Media And Political Bulletin – 08 July 2019

Media and Political Bulletin

08 July 2019

Media Summary

How the implementation of Safety Features progresses 5 months in

MHRA, Tracy Moore, 5 July 2019

Tracy Moore, Senior GMDP Inspector and GMFP Operations Manager at the MHRA, has published a blog post which suggests that the performance of FMS safety feature systems is very mixed.

Moore argues that, based on inspections in the first five months since the safety features requirement came into force in February, the MHRA has seen “some excellent examples of robust systems” but also “some systems that required improvement and examples of systems that failed to identify falsified stock.”

The MHRA have also recently published specific guidance from Italian and Greek regulatory agencies on how to check incoming stock from these countries is compliant – read more here.

UK plans £3m no-deal medicine transport

BBC News, Howard Mustoe, 7 July 2019

BBC News reports that, as part of plans to spend £3m on no-deal Brexit measures to transport medication, the Department of Health and Social Care wants to hire an “express freight service” to transport medicines, blood and transplant tissue.

But the report states that experts have warned that the deadline of 1 September set for the deal is a “tight” timeframe.

The government’s current plan is to leave the EU on 31 October, with or without a trade deal.

It has smartened up its act on procurement after running up a bill of £80m trying to arrange ferry contracts in the event of a no-deal exit.

Seaborne Freight had been awarded a £13.8m deal last year, which the BBC found had never run a ferry service.

Gus Tugendhat, founder of Tussell, a data provider on UK government contracts, which uncovered the latest move said timelines were “still tight”.

Parliamentary Coverage

There was no parliamentary coverage today.

Full Coverage

How the implementation of Safety Features progresses 5 months in

MHRA, Tracy Moore, 5 July 2019

I will be issuing a series of blog posts regarding the implementation of FMD: Safety Features and how it is progressing over the next few months. This is the first and looks at robustness of incoming checks.

The safety features element of the Falsified Medicines Directive (FMD) [EU Directive 2011/62/EU transposed into the Human Medicines Regulations (as amended) and Delegated Regulation 2016/161] came into force across the EU on 9 February 2019.

Since implementation, MHRA has been inspecting for the required new elements and we have seen some excellent examples of robust systems that have been brought in line with the FMD safety features requirements.  We have also seen some systems that required improvement and examples of systems that failed to identify falsified stock as part of the pharmaceutical quality system requirements.

The definition of a falsified medicine is as follows:

[The Human Medicines Regulations (as amended by SI 2013;1855 Regulation 8 (a)(vi))]

“Falsified medicinal product” means any medicinal product with a false representation of:

(a) its identity, including its packaging and labelling, its name or its composition (other than any unintentional quality defect) as regards any of its ingredients including excipients and the strength of those ingredients;

(b) its source, including its manufacturer, its country of manufacturing, its country of origin or its marketing authorisation holder; or

(c) its history, including the records and documents relating to the distribution channels used.

Checking your systems comply

As part of the new measures your systems should be able to identify decommissioned, stolen or recalled stock.   This should include not just using the new FMD 2D barcode unique identifier (UI) scanning systems but also identifying stock from the two countries (Greece and Italy) that are yet to implement the 2D barcode UI system.

Where the 2D barcode UI is not yet in use, the MHRA are clear that it is still your responsibility to identify falsified, stolen or recalled stock received into your systems, including those that have already been decommissioned. Inspectors will be looking for this step as part of your incoming goods checks.

We have published specific guidance from Italian and Greek regulatory agencies on how to check incoming stock from these countries is compliant on our GOV.UK guidance page.   Please visit this page to find out more about Safety Features.

UK plans £3m no-deal medicine transport

BBC News, Howard Mustoe, 7 July 2019

The Department of Health and Social Care plans to spend £3m on no-deal Brexit measures to transport medication.

It wants to hire an “express freight service” to transport medicines, blood and transplant tissue.

But experts have warned that the deadline of 1 September set for the deal is a “tight” timeframe.

The government’s current plan is to leave the EU on 31 October, with or without a trade deal.

It has smartened up its act on procurement after running up a bill of £80m trying to arrange ferry contracts in the event of a no-deal exit.

Seaborne Freight had been awarded a £13.8m deal last year, which the BBC found had never run a ferry service.

Gus Tugendhat, founder of Tussell, a data provider on UK government contracts, which uncovered the latest move said timelines were “still tight”.

Andrew Dean, director of public law at Clifford Chance, a former government adviser and procurement law expert said there was sufficient time to run a compliant and robust procurement process, but it would be tricky, given the relatively short timeframe.

Last weekend, it emerged that the Department for Transport was asking logistics companies to bid to provide extra freight capacity to be used in the event of a no-deal Brexit.

‘Within the guidelines’

The plan is to set up “an express freight contingency arrangement to support continuity of supply of medicines and medical products,” Cabinet Office Minister David Lidington told Parliament.

“This will be an urgent contingency measure for products requiring urgent delivery, within a 24-48 hour timeframe, if the UK leaves the EU without a deal.”

Together with stockpiling and helping companies with paperwork at the border, the department hopes this will allow patients to receive the medicines they need, especially rarer ones with short shelf-lives, which may require specialist transport conditions such as refrigeration.

“Government will only pay for capacity as and when it is needed and used,” Mr Lidington insisted.

It is understood that while larger pharmaceutical companies would have their own plans, smaller ones were likely to need help.

A Department of Health and Social Care spokeswoman confirmed that the contract was new, but said that the speed of the contract was “within the usual guidelines”.

Media and Political Bulletin

29 April 2019

Media Summary

Non-FMD vaccine stock in circulation until 2020, PHE admits

Dispensing Doctors’ Association, Ailsa Colquhoun, 29 April 2019

Dispensing Doctors’ Association reports that according to Public Health England’s latest vaccine update, practices may see non-FMD compliant centrally-supplied vaccines until 2020, although the first packs may be in use by the end of June.

Practices are advised to consult the ImmForm for updates, and for guidance on the FMD and centrally supplied vaccines.

 

 

Parliamentary Coverage

House of Lords Questions – 26 April 2019

Lord Taylor of Warwick: To ask Her Majesty’s Government what assessment they have made of the report from the Pharmaceutical Services Negotiating Committee about the impact of Brexit on a shortage of medicine supplies at UK pharmacies.

Baroness Blackwood of North Oxford: There is no evidence to suggest the small number of current supply issues we are managing are related to European Union exit, or increasing because of it. We have well established processes to manage and mitigate supply issues from whatever cause, including manufacturing or distribution problems.

Leaving the EU with a deal remains the Government’s priority. Under the terms of the Withdrawal Agreement, there will be an implementation period running until the end of 2020, during which there will be no changes to the current trading arrangements with the EU. Therefore, if the Withdrawal Agreement is ratified, the supply of medicines will continue on the same basis it does now during this period.

Leaving without a deal remains the legal default at the end of the extension period if no withdrawal agreement is agreed. We are considering the impact of the EU exit date being extended until 31 October 2019 on our EU exit preparations and are working closely with our stakeholders to review our position.

We are confident that if everyone does what they need to do, the supply of medicines should be uninterrupted in the event that the United Kingdom exits the EU without a deal.

 

Full Coverage

Non-FMD vaccine stock in circulation until 2020, PHE admits

Dispensing Doctors’ Association, Ailsa Colquhoun, 29 April 2019

Practices may see non-FMD compliant centrally-supplied vaccines until 2020, although the first packs may be in use by the end of June, Public Health England has said in the latest vaccine update.

Practices are advised to consult the ImmForm for updates, and for guidance on the FMD and centrally supplied vaccines.

Other items in the vaccine update include:

  • update on vaccine coverage data
  • updates to the Green book chapter 11: the UK immunisation schedule
  • update on MMR vaccine ordering restriction
  • reminder about ordering centrally supplied vaccines

Media and Political Bulletin

22 February 2019

Media Summary

10,000 pharmacies expected to be FMD compliant by end of month

Chemist+Druggist, Thomas Cox, 22 February 2019

Chemist+Druggist reports that according to Martin Sawer, all major wholesalers are already compliant with the Falsified Medicines Directive, and around 10,000 pharmacies will be by the end of February, with another 1,400 pharmacies in the process of registering.

The data shows that all wholesalers and approximately half of hospital pharmacies have registered with SecurMed, Mr Sawer explained. GP surgeries were delayed in registering, as they were agreeing a way of including the FMD model in their NHS systems, he added. But Mr Sawer expects “they’ll be ramped up pretty quick”, while registrations of dispensing doctors are “climbing”, he said.

Brexit could disrupt medicine supplies for six months – minister

Pharmaphorum, Richard Staines, 21 February 2019

A government minister has warned that a no-deal Brexit could disrupt medicines supplies to the UK for at least six months because of delays as they are shipped across the channel, instead of the previously estimated six weeks.

This stemmed from a letter from MP Stephen Hammond, sent this month, written in response to questions from the House of Lords EU Home Affairs Sub-Committee about access to medical supplies if no deal is reached by 29th March. Delays could affect “critical” prescription-only and pharmacy drugs, and UK manufacturers, Hammond warned in the letter.

