HDA UK Media And Political Bulletin – 6 October 2017

Media and Political Bulletin

6 October 2017

Media Summary

‘Any pharmacy’ could receive controlled drug scripts via EPS

Chemist and Druggist, Annabelle Collins, 4 October 2017

Chemist and Druggist reports on the NHS Digital’s recent confirmation that ‘any pharmacy in England’ could receive an electronic prescription for a controlled drug once a pilot launches across five GP practices. This pilot will enable the five practices to prescribe schedule 2 and 3 controlled drugs through the electronic prescription service (EPS), NHS Digital has confirmed to the publication.

NHS Digital has not given a specific launch date for the pilot but the Pharmaceutical Services Negotiating Committee (PSNC) said it anticipated the timings will be announced ‘shortly’.

ABPI Board not to appeal judicial review decision

ABPI, 5 October 2017

Following a decision by the Board of the Association of the British Pharmaceutical Industry, the ABPI have issued a new statement on its application for judicial review versus The National Institute for Health and Care Excellence (NICE).

​​​​​​​​​​This follows yesterday’s confirmation from the Administrative Court that The ABPI’s application for judicial review was turned down.

 

Parliamentary Coverage

 

There is no Parliamentary coverage today.

 

Full Coverage

‘Any pharmacy’ could receive controlled drug scripts via EPS

Chemist and Druggist, Annabelle Collins, 4 October 2017

“Any pharmacy in England” could receive an electronic prescription for a controlled drug once a pilot launches across five GP practices, C+D has learned.

The pilot will enable the five practices to prescribe schedule 2 and 3 controlled drugs through the electronic prescription service (EPS), NHS Digital confirmed to C+D last week (September 29).

It could not give C+D a specific launch date for the pilot but the Pharmaceutical Services Negotiating Committee (PSNC) said it anticipated the timings will be announced “shortly”.

Advance warning

The pharmacies that usually dispense prescriptions from the GP practices involved in the pilot will be informed in advance, NHS Digital said.

However, “all other pharmacies in England will be advised they could receive an EPS prescription that includes controlled drugs”, it added.

NHS Digital told C+D last year that EPS would not be able to handle controlled drugs until 2018, when systems suppliers would have the capability.

“The functionality needed to be available in all pharmacies before we [could] start the pilot,” NHS Digital told C+D last week. “In time all GP practices will include this functionality.”

The GP practices involved in the pilot would be those using the Vision GP IT system in the North West and London, NHS Digital said.

It added that “subject to the pilot being successful”, further GP practices that use ‘Vision’ will begin using EPS to prescribe controlled drugs.

The Department of Health changed the law in 2015 to allow schedule 2 and 3 controlled drugs, including opiates and barbiturates, to be dispensed through EPS.

Since 2005, drugs controlled under schedules 4 and 5 – such as diazepam and preparations containing low strengths of more heavily regulated drugs – have been prescribed electronically.

ABPI Board not to appeal judicial review decision

ABPI, 5 October 2017

Following a decision by the Board of the Association of the British Pharmaceutical Industry (ABPI), the ABPI have issued a new statement on its application for judicial review versus The National Institute for Health and Care Excellence (NICE).

​​​​​​​​​​This follows yesterday’s confirmation from the Administrative Court that The ABPI’s application for judicial review was turned down.

“Following the decision by the Honourable Justice Mrs Elisabeth Laing not to grant the ABPI a judicial review against NICE, the Board of the ABPI has unanimously agreed to accept the decision and will not appeal.

“After months of raising concerns with NICE, NHS England and the Department of Health and offering to work constructively on alternative proposals, the ABPI Board took the exceptional decision in June to apply to the courts to formally challenge new measures introduced by NICE earlier this year for evaluating and funding medicines and other health technologies.

“Our concern has always been that patients should not miss out on medicines which are proven to be both clinically beneficial and cost-effective. Throughout this action the ABPI has maintained positive and constructive dialogue with NICE, the NHS and Government and we are encouraged that the issues are now better understood.

“Working in partnership with industry, Government and the NHS we must now focus on finding real, workable solutions to help NHS patients get fast access to the medicines they need.

“The positive reception by Government to the Life Sciences Industrial Strategy recommendations is a good start and we now look forward to seeing them fully implemented.   This is best achieved through agreeing a strong sector deal that both improves access to new medicines and ensures the UK remains a successful place to research and develop medicines.”

Media and Political Bulletin

5 October 2017

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Media Summary

My pharmacy could lose £2,500 a month if generics shortages continue

Chemist and Druggist, Jennifer Offord and Grace Lewis, 4th October 2017

Chemist and Druggist reports on the potential effect to pharmacists if generics shortages continue. A pharmacy owner has told the publication that not only are the shortages having an impact on the smooth operating of his business but also that he could stand to lose thousands of pounds a month if the issues continue.

