News

Media And Political Bulletin 26 July 2018

Media and Political Bulletin

26 July 2018

Media Summary

MHRA says Falsified Medicines Directive could cost £500m over ten years

The Pharmaceutical Journal, 24 July 2018

**This article was updated by PJ due to an inaccuracy in the initial version, included in this bulletin yesterday**

The Pharmaceutical Journal reports that the Medicines and Healthcare products Regulatory Agency (MHRA) has estimated that implementing the Falsified Medicines Directive (FMD) in the UK could cost almost half a billion pounds to implement over the next ten years, depending on how the directive is introduced.

But there is no assessment of the potential costs to community pharmacy of FMD adherence in its consultation on implementing the directive, which comes into force on 9 February 2019.

The article states that a large part of the consultation considers whether wholesalers should be required to verify and decommission medicines on behalf of all Article 23 institutions, or whether some or all of these institutions should take on this responsibility themselves. An impact assessment estimates the ten-year cost of the former option at £25.7m, and the latter option at £473.2m.

The MHRA says the first option would present the best value for money.

Community Pharmacy Brexit Forum established

PSNC, Press Release, 25 July 2018

The PSNC has issued a press release highlighting the fact that it has set up a Brexit forum involving the Chief Executives of the major representative bodies involved in community pharmacy and the medicines supply chain.

They state that while the PSNC and other national representative bodies have already been holding their own internal discussions to identify relevant issues and concerns that Brexit may present, this forum will provide a platform for stakeholders to share thoughts and compile advice for community pharmacy teams.

The forum will also liaise with the Department of Health and Social Care (DHSC) to ensure that the supply of medicines to community pharmacy patients is maintained.

Community pharmacy Brexit forum set up to deal with supply of medicines to pharmacies after March 29

Pharmacy Business, Neil Trainis, 25 July 2018

Pharmacy Business also reports on the PSNC community pharmacy Brexit forum. The article comments on the fact that there has been grave concern that Brexit could precipitate a major shortage of medicines in the UK, to add to the ‘shortages that have already blighted community pharmacies and jeopardised patients’ health in recent years.’

It states that the National Pharmacy Association, Company Chemists’ Association, Association of Independent Multiple Pharmacies, Royal Pharmaceutical Society, Pharmacists’ Defence Association, Dispensing Doctors Association and Healthcare Distribution Association have indicated they will join the forum. The PSNC said it is open to accepting other representative organisations.

Brexit: Theresa May tells public not to worry about plans to stockpile food and medicine in event of no deal

The Independent, Rob Merrick, 15 July 2018

The Independent states that Theresa May has urged the public ‘not to worry’ about her government’s plans to stockpile food and medicine to prepare for a no deal Brexit.

This article reports that the Prime Minister has sought to play down the growing controversy over planning for the threat from crashing out of the EU without an agreement – insisting that people should take ‘reassurance and comfort.’

In an interview with Channel 5, Theresa May confirmed that plans for stocking up on essential goods are underway – in case imports from the EU are cut off by clogged ports, or regulatory disputes.

Parliamentary Coverage

There was no parliamentary coverage today.

Full Coverage

MHRA says Falsified Medicines Directive could cost £500m over ten years

The Pharmaceutical Journal, 24 July 2018

**Corrected from yesterday**

The Medicines and Healthcare products Regulatory Agency has opened its consultation on the Falsified Medicines Directive, but there is no estimate of the financial impact for community pharmacists.

The Medicines and Healthcare products Regulatory Agency (MHRA) has estimated that implementing the Falsified Medicines Directive (FMD) in the UK could cost almost half a billion pounds to implement over the next ten years, depending on how the directive is introduced.

But there is no assessment of the potential costs to community pharmacy of FMD adherence in its consultation on implementing the directive, which comes into force on 9 February 2019.

The MHRA said this absence is owing to the fact that the consultation focuses on areas of FMD where the UK has the legal flexibility to make changes to the delegated regulation. There is no flexibility on how community pharmacies implement FMD. Instead, the consultation concentrates on the impact of FMD on wholesalers, parallel distributors and the so-called ‘Article 23 institutions’: non-healthcare institutions who supply medicine to the public, such as care homes, opticians and prisons.