 

Parliamentary Coverage

House of Commons Questions – 21 February 2019

Julie Elliott (Sunderland Central):

  • To ask the Secretary of State for Health and Social Care, what definition will be used by the Government to determine a serious shortage of a medicine that will be used to trigger a Serious Shortage Protocol for a medicine under the Human Medicines (Amendment) Regulations 2019.
  • To ask the Secretary of State for Health and Social Care, what data source will be used to monitor stocks and availability of medicines in order to determine the need for a Serious Shortage Protocol under the Human Medicines (Amendment) Regulations 2019.
  • To ask the Secretary of State for Health and Social Care, with reference to the Human Medicines (Amendment) Regulations 2019, what process will be followed to consult with relevant health care professionals in the development of advice contained in a Serious Shortage Protocol.
  • To ask the Secretary of State for Health and Social Care, with reference to the Human Medicines (Amendment) Regulations 2019, what methods the Government plans to use to whether a Serious Shortage Protocol is necessary; what information such a decision would be based on; what level of consultation with medical experts the Government plans to seek on such protocols; and how the Government plans to engage in such consultation.

Steve Brine: The Department has well established processes to manage and mitigate the small number of medicine supply problems that may arise at any one time due to manufacturing or distribution issues and this has always been the case. The Department receives regular reports from the pharmaceutical industry about issues which may potentially interrupt the supply of medicines that may affect United Kingdom patients.

From January this year, it became a mandatory requirement that pharmaceutical companies must report this information to us in a timely manner.

A Serious Shortage Protocol (SSP) is an additional tool to manage and mitigate medicine shortages. It would only be used in the exceptional and rare situation when other measures have been exhausted or are likely to be ineffective.

In the case of a serious shortage, a SSP would only be issued by Ministers if clinicians advised that it was appropriate and after discussion with the manufacturer and/or marketing authorisation holder.

 

Full Coverage

10,000 pharmacies expected to be FMD compliant by end of month

Chemist+Druggist, Thomas Cox, 22 February 2019

All major wholesalers are already compliant with the Falsified Medicines Directive, and around 10,000 pharmacies will be by the end of February, according to the wholesaler body.

The EU’s anti-counterfeit legislation, the Falsified Medicines Directive (FMD) – which came into force on February 9 – requires all pharmacies to be able to scan barcodes on medicines packaging at the point of dispensing.

To meet the directive, pharmacies have to register with SecurMed, the non-profit organisation managing the UK’s medicine verification systems.

The number of community pharmacies registered climbed less than 6,300 on February 12 to 8,600 by Tuesday (February 19), according to the SecurMed website.

Martin Sawer, Executive Director of wholesaler body the Healthcare Distribution Association (HDA), claimed there are another 1,400 pharmacies in the process of registering. He predicts “about 10,000 locations in community pharmacy will probably be registered by the end of the month”.

SecurMed approval means the organisation has successfully tested a pharmacy’s link to the UK hub, Mr Sawer told C+D after his presentation at the Sigma conference in Muscat, Oman, on Monday (February 18).

The data shows that all wholesalers and approximately half of hospital pharmacies have registered with SecurMed, Mr Sawer explained.

GP surgeries were delayed in registering, as they were agreeing a way of including the FMD model in their NHS systems, he added.

But Mr Sawer expects “they’ll be ramped up pretty quick”, while registrations of dispensing doctors are “climbing”, he said.

“Community pharmacy is doing a good job,” he added.

Brexit could disrupt medicine supplies for six months – minister

Pharmaphorum, Richard Staines, 21 February 2019

A no-deal Brexit could disrupt medicines supplies to the UK for at least six months because of delays as they are shipped across the channel, instead of the previously estimated six weeks, a government minister has warned.

The website Hospital Pharmacy Europe reported that manufacturers may have to rethink logistics arrangements to avoid the delays when medicines are shipped via crossings at Dover and Folkestone.

It cited a letter from MP Stephen Hammond, sent this month, written in response to questions from the House of Lords EU Home Affairs Sub-Committee about access to medical supplies if no deal is reached by 29th March.

Delays could affect “critical” prescription-only and pharmacy drugs, and UK manufacturers, Hammond warned in the letter.

Flying medicines in by air freight is one option under consideration to avoid delays maintain the supply, but Hammond gave no further information about which medicines would be prioritised.

In the letter he said the Department of Health and Social Care is exploring this option, but said arrangements with air freight companies are commercially confidential.

The warning emerged as the UK government rushes emergency legislation through Parliament to ensure medicines regulation continues in the increasingly likely event of a no-deal Brexit.

The UK’s Medicines and Healthcare Products Regulatory Agency has already drawn up plans for a new system if the UK does not agree a way for it to work with European regulator after Brexit.

It’s hoped that a deal would allow for a transition period lasting until at least the end of next year that would give the UK time to agree details of new regulatory arrangements with European colleagues.

UK pharma is also concerned that the UK could drop out of a Europe-wide initiative to crack down on fake medicines as a result of Brexit.

Arrangements under the falsified medicines directive (FMD) came into effect this month allowing medicines to be traced along the supply chain using a special barcode.

But it is not clear whether the system will be in place in April as Brexit would require the UK to leave the system.

Dr Rick Greville, director of supply chain at the Association of the British Pharmaceutical Industry (ABPI), said: “Billions of packs of medicines travel around the EU annually, destined for over 500 million patients. This new system means that patients across Europe will have the best protection from fake medicines in the world.

“It would be an absolute travesty if NHS patients aren’t part of a system specifically designed to protect them. But that’s exactly what could happen in a ‘no deal’ Brexit. It is just another reason why we urgently need a Brexit deal.”

Media and Political Bulletin

21 February 2019

Media Summary

Brexit – Wollaston Resigns Party

Politico, Helen Collis, 21 February 2019

Politico reports that Sarah Wollaston, Chair of the Commons Health Committee, on Wednesday was among three Conservative party MPs who quit the party to join seven former Labour party MPs under an independent banner (not yet a formal party), primarily over the government’s handling of Brexit.

Wollaston won’t be going anywhere in the Health Committee however. Under parliamentary rules, party affiliation (or lack thereof) of the Chair is not relevant once elected.

Government sets up dedicated no-deal Brexit shipping route for medical products with ‘short lead times’

The Pharmaceutical Journal, Carolyn Wickware, 20 February 2019

The Pharmaceutical Journal reports that the Department of Health and Social Care (DHSC) has established a “dedicated shipment channel” for suppliers of medical products that need to be urgently imported to the UK from the EU after Brexit.

The plans are laid out in a letter to suppliers, which was sent on 18 February 2019 by Steve Oldfield, Chief Commercial Officer at the DHSC, as part of the government’s no-deal Brexit contingency planning.

Majority of community pharmacies failed to meet FMD deadline, figures confirm

The Pharmaceutical Journal, 20 February 2019

The Pharmaceutical Journal reports that SecurMed has confirmed that more than half of the community pharmacies in the UK did not meet the Falsified Medicines Directive (FMD) deadline for implementation.

The SecurMed figures also show that a third of wholesalers holding a wholesale dealer’s licence (731 out of 2,150 [34%]) had signed up to FMD by 12 February 2019, while 12.5% of dispensing doctors (149 out of 1,200) also met the deadline. They also show that 285 hospital pharmacies were FMD compliant on 12 February 2019. This constitutes 63% of 450 hospital pharmacies in the UK, covering both the NHS and private sector.

 

Parliamentary Coverage

Commons Tabled Written Question – 20 February 2019

Asked by Emma Dent Coad (Kensington): To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 8 February 2019 to Question 215257, on NHS: drugs, what information his Department holds on the level of medicine shortages in the last 12 months.

 

Full Coverage

Brexit – Wollaston Resigns Party

Politico, Helen Collis, 21 February 2019

Wollaston on Wednesday was among three Conservative party MPs who quit the party to join seven former Labour party MPs under an independent banner (not yet a formal party), primarily over the government’s handling of Brexit. Wollaston, Chair of the Commons Health Committee, posted the Tory MPs’ joint letter announcing her resignation “with regret.”

Staying put: Wollaston won’t be going anywhere in the Health Committee however. Under parliamentary rules, party affiliation (or lack thereof) of the Chair is not relevant once elected. So we expect to see her at the helm Tuesday to quiz experts on the nation’s sexual health. She’s involved in 10 enquiries at present including investigating the NHS long-term plan and the pricing impasse for Vertex’s cystic fibrosis drug Orkambi.

Government sets up dedicated no-deal Brexit shipping route for medical products with ‘short lead times’

The Pharmaceutical Journal, Carolyn Wickware, 20 February 2019

A “dedicated shipment channel” will enable suppliers with short lead times to import medical products to the UK from the EU after Brexit, according to government contingency plans.

The Department of Health and Social Care (DHSC) has established a “dedicated shipment channel” for suppliers of medical products that need to be urgently imported to the UK from the EU after Brexit.

The plans are laid out in a letter to suppliers, which was sent on 18 February 2019 by Steve Oldfield, Chief Commercial Officer at the DHSC, as part of the government’s no-deal Brexit contingency planning.

As part of the government’s contingency plans, companies have already been asked to create a six-week stockpile of medicines in preparation for a no-deal scenario.

