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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 University of Oxford's Centre for Research Equity (CfRE) has entered into a historic partnership with the Health and Social Care Research and Development (HSC R&D) Division in Northern Ireland to advance health equity across the region and ensure everyone benefits from healthcare advancements. Unveiled during an event at Parliament Buildings in Stormont Estate on Wednesday, this groundbreaking partnership makes Northern Ireland the first UK region to partner with CfRE. Supported by the Department of Health Northern Ireland and key health and social care agencies, the partnership aims to improve health outcomes and reduce disparities through collaborative research. Northern Ireland's Health Minister, Mike Nesbitt, highlighted that this new partnership represents "a significant step forward in efforts to address health inequalities" in the region. "By bringing together leading experts and resources from across sectors, we can work towards conducting research that truly benefits all of our communities," he said.

Pharmacy technicians will soon be recognised as fully regulated healthcare professionals in North Ireland. Work has begun to bring pharmacy technicians under statutory regulation by the Pharmaceutical Society of Northern Ireland, health minister Robin Swann has announced. The public consultation was launched in March 2022 on a proposal to introduce statutory regulation of the Pharmacy Technician workforce in Northern Ireland. The minister said: "This will be a key enabler to enhancing the contribution that pharmacy technicians can make to the delivery of healthcare across all settings. It will allow the regulator to strengthen its role in protecting patients and promoting high standards, thereby enhancing the public's confidence and trust in pharmacy practice." He added: "While there are many practical issues to be worked through with stakeholders, and legislative change required, I have now instructed my Department's officials to develop a detailed project plan to bring about the statutory regulation of pharmacy technicians by the Pharmaceutical Society of Northern Ireland".

Patients in Ireland with a specific type of lung cancer can now access Merck's TEPMETKO® (tepotinib) as a second-line treatment option, following its approval for reimbursement by the Health Service Executive (HSE). Tepotinib is the first treatment approved in Ireland specifically targeting advanced non-small cell lung cancer (NSCLC) with mesenchymal-epithelial transition factor gene (MET) exon 14 (METex14) skipping alterations. Previously, the oral MET inhibitor had been approved in the NHS across England, Wales, Scotland, and Northern Ireland. Patients with advanced NSCLC with METex14 skipping alterations typically have poorer overall survival rates compared to other NSCLC patients. According to Merck, tepotinib has shown consistent and durable antitumor activity in this group, as demonstrated in the VISION study, further cementing its role in clinical practice. Roisin Molloy, Managing Director of Merck Healthcare in Ireland, said: "This is an important step forward for targeted treatments in Ireland and it is fantastic news that the HSE has reimbursed tepotinib."

Bas Vorsteveld, who was made vice president and general manager for Great Britain & Ireland (GBI) in November last year, is joined by Monica Michalopoulou as GBI marketing director and Onyeka Anugwom as GBI commercial excellence director GSK Consumer Healthcare. He took over from Jonathan Workman, who held the position from 2018, and has now moved into the role of Business Unit general manager for Northern Europe. Vorsteveld, who has 15 years' industry experience, played at major part in the merger of Novartis and GSK consumer healthcare businesses. Most recently, he held the role of VP & head of commercial excellence EMEA LATAM at GSK Consumer Healthcare, where he spearheaded international sustainability initiatives. Commenting on his new role, Vorsteveld said: "I am incredibly honoured to have been a part of GSK Consumer Healthcare's journey to date and it is our collective ambition to deliver better everyday health with humanity for our customers, with a laser focus on 'self-care'. "The recent pandemic has shown us that healthcare matters more now than ever before for our consumers. We want to redefine the role that self-care plays in people's lives, because it can bring long-term benefits for individuals and society, and is a key component of a sustainable healthcare system.

A new legislation has been introduced to allow authorised pharmacists along with other healthcare professionals in Northern Ireland to certify 'fit notes', health minister Robin Swann has announced. Pharmacists and some other healthcare professionals in England, Scotland and Wales are already allowed to sign 'fit notes'. Swann announced that 'fit notes' were also set to go fully digital in the future, meaning they would no longer need to be signed in ink. He said: "I am delighted to introduce this legislation in Northern Ireland. This change will make it easier for people and employers to get the advice they need so people can stay in work and will help free up doctors' time. "Too often we see people being faced with unnecessary challenges to get a fit note. More professionals being able to offer this vital service will speed up the process and support people to return to or remain in work."

