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.