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Northern Ireland will see changes in the regulatory landscape following the issuance of the Windsor Framework on 27th Feb 2023 and the corresponding EU Commission proposal. An agreement, in principle, has been reached by the UK and EU. The new path forward of the Windsor Framework marks a turning point in how both the UK and the EU will work together collaboratively and constructively to ensure that the same medicines are available in Northern Ireland at the same time as they are in the rest of the United Kingdom. Whilst this is a successful result for Northern Ireland patients, this is major change for companies that have made specific provisions in their supply chains for Northern Ireland. The supply chains of companies where provisions and changes were made such as introduction of GB specific pack may be impacted as a result. However, the burden on the UK Pharma supply chain will be eased. Prime Minister Rishi Sunak walks with European Commission chief Ursula von der Leyen in Windsor on February 27, 2023 Pharma companies will need to carefully consider making changes within their processes and supply chains pending the issuance of clear guidance from the MHRA on the regulation changes resulting from the Windsor Agreement and the corresponding EU Commission proposed regulatory changes associated with medicinal products within the Northern Ireland market. Smooth access to the EU market for Northern Ireland pharmaceutical and medical technology firms has been safeguarded within the constraints of the agreement. The pragmatic dual-regulatory system protects business, patients and healthcare services, and reflects that it is an essential state function to maintain and oversee the supply of medicines within the whole United Kingdom.

The National Pharmacy Association (NPA) has asked the Secretary of State for Health and Social Care to convene a 'medicines supply taskforce', following weeks of problems with antibiotics supplies. The NPA's chief executive Mark Lyonette wrote a letter to Steve Barclay this week. It cited the precedent of the HRT Taskforce which this summer brought together representatives from across the supply chain after months of supply problems affecting women. "We strongly believe that this situation calls for a similar response from the government. It is imperative that we resolve this supply situation urgently and therefore we request that you convene a Medicines Supply Taskforce, with all the relevant stakeholders in the supply chain, to urgently discuss and agree practical solutions to address the disruptions to the supply of medicines. HRT and antibiotics are the most visible examples of a wider problem with medicines supply which needs to be addressed." NPA board members Olivier Picard and Reena Barai were among the stakeholders joining meetings convened by the HRT Taskforce this summer.

Glenmark, a multinational pharmaceutical company, has partnered with AI data-driven supply chain management platform 7bridges. Initially focusing on their European business, where they have operations in 15 markets, the supply chain and logistics function is a big focus area for this cost reduction. The partnership with 7bridges will allow Glenmark to baseline their supply chain data giving them visibility of data, cost and service performance across their network of logistics service providers. This exercise will identify areas where invoices from their logistics service providers are being incorrectly or overcharged. With automatic dispute raising, savings will be quickly achieved. The platform will then enable Glenmark to benchmark their data, so they can compare the performance and cost of their LSPs to the wider industry. With Glenmark's global vision to emerge as a leading integrated research-based global pharmaceutical company, this investment in their supply chain will be integral to achieving this. The next step in the partnership will be to run simulations to optimise road freight services and 3PL operations, with the aim to then roll out globally.

Teva UK has alerted the Secretary of State for Health and Social Care to the problem posed by steep energy prices. Teva's UK General Manager Kim Innes wrote to the minister seeking assurances that the distribution of medicines to patients will be safeguarded over what's likely to be a difficult winter. The problems posed by steep energy prices and the potential for power rationing is putting pharmacies under pressure from increased costs and the risk of losing power supplies as a 'non-domestic' energy user, said the company. Kim said: "In our letter to the Secretary of State we acknowledged that the government knows that medicines manufacture is strategically important and that it's a vital component in maintaining patient health." "But I wanted to make sure that the Secretary of State also realises the consequences of the energy crisis further down the supply chain - for example, the need for a pharmacy to have a fridge switched on at all times for storing cold chain products."

The only way to overcome the challenges facing the medicines supply chain in the UK is through close cooperation - the government, pharmacies, and the industry all working together in tandem - said Andrew Stephenson, Minister for Health and Social Care. The MP for Pendle, Lancashire made the statement while addressing the Healthcare Distribution Association's (HDA) Annual Conference at the Institute of Directors in Pall Mall, London on Thursday (25 January), where over 130 leaders from the pharma industry gathered. As the keynote speaker, Stephenson acknowledged the crucial role wholesalers, manufacturers, and retail pharmacy chains, play in the wellbeing of the nation. He said: "In the first few months that I've been in this job, it's become immediately obvious to me just how important this sector is and just how important the work that all of you do is for our country."

