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Media And Political Bulletin – 29 August 2018

Media and Political Bulletin

29 August 2018

Media Summary

Germany tells drug makers to check supply chains for no-deal Brexit risks

Reuters, Ludwig Burger, 29 August 2018

Reuters reports that German drug makers have been asked by the German Government to examine their supply chains for any vulnerability that could cause shortages of essential drugs in the event that Britain leaves the EU with no deal.

The article states that more than 2,600 drugs have some stage of manufacture in Britain and 45 million patient packs are supplied from the UK to other European countries each month, while another 37 million flow in the opposite direction.

A spokeswoman for the German Government’s Ministry of Health stated that ‘Germany’s Federal Institute for Drugs and Medical Devices has ordered the country’s main drug industry associations to gather information on the effect of a no-deal Brexit.’

No-deal Brexit Plans Include 6 Weeks’ Medicine Stockpile

MedScape, Peter Russell, 23 August 2018

MedScape reports on last week’s letter from the Department of Health and Social Care, sent to all medicine manufacturers, which outlined the Government’s contingency plans in the event of a ‘no-deal’ Brexit.

The article reports that the Department for Health and Social Care said that ‘plans were in place to ensure that the UK had an additional 6 weeks’ supply of medicines in case imports from the EU were disrupted. It said this measure would be reviewed in the light of future developments.’

Parliamentary Coverage

There was no parliamentary coverage today.

Full Coverage

Germany tells drugmakers to check supply chains for no-deal Brexit risks

Reuters, Ludwig Burger, 29 August 2018

German drugmakers have been asked by the government to examine their supply chains for any vulnerability that could cause shortages of essential drugs in the event that Britain leaves the European Union without a Brexit deal.

More than 2,600 drugs have some stage of manufacture in Britain and 45 million patient packs are supplied from the UK to other European countries each month, while another 37 million flow in the opposite direction, industry figures show.

Germany’s Federal Institute for Drugs and Medical Devices (BfArM) has ordered the country’s main drug industry associations to gather information on the effect of a no-deal Brexit, a spokeswoman for the health ministry said.

“The Ministry of Health currently has no evidence that the exit of the United Kingdom will lead to any disruptions in the supply of medicines in Germany,” the spokeswoman said.

It is not yet clear when results will be available, she said.

Britain, which voted in 2016 to leave the EU, has served notice that it will quit the bloc next March but has yet to reach a deal on future trading relations.

The EU’s drugs regulator, the European Medicines Agency (EMA), on Wednesday said that it and national regulators had set up a task force to minimise supply disruptions arising for any reason over the next two years.

“The withdrawal of the United Kingdom from the EU is also likely to affect the availability of medicines in the EU,” it said.

The UK government has already asked British drugmakers to build an additional six weeks of medicine stockpiles to prepare for any no-deal Brexit – a target the industry has said will be challenging.

Germany is using BfArM’s quarterly “Jour Fixe” meetings with various stakeholder groups on drug shortages to prepare for Brexit.

BfArM in 2016 instated the meetings with groups representing drugmakers, physicians, pharmacists, drugs distributors as well as other government bodies to monitor and mitigate against drug shortages.

The meetings have dealt with shortages of treatments such as Mylan’s Epipen against allergic shock, branded as Fastjekt in Germany, as well as disrupted supply of blood pressure drug valsartan after batches produced in China had to be recalled due to toxic impurities.

Industry groups, which include German drugmakers including Bayer, Merck KGaA and Boehringer Ingelheim as well as foreign suppliers such as Teva and Roche, have been asked to consider the “worst-case-scenario of a hard Brexit without transition period”, according to meeting protocols.

The highly regulated drugs sector is one of the most vulnerable to Britain’s decision to leave the EU because of uncertainty as to how medicines oversight will function in the event of an abrupt exit next March.

That has sparked fears of drug shortages, and some companies including AstraZeneca, Sanofi and Novartis have said they plan to increase stockpiles in Britain in case of a no-deal Brexit.

Britain is set to leave that EU regulatory system and the Europe-wide drugs watchdog is moving from London to Amsterdam, prompting many drugmakers to prepare duplicate product testing and licensing arrangements.

No-deal Brexit Plans Include 6 Weeks’ Medicine Stockpile

MedScape, Peter Russell, 23 August 2018

Patients would continue to have access to medicines, medical products and high-quality care in the unlikely event of a ‘no-deal’ Brexit, Matt Hancock, the Secretary of State for Health and Social care, has said.

He was speaking as the Government published the first tranche of technical guidance on how the UK would cope in the event that it leaves the European Union without an agreement in place.

 

In a speech in London earlier, Dominic Raab, the Brexit secretary, said a deal remained “the most likely outcome” but the country had to be “ready to consider the alternative”. He sought to make light of concerns that crashing out of the EU in March next year would have grave consequences by joking that “contrary to one of the wilder claims, you will still be able to enjoy a BLT after Brexit”.

Leave negotiations were “progressing well”, the Department of Health and Social Care (DHSC) said, but it was the duty of a responsible government to “prepare for all eventualities”.

It urged clinicians to reassure patients there would be enough medicines to go round in the event that a UK-EU deal could not be negotiated.

However, the British Medical Association (BMA) said it was clear that Brexit meant an impending catastrophe for patients, the health workforce, services, and the nation’s health.

We round up today’s technical announcements in the field of health and some of the reaction to the Government’s plans.

Batch-Testing medicines

In the event of no deal being in place, the UK would accept batch testing of medicines carried out in the EU.

“At the moment they only need to go through one set of checks, either here in the UK or in the EU in order that they are deemed safe to be used by patients, and that’s by virtue of our participation in the European regulatory network,” said Mr Raab. “Now, in a no-deal scenario, the UK won’t be a participant in the European regulatory network that supports this process.

“But, we don’t want delays or disruption to supplies from the EU so we propose accepting the testing and safety approvals of existing medicines if they’ve been carried out by a member state regulator.”

However, Mr Raab was unable to give assurances that the situation would work in reverse. “Given that we start from a position of common rules, we would also hope and I think expect, in good faith between close partners, that the EU would recognise medicines from this country with our regulatory approval,” he said. “But in a no-deal scenario we can’t guarantee it.”

Supply of Medicines

The DHSC said plans were in place to ensure that the UK had an additional 6 weeks’ supply of medicines in case imports from the EU were disrupted. It said this measure would be reviewed in the light of future developments.

Media And Political Bulletin – 29 August 2018

From Factory to Pharmacy

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