The Association of the British Pharmaceutical Industry

The investment will be used, in part, to set up 18 new clinical trial hubs across the U.K. Amid a yearslong clinical trial decline in the U.K., a new public-private partnership has emerged in efforts to reinvigorate the country’s pharmaceutical testing prowess.The Voluntary Scheme for Branded Medicine Pricing, Access and Growth (VPAG) investment program made its official debut Wednesday, according to a release from the U.K.’s top biopharma trade organization, the Association of the British Pharmaceutical Industry (ABPI).The program—which combines the powers of the country’s Department of Health and Social Care, England’s National Health Service (NHS) and ABPI—has already snared an up to 400 million pound sterling ($527 million) investment to help accelerate patient access to cutting-edge drugs, bolster clinical trials and improve medicine manufacturing in the U.K. over the next five years.Additionally, 18 new clinical trial hubs will be created across the country in a bid to hasten research into new therapies. VPAG’s funding will be channeled into three main areas across the U.K., the country’s health and social care secretary Wes Streeting said in the release.Seventy-five percent of the investment will go toward an expansion of the U.K.’s clinical trial capacity and capability, with a major part of that focus being the setup of the 18 new commercial research delivery centers, Streeting said.Researchers will also be able to get their hands on “the latest equipment and technology” so studies can be run across hospital and primary care settings, as well as those in the community and residential care areas, the secretary added.The next 20% of the funding will help foster sustainable pharmaceutical manufacturing innovation, with the goal of slashing waste and emissions generated by the drugmaking industry.Meanwhile, the final 5% will be used to support innovative Health Technology Assessment (HTA) approaches, Streeting said. In effect, HTAs are used to assess the cost and clinical effectiveness of new treatments. This portion of VPAG’s investment will provide support to the HTA Innovation Laboratory operated by the U.K.’s drug cost gatekeeper, the National Institute for Health and Care Excellence, as well as a new horizon scanning database used to provide information on new drugs coming to market.ABPI described VPAG as the “first major public-private collaboration of this scale in the world,” with Streeting noting that the initiative is expected to support an “NHS fit for the future.”ABPI has been calling for a clinical trial revamp in the U.K. for years now.Back in 2019, the trade organization issued a call for increased clinical research in the country as part of its first clinical trial report. The report found that while sponsors kicked off more phase 1 and 2 clinical trials in the U.K. in 2017 than in any other European country, the island nation was fifth on the list of countries that initiated the most phase 3 starts. At the time, ABPI said it wanted the U.K. to boost investment in clinical research to keep pace with other countries like China and Germany, which spent a higher percentage of gross domestic product on R&D than the U.K.In another sign of the recently flagging U.K. clinical trials landscape, local nonprofit the National Cancer Research Institute—which had been in operation for 22 years—had to close its doors last June over lack of funding.Fiona Driscoll, the charity’s chair, cited the “uncertainty in the wider economic and research environment” as motivation behind the decision. The closure took place despite the U.K. government passing a more than $800 million spending package for the life sciences industry early last year, with a large portion of that outlay aimed at speeding up clinical trials.More recently, ahead of the U.K.’s general election in July, ABPI put out a challenge for the country’s political parties to blueprint plans designed to unlock the nation's healthcare industry potential. The trade group specifically called on the U.K. to reverse its clinical trial decline, bolster study recruitment and create pathways between genetic testing, personalized medicine access and studies. 