Last month, the Pharmaceutical Services Negotiating Committee (PSNC) announced it is in “urgent discussions” with the Department of Health (DH) about the “catastrophic” effect of generics shortages on contractors’ cash flow.

Ensuring successful serialisation data management ahead of the EU FMD

European Pharmaceutical Review, Jean-Marie Aulnette, 4th October 2017

In this European Pharmaceutical Review article, Jean-Marie Aulnette, vice president of EMEA at TraceLink addresses the complexities of developing a comprehensive compliance solution, the importance of working collaboratively with trade partners and how the task of storing and exchanging huge amounts of serialisation data securely should not be underestimated.

Mr Aulnette argues that the task of introducing track & trace solutions has largely been underestimated by the supply chain. He also suggests that many manufacturers and packaging organisations have been slow to adopt new processes that will ensure compliance ahead of the deadlines for implementation, despite the benefits surrounding consumer protection and industry sustainability.

ABPI update on application for judicial review

ABPI, 4th October 2017

The Association of the British Pharmaceutical Industry (ABPI) have issued a statement regarding its application for judicial review versus The National Institute for Health and Care Excellence (NICE).

​​​​​​​Following confirmation from the Administrative Court that The ABPI’s application for judicial review has been turned down, the following statement has been issued:

“The ABPI is disappointed that the judicial review application has been turned down. It’s now appropriate for us to take time to reflect on the judgement with our members and decide next steps”.

This was also reported in The Telegraph.

Parliamentary Coverage

There is no Parliamentary coverage today.

Full Coverage

My pharmacy could lose £2,500 a month if generics shortages continue

Chemist and Druggist, Jennifer Offord and Grace Lewis, 4th October 2017

A pharmacy owner has told C+D he expects to lose up to £2,500 a month if generics shortages continue.

Last month, the Pharmaceutical Services Negotiating Committee (PSNC) announced it is in “urgent discussions” with the Department of Health (DH) about the “catastrophic” effect of generics shortages on contractors’ cash flow.

Speaking to C+D following PSNC’s announcement, Dipak Pau, owner and superintendent pharmacist of The Pill Box pharmacy in Chelmsford, said not only are the shortages having an “impact on the smooth running of my business”, but he could stand to lose thousands of pounds a month if the issues continue.

“Items I was buying for 15p are now in excess of £4,” Mr Pau told C+D last month (September 22).

“If I’m selling 1,000 packs a month in one single line in my pharmacy, I will lose £1,500 to £2,500.”

However, the real cost to the business will be higher, as “it’s not just one product” that is affected, Mr Pau explained.

“It’s 80 to 90 products, in different strengths and formulations,” he added.

Mr Pau claimed the cost of buying antipsychotic medication olanzapine from wholesalers increased “170 times” in just three weeks, following a shortage in the market.

The price of antipsychotic quetiapine is also increasing an “extraordinary amount”, he added.

Independents most impacted

Mr Pau warned that if the DH fails to act on the current supply issues, independent pharmacies could “slowly go bust”.

“[Independents] struggling to buy stock in, and buying stock at multiple times the value of what they are getting back from the DH, are losing money hand-over-fist,” he stressed.

“You can only sustain losses for so long.”

C+D has asked PSNC for an update on its “urgent talks” with the DH.

Ensuring successful serialisation data management ahead of the EU FMD

European Pharmaceutical Review, Jean-Marie Aulnette, 4th October 2017

Ensuring successful serialisation data management ahead of the EU FMD

Traceability and serialisation have been the talk of the industry for many years, with regulatory bodies worldwide starting to introduce legislation that will help to eradicate counterfeit medicines from the supply chain.

Despite this, it has not been top of the agenda for many pharmaceutical supply chain partners given the complexities that serialisation introduces, meaning that many marketing authorisation holders (MAHs) and contract manufacturers (CMOs) are now facing an uphill battle towards compliance.

Following the announcement that the active enforcement of the US Drug Supply Chain Security Act (DSCSA) for pharmaceutical manufacturers has been delayed due to a lack of readiness, it is vital the industry prepares for serialisation compliance not only in the US, but also in Europe. But what are the biggest challenges that companies face? And, what can contract partners learn from the DSCSA enforcement delay ahead of the EU Falsified Medicines Directive (FMD) deadline in February 2019?

In this article, Jean-Marie Aulnette, vice president of EMEA at TraceLink addresses the complexities of developing a comprehensive compliance solution, the importance of working collaboratively with trade partners and how the task of storing and exchanging huge amounts of serialisation data securely should not be underestimated.

