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European Alliance for Personalised Medicine

EAPM - Registration open: 'Recruiting serology to the long fight ahead against pandemics' 

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Greetings all! Registration is open for the European Alliance for Personalised Medicine (EAPM) ‘virtual’ event, held online next week, on 3 February, 9h30 – 11h CET. To perfectly match the less-than-perfect times we find ourselves in, the round table is entitled 'Recruiting serology to the long fight ahead against pandemics', writes EAPM Executive Director Dr. Denis Horgan.

Please find the link to register here and the agenda is here.

Europe's ability to respond effectively to health threats has already been called into question by the coronavirus pandemic. Heroic collaboration between researchers and policymakers has made the first vaccines available at record speed, but Europe still stands before a major challenge that goes way beyond the current COVID crisis. 

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Sharper identification of the nature of the virus – and any of its mutated variants – as well as greater precision over the effectiveness of vaccines and measurements of immunity are still urgently needed. 

The mechanisms are available to bring that precision and clarification. Notably, serology testing can help confirm the efficacy of vaccination, and can be used to establish a threshold for protection or immunity. It can also confirm an initial antibody response from vaccination, and provide subsequent tracking of antibody levels at regular intervals.

A key role of the round table is to bring together experts to agree policies by consensus and take our conclusions to policy makers. And this time, we go even further into the realm of expertise, given the huge crisis that we are all facing.

So, what are among the topics on the table?

The confident but chilling scientific consensus is that the next decades will bring further and more virulent pandemics that threaten disruption and death on an even greater scale than the current outbreak. 

And while the hope is that vaccines now being created in extremis will overcome the immediate danger, Europe – and the world – can no longer afford to rely on hasty improvisation. The harsh reality is that much of the current vaccine development is shooting in the dark at moving targets. 

As the first vaccines reach the general public at the start of 2021, it is still unknown for how long vaccination confers immunity (and, topically, how much flexibility in altering dosage schedules is justified), how it affects different population groups, or to what extent vaccination impedes transmission. 

As the European Medicines Agency observes in reporting on its first positive opinion on a COVID vaccine, Comirnaty: "It is not currently known how long protection given by Comirnaty lasts. The people vaccinated in the clinical trial will continue to be followed for 2 years to gather more information on the duration of protection." And: "There were not enough data from the trial to conclude on how well Comirnaty works for people who have already had COVID-19."  Similarly: "The impact of vaccination with Comirnaty on the spread of the SARS-CoV-2 virus in the community is not yet known. It is not yet known how much vaccinated people may still be able to carry and spread the virus."

The objective of this round table is to assess the factors, understand the need and frame the discussion for Serology testing for SARS-CoV-2 at a country level by engaging with experts. 

key target audience is decision making (public health professionals, public health institutes, medical authorities as WHO Europe, and EMA) so as to understand the barriers and enablers so that serology testing in vaccination surveillance systems can be adopted. 

Questions to be addressed:

  • Testing strategies: restricted vs. systematic - Is there a need to revise earlier recommendations? 

  •  Should approaches to testing adapt to different  types of vaccines, also in view of progressively lifting containment measures? 

  • What is the state of play of serological testing? Could/should we anticipate recommendations before it becomes accessible? 

The above are just an example of the huge topics, among many up for discussion on the day. So be sure to join us on 3 February, from 9h30 – 11h CET. Please find the link to register here and the agenda is here.

European Alliance for Personalised Medicine

EAPM: COVID cases fall but Europe prepares for fourth wave

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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, writes EAPM Executive Director Denis Horgan.

Deadline for orphan and pediatric consultation 

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.

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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. 

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.

Germany's divided 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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European Alliance for Personalised Medicine

EAPM: Successful IVDR meeting points the way to future collaborations

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Good afternoon, health colleagues, and welcome to the second European Alliance for Personalised Medicine (EAPM) update of the week, in which we discuss the successful In Vitro Diagnostic Regulation (IVDR) meeting conducted by EAPM yesterday (22 July), and other pressing health issues, writes EAPM Executive Director Dr. Denis Horgan. 

IVDR issues raised

Yesterday, EAPM was pleased to have conducted a successful meeting on In Vitro Diagnostic Regulation (IVDR), with more than 73 representatives from 15 countries participating as well as the European Medicines Agency (EMA) and member states’ representatives. 

