#EAPM – Sanity checks in the air as MPs pounce on unhealthy #Brexit plans

| September 4, 2019

Greetings, all! Well, there’s never a dull moment with Brexit, is there? What with UK Prime Minister Boris Johnson facing a vote in the House of Commons on blocking a no deal, the launch of a massive ‘Get ready for Brexit’ campaign (undermined on the very same day by Michael Gove telling fibs about fresh food shortages – how can anyone ‘get ready’ if you don’t tell them the truth?), a general election probably in the offing, perhaps on 15 October, a Tory party parliamentary majority of zero due to one more defection, and The Queen probably scratching her head in Balmoral wondering what’s coming next, writes European Alliance for Personalised Medicine (EAPM) Executive Director Denis Horgan.

One thing is certain – that the new prime minster received a reality check with a Commons defeat yesterday, with some MPs muttering that any no-deal Brexit policy also needs a sanity check.

As ever, more of that later…

Meanwhile, amid the relative sanity of Brussels (not a sentence we use often), incoming European Commission President Ursula von der Leyen has told German MEPs from her own EPP party that she’s considering changes to the EUs competition policy rules. Another policy sanity check, perhaps?

It’s been reported that sources at the meeting heard her say she wants to “reconsider the definition of the market”.

It is strongly believed that Von der Leyen’s comments are a reaction to the incumbent Commissions decision to block a merger between Germany’s Siemens and France’s Alstoms earlier this year.

That putative deal was deemed “incompatible” with the internal market and it was feared it would harm competition. 

In other Commission-related news, at the same meeting the president-elect said she will present her team of commissioners and their assigned portfolios “early next week”. This presumes that Italy will have made its mind up by then, of course. Von der Leyen is apparently expecting the name form Rome before the end of this week.

The incoming president seems confident of achieving gender parity among her new team, as well as colleagues who are balanced politically and geographically. 

Of course, as we already know, central and eastern European countries don’t have any ofthe top jobs in Brussels. But she’ll attempt to address this by “highlighting” commissioners from the wider region, according to Politicowhich would happen via titles rather than portfolios”. That means vice-presidents, presumably.

Von der Leyen needs to move fairly quickly, now, as she’s running a bit late in respect of the European Parliament’s timetable. The latter expected the full list of nominees and relevant portfolios by the end of August.

The parliamentary hearings for would-be commissioners are due to take place between 30 September and 8 October, plus a bit of time added-on if any candidates are rejected.

With luck and a fair wind, the new Commission should be confirmed by 23 October, one week before it moves into the Berlaymont on 1 November.

Health matters

Austria is in the midst of an election campaign and, for once, healthcare has made an appearance during the run-in to the polls due at the end of September.

Pamela Rendi-Wagner, a physician and former health minister who is also the current leader of the Social Democrats, has said her party wants to reduce waiting times in doctorsoffices. 

“Long waiting times are inhuman,” she said, and also called for an expansion of the tasks of Austrias health hotline. Those patients who call the hotline should receive an appointment right away and get the right doctor in respect of their needs.

This comes in the wake of former Austrian Chancellor Sebastian Kurz, the lead candidate of the centre-right Austrian Peoples Party, stressing that improving the countrys nursing care insurance is one of his priorities.

Over in France, meanwhile, the country’s civil society watchdog Observatoire Transparence Médicaments wants the WHO to move from a symbolic commitment for transparency” to something somewhat more concrete.

The Observatoire is releasing a recommended drug transparency checklist” calling for more transparency on the price of medicines.

Among other items, the checklist calls for the creation of databases that would detail the price information. This would include prices paid by the relevant government, list prices, transaction prices and the reimbursement rate for medicines and medical devices. 

On a broader note, and as clinical trials become more complex due to leaps in science, guidelines need to keep pace. Well, EAPM and its stakeholders have been saying this for years, of course.

The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH, for short, mercifully) is busily revising its guidance for conducting clinical trials.ahead of a big get-together on 31 October at the US Food and Drug Administrations offices near Washington DC.

In the meantime, the European Medicines Agency has urged EU regulators and other stakeholders to register to attend.

Back in Brussels, Health Commissioner Vytenis Andriukaitis recently stuck up for the Commissions work on securing the supply of medicines across the EU.

Replying to Polish MEP Anna Fotyga, he highlighted that the Commission has worked to ensure continuous supply and is now looking at “possible additional ways to address shortages”.

The commissioner also struck a word-or-two of warning by writing that any deliberate withholding of supplies may constitute an infringement of both European and national competition rules”.