Despite being the most common genetic disorder in the UK, sickle cell disease (SCD) remains significantly underfunded and underserved compared to other genetic disorders, according to a new report published by the PDA BAME (Black, Asian and Minority Ethnic) Pharmacists' Network. The report also reveals that the disease is poorly understood within the healthcare system, including amongst pharmacists, pharmacy students, and foundation pharmacists in the UK. It emphasises the urgent need for increased awareness, funding, and improved healthcare access for SCD amongst these healthcare professionals. "A lack of education about SCD within the wider healthcare community, including pharmacy, greatly contributes to disparities in care. "Though the importance of SCD education for pharmacists and allied healthcare professionals is acknowledged, it remains unclear whether this topic is adequately addressed within the MPharm curriculum," the report said. The report further noted that in the absence of explicit guidance from the General Pharmaceutical Council (GPhC) or the Pharmaceutical Society of Northern Ireland (PSNI) and without more comprehensive education surrounding SCD embedded within the pharmacy curriculum, pharmacists and future pharmacists may remain "ill-prepared to manage patients with this complex condition." As per the report, sickle cell disease is the most prevalent genetic disorder globally, impacting millions, including around 17,000 people in England.

Bas Vorsteveld, former Haleon's vice-president and general manager for Great Britain and Ireland (GBI), has been appointed as Kenvue's new area managing director for Northern Europe. In his new role, he will oversee the company's operations across the UK, Ireland, Norway, Sweden, Denmark, and Finland, managing a portfolio of iconic brands, including Nicorette, Aveeno, Johnson's Baby, Listerine, Neutrogena, Calpol, OGX, and Imodium. Vorsteveld has over 30 years of experience in consumer goods and healthcare. At Haleon, he played a pivotal role in driving its GBI business following its separation from GSK, delivering significant growth and earning notable recognition, including Best Company at the UK Pharmacy Awards 2024. He announced his departure from Haleon in October 2024, after "a journey of nearly 19 amazing years." Until recently, Vorsteveld was president of the board of the PAGB, spearheading the organisation's five-year strategy focused on advancing self-care to help alleviate healthcare pressures.

Northern Ireland's Health Minister, Mike Nesbitt, has welcomed the launch of the 2024/25 Experiential Learning (EL) Programme, designed to equip future pharmacists with the skills needed for a greater role in clinical care. Starting in 2026, pharmacy undergraduate students will qualify as independent prescribers upon registration, and this programme is designed to prepare them for that responsibility. The EL Programme provides pharmacy students with multi-sector clinical work placements across the region. Speaking at the programme's launch at Ulster Hospital, Minister Nesbitt said: "This is the second year of this successful programme, which will see pharmacy students in Northern Ireland benefit from the training by completing up to twelve weeks of practice-based learning in hospitals, community pharmacies and general practices across NI. "This will provide them with actual practice-based experiences in a range of healthcare settings, facilitating them to interact with patients and engage in interprofessional practice.

The King's New Year Honours List 2025 has been announced, recognising unsung heroes who have made outstanding contributions to their communities across the UK. Over 1,200 individuals were honoured this year across various sectors, including healthcare, academia, sports, and voluntary service. Michelle Riddalls, CEO of PAGB - the Consumer Healthcare Association, has been awarded an OBE (Officer of the Order of the British Empire) for her exceptional work in advocating for the over-the-counter (OTC) medicines sector. She played a vital role during Brexit negotiations, ensuring continued access to OTC medicines in Northern Ireland and supporting self-care initiatives across the UK. Riddalls has provided oral evidence numerous times to the House of Lords Select Committee on the NI Protocol Bill and actively engaged with the Medicines and Healthcare products Regulatory Agency (MHRA) during the rollout of the Windsor Framework.