But the DHSC said in the letter that it recognises “that not all suppliers of medical devices and clinical consumables have the capability to hold stock of their full product range in the UK, often due to the need to supply goods on a ‘just in time’ basis as part of a clinical procedure, and they routinely supply product directly from distribution centres in the EU to care providers or patients”.

The DHSC said in the letter that the route will be open to suppliers with “short lead times” of between 24 hours and 72 hours and has encouraged companies to register to use the route “as an important element of their preparedness arrangements”.

To coordinate the shipment channel’s use, the department has set up a “logistics hub in Belgium”, which is expected to “move products from mainland Europe into the UK and through to care providers and patients, typically within three days” of their arrival into the hub.

Plans for the dedicated shipment route come as health secretary Matt Hancock told Parliament on 19 February 2019 that the DHSC has spent £11m on contingency planning for a no-deal Brexit, adding that he expects “it will remain at about that level, or a little higher”.

Stephen Hammond, minister of state for health and social care, had previously said that storage facilities to hold the required six-week stockpile of medicines was “expected to cost the government in the low tens of millions of pounds with the refrigerated storage expected to cost circa £1m”.

Majority of community pharmacies failed to meet FMD deadline, figures confirm

The Pharmaceutical Journal, 20 February 2019

More than half of the community pharmacies in the UK did not meet the Falsified Medicines Directive (FMD) deadline for implementation, the body running the system in the UK has confirmed.

Figures published by SecurMed, the organisation that operates the UK National Medicines Verification System, which holds data from FMD-compliant medicine packs in the UK, show that 6,288 community pharmacies were compliant with FMD requirements on 12 February 2019, three days after the 9 February 2019 deadline. SecurMed estimates that there are 15,000 community pharmacies in the UK, meaning that approximately 42% are signed up to FMD.

The SecurMed figures also show that 285 hospital pharmacies were FMD compliant on 12 February 2019. This constitutes 63% of 450 hospital pharmacies in the UK, covering both the NHS and private sector.

A third of wholesalers holding a wholesale dealer’s licence (731 out of 2,150 [34%]) had signed up to FMD by 12 February 2019, while 12.5% of dispensing doctors (149 out of 1,200) also met the deadline.

Earlier in February 2019, SecurMed told The Pharmaceutical Journal that it expected less than half of pharmacies in the UK to meet the FMD deadline.

Media and Political Bulletin

23 November 2018

Media Summary

GIRP Wholesale Brief

GIRP, Horst Matzer, 22 November 2018

The November edition of the GIRP’s monthly UK wholesale brief comes from KNAPP’s Director of Healthcare Services and highlights the fact that in less than three months, the Falsified Medicines Directive will go live.

The article also states that ‘it is not only new regulations which we at KNAPP see coming up on the horizon, it is also additional services which have been introduced to the Pharmaceutical Supply Chain. KNAPP’s “Pack to Patient” systems consist of automated systems facilitating the consolidation of all items ordered by a patient as well as labeling of these items with patient specific data, where the legislation allows for this service. We are very pleased to see our “Pack to Patient” systems successfully entering the supply chain and thus allowing our customers to provide additional services to pharmacy as well as to the patients.’

EU, UK ‘agree’ draft on post-Brexit ties

RFI, Toby Melville, 22 November 2018

The RFI reports that the EU and British negotiators have agreed in principle on a draft declaration for post-Brexit relations.

The article includes a section on drugs shortages, stating that ‘UK industries are on tenterhooks’ as the March 29 deadline draws closer. And that in August the UK government recommnended that pharmaceutical companies stockpile six months worth of medication to avert shortage post-Brexit.

The article includes a quotation from Martin Sawer, Executive Director of the HDA, who said that ‘the risk of a shortage of medical supplies to hospitals remains real and has yet to be addressed by the government.’

Lords ask Minister for clarity on access to medicine after Brexit

Pharma Times, Anna Smith, 23 November 2018

The Pharma Times reports on the fact that the House of Lords EU Home Affairs Sub-Committee has written to Matt Hancock asking for clarity on the government’s contingency preparations to ensure the UK has continued access to medicines and medical products in the event of a ‘no-deal’ Brexit.

The article states that there is still concern that a ‘no-deal’ Brexit may limit the availability of medicines in the UK and that there was little sign to date of potential delays on the border being addressed.

Read the letter here, which contains a quotation from Martin Sawer, Executive Director of the HDA, who said in an oral evidence session to the House of Commons last December that ‘given that the Healthcare Distribution Association estimates that 45% of all medicines in the UK are imported from the EU, disruption to this supply chain could be felt acutely in the UK.’

Faster access to groundbreaking medicines as major milestones reached in deal with pharmaceutical industry

ABPI, Press Release, 23 November 2018

The ABPI has released a press release which states that patients could have access to new, ground breaking medicines up to six months earlier and that the NHS across the UK is expected to save around £930 million on its medicine bill under a new scheme being finalised with the pharmaceutical industry.

The Government and the ABPI have reached a deal on the Heads of Agreement for a new voluntary scheme for Branded Medicines Pricing and Access, which is expected to come into effect from January 2019.

The press release states that the final details are still being finalised, but a major milestone has been reached in the discussions which would see the most transformative and best value medicines made available on the NHS more quickly through better horizon scanning, earlier commercial dialogue, and faster appraisals from The National Institute for Health and Care Excellence.

See this also reported in the Financial Times, which reports that the first details have emerged overnight of the UK government’s proposed new agreement with the pharmaceutical industry on how it will pay for branded medicines from next year.

CMA closes investigation into alleged anticompetitive generic drug pricing practices

The Pharmaceutical Journal, Carolyn Wickware, 23 November 2018

The Pharmaceutical Journal reports that, owing to a lack of sufficient evidence of lawbreaking, the Competition and Markets Authority has decided to close its investigation into anticompetitive generic drug pricing.

The investigation was launched on 13 October 2017 at the height of the crisis in the generics market that hit community pharmacy. When it launched, the CMA said in a statement that the investigation related ‘to alleged anticompetitive agreements and/or concerted practices in relation to generic pharmaceutical products’.

However, the investigation was closed on 14 November 2018 because the body concluded that continuing with the case ‘would not be the best use of the CMA’s resources’.

Brexit – no-deal contingency planning

Politico, 23 November 2018

Politico reports that ‘as Hancock scrambles to explain whether the government’s preparations to mitigate risks to drug supplies is up to scratch, the ABPI has provided some details on their estimates of the potential impacts of a no-deal Brexit — as well as some new examples of its member’s contingency planning.

The details include some numbers, for example, the fact that 45 million packs of drugs move from the UK to the EU every month, with 37 million moving the other way.

Parliamentary Coverage

House of Commons, Tabled and Written Questions, 22 November 2018

Laura Smith, MP: To ask the Secretary of State for Health and Social Care, if he will make an assessment of the effect of the UK leaving the EU on the availability of Keppra for people with epilepsy.

Answered by Steve Brine: The United Kingdom’s position on medicines regulation remains clear. We want to retain a close working partnership with the European Union to ensure that medicines remain available to UK patients in a safe and timely manner. We have been clear that this involves us making sure our regulators continue to work together, as they do with regulators internationally. As the Prime Minister has said, we intend to to explore with the EU the terms on which the UK could remain part the European Medicines Agency.

Until we can be certain of the outcome of Brexit negotiations our duty as a responsible Government is to prepare for all eventualities, including ‘no deal’. On 23 August 2018, therefore, the Department wrote to all pharmaceutical companies that supply the United Kingdom with prescription only or pharmacy medicines from, or via, the European Union/European Economic Area, 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 scenario.

Since then, we have received very good engagement from industry who share our aims of ensuring continuity of medicines supply for patients is maintained and able to cope with any potential delays at the border that may arise in the short term in the event of a no-deal Brexit.

We understand that the medicine Keppra is important to many people in this country. However, the Department recognises that through its medicines supply contingency programme it is requesting sensitive commercial information from pharmaceutical companies. To reassure participating companies, we have committed to treating all information received confidentially, securely and to using it only for the purposes of the Department’s programme. That means not introducing information about a company, specific medicine or their supply routes into the public domain.

Dr Rosena Allin-Khan, MP: To ask the Secretary of State for Health and Social Care, what steps he is taking to ensure the supply of statins after the UK leaves the EU.

Answered by Steve Brine: Until we can be certain of the outcome of Brexit negotiations our duty as a responsible government is to prepare for all eventualities, including ‘no deal’. On 23 August 2018, therefore, the Department wrote to all pharmaceutical companies that supply the United Kingdom with prescription only or pharmacy medicines from, or via, the European Union/European Economic Area, 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 scenario.

Since then, we have received very good engagement from industry who share our aims of ensuring continuity of medicines supply for patients is maintained and able to cope with any potential delays at the border that may arise in the short term in the event of a no-deal Brexit.

We understand that statins are vitally important to many people in this country. However, the Department recognises that through its medicines supply contingency programme it is requesting sensitive commercial information from pharmaceutical companies. To reassure participating companies, we have committed to treating all information received confidentially, securely and to using it only for the purposes of the Department’s programme. That means not introducing information about a company, specific medicine or their supply routes into the public domain.

