News

HDA UK Media and Political Bulletin – 13 April 2021

Media Summary

Supply chain security
Pharma Times Magazine, Raja Sharif, 13 April 2021

Pharma Times reports that one in seven medicines are estimated to be counterfeit globally, and over the last few years, the development of serialisation in the pharmaceutical space has been fundamental in trying to ensure that medical products can be traced throughout the supply chain.

Serialisation has aided regulators in identifying and removing drugs that may be counterfeit, harmful, or even stolen, potentially saving many lives. In February 2016, the European Union’s Falsified Medicines Directive (FMD) was introduced to help protect patients from the potential danger posed by falsified medicines. This was achieved by giving each medicine a unique identification code and allowed for tracking from the manufacturer to pharmacy.

The UK does not have any verification system in place to validate drugs in the supply chain at the moment. This issue of drug supply security and authenticity has only been mentioned in passing as Brexit trade agreements and COVID have dominated the news agenda, yet many experts warn that the UK’s departure from the EU’s FMD has created a huge potential risk.

As such, the UK Government must look for technologies that can modernise the system. By implementing blockchain-based technologies, the UK could become the world’s foremost nation for drug security.

 

All over-50s and high-risk groups in UK offered vaccine ahead of target date

The Guardian, Aubrey Allegretti, 12 April 2021

 

The Guardian reports that Prime Minister Boris Johnson announced that the target for the first phase of the vaccine rollout has been reached.

Despite fears of a supply slowdown after a change in advice on who could get the AstraZeneca jab, PM Johnson welcomed the passing of “another hugely significant milestone”.

All over-50s and high-risk groups in the UK have been offered a coronavirus vaccine a few days before the mid-April deadline set by the Government, and now the second phase of the vaccine rollout can begin.

Sir Simon Stevens, Chief Executive of the NHS in England, included operational managers and pharmacists in his thanks as the UK reached “an incredible milestone”, describing the NHS COVID vaccination programme as “without a doubt the most successful in our history.”

Parliamentary Coverage

House of Commons – Written Question, 25 February 2021

 

Mhairi Black (Scottish National Party, Paisley and Renfrewshire South): To ask the Secretary of State for Health and Social Care, what steps he has taken with Cabinet colleagues to help ensure the importation of medicines into the UK that are manufactured in the EU.

 

House of Commons – Written Answer, 12 April 2021

 

Jo Churchill (Conservative, Bury St Edmunds): We continue to work closely with other Government departments, including the Department for Transport, HM Revenue and Customs and the Cabinet Office’s Transition Task Force, the pharmaceutical industry, the National Health Service and others in the supply chain to deliver the shared goal of continuity of safe patient care under all circumstances.

 

The Department wrote to all suppliers of medicines and medical products coming to the United Kingdom from or via the European Union on 17 November 2020. The letter sets out how we are continuing to work across Government and with suppliers to deliver our multi-layered approach to mitigate any potential disruption to supply of medicines into the UK. The letter is available at the following link:

 

https://www.gov.uk/government/publications/letter-to-medicines-and-medical-products-suppliers-17-november-2020

 

Full Coverage

Supply chain security

Pharma Times Magazine, Raja Sharif, 13 April 2021

 

Globally, one in seven medicines are estimated to be counterfeit, and over the last few years, the development of serialisation in the pharmaceutical space has been pivotal in trying to ensure that every capsule, tablet, strip or vial can be traced throughout the supply chain. It has aided regulators in identifying and removing drugs that may be counterfeit, harmful, or even stolen, potentially saving many lives. In fact, in February 2016, the European Union’s Falsified Medicines Directive (FMD) was introduced to help protect patients from the potential danger posed by falsified medicines. This was achieved by attaching a unique identification code to each medicine and allowed for tracking from the manufacturer to pharmacy.

Whilst much of the industry is still coming to terms with how to fully implement serialisation, one country, notably the UK, as of this moment does not have any verification system in place to validate drugs in the supply chain. It is nearly five years since the UK voted to leave the EU, and after the end of the transition period on January 1, 2021, Securmed, the UK National Medicines Verification Organisation (UKNMVO), said that, apart from Northern Ireland who will remain using the European system – mainland UK will be removed from the database used to track serialised medicine digital barcodes in Europe.

