and Resilience Facility: Questions and answers

Factsheet on Czechia's recovery and resilience plan

Proposal for a Council Implementing Decision on the approval of the assessment of the recovery and resilience plan for Czechia

Annex to the Proposal for a Council Implementing Decision on the approval of the assessment of the recovery and resilience plan for Czechia

Staff-working document accompanying the proposal for a Council Implementing Decision

Recovery and Resilience Facility

Recovery and Resilience Facility Regulation

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Belgium

Death toll rises to 170 in Germany and Belgium floods

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The death toll in devastating flooding in western Germany and Belgium rose to at least 170 on Saturday (17 July) after burst rivers and flash floods this week collapsed houses and ripped up roads and power lines, write Petra Wischgoll,
David Sahl, Matthias Inverardi in Duesseldorf, Philip Blenkinsop in Brussels, Christoph Steitz in Frankfurt and Bart Meijer in Amsterdam.

Some 143 people died in the flooding in Germany's worst natural disaster in more than half a century. That included about 98 in the Ahrweiler district south of Cologne, according to police.

Hundreds of people were still missing or unreachable as several areas were inaccessible due to high water levels while communication in some places was still down.

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Residents and business owners struggled to pick up the pieces in battered towns.

"Everything is completely destroyed. You don't recognise the scenery," said Michael Lang, owner of a wine shop in the town of Bad Neuenahr-Ahrweiler in Ahrweiler, fighting back tears.

German President Frank-Walter Steinmeier visited Erftstadt in the state of North Rhine-Westphalia, where the disaster killed at least 45 people.

"We mourn with those that have lost friends, acquaintances, family members," he said. "Their fate is ripping our hearts apart."

Around 700 residents were evacuated late on Friday after a dam broke in the town of Wassenberg near Cologne, authorities said.

But Wassenberg mayor Marcel Maurer said water levels had been stabilising since the night. "It's too early to give the all-clear but we are cautiously optimistic," he said.

The Steinbachtal dam in western Germany, however, remained at risk of breaching, authorities said after some 4,500 people were evacuated from homes downstream.

Steinmeier said it would take weeks before the full damage, expected to require several billions of euros in reconstruction funds, could be assessed.

Armin Laschet, state premier of North Rhine-Westphalia and the ruling CDU party's candidate in September's general election, said he would speak to Finance Minister Olaf Scholz in the coming days about financial support.

Chancellor Angela Merkel was expected to travel on Sunday to Rhineland Palatinate, the state that is home to the devastated village of Schuld.

Members of the Bundeswehr forces, surrounded by partially submerged cars, wade through the flood water following heavy rainfalls in Erftstadt-Blessem, Germany, July 17, 2021. REUTERS/Thilo Schmuelgen
Austrian rescue team members use their boats as they go through an area affected by floods, following heavy rainfalls, in Pepinster, Belgium, July 16, 2021. REUTERS/Yves Herman

In Belgium, the death toll rose to 27, according to the national crisis centre, which is co-ordinating the relief operation there.

It added that 103 people were "missing or unreachable". Some were likely unreachable because they could not recharge mobile phones or were in hospital without identity papers, the centre said.

Over the past several days the floods, which have mostly hit the German states of Rhineland Palatinate and North Rhine-Westphalia and eastern Belgium, have cut off entire communities from power and communications.

RWE (RWEG.DE), Germany's largest power producer, said on Saturday its opencast mine in Inden and the Weisweiler coal-fired power plant were massively affected, adding that the plant was running at lower capacity after the situation stabilized.

In the southern Belgian provinces of Luxembourg and Namur, authorities rushed to supply drinking water to households.

Flood water levels slowly fell in the worst hit parts of Belgium, allowing residents to sort through damaged possessions. Prime Minister Alexander De Croo and European Commission President Ursula von der Leyen visited some areas on Saturday afternoon.

Belgian rail network operator Infrabel published plans of repairs to lines, some of which would be back in service only at the very end of August.

Emergency services in the Netherlands also remained on high alert as overflowing rivers threatened towns and villages throughout the southern province of Limburg.

Tens of thousands of residents in the region have been evacuated in the past two days, while soldiers, fire brigades and volunteers worked frantically throughout Friday night (16 July) to enforce dykes and prevent flooding.

The Dutch have so far escaped disaster on the scale of its neighbours, and as of Saturday morning no casualties had been reported.

Scientists have long said that climate change will lead to heavier downpours. But determining its role in these relentless rainfalls will take at least several weeks to research, scientists said on Friday.

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