The reality of serialisation

Counterfeit drugs cost the pharmaceutical market billions each year and the impact these medicines can have on patient safety is huge. As a result, over 55 countries are introducing legislation which will allow products to be tracked or traced throughout the supply chain, until they land in the hands of the patient.

However, the task of introducing track & trace solutions has largely been underestimated by the supply chain. Many manufacturers and packaging organisations have been slow to adopt new processes that will ensure compliance ahead of the deadlines, despite the benefits surrounding consumer protection and industry sustainability. In the US, the task of not only ensuring product transaction information, history and statements (T3 records) are available electronically but also that product identifiers are added at an item and case level has proved too great for many. As such, the DSCSA enforcement date has been delayed by one year to allow companies extra time to implement solutions.

One of the most common barriers to adopting a suitable solution is the cost. Manufacturers report that on average, implementing a line management system (LMS) costs an average of €255K ($300K) per line. Added to that, the average timeframe is around 18 months, often lengthened by delays due to last minute equipment orders, which increases the cost further.

According to recent polls held at NEXUS 17 in June 2017, 60% of respondents are still in the early stages of implementation, with a further 10% having not started their serialisation journey yet. In addition, 68% of companies feel that CMOs are not well prepared for the regulations. Generally speaking, most CMOs have discovered too late that they have not allocated adequate time and resources to develop a solution and integrate it with customer requirements. With this in mind, it is imperative that pharmaceutical companies and CMOs alike learn from the mistakes that lead to the DSCSA delay.

Learning from the DSCSA enforcement delay

The lack of readiness across the external supply ecosystem can be partly attributed to a lack of understanding. No two markets have introduced the same serialisation governance and failure to understand the differences in market requirements can cause significant problems. So, what can companies learn from the industry’s mistakes thus far?

Serialisation is not a simple task. It goes far beyond simply printing a barcode. A scalable IT infrastructure that is able to adapt to different market requirements and customer demands is vital to ensure compliance and avoid supply shortages. In many cases, current infrastructures simply may not be suitable. Transaction volumes for serialisation can be in the region of tens of thousands of files, which are hundreds of megabytes in size and the capacity of each member of the supply chain will vary. For example, where one company might send and receive a single, large file, another may need to transfer and receive the data in smaller batches.

The complexity of the supply chain further complicates the task of serialisation. The pharmaceutical supply chain is not a linear one; it involves multiple partners in multiple locations from development to distribution. In addition, contract partners such as CMOs and contract packaging organisations (CPOs) are often supplying to more than one market, meaning a plethora of differing regulations to comply with.

Dealing with your data requirements

The polls held at NEXUS 17 indicated that the biggest concern for companies is data exchange. To give an idea of how much data serialisation generates, over 650 companies across the supply chain use the TraceLink Life Sciences Cloud for serialisation, which allows them to exchange data and connect to an ecosystem of 255,000 trading partners on its network.

The largest user on the TraceLink Life Sciences Cloud commissions around 18 billion serial numbers a year, and each of those will be used for an average of five transactions before the manufacturer even ships the product. This equates to at least 90 billion pieces of data that need to be validated and managed. Additional data is then generated as each serialised product passes through the supply chain after shipping.

Other stakeholders throughout the supply chain then need to be able to access this data, meaning in addition to storing their own data, supply chain partners need to be able to transfer it securely. For example, in the EU, this will be done via a central EU hub, which will share information with individual national systems that can be accessed by relevant dispensers to verify products. Given the sheer volume of medicines manufactured on a daily basis and the requirement of applying a serial number to each saleable drug unit, the data scalability and connectivity challenges for companies are massive and it is imperative that they find a way to store, manage and verify data in a way that doesn’t impact operational efficiency.

End-to-end testing is vital to ensure the successful transmission of data and to minimise disruptions to supply. The industry uses multiple formats to track serialisation information and while the GS1 global standard Electronic Product Code Information Services (EPCIS) is favoured by most, this is not a hard and fast rule. These challenges will define a company’s IT infrastructure and pharmaceutical companies may find the systems they currently have in place are simply not suitable. As the complexity of implementation is more widely recognised, many drug developers are now turning to well-prepared CMOs that they can outsource their serialisation requirements too.

Sizing up your service provider

CMOs are fast becoming an essential part of industry compliance and those who are well prepared are now in an ideal place to offer outsourced serialisation solutions. However, selecting the right partners is crucial. So, what should you be looking for in your service provider?

Taking a three-fold approach to vendor selection will help to ensure you make the right decision. Firstly, your service provider should have a reasonable implementation timeline. Even if a CMO is ready for deadlines, it will take time to integrate their solution with your requirements and considering time is tight it’s important they have a good idea of how long the process will take.