Recently, the English Health Secretary has talked about introducing a 'Pharmacy First' model similar to that which exists in Scotland. This would be a win-win outcome providing people with better access to essential healthcare support, advice and treatment whilst relieving strain on other parts of the NHS, not least GPs and A&E. It is a no-brainer and yet despite a few media headlines there are still no firm proposals on the table to make this a reality. It surely cannot be right that you can receive a broad range of patient care services in Scotland which are not available in England. It works well in Scotland, Wales is keen to develop more pharmacy-based services and Northern Ireland, leaving aside the current funding dispute, has had a minor ailments service for many years. If the English Health Secretary is sincere in his interest in adopting an English version of the Scottish model, then there are critical aspects he needs to consider. Firstly, start with the patient journey through the healthcare ecosystem from illness prevention through to long-term condition management. What is the role of community pharmacy and how do we guide people to seek support from the most appropriate healthcare professional? What is the vision for community pharmacy delivering patient care in the next decade? The lesson from Scotland is that the government needs to sit down with the sector and map that out together. There are no quick fix overnight solutions. This needs to be a long-term commitment backed by adequate funding. Supervision regulations need to change and there needs to be a thought through workforce strategy which avoids community pharmacy shortages as that does nothing to deliver improved patient outcomes.

The Department of Health has published 'A Guide to Developing the Role of Consultant Pharmacists' in Northern Ireland on Thursday (22 June). The guidance provides direction on supporting a consistent approach to the introduction of senior clinical pharmacy roles within and across HSC organisations. The Chief Pharmaceutical Officer Professor Cathy Harrison said: "There is a recognised need for increased clinical pharmacy and medicines focussed leadership across our HSC." "Consultant Pharmacists have an essential role in healthcare as clinicians and as leaders who make a significant impact to medicines optimisation and clinical governance, providing a vital link between clinical practice and service development by generating and disseminating evidence to drive improvements in care. "I am delighted that this guidance has been published to take forward the strategic development and appointment of the consultant pharmacy workforce in both primary and secondary care and to enable pharmacy to be at the forefront of healthcare in NI".

Change is sweeping through Westminster as the newly elected Labour government makes strategic cabinet appointments following their landslide victory in the general election held on Thursday, July 4. With Sir Keir Starmer stepping in as the new Prime Minister and Wes Streeting assuming the Secretary of State for Health and Social Care role, the announcement of Karin Smyth and Stephen Kinnock as health ministers on Monday marked a pivotal moment in Labour's healthcare agenda. Who is the new Minister of State for Health? Karin Smyth, the Labour MP for Bristol South, has been appointed as Minister of State for Health. Smyth has a robust background in healthcare, having served as a shadow spokesperson on health since December 2021. Her previous roles include Shadow Minister for Northern Ireland and Shadow Deputy Leader of the House of Commons. Before her parliamentary career, Smyth worked as an NHS Manager and held a non-executive director position at an NHS Trust.

The Royal Pharmaceutical Society (RPS) has published a consultation to review the 'Professional standards for the reporting, learning, sharing, taking action and review of incidents error reporting' in collaboration with Association of Pharmacy Technicians UK and Pharmacy Forum of Northern Ireland. The consultation is open from 21 April 2023 until 2 June 2023 and are due to be published in early 2024. All three professional leadership bodies are calling for contributions from anyone using the standards to ensure they are clear, current, relevant and fit for purpose. "The review affects all pharmacists, pharmacy technicians, trainees and members of the pharmacy team working in all sectors across the UK," RPS said. "The standards may also be of interest to the public, people who use pharmacy and healthcare services, healthcare and professionals working with pharmacy teams.

The Department of Health and Social Care (DHSC) has decided to enforce an 'indefinite' ban on the sale and supply of puberty blockers via private prescriptions for the treatment of gender incongruence and/or gender dysphoria in under-18s in the UK. This decision follows official advice from the Commission on Human Medicines (CHM), which found an "unacceptable safety risk" in the continued prescription of puberty blockers to children. The CHM, tasked by the health secretary and Northern Ireland Minister for Health to evaluate the safety of gonadotropin-releasing hormone (GnRH) agonists for puberty suppression, issued eight recommendations. It advised that a statutory indefinite ban be placed on the use of puberty blockers until its three recommended structures are in place to support safe UK prescribing.

