Welcome, one and all, to the last European Alliance for Personalised Medicine (EAPM) update of les grandes vacances – August ends on Monday, so most (but decidedly fewer than usual) are getting ready fo the grand return to work next week, writes EAPM Executive Director Denis Horgan.
Before we get on with the main news, be sure and check EAPM’s monthly newsletter, which is now ready, click here. It covers the health news of the past month, and looks forward to key EAPM events that are just around the corner.
But first, a word on the sad demise this week of Irish Trade Commissioner Phil Hogan (pictured), who resigned on Wednesday evening (26 August), following controversy over alleged breaches of COVID-19 guidelines during a trip to his native Ireland, a spokesman for the commissioner said.
Hogan attended a golf dinner last week that outraged the Irish public and led to the resignation of an Irish minister and the disciplining of several lawmakers. He had insisted on Tuesday (25 August) that he had adhered to all rules during the trip, and Commission President Ursula von der Leyen, while accepting his resignation, thanked Hogan for his work as trade commissioner and for his successful term as agriculture commissioner in the previous Commission, the Juncker Commission. Von der Leyen described him as a valuable and respected member of the College of Commissioners.
Of course, COVID 19 is a very serious issue, but the question is how the guidelines are applied as well as the lowest common denominator in the application of standards. If we go for the lowest commonest denominator and undermining our way of life, are we giving in to the disease in another way, and are we not losing our humanity in not seeing the issue, in this case the person that Phil Hogan is and the office he once represented?
For this part of the update, I want to highlight the good work that Hogan has done over the years as well as the work that he did on trade. The commissioner championed health care as well, and had spoken at EAPM events.
The fate of Phil Hogan is similar to the issue in the play The Crucible by Arthur Miller, in the sense that everyone acted hysterically about an alleged breach of rules, and political correctness won the day. The play is a fictionalized version of the Salem witch trials and tells the story of a group of young Salem women who falsely accuse other villagers of witchcraft. The accusations and ensuing trials pushed the village into a hysteria between February 1692 and May 1693. More than two hundred people were accused. Thirty were found guilty, nineteen of whom were executed by hanging (fourteen women and five men).
Of course, the former commissioner made a mistake, but the issue was blown into the stratosphere by those wanting to say that they are whiter than white, so as to protect the public good and score political points with the broader public.
Clearly, public health guidelines must be adhered to but one must look to each case as UK Prime Minister Boris Johnson did, with Cummings. Hogan did have a COVID-19 test, was negative, checked with the relevant website as well as the department but to no avail, he had to bow out...as political correctness won the day. The controversy of what he did or did not do has now fallen silent, as there was really nothing to it in the end. There was no monetary fine, no punishment of any kind, but the fact was that he had to resign ....
By all accounts, he was the right person for the job and in his interaction with EAPM was a very considered and supportive member of the broader health-care community.
A real shame. European Commission Vice President Valdis Dombrovskis will take over the trade portfolio temporarily after Hogan’s resignation, Commission President Ursula von der Leyen announced on Thursday. The Hogan saga was evidence writ large that von der Leyen has raised the European Commission’s ethical bar — and that may make it harder to clear in future. “As Europe fights to reduce the spread of the coronavirus and Europeans make sacrifices and accept painful restrictions, I expect the members of the College to be particularly vigilant about compliance with applicable national or regional rules or recommendations,” von der Leyen said on Thursday (27 August).
World Health Organization Pandemic Policy Committee meets
The World Health Organization (WHO) Pan-European Commission on Health and Sustainable Development met for the first time on Thursday. At its concluding press conference, chairman Mario Monti — former Italian PM and current president of Bocconi University — drew attention to the way COVID-19 has revealed weaknesses in current health systems. “The pandemic has illuminated with a rather dark light the stark inequalities in our modern world,” he said. “But it also has also underlined the truism that no one is safe until everyone is safe.”
Rethinking the PHEIC
And the WHO said on Thursday it was setting up a committee to consider changing the rules on declaring an international health emergency, following criticism of its COVID-19 pandemic response. The World Health Organization declared a Public Health Emergency of International Concern (PHEIC) over the new coronavirus on 30 January 30 – at which time the respiratory disease had infected fewer than 100 people outside China, and claimed no lives beyond its borders. But under the current International Health Regulations (IHR) governing preparedness and response for health emergencies, there are no lower, intermediate levels of alarm beneath a full PHEIC, either on a global or regional scale. The WHO intends to interact with the new independent review panel looking at the broader response, as well as the WHO’s internal oversight panel, with plans to deliver an update at the World Health Assembly in November, and a final report at that gathering in May 2021.
The EU, Britain and other EU partners such as Switzerland and Norway want a future vaccine to cover 40% of their populations, as opposed to the 20% initially set out by the global procurement mechanism COVAX. According to a document adopted in late July, the countries noted that at-risk groups account for around 40% of the population.
Back to school
According to a study by BMJ, COVID-19 has not caused the deaths of any otherwise healthy schoolchildren in the UK. Children's risk of needing hospital treatment for coronavirus is "tiny" and critical care "even tinier", they say. However, black children, those who are obese and very young babies have a slightly higher risk. The BMJ study looked at 651 children with coronavirus in hospitals in England, Wales and Scotland. It covers two-thirds of all children's admissions in the UK due to COVID-19 between January and July and confirms what is already known about the minimal effects of the virus on children. A "strikingly low" 1% of these 651 children and young people - six in total - had died in hospital with COVID-19 compared with 27% across all other age groups, the study found. Eighteen per cent of the children needed intensive care. And the six who had died had had "profound" underlying health conditions that had often been complex and themselves life-limiting. Children with such conditions remained vulnerable to the virus and must take precautions, the researchers said. But for others, the risk was extremely low.
