Here at the European Alliance for Personalised Medicine (EAPM) we often flag up the issues of a lack of early diagnosis and equitable treatment opportunities for many patients across the EU. These are patients suffering from any number of different diseases. Obviously, those dealing with various cancers form one of the biggest groups falling into this category, and this is not just when it comes to rare cancers - which is an area in which you might reasonably expect more difficulties. Not enough early diagnosis (often through a lack of screening programmes and guidelines) and a lack of access to the best treatments available in a timely and affordable fashion are issues that have long been with us. But the situation just got markedly worse due to the COVID-19 pandemic, writes EAPM Executive Director Denis Horgan.
Here, we talk to a 58-year-old man who has been diagnosed with tongue and jaw cancer and who is about to undergo treatment. The diagnosis, and then the waiting for a treatment start date, made for a long haul. Denis Horgan is the interviewer. Let’s call our patient ‘Peter X’.
DH: Peter, it’s been reported across various countries that the novel coronavirus situation has had a negative impact on other equally important diseases. Can you shed some light on that, please?
PX: OK, well, many countries have seen a drop-off in people actually making it to very important appointments due to the constraints currently being placed on much of society and, as tends to happen, priorities for citizens change what can look like illogically. Many people seem to think that they shouldn’t be taking up the time of any healthcare workers. They need treatment too, but they “don’t want to be any trouble”.
Meanwhile, some areas have actually suspended chemotherapy treatment altogether on at least a temporary basis for the same reasons, leaving patients with no choice anyway. That’s not the case where I am, as it turns out.
The simple fact is that untreated cancer patients run just as high a risk of dying as vulnerable people catching the Covid-19 virus. It goes beyond cancer to other afflictions, of course, but it’s a good example.
DH: To the nitty gritty… In your case, how long did diagnosis take?
PX: A lot longer than I would have thought if you’d asked me at the start but, exact details aside, my story is, apparently, not so unusual.
It began with my suffering from an earache at the same time as a slightly wobbly tooth. Same side of the face, so every expert down the pub said that they were probably connected and, for once in such circumstances, they were probably right!
So, after trying some earwax remover from the pharmacist - didn’t work - I eventually went to the hospital to have my ears syringed. Two for the price of one! They definitely needed it but it made no difference to the pain.
Next up was a trip to the dentist and we decided, what the hell, and took the tooth out. After a while, and reluctantly prescribed antibiotics from the dentist, it became clear that the cavity left by the tooth wasn’t healing properly. Also, the pain in the ear was still there, so the next stop was the ‘ear, nose and throat’ department of the hospital.
At that point I was told to undergo a couple of scans, one radioactive, and was a few days later referred to a hospital in another city for a biopsy, on the basis that if it turned out to be cancer I would have to be treated there anyway. This was a three-hour trip.
DH: What was the overall time period at this point?
PX: Several weeks, all spent taking various painkillers, which I usually avoid.
DH: So what happened next?
PH: Well, somewhat despondently, and with a friend in tow, I trooped off to a hotel in the city in question and underwent a tongue and jaw biopsy at the relevant hospital. I won’t go into the details, but I do not recommend a tongue biopsy - it was painful and uncomfortable. Not nice at all.
Then, after what was effectively a minor operation, I was advised not to talk for some time while my tongue healed, which many found amusing, of course. Always look on the bright side…
Then, I had to wait for three weeks for the results. Eventually I got the call and went back, on the coach for three-plus hours and to the hotel, to the city hospital. To be told, as I expected by then, that it was cancer.
The talk at that time was of an operation to remove part of my tongue and replace it with a pectoral muscle and to do the same with part of my jaw, replacing that from a rather different part of my anatomy.
But first I would have to have an all-over scan - CAT? - but they couldn’t fit me in for one month. So here am I knowing I have cancer, they know i have cancer, all my friends know I have cancer, and now I have to wait for a month to see where else it may or may not be before they decide on the final treatment.
DH: I can only imagine your frustration.
PX: Yes, and by this time I was on even stronger drugs which interfered with my sleep and also caused constipation. Happy days, not.