What is the capacity of your CMO? And, does this meet your future requirements as well as your current ones? Are its line systems ready for serialisation or is it still waiting on line equipment? Visit its facility, assess the scale of its operations and use the opportunity to get a feel for where it is in its implementation programme. Finally, given the complexities of handling serialisation data, how does your CMO plan to address your data management and connectivity requirements?

Going forward it is likely that regulations will change so your CMO also needs to be ready to make any necessary modifications. Failure to adapt will lead to future non-compliance so make sure your provider has a flexible solution that has been designed with the continued evolution of regulations in mind. It is the sole responsibility of the market authorisation holder (MAH) to ensure compliance, which makes vendor selection vital.

Summary

The delay to the DSCSA deadline offers the pharmaceutical industry an important insight into how best to tackle serialisation requirements in the run up to the EU FMD. Serialisation solutions stretch across the whole organisation and can present a number of resource conflicts and dependencies.

The task of developing an effective system to manage and transfer the vast amounts of data generated through serialisation is huge and as such many companies are looking to outsource their requirements to well-prepared third parties with a comprehensive solution already in place. Patient safety should be the core concern when it comes to traceability and serialisation so companies should act now to ensure full compliance ahead of the deadlines.

ABPI update on application for judicial review

ABPI, 4th October 2017

The Association of the British Pharmaceutical Industry (ABPI) have issued a statement regarding its application for judicial review versus The National Institute for Health and Care Excellence (NICE).

​​​​​​​Following confirmation from the Administrative Court that The ABPI’s application for judicial review has been turned down, the following statement has been issued:

“The ABPI is disappointed that the judicial review application has been turned down. It’s now appropriate for us to take time to reflect on the judgement with our members and decide next steps”.

MEDIA SUMMARY 

Who are newest recruits to parliamentary pharmacy group?
Chemist and Druggist, Emily Bright and Annabelle Collins, 27 July 2017

The All-Party Pharmacy Group (APPG) has approved two Conservative MPs to sit as vice-chairs on the organization. Julian Sturdy, MP for York Outer, and Steve Double, MP for St Austell and Newquay will replace MPs who lost their seats in the election. Both Mr Double and Mr Sturdy voted for pharmacy cuts after a parliamentary debate in November 2016. Mr Sturdy has consistently voted to allow GPs to commission services on behalf of patients. Mr Double “voted against ‘immediate extra social care funding and better NHS and social care funding'”.

UK government hires ex-pharma chief to lead pricing talks with industry
Pharmaphorum, Andrew McConaghie , 27 July 2017

Pharmaphorum reported on the recent news at the NHS, with the appointment of Steve Oldfield as Chief Commercial Officer. It is a newly created position and Mr Oldfield will lead negotiations with the ABPI over the upcoming renewal of the PPRS. Given Mr Oldfield’s long career in the private sector, Pharmaphorum notes that the appointment is somewhat like the “poacher turned gamekeeper”, with someone with deep knowledge of pharmaceutical negotiating tactics now working for the other side. McConaghie also supposed that it is a sign of trust between the Department of Health and industry that the Department would so readily appoint someone from the latter’s ranks.

PARLIAMENTARY COVERAGE

There is no parliamentary coverage.

FULL COVERAGE 

UK government hires ex-pharma chief to lead pricing talks with industry
Pharmaphorum, Andrew McConaghie , 27 July 2017

The Department of Health has appointed a former UK head of Sanofi and Teva to be its chief commercial officer, with responsibility for negotiating a new pricing deal top of his priorities.

Steve Oldfield will take up this newly-created position in October, and will lead talks with the industry association the ABPI on the PPRS, the key pricing agreement between pharma and the NHS.

The new position is very much a break with tradition, as such senior roles have been filled by civil servants in the past.

But the Department of Health (DH) has lost a great deal of its in-house expertise over the last few years, seeing its headcount slashed thanks to Whitehall spending cuts. It has also just seen the Commercial Medicines Unit (CMU) transferred to NHS England, which is increasingly cutting its own pricing deals direct with pharma.

But the DH still retains responsibility for negotiating the PPRS for the whole of the UK, which covers around £8 billion a year in medicines spending.

The current PPRS agreement is due to expire in December 2018, and both sides are keen to start talking about what should replace it. NHS England and the ABPI are both keen to see more outcomes-based pricing deals, but the current PPRS and limitations on NHS data make this difficult to extend to all medicines.

The NHS is also under extreme budget pressure, and the DH and NHS England want to keep a tight grip on medicines expenditure, especially in the face of a boom in highly specialised, high cost new drugs coming to market.