近日，时值英国大选落下尾声，英国制药工业协会（ABPI）指责辉瑞，诺和诺德，大冢，诺华四家药企违反了药企行为准则。 ABPI本身是英国150多家生物制药企业组成行业协会，共同生产了英国国家医疗服务体系（NHS）中所使用的90%的药品。由于采用的是会员制度，实际上可能类似于一个共享合作的平台，被ABPI取消会员资格就会导致市场准入受限，因此，此次指责也被视为一种警告。 本文将简单介绍此次指责的主要内容。 诺和诺德 最令ABPI担忧的就是诺和诺德，该公司未能披露2020年至2022年期间发生的价值约780万英镑（约合1000万美元）的资金流转。 而事实上，这并不是该公司第一次违反ABPI的行为准则。去年3月时，该协会就表示，因为“严重违规”将停止2年诺和诺德的会员资格。 “严重违规”的起因主要是领英上发布的体重管理赞助课程（其中主要宣传的是诺和诺德的利拉鲁肽），但考虑到没有按照ABPI法典的要求进行认证，同时它也没有包含所需的处方信息。这就相当于“贿赂医疗专业人员，诱使他们开处方。” 虽然当时遭到了2年会员资格“停牌”的惩罚，但是后续也是小事化了，在2023年年末ABPI审计后，诺和诺德的会员资格再度恢复。 诺和诺德对此自愿表示，它未能披露向155家供应商（包括医疗机构，患者和记者）的大约500笔转账。根据诺和诺德的声明，未披露的转账约占每年总转账的10%-14%。 ABPI将诺和诺德未能披露付款标记为“非常令人担忧”，并表示该公司“缺乏监督，其流程完全不足”。 诺华 诺华的违规行为集中在其心力衰竭药物Entresto（沙库巴曲/缬沙坦）的违规营销和误导信息上。 Entresto可以说是诺华的重磅炸弹，诺华对该药物的商业化推广也重视。可这样，也造成了对Entresto的过度吹捧。 问题就出在诺华制药组织并资助的一次活动中。 这是一个叫做“心连心”的播客活动。是专门面向心衰专科护士们开发的电视节目，在其中一集里，诺华公司展示了Entresto的一系列功效和安全性说明。这些断言在匿名举报下引起了处方药品行为准则管理局（Prescription Medicines Code of Practice Authority, PMCPA）的注意，而PMCPA则是专门负责监督英国药品营销法规的组织。 引起PMCPA关注的主要功效问题在于Entresto可能导致能量水平增加的断言。值得注意的是，这种说法与穿衣行为和穿衣过程中消耗的能量有关（？？？）。PMCPA认为这种说法“具有误导性，因为它无法得到证实。” 最严重问题来自于播客中提到的Entresto“肾功能轻微但可接受的下降”，这是一项安全声明。PMCPA表示，这一说法其实“没有任何限定条件”，并且“淡化了肾功能的重要性。” 我们实际上可以从Entresto的说明书里看到，对于一些本来肾功能就不好的患者来说，是应当慎用的。所以这一说法其实可能误导医生错误为肾功能较差的患者开出药方。 辉瑞 辉瑞的违规行为是在 X（当时还是推特）上推广未经许可的 Covid-19 疫苗。肇事推文是由辉瑞开发团队的一名高级职员发布的，然后由辉瑞英国的一名高级职员分享。2022年12月辉瑞英国在Twitter feed上有一篇帖子的标题为“随着英国进入2019年以来的第一个“无封锁冬天”，我们的辉瑞高级医疗员工解释了呼吸系统疾病在寒冷月份可能带来的毁灭性影响。 而匿名的投诉人声称，这篇文章的语气和内容明显是为了鼓励使用疫苗，特别是辉瑞的疫苗。例如，在题为“合作是支持国民保健服务恢复的关键”的一段中，作者说“我确信新冠肺炎只是冰山一角”。为了减轻卫生服务的压力，制药业、政府和科学界需要共同努力，为需要的人提供疫苗和治疗。疫情向我们展示了有效协作在帮助加快向患者交付解决方案方面的价值。我们需要在新冠肺炎之外继续发展和加强这些伙伴关系。 在题为“投资于新冠肺炎以外的预防”的段落中，作者继续说道，“投资于疫苗已被证明是具有成本效益的——最近的一项研究评估了三种疫苗接种计划的影响，包括肺炎球菌疾病，发现英国政府每投资1英镑的平均投资回报为2.18英镑。投诉人声称，该引用的研究(由ABPI委托和资助)中讨论的疫苗适用于许多疾病，但文章仅提到了肺炎球菌疾病，即作者的公司销售疫苗所针对的疾病。因此，这份声明是辉瑞疫苗的宣传声明。 大冢 大冢制药的违规行为和2015年发生的一起吹哨人事件有关。 主要涉及大冢制药英国分部的男性高级职员行为不当，他在酒宴后，试图为一位已经喝醉酒了的女性保健专业人员继续提供饮料，并在肢体上有挑逗行为。 而三名同公司女同事举报了该高级职员的行为。 具体违规点在于，大冢制药公司在这次案件中，未能披露相关信息，且存在报复吹哨人行为。 在涉及该案件时，被采访的员工没有被大冢制药允许查看或签署提交给PMCPA的陈述。这实际上违反了透明度和公正性的原则，因为员工应该有权了解并确认与自己相关的陈述内容。 投诉进一步指出，有三名员工因被视为吹哨人而被迫离开公司。这反映了公司内部可能存在的报复举报人的行为，这不仅是对员工的不公正对待，也违反了职业道德和行业规范中关于保护吹哨人的规定。 点击下方“药渡“，关注更多精彩内容 免责声明 “药渡”公众号所转载该篇文章来源于其他公众号平台，主要目的在于分享行业相关知识，传递当前最新资讯。图片、文章版权均属于原作者所有，如有侵权，请及时告知，我们会在24小时内删除相关信息。 微信公众号的推送规则又双叒叕改啦，如果您不点个“在看”或者没设为"星标"，我们可能就消散在茫茫文海之中~点这里，千万不要错过药渡的最新消息哦！

The Labour party has made a number of pledges to the UK’s clinical trial space. Image credit: Cameron Smith / Getty Images. On 4 July 2024, the people of the UK took to the polls and made their voice heard, voting for a new Labour government and stripping the Conservative party of its 14-year majority. Sir Kier Starmer’s party has taken control of parliament having taken 410 seats, compared to the Conservative Party’s 117 seats, a loss of 247 seats from the 2019 election. A new government means changes in industry investment, with the National Health Service (NHS) being a huge part of the election campaign for all parties. The Labour Party and Wes Streeting, who is likely to be appointed as Health Minister, have pledged to invest in various areas of the NHS, including commercial clinical trials. Speaking on Channel 4’s Election Night Show , Streeting spoke about how the UK life science and medtech sectors will be an important support network for the NHS, saying that by marrying together industry and service, “the sky is the limit”. See Also: Roche gains FDA approval for Vabysmo prefilled syringe Aflibercept biosimilar by Lupin for Wet (Neovascular / Exudative) Macular Degeneration: Likelihood of Approval The Association for the British