#EAPM – Seychell swaps DGs as Commission stays busy, busy, busy

Welcome all, to the latest European Alliance for Personalised Medicine (EAPM) update, not surprisingly dominated by the coronavirus crisis. Before we give you the round-up, here’s just a quick reminder of our upcoming virtual conference on 30 June, writes EAPM Exececutive Director Denis Horgan.

Entitled ‘Maintaining public trust in the use of Big Data for health science in a COVID and post-COVID world‘, it acts as a bridging event between the EU Presidencies of Croatia and Germany. Alongside our many great speakers, attendees will be drawn from leading experts in the personalised medicine arena – including patients, payers, healthcare professionals, plus industry, science, academia and the research field.

Here is the link to register.

Meanwhile, a great supporter of personalised health and the public health community, and a shining light within DG SANTE, Martin Seychell will be leaving his current DG – where he is deputy director general for health – to take the number two place at International Cooperation and Development. Martin has been involved in several EAPM events, and we’d like to take this opportunity to thank him for his support, while wishing all the best to his successor – who will be Sandra Gallina from DG TRADE.

Touted as a “strong negotiator”, Gallina will “bolster [the Commission’s] work on numerous health priorities in the current context”, including on the advance vaccine purchase strategy announced this week. She will also “contribute to the massive effort the Commission is currently making on global access to vaccines following last week’s mandate from Council”. Moving Martin “allows the Commission to reinforce its capacity in terms of the global health dimension of development actions” according to a statement. 

“His expertise in ensuring synergies between different policies will allow him to add significant value in the current context of a global health crisis and its expected social and economic consequences in the EU’s partner countries.” We wish him the very best of luck.

And so to COVID-19…

The Lancet medical journal has published a study that estimates that 22% of the global population – which equates to 1.7 billion people – has an underlying condition that puts them at a higher risk of COVID-19 infection. Such conditions are most common in countries with older populations; African nations with a high prevalence of HIV/AIDS; and small island countries with high numbers of patients with diabetes. Andrew Clark, of the London School of Hygiene & Tropical Medicine, said of the study: “We hope our estimates will provide useful starting points for designing measures to protect those at increased risk of severe disease.” Further research meanwhile, shows that people suffering from obesity and related conditions such as type 2 diabetes and hypertension are also particularly vulnerable to this virus.

And a third study – this time commissioned by the World Health Organization – has come under attack from scientists. Its topic is optimal distancing measures to reduce coronavirus transmission rates, and states that reducing minimum distance requirements between people to one metre from two raises the risk of infection only slightly. But David Spiegelhalter, a statistician from Cambridge, as well as others, has questioned its reliability. – just as UK Chancellor Rishi Sunak said that the government is reviewing the two-metre rule currently in force in the country.

APPs the way to do it

Amid news that the UK’s bluetooth track and trace app is to be ditched and swapped (it’s not the only nation, by any means, that has found that it doesn’t work particularly well), Germany has gone ahead with its own national app to trace interactions between smartphone users and track potential infections with the coronavirus. Chancellor Angela Merkel’s chief of staff Helge Braun said: “The app we’re presenting today is unique,” although like the Brit version it also uses short-range Bluetooth signals. It is, however, “very secure” from a privacy point of view (which is more than we can say for many of them), and is totally voluntary. 

Lars Lensdorf, who’s a partner at law firm Covington and Burling’s Frankfurt office, said: “Nobody can force you to download the app,” including an employer or a restaurant that you may visit. His colleague at the firm, Moritz Hüsch, noted that consent is continually required, even for example, when inputting a coronavirus test result. Meanwhile, in France, it turns out that its own ‘StopCovid’ tracing app may not be able to connect with others across the EU due to it storing data centrally. 

European Commission Vice President Margrethe Vestager told the French parliament earlier this week: “It’s somewhat more tricky to develop the technical standards for interoperability between decentralised systems, as I think will be the general rule, and the centralised system that France has been aiming for.” German medtech to flex muscles? Germany’s medical device industry is already powerful, and looks likely to ramp up its influence during Berlin’s six-month European Council presidency which begins on 1 July.

The country’s BVMed lobby group has made its priorities known to German Health Minister Jens Spahn as well as Health Commissioner Stella Kyriakides. Topics at the top of the list are bringing medicine production back to Europe (with a note on concerns about environmental and bureaucratic regulations), tracking stockpiles, and “alternative evaluation procedures” to the Medical Device Regulation. Pharma strategy The Commission this week began its public consultation on its Pharmaceutical Strategy for Europe. The strategy will aim to build up Europe’s pharma industry, while improving access to medicines, and the above-mentioned Stella Kyriakides has called on patients’ associations, industry, public authorities, academia and the general public to contribute input. Also in the realm of pharmaceuticals and beyond, bringing their production back to Europe has been an oft-heard theme. And now French President Emmanuel Macron is grasping the nettle. He recently visited a vaccine production plant owned by big-hitters Sanofi, and took the opportunity to announce a €200 million investment aimed at building up France’s capacity in the sector.

The cash is also ear-marked to avoid any future shortages of medical goods.

Vaccine latest

The Commission has been pretty busy by all accounts, not least its unveiling of a vaccine plan to shovel billions of euro towards pharmaceutical companies manufacturing coronavirus vaccines. Most won’t work, of course, but for any that do, global health groups are looking to see concrete proposals to ensure effective vaccines are given to low income and fragile countries. 

For its own part, the Commission’s plan will use EU funds to purchase vaccines in exchange for guaranteed supplies if it actually works. The Berlaymont will negotiate with vaccine developers to give them the funding to begin manufacturing the most promising candidates immediately. “There is a very real risk that none of the supported candidates will be successful,” the Commission has said.

“However, the value of earlier access to a vaccine is enormous, in terms of lives saved and economic damage avoided. This makes the risk worth taking.” Anyone remember the HTA talks? Amidst new health proposals from the EU Executive, and the aforementioned vaccines and pharmaceutical strategy, it’s good to know that the Health Technology Assessment file’s lead rapporteur, MEP Tiemo Wölken, has kept his eye on the ball.

The German deputy and the file’s shadow rapporteurs have sent a letter to Commission Vice President Margaritis Schinas and health supremo Stella Kyriakides calling for movement. The letter from MEPs states that the coronavirus pandemic has proved the importance of HTA, thus: “If the HTA proposal would have been already in place it could have enabled a much quicker and more efficient exchange of information between HTA bodies on what works and what does not work in terms of treatment options, diagnostic kits and protective equipment, based on available evidence.” Of course, key to the proposal is improving the availability and accessibility of medicines, so Wölken et al have urged the Commission on. “We want to improve the quality and efficiency of health-care interventions and the sustainability of health systems – a European HTA procedure will help us,” they wrote.

That’s all for now. More next week – and don’t forget to register here in advance for the conference on 30 June.

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