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Media And Political Bulletin 25 July 2018

Media and Political Bulletin

25 July 2018

Media Summary

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

Pharmaceutical Journal, 24 July 2018

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

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 that 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 consultation documents are available for download here.

The Government Is Considering Stockpiling Medicine And Food In Case Of A ‘No Deal’ Brexit

Huffington Post, Jasmin Gray, 24 July 2018

The Huffington Post reports that the government is looking into plans to stockpile medicines in case a ‘no-deal’ Brexit leads to medical supply shortages. Matt Hancock, the newly appointed Health Secretary, said that despite being ‘confident’ that the UK will not crash out the EU without a deal. He has accelerated preparations for such an eventuality since joining the department at the beginning of July.

Hancock, appearing before MPs during his first appearance in front of the Commons’ health and social care committee on Tuesday, said: “We are working right across government to ensure that the health sector and the industry are prepared and that people’s health will be safeguarded in the event of a ‘no deal’ Brexit.”

He added that there was “obviously going to be a cost implication of doing this,” but that “this is exactly the type of contingency planning you would expect us to be doing.”

Read more about this in the Independent , Daily Mail , Business Insider and the BBC.

Parliamentary Coverage

House of Commons Questions, 24 July 2018

Dr Philippa Whitford, SNP: I too welcome the Secretary of State to his place. Membership of the European Medicines Agency has enabled early access to new drugs for UK patients through a single Europe-wide licensing system for a population of 500 million. Can the Minister clarify whether it is still the Government’s intention to remain a member of the EMA, and perhaps explain why on earth they voted against the EMA amendment last Tuesday?

Stephen Barclay, MP: As the hon. Lady will be aware, we accepted the amendment, and it is our intention to work as closely as possible on that as part of taking that forward—[Interruption.] To correct the—[Interruption.]

Mr Speaker: Order. To be fair, it is a speedy correction.

Dr Philippa Whitford, SNP: It is still rather hard to understand why the Government voted against it in the first place. There is no current associate membership of the EMA for the UK to re-join as a third country, so if it is not possible to stay in the EMA what is the plan to avoid delays of up to a year in the licensing of new drugs for UK patients?

Stephen Barclay, MP: There are a number of things that can be taken advantage of. We can use the flexibilities we have in terms of assessments with shorter timescales so that we can prioritise UK drugs that are bespoke to the UK market. There will be opportunities as part of this, as well as our working closely with European colleagues.

House of Commons, Tabled and Written Questions, 24 July 2018

Liz Twist, MP: To ask the Secretary of State for Health and Social Care, what steps he is taking to ensure that the next Pharmaceutical Price Regulation Scheme sets an ambitious framework for delivering quick patient access to new and clinically-effective medicines.

Liz Twist, MP: To ask the Secretary of State for Health and Social Care, what steps he is taking in the pharmaceutical price regulation scheme negotiations to ensure that modern cancer therapies are categorised as cost-effective.

Darren Jones, MP: To ask the Secretary of State for Health and Social Care, if he will make it his policy to maintain the current cost-effectiveness threshold per quality-adjusted life year in the next Pharmaceutical Price Regulation Scheme.

Darren Jones, MP: To ask the Secretary of State for Health and Social Care, if he will make it his policy to establish a formal mechanism to (a) involve and (b) listen to patient groups during the next Pharmaceutical Price Regulation Scheme negotiations.

Full Coverage

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

Pharmaceutical Journal, 24 July 2018

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 wholesalers almost half a billion pounds 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.

The Government Is Considering Stockpiling Medicine And Food In Case Of A ‘No Deal’ Brexit

Huffington Post, Jasmin Gray, 24 July 2018

The government is looking at plans to stockpile medicines in case a ‘no deal’ Brexit leads to medical supply shortages, the newly-appointed health secretary has admitted.

Matt Hancock said that despite being “confident” the UK will not crash out of the EU without a deal, he had accelerated preparations for such an eventuality since joining the department at the start of July.

Elsewhere, Brexit Secretary Dominic Raab said the Government would also take steps to ensure an “adequate food supply”.

Hancock, appearing before MPs during his first appearance in front of the Commons’ health and social care committee on Tuesday, said: “We are working right across government to ensure that the health sector and the industry are prepared and that people’s health will be safeguarded in the event of a ‘no deal’ Brexit.

“We are working with industry to prepare for the potential need for stockpiling in the event of a ‘no deal’ Brexit,” Hancock said, adding that there was “obviously going to be a cost implication of doing this”.

“This is exactly the type of contingency planning you would expect us to be doing,” the minister added.

The government is also focusing on the importance of guaranteeing a continuous supply of drugs with a short shelf-life, Hancock said, explaining that some medicines could be flown into the UK if there are issues at ports.

“You can imagine that it is incredibly important for me, as Secretary of State, to ensure that people will have access to the medicines that they need,” he continued.

“It is vital that we get the preparations right, but I am also confident that with the right amount of work, we can mitigate the worst of the circumstances.”

Media And Political Bulletin 25 July 2018

From Factory to Pharmacy

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