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EAPM: How biomarker testing can pierce the fog of Alzheimer’s and related dementia

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Hello and welcome, health colleagues, to the second update of the week from the European Alliance for Personalised Medicine (EAPM). There is plenty of news today about a recent academic publication from EAPM, the evolution of the EU’s pharma strategy and updates on the ongoing COVID-19 crisis, writes EAPM Executive Director Denis Horgan.

A fundamental shift in Alzheimer's Disease (AD) health-care strategy

EAPM recently launched an academic publication with a multistakeholder perspective to tackle the issue of biomarkers entitled Piercing the Fog of Alzheimer’s and Related Dementia. This paper discusses the challenges, lists the achievements to date, and highlights the actions needed to allow biomarker testing to deliver more fully on their potential in AD. 

The paper is available here. Biomarker testing is improving the prospects for tackling Alzheimer Disease and other dementias, and holds the key to discovering new treatments. Early diagnosis and more personalised health care will have a central part to play in confronting this massive challenge to Europe’s citizens and its health-care systems. 

The EU is itself in constant evolution, both organically, as its competences are progressively refined, and in response to changes in the wider world. In health care, its evolution is marked not only by the emergency of the COVID-19 pandemic, which has largely monopolized the attention of all the major EU institutions throughout most of the  year, but also by the constant increase in morbidity, which now affects more than its ageing population.

With the initiation of a European Health Data Space and a new Pharmaceutical Strategy which will be discussed below, it is an appropriate moment also for it to review its approach to diagnostic testing as an intrinsic element in an integrated health strategy. 

In these straitened circumstances, a reappraisal of the significance and potential of biomarker testing in AD can provide the EU and its citizens with a much-needed immediate up-tick in quality and accuracy of care. 

The COVID-19 pandemic should also provide a warning of how vulnerable society is to inadequacies in healthcare preparation – and should serve to highlight the risk that dementia could, if unchecked, present a pandemic of similar or greater proportions within decades. Europe, with real foresight, can now make a change in policy that holds out the prospect of a radical transformation of care in the coming years as the full benefits of an optimum approach to the use of biomarkers begin to be felt.

EAPM lung-cancer screening event 

On 10 December, the EAPM will be holding on online conference on lung cancer screening. The Alliance and its stakeholders realize that, among other elements, what is required in Europe is continuous screening monitoring, with regular reports; assured consistency and enhanced quality of commented data for the screening reports; reference standards for quality and process indicators should be developed and adopted. 

You can check out the agenda of the 10 December conference here, and register here.

Kyriakides presents pharma strategy in Parliament 

On Thursday (26 November), access to safe and affordable medicines and supporting EU pharmaceutical innovation were debated in Parliament. Health and Food Safety Commissioner Stella Kyriakides presented the new Pharmaceutical Strategy as an important component of the new EU Health Union. 

A new strategy was already expected before COVID-19, but in the light of the pandemic, a more ambitious proposal is essential. Most MEPs welcomed the new strategy, which puts into effect Parliament’s requests to step up efforts to tackle medicine shortages – a problem exacerbated by COVID-19 – and to move towards a more sensible use and disposal of pharmaceuticals in order to prevent risks to the environment and public health. Several MEPs highlighted the need for all EU citizens to have equal access to high-quality medicines. 

They emphasized the need to decrease the EU’s dependence on imports of active pharmaceutical ingredients from non-EU countries, namely by increasing their production in Europe and supporting innovation in the EU pharmaceutical industry. The Commission has said that it wants to “work with the European Parliament and the Council towards the adoption of the Regulation on health technology assessment”. 

EPP MEP Peter Liese, while supportive of the Pharmaceutical Strategy, said, in an emailed statement: “The core of the current debate is how we can be less dependent on China and India when it comes to lifesaving pharmaceuticals. The coronavirus crisis has shown that the problem that has existed before is getting bigger and bigger.”

Advance funds for COVID-19 – Parliament seals its approval

On Tuesday (24 November), Parliament approved €823 million in EU aid in response to the coronavirus crisis in seven EU countries. The aid from the European Union Solidarity Fund (EUSF) will be distributed in advance payments to Germany, Ireland, Greece, Spain, Croatia, Hungary, and Portugal in response to the major public health emergency caused by the COVID-19 pandemic in early 2020.

Medicine supply to be prioritized in Portuguese Council presidency 

A secure supply of medicines will be a key priority for the Portuguese Council presidency — set to begin in 2021 — said Rui Ivo Santos, the president of Portugal’s drug agency Infarmed. Speaking at a panel organized by the European Public Health Alliance on Wednesday (25 November), Santos said he fully supported the Pharma Strategy’s goal of ensuring adequate availability of drugs.

