Good morning, health colleagues, and welcome to the first update of the week from the European Alliance for Personalised Medicine (EAPM). It is a big week for health in general next week, as from 3 February the European Commission will be officially publishing its EU Beating Cancer Plan and there are still questions whether the EU Beating Cancer Plan will address lung cancer screening sufficiently, writes EAPM Executive Director Dr. Denis Horgan.
Lung cancer – transformation in local and country with the support of EU policies needed.
In Europe, lung cancer (LC), is far ahead as the leading cause of death from the disease, and causes more than 266,000 deaths each year - 21% of all cancer-related deaths.
That's not quite as high as COVID's death rate in 2020, but these lung cancer deaths are not a one-off crisis that has provoked an unprecedented mobilization to bring it under control. EAPM is pushing very hard for an increased focus on lung cancer (LC), which needs a transformation in national care pathways as well as local and country policies. LC care receives high priority within only a few national health strategies.
But it is largely up to the member states – incentivized by the European Union – to recognize that reorganization and reallocation of health-care resources are justified by the current massive costs to individuals and to society of the growing incidence of this type of cancer. These are key issues that should be taken into account as highlighted by the multistakeholder engagement that EAPM has undertaken.
Screening is the most obvious route to arresting this destruction of life and is a question of looking for cancer before a person has any symptoms. This can help find cancer at an early stage. When abnormal tissue or cancer is found early, it may be easier to treat. By the time symptoms appear, cancer may have begun to spread.
The same is true for lung cancer.
Over the past two decades the evidence has become overwhelming that screening can transform the fate of lung cancer victims. Disturbingly, however, EU member states still hesitate over its adoption, and it remains low on policy priorities nationally and at EU level. In consequence, funding for it, and reimbursement of screening services, remain patchy and inadequate, and it is not yet integrated satisfactorily into the healthcare system.
The tools are there to improve the situation. As EAPM has highlighted with its members to policymakers: "Efficacy is proven. Don't waste more time! Now we have all the evidence we could be blamed for doing nothing."
The EU Beating Cancer Plan should address this unmet issue.
EMA expert unimpressed by the EU's COVID trials
The European Medicines Agency (EMA) has established dedicated task forces to deal with the scientific, regulatory and operational challenges created by the COVID-19 pandemic and initiated its business continuity plan. The aim of these measures is to safeguard the Agency's core activities related to the evaluation and supervision of medicines during the pandemic and to ringfence resources dealing with COVID-19.
However, the EMA’s Senior Medical Officer Hans-Georg Eichler has been unflinching in his assessment of the EU’s track record for clinical trials during the coronavirus pandemic: “When compared to other regions, the EU was not very successful in implementing large meaningful … trials for the COVID-19 medicines.”
“If you look at what we have in terms of meaningful trial results, they come mostly from outside the current EU,” he added.
If Europe wants to improve, Eichler said, it needs infrastructure and governance as well as funding for large, pan EU-trials. It also needs real world health-care data that can help answer questions, around, for example, the long term of vaccines and treatments.
European Council president expresses doubt over vaccinating 70% by summer
Charles Michel, president of the European Council, made his comments as the EU faces scrutiny over its slow rollout of coronavirus vaccines, weeks after Britain set the ball rolling. Speaking on Sunday (24 January), Michel told Europe1 radio: "There are difficulties in the production lines in the coming weeks and that will make the process more complex.But if we manage to mobilize the production lines, we may be able to succeed.It's going to be difficult.” The EU has not yet given the go-ahead to the Oxford/AstraZeneca vaccine.
'More deadly' UK variant claim played down by scientists
Scientists say signs a new coronavirus variant is more deadly than the earlier version should not be a "game changer" in the UK's response to the pandemic. UK Prime Minister Boris Johnson has said there is "some evidence" the variant may be associated with "a higher degree of mortality". But the co-author of the study the PM was referring to said the variant's deadliness remained an "open question". Another adviser said he was surprised Mr Johnson had shared the findings when the data was "not particularly strong". A third top medic said it was "too early" to be "absolutely clear".
Brazilian variant raises concerns
Paul Hunter, professor in Medicine at the University of East Anglia, said he believed it’s likely that the Brazilian variant will also show increased resistance to antibodies. “We are likely to see gradual accumulation of variants that are more and more able to escape vaccine induced immunity and indeed naturally induced immunity,” Hunter said.
Commission proposes tougher coronavirus travel restrictions
The European Commission has proposed ramping up coronavirus restrictions for travelers within the bloc as well as those coming from third countries. On Monday, Justice Commissioner Didier Reynders said: “There’s an urgent need to reduce the risk of travel-related infections to lessen the burden on overstretched health systems.”
A study in US nursing homes has shown for the first time that monoclonal antibodies, mass-produced in a laboratory, can protect people from developing symptomatic COVID-19. Their manufacturer, Eli Lilly, hopes these antibodies will provide an additional way to protect people at risk of serious disease from the pandemic coronavirus. But given the success of COVID-19 vaccines and their increasing availability, it’s not clear that the expensive and somewhat cumbersome intervention will be widely used.
Both Eli Lilly’s monoclonal antibody and a similar two-antibody cocktail from Regeneron Pharmaceuticals—famously used to treat former US President Donald Trump in October 2020—have already received emergency use authorization (EUA) as a therapeutic for those who have become infected and are at high risk of developing severe COVID-19. So far, they are not widely used because they must be given early in infection and infused in a hospital or clinic. But now that they appear effective at preventing even mild disease, Eli Lilly plans to ask the US Food and Drug Administration to expand the EUA to include use as a preventive.
And that is everything from EAPM for now – have an enjoyable, safe week, stay well, and see you on Friday for more updates.
