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EAPM: Các trường hợp COVID giảm nhưng châu Âu chuẩn bị cho làn sóng thứ tư

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Good morning, health colleagues, and welcome to the second European Alliance for Personalised Medicine (EAPM) update of the week, before the August break, but EAPM will be with you throughout summer, viết Giám đốc Điều hành EAPM Denis Horgan.

Deadline for orphan and pediatric tham khảo ý kiến 

Today (30 July) is the deadline for the public consultation on the revision of EU rules on medicines for children and rare diseases — and the process has been ongoing, in November 2020, the Commission published an inception impact assessment evaluating proposals to change EU regulations for medicines for rare diseases and for children. The Commission concluded that the orphan regulation has had a positive impact by adding 210,000-440,000 quality-adjusted life years for patients in the EU despite increasing costs by €23 billion from 2000-2017. Nearly three quarters (73%) of orphan medicines had annual sales of less than €50 million in the European Economic Area, while only 14% had annual sales over €100 million. The report found that orphan medicines on average received an additional 3.4 years of market exclusivity, which equates to about 30% of sales revenue for those products. While some sponsors may have been “overcompensated,” the Commission says that the additional market exclusivity “has helped to increase profitability, without giving the sponsor an unbalanced compensation” in most cases. The evaluation also looks at whether the current threshold of affecting fewer than 5 in 10,000 patients in the EU “is the right tool” for defining rare diseases.

EIF looks to decentralized software architecture

Fabric Ventures, a venture manager that backs ‘open economy’ founders across the globe, has today (30 July) announced Europe’s biggest fund of its type, valued at $130 million, which includes $30 million from the European Investment Fund (EIF). Fabric Ventures’ 2021 fund is the very first EIF-backed fund specifically mandated to invest in digital assets. It will back traditional equity as well as the software tokens and other digital assets native to these new, inclusive and collaborative networks and applications. These are all underpinned by the recent invention of digital scarcity and hence ownership. The founders of the open economy frequently have the explicit objective of delivering solutions to many of humanity’s most fundamental challenges, particularly health concerns.

Third vaccine doses set to begin

European countries have yet to start rolling out booster shots, although several countries have said they plan to — including Hungary, which is set to start on Sunday (1 August). Last week, Israel published data indicating that the effectiveness of the Pfizer/BioNTech vaccine could drop to 39%.The data has added further fuel to Israel’s justification to give a third dose.  Hungary would become the first EU country to offer a booster if it also goes ahead with plans to start offering the shot on Sunday. Alongside BioNTech/Pfizer, Oxford/AstraZeneca, Moderna and J&J vaccines, Hungary has also used Sputnik V vaccines and jabs from China’s Sinopharm. It’s unclear which vaccine would be used as a booster shot. 

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COVID-19 hospitalizations and deaths are increasing due to Delta

The surge in COVID-19 cases fuelled by the Delta variant and vaccine hesitancy has now led to increasing rates of hospitalizations and deaths. Data from Johns Hopkins University shows that the average number of new COVID-19 cases each day in the past week was 32,278. That's a 66% jump from the average daily rate the previous week, and 145% higher than the rate from two weeks ago. There's a common theme among those behind the worsening COVID-19 numbers, said Dr. Rochelle Walensky, director of the US Centers for Disease Control and Prevention. "This is becoming a pandemic of the unvaccinated," Walensky said at a COVID-19 briefing.

Austria to set out guidelines on ‘long’ COVID

Austria is setting out new guidelines for long COVID, with doctors set to receive advice on identifying and treating patients. The health ministry said that current estimates indicate that 10-20% of all people infected with coronavirus could have long-term consequences. The announcement comes as countries look to provide more support for patients who are still living with side effects long after having recovered from the virus.

Đức Chia over pandemic strategy

German Health Minister Jens Spahn rebutted experts at the Robert Koch Institute (RKI), who have been arguing that the infection rate should remain the leading indicator for pandemic management. Spahn argued that increasing levels of immunization mean that the rate of infections is less meaningful than it used to be. What’s needed are “additional data points to assess the situation” Spahn said, adding as an example the “number of newly admitted [COVID-19] patients in hospitals”. That rate has recently been rising again, but like elsewhere in Europe, hospitalizations are well below the peaks from the pandemic. That led Spahn to recently proclaim that a higher cut-off is now acceptable because infections lead to far fewer hospitalizations than they used to, and therefore fresh lockdown measures are not needed. Spahn’s position also aligns him with some of Germany’s state premiers, who disagree with Wieler and want to keep the economy as open as possible.

EU faces difficulties in repaying recovery fund's joint debt

The European Commission will shortly start transferring billions in grants and loans to EU member countries under its €750 billion pandemic recovery fund — but its plan to repay the borrowings through new levies at the EU level is unraveling.

The recovery fund — known as Next Generation EU — came together last summer after EU leaders reached an unprecedented agreement to issue hundreds of billions in joint debt to help the bloc’s economy get through the COVID-19 crisis. But the details of reimbursement, which will stretch over three decades, were left to the Commission to propose.  

Should all EU attempts to generate the revenue fail to deliver the needed sum of €15 billion a year, countries will have to cough up increased amounts for the EU’s budget starting from the next budget cycle in 2028 — a highly unpalatable option for countries in Northern Europe that are net contributors to the bloc’s budget. Another option is cutting programs, which in turn would upset net beneficiaries of EU funds like Central and Eastern European countries.

Taxing the behemoths

Mammoth digital services companies like Facebook, Google and Amazon are practised and skilled in the art of manipulating global tax laws - entirely legally, it should be said - to pay as little tax as possible.

There is a growing consensus that these humungous entities, whose borderless products can earn hundreds of millions in revenue while maintaining a skeleton staff on shore, are skirting their obligations.

Numerous ideas have been floated to force these corporations to pay more: Australia and the UK introduced 'Google taxes', aimed at forcing companies that channel their profits through offshore administrations to pay a higher tax rate.

Earlier in July, the G20 and OECD unveiled a new idea - to introduce a global minimum tax rate of 15%, thus enabling millions to be raised for essential services such as health.

Fourth coronavirus wave in Europe

Europe is dealing with the highly contagious Delta variant, first identified in India, which is threatening to prolong the pandemic and derail economic recovery. Authorities are stepping up efforts to facilitate mass vaccination and are ramping up outreach to those who have not made appointments. After a year-and-a-half of relentless fighting against the disease, coronavirus is showing tenacity while a fourth wave of contamination has started and is expected to make European ICUs very busy again in the fall.

Good news to finish: Cases fall dramatically in UK

Cases are falling dramatically in the UK — and epidemiologist Neil Ferguson told BBC Radio 4 that vaccines had changed the threat of COVID-19. “The effect of vaccines is hugely reducing the risk of hospitalizations and death, and I’m positive that by late September or October-time we will be looking back at most of the pandemic,” he said.

That is all from EAPM for now – during August, EAPM will be doing one update per week, so make sure you stay safe and well and have an excellent weekend.

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