Finally, I went back to the hospital for the scan and it was three more weeks until I was called back for the results. At that point, one of the consultants (I’d seen several by then) told me I had to visit various other specialists prior to a final, final, final decision on how to move forward and, given how far away I lived, it made sense to arrange all these quick consultations for one day. That turned out to be possible - but only by waiting another three weeks.
In the meantime, the cancer was certainly not going away, was it? Quite the opposite. And I was getting beyond frustration into anger territory at this point. And almost some tears on a few occasions.
Anyway…Eventually these appointments take place and I stay in a hotel for three nights and finally see the surgeon who, to my disbelief after all this time mucking about, tells me that it’s too late to operate and that I have to skip that bit and go straight to chemo and radiotherapy.
I had all on not to blow my top there and then. There I sit with an advancing cancer that everyone knows about having been shoved from pillar to post to be told it’s now too late for Plan A and we have to jump to Plan B.
DH: Alright. What next?
PX: Cue yet another consultation, then another wait and round-trip and a measurement for a ‘mask’ to keep my head still during radiotherapy. Followed by a start date two weeks down the line. By which point I would have had to move to the city - at huge expense - and live for two months in a hotel in a place where I know no-one while undergoing a horrible combination of chemo and radio.
And that’s where we are. Treatment starts tomorrow, Denis. I’m lonely and frightened, and under great financial stress, trying not to think about the fact that if this had all been done months ago, it would have been done-and-dusted for better or for worse, and I would be back at home right now rather than living out of a suitcase in a hotel in a strange city.
Of course, this would all have been bad enough, anyway. But the Covid-19 outbreak certainly had an impact on staff availability. On the big plus side, at least I’m lucky that they haven’t stopped chemo where I am.
This is literally a matter of life or death for me, as it is for the worst affected Covid patients, although in a different context, of course.
DH: So how do you feel about all this?
PX: Obviously frustrated, a little angry, frightened because it’s going to be dreadful in every respect, and knowing that - according to my consultant - some days I may feel so ill that they’ll keep me in hospital overnight.
Meantime, I’ve already lost loads of weight, am on liquid-based food supplements, as it hurts to eat most solids, and I can’t have a drink for the next two months if ever again!
Thinking positively, now we’re finally on track, I might come out of it cancer free. One can but hope. I’m trying to be positive.
What I will say finally is that, while all of this very serious COVID-19 situation is ongoing, please do not suddenly think that other seriously ill patients can be pushed to one side.
DH: Thank you, Peter.
Very sadly, our interviewee passed away from cancer in July 2020 – we would have so liked him to be able to attend our next conference, EAPM’s 9th EU Presidency conference, under the auspices of the Portuguese EU Presidency. The conference, which takes place on 8 March from 9-16h, is entitled ‘Forward together with innovation: The why, what and how of tackling the implementation gap for health care in the EU Portugese Presidency’. Please find the link to register here and the agenda here.
EAPM: A packed schedule, with treaty changes and biomarker testing
Good morning, and welcome one and all to the European Alliance for Personalised Medicine (EAPM) update. The Alliance is set for a packed schedule in the weeks and months ahead, and thankfully it is not just concerning COVID-19. A proposed change to the EU’s health powers is aiming to ensure that the EU can do more, health-wise, during emergencies, and biomarker testing is also high on the EU’s priorities, writes EAPM Executive Director Denis Horgan.
Commission aspires for treaty change on health
The European Commission is hoping for a treaty change so that it has more say on health. "If the moment is right, it will happen," Margaritis Schinas, the vice president of the European Commission has said. This echoes similar sentiments expressed by outgoing German Chancellor Angela Merkel, who said Wednesday (21 April) that the European Union needs more power to coordinate the bloc’s response to health crises like the coronavirus pandemic, and did not rule out a treaty change to secure them. Her comments to an online meeting on the Future of Europe of fellow European conservatives raised eyebrows in Brussels, where the start of a large-scale public debate on the future of the EU has revived talk of reopening the bloc’s governing structure.