The Pharmaceutical Services Negotiating Committee (PSNC) told The Pharmaceutical Journal that, as part of the UK FMD Working Group for Community Pharmacy, it was continuing to work on an assessment of the costs of implementing and operating FMD for pharmacy contractors. The assessment would, they said, be used in forthcoming negotiations with the Department of Health and Social Care and NHS England. In February 2018, Alastair Buxton, head of NHS Services at the PSNC, said that the body would “work to ensure that contractors’ FMD-related costs are recognised in future NHS funding settlements”.

A large part of the consultation considers whether wholesalers should be required to verify and decommission medicines on behalf of all Article 23 institutions, or whether some or all of these institutions should take on this responsibility themselves. An impact assessment estimates the ten-year cost of the former option at £25.7m, and the latter option at £473.2m.

The MHRA says the first option would present the best value for money.

The consultation also invites views on possible sanctions for non-compliance within the supply chain. The MHRA said the government is “minded to move to an approach that would use a mixture of both criminal and civil sanctions”, with non-compliant bodies or persons initially being faced with civil sanctions including written warnings and civil fines, and only the most serious, intentionally fraudulent, breaches being subject to criminal sanctions.

Respondents are asked for their views on the most effective way of enforcing FMD across the supply chain.

The Royal Pharmaceutical Society (RPS) will be responding to the consultation and has invited its members to contribute to the response.

Gino Martini, chief scientist at the RPS, said: “We would urge people to get actively involved in this conversation, because it will affect a significant part of the supply chain.

“Globally, counterfeit medicine levels reached their highest ever levels during 2017. Anything that prevents counterfeit medicine coming into the UK is a good thing.”

The consultation documents are available to download from the MHRA website. The consultation closes at 15:00 on 23 September 2018.

Community Pharmacy Brexit Forum established

PSNC, Press Release, 25 July 2018

PSNC has set up a Brexit forum involving the Chief Executives of the major representative bodies involved in community pharmacy and the medicines supply chain.

Whilst PSNC and the other national representative bodies have already been holding their own internal discussions to identify relevant issues and concerns that Brexit may present, this forum will provide a platform for stakeholders to share thoughts and compile advice for community pharmacy teams.

The forum will also liaise with the Department of Health and Social Care (DHSC) to ensure that the supply of medicines to community pharmacy patients is maintained. We expect DHSC, NHS England and the Medicines and Healthcare products Regulatory Agency (MHRA) to have contingency plans and to monitor the medicines supply market during and after Brexit, but the forum will help to identify relevant issues and seek appropriate clarification as required, in the approach to the Brexit deadline.

For example, contractors may be aware of a Parliamentary vote last week on continued UK involvement in the European Medicines Agency (EMA). MPs voted for the UK to take “all necessary steps” to participate in the regulatory network operated by the agency after we leave the EU, which the Government had already committed to. The UK’s future relationship with the EMA is of importance to the medicines supply chain, so this will be an issue for the new Community Pharmacy Brexit Forum.

There have also been recent reports in the national press that the NHS is considering stockpiling medicine supplies to protect against the possibility of a no-deal Brexit. The forum will want to ensure that community pharmacies have appropriate access to all sources of medicines so they can continue to fulfil prescriptions of vital medicines for their patients.

PSNC agreed to set up the forum at its July meeting. The National Pharmacy Association, the Company Chemists’ Association, the Association of Independent Multiple Pharmacies, the Royal Pharmaceutical Society, the Pharmacists’ Defence Association, the Dispensing Doctors Association and the Healthcare Distribution Association have indicated they will join the forum. Any other representative organisations wishing to join should email PSNC Director of Operations and Support, Gordon Hockey.

Community pharmacy Brexit forum set up to deal with supply of medicines to pharmacies after March 29

Pharmacy Business, Neil Trainis, 25 July 2018

A community pharmacy Brexit forum has been set up by the PSNC which will see the profession’s representative bodies and medicines supply chain discuss issues around the channelling of medicines to pharmacies in the UK after it leaves the European Union in March next year.

The forum, pharmacy’s negotiator said, “will help to identify relevant issues and seek appropriate clarification as required in the approach to the Brexit deadline” as well as communicate with the Department of Health and Social Care (DHSC) to ensure patients are able to access a continuous supply of medicines from community pharmacies.