This issue of drug supply security and authenticity has only been mentioned in passing as Brexit trade agreements and COVID have dominated the news agenda, yet many experts warn that the UK’s departure from the EU’s FMD has created a huge potential risk. Concurrent with the significant change we are, of course, also undertaking the world’s largest ever mass immunisation programme for COVID vaccines – at the time of writing AstraZeneca, Moderna and Pfizer vaccines are already being rolled out with several more expected to follow imminently. So the issue of medical verification systems is in the national consciousness more than ever before – as it represents our only means of verifying a vaccine is genuine, and/or any other drug taken for that matter.

Yet we also believe there are still two ways to view this problem, and the glass is not empty, and this should be a moment to think of it simply as glass half full. It’s an ideal moment to re-evaluate our entire medicines supply chain. Serialisation is not perfect by design, and modern blockchain based solutions – which are immutable by definition – were not widely available when FMD came in back in 2016 and can provide far greater visibility and a full custody of medicines. It is a future-proof solution that undoubtably advanced nations will gradually switch to and the UK, with Brexit, has the opportunity to implement the world’s safest medicine supply chain.

As such, we believe the UK government must look ahead, not back, for technologies that can modernise the system and jump ahead of the rest of the world.

In fact, by implementing blockchain-based technologies, the UK would become the world’s foremost nation for drug security, leapfrogging the US – whose Drug Supply Chain Security Act (DSCSA) is widely acknowledged as the current gold standard – and the EU’s current solution. While the FMD is widely seen as a competent solution that ‘does the job’, it is not flawless. Similarly, the European Medicines Verification System (EMVS) provides a very high level of protection against counterfeiting, but only if the products are supplied in compliance with the EU-FMD/EMVS processes.

 

‘The benefit to the UK of a flexible, operational and configurable blockchain platform cannot be underestimated’

A further benefit of blockchain based solutions is that they can also prevent critical medicines being diverted away from UK shores – a common pharmaceutical distribution problem – and identify sub-standard drugs quickly for recall, all in real time. This is currently not possible with the EU’s FMD solution. A real-time solution, however, will enable patients and doctors to be reassured, as they will have a transparent digital record of every medicines journey from factory to the pharmacy or surgery. Moreover, it will also empower doctors, innovators and patients with the exact details of shipping and storage conditions, so vital in the transport of sensitive therapies.

To take a recent example currently forming the nadir of global attention. The novel mRNA vaccines developed by both Pfizer and Moderna require extreme temperatures (-20 for Moderna and -70 degrees Celsius in the case of Pfizer) and transportation conditions must be maintained to ensure the integrity of dosages. A blockchain solution utilising essential data would provide valuable control processes from a single dashboard accessible by all authorised entities in real-time. The benefit to the UK of a flexible, operational and configurable blockchain platform cannot be underestimated – and would enable a robust distribution system that provided complete supply chain custody.

In October 2020, the Royal Pharmaceutical Society (RPS) wrote to health secretary Matt Hancock, asking for robust plans to be put in place ‘to help authenticate the legitimacy of medicines that move between the EU and the UK’ and how there is ‘legitimate concern around how removal of these safeguards could leave the UK vulnerable to an influx of counterfeit medicines, impacting on patient care in the UK and across the EU’. The very fact that even GAVI’s COVAX programme – the vaccine distribution scheme for lower- and middle-income countries – is exploring a robust medicine verification system is good indication of the immediate risk.

 

Taking out the politics of the present, we also have the chance to create a new system fit for purpose in the 21st century and not one that reacts to replace past regulations, but one that is adaptable to the personalised medicines of the future where chain of custody and transport conditions are critical to medical efficacy. It’s a moment in time where if we look at the problem as ‘glass half empty’ we will just replace the old with the old. Yet if we take a ‘glass half full’ view of the world we have the chance to reimagine the supply chain verification process that will be an activate enabler of tomorrow’s medical delivery – from factory to patient and with the scope to build in new approaches like automation of customs documentation and AI-enhanced supply chains with warehouse robotics. In the case of the latter, Amazon is well known to already use this, and we don’t believe it will be too far into the future that pharma and national health providers realise the productivity gains that can be made in drug supply chains.

