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Media And Political Bulletin – 27 November 2018

Media and Political Bulletin

27 November 2018

Media Summary

Brexit – How to Safeguard the NHS

Politico, Helen Collis, 27 November 2018

Politico reports that yesterday evening in the House of Commons, Dr Sarah Wollaston MP, the Conservative Chair of the U.K. government’s Health and Social Care Committee, co-chaired a press reception hosted by the Brexit Health Alliance to stress the demands of those working in the sector.

“The Brexit Health Alliance says it will be there to provide support if the U.K. leaves the EU. That’s a big ‘if’ in my opinion,” she said, advocating for a second referendum on the final terms of the deal.

Brexit proposals only promises ‘possibility’ of ties with EMA

The Pharmaceutical Journal, Kathy Oxtoby, 26 November 2018

The Pharmaceutical Journal reports that despite government ministers emphasising the importance of the need for close relationships with the European Medicines Agency (EMA) in 2017, the Brexit political agreement does not guarantee ties with the drugs safety organization.

Pharmacists should be enabled to make therapeutic switches before Brexit

The Pharmaceutical Journal, Sibby Buckle, 26 November 2018

The Pharmaceutical Journal reports that there is genuine concern among pharmacists and the pharmaceutical industry that medicines stock shortages will worsen post Brexit.

At a Conservative Science and Technology Forum (CSTF) meeting with Health Minister Lord James O’Shaughnessy in October 2018, Sibby Buckle proposed that the law should be changed to enable community pharmacists to make therapeutic substitution as well as generic drug switching.

The government is already working with the pharmaceutical industry to increase medicines storage capacity pre-March 2019, but Sibby Buckle has added that community pharmacists need to be prepared too.

Brexit – Another Hurdle Jumped

Politico, Helen Collis, 25 November 2018

Politico reports that on Sunday, EU leaders endorsed the U.K.’s Withdrawal Agreement and Political Declaration on its intentions for the future relationship with Europe. The legally-binding Withdrawal Agreement (if it gets approved by the U.K. parliament) sets the conditions of the relationship between the two sides during a transition period from March 29. This includes alignment on medicines and devices regulations, but no vote on EU regulations or decisions within the European Medicines Agency. Within the EU, the role of the U.K.’s drugs agency will also be diminished during this period (refresher). Beyond the transition period, the Political Declaration expresses a willingness to continue regulatory alignment with the EMA, potentially by adopting its decisions.

Commenting on the EU leaders’ endorsement, Mike Thompson, Chief Executive of the Association of British Pharmaceutical Industry, said: “Medicines will continue to reach the patients who need them when the U.K. leaves the EU in March.”

Drug Safety – Warning of EpiPen shortages

Politico, Helen Collis, 25 November 2018

Politico reports that in a sign of the real and deadly impact drug shortages may have on patients if warnings about a no-deal Brexit come to pass, the U.K. is already experiencing a shortage of vital EpiPens.

 

Parliamentary Coverage

House of Commons, Tabled and Written Questions, 26 November 2018

Jenny Chapman MP (Darlington): To ask the Secretary of State for Health and Social Care, what advice he has issued to manufacturers of general sales list medicines on whether to stockpile medicines in preparation for the UK leaving the EU without a deal; whether he plans to update that advice before the end of 2018; and if he will make a statement.

Answered by Stephen Hammond MP: On 23 August 2018 the Department wrote to all pharmaceutical companies that supply the United Kingdom with pharmacy (P) or prescription-only medicines (POM) from, or via, the European Union/European Economic Area (EEA), asking them to ensure they have a minimum of six weeks’ additional supply in the UK, over and above their business as usual operational buffer stocks, by 29 March 2019 in the event of a no deal EU Exit.

Over-the-counter ‘General Sales List’ (GSL) medicines are not included in the Department’s medicines supply contingency programme. GSLs are not considered in-scope for the programme as there are multiple alternatives available should a single GSL medicine be subject to a short-term supply disruption.

The Department is currently considering how best it may support pharmaceutical companies as part of its medicine supply contingency programme. Part of this support will include funding to provide additional capacity for the storage of P and POM medicines in the UK. A process to apply for such funding has been undertaken in recent weeks and contract agreements are imminent.

Jenny Chapman MP (Darlington): To ask the Secretary of State for Health and Social Care, whether he plans to offer financial support to manufacturers of general sales list medicines for the stockpiling of medicines in preparation for the UK leaving the EU without a deal.

