Latest news with #ABPI
Yahoo
21-07-2025
- Health
- Yahoo
Major HRT supplier sanctioned after whistleblowers raise concerns over patient safety
A major UK supplier of menopause drug HRT has been sanctioned after whistleblowers claimed patients were being put at risk, it has emerged. A group of employees from Theramex, which supplies HRT treatments to millions of patients in the UK, wrote a letter to the pharmaceutical regulator Association of the British Pharmaceutical Industry over allegations the company was not following regulatory standards and may 'jeopardise' patient safety. The whistleblowers claimed some products featured inaccurate prescribing information and failed to highlight common side effects. They claimed they had been forced to contact the regulator after their attempts to raise issues internally were brushed off. The company has now admitted it breached regulatory codes, amounting to 'bringing discredit upon, and reducing confidence in the pharmaceutical industry', according to an interim case report from the ABPI. It also failed to maintain high standards and provide accurate and up-to-date prescribing information, the report said. Theramex is a global pharmaceutical company specialising in women's health products, such as hormone replacement therapy (HRT) and fertility treatments. Theramex UK is its London-based arm. It supplies common HRT therapies including Evorel, Bijuve and Intrarosa. From April to June 2025, there were 760,000 prescriptions of Evorel and 2,748 prescriptions of Bijuve, according to data from the NHS Business Services Authority. In 2023-24, there were 2.8 million prescriptions of Evorel. One employee wrote the complaint on behalf of a group, according to the complaint published by the Prescription Medicines Code of Practice Authority, which is part of the ABPI. The complaint, filed in October 2024, said: 'We are a group of employees from various cross-functional teams at Theramex, and we are writing to express our growing concerns regarding the company's adherence to regulatory standards and the accountability of its leadership. 'While we have attempted to escalate these issues internally on numerous occasions, there has been a consistent lack of action or meaningful response, which leaves us with no choice but to seek external guidance and support.' The complaint alleged that some of Theramex's products, such as Intrarosa and Evorel, had not had their prescribing information updated. In the case of Evorel, information for health professionals was 'incomplete' and did not include information on common side effects such as uterine spasms and vaginal infection, the letter claimed. For another drug, the letter alleged that prescribing information had not been updated for five years. The complaint warned: 'This oversight can lead to healthcare professionals (HCPs) not being fully informed of potential risks, which could jeopardise patient safety.' The PMCPA panel found Theramix's 'failure to provide accurate and complete prescribing information was unacceptable'. The employees also alleged the company failed to comply with regulators for clinical trial compliance warning. 'The lack of resources within Theramex's global headquarters to ensure compliance with these standards is alarming,' it said. Finally, the letter alleged the company has a 'blame culture' that was 'deeply concerning.' In response to the complaint, Theramex UK said it took its obligations under the ABPI code of practice 'very seriously' and launched an internal investigation. It said that, although it had a process to update prescribing information, this was not sufficiently robust to ensure prescribing information was immediately updated. The pharma company acknowledged it did not meet standards concerning this allegation and admitted that, at the time of the complaint, it did not have a process in place for clinical studies. The employees' letter claimed it had tried to escalate matters to senior leaders within Theramex. The company claimed it was not aware of any of the matters having been escalated internally prior to them being reported to the regulator. As part of the sanction, Theramex must provide written confirmation that it will cease practices that breach codes, pay a charge and advertise details of the case. Theramex UK said it 'absolutely acknowledges' the recent ruling and 'respects the [regulator's] decision'. 'Of course, we remain fully committed to ensuring our practices align with the highest ethical standards and necessary steps and corrective measures have been taken,' it said.