And Health Commissioner Stella Kyriakides made a push to look at the EU’s health powers on Thursday (22 April) in the Parliament’s health committee, telling MEPs that the Conference on the Future of Europe is a “unique opportunity” to discuss health competences. When asked about doing this for medicines, Kyriakides said the EU is “ready to work in all areas for this where there is a clear EU added-value”, she said. “But ultimately, this is a decision also in discussion to be having with member states.”
MEP Cristian-Silviu Buşoi, rapporteur for the EU4Health program, said: “The COVID-19 crisis has clearly proven European Union’s need for well-defined and adequately financed policy instruments.”
And Chancellor Merkel added that she is open to making changes to the EU’s founding treaties, particularly in the area of health policy, and urged the bloc to find ways to make its foreign policy more efficient.
Merkel said the World Health Organization had told the EU that it should not only see itself as a single market in economic terms but also when it comes to health policy. “Ideally, we should always have had a uniform European approach to lockdowns, shutdowns and other measures,” she said. “And that’s why I think it’s right that the president of the Commission, Ursula von der Leyen, says we need a health policy that is more strongly coordinated, at least for such supra-regional health hazards — be it at intergovernmental or at European level.
“If we do not speak with one voice, we will not be able to speak strongly,” Merkel said. “That is not how Europe achieves strength.”
Take-up in health systems needs to match advances in biomarker testing and it should be a priority in the implementation of the EU Beating Cancer Plan
Rapid and continuing advances in biomarker testing are not being matched by take-up in health systems, and this is hampering both patient care and innovation. It also risks costing health systems the opportunity to make their services more efficient and, over time, more economical. The potential that genomics has brought to biomarker testing in diagnosis, prediction and research is being realised, pre-eminently in many cancers, but also in an ever-wider range of conditions. But development is impeded by data deficiencies, and lack of policy alignment on standards, approval and reimbursement.
Europe should already have in place a guarantee of universal access to a minimum suite of biomarker tests, and should be planning for an optimum testing scenario with a wider range of biomarker tests integrated into a more sophisticated health system articulated around personalised medicine. Improving health care and winning advantages for Europe's industrial competitiveness and innovation require an appropriate policy framework – starting with an update to outdated recommendations.
The list of deficiencies and barriers to exploiting the potential of biomarkers is long, but so too is the list of solutions that are already available – or should be.
Many of the issues relating to funding can be solved with only marginal adjustments to healthcare funding. European health authorities should put in place a policy framework to support diagnostics in the EU by 2022, with a ring-fenced budget allowance for biomarker testing development and clinical validation.
Research on biomarkers discovery and early testing should benefit from policies that promote investment and funding. What is currently missing for innovative diagnostic technologies is a dedicated and specific reimbursement pathway, on the basis of the value of information delivered, implemented consistently across Europe.
Models of well-evolved HTA mechanisms – if connected to a reimbursement decision - would inspire other countries without relevant structures. In such a system, decision makers, including HTA bodies informed by input from patients, would define evidentiary standards for diagnostics and would commit to pay for products that met them.
Much of this can be achieved by more effective collaboration. The EU should agree by 2023 a business model for public-private cooperation for optimal biomarker testing available across the EU, based on a recognition of the business and value case to provide infrastructure to meet testing requirements. This would make it possible to build the evidence base on biomarker testing, and define how this is accessed. This is a key focus of work in the next few months.
Since data collection, data quality, data standards and data interoperability are notoriously deficient in many of Europe’s health and research systems, with frequently incomplete, non-standardised, retrospective, non-accessible and siloed methods, health authorities should provide guidelines on how clinically-relevant biomarkers should be measured and reported.
Member states should agree on a federated structure of national databases, and regulatory barriers to data transmission and the transport of human samples should be eased to permit large international multi-centre clinical validation studies of biomarkers (especially early diagnostic and prognostic biomarkers), which require large and long-lasting cohorts.
The EU should establish a framework for quality of testing and value of diagnostics information. Testing data should come from standardised laboratories where samples are collected, transported stabilised and stored under standardised conditions and include sample metadata on the complete preanalytical phase.