Bill Esterson, MP: To ask the Secretary of State for Health and Social Care, with reference to the European Medicines Verification Organisation’s report, NMVO’s Fee Models Status, published on 21 August 2018, what discussions his Department has had with the UK’s National Medicines Verification Organisation on reducing the entrance fees for small companies in line with those of other European countries.

Answered by Jackie Doyle-Price: SecurMed, the not-for-profit company set up by stakeholders in the United Kingdom medicines supply chain, is responsible for setting the fee model and level of fees as the UK’s National Medicines Verification Organisation (NMVO). In their supervisory capacity, the Medicines and Healthcare products Regulatory Agency (MHRA) and the Department’s aim is to ensure that SecurMed is complying with the regulation in a fair and proportionate way. As part of that role, the MHRA and the Department have been involved in discussions with SecurMed to challenge and seek to influence the pricing model to ensure that the UK’s fee structure is fair and proportionate.

The European Commission has confirmed that the fee model being used by SecurMed is in line with the majority of other member states NMVO’s across the European Union. It is based on the number of users and cost per connection where larger organisations, which are more likely to have multiple marketing authorisations, pay more. An annual fee waiver scheme exists for micro Marketing Authorisation Holders which is designed to support start-ups and help ensure there is not a barrier to market entry.

Full Coverage

GIRP Wholesale Brief

GIRP, Horst Matzer, 22 November 2018

In less than 3 months, an incredible piece of work carried out by GIRP will go live – the Falsified Medicine Directive as well as the GDP requirements will come into force and will be enacted by February 2019. Countless hours of support provided by GIRP to its members over the last months and years will assure a smooth start of this regulatory framework in the Pharmaceutical Supply Chain.

But it is not only new regulations which we at KNAPP see coming up on the horizon, it is also additional services which have been introduced to the Pharmaceutical Supply Chain. KNAPP’s “Pack to Patient” systems consist of automated systems facilitating the consolidation of all items ordered by a patient as well as labeling of these items with patient specific data, where the legislation allows for this service. We are very pleased to see our “Pack to Patient” systems successfully entering the supply chain and thus allowing our customers to provide additional services to pharmacy as well as to the patients.

For GIRP members and KNAPP customers, offering a variety of services is not only relevant but it is also essential to be able to provide services efficiently as well as consistently: in a nutshell, to maintain an extremely high service level while also monitoring the costs thereof. KNAPP’s Smart Services, a suite of key performance indicators constantly online and available at your fingertips, supports the monitoring of order processing as well as the monitoring of the warehouse logistics. Live data, benchmarks and trends easily displayed allow for a so far unparalleled operation in all aspects.

With your input, dear GIRP members, KNAPP was able to develop and provide systems featuring new services while also developing the tools – Smart Services – to master the increasing complexity of the operational aspect of the business.

Undoubtedly, the combination of well-established business partners, you, dear GIRP members and KNAPP on the other hand as well as a highly active and professional association, namely GIRP, assures success – on behalf of KNAPP, thank you all for your cooperation.

EU, UK ‘agree’ draft on post-Brexit ties

RFI, Toby Melville, 22 November 2018

European Union and British negotiators have agreed in principle on a draft declaration for post-Brexit relations, that is now to be sent to EU leaders for endorsement, according to European Council President Donald Tusk.

The two sides have also agreed a draft deal extending the transition period by one or two years beyond the end of 2020, a final sticking point of the divorce deal.

European Council President Donald Tusk said the EU executive, the European Commission, informed him it has agreed the political declaration on the future ties with Britain.

“I have just sent to EU27 a draft Political Declaration on the Future Relationship between EU and UK,” said Tusk, who represents the 27 remaining EU member countries.

The Commission President (Jean-Claude Juncker) has informed me that it has been agreed at negotiators’ level and agreed in principle at political level,” Tusk tweeted.

He said EU leaders still have to endorse the draft declaration, which is due to accompany a draft of agreed terms for Britain’s withdrawal from the bloc on March 29.

Austria’s key role

Shortly before a meeting with her Austrian counterpart – Sebastian Kurz – Theresa May described the latest development as, “the right deal for the UK that delivers on the referendum vote.”

Austria currently heads the EU presidency and so Kurz is set to play a key role when EU leaders meet at a summit in Brussels on Sunday to endorse both documents.

Speaking alongside May, Kurz expressed his country’s desire to maintain the unity of the EU, but warned that Spain needed reassurances about the status of the British island of Gibraltar.

Transition period extended

The other areas cover law enforcement, criminal justice, foreign policy, security and defence and wider areas of cooperation, according to the draft.

In an update of the withdrawal agreement, both sides have agreed to extend the post-Brexit transition period from December 31, 2020 “for up to one or two years.”

The transition period is designed to allow governments and businesses to adjust to a new relationship after more than four decades of close ties.

Following the announcement of the draft declaration, the British parliament said Prime Minister Theresa May will make an “emergency statement” to MPs on Thursday.

Downing Street said the prime minister was holding a teleconference with cabinet ministers about the deal.

Shortages feared

UK industries are on tenterhooks as the March 29 deadline draws closer. An extended transition period is likely to calm the nerves of the food and pharmaceutical industries.

In August the UK government recommnended that pharmaceutical companies stockpile six months worth of medication to avert shortage post-Brexit.

“The risk of a shortage of medical supplies to hospitals remains real and has yet to be addressed by the government,” Martin Sawer, Director of Healthcare Distribution Association, told RFI.

Food distribution companies are also making provisions to avert post-Brexit shortages by doubling the time food is stored before being distributed.

“Some companies are now storing food for twelve days instead of five, but they cannot store food for three months,” Tim Long, Vice President for Sales and Distribution at Tiger Soybeans, told RFI.

Lords ask Minister for clarity on access to medicine after Brexit

Pharma Times, Anna Smith, 23 November 2018

The House of Lords EU Home Affairs Sub-Committee has written to Matt Hancock MP, Secretary of State for Health and Social Care (DHSC), asking for clarity on the government’s contingency preparations to ensure the UK has continued access to medicines and medical products in the event of a ‘no deal’ Brexit.

There is still concern that a no deal Brexit may limit the availability of medicines in the UK and that there was little sign to date of potential delays on the border being addressed.

Despite pharmaceutical companies “doing everything in their power” to minimise disruption to the supply of medicines should the UK leave the EU under a ‘no-deal’ scenario, MPs have been told a deal is urgently needed to fully protect patients.

The Minister has been asked to clarify issues such as: “How confident are you that the contingency measures deployed as an immediate response to secure the supply of medicines and medical products can be sustained beyond the first six weeks after Brexit, should this be required?” and “What plans has the Government made to secure and prioritise airborne routes for medical products?”

The Government’s current guidance is to stockpile six weeks’ worth of medicines and medical products in the event of blockages at borders, however medicines with short shelf lives cannot be stockpiled and would have to be flown in.

Mike Thompson, chief executive of the Association of the British Pharmaceutical Industry (ABPI), recently reminded a commons select committee that there are medicines “which simply can’t be stockpiled due to temperature control, short shelf life or inability to travel,” stressing “that is why we urgently need a deal.”

Faster access to groundbreaking medicines as major milestones reached in deal with pharmaceutical industry

ABPI, Press Release, 23 November 2018

Cutting-edge and best value drugs will be fast-tracked through the approval process so patients can gain access up to six months earlier

Deal will also mean a more flexible and streamlined commercial process which will make UK more attractive to investors

Under the new Voluntary Scheme for Branded Medicines Pricing and Access, the NHS across the UK would save almost £1 billion on medicines next year which could be put back into NHS services.

Patients could have access to new, ground-breaking medicines up to six months earlier and the NHS across the UK is expected to save around £930 million on its medicine bill under a new scheme being finalised with the pharmaceutical industry.

The Government and the Association of the British Pharmaceutical Industry (ABPI) have reached a deal on the Heads of Agreement for a new voluntary scheme for Branded Medicines Pricing and Access, which is expected to come into effect from January 2019.

The final details are still being finalised, but a major milestone has been reached in the discussions which would see the most transformative and best value medicines made available on the NHS more quickly through better horizon scanning, earlier commercial dialogue, and faster appraisals from The National Institute for Health and Care Excellence (NICE).

Health Secretary Matt Hancock said:

“This new deal will be good for patients, good for the NHS and good for the UK life sciences industry. Cutting-edge and best value medicines will be fast-tracked and we will cut our medicines bill by £930 million next year following tough but constructive negotiations with the pharmaceutical industry – money we can redeploy into better NHS services, alongside the NHS Long Term Plan.

“The deal will also ensure the UK remains an attractive hub for research and investment so the next generation of ground-breaking treatments can be developed here with patients benefitting earlier.”

The terms in the Heads of Agreement set out how the 2019 Voluntary Scheme, once agreed in full, will benefit patients by ensuring the NHS gets the best value and most effective medicines into use more quickly by:

Faster NICE appraisals meaning that patients are likely to get access to new medicines up to six months earlier than today

More NICE technology appraisals than ever before so all new medicines are assessed by NICE, and the NHS is required to fund all those recommended for use

Smoother and faster introduction of transformative medicines through better horizon scanning and early engagement with companies to ensure clinicians and the NHS infrastructure are ready to use them more quickly

More commercial options to incentivise better value for the NHS

Health Minister Lord O’Shaughnessy said:

“The agreement is a vote of confidence for our world-leading life sciences sector, and shows the NHS is ready to embrace innovation so that patients get the best medicines earlier.