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The IVDR will come into force on 26 May 2022. There are a number of areas in which there is a lack of awareness or clear guidance to support implementation at member state level. The main areas of concern relate to two issues, namely the limited capacity within Notified Bodies to grant CE marking in a timely manner, with a bottleneck occurring in the approval of some IVDs which are likely to be used for patient selection for use with precision medicines. The Commission’s Medical Device Coordination Group (MDCG) Task Force is reviewing this.

In addition, a significant proportion of predictive testing in Europe to support access to oncology precision medicines is delivered through the use of laboratory developed tests (LDTs), and there will be a new legal requirement for labs to use commercially approved tests (CE-IVD) in place of their current LDTs. If there is no CE-IVD commercial test available, public laboratories may be able to use an LDT, subject to certain provisions in the IVDR. The lab will be required to meet all the relevant requirements for safety and performance, whilst carrying out the manufacture under an appropriate quality management system.

Although health institutions are broadly aware of the IVDR, further guidance for laboratories on compliance with its key provisions would be welcomed, particularly on the exemptions to the Regulation granted under Article 5. An MDCG Task Force has very recently been established to develop such guidance, although there is little time left for laboratories to prepare for the regulation. 

Another key issue was whether member states are expecting cost impacts as a result of the IVDR (incurred through either the switch from LDTs to CE-IVDs or the need to improve their laboratory’s quality and performance processes), and whether they have engaged with their national health authority or other relevant stakeholders on this issue. 

Finally, a key outcome of the meeting was the issue of how the regulation can facilitate some of the solutions that were proposed by member states’ representatives, and a meeting will be organized with the Commission and member states at a later date. 

On to other EU health news...

Making Europe fit for the digital age

The EU continues to lag behind China and the US when it comes to investments into key technologies such as artificial intelligence and quantum computing, the European Commission President Ursula von der Leyen has warned. “Europe is still punching well below its weight. I believe this is because of two main reasons. The first one obvious, a lack of investment,” she said. 

While European companies invest massively in research and development in sectors such as automotive or pharma, “our investment in other fields still lags behind the US and China” she added. “Artificial intelligence and quantum computing are two good examples, and due to this, far too many European startups in the tech world have had to leave the continent in order to scale up.”

Bulgaria creates patients rights’ body

Bulgaria’s council of ministers has given the go-ahead to the creation of a new directorate for patients rights under the health ministry. The new body will aid the health ministry in ensuring that patients rights are protected and work on creating programs and guidelines to improve patient protections. Generally, in Bulgaria the rights envisaged in the European legislative framework have been regulated. 

A person’s rights, including in a situation of illness (when a person is in the position of a “ patient” ) are part of the human rights regulated by the UN convention ratified in Bulgaria in 1992. 

The citizens of the Republic of Bulgaria are entitled to accessible health care and health insurance (Art. 52 ofthe Constitution, Art. 33, 35 of the Health Insurance Act (HIA)), healthy environ-ment and conditions of work, guaranteed food quality and protection against abuse of their personality. Each patient is entitled to obtain the best healthcare in conformity with the legislation. 

Cyber concerns on health 

Plans to set up an EU rapid-response cyber unit that could quickly respond to attacks like the recent ransomware hack of Ireland’s Health Service Executive (HSE) have been unveiled. Across Europe, cyberattacks rose 75% last year, with 756 such incidents logged, including an increasing number of attacks on health-care systems, representing a growing risk to society with critical infrastructure at stake, according to the European Commission. “We have a lot of cyber enemies around us,” 

European Commissioner Thierry Breton said. “Ireland’s public healthcare system suffered a pretty strong ransomware attack. I believe it affected a system with more than 80,000 computers, so that was something which was pretty, pretty strong. It could have been a very important plus, if we could have sent dedicated experts very quickly to react even faster, because we know that, of course, the longer you wait the worse it is.” 

The HSE expects it will take as long as six months to recover from the attack, with many hospital and patient data systems still affected. The cyberattack was part of a growing trend of attacks on critical systems, including on the Colonial Pipeline in the US.

Spain offers to test-run the EU's AI regulation

Spain has pitched itself to the European Commission as a laboratory to test the Artificial Intelligence Act - with more 117 AI ethics initiatives springing up around the world, initiatives to regulate artificial intelligence (AI) have sprung up around the world, spearheaded by the likes of Spain, OECD and UNESCO. It‘s time to harmonize and consolidate, a conference on AI ethics held under the auspices of Slovenia’s presidency of the EU Council heard this week. “We are clearly at a developmental point where you’ve got a lot of actors right now contributing to this movement from principles to practice, and we simply need to work together in a multistakeholder way to harmonize these approaches,” said David Leslie, of the Council of Europe’s Ad hoc Committee on Artificial Intelligence (CAHAI). 

