EU-Kazakhstan aim to co-operate on green projects

Welcome, health colleagues, to the European Alliance for Personalised Medicine (EAPM) update – at present, EAPM is focusing on a member-state level regarding the Draft Council Conclusions on Access to Medicines and Medical Devices for a Stronger and Resilient EU, which will be issued under the Portugese Presidency. The issues on which EAPM is working include real-world evidence/data and in-vitro diagnostics improving access and testing for patients (more on that below), writes EAPM Executive Director Dr. Denis Horgan.

Trinity of Accessibility, Availability, Affordability of medicines and medical devices as a focus in the Draft Council Conclusions 

New understanding of epidemiology, precision medicine, and pharmacogenomics, the deployment of technologies such as genomics, single cell sequencing, microbiome analysis and transcriptomics, and the opportunities arising from bioinformatics and digital innovations can be transformative for individual patients. It could deliver equivalent benefits for public health in terms of disease prevention, prediction of risk, and promotion of healthy lifestyles. And it could prompt adaptations in healthcare organisation, with cross-fertilisation and collaboration between disciplines and professions, greater patient participation in care, and a more comprehensive view of the strategic aims and even funding of healthcare systems. It constitutes a shift from working with averages to a more efficient and customised appreciation of the individual, obviously in terms of diagnosis or treatment, and extending even to the entire life cycle.

But health-care systems are not always ready to respond to the opportunities. The disruptive nature of personalised care challenges traditional patterns of thinking. Practices, presumptions and even prejudices that date from before the millennium resist a 21st century approach to healthcare. A policy framework is needed to realise the potential of personalised healthcare – and not only in Europe: Europe’s engagement in global research and scientific enterprise can benefit the population of the entire planet.

Taking into account COVID 19, wide-ranging changes are underway in European society and governance, there is a growing conviction among Europe’s policymakers that people must be at the centre of any successful and sustainable strategy. AS the Commission President Ursula von der Leyen said in 2019, Europe must  ‘lead the transition to a healthy planet and a new digital world’.   The Conclusions will be finalized in June, 2021. 

HTA trilogues

Following three years of proposals, trilogues have begun for EU-wide health technology assessment. Since 2018, EUnetHTA, a voluntary HTA network, has been in dialogue with the Commission on the HTA regulation. In fact its latest work programme, Joint Action 3, has been a “proof of concept” for the regulation, according to Marcus Guardian, head of EUnetHTA, by showing how collaboration can work. 

Negotiations between the Council and Parliament started last month, and Guardian hopes they will thrash out some areas of the proposal he’s concerned about. One is the current Council proposal that allows EU countries to veto the EU-wide adoption of an assessment after it’s done.

Germany and France spearhead panel to prevent future zoonotic pandemics

The World Health Organization (WHO), the Federal Republic of Germany and France will establish a new global hub for pandemic and epidemic intelligence, data, surveillance and analytics innovation. The Hub, based in Berlin and working with partners around the world, will lead innovations in data analytics across the largest network of global data to predict, prevent, detect, prepare for and respond to pandemic and epidemic risks worldwide. 

Chancellor Dr. Angela Merkel said: “The current Covid-19 pandemic has taught us that we can only fight pandemics and epidemics together. The new WHO Hub will be a global platform for pandemic prevention, bringing together various governmental, academic and private sector institutions. I am delighted that WHO chose Berlin as its location and invite partners from all around the world to contribute to the WHO hub.”

The WHO Hub for Pandemic and Epidemic Intelligence is part of WHO’s Health Emergencies Programme and will be a new collaboration of countries and partners worldwide, driving innovations to increase availability and linkage of diverse data; develop tools and predictive models for risk analysis; and to monitor disease control measures, community acceptance and infodemics. Critically, the WHO Hub will support the work of public health experts and policy-makers in all countries with insights so they can take rapid decisions to prevent and respond to future public health emergencies.

WHO chief: Vaccination of kids a ‘moral catastrophe’ as health workers await jabs

The World Health Organization’s (WHO) Executive Director Tedros Adhanom Ghebreyesus has said: “In a handful of rich countries which have bought up the majority of the vaccine supply, lower-risk groups are now being vaccinated,” he said. “I urge them to reconsider and to instead donate vaccines to COVAX.” 

The US and Canada have both authorized the BioNTech/Pfizer vaccine for children as young as 12. However, on Thursday Kate O’Brien, director of the WHO’s department of immunization, vaccines and biologicals, said that just because a vaccine is authorized for children, doesn’t mean that countries should be prioritizing them. 

ECDC releases coronavirus variant dashboard

A new dashboard released by ECDC now provides an overview of the proportion of SARS-CoV-2 variants of concern and variants of interest among sequenced samples in EU and European Economic Area (EEA) countries, as well as sequencing volumes. It complements the data published in ECDC’s weekly country overview report. Data are sourced from The European Surveillance System (TESSy) (weekly reports submitted to ECDC by countries) and the GISAID EpiCoV database (extracted weekly). The maps within the dashboard will be updated every Thursday afternoon, and the data behind the dashboard are available to download. 

Premature to be envisaging second European stimulus plan: EU antitrust chief

Margrethe Vestager, the European Commission’s executive vice president, has shot down the need for an additional economic stimulus package for now. US President Joe Biden is proposing a $4 trillion package to rebuild the economy, including programmes for infrastructure, childcare and education. 

His push has raised questions among some in Europe over whether more would be needed to boost companies and investment programmes post-COVID 19. “It’s way too soon to be considering it,” Vestager was quoted as saying in Les Echos. “I find it a bit bizarre to be talking about a new stimulus plan that we are not sure we need, when we already have so much to do.” France has pushed for a more ambitious economic recovery plan than the one already outlined, although the €750 billion, agreed last summer after the epidemic’s first wave, has yet to be disbursed.

Clash looms over the EU’s coronavirus travel certificates 

The European Parliament is taking aim at member countries’ travel policies in an effort to set rules for coronavirus “green certificates” aimed at lifting travel restrictions and reviving tourism. Brussels is racing to get the certificates in place by June — creating common standards allowing travelers to show if they’ve been vaccinated or tested, or if they’ve survived the disease. 

But the Parliament and member countries look set to be far apart — which could undermine efforts to get the certificates in place on time. Parliament is due to vote on its position on Wednesday. In a stance that has broad political backing, MEPs want free COVID tests, for the certificates to only cover vaccines approved by the European Medicines Agency (EMA), and a ban on additional restrictions to ensure the certificate is more than just “a piece of paper” lawmakers in charge of the negotiations in Parliament have said. “We cannot agree to another patchwork of measures whereby every member state just does as it pleases,” said Renew MEP Sophie in ‘t Veld, a shadow rapporteur on the file.

And that is all from EAPM for now – stay safe and well, have an excellent weekend, see you soon. 


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