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#EAPM - No substitute for evidence-based information

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Obviously, the hot topic at the moment and going forward into the foreseeable future is the COVID-19 outbreak - an outbreak that has already seen a lockdown of a quarter of the Italian population, school closures and the cancelling of major events, and is emerging at various speeds across Europe and the rest of the world, writes European Alliance for Personalised Medicine Executive Director Denis Horgan.

Its coverage on the news and social media is dwarfing what would normally be the Number One news story right now, namely the re-emerging refugee crisis involving Syria, Turkey, Russia, Greece and, inevitably, the EU leadership. 

Meanwhile, shortages of masks - do they work, anyway? - entreaties to “Sing ‘happy birthday’ and wash your hands” - thanks, Boris Johnson - and fights in the supermarket aisles for toilet paper are just some of the consequences of what has, in some cases, undeniably turned to panic.

It doesn’t help that the last few weeks and those immediately ahead are traditionally among the worst for already over-stretched European health-care systems, given that treatment needs for colds and flu are part of the winter landscape every year.

EAPM Conference to go ahead

On one positive note, the EAPM conference is fast approaching and will go ahead as planned in just a few short weeks, and in these times of muddled communication in health care, you can at the very least expect clarity during our time in Brussels this month.

What the Alliance certainly can say here and now is that there is a shortage of evidence-based information on the virus, totally reflected in many of the national media outlets across the EU and certainly on social media platforms such as Facebook and Twitter. 

Regarding the conference, registration remains open for EAPMs Annual Presidency Conference on 24 March in Brussels and you can be sure to join us by following this link

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The event, under the auspices of the Croatia Presidency of the EU, will have as its over-arching goals ensuring that innovation makes its way into healthcare and future proofing Europes health-care systems.

This year, the conference is entitled Defining the healthcare ecosystem to determine value.

It is timely to say the least because what we certainly need to do very quickly is re-align priorities to evaluate the needs of patients, health-care professionals and health systems across the EU to facilitate improved and safer therapies, while enhancing collaboration between EU regulatory and payer groups.

At the same time, there’s the small matter of a virus to be discussed…

Experts, COVID-19, the media, and the public

Where are this experts when we need them? While opinions among them on COVID-19 may differ, and angles may vary, there is surely no benefit in having multi-stakeholders drowned out by loud ‘noise’ coming from ill-informed and often sensational sources.

Governments everywhere are under huge pressure to act, quickly and effectively, and there is an argument that effectively putting 16 million people under quarantine in Italy’s northern powerhouse regions is a knee-jerk reaction and a very noisy way of saying “Well, at least we did what we could” further down the line.

In the meantime, every health-care system in Europe needs support - no matter how good and efficient it is. This has always been the case - the need to reassure a head-scratching and, right now, nervous public with clear messages of how to stay or attempt to stay healthier.

On that topic - the responsibility of a well-informed population - you may not have read this in mainstream media but studies are already emerging from China that not only is the virus hitting the elderly hard, it is also hitting life-long smokers very hard. Yes, those who personally made arguably not the best lifestyle choice.

As it stands in Europe, everything from test kits to respirators are already in short supply and, while there are - and will continue to be - large queues of people awaiting testing and/or treatment, sensible precautions and actions need to be employed by responsible citizens in order to protect themselves as much as possible.

This is not merely in respect of COVID-19, this is a general healthcare pillar. Perhaps, at least sometimes, those who seek to inform the population via the media should lower the rate of sensationalizing health news and up, up, up the advice on living healthy lifestyles?

What Europe is saying about COVID-19

EU health ministers recently met once again to discuss the virus and its implications. 

One EU diplomat has been quoted as saying: “We wanted to have extensive debate to cover all the possible issues due to the recent situation that didnt exist when we convened last time,” adding that there is still room for improvement in information-sharing through different expert and political instruments at the EU’s disposal.

Different tactics are currently being employed, it seems, with some member states trying to contain the virus and others choosing to focus on early detection and treatment. 

ECDC Director Andrea Ammon told members of the European Parliaments ENVI committee recently that most European countries are now at scenario one”, during which there are multiple imported cases of COVID-19 with very small clusters.

However, there are clear moves towards “scenario two,” which sees increasing numbers of introductions and more widespread reports of transmission. 

‘Scenario three’, meantime, would see localized outbreaks merge and start becoming indistinct”. 

MEPs obviously and quite rightly wanted to know whether its inevitable Europe will get to scenario four”. This would see a widespread transmission of COVID-19 with consequent overburdened healthcare systems. 

Amman said: “I am sure we will not be able to avoid this in every case,” and added that Member States need to slow down the further spread of the virus, while activating pandemic plans that build healthcare capacity and boost prevention.

Other health matters in the EU…

The European Commission’s upcoming new pharmaceutical strategy roadmap is also a hot topic at  the moment. It’s due this week.

Meanwhile, pharmaceutical industry lobbyists EFPIA, have already released recommendations for Europes renewed industrial strategy, calling for the EU to prioritise “maintaining and developing Europes world-class IP system”, while bigging-up the need for a framework that protects investment in medical research”.

EFPIA also wants a high profile for “research infrastructure” that helps deliver the next generation of vaccines and treatment”, plus a “faster, more equitable access to new vaccines and treatments”. 

Yes, well, we all want that...

Also, (and we all want this, too) they calls for “a regulatory framework that is stable, fast, effective and global,” and not surprisingly makes note of the pharmaceutical industry’s “critical strategic importance to Europe“.

Part of the EU’s pharmaceutical roadmap will be the Orphan and paediatric medicines review.  Olga Solomon, who is DG SANTEs head of unit for medicines policy, authorisation and monitoring, recently said that preliminary results show 95% of rare disease patients do not have a treatment, and that theres still unequal access to authorised medicines. 

Future scientific developments may have an impact on the functioning of regulations,” Solomon added.

Meanwhile, in Spain, the Council of Ministers has given the release of additional research funding for rare diseases the thumbs up. 

Madrid wants to encourage the pharmaceutical industry’s investment in Orphan drug research and sales of such medicines afterwards and says Orphan medicines will be excluded from the country’s reference price system.

‘New look’ EMA

The European Medicines Agencys (EMA) has officially launched its new structure, which includes integrating all internal human medicines under one division. 

The department’s new head is Alexis Nolte, formerly chief of information management. 

EMA’s big boss, Executive Director Guido Rasi, has openly strived to get the agency ready for what will inevitably be more reliance on, and use of, data and more personalised medicines in the future, in advance of his stepping down from the role.

That’s all for now. Stay safe - and wash your hands, with or without singing ‘Happy Birthday’.

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