All this means that the DH needs someone with a deep understanding of medicines pricing to get the best deal from pharma.

Oldfield will be joining the Government Commercial Function and his initial focus will be to create and develop a commercial strategy, which the DH says will ‘underpin upcoming negotiations with a variety of commercial suppliers, including key engagements with the pharmaceutical industry in particular on the PPRS scheme’.

Currently chief operating officer for PGT (the consumer health joint venture between Procter & Gamble and Teva) based in Geneva, Steve Oldfield has more than 25 years of experience in pharma.

In addition to his UK leadership roles at Sanofi and Teva, he has also held senior positions in Asia and Latin America. He has been involved in industry-government initiatives over the years, having served on the ABPI’s board and co-chaired committees looking at the introduction and adoption of new medicines.

Steve Oldfield commented: “I am delighted to be joining the Department of Health, especially at such an exciting time. Demands on the health system have never been greater, and I hope to be able to bring my previous commercial experience to bear on the activities of the department.”

He added, “In particular, I look forward to working collaboratively across the department, the NHS and the life sciences to find new ways of working for the benefit of patients and the health economy.”

The appointment looks to be very much in the mould of ‘poacher turned gamekeeper’, in that Oldfield will have first-hand insights into pharma’s business models, and will use this to drive the best possible deal for the government.

At the same time, his ‘pharma insider’ status can also be seen as a sign of trust between the DH and the industry, demonstrating a desired wish to support the life sciences sector.

This is particularly vital at the moment, as Brexit and the threat of an economic slowdown in the UK are threatening the future of the industry here, as well as the NHS’ ability to pay for new medicines.

The ABPI was quick to welcome the appointment, its chief executive Mike Thompson saying Oldfield would provide it with ‘valuable expertise’.

Mike Thompson added: “I’m confident that this appointment will also positively impact our ability to have open and transparent negotiations with Government and find win-win solutions in which everyone can have confidence.”

Feelings are running high in the industry about an ongoing squeeze on prices, however. The ABPI recently revealed it is seeking a judicial review of the new NICE and NHS England budget impact test, a new mechanism which could be used to delay and limit uptake of new medicines.

MEDIA SUMMARY 

UK, EU medicines trade groups lobby Barnier, Davis for medicines alignment
Politico Europe,  Helen Collis, 12 July 2017

Eight life sciences trade associations from the United Kingdom and the European Union have hammered home the importance of maintaining ongoing cooperation between EU and UK authorities on medicines rules. The trade group, which includes ABPI, called for “as much certainty as possible, as soon as possible”. They also called for a reasonable implementation period, so that any changes arising from Brexit could be properly discussed and adhered to. They also expressed concern on the workload to be placed on regulators in the event of a wide divergence in regulatory frameworks between the UK and the EU.

Letter to Michael Barnier and David Davis
ABPI et al., 12 July 2017

The letter reported by Politico also included support for the letter signed by Jeremy Hunt and Greg Clark that appeared in the Financial Times and encourage a close relationship between EU and UK regulators. The trade group, which includes ABPI and the European Foundation of Pharmaceutical Industries and Associations (EFPIA), insisted that cooperation would be “in the best interest of public health and patient safety”. Further, they warned that any unnecessary disruptions would lead to “potential supply disruptions for life changing medicines”. They firmly placed the ball in the negotiators court, saying that “we are confident that, with your support, an agreement can be reached”.

‘The EU medicines scanning law convinced me we need Brexit’
Chemist and Druggist, John D’Arcy, 12 July 2017

In an opinion piece, John D’Arcy roundly criticized the falsified medicines directive (FMD) for failing to take into account the pecularities of national pharmaceutical networks and the slow pace of implementation. He notes that a scanner provider has not been appointed yet, despite the fact that scanning of medicines will be a cornerstone of the FMD. Because of the confusion, he argued that pharmacy is “nowhere near an understanding of how it will be able to fufill its obligations under the directive”. All in all, he said, the implementation of the FMD thus far has been a “dogs breakfast”, and implementation will be largely “incompatible with community pharmacy practice”.

PARLIAMENTARY COVERAGE

There is no parliamentary coverage.

FULL COVERAGE 

UK, EU medicines trade groups lobby Barnier, Davis for medicines alignment
Politico Europe,  Helen Collis, 12 July 2017

LONDON — Eight life sciences trade associations from the U.K. and Europe Wednesday wrote to the chief Brexit negotiators for the EU and U.K. to hammer home the importance of ongoing cooperation on medicines rules after March 2019.

Such an agreement would be the “best way” of ensuring that patients on both sides of the Channel maintain access to safe medicines and avoiding any harm to public health, they wrote, according to a copy viewed by POLITICO.