This way the data can be compared and analyzed as it is not polluted with irreproducible and or unusable data for further analysis. This would facilitate centralised and standardised registries of diagnosis including sequence and biomarker data, pre- analytical sample metadata, and treatment and outcome data. It would feed into a fast track approval mechanism for biomarker validation, accompanied by guidance on minimal testing standards and resource allocation.
Clarity for clinicians on where and when tests should be performed should be provided, within a system capable of allowing for evolving testing needs and permitting new tests to be rapidly made available to patients. In a virtuous feedback loop, the captured testing data would inform service improvement, benchmarking and research. The clinical infrastructure would turn fit-for-purpose real world data into real world evidence to help close evidence gaps, overcoming the deficiencies of existing datasets, Global or even pan European pan-cancer registry could demonstrate the insights possible from a large data set of high quality and provide valuable learning on what is needed to share data across borders.
Collaboration also would have to be systemized to provide for the engagement of multiple specialties in shifting testing objectives from risk assessment to informing treatment decisions, with drug and diagnostic developers, clinicians, biologists, biostatisticians and digital technology groups routinely cooperating on studies. Member states should promote engagement between payer organizations, biomarker developers and the wider healthcare stakeholder community, through vertical and horizontal integration, and member states should ensure that new validated biomarker tests are rapidly made available to patients without unrealistic evidentiary burdens being imposed by regulators.
There are opportunities still to be explored – such as providing simpler testing kits for complex conditions, and notably the development of blood biopsy, or the convergence of complex test offerings with predictive protein-, genetic-, epigenetic-based biomarkers or NGS panels, or the development of predictive potential of prognostic tests (effectively as companion diagnostics) with emerging drugs.
Parliament and Council to begin HTA negotiations on Monday
Proposed joint Health Technology Assessment legislation will enter negotiations between the European Parliament and the Council on Monday (26 April), said an EU diplomat today (23 April).
The proposal seeks to establish EU-level assessments of pharmaceuticals and medical devices. The piece of legislation had been stalled for years in the Council as countries debated how much of their own powers to give up, but the capitals agreed to a proposal in March clearing the way for discussions with the Parliament to begin.
Facebook 'fails to clamp down on COVID-19 misinformation in Europe'
Facebook leaves European users exposed to dangerous conspiracy theories about the pandemic and COVID-19 vaccines with an “America First” policy that fails to clamp down on misinformation in Europe, according to a report by US campaign group Avaaz. The report says that most of the false content posted in French and Italian was not acted on by Facebook moderators and that the social media platform is typically nearly a week slower to flag misleading content posted in languages other than English.
Responding to the report, a Facebook representative said that it did not reflect the company's “aggressive steps to fight harmful COVID-19 misinformation in dozens of languages”. Action taken by Facebook included adding warning labels to some misleading posts, and removing others altogether, it said. But the Avaaz report said 69% of false posts in Italian and 58% of those in French lacked any kind of visible red flag from Facebook. The same was true of 50%of Portuguese content and 33% of that in Spanish, according to the study. By contrast, only 29% of English language posts were similarly unmarked, the report said.
And that is everything for this week from EAPM, stay well, and have an enjoyable, safe weekend, see you next week.
EAPM: Fears of new waves raised as lockdowns ease
Good morning, health colleagues, and welcome to the European Alliance for Personalised Medicine (EAPM) update – with lockdowns easing across Europe, but fears of second or even third waves being raised globally, there is much to discuss in the health arena, writes EAPM Executive Director Denis Horgan.
COVID-19 in India
In India, a second COVID wave is wreaking havoc. Data suggests that this wave is proving to be more infectious and deadlier in some states, although India's death rate from the virus is still relatively low. But the county's healthcare system is crumbling amid the surge in cases - doctors say it's hard for them to "see the light at the end of the tunnel this time". Sharp rise in cases The rise in case numbers has been exponential in the second wave. On 18 June last year, India recorded 11,000 cases and in the next 60 days, it added 35,000 new cases on average every day. On 10 February, at the start of the second wave, India confirmed 11,000 cases - and in the next 50 days, the daily average was around 22,000 cases. But in the following 10 days, cases rose sharply with the daily average reaching 89,800. Chart showing cases in first and second wave Presentational white space Experts say this rapid increase shows that the second wave is spreading much faster across the country. Dr A Fathahudeen, who is part of Kerala state's Covid taskforce, said the rise was not entirely unexpected given that India let its guard down when daily infections in January fell to fewer than 20,000 from a peak of over 90,000 in September.
