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European Alliance for Personalised Medicine

Update: All go in health concerns as EU pushes for COVID and monkeypox vaccines and welcomes Digital Decade policy programme

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Good afternoon, health colleagues, and welcome to the European Alliance for Personalised Medicine (EAPM) update – at the moment, EAPM is busy as ever finalizing a number of articles as well as preparing for European Society of Medical Oncology congress, writes EAPM Executive Director Dr. Denis Horgan.

Commission welcomes political agreement on Digital Decade policy programme 

The Commission welcomes the political agreement reached by the European Parliament and the Council of the EU on the 2030 Policy Programme: Path to the Digital Decade. The programme sets up a monitoring and cooperation mechanism to achieve the common objectives and targets for Europe's digital transformation set out in the 2030 Digital Compass. 

This concerns the area of skills and infrastructure, including connectivity, the digitalisation of businesses and online public services as well as the respect of the EU's Digital rights and principles in achieving the general objectives. A Europe Fit for the Digital Age Executive Vice-President Margrethe Vestager said: “The Digital Decade is about making digital technology work for people and businesses. It is about enabling everyone to have the skills to participate in the digital society. To be empowered. It is about empowering businesses. It is about the infrastructure that keeps us connected. It is about bringing government services closer to citizens. Europe's digital transformation will give opportunities for everyone.” 

Through multi-country projects, member states can pool resources and co-operate closely to build digital capacities that they would struggle to deliver on their own.   Of course, there is an impact on healthcare. 

Call for EU reference laboratories sent to member states

In case you missed it, in July 2022, the European Commission sent a call for EU reference laboratories under Regulation (EU) 2017/746 to the EU member states, as well as Iceland, Norway, Liechtenstein and Turkey. The deadline for member states to submit nominations to the Commission is 31 March 2023. Interested candidate laboratories should contact their member state for further information and instructions.  

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Prescription for the EU

In a paper published on Monday (8 August), the European Commission’s eHealth Network outlined the requirements needed to build an interoperable electronic prescription system across the bloc. 

The idea is simple: at the moment, in many EU countries you can get a digital prescription for a medicine — in the form of a barcode — that you can take then take to your local pharmacy. There it can be scanned so that you can receive your medication. But that isn’t everywhere, and most importantly, a barcode in one country won’t work in another. An EU ePrescription system would allow you to pick up that medicine from any pharmacy in the EU. 

The European Health Data Space regulation aims to give EU citizens more control over their health data through the creation of a so-called digital wallet — a digital space that verifies the user’s identity and gives them access to their medical history and outstanding prescriptions they might have.

EU ‘must accelerate vaccine uptake’

European nations must accelerate vaccine uptake and bring back mask wearing to tackle a surge in COVID-19 cases driven by an Omicron offshoot and avoid stricter measures later in the year, a senior World Health Organization official said on Tuesday. In an interview, WHO Regional Director for Europe Hans Kluge urged countries to take action now to avoid overwhelming health systems in the autumn and winter as the Omicron subvariant, BA.5, continues to spread rapidly. Close to three million new COVID-19 cases were reported in Europe at the tail end of July, which accounted for nearly half of all new cases globally. Hospitalization rates have doubled over the same period, and close to 3,000 people die of the disease every week, Kluge said in an accompanying statement.

The fightback against monkeypox has begun with European nations finally taking action to vaccinate at-risk groups against the disease.

The outbreak has seen cases in more than 30 countries in the European region of a disease which was previously localised in Western and Central Africa.

Spreading through close skin contact, contact with clothes or the bedding of someone infected, and through large breath droplets, the disease is mainly circulating amongst men who have sex with men (MSM). Though it’s believed to currently be mainly transmitted through sexual contact (including kissing and cuddling), it’s not a sexually transmitted infection.

The first case of monkeypox was detected in Europe in early May, but it was July when the EU Commission announced it had ordered 109,090 doses of the Bavarian Nordic vaccine.

A further 54,530 doses were ordered later in the month by the European Centre for Disease Prevention and Control (ECDC), bringing the total to 163,620.

EU’s big medevac

The 1,000th Ukrainian patient was transferred to an EU hospital on Friday (5 August) under the Commission’s medical evacuation program, marking a milestone since the scheme was first launched at the beginning of March. 

It was then that Health Commissioner Stella Kyriakides announced that the EU was making 10,000 hospital beds available to help deal with the influx of Ukrainians needing medical attention, and to ensure that frontline countries like Poland and Moldova don’t get overwhelmed.   

The 18 countries taking part in the patient transfer program are: Germany, France, Ireland, Italy, Denmark, Sweden, Romania, Luxembourg, Belgium, Spain, Portugal, the Netherlands, Austria, Norway, Lithuania, Finland, Poland and the Czech Republic.    

European solidarity: “From day one, the EU has been working tirelessly to support Ukraine and its people in the face of Russia’s brutal military aggression. As part of this, the EU Civil Protection Mechanism has allowed patients in urgent need of treatment and care to receive it in hospitals across the EU,” said Kyriakides, adding that this was an example of “true European solidarity in action.”

Some pharma bemoans drug pricing bill as patient advocates celebrate 

With the passage of a new bill, the US Senate is opening the door to major drug pricing reform, leaving the drug industry licking its wounds. The US government will be able to negotiate drug prices for the Medicare program if the sweeping climate and tax reforms bill that the Senate passed over the weekend becomes law. 

Although the scope of the bill is limited to a few of the costliest drugs under Medicare and only for products that have been on the market for a long time, it still marks a serious setback to the pharma industry. But as SVB Securities analysts see it, pharma companies may have a few tools to fight the new plan. The new bill allows the federal government to directly negotiate with pharmas the prices of 10 most costly prescription drugs in Medicare Part D in 2026, expanding to another 15 drugs in 2027. Failure to comply would draw pharma companies financial penalties. 

Time for EU to step up

Europe needs strong EU leadership to launch vaccination campaigns with new variant-adapted jabs in September, as was the case when the first COVID-19 shots arrived. That’s the view of Peter Piot, a leading epidemiologist and independent adviser on EU health threats to the European Commission.

“Leadership is always key,” Piot, the former head of the London School of Hygiene & Tropical Medicine, said. Asked if this leadership should once again come from the EU, as seen in January 2021 in promoting the fast rollout of the first shots, he said: “Yes, yes, yes.”

No complacency: Vaccination has slipped down the EU’s agenda as the threat from the pandemic has subsided, vaccines have helped to bring serious case rates under control, and other crises have emerged. Nonetheless, a look at Hong Kong shows what happens when populations don’t vaccinate, he said, pointing to the soaring death toll from Omicron.

Pulling out the stops: “It seems like we’ve reached the ceiling of uptake of vaccines, including among the most vulnerable … and I think what we need to do now is an all-stops-out campaign in September,” said Piot.

The European Medicines Agency is expected to approve the first variant-adapted vaccines at the end of the month. Its medicines committee is looking at mRNA shots that target the original strain and the first BA.1 Omicron strain.

And that is everything from EAPM for now. Stay safe and well, and, if you are departing on an August holiday, do enjoy.

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EU Reporter publishes articles from a variety of outside sources which express a wide range of viewpoints. The positions taken in these articles are not necessarily those of EU Reporter.

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