In the letter to David Davis and Michel Barnier, the trade groups acknowledge the phased approach to negotiations — leaving technical details like medicines regulations until after the divorce agreement has been settled — but stress the importance of setting out a position early given the “significant time pressure.”

They call for “as much certainty as possible, as early as possible” around pharmaceutical regulations and highlight the recent support by Health Secretary Jeremy Hunt and Business Secretary Greg Clark for regulatory cooperation.

Medicines marketing authorizations across the U.K. and Europe should stay in place after Brexit, they urge. They also call for a reasonable implementation period so the sector has time to adjust to the new framework, not to mention the added workload for EU regulators once U.K. experts are no longer helping out.

The letter’s signers include heads of the Association of the British Pharmaceutical Industry, the European Federation of Pharmaceutical Industries and Associations, EuropaBio, Medicines for Europe and others.

Letter to Michael Barnier and David Davis
ABPI et al., 12 July 2017

Dear Mr Barnier and Dear Secretary of State, We are writing to you as the associations representing the European and British pharmaceutical and life science industry (AESGP, EFPIA, EuropaBio, Medicines for Europe, ABPI, BGMA, BIA and PAGB) to underline the importance of securing ongoing cooperation between the UK and EU on medicines as part of the negotiations to agree a new relationship between the UK and the EU.

Securing such an agreement is the best way of ensuring that patients across Europe and the UK are able to continue to access safe and effective medicines and to ensure that there is no adverse impact on public health.

We take note of the phased approach of the negotiations as agreed at your first meeting. However, we feel that it is important to set out our position at this early stage given the significant time pressure to ensure that the necessary arrangements are in place to secure patient access to medicines, and avoid any adverse impact on public health and patient safety in both the EU-27 and UK after the UK leaves the EU.

As you will be aware, our industry is highly integrated across Europe, and regulated under EU law through a sophisticated system of legal and regulatory arrangements between EU institutions, Member States and national competent authorities. It is important that there is as much certainty as possible, as early as possible, to enable the pharmaceutical and life science industry to transition smoothly into the new framework, ensuring there is no disruption to patient access to medicines.

The recent letter published by the UK Business Secretary, Greg Clark MP and the Health Secretary, Jeremy Hunt MP, signalled an opportunity to secure cooperation on the regulation of medicines as part of the negotiations. We would like to explore this possibility to maintain close regulatory ties between the EU and the UK and to begin these discussions immediately.

The maintenance of previously granted European marketing authorisations both in the UK and the EU, and the continued cooperation between national competent authorities as facilitated by the EMA and European Commission, will be important in achieving this. Similarly, any changes to the EU-UK trading relationship should not adversely affect the research, development, manufacture and supply of medicines across Europe, including for clinical trials.

Securing such a cooperation agreement would be in the best interest of public health and patient safety. The UK’s MHRA currently makes a significant contribution to the work of the  European regulatory network (EMA, HMA, CHMP, CMDh), and its withdrawal would mean a loss of capacity and expertise for the network for the review of medicines as well as the capacity across Europe for the surveillance and safety supervision of products. A capacity building exercise would be needed leading to duplication of assessment work at EU and national level. UK based Qualified Persons Responsible for Pharmacovigilance (QPPV) would need to be relocated, trained or replaced. This would have an overall impact on the running of the systems that ensure the safety and efficacy of medicines treating EU patients.

More importantly, in the case of an unorderly withdrawal there is a risk that all goods due to be moved between the UK and EU could be held either at border checks, in warehouses or manufacturing and/or subject to extensive retesting requirements. In fact, this would lead to a severe disruption of most companies’ supply chains, which would lead to potential supply disruptions of life-saving medicines.

Implementation period An implementation period that adequately reflects the time needed by pharmaceutical and biotech companies to transition to a new framework should be agreed on by negotiators. This will allow companies time to make the necessary arrangements to avoid any unintended consequences on the availability of the medicines that patient rely on, both in the UK and the EU-27. For example, pharmaceutical and biotech companies may need to submit applications for the transfer of marketing authorisation for specific products, move batch release for products or move personnel into the EU-27 from the UK, all of which would take a significant amount of time.

An implementation period will also be necessary for national competent authorities who need to ensure they are adequately resourced to deliver the procedures and maintenance activities associated with the new regulatory framework. We are confident that, with your support, an agreement can be reached which provides for an EU-UK partnership on the regulation and supply of medicines. Alongside an adequate implementation period, this will ensure that patients continue to have access medicines after 29 March 2019.

