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EAPM: HTA delays, EMA…and beating cancer

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Greetings, colleagues, and here’s the latest European Alliance for Personalised Medicine (EAPM) update as we approach what we hope will be a normal ‘summer’. It’s all just a bit different and better this year, of course, with the vaccine rates picking up. While a lot of countries are winding-back their lockdown processes slowly but surely, it remains to be seen how many of us will have the oppurtunity to take a holiday abroad - wherever that may be - amid continuing fears in respect of COVID-19 variants. Some daring souls have made their reservation, of course, but  ‘staycations’ are in some cautious travellers likely to be the order of the day this time around again, with many deciding to holiday in their own countries. In the meantime, don’t forget that EAPM has a virtual conference coming up very soon - in less than two weeks, in fact, on Thursday, 1 July, writes EAPM Executive Director Dr. Denis Horgan. 

Entitled Bridging Conference: Innovation, Public Trust and Evidence: Generating Alignment to facilitate personalized Innovation in Health Care Systems, the conference acts as a bridging event between the EU Presidencies of Portugal and Slovenia.

Alongside our many great speakers, attendees will be drawn from leading experts in the personalised medicine arena – including patients, payers, health-care professionals, plus industry, science, academia and the research field.

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.

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HTA deal

On Wednesday, (16 June) EU deputy ambassadors signed off on the Portuguese Council presidency’s latest health technology assessment (HTA) proposal so it can move to trilogues on 21 June. Countries are willing to shorten the date of application and compromise on the voting system, but are not eager to budge on Article 8 — a debate that could delay the deal. In the event there are divergent opinions, EU countries agreed that any country must explain the scientific basis for contrarian views. 

EMA reform proposal – EU common position agreed

EU health ministers have met for the last time under Portugal’s presidency of the Council of the EU to agree on that body’s position for negotiations with the European Parliament on new rules to strengthen the role of the European Medicines Agency (EMA).

At a meeting in Luxembourg on Tuesday (15 June) chaired by Portuguese Health Minister Marta Temido, the 27 governments agreed on their position for the upcoming negotiations with the Parliament.

They had already agreed on some changes to the initial proposal presented by the European Commission in November on the revision of rules to strengthen the mandate of the EMA, as part of a broader package on the so-called European Health Union.

One of the main objectives of the new draft EMA rules is to better enable it to monitor and mitigate potential and actual shortages of medicines and medical devices that are considered critical to respond to public health emergencies such as the COVID-19 pandemic, which revealed shortcomings in this regard.

The proposal also aims to “ensure the timely development of high-quality, safe and efficacious medicines, with particular emphasis on responding to public health emergencies” and to “provide a framework for the operation of expert panels that assess high-risk medical devices and provide essential advice on crisis preparedness and management”.

Life after cancer with BECA 

The Parliament’s special committee for beating cancer (BECA) held a hearing on national cancer control programmes on Wednesday to hear how different countries were tackling the challenge. 

Despite advances in cancer diagnoses and effective therapies which have helped to increase survival rates, cancer survivors continue to experience significant challenges. According to Europe’s Beating Cancer Plan, cancer should be tackled across the entire disease pathway, from prevention to improving the quality of life of cancer patients and survivors. In fact, ensuring that survivors “live long, fulfilling lives, free from discrimination and unfair obstacles” is of utmost importance. 

Life after cancer is multifaceted yet the focus of this online debate is on the implementation of policies addressing the specific challenge of returning to work for cancer survivors. 

Northern Ireland cross-border health care directive reinstated

Health Minister Robin Swann is to reinstate the cross-border health care directive to the Republic of Ireland. The directive is a temporary measure for a 12-month period to help reduce Northern Ireland waiting lists and will be subject to strict criteria. 

The minister said: “A key principle of our health service is that access to services is based on clinical need, not on an individual’s ability to pay. However we are in exceptional times and we must look at every option to tackle the waiting lists in Northern Ireland. 

“Reinstating a limited version of the cross-border health-care directive to Ireland will not have a dramatic impact on the overall waiting lists, but it will provide an opportunity for some to have their treatment much earlier. 

“We need an urgent and collective approach across government to tackle this issue and deliver a health service that is fit for the 21st century.” 

The Republic of Ireland Reimbursement Scheme sets out a framework, based on the Cross-Border Health Care Directive that will allow patients to seek and pay for treatment in the private sector in Ireland and have the costs reimbursed by the Health and Social Care Board. Costs will be reimbursed up to the cost of the treatment in Health and Social Care in Northern Ireland. 

Survey reveals attitudes of public toward rare diseases and medicines access 

The UK BioIndustry Association (BIA) has published a report presenting the findings of a survey on the public attitudes toward equal access to medicines for those living with rare diseases, it was announced in a 17 June press release. 

Results of the survey, which was conducted by YouGov, have shown that the public strongly believe that patients living with rare diseases should have equal access to medicines via the National Health Service (NHS) as those living with more common conditions. 

Additionally, the majority of survey respondents agreed that patients with rare diseases should have access to medicines assured by the NHS on a basis of clinical need, irrespective of cost. 

The survey findings follow recent assertions made by the National Institute for Health and Care Excellence (NICE), specifying that there isn’t an appetite among the general public for specific measures to tackle rare disease. BIA’s report, Public Attitudes to Rare Diseases: 

The Case for Equal Access, recommends that NICE revises its position on rare conditions and medicines access, and that the body consider the value of a rarity modifier when performing health technology assessments. 

This survey demonstrates that there is broad public support for measures to ensure access to medicines for rare diseases based on clinical need even if that would entail higher costs..

That is all from EAPM for this week – do enjoy your weekend, stay safe and well, and don’t forget to register for the EAPM Slovenian EU Presidency conference on 1 July here, and download your agenda here.

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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