Professor Mahendra Patel OBE, CEO of the Oxford University Centre for Research Equity (CfRE), has been appointed as an independent expert member of the UK Pharmacy Professional Leadership Advisory Board. The newly established Board comprises nine independent expert members (IEMs) with outstanding leadership capabilities, who were appointed through open recruitment, ensuring a "broad, balanced, and diverse" representation. Sir Hugh Taylor KCB, the Independent Chair of the Board, and the UK Chief Pharmaceutical Officers (CPhOs) - Andrew Evans (Wales), Cathy Harrison (Northern Ireland), Alison Strath (Scotland), and David Webb (England) - announced the appointment of IEMs in an open letter to the UK pharmacy professions. "Bringing a wealth of experience and expertise, they will play a pivotal role in the Board's work to deliver an exciting vision through supporting a new and dynamic phase of collaboration," the CPhOs said. As the CEO of CfRE, Professor Patel spearheads efforts aimed at addressing inequalities in healthcare.

The World Health Organization (WHO) issued a warning on Thursday regarding falsified semaglutide medications used for treating type 2 diabetes and obesity in select countries. This WHO Medical Product Alert addresses three falsified batches of the specific brand Ozempic that were detected in Brazil (October 2023), the United Kingdom and Northern Ireland (October 2023), and the United States (December 2023). These falsified semaglutide products were distributed through the regulated supply chain. Novo Nordisk, the genuine manufacturer of Ozempic, confirmed that the three products mentioned in the alert are falsified and were not produced by the company. Healthcare professionals, regulatory authorities and the public are advised to remain vigilant regarding these falsified batches of medicines. Dr Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products, urged stakeholders to stop any usage of suspicious medicines and report them to relevant authorities.

The government has announced a £100 million public-private investment to establish 20 new commercial research delivery centres (CRDCs) across the UK, aimed at increasing access to innovative treatments and clinical trials in underserved communities. These centres will be set up in all four nations: England, Scotland, Wales, and Northern Ireland, acting as regional hubs for pioneering clinical trials. These trials will span various conditions, including cancer, obesity, and infectious diseases like flu and respiratory syncytial virus (RSV). The hubs will facilitate the swift launch of commercial studies, ensuring that patients can access experimental treatments as soon as possible. Health Minister Baroness Gillian Merron hailed the investment as "a powerful vote of confidence in the UK's leading research and life sciences sector." She noted that the new hubs will shift research into smaller communities, allowing more people to access cutting-edge treatments faster.

Boots UK has agreed to grant a five per cent pay increase to its pharmacists following a collaborative agreement with the Pharmacists' Defence Association (PDA). This raise acknowledges the unique market conditions faced by pharmacists in the community pharmacy sector, Boots UK and PDA said in a joint statement on Oct. 9. According to the statement, the pay increase applies to all pharmacists within the PDA Union's bargaining unit, except for those who joined or received a pay raise after August 2023. Moreover, trainee pharmacists or those not meeting performance standards are not eligible for the raise. Additionally, pharmacists and store managers will receive a pro-rata, one-time non-consolidated payment of £750 in August 2024. This payment serves as recognition for their dedication to establishing and providing new core and advanced NHS services, particularly in light of the substantial changes anticipated in the upcoming year, the joint statement said. The services include new medicines, hypertension, contraception, and common conditions services in England, the clinical community pharmacy service in Wales, and the Pharmacy First services in Scotland and Northern Ireland.

The Royal Pharmaceutical Society (RPS) has updated the Professional Standards for Homecare Services to ensure high quality care for patients receiving medicines and associated services in the comfort of their own homes. Originally published in 2013, these standards provide a comprehensive framework to support teams involved in planning, commissioning, and delivering homecare services. The RPS said that these standards were updated to ensure that they align with the needs and expectations of recipients of homecare services, as well as commissioners and providers. Changes were made based on responses received through a consultation process, which was participated by representatives from the National Homecare Medicines Committee, the Association of Pharmacy Technicians, the Pharmacy Forum of Northern Ireland, and the Royal College of Nursing.