Group items tagged

The British Generic Manufacturers Association (BGMA) has sought a judicial review of the Department of Health and Social Care's (DHSC) decision to negotiate a new Voluntary Scheme for branded medicines with the Association of the British Pharmaceutical Industry (ABPI). Mark Samuels, Chief Executive of BGMA said: "The Government has decided not to involve the trade body representing these medicine suppliers in its negotiations on the voluntary scheme for branded medicine pricing (VPAS). "We are deeply concerned by this decision. It has left us no choice but to take legal action." "While not all generic drugs fall within VPAS, four out of ten products in the current scheme are branded generics or biosimilars. As the representative trade body for both generic and biosimilar UK manufacturers, we must play a full part in the VPAS negotiations for the next period of the scheme from 2024 to 2028." "The VPAS tax has risen five-fold in under two years, an unprecedented tax increase. Yet our sector currently has no input into the negotiations on future schemes or rates; this is untenable as any decisions made on VPAS could significantly define the future of our sector in the UK and its ability to supply the NHS. The association had raised its full participation in the negotiations with the Government last November.

India will make tests mandatory for cough syrups before they are exported, a government notice showed on Tuesday, after Indian-made cough syrups were linked to the deaths of dozens of children in Gambia and Uzbekistan. Any cough syrup must have a certificate of analysis issued by a government laboratory before it is exported, effective June 1, the government said in a notice dated May 22 and shared by the health ministry on Tuesday. India's $41 billion pharmaceutical industry is one of the biggest in the world but its reputation was shaken after the World Health Organization (WHO) found toxins in cough syrups made by three Indian companies. Syrups made by two of these companies were linked to the deaths of 70 children in Gambia and 19 in Uzbekistan last year. "Cough syrup shall be permitted to be exported subject to the export sample being tested and production of certificate of analysis," said the notice issued by the trade ministry. The health ministry did not immediately respond to a query on whether testing would be required for cough syrups sold in the domestic market.

Susan Rienow, UK Managing Director and Country President of Pfizer is all set to take up her role as President of the Association of the British Pharmaceutical Industry (ABPI). The association had announced her appointment in March. Last year in September she was appointed as the vice-president of ABPI. In her new role, she will oversee the ABPI, the ABPI Board, and the ABPI's Code of Practice, which is administered by the Prescription Medicines Code of Practice Authority (PMCPA). Susan takes up the Presidency as negotiations begin for a new Voluntary Scheme for branded medicines pricing between the government, NHS England and the ABPI. All parties are looking to secure a new agreement that will help improve patient outcomes, support a healthier population and a financially sustainable NHS, while also supporting economic growth for the UK.

Ceuta Group, a global brand building business providing end-to-end outsourcing services in the health and wellness industry has appointed David Wright as a non-executive board director. With extensive experience of leading global consumer healthcare companies, David joins Ceuta Group following five years as CEO/President of global pharmaceutical company, HRA Pharma and six years as Global Head of Boehringer Ingelheim's consumer business. During his time at HRA Pharma and Boehringer Ingelheim GmBH, David led both companies through substantial organisational and strategy re-design which led to sustainable growth and profitability. The company said: "David has a strong belief that combining the right structure, operational priorities and processes, with a strong focus on company culture, are critical factors in building successful businesses. This approach saw him lead a period of transformation at HRA Pharma resulting in the company's successful acquisition by Perrigo Company plc." David will take an active role on the Ceuta Group Board supporting and building the company's strategic vision and priorities. He will also help shape the company's growth plans on an operational level to ensure Ceuta Group continues to meet client's needs today and into the future.

The British Generic Medicines Association (BGMA) has called for exemption from the Voluntary Scheme for Branded Medicines Pricing and Access (VPAS), an agreement between the UK Government, NHS England, and the pharmaceutical industry for branded generics and biosimilars. "Due to the rising rate of VPAS on top of existing competition, manufacturers are finding the additional levy economically unviable given their already low prices," the association said. According to research by the Office of Health Economics OHE and Professor Alistair McGuire (LSE) the rising rate of VPAS will force manufacturers pull out of the market which may lead to prices rise due to a lack of competition and critical savings to the NHS will be lost. The new study stated that Government levy on medicines designed to increase access to new treatments and promote affordability could actually be denying the NHS billions of pounds of annual savings due to the impact it is having on branded generics and biosimilars.