NICE launches consultation on its methods of drug evaluation 

The UK’s National Institute of Health and Care Excellence (NICE) is set to review its methods of evaluation for drugs, medical devices and diagnostics. The health technology assessment (HTA) agency launched a public consultation last week on a proposal for changes to the methods it uses to evaluate potential medical treatments. NICE uses the Quality-Adjusted Life Year (QALY) measure to determine whether or not a treatment is cost-effective, with the current threshold set at around £30,000 per QALY. 

This formula weighs the cost of a potential drug for a year against the extension of life and improvement in the quality of life. In addition, new cancer treatments can be approved via NICE’s Cancer Drugs Fund (CDF) which was introduced in 2016. 

Through the CDF, NICE can appraise drugs while providing interim funding for up to two years to give patients access to drugs that have either a draft recommendation for routine use on the NHS or a draft recommendation for use within the CDF. While NICE regularly undergoes reviews of its processes, many industry experts have called for fundamental changes to the way in which it evaluates new technologies and medicines in an effort to improve patient access to the latest medical innovations.

EU must ease COVID-19 curbs slowly to avoid new wave, von der Leyen says

The European Union must only lift coronavirus restrictions slowly and gradually to avoid another wave of infections, the head of the bloc’s executive said. Ursula von der Leyen spoke after the 27 national leaders discussed stepping up joint testing efforts in the bloc, doling out vaccines and coordinating easing lockdowns as a second wave of the pandemic weighs on Europe. 

She said: "We will make a proposal for a gradual and coordinated approach to lifting containment measures. This will be very important to avoid the risk of yet another wave.”

Europe has had about 11.3 million confirmed COVID-19 cases and nearly 280,000 people have died, according to data from the European Centre for Disease Prevention and Control. The pandemic has also thrust the EU into its deepest recession.

And that is everything from EAPM for this week, don’t forget to check out the agenda of our 10 December conference on lung-cancer screening here, and register here, and EAPM’s multistakeholder paper on biomarker testing for dementia is available here. Have an excellent, safe weekend, and see you on Monday (30 November) for EAPM’s monthly newsletter.

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Dutch PM condemns lockdown riots as 'criminal violence'

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Dutch Prime Minister Mark Rutte (pictured) on Monday (25 January) condemned riots across the country at the weekend in which demonstrators attacked police and set fires to protest against a night-time curfew to slow the spread of the coronavirus, calling them “criminal violence”, writes .

The police said hundreds of people had been detained after incidents that began on Saturday evening and lasted until the early hours of Monday, including some in which rioters threw rocks and in one case knives at police and burned down a COVID-19 testing station.

“This has nothing to do with protest, this is criminal violence and we will treat it as such,” Rutte told reporters outside his office in The Hague.

Schools and non-essential shops in the Netherlands have been shut since mid-December, following the closure of bars and restaurants two months earlier.

Rutte’s government added the curfew as an additional lockdown measure from Saturday over fears that the British variant of COVID-19 may soon lead to an increase in cases.

There have been 13,540 deaths in the Netherlands from COVID-19 and 944,000 infections.

The police trade union NPB said there could be more protests ahead, as people grow increasingly frustrated with the country’s months-long lockdown.

“We haven’t seen so much violence in 40 years,” union board member Koen Simmers said on television program Nieuwsuur.

Police used water cannon, dogs and officers on horseback to disperse a protest in central Amsterdam on Sunday afternoon. Nearly 200 people, some of them throwing stones and fireworks, were detained in the city.

In the southern city of Eindhoven, looters plundered stores at the train station and set cars and bikes on fire.

When police said the demonstrators were violating the country’s current lockdown rules “they took weapons out of their pockets and immediately attacked the police”, Eindhoven Mayor John Jorritsma said.

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Head of French health regulatory body: COVID situation is 'worrying'

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The COVID-19 situation in France is worrying, the head of the country’s Haute Autorite de Sante (HAS) health regulator told France Inter radio on Monday (25 January), as President Emmanuel Macron’s government considers a new lockdown, write Sudip Kar-Gupta and Dominique Vidalon.

France has the world’s seventh-highest COVID-19 death toll, with more than 73,000 deaths.

“It is a worrying moment. We are looking at the figures, day by day. We need to take measures pretty quickly....but at the same time, not too hastily,” said HAS head Dominique Le Guludec.

