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#EAPM - Santa comes early for convincing Boris victory, but so does flu

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UK Prime Minister Boris Johnson is already in festive mood, given his impressive win in last week’s general election, writes European Alliance for Personalised Medicine (EAPM) Executive Director Denis Horgan.

We can be equally certain that US President Donald Trump is feeling anything but festive, though, given his upcoming impeachment and judging by the six-page letter he fired off to Speaker of the House of Representatives Nancy Pelosi on the topic.

Of course, the upshot of Johnson’s victory is that it is all-but-certain that Britain will now leave the EU on 31 January. Except… to all intents and purposes it won’t. There is still a year of what can optimistically be called ‘negotiating’ to come, or less kindly ‘wrangling’, to agree a future trade deal between the UK and the EU.

A year is unlikely to be enough, as Johnson and the EU’s chief negotiator Michel Barnier well know, so there’s still more than a fair chance of a no-deal Brexit down the line.

How many times have we heard this? It’s like having to listen to Chris Rea singing Driving Home For Christmas for the 1000th time…

The UK and health, going forward

In his much-reported victory speech, Prime Minister Johnson said that the NHS would be his priority, and highlighted plans to massively increase” investment, bring 50,000 more nurses in and build 40 new hospitals.

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Unfortunately, PM Bo-Jo faces A&E services that are in big trouble, with the percentage of patients that meet the target of being seen within four hours being the lowest ever.

The Nuffield Trust Chief Executive Nigel Edwards says that meeting the target of 50,000 extra nurses will be crucial to improvement efforts, and points out that the UK premier might have to rely on more migrant staff to do so. Irony anyone?

Meanwhile, the pharmaceutical and life sciences industries appear cautiously optimistic in the wake of the election. The chief executive of the Association of the British Pharmaceutical Industry, Mike Thompson, said that Johnson’s manifesto “included strong commitments to improve the availability of new medicines to NHS patients, the uptake of vaccines, and to place life sciences at the centre of an innovation based economy”.

The industry chief added, however, that close cooperation with the EU on medicines regulation will be vital, and the sentiments were echoed by the BioIndustry Associations Chief Executive Steve Bates, who said that the possibility of a close relationship on medicines regulation as well as science and innovation would frame key parts of the coming negotiations”.

Meantime, hundreds of thousands of people across the Channel could have their Christmas ruined by flu, according to England's doctors.

They predict a rise in cases, adding that the flu season has started early this year, and that GP consultations for flu-like illness were up by a quarter. That’s already almost 7,500 visits in the week ending 8 December.

Grandmas and grandpas visiting their grandchildren may be particularly at risk, as children are "super-spreaders" of flu with the over-65s one of the "at-risk" groups from complications.

Anyone who has not yet had their flu vaccine is being urged to get immunized.

Horizon (budget) scanning

Back here in the EU, researchers have been lobbying hard of the Horizon Europe budget, with academic and industry experts urging Europe’s powers-that-be to “make EU health research count”.

They say that the soon-to-be 27 member bloc needs more in the way of significant, coordinated and balanced investment programmes”. 

Those arguing the case form part of the LifeTime Initiative, which is a European consortium of 90-plus research institutions, backed by more than 70 companies. The group is in favour of mapping, understanding, and targeting human cells during disease.

The group say: “Only long-term large-scale research initiatives have the potential to overcome the healthcare challenges facing Europe,” and call for Member States to preserve the already existing Horizon Europe budget. 

In Germany, meanwhile, the country’s far-right Alternative for Germany (AfD) party has used a parliamentary motion to call on the government to come up with new legislation to prevent medicines shortages. 

The AfD also wants pharma companies to report any shortage of a prescription drug in Germany thats expected to last more than two weeks immediately to the relevant authorities. The motion would also allow the government to ban affected medicines from being exported.

At the same time, the AfD warned of a dangerous dependency on non-EU countries, especially China and India”. 

Also discussed last week was legislation proposed by German Health Minister Jens Spahn aimed at improving competition among health insurers while tackling drug shortages. 

The Federal Association of Drug Manufacturers (BAH) - Germany’s pharmaceutical lobby - is far from happy with the plan, which requires manufacturers to supply additional storage capacity for pharmaceuticals. 

BAH boss Hubertus Cranz says the move would require that sufficient drugs are produced beforehand”, so wouldnt really be helpful against bottlenecks. His alternative is to strengthen the production of drugs - preferably in Europe -with appropriate incentives. 

We’ll stop right there, as pharma companies talking about incentives is right up there with Chris Rea still driving home for Christmas…

Over in Italy, the health ministry is yet to find a new boss for its medicines agency, the AIFA. The previous chief was Luca Li Bassi, who was kicked into the long grass by new Health Minister Roberto Speranza. Until any new appointment, Italy’s AIFA will be led by Renato Massimi.

Any advance on therapies?

Given that the number of advanced therapy medicinal products (ATMPs) on the European market is predicted to double in 2020, talk has turned to how we should provide access to them.

In that vein Kite, owned by drugmaker Gilead, will next month open a manufacturing facility for CAR-T therapy in Amsterdam, The Netherlands.

This is according to Kite Pharma’s European head, Dick Sundh, who added that the facility will have the capacity to produce the therapy for round 4,000 European patients - it’s currently produced in California.

Meanwhile, according to GKV, the organization representing state-backed health insurers in Germany, one fundamental question going forward is whether ATMPs coming into the market will survive long term, given that some earlier ones didnt.

“Immature approvals” were given as a reason for the failures, which essentially means the limited data that ATMPs have when the European Medicines Agency approves them.

Ana Hidalgo Simon, EMA’s head of the specialised scientific disciplines department, conceded that “they work very well sometimes, and sometimes we dont understand why they dont work so well”.

We’ll be back with further news going forward, of course. But if you are starting your holiday time early, do please enjoy the well-earned break - and be sure to find just a little of your valuable downtime to look out for our next update and newsletter!

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