Professional translators recreate texts, not simply matching word-for-word, but understanding the underlying meaning, purpose, and interpretation of the original language, and reproduce it using appropriate terminology and structure to ensure there is no potential for misunderstanding. An experienced technical translator addresses conventions to ensure the meaning of the information is preserved, using medical expertise and quality review processes to adapt documentation to meet the needs of patients, medical practitioners, and peers. Attention to detail is fundamental to medical translations and a non-technical translation is an unacceptably high risk for any organisation involved in publishing or circulating medical information of any kind. WHAT IS MEDICAL TRANSLATION? Medical translation is a technical process where capable translators reproduce content or documentation used anywhere in the medical industry, including psychiatry, systematic reviews, tuition and training, patient communications for pharmaceutical translation services. Important clinical trial translations can include labelling, prescriptions, medical devices and patient records, with millions of medicines and treatments used globally and written in multiple languages. Qualified medical translators must have exceptional linguistic skills but also a thorough understanding of medical sciences in all the native languages concerned. However, the complexity of translating one label or one document into several languages can mean that organisations may assume a simple translation is sufficient - when it is anything but!

The British Generic Manufacturers Association (BGMA) has published a positioning paper which sets out the objectives that need to be delivered through the next Voluntary Pricing and Access Scheme (VPAS) on Thursday (15 June). The paper details how a financially sustainable VPAS can support widened medicines access to patients. VPAS is an agreement between the Department of Health and Social Care (DHSC), NHS England and The Association of the British Pharmaceutical Industry (ABPI). The scheme aims to limit increases in spending on branded medicines to no more than 2% per year via a rebate system which is charged on companies' sales revenues. Two years ago, the rate was 5.1% but for 2023 it has soared to 26.5%. Last year, the association had raised concerns over the rise in the VPAS rate for 2023 to 26.5 per cent. "The rocketing rate is in large part due to the growth in spend in on-patent medicines since 2019. Looking at the four completed years of the current VPAS scheme, data shows that the average annual growth rate for on-patent medicine sales value from 2019-22 was 18% compared to just 2% for off-patent products," said the association.

The Department of Health and Social Care (DHSC), NHS England and the Association of the British Pharmaceutical Industry (ABPI) have reached an agreement on the 2024 voluntary scheme for branded medicines pricing, access and growth (VPAG). The landmark deal will save the NHS £14 billion over 5 years in medicines costs, boost the nation's health, and support research investment. The new VPAG scheme, which will be a non-contractual voluntary agreement between DHSC and ABPI, will run for 5 years from 1 January 2024 until 31 December 2028. It will double the annual allowed growth of sales of branded medicines from two per cent per year in 2024 to four per cent per year by 2027.

Mental health has become a major concern worldwide and across all sectors,including pharmacy and pharmaceutical industry. The penetration of the issue exacerbated during the Covid-19 pandemic, due to mental fatigue, anxiety and most importantly the social distancing. Therefore, building an environment of trust and comfort is utmost essential to understand and tackle mental health challenges, said panelists in a discussion on Mental Health And Wellbeing In The Workplace, held during the Pharmacy Business Diversity Conference on Thursday (December 9).Talking in context of workplace, Monika Misra, head of Employee Health and Wellbeing, Europe and MEA, said: "We really need to create an environment of trust where we a have the manager, really trying to understand the unique challenges and needs of the individual, but be also ensuring that the individual feels comfortable to open up and have that conversation with their manager."

Following intermittent shortages during the holiday period and amid continued high level of demand for lateral flow tests (LFT) in pharmacies, the industry has voiced concerns over supplies. Royal Pharmaceutical Society in England chair Thorrun Govind recently gave numerous media interviews over the issue, supporting pharmacists and reassuring the public. She said it is 'frustrating' for pharmacy teams who are unable to access enough test kits to meet the growing demand and highlighted that placing all supplies with a single distributor as a key issue. Many in the sector have raised questions about the government's strategy for LFT distribution after it emerged that the sole distributor to pharmacies closed for four days shortly after receiving 2.5 million tests. Alliance Healthcare, from whom pharmacies receive LFTs, reportedly took delivery of the tests on Christmas Eve and then shut.

