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Media And Political Bulletin – 28 August 2018

Media and Political Bulletin

28 August 2018

Media Summary

Pharmacy stockpiling ahead of Brexit will be investigated, DH warns

Chemist and Druggist, Grace Lewis, 24 August 2018

Chemist and Druggist 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 includes a statement from Martin Sawer, the HDA’s Executive Director, who said that the HDA ‘supports’ the government’s proposals, and that its members are ‘well-versed in managing demand challenges’.

He also warned, however, that ‘any stockpiling [should] be carefully managed in order to avoid challenges such as medicines shortages, caused by changes in purchasing patterns’.

‘Brexit – Paying for No-Deal

Politico, Katie Jennings, 24 August 2018

Politico also reported on the Government’s no-deal Brexit guidance, stating that there are only 200 days with which to figure out which storage facilities the requested six-week supplies will be housed, and to figure out how much the effort will cost.

The article also includes a statement from Martin Sawer, who told Politico that his members, which are responsible for distributing over 92 percent of NHS medicines, are ‘well placed’ to support the government’s no-deal preparations. ‘However, the devil will be in the detail, with the need for any stockpiling to be carefully managed in order to avoid challenges such as medicine shortages, caused by changes in purchasing patterns,’

Elliot Dunster, Head of External Affairs at the ABPI, takes a closer look at the ‘no deal’ guidance published by Government.

ABPI, Press Release, 24 August 2018

Elliot Dunster, Head of External Affairs at the ABPI, has shared some ‘initial thoughts’ on the ‘no-deal’ guidance published by the Government.

He states that stockpiling ‘won’t be easy’, and that ‘what is clear is that the UK Government and the EU Commission agree there needs to be a deal…getting  a deal, which includes cooperation on medicines, is in the best interests for patients not just in the UK but in the EU as well.’

Parliamentary Coverage

There was no parliamentary coverage today.

Full Coverage

Pharmacy stockpiling ahead of Brexit will be investigated, DH warns

Chemist and Druggist, Grace Lewis, 24 August 2018

Pharmacies caught over-ordering medicines ahead of Brexit will be investigated, but manufacturers should stockpile six weeks’ worth of supplies, the government has said.

In a letter published yesterday (August 23), health secretary Matt Hancock warned community pharmacies, as well as hospitals and GPs, not to stockpile any medicines ahead of Brexit, and said “there is also no need for clinicians to write longer NHS prescriptions”.

“Local stockpiling is not necessary and any incidences involving the over-ordering of medicines will be investigated and followed up with the relevant chief or responsible pharmacist directly,” Mr Hancock stressed.

However, Mr Hancock said “pharmaceutical companies should ensure they have an additional six weeks’ supply of medicines in the UK on top of their own normal stock levels”, in case the UK and the European Union fail to secure a deal ahead of Brexit next March.

As part of the Department of Health and Social Care’s (DH) “medicines supply contingency planning programme” – setting out the government’s preparations for a “no-deal” Brexit – it has also asked pharmaceutical companies “to ensure they have plans in place to air freight [short shelf-life] products” whose import routes through the EU may be affected.

Supply issue concerns

The Healthcare Distribution Association (HDA) said it “supports” the government’s proposals, and that its members are “well-versed in managing demand challenges”.

However it warned that “any stockpiling [should] be carefully managed in order to avoid challenges such as medicines shortages, caused by changes in purchasing patterns”.

Warwick Smith, director general of the British Generic Manufacturers Association (BGMA), said the proposals show a “welcome determination” from the government to “ensure [the] continued supply [of medicines] to British patients”.

It is “wise to plan for appropriate stockpiling of medicines to deal with possible delays at the borders”, he added.

“We don’t see a problem with generics coming into the UK from non-European countries. The problem is stuff that gets trucked [via the English] channel, where the trucks might be delayed,” he told C+D.

“So if you’re putting your stuff on a ship in Mumbai and it comes into Felixstowe, that is not an issue. If it comes into Rotterdam, or is manufactured in Poland and trucked across Europe, that is an issue.

“That is why the government has proposed that there should be an extra six weeks’ supply.”

DH response

The DH told C+D this morning that it is “currently asking [wholesalers and manufacturers] to provide specific information on their stockpiling programmes to gauge how prepared the industry is already”.

“We have put in place a dedicated team to support suppliers in making arrangements for stockpiling and we will work with companies to develop plans to minimise any additional costs of stockpiling,” it added.

Pharmacy Brexit forum

The Pharmaceutical Services Negotiating Committee (PSNC) has been working alongside other pharmacy bodies, and the government, on the “important discussions” around “secur[ing] the supply of medicines to pharmacies and patients”, it said yesterday.

PSNC has invited the DH to attend the first meeting of its Brexit forum, which was set up “to identify issues and concerns that Brexit may present”. The forum will also monitor the impact of the stockpiling contingency plans on medicines prices, it added.