Majority of the pharmacies are facing aggression from patients due to the medicine supply chain issue, a PSNC survey has revealed. The Pharmacy Pressures Survey by the trade body has seen nearly 83 per cent of pharmacies reporting a significant increase in medicine supply issues in the past year, leading to extra work and additional stress for staff. The survey of over 5,000 pharmacy premises and 1,000 pharmacy team members in England took place in early 2022. Two-thirds of respondents said that medicines supply chain issues are a daily occurrence, with 97 per cent reporting that this led to frustration from patients. "The results of PSNC's Pressures Survey make distressing reading for anybody in the sector - they tell a story of teams under immense pressures, and of businesses at crisis point," said Janet Morrison, PSNC chief executive.

The Department of Health and Social Care (DHSC) has issued Serious Shortage Protocols (SSPs) on three HRT medicines to limit dispensing supply to three months. To ensure women across the UK will be able to more reliably access HRT products SSPs has been issued on the supply of Oestrogel, Ovestin cream and Premique Low Dose. DHSC stated, "Women who have a prescription for more than three months but are only able to access three months' supply will not have to pay an additional prescription charge." "This means women will not incur any additional costs. Imposing a three month limit will mean more women are able to access the medication they want. Any woman who is worried about access to HRT or is unable to access HRT should speak to her GP." Recently, Vaccine Taskforce Director General Madelaine McTernan has been appointed to spearhead a new HRT Supply Taskforce, applying lessons learned from the successful procurement seen during the Covid vaccination programme to identify ways to support the HRT supply chain ensuring it can meet both short and long term demand. The move will save time for patients as well as pharmacists and prescribers who are working tirelessly to tackle the covid backlog.

With the government gearing up and pushing community pharmacies in England to adopt the hub and spoke dispensing model, stakeholders of the sector and industry leaders analyse the pros and cons related to the new concept. The model rose to prominence in 2015 in community pharmacy and the medicine supply chain in the UK, and has undergone a few consultations and reviews at the professional and governmental level since then. From a broader perspective, the industry agrees that the model will bring in efficiency to the system, much needed amid community pharmacy's flat funding settlement in England, at the same time highlighting some real challenges. The National Pharmacy Association (NPA) has so far released three reports on this matter and a review of the challenges and enablers of the hub and spoke in the UK in 2016. Besides, a review of international evidence and the report of a roundtable meeting was brought together in the supply chain with government and regulators in early 2020.

British Pharma giant, GSK is planning to invest more than £200 million (about $253 million) into the United Kingdom over the next two years to strengthen its manufacturing network. The money will be used to improve the pharmaceutical group's UK sites, including construction of new facilities and assembly lines, The Daily Mail first reported on Sunday. GSK has already earmarked £67 million to upgrade its manufacturing site in Montrose, Scotland, where a new production facility is being constructed. The upgrade is expected to help boost its production of active pharmaceutical ingredients (API) for the future supply of medicines. Regis Simard, head of global supply chain, told the publication that their six UK manufacturing sites, including Montrose, are an important part of their global manufacturing network.

Alliance Healthcare UK has won a 'special achievement' award for its work during the Covid-19 pandemic at the Logistics UK Awards 2021. The pharmaceutical wholesaler and it's subsidiary, Alloga UK - a specialist provider of supply chain solutions for healthcare manufacturers - received the 'Special Recognition Award for Outstanding Response to Covid' at an event held in central London on Thursday, December 9, 2021 - beating off stiff competition from a number of high profile challengers. Alliance Healthcare's new managing director Marie Evans said: "I am delighted that our business and team of 6,000 colleagues have been recognised at this level for our contribution to the fight against Covid-19. Our main aim over this unprecedented period is to support the NHS, pharmacy and all UK patients, and this award is true recognition for all of that hard work and dedication." The special award category was open to an individual or organization that demonstrated an outstanding response to the pandemic in 2020 within the logistics sector and included seven other nominees including the likes of National Highways, Hermes UK and Yodel.