Alitam Group, the 100-plus pharmacy store consolidation, has appointed Bharti Patel, the former group executive director of Avicenna to its executive board. Patel, who was part of the leadership team at Avicenna until late 2021, brings with her a wealth of experience covering pharmaceuticals, multiple retail and independent pharmacy, homecare and NHS primary and secondary care. In her early career, she worked at Lloyds Pharmacy, where she rose from a prescription medicines buyer to director of procurement over a period of eight years. She is known in the industry for her strong leadership, commercial acumen and ability to create opportunities for innovation and strategic partnerships. Alitam founder and CEO Feisal Nahaboo said in a statement that Patel's appointment will further strengthen the group's ability to deliver its transformative multi-billion-pound 'Pharmacy of the Future' concept.

Governments should invest in vaccines for all strains of influenza virus that exist in the animal kingdom as an insurance policy in case of an outbreak in humans, the incoming chief scientist at the World Health Organization said on Monday (Feb. 20). Countries ranging from the United States and Britain to France and Japan have suffered record losses of poultry in outbreaks of avian flu in the past year. The recent spread to mammals of H5N1 - commonly known as bird flu - needed to be monitored, but the risk to humans remained low, the WHO said earlier this month. Incoming WHO chief scientist Jeremy Farrar said he would like to see the pharmaceutical industry at least conduct some clinical trials for all influenza strains such that the world would not have to start from scratch to initiate global manufacturing should the need arise. "My concern that we're in slow motion watching something which may never happen," he added in a media briefing. "But if it were to happen, would we look back on what we're doing at the moment and say, why didn't we do more?"

While Northern Irish business groups has welcomed the certainty a new EU-UK deal on post-Brexit trade rules for the region provided, the pharmaceutical industry too has expressed cautious optimism. In his speech on the Windsor Framework on Monday (February 28) Prime Minister Rishi Sunak said the agreement "delivers a landmark settlement on medicines". "From now on, drugs approved for use by the UK's medicines regulator will be automatically available in every pharmacy and hospital in Northern Ireland," he announced. The National Pharmacy Association's Northern Ireland manager Anne McAlister expressed a sense of cautious optimism. She said: "While the devil may yet be in the detail, the Windsor Framework would appear to be good news for pharmacies in Northern Ireland. It seems to address the main concerns we have expressed about medicines supplies to NI, but we want to examine the small print to ensure the new arrangements meet the needs of our members and the patients they serve.

The Association of the British Pharmaceutical Industry (ABPI) has welcomed the new research guidance published by NHS England for the integrated care systems. The guidance is said to reflect the benefits of delivering research, for patients, staff and healthcare system performance, including the economic benefits for the NHS. Jennifer Harris, ABPI's Director of Research Policy, said: "This guidance is clear on what good research practice looks like and it's great to see it out and available for the NHS to use. "A research-active NHS delivers huge value to patients, staff and the system itself. We hope that putting this guidance into action will help Integrated Care Systems realise the huge benefits that research can offer, and help make the UK once again a destination of choice for developing the medical breakthroughs people need."

Orphan Drug development specialist TMC Pharma has appointed Gordon Cameron to its board as a non-executive director. Mr Cameron has 25 years' board-level experience in biotech and pharmaceutical services sectors. He started his career with EY, then spent several years in investment banking at Rothschild before becoming CFO, and then CEO, of international vaccine company Acambis. For the past 15 years, Mr Cameron has been CFO of Quotient Sciences, an international Contract Development and Manufacturing Organisation and Clinical Research Organisation. In 2004, he was awarded the Officer of the Order of the British Empire for services to the British biotechnology industry. Julie Matthews, chief executive officer of TMC Pharma, said that the new appointment would "enhance our strategic capability and tactical execution as we consolidate our position as a global leader in the Orphan Drug development market."