As stated above, our organisations are committed to a continued and open dialogue with you and your officials and are ready to contribute our expertise to the negotiations in order to ensure patients are able to continue to access the medicines they need, and avoid adverse impact on public health across Europe. We also continue to engage in constructive conversations with EU and UK regulators to ensure that there can be a successful transition to new arrangements as determined by the negotiations. A continuing role for the MHRA in the EMA’s committees and processes during this transition would be valuable for the continuity of the EMA’s operations.

We look forward to hearing from you and would very much welcome the opportunity to set up meetings with your services for in-depth discussions around our priority issues, given our sector’s technicality and complexity

MEDIA SUMMARY 

Group behind delivery safety review sets out next priorities
Chemist and Druggist, Grace Lewis, 5 July, 2017

The Community Pharmacy Patient Safety Group has released a joint report with the National Pharmacy Association (NPA) examining best practices in medicine delivery. The group aims to improve delivery and distribution, as well as improving the reporting of patient safety incidences. They examined in particular how to improve children’s safety. The report looked at improving lettering on prescriptions and figuring out ways that drug packaging could be improved to reduce dispensing errors and over-prescription.

ABPI respond to statement of UK Government’s medicines regulation plans
European Pharmaceutical Review, 4 July, 2014 

The European Pharmaceutical Review continued coverage of Jeremy Hunt’s and Greg Clark’s letter to the Financial Times regarding the pharmaceutical industry. In the response letter from the Association of the British Pharmaceutical Industry (ABPI) Mike Thompson, APBI CEO, stated that the letter was “a welcome recognition that the future of medicines regulation is a key priority”. The article also noted that the ABPI are at the heart of establishing a “consensus on key Brexit issues” such as trade and science research. The work encompasses over 200 experts, leading academic and public institutions as well as several regulatory agencies.

PARLIAMENTARY COVERAGE

There is no parliamentary coverage.

FULL COVERAGE 

Group behind delivery safety review sets out next priorities
Chemist and Druggist, Grace Lewis, 5 July, 2017

The Community Pharmacy Patient Safety Group has set out its next priorities, following the publication of its review of medicines delivery services.

The group (see more details below), which consists of representatives of all of the larger pharmacy chains, as well as the National Pharmacy Association (NPA), published a report on best practices for medicines delivery services last month.

As well as delivery services, the group’s other priorities include working with the NHS to improve the systems by which pharmacies can report patient safety incidences, as well as creating “top tips around dispensing children’s medicine”, according to Company Chemists’ Association senior policy adviser Kate Livesey, who provides secretariat support for the group.

“Children are one of the most vulnerable patient groups. So that is an area we’re focusing on, because different pharmacies do things in different ways,” Ms Livesey told C+D last Friday (June 30).

“There’s a really simple tip somebody mentioned the other week, which was…using a stamp that said ‘child’ in red ink. Every time a prescription came in for somebody who was under 14, they stamped it.”

“It draws the team’s attention to that script in a different way,” Ms Livesey said. “They think about the small person behind the prescription, rather than potentially just seeing a piece of paper.”

The group will also follow up on some of the issues featured in the NPA’s medication safety officer’s reports, Ms Livesey explained.

“Everyone just accepts [what] the most common errors in [pharmacies] are. But we don’t want to accept that.”

As well as “looking at lettering on prescriptions”, she added that the group will consider if there is “a different way dispensaries can be organised that would help reduce the likelihood of some of those errors?”.

“It’s recognising that packaging…will be a contributory factor, but there may be other things that come into it – especially human factors.”

ABPI respond to statement of UK Government’s medicines regulation plans
European Pharmaceutical Review, 4 July, 2014 

The ABPI has responded to a joint letter from Jeremy Hunt, Secretary of State for Health, and Greg Clark, Secretary of State for Business, published by the Financial Times, that outlined the UK Government’s plans for the regulation of medicines as the UK leaves the European Union (EU).

In the response from the Association of the British Pharmaceutical Industry, Mike Thompson, ABPI Chief Executive said:
“This letter is a welcome recognition that the future of medicines regulation is a key priority for the Government as we negotiate a new relationship with the EU. It also signals a readiness to take a pragmatic approach to Brexit negotiations that puts people’s health first. This is a great first step and we look forward to seeing more detail in the coming weeks and months.

ABPI aims to strengthen UK Life Sciences

The Association of the British Pharmaceutical Industry (ABPI) are at the heart of a health sector-wide effort, post-Referendum, that aims to establish consensus on key Brexit issues such as a regulation, trade, immigration and UK science. This has been to ensure that patients and public health are central to Brexit negotiations, and that UK Life Sciences is in as strong a position as possible as the UK establishes a new relationship with Europe.