The Independent
21-07-2025
- Health
- The Independent
Major HRT supplier sanctioned after whistleblowers raise concerns over patient safety
A major UK supplier of menopause drug HRT has been sanctioned after whistleblowers claimed patients were being put at risk, it has emerged. A group of employees from Theramex, which supplies HRT treatments to millions of patients in the UK, wrote a letter to the pharmaceutical regulator Association of the British Pharmaceutical Industry over allegations the company was not following regulatory standards and may 'jeopardise' patient safety. The whistleblowers claimed some products featured inaccurate prescribing information and failed to highlight common side effects. They claimed they had been forced to contact the regulator after their attempts to raise issues internally were brushed off. The company has now admitted it breached regulatory codes, amounting to 'bringing discredit upon, and reducing confidence in the pharmaceutical industry', according to an interim case report from the ABPI. It also failed to maintain high standards and provide accurate and up-to-date prescribing information, the report said. Theramex is a global pharmaceutical company specialising in women's health products, such as hormone replacement therapy (HRT) and fertility treatments. Theramex UK is its London-based arm. It supplies common HRT therapies including Evorel, Bijuve and Intrarosa. From April to June 2025, there were 760,000 prescriptions of Evorel and 2,748 prescriptions of Bijuve, according to data from the NHS Business Services Authority. In 2023-24, there were 2.8 million prescriptions of Evorel. One employee wrote the complaint on behalf of a group, according to the complaint published by the Prescription Medicines Code of Practice Authority, which is part of the ABPI. The complaint, filed in October 2024, said: 'We are a group of employees from various cross-functional teams at Theramex, and we are writing to express our growing concerns regarding the company's adherence to regulatory standards and the accountability of its leadership. 'While we have attempted to escalate these issues internally on numerous occasions, there has been a consistent lack of action or meaningful response, which leaves us with no choice but to seek external guidance and support.' The complaint alleged that some of Theramex's products, such as Intrarosa and Evorel, had not had their prescribing information updated. In the case of Evorel, information for health professionals was 'incomplete' and did not include information on common side effects such as uterine spasms and vaginal infection, the letter claimed. For another drug, the letter alleged that prescribing information had not been updated for five years. The complaint warned: 'This oversight can lead to healthcare professionals (HCPs) not being fully informed of potential risks, which could jeopardise patient safety.' The PMCPA panel found Theramix's 'failure to provide accurate and complete prescribing information was unacceptable'. The employees also alleged the company failed to comply with regulators for clinical trial compliance warning. 'The lack of resources within Theramex's global headquarters to ensure compliance with these standards is alarming,' it said. Finally, the letter alleged the company has a 'blame culture' that was 'deeply concerning.' In response to the complaint, Theramex UK said it took its obligations under the ABPI code of practice 'very seriously' and launched an internal investigation. It said that, although it had a process to update prescribing information, this was not sufficiently robust to ensure prescribing information was immediately updated. The pharma company acknowledged it did not meet standards concerning this allegation and admitted that, at the time of the complaint, it did not have a process in place for clinical studies. The employees' letter claimed it had tried to escalate matters to senior leaders within Theramex. The company claimed it was not aware of any of the matters having been escalated internally prior to them being reported to the regulator. As part of the sanction, Theramex must provide written confirmation that it will cease practices that breach codes, pay a charge and advertise details of the case. Theramex UK said it 'absolutely acknowledges' the recent ruling and 'respects the [regulator's] decision'. 'Of course, we remain fully committed to ensuring our practices align with the highest ethical standards and necessary steps and corrective measures have been taken,' it said.
Reuters
16-07-2025
- Business
- Reuters
Britain's life sciences plan gets mixed reception from pharma industry
LONDON, July 16 (Reuters) - Britain launched a life sciences sector plan on Wednesday to a mixed response from the pharmaceutical industry, which welcomed proposals to boost R&D but warned it would fail to keep firms competitive unless there was a deal on drug pricing. Life sciences is one of eight priority sectors under a new industrial strategy launched by the government last month, but the publication of a sector-specific plan was delayed as the pharma industry and government failed to agree a deal on how much revenue from UK sales firms must return to the country's health service. Industry figures have voiced dissatisfaction with Britain's tough pricing regime which they say prioritises low costs over investing in innovation and securing access to the latest medicine. While there was still an impasse on drug pricing, the government released the sector plan, which noted "intense competition for investment" and pledged to reform the regulation of medicine so more drugs get to the state-run National Health Service quicker. However, the Association of the British Pharmaceutical Industry (ABPI) said the plan was "not enough to turn around the UK's decline" and Britain still needed to address "the long-term disinvestment in innovative medicines." "For too long, the UK has sought to be the place where innovation happens, but not the place where it is used," said Richard Torbett, chief executive of the ABPI. The government cited supportive comments from pharma firms GSK, Moderna and BioNTech for its plan, even as industry sources said the unresolved drug-pricing talks were an "elephant in the room." AstraZeneca, the UK stock market's most valuable company, was not quoted in support of the sector plan in the government's statement. Earlier this month, the company declined to comment on a Times report that it was considering shifting its stock market listing to the United States. Tony Wood, chief scientific officer at GSK, said he welcomed reforms to incentivise more clinical trials and create a new lab network to accelerate drug discovery and development. But a GSK spokesperson added it was "critical that the UK also takes action with this new plan to recognise the value of innovative new medicines and vaccines for patients." Torbett said ABPI was in the "final stages of an intensive discussion" on drug pricing, to "get these issues out of the way and allow our sector to deliver on its potential."