UK coronavirus: Boris Johnson warns of third wave
Pills taken at home to prevent severe Covid-19 infection could be available by the autumn, Boris Johnson said as he warned that a third wave of cases could hit the UK. The Prime Minister announced the creation of an “antivirals task force” charged with developing early-stage treatments for the disease. At a Downing Street press conference, he said that the UK’s “vaccination programme has demonstrated what the UK can achieve when we bring together our brightest minds”. It came as Mr Johnson acknowledged soaring cases overseas and warnings from scientists that there will be another wave this year. However, he said that he saw nothing that would cause the UK to "deviate" from its opening up schedule, and that we must "learn to live with the disease as we live with other diseases".
France launches digital health pass for air travel
France has launched an experimental digital health pass this week, becoming the first European country to allow air travel for those who have a negative coronavirus test or those who have recovered. The feature called notebook was introduced Monday (19 April) on the government’s TousAntiCovid app - allowing users to upload antigen or PCR tests by scanning a QR code on the test result form. A negative test result can be used for limited air travel to Corsica on Air France and Air Corsica flights and to overseas territories beginning at the end of May. Authorities are discussing the possibility of allowing the app to be used for entries to mass public events like music concerts, festivals, trade shows, but have ruled out its use for entry to "bars or restaurants," according to a report in Le Monde. “This system is more secure as there is no scope for fake paper certificates. It’s simple and can be easily shown at the airport,” Minister of State for Digital and Telecommunications Cedric O told France 3 news.
Commission probes biotech 'killer acquisition' thanks to new rule guidance
The European Commission has used new guidance on a key merger rule against so-called “killer acquisitions” to look into biotech company Illumina’s $7 billion deal to acquire cancer-test startup Grail. The takeover fell below the thresholds which normally trigger a merger investigation at the EU level. But Brussels was able to launch a probe at the request of France — subsequently joined by Belgium, Greece, Iceland, the Netherlands, and Norway — given the potential impact of the takeover on the market for cancer detection tests, the Commission said in a statement. The referral was possible thanks to new guidance from Brussels on a provision in EU merger rules, Article 22. According to the new reading, published on March 26, national regulators can ask Brussels to vet potentially harmful mergers that fall below the regulatory thresholds for a review. “A referral of this transaction is appropriate because Grail’s competitive significance is not reflected in its turnover,” the Commission explained. France’s competition authority, which first referred the deal to Brussels, took pride of having been the first to trigger the new tool. “This development has been called for by the authority for several years,” the French watchdog said in a statement.
The catch in Europe's 'green certificates' plan: COVID testing costs
New measures to allow Europeans to travel more easily this summer come with a hidden cost, say MEPs, who warn that the high-price tag of necessary coronavirus tests infringes on unvaccinated people’s right to free movement. The European Commission’s proposal for a so-called “digital green certificate” is intended to allow Europeans to move around more easily and safely despite the pandemic, and give a boost to the travel industry and tourism-reliant countries. The certificate, which will be issued free of charge, will indicate whether a person has been vaccinated, tested negative or recovered from the coronavirus. In theory, this ensures that unvaccinated people are not discriminated against. But coronavirus tests are expensive. That — in addition to quarantine measures demanded by some countries — creates an additional barrier to travel for unvaccinated people, said Dutch MEP Sophie in ‘t Veld.