“Small and medium-sized business in particular will be better supported through greater commercial flexibility, helping SMEs to bring their innovative treatments into the NHS.

The agreement will also ensure the UK remains an attractive hub for our world-leading life sciences sector, a central part of the government’s Industrial Strategy.

Mike Thompson, Chief Executive of The Association of the British Pharmaceutical Industry, said:

“This agreement is a commitment by the Government and the NHS to work with us to support innovation for the benefit of patients. This means that people across the UK should see better and faster access to the most effective new medicines and vaccines.

“Under the scheme the NHS will have absolute certainty that the sales of branded medicines will not grow by more than two per cent in any of the next five years – or industry refunds the money.  This is a significant contribution by pharmaceutical companies to support the NHS.”

The scheme is designed to keep growth in the branded medicine bill predictable and affordable by:

Placing a 2% cap on the growth in sales of branded medicines to the NHS, with pharmaceutical companies repaying the NHS for spending above that limit – delivering expected savings of around £930 million in 2019.

Supporting smaller companies to innovate through payment exemptions and targeted case management through NHS England commercial discussions

Simplifying price controls: reducing unpredictability and complexity for companies and the NHS

Enabling faster and more flexible commercial discussions than ever before to get the best value and most effective new medicines into use as quickly as possible.

CMA closes investigation into alleged anticompetitive generic drug pricing practices

The Pharmaceutical Journal, Carolyn Wickware, 23 November 2018

Owing to a lack of sufficient evidence of lawbreaking, The Competition and Markets Authority has decided to close its investigation into anticompetitive generic drug pricing.

The Competition and Markets Authority (CMA) has closed an investigation into alleged anticompetitive generic drug pricing after concluding that the case was not a good use of its resources.

The CMA said the investigation had been looking into “suspected breaches of competition law” relating to a range of drugs.

However, the investigation was closed on 14 November 2018 because the body concluded that continuing with the case “would not be the best use of the CMA’s resources”.

The investigation had focused on potential breaches of the Competition Act 1998, but no details were released onwhich companies or organisations were under investigation.

The investigation was launched on 13 October 2017 at the height of the crisis in the generics market that hit community pharmacy. When it launched, the CMA said in a statement that the investigation related “to alleged anticompetitive agreements and/or concerted practices in relation to generic pharmaceutical products”.

The CMA added that it “had not reached a view on whether there is sufficient evidence of an infringement of competition law for it to issue a statement of objections to the parties under investigation”.

In a summary of its decision to close the investigation on 7 November 2018, the CMA said that although this case was now closed, two of the alleged anticompetitive agreements “in relation to generic pharmaceutical products” were being investigated further as two new cases.

The Pharmaceutical Journal previously revealed in July 2018 that the CMA had opened six new investigations into anticompetitive practices in the pharmaceutical sector at the height of the pricing crisis in the generics market. At the time, it was not clear whether the products involved were generics.

Brexit – no-deal contingency planning

Politico, 23 November 2018

And here‘s why it matters. As Hancock scrambles to explain whether the government’s preparations to mitigate risks to drug supplies is up to scratch, ABPI gave us some details on their estimates of the potential impacts of a no-deal Brexit — as well as some new examples of its member’s contingency planning.

BY THE NUMBERS:

£24.9 billion: The value of pharmaceutical products the U.K. exported in 2016. Half went to Germany, the Netherlands and France. Additionally, 54 percent of U.K. pharmaceutical imports come from Germany, Belgium and the Netherlands.

45 million packs: The volume of drugs that move from the U.K. to the EU every month, with 37 million packs moving the other way.

50 percent: An estimate of the proportion of the new medicines approved last year that require cold storage.

PREPARATION PLANS:

AstraZeneca has increased the number of finished medicines available to pharmacies and hospitals in both the U.K. and EU by 20 percent. It has spent £40 million preparing for a no-deal Brexit, including building labs in Sweden to duplicate product testing.

GSK is expanding re-testing and certification processes, updating packaging and leaflets and transferring U.K. marketing authorizations to an EU entity. It estimates the cost of planning at £70 million over the next two to three years, with ongoing additional costs of £50 million per year.

Ipsen has one U.K.-made drug that’s distributed to more than 80 territories worldwide. The company has changed distribution channels and boosted stocks in the U.K. and in the EU.

Lilly has moved lab testing for specific medicines from the U.K. to Spain, secured additional warehouse and cold-chain space to enable stockpiling and transferred marketing authorizations.

MSD, the European branch of Merck & Co, is supporting EU employees in getting settled status in the U.K. post Brexit. It’s also stockpiling medicines.

French pharma Sanofi is securing additional U.K. warehouse space for medicines and vaccines that require cold storage and also moving some manufacturing operations from the U.K. to EU27 countries.

Media and Political Bulletin

08 October 2018

Media Summary

 DH expands on health secretary’s desire for ‘French model’ of pharmacy

Chemist and Druggist, Isabel Finch, 8 October 2018

Chemist and Druggist reports that the government has expanded on the health secretary’s desire to move to a French model of pharmacies.

Matt Hancock told C+D at the Conservative party conference last week that he wants to “move towards the French model for pharmacies, where they do more”.

Asked to shed more light on Mr Hancock’s comments, the Department of Health and Social Care said that pharmacy services on the continent offer a wider range of services to members of the community.

The DH is keen to see local pharmacies play a stronger role in the community, it said.

PSNC: FMD funding to be discussed in 2019-20 contract negotiations

Chemist and Druggist, Grace Lewis, 8 October 2018

Chemist and Druggist also reports on the fact that the government has agreed to discuss the possibility of remuneration for pharmacies complying with the EU scanning law as part of the sector’s funding for 2019-20, according to the PSNC.

PSNC’s CEO, Simon Dukes stated that ‘[The government] knows we want to talk about it (the FMD). They have asked and I’ve agreed to discuss it in the 2019-20 contract negotiations.’

But, speaking in a separate session on the FMD, Claymore Richardson, senior policy manager for pharmacy at the Department of Health and Social Care, told delegates: ‘There is no big pot of money for implementing FMD.’

The DH has been working with NHS Digital and others on ‘the options for people working in the community,’ Mr Richardson added.

Parliamentary Coverage

House of Commons, Written and Tabled Questions, 8 October 2018

Tom Brake, MP: To ask the Secretary of State for Health and Social Care, what steps his Department is taking to ensure that the next Pharmaceutical Price Regulation Scheme considers combination treatments for cancer to be cost-effective.

Tom Brake, MP: To ask the Secretary of State for Health and Social Care, when the heads of agreement for the next Pharmaceutical Price Regulation Scheme will be published.

Tim Farron, MP: To ask the Secretary of State for Health and Social Care, what steps he has taken to make pharmacies (a) aware and (b) prepared for the implementation of the Falsified Medicines Directive by February 2019.

Tim Farron, MP: To ask the Secretary of State for Health and Social Care, what steps he has taken to assist independent pharmacies in the purchase of the (a) hardware and (b) software required by the implementation of the Falsified Medicines Directive.

Full Coverage

DH expands on health secretary’s desire for ‘French model’ of pharmacy

Chemist and Druggist, Isabel Finch, 8 October 2018

The government has expanded on the health secretary’s desire to move to a French model for pharmacies.

Matt Hancock exclusively told C+D at the Conservative party conference last week (October 2) that he wants to “move towards the French model for pharmacies, where they do more”.

Asked to shed more light on Mr Hancock’s comments, the Department of Health and Social Care (DH) told C+D that pharmacy services on the continent offer a wider range of services to members of the community.

The DH is keen to see local pharmacies play a stronger role in the community, it said.

Pharmacies are integral to the DH’s plan for a fully integrated health service and are well placed to play an enhanced role in helping people stay well, it added.

Pharmacies “absolutely vital to community health”

At the Conservative party conference, Mr Hancock also told C+D that pharmacies are “absolutely vital to community health”.

“Pharmacy is incredibly important in the whole prevention agenda,” he added.

“I didn’t have enough time on the platform, because if I had one more minute I would have spent one more minute talking about the importance of pharmacies.”

In his speech, Mr Hancock called for “more treatment closer to home” and cemented his plans for “bringing new technology across the health and care system”.

PSNC: FMD funding to be discussed in 2019-20 contract negotiations

Chemist and Druggist, Grace Lewis, 8 October 2018

The government has agreed to discuss the possibility of remuneration for pharmacies complying with the EU scanning law as part of the sector’s funding for 2019-20, PSNC has said.

The Falsified Medicines Directive (FMD) – created to prevent counterfeit medicines from entering the supply chain – will require every pharmacy in the UK to scan barcodes and check tamper-proof devices from February 9, 2019.

The Medicines and Healthcare products Regulatory Agency (MHRA) has not published specific calculations of the cost of the legislation to community pharmacies, but its impact assessment estimates that “healthcare institutions” face paying up to £4,000 every five years to buy scanners to comply with the directive.