Answered by Stephen Hammond MP: On 23 August 2018 the Department wrote to all pharmaceutical companies that supply the United Kingdom with pharmacy (P) or prescription-only medicines (POM) from, or via, the European Union/European Economic Area (EEA), asking them to ensure they have a minimum of six weeks’ additional supply in the UK, over and above their business as usual operational buffer stocks, by 29 March 2019 in the event of a no deal EU Exit.

Over-the-counter ‘General Sales List’ (GSL) medicines are not included in the Department’s medicines supply contingency programme. GSLs are not considered in-scope for the programme as there are multiple alternatives available should a single GSL medicine be subject to a short-term supply disruption.

The Department is currently considering how best it may support pharmaceutical companies as part of its medicine supply contingency programme. Part of this support will include funding to provide additional capacity for the storage of P and POM medicines in the UK. A process to apply for such funding has been undertaken in recent weeks and contract agreements are imminent.

 

Full Coverage

Brexit – How to Safeguard the NHS

Politico, Helen Collis, 27 November 2018

While the rest of us take a brief respite from Brexit news, Sarah Wollaston, the Conservative Chair of the U.K. government’s Health and Social Care Committee, is on a campaign to keep patients’ interests high on the agenda. In the House of Commons Monday evening, Wollaston co-chaired a press reception hosted by the Brexit Health Alliance to stress the demands of those working in the sector. While all the speakers said the Alliance was non-partisan and took no position on Brexit, Wollaston took a stronger line. “The Brexit Health Alliance says it will be there to provide support if the U.K. leaves the EU. That’s a big ‘if’ in my opinion,” she said, advocating for a second referendum on the final terms of the deal.

Medicines at risk of shortage: Wollaston also joined her House of Lords EU Affairs Committee colleagues (refresher) in demanding more information from Health Secretary Matt Hancock on contingency plans for medicines supplies in the event of a no-deal Brexit. In a letter dated November 21, she demanded Hancock publish a list of medicines and medical products identified as having a potential supply risk, along with steps to mitigate those risks. She also wants to know how the Department of Health will ensure small companies do not fall into financial difficulty from Brexit planning — and called out the government over its non-disclosure pact with pharmaceutical companies involved in contingency planning.

The Health and Social Care Committee published this useful table outlining the impact on health services from each of the Brexit outcomes.

Brexit proposals only promises ‘possibility’ of ties with EMA

The Pharmaceutical Journal, Kathy Oxtoby, 26 November 2018

The Brexit political agreement does not guarantee ties with the European Medicines Agency (EMA), despite government ministers emphasising the importance of the need for close relationships with the drugs safety organisation in 2017.

The document, ‘Political declaration setting out the framework for the future relationship between the European Union and the United Kingdom’, which was published on 22 November 2018, said the UK and EU would “explore the possibility” of co-operation of UK authorities with EU agencies, such as the EMA.

But in March 2018, Prime Minister Theresa May said the UK would seek to remain a member of the EMA.

“Membership of the EMA would mean investment in new innovative medicines continuing in the UK, and it would mean these medicines getting to patients faster as firms prioritise larger markets when they start the lengthy process of seeking authorisations,” she said at the time, in a speech setting out her goals for the future relationship between the UK and the EU.

May added that the government would “explore with the EU, the terms on which the UK could remain part of EU agencies,” including the EMA.

“We would, of course, accept that this would mean abiding by the rules of those agencies and making an appropriate financial contribution,” May said.

Commenting on the Brexit document, Labour Party member of the European parliament for the East Midlands, Rory Palmer tweeted: “Theresa May said she would aim for ‘associate membership’ of EMA: that’s now downgraded in #PoliticalDeclaration to ‘explore the possibility of co-operation’. Not good at all.”

The political agreement will now be voted on by the UK parliament.

Pharmacists should be enabled to make therapeutic switches before Brexit

The Pharmaceutical Journal, Sibby Buckle, 26 November 2018

There is genuine concern among pharmacists and the pharmaceutical industry that medicines stock shortages will worsen post Brexit.

At a Conservative Science and Technology Forum (CSTF) meeting with Health Minister Lord James O’Shaughnessy in October 2018, I proposed that the law should be changed to enable community pharmacists to make therapeutic substitution as well as generic drug switching. This precedent was established during the swine flu pandemic, and should now be reconsidered to ensure continuity of treatment.