Europe’s slow vaccine rollout means that most European adults are still waiting to receive their jabs, while high rates of vaccine skepticism in some countries suggest many may opt not to get vaccinated at all. “Many people can’t, or don’t want to, get a jab,” in ‘t Veld said in an interview. “Such a green certificate on the basis of a test must be a real alternative.” For that to be the case, tests have to be within reach for everyone, “and currently that’s simply not the case,” she added. The price for a PCR test varies wildly across Europe: France and Denmark offer tests free of charge, while a test costs 19,500 forints (€54) in Hungary and 520 złoty (€115) at Warsaw’s Chopin Airport.
According to data from travel association ABTA, Belgians are charged between €47 and €135, while Italians pay €63 on average and Portugal charges €75. It’s money travelers must be able to cough up several times, as countries often require two tests upon arrival, sometimes on top of a pre-departure test. In the Netherlands, tests cost between €70 and €140 — an “insurmountable obstacle” for many, especially for larger families or people who regularly commute across borders, such as truckers, according to in ‘t Veld. A divorced father who wants to visit his child in another country reached out to her, she said, because he couldn’t afford the tests. The difference in prices between countries also goes against EU treaties, which dictate that citizens should not be discriminated against on the basis of their nationality and that the single market should be free of disproportionate obstacles, in ‘t Veld said. The Dutch lawmaker, a member of the liberal Renew Europe group in the Parliament, has called on the Commission to put forward an emergency legislative proposal to cap the price of testing and suggested that EU citizens should have access to a number of free tests to allow them “to travel at least once during the holiday period”.
In ‘t Veld is not alone in seeing an issue with expensive testing. Greens MEP Tineke Strik said earlier this week that her group would put forward amendments to the green certificate proposal to ensure testing is free of charge. The Parliament is expected to nail down its position on the green certificates later this month, and in ‘t Veld is hoping to drum up support for a separate resolution — calling for Commission action on test prices — to be adopted at the same time. So far, the Commission’s response has been lukewarm. Making tests free of charge or capping their price “would constitute a serious interference in member states’ competence in the field of public health,” Commissioner for Justice Didier Reynders said Tuesday at a hearing of the Parliament’s industry committee. Such a proposal “would have to be carefully analyzed for its legality and feasibility,” he added. In ‘t Veld argues there’s “more than enough” of a legal basis for the Commission to step in, as the price of tests constitutes a “very clear obstacle to free movement” in the EU and the single market. She pointed at similar interventions to regulate credit card fees and bank transfer costs. “It’s as if this Commission is the lapdog of the member countries. They don’t dare to do anything without getting the green light from countries first,” she said.
Brexit to hit supplies of cancer, epilepsy and diabetes medicines to Northern Ireland, government warned
Brexit will prevent vital medicines to treat cancer, epilepsy and diabetes from reaching Northern Ireland, drug experts are warning. Firms making non-branded drugs are already starting to withdraw them because of costly new red tape, ministers are being told – threatening to cut the treatments available. The British Generic Manufacturers Association said planned new products being pulled before the rule changes come in next January included “treatments for epilepsy diabetes, and cancer”. “We need an urgent solution today,” said Mark Samuels, the trade body’s chief executive, adding: “If we don’t have a solution immediately, they will feel it in January.”
The threat has blown up because, at the end of a 12-month ‘grace period’, medicines made in Great Britain will require separate licences for use in Northern Ireland, as well as different safety inspections and other checks. The barrier is the latest to be put in the spotlight by the Northern Ireland Protocol, the 2019 treaty signed by Boris Johnson which has created a trade border in the Irish Sea. The new red tape emptied supermarket shelves in January, leading to the UK unilaterally shelving further checks – and a legal action launched by Brussels.