Daily Mail
11-06-2025
- Business
- Daily Mail
UK Pharmaceutical industry at risk from government's 'sky-high' rebates system
The UK's status as a leader in medical research is at risk from 'sky-high and unpredictable' repayments pharmaceutical firms hand the Government, says an industry boss. Richard Torbett, chief executive of the Association of the British Pharmaceutical Industry, said the rebate system – where firms repay money they make through selling medicines to the NHS – was sending 'a terrible message to international investors'. Rachel Reeves promised to support 'the UK's strengths in life sciences' and 'ensure patients get rapid access to the most clinically and cost-effective new technologies'. The Treasury plans to invest up to £520million in drug manufacturing in the next five years. Another £600million is earmarked for a health data research service to accelerate the discovery of new medicines. But Torbett said more was needed. 'Over the past decade, accounting for inflation, the NHS budget has grown by a third in real terms, while investment in the most rigorously cost-benefit-tested part of health spending – investment in the medicines needed to treat people – has fallen from around 11 per cent to 9 per cent of the health budget,' he added. And he attacked plans to increase what drug companies must repay from drug sales to 31.3 per cent, from 15.5 per cent. 'The sky-high and unpredictable payment rates send a terrible message to international investors when the UK is trying to position life sciences research and development as an engine for health and growth. For the sake of patients, the NHS and the economy, we need a commitment to bring these unsustainable rates down.'
Business Mayor
11-05-2025
- Business
- Business Mayor
Pharma giants pin US tariff hopes on NHS price cap deal
Updated: 21:51 BST, 10 May 2025 Ministers are reviewing a controversial medicine tax that pharmaceutical companies say makes Britain 'uninvestable' as part of a wider US trade deal, The Mail on Sunday understands. Donald Trump's transatlantic trade pact last week slashed tariffs on British cars, steel and aluminium, but left the pharmaceutical sector in limbo. Drugs firms, including AstraZeneca and GSK, still don't know what, if any, tariffs they may have to pay. The President threatened to slap a 25 per cent tariff on UK pharmaceuticals entering the US, which last year totalled £6.6 billion. But last week's deal promised the sector 'significantly preferential treatment', with ministers vowing 'to improve the overall environment for pharmaceutical companies operating in the UK'. Industry sources say this refers to a drug-pricing scheme that already puts investment in the UK at risk. Under it, drugmakers discount the price of medicine sold in bulk to the NHS in England. The aim is to stop the health service busting its £20 billion-a-year drugs budget by imposing a cap. Any revenues above that limit are paid back by the drugs companies to the NHS in the form of a rebate. But the rebate has soared as inflation rocketed and expensive new drugs became available. Drug companies now pay back almost a quarter of their UK sales to the Government – far more than the 15 per cent estimated – meaning they make a lower return on their investment in research and development. The average rebate is 5.7 per cent in France, 7 per cent in Germany and 9 per cent in Ireland. Drugmakers say repayment rates are 'not viable' and put investment in the UK at risk – just as the Government earmarks life sciences as one of eight sectors key to kickstarting growth. The Association of the British Pharmaceutical Industry (ABPI) said: The medicine levy 'makes the UK uninvestable.' The trade body's members include US drugs giants such as Pfizer, Bristol Myers Squibb, Amgen, Johnson & Johnson, Merck and Biogen, which also operate in the UK and would stand to benefit from lower rebates. Health Secretary Wes Streeting is reviewing the rebate, which is likely to be wrapped in with ongoing US tariff talks, sources add. The UK spends a smaller share of its overall healthcare costs on medicines than any comparable country, according to the ABPI. Just 9 per cent of healthcare spending goes on drugs, compared with 17 per cent in Germany and Italy and 15 per cent in France. It is still unclear what type of special treatment British pharma firms would receive from Trump. Mark Dayan at the Nuffield Trust health think-tank said details were still 'very vague'. ABPI boss Richard Torbett said a free trade deal with the US was 'critical' for patients to have access to the medicines and vaccines they need, adding: 'US tariffs on UK pharmaceuticals run counter to that goal and should be avoided. We will also continue our discussions with the UK Government to ensure Britain's life science sector can return to international competitiveness to enhance UK attractiveness as a destination for investment.' Read More Royal Mail boss could be 'let go quietly' after deal with unions A Government spokeswoman said the US trade deal 'presents rich opportunities for collaboration on pharmaceuticals, life sciences and advanced technologies'. The review of medicine pricing is due to be complete next month, she added. Easy investing and ready-made portfolios Free fund dealing and investment ideas Flat-fee investing from £4.99 per month Account and trading fee-free ETF investing Free share dealing and no account fee Affiliate links: If you take out a product This is Money may earn a commission. These deals are chosen by our editorial team, as we think they are worth highlighting. This does not affect our editorial independence. Compare the best investing account for you