What will it take to get help from the government before an individual or sector breaks? Pharmacists raised questions after the Pharmaceutical Services Negotiating Committee (PSNC)'s 2023 Pharmacy Pressures Survey confirmed the ongoing pressures and health issues faced by the pharmacies. Pharmacists are not all shocked by the PSNC's survey report as they feel the same as what has been reported related to their businesses and health. They hope the government listens and work with them to find resolutions. "We are bullied into a corner," said Salim Jetha Chairman, Avicenna. "Unlike other industries, we can't increase our prices. Most of the daily calls I get from Independents is about financial health of their business and any cost cutting would be detrimental to patient care. Urgent holistic review is required." Bristol pharmacist Ade Williams said: "The report is a dire indictment, and I would also warn, likely an underestimate of the extent and detrimental impact of the ongoings pressures and squeeze on Community pharmacies." "If the closest interface of the NHS to communities and patients is so distressed, what does that mean for those that need and depend on us? We are notoriously very stoic, so this is a warning light, which, taken with workforce pressures, market-exit activity, and other reports raising concern about wellbeing and stress, must beg the question; what will it take to get help before the sector and individuals break?" he questioned. The survey results don't surprise Kent-based community pharmacist Amish Patel. He said, "I have been feeling exactly what has been reported for far too long. I'm burnt out and would say beginning to suffer with my own health because of it. Now it's for PSNC to talk to government, and government to listen and work with us to find resolutions."

What initially began as two close friends taking a leisurely walk to escape their everyday routine has evolved into a meaningful endeavour to support the fight against cancer. Jamie Sparrow, Senior Vice President - Commercial, EMENA at Accord Healthcare, and Jamie Durbidge, Owner & Managing Director of Perennial Pharma, will be undertaking a 5-day walking challenge to support The Luke Hart Foundation in raising funds for Cancer Research UK. The two Jamies have been friends for more than 15 years and worked together at Mylan, now Viatris, where Jamie S served as Managing Director, while Jamie D held the position of Sales Director for some years. During the COVID pandemic when everybody was stuck at home, the two friends, both early risers, used to spend hours in the mornings walking and talking over the phone, about anything and everything - work, life, family, the Pharmaceutical Industry, politics, sport, and about challenges that people were having during the lockdown. After continuing this routine for several months, they eventually planned to transform their daily ritual into a "walking and talking" trip to reconnect, catch up on things, and enjoy some time together and with friends who wanted to join them.

Thorrun Govind, a former chair of the English Pharmacy Board of the Royal Pharmaceutical Society, has joined Brabners' regulatory & professional conduct team. With nearly a decade of experience as a GPhC-registered pharmacist, Govind will provide guidance on regulatory and professional conduct issues. Govind's expertise extends to healthcare advisory and disputes involving NHS Trusts and social care organisations. She has been recognised as the 'Young Pharmacist of the Year' by Pharmacy Business Magazine and is a frequent commentator on public health and healthcare law for major television networks. Her appointment underscores Brabners' commitment to offering top-tier legal services to the healthcare industry.

The Association of the British Pharmaceutical Industry (ABPI) has laid out a series of urgent actions it wants the newly elected Labour government to implement within its first 100 days in office. Among the top priorities, the ABPI has emphasised the urgent need to appoint a new Chair and Chief Executive for the Medicines and Healthcare products Regulatory Agency (MHRA). Additionally, the ABPI has urged the new government to launch the Life Sciences Manufacturing Capital Grants Facility without delay. Other measures the ABPI wants Labour to prioritise include: Rapidly passing outstanding UK clinical trials legislation to enhance the UK's attractiveness for inward investment, including into research within the NHS. Increasing commercial flexibility in the NHS England Commercial Framework for New Medicines to remove barriers for companies to launch new medicines and indications so that NHS patients can access the latest innovative medicines.

Possess state-of-the-Art manufacturing facilities for finished Dosage Forms & API's conforming to the most Stringent International Norms WHO-GMP, TGA (Australia), MHRA (UK). Manufacturing capacity (Finished Dosage) : 2300 million Tablets 64 million Ampoules 27 million Vials 84 million Capsules 18 million Dermatological products 62 million Oral liquid bottles Manufacturing capacity (API) : 1,50,0000 (15 lakhs) sq.