Johnson & Johnson to resume deliveries of COVID-19 vaccine to EU
Pharmaceutical company Johnson & Johnson is to resume deliveries of its one-shot COVID-19 vaccine to the European Union after the European Medicines Agency (EMA) confirmed its benefits outweighed the risks of blood clots as a very rare side effect. The vaccine leaflet is to be updated to include information on the diagnosis and treatment after the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) reviewed eight reported cases of unusual blood clots combined with low platelets among over seven million people who received the jab in the United States. It is likely to be several days before the National Immunisation Advisory Committee (Niac) will issue advice on the use of the Johnson & Johnson vaccine and the potential for spacing out between doses. Addressing an Oireachtas committee after the EMA announcement, Niac chairwoman Prof Karina Butler said it was awaiting further data from the European agency which may impact decisions on restricting access to specific age groups for some vaccines, and from the UK on dose intervals. This would be studied, along with projections on supplies of other vaccines and the potential impact of any decision on the wider programme, before recommendations were made to Government. On Monday (19 April), the National Public Health Emergency Team said it would not change its advice on extending the interval between doses of the Pfizer and Moderna vaccines until there was clarity on the Johnson & Johnson shot. Asked about the matter on Tuesday (20 April), Prof Butler said spacing out shots allowed to get “some vaccine into more people”, but that it could also favour the emergence of variants, and had to be balanced as it “will necessarily lengthen the time to get everybody fully vaccinated”.
And that is everything for now from EAPM – thank you for your company, stay safe and well, see you soon.
EU pharma rules, EAPM newsletter and treaties
Another Easter is around the corner, a further EAPM dispatch for your delight and delectation…and more developments in the current COVID-19 crisis as a new holiday looms. With the aforementioned Easter weekend coming up, it will be interesting to see how many Europeans defy strong recommendations to stay at home. And taking into account the day that it is, EAPM’s newsletter is available here, writes European Alliance for Personalised Medicine Executive Director Dr. Denis Horgan.
In other news....
Changes to EU pharma rules en route
The European Commission has inched a little closer to the wide-ranging changes to EU pharma rules envisioned in its Pharmaceutical Strategy, publishing today (30 March) a document that sets out the objectives of upcoming policy reports and proposals on the topic.
Plans to cut the time it takes to gain regulatory approval for medicines and medical devices, and drive the development of new antibiotics and other products for treating rare diseases, have been outlined in a wide-ranging new pharmaceutical strategy for Europe.
The strategy, developed by the European Commission, is patient-focused and seeks to build on the collaborative efforts of industry seen during the coronavirus crisis. The Commission hopes to deliver the strategy over a number of years.
Its new Pharmaceutical Strategy seeks "to ensure affordable, safe, quality, innovative and solutions-oriented pharmaceuticals for all citizens in the EU", Vice President Margaritis Schinas announced at the strategy's unveiling. The 25-page document is packed with technical suggestions to fine-tune Europe's pharma system, but the challenge will be to translate these into tangible changes for European consumers. Experts think the strategy — if properly implemented — has the potential to make drugs more affordable, boost the variety of treatments available, drive forward innovation and firm up supply chain resilience.
COREPER vaccine controversies
An internal squabble with COREPER over extra vaccines was just the latest controversy as the EU tries to speed its inoculation campaign. The decision to seek arbitration among the ambassadors came after Austrian Chancellor Sebastian Kurz virtually sabotaged the meeting by insisting that his country receive extra doses, even though European Commission data shows Austria faring relatively well among EU nations in terms of vaccine supplies.
Kurz in a corner
A discussion tomorrow (31 March) will focus on Austrian Chancellor Sebastian Kurz’s attempt to get more vaccines. On 12 March, the 34-year-old vehemently accused the EU of unfairly distributing vaccine doses among its 27 member states.
Lashing out at the ‘EU bazaar’, he demanded adjustments in favor of member states that received less doses than others. Kurz took the dispute all the way to the European Council meeting in Brussels last week, taking precious time away from pressing issues on the agenda—transatlantic relations, a common vaccination “passport,” and possible vaccine export bans. German Chancellor Angela Merkel reportedly got so annoyed with Kurz that she reminded the group that vaccine contracts were signed by member states themselves “and not by some stupid bureaucrats” in Brussels.
Pandemic treaty push
Leaders from 23 countries, the EU and WHO today (30 March) backed a push for a new global treaty to better prepare the world to tackle future pandemics. The call came in an op-ed published internationally that was signed off by leaders from five continents, including Germany’s Angela Merkel, Britain’s Boris Johnson, France’s Emmanuel Macron, South Korea’s Moon Jae-in and South Africa’s Cyril Ramaphosa. “We believe that nations should work together towards a new international treaty for pandemic preparedness and response,” the op-ed said.