Reena Barai, a contractor and National Pharmacy Association (NPA) board member, said pharmacy owners continue to be concerned about the associated costs of complying with the FMD.

“Every contractor I have met over the last couple of days has said that is the one thing they want to find out about at the Pharmacy Show,” she said at the conference in Birmingham yesterday (October 7).

“Are we going to be funded for it?” Ms Barai asked Pharmaceutical Services Negotiating Committee (PSNC) CEO Simon Dukes.

In response, Mr Dukes said: “I don’t know yet, is the answer. I have flagged this significantly with the government.”

“[The government] knows we want to talk about it. They have asked and I’ve agreed to discuss it in the 2019-20 contract negotiations,” he added.

“Those negotiations are yet to start. I am hopeful that they will do so in the next month, and [the FMD] is on the agenda.”

“No pot of money for FMD”

Speaking in a separate session on the FMD, Claymore Richardson, senior policy manager for pharmacy at the Department of Health and Social Care (DH), told delegates: “There is no big pot of money for implementing FMD.”

The DH has been working with NHS Digital and others on “the options for people working in the community”, Mr Richardson added.

In the same session, Raj Patel, chair of the UK FMD working group for community pharmacy, insisted: “There needs to be a pot for FMD.”

Contract negotiations “need to gather pace” if pharmacies are to afford FMD hardware and software installation by the February 2019 deadline, he added.

Leon Finnerty, NHS Digital FMD programme manager, said that rather than see it as a “burden”, pharmacists should consider the positive impact medicines scanning could have on the sector – including greater control over their stock and drug shortages.

“Take the fact that you’ve got [to comply with the] FMD as a given,” he told delegates, before suggesting they ask themselves: “How can I turn this into a benefit for me?”

Falsified Medicines Directive

FMD error and alert messages guidance notes

To accompany “FMD – scanning and alert messages” chart

October 2018

 

These guidance notes accompany the “FMD – error and alert messages (for pharmacy and wholesale)” chart (v5a) and are based on a workshop held at Walgreens Boots Alliance, Weybridge, on 5th September and subsequent discussions with relevant experts. The chart looks specifically at handling of alert messages and is intended to inform wider discussions on implementing FMD, including amending Standard Operating Procedures. It will link with other industry guidance on the assessment of suspect packs once an alert has been raised and professional guidance on ethical decision making related to FMD.

NOTE: This is a working document and will be updated in light of feedback and experience. It represents current thinking on these issues at this point. Comments and feedback are encouraged.

 

NOTEAnti-tampering devices All packs bearing safety features will also require their anti-tampering devices (ATDs) to be visually examined before decommissioning. The normal (positive) response assumes that each pack has passed. If operators suspect that packs have been tampered with then they are required to report this to the National Competent Authority in the same way as for a pack that fails a verification or decommissioning scan. See section on “Handling packs that generate alerts”.

TERMINOLOGY: An alert is a message generated by a response from the NMVS following a scan of a unique identifier. A warning is a message generated by a local system. There are a large number of potential alerts that can be generated by NMVS/EMVS, not all of which are passed to end users. Some are condition-specific (eg, unable to reverse decommissioning after 10 days). The chart and this guidance captures the main categories of alert (grouped together) and the actions required by end users.

 

Positive scan (Green)

It is assumed that the vast majority of all stock being verified and/or decommissioned will produce a positive response from the NMVS. The aim of the process should be to minimise the response or action to be taken by end user operators. There should be a positive confirmation that a scan has taken place (single “beep”) in line with other automated processes (eg, supermarket self-checkouts).

Local systems should display a list of all products that have been scanned along with the product details (name, strength, form, etc) derived from the full data product master data, as well as batch, expiry and serial numbers. This should be enabled as the default setting by the NMVO. The most recently scanned product should be at the top of the list displayed by the local system to the end user to enable checking in case an operator is distracted or has to break off from scanning. Preferably there should be at least one screen or display per operator.

The status of the product (and the confirmation of any change of status at decommissioning) should be indicated in the list (using symbols [P] and colours that are unambiguous) as and when the response is received from the NMVS. This information should be stored in local data audit trails.

When scanning or verifying large numbers of packs, especially in wholesale settings, local systems may also be pre-configured to request or prompt the number of packs to be scanned and indicate when this has been reached.

 

Not FMD or fails to scan (Amber)

A wide range of products will not require verification or authentication under FMD at any time. This includes non-prescription products, medical devices, non-medicines, specials and other out-of-scope items, as well as POM stock produced and released before 9th February 2019. Local processes should make it clear that these products can still be dispensed and do not have to be returned to wholesalers or suppliers (unless there is another kind of problem).

Ideally, local systems should be able to distinguish between “right” (FMD) and “wrong” (not FMD) stock by drawing on NMVS master data loaded on to local systems. This would allow a process of “scan everything, system sorts it out”. Whenever possible there should be a positive audible confirmation that a scan has taken place.

Where this is not technical possible then end user operators should have access to visual training guides that distinguish between “right” and “wrong” products in order to minimise scanning errors.

Excessive “amber warning” pop-up boxes saying that certain packs do not need to be verified should be avoided in case they cause operator “alert fatigue”.

Some products may fail to scan because of damage to the 2D data matrix. SOPs should indicate that a lack of audible confirmation should prompt the process for manual data entry. In general, damaged packs should be a rare occurrence. Where a product has multiple packs that fail to scan, this should be reported to the wholesaler, supplier or NCA as a defective medicine using existing procedures.

NOTE: See “data error” red alert for packs that do scan but contain incorrect data.

 

Warnings generated by local systems (Red)

These warnings can be generated in response to data held within a unique identifier 2D data matrix (eg, expiry data) or in response to end user operator actions (eg, double scans of same pack). They do not require a live connection to the NMVS at the time of scanning to generate a warning, however the NMVS will also generate an alert message, when or if connected.

Out of date As a minimum, local systems should warn operators about products that have passed their expiry date by cross-referencing with calendar date. It would be preferable and a major benefit for systems to also warn about products that are close to their expiry date (eg, less than three or six months or another user-defined period).

Double scan A double scan occurs when the same pack is scanned more than once at the same location in quick succession. Agreement should be reached with system suppliers and the NMVO on how many repeated scans, and how frequently, is an acceptable limit.

Local systems should capture and warn operators about this, requiring an acknowledgement. Local limits should be agreed after which operators’ local management is alerted (to prompt training or process improvement).

If a national limit is to be set on the number of double scans permitted before an alert is raised with the NMVO (and/or NCA) then this should be set at a very high level for the initial phase following the start of FMD authentication. This will avoid swamping the system with unnecessary alerts. The permitted level could be reduced in due course once experience is gained across the supply chain.

 

Alerts generated by NMVS (Red)

These alerts are generated when UI data from packs is compared with the data and status information held on NMVS. They require a live connection to the NMVS.

Recalled pack The status of the pack in the NMVS is set to “recalled” or “withdrawn”. This may be at a pack or batch level. In these circumstances end users should follow existing procedures for the return or disposal of affected packs, including processes for reordering and reimbursement.

Status error The status of the pack in the NMVS is set in such a way that the product cannot be decommissioned and supplied. This includes packs marked as “stolen”, “sample (not for commercial sale)”, “free sample”, “exported from EU”, “for destruction” or “checked-out” (part of the parallel import process). These indicate packs that should not be in circulation in the supply chain. See below for guidance on handling these packs.

Data error The data on the pack does not match corresponding data held in the NMVS or the data on the pack has gaps or missing fields (ie, missing one or more of serial, product, batch, expiry or national reimbursement number, where relevant). This also includes packs where data is encoded using formats or characters that are not permitted by EMVO or other relevant authorities (eg, GS1). Manufacturers are expected to scan all 2D data matrix codes as they are produced to avoid such errors. Improper coding may indicate falsified packs. See below for guidance on handling these packs.

Data errors may also occur if packs are released to market before data uploads to EMVS are successfully completed. This should be avoided and, where this is confirmed as an issue, such packs should be reported as defective medicines

Already used The UI data is correct but the status indicates that it has already been decommissioned at another location, either in the same country or in another country. This could indicate duplication of UIs and potential falsification. This is different to the “double scan” error which only occurs when packs are re-scanned at the same location. See below for guidance on handling these packs.

Locked packs Packs can have their status set to “locked” on a temporary basis. Only manufacturers and wholesalers can do (and undo) this. There is no 10-day rule on reversing locked status. However, since dispensing entities cannot undo locked packs they would be unable to dispense them. For this reason, packs should only be locked electronically after they have been physically locked up (quarantined). Those doing the locking should have “pack in hand” at the time. It should never be used for packs that are in transit or which have been widely distributed. If packs are not in the possession of the person wishing to lock them then the recall route should be used instead.

 

Handling of packs that generate alerts (Red)

Packs marked “recalled” or “withdrawn” should be handled in the normal way for return or disposal, including reimbursement.

Packs with “status error”, “data error” or “already used” alerts need to be quarantined, investigated, reported and, if required, handed over to manufacturers or NCA inspectors for examination.

Quarantine Suspect packs should be physically quarantined away from normal stocks. Where possible and practicable, suspect packs should be placed in separate plastic bags and labelled with relevant details, including the alert ID number raised by the NMVS.