WTO and WHO demand more vaccines

The World Trade Organization (WTO) and the World Health Organization (WHO) The World Trade Organization (WTO) have mapped critical inputs for the production of COVID-19 vaccines, in a bid to clarify complex supply chains for sourcing raw materials and components. The organizations this week published an indicative list of 83 inputs, most of which cover the manufacturing of coronavirus jabs, but also those relevant to storage, distribution and administration. It covers the vaccines produced by AstraZeneca, Janssen, Moderna and Pfizer-BioNTech, including product details and their likely HS codes when exported. The list was jointly produced with the Asian Development Bank, the OECD and the World Customs Organization, as well as representatives from the pharmaceutical industry, academia and logistics. It is subject to further modification and improvement depending on expert advice, the WTO says. The exercise was carried out amid concerns over the rate of vaccine production.

MEPs call for mutual recognition of intensivists

While Europe is getting ready to spend a second summer under the shadow of COVID-19, European decision-makers are pushing forward an ambitious agenda and preparing to deliver a more resilient and sustainable European Health Union. To make the best use of the hard-learned lessons from the pandemic, policymakers are now joining the call of the heroes of this unprecedented health crisis: the health-care workers in Intensive Care Units (intensivists) who came under enormous pressure and outdid themselves constantly to save lives. Pandemics don’t stop at our borders and Members of the European Parliament (MEPs) acknowledge the need for European solutions to a European problem. In a letter addressed to European Commission President Ursula von der Leyen, MEPs urge for intensive care medicine to be recognized as a main pillar of the new European Health Union. According to the MEPs, there is a lack of mutual recognition for intensive care medicine training among many EU countries, which prevents a fast and efficient European response in times of pandemics and other cross-border health threats.

Good news to end: EU countries double vaccine-sharing promise to 200M doses

EU countries have committed to sharing 200 million doses of coronavirus vaccines to low- and middle-income countries by the end of 2021, doubling a previous commitment.

The Commission has also pointed today to its other efforts to increase access to vaccines in Africa in particular, however the EU remains firmly opposed to a waiver of intellectual property rights for coronavirus vaccines.

That is all from EAPM for now – make sure you stay safe and well and have an excellent weekend, see you next week.

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European Alliance for Personalised Medicine

EAPM: Truly active summer ahead for EU health policy

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Good afternoon, health colleagues, and welcome to the first European Alliance for Personalised Medicine (EAPM) update of the week, in which we discuss the range of items ahead for the summer months as far as EU health policy is concerned, so it’s a busy time ahead for EAPM, writes EAPM Executive Director Dr. Denis Horgan. 

In-vitro diagnostic expert panel

And it is a busy week for EAPM, with an in-vitro diagnostic expert panel on Thursday (22 July). This deals with legislation that is due to come into force next year on 26 May, 2022 - the question will be how will this legislation have an impact on bringing innovation into health-care systems and being able to diagnose patients earlier? 

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At present a significant proportion of predictive testing in Europe to support access to oncology precision medicines is delivered through the use of laboratory developed tests (LDTs), with the following implications under the IVDR, and there will be a new legal requirement for labs to use commercially approved tests (CE-IVD) in place of their current LDTs. If there is no CE-IVD commercial test available, public laboratories may be able to use an LDT, subject to certain provisions in the IVDR. 

The lab will be required to meet all the relevant requirements for safety and performance, whilst carrying out the manufacture under an appropriate quality management system. As a consequence, many laboratories may face additional procurement costs for commercially approved tests and/or the need to improve their safety and performance requirements for any LDT offerings.

All these issues will be discussed in the expert panel this Thursday through various case studies. A policy paper will be the outcome of this meeting so more on this in the months ahead. 

EU Health Union 

As discussed in the previous updates, the European Health Union package includes proposals to strengthen the European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC), and a regulation on cross-border health threats. 

Slovenia, who holds the EU Presidency now and its predecessors at the helm of the EU, Portugal and Germany, are working to finalize negotiations on three draft regulations that form the basis of the EU Health Union, Slovenian Health Minister Janez Poklukar has said. 