Jean-François Delfraissy, head of the scientific council that advises the government on COVID-19, had said on Sunday that France probably needed a third national lockdown, perhaps as early as the February school holidays, because of the circulation of new variants of the virus.

French European Affairs Minister Clement Beaune, when asked about this on French radio on Monday, replied that no firm decision had been taken on the matter.

France is currently in a nationwide 18h to 6h curfew, in a bid to slow down the spread of the virus, but the average number of new infections has increased from 18,000 per day to more than 20,000.

Geoffroy Roux de Bézieux, head of the MEDEF French business lobby group, said he would call on the government to keep as many businesses and schools open as possible in any new lockdown, to protect the economy and help children’s education.

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EU urges AstraZeneca to speed up vaccine deliveries amid 'supply shock'

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The European Union has urged AstraZeneca to find ways to swiftly deliver vaccines after the company announced a large cut in supplies of its COVID-19 shot to the bloc, as news emerged the drugmaker also faced supply problems elsewhere, write and

In a sign of the EU’s frustration - after Pfizer also announced supply delays earlier in January - a senior EU official told Reuters the bloc would in the coming days require pharmaceutical companies to register COVID-19 vaccine exports.

AstraZeneca, which developed its shot with Oxford University, told the EU on Friday it could not meet agreed supply targets up to the end of March, with an EU official involved in the talks telling Reuters that meant a 60% cut to 31 million doses.

“We expect the company to find solutions and to exploit all possible flexibilities to deliver swiftly,” an EU Commission spokesman said, adding the head of the EU executive Ursula von der Leyen had a call earlier on Monday with AstraZeneca’s chief Pascal Soriot to remind him of the firm’s commitments.

A spokesman for AstraZeneca said Soriot told von der Leyen the company was doing everything it could to bring its vaccine to millions of Europeans as soon as possible.

News emerged on Monday that the company faces wider supply problems.

Australia’s Health Minister Greg Hunt told reporters AstraZeneca had advised the country it had experienced “a significant supply shock”, which would cut supplies in March below what was agreed. He did not provide figures.

Thailand’s Health Minister Anutin Charnvirakul said AstraZeneca would be supplying 150,000 doses instead of the 200,000 planned, and far less than the 1 million shots the country had initially requested.

AstraZeneca declined to comment on global supply issues.

The senior EU official said the bloc had a contractual right to check the company’s books to assess production and deliveries, a move that could imply the EU fears doses being diverted from Europe to other buyers outside the bloc.

AstraZeneca has received an upfront payment of 336 million euros ($409 million) from the EU, another official told Reuters when the 27-nation bloc sealed a supply deal with the company in August for at least 300 million doses - the first signed by the EU to secure COVID-19 shots..

Under advance purchase deals sealed during the pandemic, the EU makes down-payments to companies to secure doses, with the money expected to be mostly used to expand production capacity.

“Initial volumes will be lower than originally anticipated due to reduced yields at a manufacturing site within our European supply chain,” AstraZeneca said on Friday.

The site is a viral vectors factory in Belgium run by the drugmaker’s partner Novasep.

Viral vectors are produced in genetically modified living cells that have to be nurtured in bioreactors. The complex procedure requires fine-tuning of various inputs and variables to arrive at consistently high yields.

“The flimsy justification that there are difficulties in the EU supply chain but not elsewhere does not hold water, as it is of course no problem to get the vaccine from the UK to the continent,” said EU lawmaker Peter Liese, who is from the same party as German Chancellor Angela Merkel.

The EU called a meeting with AstraZeneca after Friday’s (22 January) announcement to seek further clarification. The meeting started at 1230 CET on Monday.

The EU official involved in the talks with AstraZeneca said expectations were not high for the meeting, in which the company will be asked to better explain the delays.

Earlier in January, Pfizer, which is currently the largest supplier of COVID-19 vaccines to the EU, announced delays of nearly a month to its shipments, but hours later revised this to say the delays would last only a week.

EU contracts with vaccine makers are confidential, but the EU official involved in the talks did not rule out penalties for AstraZeneca, given the large revision to its commitments. However, the source did not elaborate on what could trigger the penalties. “We are not there yet,” the official added.

“AstraZeneca has been contractually obligated to produce since as early as October and they are apparently delivering to other parts of the world, including the UK without delay,” Liese said.

AstraZeneca’s vaccine is expected to be approved for use in the EU on Jan. 29, with first deliveries expected from 15 February.

($1 = €0.8214)

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