PSNC CEO Simon Dukes said: “There will be operational issues to explore for community pharmacies, and [the] Brexit forum will…ensur[e] that all pharmacy contractors have the information they need as we approach the Brexit deadline.”

‘Brexit – Paying for No-Deal

Politico, Katie Jennings, 24 August 2018

The U.K. government at last released its health sector guidance for the event of a no-deal Brexit —check out our rundown, also below. It placed the responsibility of stockpiling six weeks worth of medicines squarely on industry. But it didn’t answer one of the most important questions for all the companies involved: Who is on the hook for funding this effort.

While pharmaceutical companies manufacture drugs, a vast network of pre-wholesalers buy and store them (in line with the drugs’ temperature and security regulations). Wholesalers then store stocks for shorter amounts of time before they are delivered to hospitals and pharmacies.

There are only 200 days to figure out which storage facilities the requested six-week supplies will be housed in and how much the effort will cost. Martin Sawer, executive director of the U.K. Healthcare Distribution Association, said his members, which are responsible for distributing over 92 percent of NHS medicines, are “well placed” to support the government’s no-deal preparations.

“However, the devil will be in the detail, with the need for any stockpiling to be carefully managed in order to avoid challenges such as medicine shortages, caused by changes in purchasing patterns,” he said in a statement.

Elliot Dunster, Head of External Affairs at the ABPI, takes a closer look at the ‘no deal’ guidance published by Government.

ABPI, Press Release, 24 August 2018

Yesterday the Government published the first tranche of their ‘no deal’ technical notices to help prepare for the possibility of the UK leaving the EU without a deal.

Alongside the publication of the technical notices, the Health Secretary, Matt Hancock MP, also issued letters to pharmaceutical companies, medical devices companies and the NHS frontline to give guidance about how they should prepare for ‘no deal’.

Since last year, the ABPI has advised pharmaceutical companies that as they prepare for all possible outcomes from the negotiations, they should ensure they are ready for a ‘no deal’.  This guidance will help companies make these preparations and the ABPI has been looking closely at how this guidance will impact on companies.

And there’s a lot in there to unpack with notices on Horizon 2020; batch testing of medicines; quality and safety of organs, tissues and cells; medicines, medical devices and clinical trials regulation; submitting regulatory information on medicinal products; trade; VAT for business; and tariffs.

Here are some initial thoughts on some of the most important aspects of the announcement.

A practical, pragmatic approach to the regulation of medicines

Companies will be warmly welcome the pragmatic approach set out in the technical notice on ‘medicines, medical devices and clinical trial regulation’.  The notice states that, ‘In order to ensure continuity of supply in medicines, however, the UK will continue to accept batch testing of human medicines carried out in countries named on a list set out by the MHRA.’  This list will include EU and EEA countries.  This announcement was a central part of Dominic Raab’s speech.

As the notices make clear, if there’s ‘no deal’, the UK would no longer be part of the EMA network and the sharing of common systems and exchanges of data would end.  That’s why announcing that the UK would recognise EU batch testing and release of medicines is critical to ensure they are available to UK patients from day 1 of Brexit.

Consultations to come

A key feature of the technical notice on how companies would submit regulatory information on medical products was that there will be an consultation from the MHRA in the autumn.  This consultation will look at the ‘new systems’ that are being developed for March 2019, including a ‘national portal for companies to submit regulatory information to’, alongside a range of other issues.  This is likely to inform the necessary statutory instruments to the EU Withdrawal Bill.

The ABPI will be working with members and responding to this consultation in full.

It won’t be easy

The letter from the Health Secretary to pharmaceutical companies didn’t form one of the ‘technical notice’, but was published separately alongside letters to medical device companies and the NHS.  The key requests to pharmaceutical companies were to have a minimum of six weeks additional supply of medicines which arrive in the UK from or via the EU; and to make arrangements to ‘air freight’ products with short shelf lives.

ABPI members have been planning since the day of the referendum result.  And some have been public about the work they have done to increase their stocks of specific medicines, and many already have significant stocks of medicines.

But this won’t be easy.  The letter talks about Government ‘support’, and the ABPI engaging with Government closely about what the support should look like.

… and we still need a deal

The October EU Council meeting takes on ever more important significance.  Dominic Raab and Michel Barnier have agreed that the negotiations will progress on a weekly basis in the run up to that meeting.

What is clear is that the UK Government and the EU Commission agree there needs to be a deal.  We agree.  Mike Thompson, ABPI’s CEO was able to say this directly to Dominic Raab at the press conference after his speech.  We need the full focus of Government on getting the right deal.

Getting a deal, which includes cooperation on medicines, is in the best interests for patients not just in the UK but in the EU as well.

Media And Political Bulletin – 28 August 2018

From Factory to Pharmacy

As part of our mission to build awareness, understanding and appreciation of the vital importance of the healthcare distribution sector, we developed an infographic explaining the availability of medicines. It identifies the factors that can impact drug supply, as well as the measures that HDA members undertake day in, day out to help mitigate the risks of patients not receiving their medicines.

See the Infographic

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