We’re not sure how impressed hospital pharmacists in Luxembourg will be with the commissioner’s remarks. Probably ‘not very’ given that shortages have been a problem in the Duchy over the last five years.

Hospital pharmacists say they have consistently asked drug companies to give them warning in advance of anything in short supply, apparently to no avail.

RTL reported that this means pharmacists are unable to prepare themselves, let doctors know about shortages, and clarify the issue to patients”.The Luxembourg Association of Hospital Pharmacists is adamant that there are critical communication issues on the side of suppliers.

All OK in UK?

Well, we know it isn’t. The current situation is a mess. But at least there’s some good news for Brits  as the nation’s notified body BSI announced it has given a CE mark to a medical device as conforming to the EUs new regulations. For the first time. Ever.

BSI didn’t say what the product is or name the manufacturer,but the device in question moved to a new, higher risk category under the rules, and had to be re-certified before the May 2020 deadline.

NHS England, meanwhile, has announced that children diagnosed with a rare inherited eye disease that causes blindness will be eligible for treatment with a new gene therapy from January 2020.

NICE, which handles HTA, said in a statement that its cost-effectiveness evaluation of the expensive therapy was concluded in 20 weeks instead of the 38 weeks under its highly specialized technology programme”.

Meindert Boysen, head of Health Technology Evaluation at NICE said that Novartis’ “willingness to work with us early and constructively has allowed us to publish this guidance on a much faster timeline than normal, which is good news for patients”.

Back to Brexit…

Under an attempted parliamentary bill in Westminster, if there is no new deal, and no parliamentary consent for no deal by 19 October, Boris Johnson must request an extension to negotiations with the EU until 31 January, 2020.

Health-care think tanks should be pleased, as in an open letter to MPs three of them – namely the Kings Fund, the Health Foundation and the Nuffield Trust – highlighted four areas where no-deal Brexit would have a particularly nasty impact.

These are staffing, medicine and device shortages, caring for returners, and funding shortfalls.

In the instance of the medicine and device shortages, despite stockpiling and new supply routes, the think tanks say that extra red tape will increase import hurdles, as well as manufacturing costs, and forecasts that the already cash-strapped and under-staffed NHS will incur an estimated £2.3 billion in extra charges per year.

Meanwhile, the UK’s Office for Budget Responsibility has forecast that Britain’s public finances would be around £30 billion worse off each year in a no-deal scenario with medium disruptiveness. 

Shadow Foreign Secretary Emily Thornberry has this week told MPs that she is seeking to access the governments advice on what will happen to medicines that cant be stockpiled, and whether the courts could rule that any people who die as a result of a lack of such medicinesdied as a result of government neglect.

Bordering on the ridiculous

Tom Black, chair of the British Medical Association in Northern Ireland, has stressed that no amount of reassurance from the Johnson government over the Irish border in a no-deal Brexit will prevent serious consequences for patients. 

He says that, regardless of the UK’s stated intention not to return to a hard border, it’s in the EUs interests to protect the single market if theres no prior arrangement.

Black says that if a hard border returns, delays will inevitably have an impact on patients: “We know what a hard border looks like. Long queues of traffic, sometimes 10 hours.”

Meantime, Northern Ireland only has one medical school, while the Republic of Ireland has six. And with existing staff shortages in the National Health Service, we need a continuing flow of these doctors from the Republic of Ireland to Northern Ireland”, Black said. 

Worryingly, he also said that, with 750 million prescriptions a year in the UK across 7,500 different items coming from the EU, there will be “huge problems” for medicines supplies, especially those needing refrigeration such as insulin.

“If my patients had a problem I would send them to the Republic of Ireland to get a prescription,” he said, pointing out that the UK imports 100%of its human insulin from France and Denmark.

On top of this news, Martin McKee, who is professor of European public health at the London School of Hygiene and Tropical Medicine, has written in the British Medical Journal to flag-up the extent of health harm Brits can expect from Brexit.

The most immediate impacts, says McKee, will be increased suicide, homicide or violence, alcohol abuse, poor nutrition and an increase in communicable and non-communicable diseases.Wow!

Recent document leaks, meanwhile, show epilepsy and mental health medicines are most at risk of shortages.

And yet another report – this one from the UK in a Changing Europe research programme – states that a no-deal Brexit would push the UK towards a recession via a combination of barriers to trade with the EU, a falling pound and increased inflation.

And still, and still, Michael Gove stares the TV cameras (and broadcaster Andrew Marr) in the face and says that reports from the fresh food industry of inevitable shortages are false.

Rotten tomatoes, anyone?

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