The General Pharmaceutical Council (GPhC) has urged health and care professionals to meet relevant regulatory standards amidst the shortage of GLP-1 receptor agonists (GLP-1 RAs). The council said: "We are concerned to hear that people with Type 2 diabetes are experiencing problems accessing GLP-1 receptor agonists (GLP-1 RAs). We know that these are being widely prescribed for weight loss purposes and in some cases prescribed off-label." "We recognise the adverse impact that shortages and supply chain issues can have on patients, the public and wider health and care teams. The Council understands that health and care professionals are using their professional judgement and making decisions in challenging situations, balancing a range of factors such as individual patient needs, wider public health and pressures and limitations on available resources such as medicines shortages or other supply chain issues.

Switzerland is experiencing medicine shortages due to supply chain issues linked to COVID lockdowns in China and war in Europe, the country's pharmacists association said. "We have the biggest problems with children's medications, especially fever-reducing syrup," Enea Martinelli from pharmaSuisse told Swiss broadcaster SRF. "There are also shortages of blood pressure medications, psychiatric medications and Parkinson's medications," he said.

AAH Pharmaceuticals Ltd (AAH) has exceeded the milestone of delivering over 70 million COVID-19 vaccination doses across England, since it was awarded a contract in December 2020. In addition, AAH has delivered over 100 million ancillary items to more than 3,000 healthcare providers. David Bound, chief executive officer of AAH, said: "This is a huge milestone for AAH as we work tirelessly to support our communities. It's also a ringing endorsement of our delivery drivers, warehouse operatives, and specialist logistics teams and the determination, dedication, and passion they continue to show throughout this extraordinary period." The vaccination programme was also recognized by the Supply Chain Excellence Awards. Chris Emmott, senior project lead - Supply Chain, commented: "I'm incredibly proud that AAH was chosen for this job, particularly as we had the skills, the experience, and a great team to help facilitate the needs of the country. To get ready for a project like this, everybody's worked very long hours, they've worked weekends to get everything ready.

AmerisourceBergen, a leading pharmaceutical solutions organisation announced its intent to change its name to 'Cencora' to better reflect its bold vision and purpose-driven approach to creating healthier futures. Steven H. Collis, Chairman, President & Chief Executive Officer of AmerisourceBergen said: "Over time, we have established ourselves as a trusted industry partner that prioritizes innovation, advocates for patient access and advances strategic partnerships across the global pharmaceutical supply chain. To further bolster our position, we must continue to adapt and evolve within our dynamic industry as we pursue the goal of enhancing health outcomes. Building a unified brand is fundamental to our identity as a global healthcare company. We believe our new name better reflects who we are today and our impact across pharmaceutical care." AmerisourceBergen intends to begin operating as Cencora in the second half of calendar year 2023. The change to Cencora is aligned with the organisation's growth strategy and continued emphasis on innovation. AmerisourceBergen has focused on supporting pharmaceutical advancement and access for patients, manufacturers, and providers across the global healthcare supply chain.

The UK GDP Association has been established as a non-profit organisation, operating as a Community Interest Company (CIC), with a focus on providing a broader support network, particularly for small and medium business enterprises and pharmacy wholesalers. In addition to delivering commercially viable Good Distribution Practice (GDP) consultancy services for simple models with smaller budgets, the association aims to function as a networking platform for Responsible Persons in the UK. As members of the association, companies and individuals can gain multiple benefits that will add value to their business through access to knowledge, discounted training, consultancy services, audit and inspection support, as well as resources like document templates for risk assessments, CAPA, deviations, and more. Moreover, members can enjoy the benefit of a like-minded support network via a dedicated GDP community hub, providing a platform for discussions, seeking advice, and fostering new relationships. "Our mission is to ensure that patient safety, GDP compliance, and excellent quality is paramount in all organisations, regardless of budget," the company said.

People who use pharmacies in parts of Pendle have suffered shortages or delays in buying prescription medicines such as insulin, councillors have been told. In the Barnoldswick area, a number of pharmacies have been impacted and some councillors hope a new regional NHS organisation might look into the problems. However, pharmacies in the neighbouring town of Nelson are facing shortages with other medicines. A pharmacists in Nelson Pharmacy told Pharmacy Business that he was struggling to meet local demand for children's paracetamol due to ongoing shortages. Pendle Council's West Craven Area Committee heard about the issues at its latest local meeting, held in Earby. An agenda for the committee stated: "Pharmacy provision in West Craven. It is reported that there is an acute problem with people being unable to get prescriptions filled, with Whitworth chemists suffering a breakdown in service. Previously, Well chemists has suffered similar problems." Speaking at the meeting, Lib-Dem Coun David Whipp said: "It's quite an appalling situation where people are queuing 30 minutes to get a prescription filled but when they get to the counter they are told it's not ready. They have to go home and come back at 5pm. It's an ongoing problem. "It includes insulin, which is critical for people with diabetes. I know several people who have failed to get insulin, It's a very serious problem." He added: "I think the committee should contact the local integrated care service. I think they are responsible for primary care which includes pharmacies. We need to find out what's happening and improve things in future. "