“Such a renewed collective commitment would be a milestone in stepping up pandemic preparedness at the highest political level.”The push to bolster common efforts comes as the planet struggles to combine forces to overcome the COVID-19 pandemic that has killed almost 2.8 million people worldwide.
The spread of the virus has seen blame traded between capitals and accusations that rich nations have hoarded vaccines as economies around the globe have been battered.
“Together, we must be better prepared to predict, prevent, detect, assess and effectively respond to pandemics in a highly coordinated fashion,” the leaders said. “At a time when COVID-19 has exploited our weaknesses and divisions, we must seize this opportunity and come together as a global community for peaceful cooperation that extends beyond this crisis.”
ECDC – immune transmission
More than one year into the SARS-CoV-2 pandemic, over 120 million people have been infected with the virus across more than 200 countries. Reinfections following natural infections with the same or a new SARSCoV-2 variant have been reported sporadically and questions remain concerning the duration of immunity following natural infection, and whether asymptomatic reinfected individuals may be able to transmit the virus.
COVID-19 vaccines have been evaluated for their efficacy and effectiveness against symptomatic COVID-19 infection and for reducing and/or preventing mild, moderate, or severe COVID-19 disease, including mortality. However, the vaccine trials have not been designed to measure reduction in transmission risk from infected vaccinated individuals to susceptible contacts.
In this context, it is important to understand the available scientific evidence on the extent to which previous SARS-CoV-2 infection or COVID-19 vaccination prevents onward transmission from infected individuals to susceptible contacts. Therefore, ECDC has conducted a review of published and pre-print literature on duration and characteristics of immunity following a natural SARS-CoV-2 infection due to any variant or after COVID-19 vaccination with any of the EU-authorized vaccines now available.
Evidence from studies specifically designed to assess the impact of previous infection on the risk of transmission is currently lacking. Infection with SARS-CoV-2 does not provide sterilising immunity for all individuals and some who are reinfected might still be able to transmit SARS-CoV-2 infection to susceptible contacts.
There is evidence that reinfection remains a rare event. Results from cohort studies confirm that the protective effect of previous SARS-CoV-2 infection ranges from 81% to 100% from Day 14 following initial infection, for a follow-up period of five to seven months. Protection against reinfection is lower in individuals aged 65 years and older.
As the number of individuals acquiring natural immunity increases, the total number of infections is expected to decrease significantly, leading to decreased transmission overall, unless the genetic changes in the circulating variants induce significant immune escape.
Brain on centre stage
The launch of the OneNeurology Partnership, a new initiative from the European Federation of Neurological Associations (EFNA), has taken place — together with the European Academy of Neurology, European Brain Council, World Stroke Organisation and Alzheimer’s Disease International, the partnership is aiming to raise the profile of brain diseases. The goal is “to build political interest” so that the Commission and member countries pay attention to the disease group and start formulating national-level neurology plans. The Commission can act as an organizer and facilitator to co-ordinate different national plans.
EU vaccine chief says vaccine passports to be launched in June
Internal Market Commissioner Thierry Breton, who back in February this year was put in charge of the new vaccine production task force by the Commission, has unveiled the prototype of the announced EU vaccine passports.
During an interview for RTL radio and TV channel LCI, Commissioner Breton also said that the new documents which will prove that the traveller has been vaccinated, recovered from COVID-19, or his/her test results in case none of the two first has taken place, will be issued to EU citizens somewhere in mid-June ideally.
“From the moment we can be sure that every European who wants to be vaccinated will have fair access to the vaccine, as will be the case in the next two to three months – it will be good to have a health certificate that demonstrates your condition,” the commissioner said.
The Commission brought forward its proposal for the creation of a Digital Green Certificate in a bid to restore travel amid COVID-19 for those who have been vaccinated against the virus, SchengenVisaInfo.com reports.
And that is all from EAPM for now – don’t forget to have a read of our newsletter here, and our very best wishes to you all for a safe and happy Eastertide. Here is the link to our newsletter again.
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