The desire is to co-ordinate the regulations in trialogue with other EU institutions as soon as possible, the minister added in a statement. The comments came after a high-level conference on implementing innovative solutions for resilient health systems that also featured the health ministers of Portugal and Germany, Marta Temida and Jens Spahn. Spahn said the shared objective of all three countries was to establish a trialogue with the European Parliament and the Commission. 

“We want actual results in practice,” Spahn added. Temida said it was essential that the work done by the German and Portuguese presidencies continues to produce good results and that the transition was smooth. 

She said adoption of the legislative package would mark “a significant milestone in Europe’s preparedness for extraordinary health events”. The Health Union package includes proposals to strengthen the European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC), and a regulation on cross-border health threats.

Research and innovation 

The Commission has adopted its proposal for a Council Recommendation on ‘A Pact for Research and Innovation in Europe' to support the implementation of national European Research Area (ERA) policies.

This is an issue that the EAPM has followed closely. 

The Pact proposal defines shared priority areas for joint action in support of the ERA, sets out the ambition for investments and reforms, and constitutes the basis for a simplified policy coordination and monitoring process at EU and member states' level through an ERA platform where member states can share their reform and investment approaches to enhance exchanges of best practices. Importantly, to ensure an impactful ERA, the Pact foresees the engagement with research and innovation stakeholders. 

A Europe fit for the Digital Age Executive Vice President Margrethe Vestager said: “The pandemic has shown us the importance of uniting research and innovation efforts that swiftly bring results to the market. It has shown us the importance of investment in jointly agreed strategic priorities between Member States and the EU. 

"The Pact for Research and Innovation we propose today, will facilitate better collaboration and join our efforts to tackle research and innovation objectives that matter the most for Europe. And it will allow all of us to learn from each other.” 

New rules on open data and reuse of public sector information start to apply 

17 July marked the deadline for member states to transpose the revised Directive on open data and reuse of public sector information into national law. The updated rules will stimulate the development of innovative solutions such as mobility apps, increase transparency by opening the access to publicly funded research data, and support new technologies, including artificial intelligence. 

A Europe Fit for the Digital Age Executive Vice President Margrethe Vestager said: “With our Data Strategy, we are defining a European approach to unlock the benefits of data. The new directive is key to make the vast and valuable pool of resources produced by public bodies available for reuse. Resources that have already been paid by the taxpayer. So the society and the economy can benefit from more transparency in the public sector and innovative products.” 

Internal Market Commissioner Thierry Breton said: “These rules on open data and reuse of public sector information will enable us to overcome the barriers that prevent the full re-use of public sector data, in particular for SMEs. The total direct economic value of these data is expected to quadruple from €52 billion in 2018 for the EU member states and the UK to €194bn in 2030. Increased business opportunities will benefit all EU citizens thanks to new services.” 

Commission to make HERA proposal on 14 September

The European Commission will present its European Health Emergency Preparedness and Response Authority (HERA) package on 14 September. The COVID-19 pandemic demonstrated the need for co-ordinated EU level action to respond to health emergencies. It revealed gaps in foresight, including demand/supply dimensions, preparedness and response tools. 

A European HERA is a central element for strengthening the European Health Union with better EU preparedness and response to serious cross-border health threats, by enabling rapid availability, access and distribution of needed countermeasures. Last year, the Commission proposed changing the mandates for both the EU’s infectious disease agency and medicines agency, and made a proposal for a regulation on serious cross-border health threats.

Some good news to end: COVID-19 antibodies persist 'at least nine months after infection', study finds 

Antibodies in COVID-19 patients remain high even nine months after infection, according to a landmark study which tested almost the entirety of a small Italian town. The study, published in the journal Nature Communications, focused on the town of Vo which became the centre of the country's coronavirus pandemic in February 2020 when it recorded Italy's first death. 

Now, researchers from the University of Padua and Imperial College London have tested more than 85% of the town's 3,000 residents for antibodies against COVID-19. 

The researchers found that 98.8% of people who had been infected in the first wave of the pandemic were still showing detectable levels of antibodies nine months later, regardless of whether their infection had been symptomatic or not. Residents' antibody levels were tracked using three different "assays", or tests that detected separate kinds of antibodies which respond to different parts of the virus.

That is all from EAPM for now  - make sure you stay safe and well and have an excellent week, see you on Friday.

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