Global instant logistics leader, Zipline is partnering with UK drone delivery startup, Apian Aero to launch a drone delivery programme of critical medical supplies for the Northumbria Healthcare NHS Foundation Trust. The new service, expected to begin in the autumn of 2024, will see delivery of medical supplies to hospitals, GPs and care homes, using electric, autonomous drones. Zipline announced the partnership on Sunday, and said drone delivery service will help provide timely access to prescription medicines, wound care products, joint replacement implants, and other frequently ordered medical products, which could allow healthcare providers to reduce the number of cancelled procedures, and thus decrease wait times. Also, the expansion of the programme will help in creating local job opportunities in the region, it added.

DE Group, one of the UK's leading independent pharmaceutical wholesalers, has gone into administration. Pharmacy Business has learnt that the group was put into administration on Monday (May 9), putting hundreds of jobs at risk and stoking fears of a "sudden shock" to pharmaceutical supply chain. A community pharmacy contractor who has done business with the wholesaler for over 20 years told Pharmacy Business: "I fear for the worst. I don't think there will be enough supply of medicines to cope up with a surge at such a short notice." Bharat Shah, founder and CEO of Sigma Pharmaceuticals, another leading short-line wholesaler, said the news will send shock-waves and have "a massive impact on the market" because DE Group enjoyed a "substantial coverage and market share" in the independent pharmacy sector. "It won't be easy for anyone to take on the extra volume as it could jeopardise their own business," he said, adding that Sigma was actively looking into expanding its own operations in the foreseeable future.

The International Pharmaceutical Federation (FIP) has offered a new resource to help countries self-assess readiness of their regulations to enable pharmacist-delivered vaccination services and, where needed, to implement such regulations. Developed by FIP's Regulators Advisory Group, it covers broad pharmacist-led roles related to vaccination from supply chain management to administration and prescribing. "This new resource from FIP is based on the experiences of professional regulators in countries where pharmacy-led vaccination has been successfully introduced and regulated. With it, we aim to support regulators, policymakers and national organisations in developing strategies or enabling regulatory frameworks in countries where the pharmacy workforce has a limited role in vaccination strategies so that it can contribute further to the global imperative of improving immunisation coverage," said Brett Simmonds, group chair. The "Pharmacy-led vaccination services: Regulatory self-assessment and implementation tool" aims to help identify strengths and areas for improvement in order to inform vaccination policy and planning efforts.

The recent announcement that Royal Mail will be partnering with distance selling pharmacy (DSP) giant pharmacy2U highlights how standards of regulatory enforcement are being ignored to accommodate the DSP model. The brunt of these double standards hinges around the levelling down of temperature enforcement standards by the Medicines and Healthcare products Regulatory Agency (MHRA) which demands mapping must be audited from the point of dispensing to the patient. The MHRA has a well recognised duty to ensure medicines reach patients in a safe condition. The current anomaly appears to turn a blind eye to this step in the supply chain at the point the wholesaler releases goods to the pharmacy hub. Equally the training on delivering medicines safely and effectively direct to patients should apply fully to all hubs including DSPs. Why is it that DSPs are being treated differently to bricks and mortar pharmacies? It's essentially the same patients receiving the same medicines from the same wholesalers. A further regulatory disparity exists around how parcels must be "tracked and signed for" to be reasonably certain medicines are delivered into the hand of the intended recipient, as per existing regulations. Clearly an untracked, unsigned package cannot be guaranteed to finish in the hands of the intended recipient. There is a very real possibility that such omission could lead to community pharmacy closures which will, in turn, lead to unemployment and a reduction in the care services. At a time when integrated care systems have just gone live, the removal of vital support services leading to further inequalities is the wrong message for both providers and patients alike.