#EAPM – G7, #Brexit and the von der Leyen Commission

| August 22, 2019

Greetings, and welcome to the latest update from EAPM, writes European Alliance for Personalised Medicine (EAPM) Executive Director Denis Horgan. 

Here at the Alliance we’re delighted to learn, via an announcement by Croatias Prime Minister Andrej Plenković, that current MEP Dubravka Šuica will be nominated as the country’s European commissioner.

Dubravka was a strong ally of all of us going into the Declaration of Cooperation on the one-million genomes project, so we’ll keep a close watch on developments and offer support where possible.

Rumour has it that Croatia is keen on the regional policy portfolio, so there may well be opportunities for our SMART Outlook programme. Either way, we congratulate Dubravka and look forward to meeting her at some point in her new role.  As for the remaining MEPs, EAPM is already gearing up for effective action alongside the new intake and many faithful friends who are back in the hemicycle.

Meanwhile, back at the European Commission, the President-elect Ursula von der Leyen reportedly plans to start interviewing College candidates from next week.

Bulgaria has said it wants current Digital Commissioner Mariya Gabriel for the powerful agriculture dossierwhile von der Leyen and French President Emmanuel Macron will discuss the French nominee for the Commission very soon (if not already), with an announcement of the candidate expected before 26 August.

Keeping genomics personal

Regarding genomic data (see the Alliance’s MEGA+ initiative, which aims to take the one-million genome further by adding all forms of healthcare data), a recent survey has taken a look at citizens’ views on their DNA and potentially sharing the resulting data.

Belgian charity The King Baudouin Foundation conducted a survey of 29,000 EU citizens, and it’s not particularly good news for pharmaceutical companies, given that only four in 10 respondents said they agree with the statement: “Im willing to share my genetic information with pharmaceutical companies.” 

Even worse, roughly one in four said they “strongly disagree”.

On the other hand, the sharing of genetic information with academic researchers is more popularwith 58% saying they would do thatAlso, a hefty 73% said they want to know “as much as possible” about their DNA.

A focus group of 32 citizenstied to the Foundation’s work, meanwhile indicated that people want to be able to make autonomous decisions via informed consent. However,they will need better information about genomic data, its implications and how it will be used.

Which highlights a need, of course, for new training for health care professionals and more options available from health systems when it comes to preventive care.

Defining ‘fair’ 

EAPM has often talked about the need for definitions in health care – not least regarding what constitutes ‘value’. Now we have a definition of ‘fair pricing’ in respect of medicines from the WHO. 

The organization’s Fair Pricing Initiative says: “A fair price is one that is affordable for health systems and patients and that at the same time provides sufficient market incentive for industry to invest in innovation and the production of quality essential health products.” 

But it wants to know whether or not you agree, or would change it instead. So head off to WHO’s survey, logging in with fair-pricing as the user name and 2019 as the password.

The survey also wants feedback on what proposed expert groups should focus on and what type of research they should generate.

Conditional reimbursement to continue?

Finland holds the current presidency of the EU, and its own health ministry wants,to all intents and purposes, to extend its experiment with conditional reimbursements in respect of some new medicines.

This is due to expire on 1 January 2020 but the talk now in Helsinki is of extending the programme until 2025.

Since 2017, Finland has approved 25 out of 33 drugs for conditional reimbursement, allowing them to work in realworld conditions before deciding whether the health system will pay. Parliament will decide on the new proposal in autumn.

Medtech moves in Germany 

The German medtech lobby hopes to heap extra pressure on EU and national policymakers to deal with implementation issues around new medical device rules.

An article in a top German newspaper has put the spotlight on the plight of small manufacturers who are having problems complying with EU regulations brought in in 2017, and these small companies have a powerful voice –  making up the majority of Germanys €30 billion medtech industry.

Academics have blamed the rules for a drop in German medtech patent registrations since 2016.