The government is already working with the pharmaceutical industry to increase medicines storage capacity pre-March 2019, but we need community pharmacists to be prepared too. We community pharmacists are at the frontline — patient facing, giving advice, ensuring medicines are taken correctly — and we need to be better empowered to act in the event of medicines shortages. At the CSTF, I used the example of substituting Otomize ear spray for Sofradex ear drops in the event that Sofradex was unavailable, with the community pharmacist endorsing the prescription accordingly. Both are suitable for the treatment of eczematous inflammation in otitis externa, as are a number of other ear drops, and it is a category which has experienced significant stock shortages over recent years. The patient would be fully involved in the decision making process and the GP notified. Indeed, it is not unknown for the GP to contact the pharmacy to establish which products are available and ask the community pharmacist to make a recommendation for substitution.

In hospital, during ward rounds, once diagnosis has been established by the medical team, the hospital pharmacist will often recommend the most appropriate medication. This now needs to happen in community pharmacy. The community pharmacist would have to be aware of any differences in drug tariff prices, but this is well within the community pharmacist’s competency. Currently, when this type of situation has arisen, as it invariably does, Community pharmacists have to contact the GP to obtain a replacement prescription (Rx). Some GP’s will issue a new Rx by electronic prescription service and the transaction can be relatively straightforward — assuming it takes less than the 30 minutes that it often does to get through to the surgery! However, many GPs still insist on the patient returning to the surgery to collect the new Rx, inconveniencing the patient and delaying the start of their treatment.

Of course if the Rx is written generically the community pharmacist can provide either the generic or a brand equivalent, so it makes sense to enable this in the opposite direction. We will have to be mindful of those medicines which are not directly equivalent, like some epilepsy medicines or where the patient has a genuine intolerance to certain excipients, or controlled drugs, but this should be within a community pharmacist’s competency and training. The biological medicines or biosimilars category is not suitable for substitution, as automatic substitution of brands is not appropriate for biologics. However, the majority of categories are suitable for inclusion. Indeed this type of community pharmacist-enabled substitution could benefit patients even when supply is not the issue. For example, following a medicines use review where it might be obvious to the community pharmacist that the patient would be more compliant and better efficacy obtained with a breath actuated inhaler rather than an metered-dose inhaler, providing better clinical satisfaction and improved patient care.

So, in my campaign to better utilise the clinical skills of community pharmacists, therapeutic substitution of medicines by community pharmacists to improve patient care will be a priority. As will enabling community pharmacists to populate the GP-held patient record through interoperability of the GP and community pharmacist systems. That way, when we make the therapeutic substitution, we can directly inform the GP in real time. No more messing around with 30-minute long phone calls to the surgery.

Brexit – Another Hurdle Jumped

Politico, Helen Collis, 25 November 2018

EU leaders on Sunday endorsed the U.K.’s Withdrawal Agreement and Political Declaration on its intentions for the future relationship with Europe. The legally-binding Withdrawal Agreement (if it gets approved by the U.K. parliament) sets the conditions of the relationship between the two sides during a transition period from March 29. This includes alignment on medicines and devices regulations, but no vote on EU regulations or decisions within the European Medicines Agency. Within the EU, the role of the U.K.’s drugs agency will also be diminished during this period (refresher). Beyond the transition period, the Political Declaration expresses a willingness to continue regulatory alignment with the EMA, potentially by adopting its decisions.

EU leaders had a strong message for British MPs: This is as good as you’ll get. “This is the only deal possible,” Commission President Jean-Claude Juncker declared.

Competing with US, China: Commenting on the EU leaders’ endorsement, Mike Thompson, Chief Executive of the Association of British Pharmaceutical Industry, said: “Medicines will continue to reach the patients who need them when the U.K. leaves the EU in March.” However, he urged politicians “to move swiftly to confirm the closest cooperation in regulation and scientific research which will maximise Europe’s ability to compete globally,” after the transition period. “Without this, the U.S. and China will continue to attract the major share of new life sciences investment,” he warned.

Drug Safety – Warning of EpiPen shortages

Politico, Helen Collis, 25 November 2018

In a sign of the real and deadly impact drug shortages may have on patients if warnings about a no-deal Brexit come to pass, the U.K. is already experiencing a shortage of vital EpiPens, which deliver life-saving medicine to those with severe and possibly lethal reactions to foods such as peanuts. Writing in a blog post, lawyer Punam Sood, of Kingsley Napley law firm, whose son has a peanut allergy, questions the legality of the government’s advice to use out of date medicines, which she fears is in preparation for potential Brexit drug shortages.

Media And Political Bulletin – 27 November 2018

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