And that is everything for this week – enjoy your weekend, which is possibly your last before returning to work, here is our newsletter again and be sure to check in with EAPM again on Tuesday (1 September).
Germany wants to use Regeneron's COVID-19 antibody therapy more broadly
Germany would like to use Regeneron’s COVID-19 monoclonal antibody cocktail as a treatment for this disease more broadly but needs to finalize some details on reimbursement, Health Minister Jens Spahn said on Thursday (15 April), writes Caroline Copley.
“The drug is available in Germany, we need it much more and we want it much more and we are working on rolling it out across the nation,” he told a weekly news conference.
President von der Leyen on developments in the Vaccines Strategy
In a press statement on 14 April, President of the European Commission, Ursula von der Leyen, announced an agreement with BioNTech-Pfizer to accelerate the delivery of 50 million vaccine doses to the second quarter of this year, starting this month: “We are in a race against time. The faster we reach our target of having 70% of adults in the European Union vaccinated, the better chances we have of containing the virus. And the good news is: Vaccination is picking up speed across Europe! Member states have received over 126 million doses of vaccines as of yesterday (13 April). And I am happy to say that today we have reached 100 million vaccinations in the EU. This is a milestone that we can be proud of. Of these 100 million vaccinations, more than a quarter are second doses – which means that we have now more than 27 million people fully vaccinated I am pleased to announce that we have reached an agreement with BioNTech-Pfizer to, once again, speed up the delivery of vaccines. 50 million additional doses of BioNTech-Pfizer vaccines will be delivered in quarter 2 of this year, starting in April. This will bring the total doses delivered by BioNTech-Pfizer to 250 million doses in the second quarter. These doses will be distributed pro-rata to the population, among all the member states. This will substantially help consolidate the roll-out of our vaccination campaigns.” As part of preparations for the medium term, the Commission is also entering into a negotiation with BioNTech-Pfizer for a third contract, to foresee the delivery of 1.8 billion doses of vaccine over the period of 2021 to 2023. This contract will entail that not only the production of the vaccines, but also all essential components, will be based in the EU. The President's full statement is available online in English, and French and shortly in German. You can watch it here.
Coronavirus response: Commission proposes to exempt vital goods and services distributed by the EU from VAT in times of crisis
The European Commission has proposed to exempt from Value Added Tax (VAT) goods and services made available by the European Commission, EU bodies and agencies to Member States and citizens during times of crisis. This responds to the experience gained during the course of the Coronavirus pandemic. Among other things, it has shown that the VAT charged on some transactions ends up being a cost factor in procurement operations that strains limited budgets. Therefore, today'sinitiative will maximise the efficiency of EU funds used in the public interest to respond to crises, such as natural disasters and public health emergencies. It will also strengthen EU-level disaster and crisis management bodies, such as those falling under the EU's Health Union and the EU Civil Protection Mechanism.
Once in place, the new measures will allow the Commission and other EU agencies and bodies to import and purchase goods and services VAT-free when those purchases are being distributed during an emergency response in the EU. The recipients might be Member States or third parties, such as national authorities or institutions (for example, a hospital, a national health or disaster response authority). Goods and services covered under the proposed exemption include, for instance:
- Diagnostic tests and testing materials, and laboratory equipment;
- personal protective equipment (PPE) like gloves, respirators, masks, gowns, disinfection products and equipment;
- tents, camp beds, clothing and food;
- search and rescue equipment, sandbags, life jackets and inflatable boats;
- antimicrobials and antibiotics, chemical threat antidotes, treatments for radiation injury, antitoxins, iodine tablets;
- blood products or antibodies;
- radiation measuring devices, and;
- development, production and procurement of necessary products, research and innovation activities, strategic stockpiling of products; pharmaceutical licences, quarantine facilities, clinical trials, disinfection of premises, etc.
Economy Commissioner Paolo Gentiloni said: “The COVID-19 pandemic has taught us that these kinds of crises are multifaceted and have a wide-ranging impact on our societies. A rapid and efficient response is essential, and we need to provide the best response now in order to prepare for the future. Today's proposal supports the EU's goal to react to crises and emergencies in the EU. It will also ensure that the financial impact of EU-level relief efforts to fight the pandemic and support the recovery is maximized.”
The legislative proposal, which will amend the VAT directive, will now be submitted to the European Parliament for its opinion, and to the Council for adoption.
Member States shall adopt and publish, by 30 April 2021 the laws regulations and administrative provisions necessary to comply with this Directive. They shall apply those measures from 1 January 2021.
The Coronavirus pandemic has thrown into sharp light the importance of coherent, decisive and centralised EU-level preparation and response in times of crisis. In the context of the Coronavirus pandemic, the von der Leyen Commission has already outlined plans to strengthen EU preparedness and management for cross-border health threats, and presented the building blocks of a stronger European Health Union. At the same time, the Commission has proposed to strengthen cooperation between EU Member States through the EU Civil Protection Mechanism with the aim of improving responses to future natural or man-made disasters. For instance, in the context of the new European Health Union, the Commission announced the creation of the Health Emergency Response Authority (HERA) to deploy rapidly the most advanced medical and other measures in the event of a health emergency, by covering the whole value chain from conception to distribution and use.
The EU has already taken action in the field of taxation and customs to support the fight against and the recovery from the coronavirus pandemic. In April 2020, the EU agreed to waive customs and VAT charges for imports of masks and other protective equipment needed to fight the pandemic. This waiver remains in place and plans are underway for its extension. In December 2020, EU member states agreed on new measures proposed by the Commission to allow a temporary VAT exemption for vaccines and testing kits being sold to hospitals, doctors and individuals, as well as closely related services. Under the amended Directive, member states can apply either reduced or zero rates to both vaccines and testing kits if they so choose.
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