There has been grave concern that Brexit could precipitate a major shortage of medicines in the UK to add to the shortages that have already blighted community pharmacies and jeopardised patients’ health in recent years.

Earlier this year Richard Freudenberg, the chief executive of the European Association of Euro-Pharmaceutical Companies (EAEPC), warned a significant number of drugs may no longer be available to patients in Britain from midnight on March 29 next year unless an impasse between the Medicines and Healthcare products Regulatory Agency (MHRA) and European Medicines Agency (EMA) was brought to an end.

It was feared that more than 400 drug molecules centrally approved in Europe would no longer be available for distribution to patients in the UK post-Brexit, with all medicines manufactured in the UK after March 29, 2019 regarded as imports from a ‘third country.’

Freudenberg said the MHRA, who he called on to register products to allow patients in the UK to continue accessing them, was passing responsibility for avoiding a potentially devastating shortage to the EMA.

However, a vote in the House of Commons last week narrowly went in favour of the UK’s continued participation in the EMA, an issue the PSNC said will be of importance to the forum.

The National Pharmacy Association, Company Chemists’ Association, Association of Independent Multiple Pharmacies, Royal Pharmaceutical Society, Pharmacists’ Defence Association, Dispensing Doctors Association and Healthcare Distribution Association have indicated they will join the forum. The PSNC said it is open to accepting other representative organisations.

“There have also been recent reports in the national press that the NHS is considering stockpiling medicine supplies to protect against the possibility of a no-deal Brexit,” the PSNC said.

“The forum will want to ensure that community pharmacies have appropriate access to all sources of medicines so they can continue to fulfil prescriptions of vital medicines for their patients.”

Brexit: Theresa May tells public not to worry about plans to stockpile food and medicine in event of no deal

Independent, Rob Merrick, 15 July 2018

Theresa May has urged the public not to be “worried” by her government’s plans to stockpile food and medicine to prepare for a no deal Brexit.

The prime minister sought to play down the growing controversy over planning for the threat from crashing out of the EU without an agreement – insisting people should take “reassurance and comfort”.

This week, ministers have lifted the lid on plans for ensuring food, medicines and blood will still be available after exit day next March.

Interviewed by Channel 5, Ms May confirmed that plans for stocking up on essential goods are underway – in case imports from the EU are cut off by clogged ports, or regulatory disputes.

But, asked it was “alarming” for people, the prime minister said: “Far from being worried about preparations that we are making, I would say that people should take reassurance and comfort from the fact that the government is saying we are in a negotiation, we are working for a good deal.

A Guardian/ICM poll gave her an eight-point lead over Jeremy Corbyn over who could be trusted to negotiate a good Brexit deal – down from 16 points in January and 34 points before the 2017 general election.

Earlier, the Irish government dismissed the UK’s threats of a no-deal Brexit if necessary as “bravado”, insisting the damage to the UK would be too great.

Simon Coveney, Dublin’s deputy prime minister, instead urged Britain to delay Brexit if the talks remain deadlocked – offering to press for an extension to the Article 50 deadline.

“I have heard a lot of comment on this issue in recent weeks and, to be honest with you, I think some of it is bravado,” Mr Coveney said.

“I believe we can get a good deal, but, it’s right that we say – because we don’t know what the outcome is going to be – let’s prepare for every eventuality.”

She added: “This is not just about stockpiling. That concept, what it is, is about making sure that we will be able to continue to do the things that are necessary once we have left the European Union, if we leave without a deal.”

Ms May’s comments came as a new poll suggested trust in her ability to handle Brexit is plunging.

“The truth is that I don’t believe Britain can afford to have no deal on Brexit. I don’t believe that Ireland and the EU want that either.”

The government will issue a series of “technical notices” in the coming months, designed to prepare the public and businesses for the worst-case scenario of leaving without a deal.

The International Monetary Fund (IMF) has warned the overall UK economy would suffer far more than the EU’s – losing 4 per cent of national output, compared with 1.5 per cent across the Channel.

Asked if the Irish government would push the rest of the EU to extend Article 50, to avoid a no deal next year, Mr Coveney replied: “Absolutely.

“If Britain asks for more time, and if that’s necessary to get to a sensible agreement, then we would support that – of course we would.”

Media And Political Bulletin 26 July 2018

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