EAPM: 2nd Bridging Presidency Conference on 'Innovation, Public Trust and Evidence' beckons: Register now!
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
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.
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.
Oncogenomics and pediatric health - Call for Papers and G7, HTA
Good afternoon health colleagues, and welcome to the first European Alliance for Personalised Medicine (EAPM) update of the week. Work between EAPM and different journals is now ongoing concerning a special issue relating to the diagnosis and treatment of cancer and blood diseases in children in developed and developing countries, writes EAPM Executive Director Dr. Denis Horgan.
Oncogenomics and pediatric health: Call for Papers
The landscape for pediatric blood cancer therapy is just beginning to realize the potential predicted by precision oncogenomics. These developments have created a new environment, one in which parents with a child newly diagnosed find themselves navigating a very different landscape than the one a parent might have encountered in 2010.
In this Special issue, we invite authors from developed and developing countries to contribute original research and review articles focusing on different aspects of pediatric cancer development, causes, maintenance, and therapeutic strategies.
Topics include, on developments, challenges, and opportunities in the diagnosis and treatment of cancer and blood diseases in children in developed and developing countries.
This special issue has a global reach, so articles are being sought not only from the EU but also Africa, Asia, Latin America and the Middle East.
The contents of this Topic should provide an insight into current pediatric cancer precision medicine efforts in developed and developing countries, reflecting only a microcosm of the current applications of oncogenomics in this bustling space of clinical translation. The Topic will publish research, commentaries, policy perspectives, historical insights, and clinical and laboratory observations.
The findings from the Topic will be presented in an international conference in the second half of 2021 – the deadline for abstract submissions is 1 September 2021 and the deadline for manuscript submissions is 1 October 2021. For more information, please see link.
Trialogues on the European Health Union
September could be the month for the European Health Union plans, with a Commission official highlighting that trilogues on the three EHU files could start after the summer recess if all goes according to plan.
G7 health ministers agree to clinical trials charter
Health ministers from some of the world’s largest democracies have committed to a new international agreement making it easier and quicker to share results from vaccine and therapeutic trials to tackle COVID-19 and prevent future health threats. Following the conclusion of the UK-hosted, in-person G7 Health Ministers’ meeting in Oxford, a Therapeutics and Vaccines Clinical Trials Charter will be rapidly implemented. This will help deliver high-quality, reliable and comparable evidence from international clinical trials to speed up access to approved treatments and vaccines, benefiting people in the UK and globally.
This will include stronger collaboration in large-scale international trials to enable greater diversity of participants, including pregnant people and children. The charter will also help to avoid unnecessary duplication of efforts, more quickly eliminate medicines that do not work, and produce robust clinical evidence that can be extrapolated to a larger number of populations and places to save more lives. The agreement follows news that industry leaders are joining forces to step up collective efforts to save lives from diseases and tackle global pandemics, with a new commitment to protect against future pandemic threats and slash time to develop and deploy new diagnostics, therapeutics and vaccines to just 100 days.
Health technology assessment
The Commission, Council and Parliament met last week for the latest trilogue talks on the health technology assessment (HTA) file — HTA and increasingly aggressive pricing methods have put drug manufacturers under pressure, but an EU diplomat said they made made good progress: “The co-legislators confirmed the work done at technical level and exchanged views on the Council and EP positions on almost all political issues … and decided to continue the technical discussions in order to prepare for the next and hopefully last trilogue, already scheduled to 21 June.”
EU Beating Cancer Plan
The stakeholder contact group of Europe’s Beating Cancer Plan — a mix of some 200 representatives from the world of patient groups, NGOs, and industry — met virtually for the first time on Friday (4 June) to discuss the Commission’s cancer strategy. The EU’s Cancer Mission — not to be confused with Europe’s Beating Cancer Plan — was also discussed during the contact group meeting. It is one of the five missions of the EU’s research agenda, known as Horizon Europe. According to one participant of the stakeholder meeting, however, all may not be well: When asked about the likelihood of the mission not going ahead, Jan-Willem van der Loo, the team leader for Cancer at the Directorate-General for Research and Innovation, said that the “review process on the missions is being tough” and declined to “give a percentage answer on that, seemingly acknowledging there was some kind of issue,” according to a participant.
Some 50% of Europeans dissatisfied with EU pandemic management
Nearly half of European respondents are unsatisfied with the EU's measures in response to the COVID-19 pandemic, a new survey has revealed. It found 49% were unhappy with measures taken by the bloc, while 43% were satisfied and 8% undecided. The highest proportion of dissatisfaction was found in Greece, Luxembourg and Belgium, the Eurobarometer poll found. The findings, which stems from a survey conducted between 12 February and 11 March across the 27 EU countries and 12 other countries outside the EU, including the UK, showed dissatisfaction with the EU over coronavirus was up by five percentage points since last summer. It also compares to 43% of people who said they were satisfied with the EU's COVID-19 measures - down two percentage points since the summer - and 8% who said they "don't know" how they feel about the EU's coronavirus response, down three percentage points.
The highest proportions of satisfaction were found in Denmark (68%), Lithuania (67%) and Portugal (66%). Meanwhile, 12 member states had a majority of respondents express dissatisfaction, with Greece leading the way at 68%, followed by Luxembourg (63%) and Belgium (61%). In Spain and the Netherlands, public opinion was evenly divided, with 44% satisfied and 44% not satisfied in the former country and latter seeing the same, but at 43%.
And that is all from EAPM for now – don’t forget, there is more information to be found here on the diagnosis and treatment of cancer and blood diseases in children Special Issue, stay safe, have an excellent week, see you soon.
EAPM: Medical access, medical devices, jabs for kids
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.
"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.
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