Investigation An internal investigation should be conducted by a suitable person within the organisation, such as a Qualified Person, Responsible Person (wholesale) or Responsible Pharmacist or Pharmacy Manager (community pharmacy) to rule out any technical or procedural issues, including double scanning. Senior managers, such as Chief Pharmacists, Superintendent Pharmacists, Operations Directors, or GP practice partners, should be informed of the outcome as appropriate.

External reporting Although the NMVS will generate a report that can be accessed by the NCA, wholesalers and dispensing entities have a duty placed on them by the Delegated Regulation (2016/161, Articles 18 & 30) to report suspected falsification incidents. This should be done through a suitable portal provided by the NCA. In the UK, this should be a specific “Report FMD alert” page as part of the existing Yellow Card scheme. The NCA should make available and publicise a hotline line for urgent incident reporting.

Analysing packs When requested by Marketing Authorisation Holders (MAHs) and/or NCA inspectors, suspect packs should be supplied to them for further analysis. It is up to MAHs to make suitable arrangements with the person holding the pack for its return. Persons returning packs should receive appropriate reimbursement for the cost of the pack and any relevant out-of-pocket expenses incurred from the MAH (or NCA, if they have taken possession of the pack). The NCA should indicate to the person supplying the suspect pack when or if they might receive any feedback on the investigation, whether directly or through a more general update.

NOTE: Work on a pathway for MAHs for handling alerts and analysing suspected falsification incidents is being undertaken by the European Federation of Pharmaceutical Industry Associations (EFPIA) and Medicines for Europe (MfE).

 

Guidance notes prepared by:

Jonathan Buisson MRPharmS MFRPSII

International Pharmacy & Policy Manager

Walgreens Boots Alliance
(jonathan.buisson@wba.com)

 

23rd October 2018

Further reading

Naughton B, Roberts L, Dopson S, Chapman S, Brindley D. Effectiveness of medicines authentication technology to detect counterfeit, recalled and expired medicines: a two-stage quantitative secondary care study. BMJ Open. 2016 Dec 1;6(12):e013837.
Naughton B, Roberts L, Dopson S, Brindley D, Chapman S. Medicine authentication technology as a counterfeit medicine-detection tool: a Delphi method study to establish expert opinion on manual medicine authentication technology in secondary care. BMJ Open. 2017 May 6;7(5):e013838.

Media and Political Bulletin

24 September 2018

Media Summary

FMD must not compromise integrity of supply chain or delay passage of medicines to patients, warns CCA

Pharmacy Business, Neil Trainis, 21 September 2018

Pharmacy Business reports that the Company Chemists’ Association has warned that safety features that are due to come in under the Falsified Medicines Directive must ‘not compromise the integrity of the supply chain or delay the passage of medicines to patients.’

From February 9 next year pharmacists will be required to scan the barcodes of all medicines at the point of dispensing and check the anti-tampering device, a regulation that comes into effect just weeks before the UK leaves the European Union on March 29.

In its response to a consultation by the Medicines and Healthcare products Regulatory Agency, the CCA called for ‘a proportionate and risk-based approach to the implementation of the safety features aspect of the Falsified Medicines Directive.’ The body said that it was concerned that pharmacy businesses were having to enter into legal agreements and commit to financial investments in IT, staff training and other areas to the backdrop of uncertainty over how long FMD will be in place given ongoing Brexit negotiations.

Parliamentary Coverage

There was no parliamentary coverage today.

Full Coverage

FMD must not compromise integrity of supply chain or delay passage of medicines to patients, warns CCA

Pharmacy Business, Neil Trainis, 21 September 2018

Safety features that are due to come in under the Falsified Medicines Directive (FMD) must not compromise the integrity of the supply chain or delay the passage of medicines to patients, the Company Chemists’ Association (CCA) has warned.

From February 9 next year pharmacists will be required to scan the barcodes of all medicines at the point of dispensing and check the anti-tampering device, a regulation that comes into effect just weeks before the UK leaves the European Union on March 29.

In its response to a consultation by the Medicines and Healthcare products Regulatory Agency, the CCA called for “a proportionate and risk-based approach to the implementation of the safety features aspect of the Falsified Medicines Directive.”

“This is in order that patient safety and integrity of the supply-chain can be assured, while not undermining the efficiency and cost-effectiveness of dispensing in community pharmacy,” the CCA said.

The body said it was concerned that pharmacy businesses were having to enter into legal agreements and commit to financial investments in IT, staff training and other areas to the backdrop of uncertainty over how long FMD will be in place given ongoing Brexit negotiations.

CCA chief executive Malcolm Harrison said: “Our priority for FMD is to ensure patient safety and integrity of the supply chain are maintained as the UK leaves the EU, while not undermining the efficiency and cost-effectiveness of dispensing in community pharmacy.

“Our members are all working hard to ensure they will be compliant with FMD once it takes effect in February.”

He added: “We agree with the FMD Working Group that the government must be open and transparent with the pharmacy sector. This is to ensure that community pharmacy, which is already financially challenged, is not required to invest in FMD systems if they will not be needed in the future.

“If community pharmacies remain required to comply with these new aspects of the Directive, we believe the additional cost burden should be taken into account within any new NHS funding settlement.

“In the event of the UK medicines verification system being disconnected from the European hub after Brexit, we similarly agree with the FMD Working Group that the government should fully compensate the sector, where all or part of the system which has been invested in becomes redundant.”

Media and Political Bulletin

10 August 2018

Media Summary

Falsified Medicines Directive: Six months, six thoughts

Securing Industry, Mark Davison, 9 August 2018

This article highlights the fact that yesterday marked six months until the implementation of the Falsified Medicines Directive (FMD).

It states that despite Brexit, FMD is ‘not going away,’ and the UK is tied to it until at least December 2020, and despite the fact that not everything will be ready by February, that does not mean that the project will stop.

The article also states that it is not too late to be ready. It notes that if companies haven’t yet started to address FMD, but are able to make quick decisions and take standard options, they can still have the software implemented within the next few months.

No-deal Brexit could hit drug supply on continent too, ABPI head warns

The Pharmaceutical Journal, Debbie Andalo, 10 August 2018 

The Pharmaceutical Journal reports that Mike Thompson, the Chief Executive of the ABPI, has warned that disruption to drug supply as a result of Brexit could also affect EU member states after Brexit.

It states that, according to Thompson, European governments have failed to recognise the impact a no-deal Brexit will have on their own medicine supply chains. He said that a no-deal Brexit would not only impact the 37 million packs of drugs imported into the UK from across the EU each month, but will also hit the 45 million packs that travel in the opposite direction from the UK to the rest of the EU.

Supply chains in France, Germany and the Netherlands would be the most vulnerable as they have the biggest share of drugs coming from the UK, he said.

Thompson added that while the drug industry understood the potential risk to supply chains across Europe, the same consensus did not exist at government-level.

Parliamentary Coverage

There was no parliamentary coverage today.

Full Coverage

Falsified Medicines Directive: Six months, six thoughts

Securing Industry, Mark Davison, 9 August 2018

Today is exactly six months before the Falsified Medicines Directive (FMD) comes into force. On 9 February, 2019, more than thirty countries in the European Economic Area will have new rules for coding and verifying prescription medicines.

We’ve had two-and-a-half years of the three year implementation window now: what conclusions can we draw and what recommendations can be made?

1. It will happen.

Those of you waiting for Brussels or Brexit to cancel FMD are wasting your time. Even if there is a delay, FMD is not going away and the UK is tied to it until at least Dec 2020. Will everything be ready by February? No, quite clearly not, especially at pharmacy level. That doesn’t mean the whole project will stop.

2. It’s too late.

If you’re a marketing authorisation holder (MAH) and still need to convert production lines then it is too late to be ready. You have two options. You can make excess inventory, release it before February, and hope it lasts until your lines are ready, or you can send your finished goods to a contract manufacturer (CMO) for coding. Both inconvenient, but you’re still in business.

3. It isn’t too late.

There is still time to get ready if you just need software to manage and report serial numbers (e.g. to the European Medicines Verification Organisation, EMVO) or if you’re a downstream distributor or pharmacy needing to verify and decommission packs. If you haven’t started, but can make quick decisions and take standard options, ACT NOW, and you could have your software implemented within the next few months.

4. Choose experience over price.

Saving a few thousand euros using unproven but cheap serialisation vendors is a false economy if you can’t sell or dispense products by next February. It is too late for home-made solutions or inexperienced me-too suppliers. Competition means that prices are already pretty keen amongst the market leaders. Don’t chase the last cent.

5. KISS

Simple FMD projects work best. Only make system linkages you need. Usually (for manufacturers) that means MAH to CMO and MAH to EMVO. For distributors and dispensers it means to your national system (NMVO). There is the ability to integrate with your FMD solution, with the planning software, warehouse system, dispensing software or your Apple Watch if you want to. It’s not just for those items on the critical path for FMD compliance. Starting with a standalone approach as part of a roadmap to deeper integration is the best balance of risk and ROI.