UK life sciences sector productivity doubles national average

This work is ongoing, and continues to involve more than 200 global experts from leading pharmaceutical and biotech companies; leading academic groups and research charities (such as the Wellcome Trust); the UK’s Medicines and Healthcare products Regulatory Agency (MHRA); the NHS and Public Health England; as well as a vast range of UK Government departments.

Funding cuts equivalent to 12% ‘net’ loss over 6 months

C&D, Samuel Horti, 11 January 2016

The Government confirmed that the announced funding cuts would fall between October 2016 and March 2017, which amounts to a net funding fall by 12%. Accountant Umesh Modi explains that pharmacists will be overpaid in the first 6 months, before the capital is “clawed back”.

 

ABPI response to publication of the latest figures on the uptake and use of NICE approved medicines in the NHS in England

ABPI, Press Office, 12 January 2016

Alison Clough, ABPI’s acting CEO, responds to the publication of the NICE Technology Appraisals in the NHS in England – Innovation Scorecard. The ABPI calls out the variations in access to modern medicines highlighted by the Scorecard. It will investigate the causes of this variation and cooperate with the appropriate bodies to overcome these barriers.

 

January NCSO/Price Concessions

PSNC, 12 January 2016

The Department of Health granted the following price concessions for January 2016:

The price concession only applies to the month that it is granted.

No additional endorsements are required for price concessions.

Drug Pack size Price concession
Celiprolol 200mg tablets 28 £19.83
Celiprolol 400mg tablets 28 £39.65
Cimetidine 400mg tablets 60 £10.30
Clindamycin 150mg capsules 24 £11.80
Ferrous Sulfate 200mg tablets 28 £2.85
Flecanide 50mg tablets 60 £5.05
Flecanide 1000mg tablets 60 £5.29
Lamotrigine 5mg dispersible tablets sugar free 28 £8.50
Lercanidipine 10mg tablets 28 £5.70
Mefenamic acid 500mg tablets 28 £10.80
Nefopam 30mg tablets 90 £35.00
Pioglitazone 15mg tablets 28 £25.83
Pioglitazone 45mg tablets 28 £39.55
Procyclidine 5mg tablets 28 £14.00
Trazodone 50mg/5ml oral solution sugar free 120ml £140.00
Trazodone 100mg capsules 56 £28.14

 

If you have problems obtaining a Part VIII product or problems obtaining the product at the set Drug Tariff price, please report the issue to PSNC using the online feedback form on the PSNC Website. If you have been able to source the product, please provide full details of the supplier and price paid.

PSNC will investigate the extent of the problem and if appropriate discuss the issue with the Department of Health. Please note that PSNC cannot provide details of generic products that are suspected of being affected by generic supply problems unless and until the Department of Health grants a concession. PSNC is in discussion with the Department of Health on a number of generic medicines in short supply.

 

Parliamentary Coverage

 

There is no Parliamentary coverage today.

 

Full Coverage

ABPI response to publication of the latest figures on the uptake and use of NICE approved medicines in the NHS in England

ABPI, Press Office, 12 January 2016

The figures, published today [Tuesday, 12 January] are from latest publication of the NICE Technology Appraisals in the NHS in England – Innovation Scorecard. Published by the Health and Social Care Information Centre (HSCIC), the Scorecard pulls together existing local data from across the NHS to show the regional provision of NICE-approved medicines and technologies.

Click here to view the Scorecard data.​

ABPI’s acting CEO, Alison Clough, said:

“We are not surprised to see that today’s figures show that access to modern medicines to treat and prevent a wide range of diseases, including cancer and diabetes, is still subject to wide variation across England. In some cases we are seeing variation of 30 fold in access to GP or hospital prescribed medicines – for example for newer stroke prevention medicines – all of which are approved by NICE as being clinically and cost effective and should therefore be widely and routinely available.

Without further detail and analysis of the figures it is difficult to know why we are seeing such wide variation in patient access to newer medicines. The ability to access potentially life-saving or life-enhancing medication shouldn’t be dependent solely on cost or geography and it would be disappointing if this was the case in some areas. The ABPI will be carrying out an immediate investigation into today’s figures and we will be working with the appropriate bodies – NHS, patient groups and charities – to try and address issues of inequality of access for those patients who, for whatever reason, are missing out on the most appropriate medicines for their care.

The ABPI is completely supportive of the Scorecard to measure the uptake of new medicines and drive innovation. For the scheme to be a success we – and all of the organisations involved – must begin to address the reasons for the persistently low levels of medicines access that we believe the Scorecard is highlighting and take action.

In order to achieve this the Scorecard needs to be more widely understood so that it can be used at local planning level by the NHS. For this to happen it is vital that the scorecard be launched in a more user friendly and easy to understand format.”

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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