Poles apart… 

Given the recent kerfuffle over US President Donald Trump’s ideas on buying Greenland, the rebuff from Denmark, and Trump consequently throwing his teddy out of the pram and cancelling a visit to the country, a new joke is doing the rounds. It runs as follows:

“It’s not been widely reported, but Donald Trump also cancelled a trip to Warsaw…as he found out that neither the North nor South Poles were for sale.”

Boom!

Bad jokes aside, Trump hardly helped matters, either, when he accusedDanish Prime Minister Mette Frederiksen of disrespecting the US after she expressed “regret and surprise” over Trumps decisionto cancel the Copenhagen visit, noting that preparations had been “well under way.”

OK, she had previously called Trump’s ideas over Greenland “absurd”, which really got the US President’s goat.

He told reporters: “I thought that the prime ministers statement that it was ‘absurd,’ that it was an ‘absurd’ idea, was nasty. I thought it was an inappropriate statement.

“All she had to do is say, ‘No, we wouldnt be interestedShes not talking to me. Shes talking to the United States of America. You dont talk to the United States that way at least under me.

In better news for EU-US relations, it turns out that the European Medicines Agency (EMA) and the Food and Drug Administration (FDAhave a high degree of alignment in marketing application decisions, more than 90%, in fact.

This was uncovered by a  joint EMA/FDA analysis that compared decisions on 107 new medicine applications at the agencies from 20142016.

The study found that the most common reason for diverging decisions were differences in their conclusions about efficacy, followed by.differences in clinical data submitted in support of an application.

Zaide Frias, the head of EMA’s  human medicines evaluation division, said: ”The high rate of convergence in the authorization of new medicines at EMA and the FDA is the result of expanded investment in dialogue and co-operation since 2003 and has fostered alignment between the EU and the US with respect to decisions on marketing authorisations, while both agencies evaluate applications independently of each other.”

She added: “Our co-operation clearly supports both agencies in achieving a common goal of maximizing patient access to safe, effective and high quality medicines in both regions.”

In the past ten years, the agencies have established joint working groups for sharing information and collaborating, using experts drawn from both the EU and US.

Brexit – last roll of the dice

Interesting developments – well, sort of – after UK Prime Minister Boris Johnson’s chat with German Chancellor Angela Merkel this week. 

The latter spoke of“possibilities”when it comes to solving the Irish backstop problem and, thereby, avoiding a no-deal Brexit while at the same time making clear it was up to Britain to come up with a workable plan. Boris seemed to agree that the onus is, indeed, on the UK.

The timetable’s tight, though, with Berlin’s finest saying of any putative solution: “We can maybe find it in the next 30 days.”

France’s Macron, whom Johnson is scheduled to meet in Paris today (22 August) was less enthusiastic, and appeared to be ready to put the dampers on any such talk, given his lack of patience with the whole regrettable process.

He even went so far as to say that any trade deal between the UK and US will not compensate for the cost of Brexit, and would come at “the cost of a historic vassalization”.

I don’t think its the will of the British peopleto become the junior partner of the US,Macron added.

Meanwhile, Irish EU Agriculture Commissioner Phil Hogan didn’t pull any punches when paraphrasing Winston Churchill in respect of the British handling of Brexit:  Never have so few done so much damage to so many,” he said.

Hogan is after the trade job at EU level warned that a no-deal Brexit would create a “foul atmosphere” between London and the rest of the EU that would have “serious consequences” for any future trade negotiations between the two.

Once Boris Johnson has met the French president, hell head to Biarritz for the G7 Summit followed by a meeting with European Council President Donald Tusk on Sunday (25 August) on the fringes of the gathering.

Back in Britain, of course, head of the UK Labour Party and official leader of the Opposition Jeremy Corbyn has called for a cross-party meeting of senior politicians, urging them to work with him to “do everything we can to stop” a no-deal Brexit.

He’s facing a struggle, as plenty have already said they don’t want Corbyn in Number Ten, even during any possible period of transition.

Let’s hope von der Leyen has better luck getting her College of Commissioners approved by the European Parliament. See you soon!

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