6. Adapt processes, train people.

For every euro spent on vendor technology, several euros need to be spent on your own people and processes to bend them into shape. Don’t skimp on this bit. Pack-level traceability changes everything all along the supply chain. If people carry on with old ways of working your FMD project will fail: expensively.

No-deal Brexit could hit drug supply on continent too, ABPI head warns

The Pharmaceutical Journal, Debbie Andalo, 10 August 2018 

Mike Thompson, chief executive of the Association of the British Pharmaceutical Industry, has warned that disruption to drug supply as a result of Brexit could also affect EU member states after Brexit.

European governments have failed to recognise the impact a no-deal Brexit will have on their own medicine supply chains, the head of the Association of the British Pharmaceutical Industry (ABPI) has warned.

Mike Thompson, chief executive of the ABPI, told The Pharmaceutical Journal that a no-deal Brexit would not only impact the 37 million packs of drugs imported into the UK from across the EU each month, but will also hit the 45 million packs that travel in the opposite direction from the UK to the rest of the EU.

Supply chains in France, Germany and the Netherlands would be the most vulnerable as they have the biggest share of drugs coming from the UK, he said.

Thompson added that while the drug industry understood the potential risk to supply chains across Europe, the same consensus did not exist at government-level.

He told The Pharmaceutical Journal: “I think that Brexit is a high priority in the UK, more than it is in other member states. My concern is that other member states don’t quite understand that is their patients — and not just those in the UK — which need to be protected as well.”

UK drug manufacturers have, since the end of 2017, been taking steps to mitigate the impact of a no-deal Brexit, which includes preparing to hold “in excess of buffer stocks”, he revealed.

And although ministers have spoken about making it a priority to protect the UK medicines supply chain, he admitted: “It’s become difficult for either the UK government or the EU to give us any real clarity on which [Brexit] scenario we should be planning for.”

He added: “ We are working with our members to understand where the pressure points are and to make sure that we do everything we can to continue to supply medicines to patients across the whole of Europe.”

The ABPI is also calling on the UK and the EU to mutually recognise the quality assurance of drugs either side of the UK/EU borders so that drug companies do not have to invest time and money creating duplicate quality assurance systems after Brexit.

“If they continue to recognise quality assurance of manufactured products that happens in each other’s jurisdiction, that will help us to [devote time and investment] on some of the other [supply chain] issues,” he said.

Thompson’s warnings about the potential impact of Brexit on EU patient’s medicine supply follow similar comments from drug giant AstraZeneca on 3 August 2018.

Ad Antonisse, the company’s Dutch external affairs director, told the Brexitloket website: “If we do not prepare well for Brexit, patients in the EU may no longer be able to receive their medicines.”

Media and Political Bulletin

06 August 2018

Media Summary

6 questions about the EU scanning law pharmacy still needs answers to

Chemist and Druggist, Lilian Anekwe, 3 August 2018

With just six months until pharmacists must have new barcode scanners up and running, Chemist and Druggist examines the questions that the pharmaceutical sector still needs answers to, in the run up to the implementation of FMD.

The article states that very little is known about how the FMD will work, and that one of the key questions relates to whether pharmacies will be given any flexibility.

It highlights that the consultation document states that decommissioning should happen ‘as close to the time of supply to the patient as possible,’ and in the case of deliveries to patients, ‘before handover to the driver.’ But the EU will allow ‘a small number of flexibilities…to accommodate the way in which medicines are supplied on a national basis.’ Under the ‘preferred or more likely option’, wholesalers will be required to verify and decommission on behalf of certain providers – but this does not include pharmacy.

It also allows for ‘healthcare institutions’ to be exempt from having to verify and decommission medicines, if they are supplying a medicine obtained from a wholesaler that belongs to the same legal entity as the healthcare institution. In light of this, the article asks whether pharmacies that have a wholesale arm will also be afforded the same ‘flexibility.’

In a guidance document published in January, the National Pharmacy Association’s (NPA) FMD Working Group speculated that ‘these flexibilities do not primarily impact community pharmacy dispensing, but may have some impact on pharmacies that hold wholesale dealer’s licenses.’ The article includes a quotation from HDA’s Executive Director, Martin Sawer, who states that he ‘doesn’t think’ this kind of arrangement will be possible.

Parliamentary Coverage

There was no parliamentary coverage today.

Full Coverage

6 questions about the EU scanning law pharmacy still needs answers to

Chemist and Druggist, Lilian Anekwe, 3 August 2018

With just six months until all pharmacies must have new barcode scanners up and running, what are the burning questions the sector still needs answers to?

It looks like, whatever Brexit deal the UK ends up with, community pharmacies will be expected to comply with the EU’s anti-counterfeiting legislation, the Falsified Medicines Directive (FMD), from next year.

This will mean that, when the legislation comes into force on February 9, 2019 – seven weeks before the UK is due to withdraw from the EU – every pharmacy in the UK will be required to scan new barcodes on medicines and check their anti-tampering device at the point of dispensing.

Scanning a product’s 2D barcode – which, as part of the legislation, manufacturers will have to include on the packaging – will be part of the process of verification and ‘decommissioning’.

We know this much – but very little else about the detail about how the FMD will work. Last month, the government’s medicines watchdog, the Medicines and Healthcare products Regulatory Agency (MHRA), published documents setting out how it proposes to implement the FMD. But it still left some glaring questions unanswered.

1.What will the impact on pharmacies be?

In its impact assessment, the MHRA suggested that sites decommissioning medicines – which includes pharmacies –could face costs of up to £1,300 per scanner, as well as “regulatory inspections” to monitor compliance. This could be enforced with “a mixture of both criminal and civil sanctions”.

But the legitimate questions community pharmacists have raised, which are stopping them from preparing for FMD, have not been fully answered. Salim Jetha, chief executive of pharmacy buying group Avicenna, tells C+D that “there are still lots of operational details [that are] not clear” – such as how to dispense from split and bulk packs, what to do with uncollected medicines, and staff training, to name just a few.

2. Who will pay for the scanners?

The legislation stipulates that each sector, including pharmacy, is responsible for its own costs for connecting to the UK’s safety database, the National Medicines Verification System. While the Pharmaceutical Services Negotiating Committee says it and the other national negotiators are “working to ensure that contractors’ FMD-related costs are recognised in future NHS funding settlements”, it remains to be seen whether this will come to pass.

3. Will pharmacies get flexibility?

The consultation document states decommissioning should happen “as close to the time of supply to the patient as possible”, and in the case of deliveries to patients, “before handover to the driver”.

But the EU will allow “a small number of flexibilities…to accommodate the way in which medicines are supplied on a national basis”. Under the “preferred or more likely option”, wholesalers will be required to verify and decommission on behalf of certain providers – but this does not include pharmacy.

It also allows for “healthcare institutions” – defined as “a hospital, in- or outpatient clinic or health centre” – to be exempt from having to verify and decommission medicines, if they are supplying a medicine obtained from a wholesaler that belongs to the same legal entity as the healthcare institution.

So would pharmacies that have a wholesale arm also be afforded the same “flexibility”?

In a guidance document published in January, The way forward for FMD in community pharmacy, the National Pharmacy Association’s (NPA) FMD Working Group speculated that “these flexibilities do not primarily impact community pharmacy dispensing, but may have some impact on pharmacies that hold wholesale dealer’s licenses.”

But Martin Sawer, chief executive of the Healthcare Distribution Association, tells C+D that he “doesn’t think” this kind of arrangement will be possible.

“Given that the legislation says that healthcare institutions and pharmacies should decommission on supply to members of the public, I don’t think there’s a derogation there for a pharmacy that might also be a wholesaler,” he explains.

“Within that type of business, there’s usually a separate legal entity for the wholesaler and the pharmacy. The products are passing from one legal entity to another – to the pharmacy to verify [a medicine] on receipt, and then decommission when they hand it to the patient.”

4. How much will it cost?

The impact assessment details the highest, lowest, and best estimate of “the true social cost” of FMD, under each of the policy options. It assumes that there will be 3.1 billion prescription medicines dispensed in the UK in 2019, increasing annually by 2%.

The best estimate of this “social cost” for scanners, “training and familiarisation”, and decommissioning, is estimated at £666.1m – ranging between £522m and £813.5m under the low and high estimates, respectively.

5. How big is the problem of counterfeit medicines?

The MHRA claims the legislation will prevent harm to public health, but it admits “we do not have the data to provide a plausible model of the impact” of FMD on counterfeit medicines. The European Commission estimates that 0.005% of medicines in the legitimate supply chain are fake, but the MHRA admits “we do not have the evidence to show that this is the case in the UK”.

“This is our initial analysis and is published with evidence gaps,” it says. “Many of the systems and pieces of equipment required to implement the policy are still being designed…therefore the figures are illustrative and should be used with caution”.

6. What happens now?

Raj Patel, chair of the NPA’s FMD working group, warns that pharmacies “are mandated to comply” with the EU legislation, “so must proceed, albeit with caution”. The FMD consultation runs until September 23, and pharmacists and their staff can respond by completing the online response form and emailing it to FMD.safetyfeatures@mhra.gov.uk.

This is the opportunity pharmacists have to fill in the “evidence gaps”. With less than seven months to go until implementation, clarity cannot come too soon.

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.

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