In our view, dropping out of the FMD is a key inflection point with respect to the UK’s pharma supply chain security. We either run the risk of being exposed to counterfeit drugs or it could be the first Western government to adopt blockchain for supply chain security. Not only would it be used for supply chain security, but it can also be used for the development of new networks in emerging areas like advanced therapies, creating the initial networks that will rapidly spread into mainstream pharma adoption globally – perhaps giving new resonance to the idea of global Britain. A system that regulators like the FDA and EMA may want to take learning from and build into their own future systems.

Adopting blockchain, we can be the ones providing an immutable and secure platform around which new data hubs can be built, with new innovations plugging into to the chain linking the patient, doctor, innovators, devices and records in a way never before possible. It is now on the government to have a moment of Blue Sky thinking and provide the UK with the best possible supply chain security solution or risk being exposed to counterfeits.

 

All over-50s and high-risk groups in UK offered vaccine ahead of target date

The Guardian, Aubrey Allegretti, 12 April 2021

 

All over-50s and high-risk groups in the UK have been offered a coronavirus vaccine a few days before the mid-April deadline set by the government – meaning the second phase of the rollout to younger cohorts can now begin.

 

Despite fears of a supply slowdown and possible knock in confidence after a change in advice on who could get the Oxford/AstraZeneca jab, Boris Johnson hailed the passing of “another hugely significant milestone”.

 

With more than 32 million people now having had a first dose and 7.6 million of those having received their second, the prime minister said “many thousands of lives” had been saved.

The government had promised all those in the first phase of the vaccine rollout in categories one to nine – which included people over 50, care home residents and staff, frontline health workers and the clinically vulnerable – would be offered a vaccine by 15 April.

 

On Monday evening, a few days early, Johnson announced that the target had been reached, and the Joint Committee on Vaccination and Immunisation – which advises which groups should be prioritised for a jab – are to publish their final advice later this week on who should be next in line.

He hinted that their current plan would continue, suggesting those in their late 40s will be offered a vaccine next. The JCVI’s interim plan published at the end of February said the rollout should continue down the age groups – to those over 40 first, then over-30s and finally over-18s.

 

Sir Simon Stevens, chief executive of the NHS in England, said: “Vaccinating 19 out of 20 people aged 50 and over is an incredible milestone. Thanks to our NHS nurses, doctors, pharmacists, operational managers and thousands of other staff and volunteers, the NHS COVID vaccination programme is without a doubt the most successful in our history.”

 

Jonathan Ashworth, Labour’s shadow health secretary, said the news was “hugely welcome progress”, and paid tribute to the NHS. However, he said he wanted to “drill down into the figures” and warned “there are pockets where uptake is lower than average, often in areas of disadvantage”.

He added: “This must be urgently addressed by ministers so no area is left behind. There will be no ‘levelling up’ if COVID remains stubbornly endemic in parts of the country.”

 

There was concern that the government’s next target, to offer all adults a dose by the end of July, could be harder to hit, after the JCVI advised that under-3os be offered an alternative vaccine to AstraZeneca where possible, following concerns over blood clots, of which there may be an extremely small risk.

 

Ministers maintained that there would be no slowdown to the roadmap out of lockdown – the next step of which would allow six people to meet indoors and 30 to gather outside from 17 May at the earliest – and said the next vaccine target would be met.

Matt Hancock, the health secretary, said the “significant impact” of vaccines had seen pressures on hospitals reduced, meaning it should be possible to ease restrictions. He added: “I urge everybody eligible to come forward for their vaccine as soon as possible to protect yourself and your loved ones.”

 

While the number of daily doses administered has remained broadly stable, the seven-day rolling average has recently dipped back down to levels first seen at the start of March. Johnson had tried to set expectations by telling people the number of first doses would likely dip while the rollout focused on making sure those who had their first jab in the winter were fully inoculated with their second.

 

NHS England warned several weeks ago that from the end of March there would be a “significant reduction in weekly supply available from manufacturers … meaning volumes for first doses will be significantly constrained”.

HDA UK Media and Political Bulletin – 13 April 2021

From Factory to Pharmacy

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