EU budget blocked by Hungary and Poland over rule of law issue

Good morning, and welcome, health colleagues, to the first European Alliance for Personalised Medicine (EAPM) update of the week. It is busy, busy, busy as per usual – neither health care nor personalised medicine can afford to rest as the coronavirus crisis, despite the possible advent of effective vaccines, throws up challenge after challenge, writes EAPM Executive Director Denis Horgan.

Awaiting a health-care revolution

Famously, the Scottish biologist Alexander Fleming accidentally discovered the anti-bacterial ‘mould’ penicillin in a petri dish in 1928. That came at the tail-end of the “roaring twenties”, and led to a revolution in health care over subsequent decades. Now, a century later, thoughtful policymakers able to see the merits of incorporating personalised care and targeted therapies into the changes they are making in their own health-care systems could bring on a new age of the “roaring twenties”. 

Creating a structure and a climate in which personalised health care can realise its potential is a long-term exercise, but an approach that is one of the outcomes of COVID 19 is bearing fruit and can potentially tackle the many challenges ahead across the many health stakeholder groups. 

EU budget crisis – Hungary and Poland block

Hungary and Poland have blocked a key step toward the EU’s huge new Multiannual Financial Framework (MFF), holding up the budget-plus-recovery-fund designed to turn around the corona-induced economic crisis. There is no evident way out of the stalemate: “There is no Plan B,” said one diplomat after the EU slid back into crisis mode.

EU4Health programme call

Ahead of the trilogue negotiation process, public interest civil society organizations of the EU4Health Civil Society Alliance call on the national governments, European Parliament and the European Commission to make their best efforts during the upcoming, complex negotiations process, to ensure a well-resourced, well-designed and well-governed EU4Health Programme with meaningful involvement of civil society. 

Only a strong EU4Health programme will steer the EU’s actions towards an ambitious but realistic European Health Union and provide a clear message for individual people who rely on the EU to put their health and well-being first as we rebuild our societies, post-COVID-19.

Battle plans laid out by Commission concerning more health power

According to the European Commission, EU policies and actions in public health aim to protect and improve the health of EU citizens, support the modernization of health infrastructure and improve the efficiency of Europe’s health systems. 

Strategic health issues are discussed by representatives of national authorities and the European Commission in a senior-level working group on public health. EU institutions, countries, regional and local authorities, and other interest groups contribute to the implementation of the EU’s health strategy. 

The Commission’s Directorate for Health and Food Safety (DG SANTE) supports the efforts of EU countries to protect and improve the health of their citizens and to ensure the accessibility, effectiveness and resilience of their health systems. This is done through various means, including by proposing legislation, providing financial support and co-ordinating and facilitating the exchange of best practices between EU countries and health experts. The Council of the EU can also address recommendations on public health to EU countries.

Moderna reports positive results on COVID-19 jab

On 16 November, the Moderna pharmaceutical company published phase 3 results for its mRNA vaccine indicating an estimated vaccine efficacy of 94.5%. Moderna’s vaccine may be easier to roll out, especially in developing countries, as it can remain stable at standard refrigerator temperatures of 2° to 8°C for 30 days, as opposed to the ultra-low temperatures required by the Pfizer BioNTech vaccine. 

On 24 August, the European Commission concluded exploratory talks with Moderna to purchase a potential vaccine against COVID-19. Moderna is the fifth company with which the Commission has concluded talks, following Sanofi-GSK on 31 July, Johnson & Johnson on 13 August, CureVac on 18 August, in addition to the signature of an Advance Purchase Agreement with AstraZeneca on 14 August. 

The Moderna contract envisages the possibility for all EU member states to purchase the vaccine, as well as to donate to lower and middle-income countries. The initial purchase would be for 80 million doses for the EU, plus an option to purchase up to a further 80 million doses, to be supplied once a vaccine that has proven to be safe and effective against COVID-19 has been approved by regulatory authorities. It is also reported that the Moderna vaccine efficacy is estimated at 94.5%.

Health Committee discussion with commissioner

On 16 November, the Health Committee discussed how better to prepare the EU for possible future health threats with Health and Food Safety Commissioner Stella Kyriakides. The commissioner said it hopes that a “health union” will pave the way for better co-ordination to respond to new possible health crises and also provide a deeper monitoring of the epidemiological situation in Europe.

The executive has also called for reinforced research and a swift mitigation of medicine and medical supply shortages through notably joint procurements at a European level.

MEPs call for urgent action on AMR

A group of MEPs, led by the S&D’s Tiemo Wölken, have called on the European Commission to tackle antimicrobial resistance (AMR) through the new Pharmaceutical Strategy for Europe. The European Commission’s Pharmaceutical Strategy for Europe aims to ensure Europe’s supply of safe and affordable medicines in order to meet patients’ needs and support the pharmaceutical industry to remain innovative. 

Members of the MEP Interest Group on AMR have now written a letter to Vice-President Schinas and Commissioner Kyriakides welcoming the initiative and calling for the strategy to integrate the development of, and access to, affordable and quality antimicrobials. The MEPs highlight that AMR is a key cross-border health issue for Europe, and that the COVID-19 pandemic is impacting European health, noting: “Without effective action, AMR will take us back to a pre-antibiotic age when death by infection was much more common.”

New strain of coronavirus identified at mink farms

The European Commission has approved a €5 million scheme to support companies active in the fur farming sector that are affected by the coronavirus outbreak. The scheme was approved under the state aid Temporary Framework. 

The aid will take the form of direct grants. The purpose of the scheme is to address the liquidity needs of companies active in the fur farming sector, as fur-trading auctions are closed and all production is stored in farms, following a new strain of coronavirus being identified in mink farms. The scheme will also help them to continue their activities during and after the outbreak and is expected to benefit approximately 150 companies.

Coronavirus scientist suggests ‘normal winter’ possible next year

Life could return to a pre-coronavirus status quo by the winter that begins a year from now, a co-developer of Pfizer’s vaccine candidate told the BBC. “If everything continues to go well, we will start to deliver the vaccine at the end of this year, beginning of next year,” Ugur Sahin, co-founder and chief executive of BioNTech, said on Sunday (15 November). 

“Our goal is to deliver more than 300 million vaccine doses until April next year, which could allow us to already start to make an impact.” While predicting that this coming winter will be a tough period, Sahin said he is confident of full immunization by next fall. “We could have a normal winter next year,” he said.

And, with that piece of perilously close to good news, that is everything from EAPM for now – it is fair to say, we need to learn our lessons from the COVID 19 crisis and focus on increasing bringing health innovation into health-care systems. Don’t forget, we also have our lung cancer screening event coming up on 10 December, so look out for our updates on that, which will be available presently. See you next time, stay safe and enjoy your week.


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