Pharmaceutical Industry (ABPI) reports that the number of commercial clinical trials in the UK fell from 667 initiated trials in 2017, decreasing by 34% in 2020. Lord James O’Shaughnessy was asked to write a review on the state of the UK clinical trials industry, which found that the country had dropped from fourth to tenth globally in clinical trial initiation. This led to apprehension from sponsors about conducting trials in the UK in a post-Brexit world . A decline in clinical trials in the NHS not only impacts the country’s contribution to development on a global scale but also directly impacts financing for the service. In 2020/2021, the ABPI reports the NHS lost £447m in revenue due to a drop in commercial clinical trial activity due to the pandemic. The Labour manifesto pledges that the party will make the trial space more competitive, efficient and accessible. The manifesto says it will reduce trial set-up times by standardising the process and minimising the number of contracts and agreements required to set trials up in the UK. The party also hopes that it can make trials more accessible by setting up sites in community settings and GP practices. Partner at UK-based law firm Freeths, Claus Andersen, who specialises in the life sciences and technology sector, said that the Labour manifesto looks good on the surface but is only effective if it is implemented. “It’s interesting to see how Labour in their manifesto in some of the commentary leading up to the election has been focusing on developing the clinical trial space. It goes, to some extent, hand-in-hand with the wider push to make the NHS more efficient,” Andersen said. “The devil will be in the detail in that we obviously need to see what is actually implemented from the manifesto to actual legislation, but it does look as if they will be focusing quite significantly on streamlining the clinical trials process and the ability to get patients signed up to trials.” The manifesto goes on to say that the party will use data-led recruitment through current infrastructures such as the NHS app. The party hopes to speed up recruitment by making patients more aware of research in which they are eligible to be enrolled. Currently, the NHS app does redirect patients to a page where they can sign up to be involved in research if they have an interest. The party also hopes to provide access to patients from across the country and not make clinical research a postcode lottery. They also pledge to improve the diversity of patients enrolled in clinical trials to make it more representative of the patient population who will use the drug post-market. The party also claims that it will increase the workforce with 10,000 nurses and 7,500 doctors to help support those who want to be involved in clinical research. Those workers who wish to be involved in research will receive training about how they can support clinical trials and recruit patients. Finally, the party hopes that improving the amount of research conducted by the NHS will help to retain staff. “It is not only a matter of pay, but it’s also about terms. I believe that by involving more people in clinical research, you can add additional skills so it can be used as a useful recruitment tool,” Andersen added. “For those who are more inclined to get involved in academic research, I think that increasing access to that could be quite useful in staff retention. It won’t of course cancel out the staff demand for higher pay so that still needs to be addressed.” Responding to the Labour manifesto after it was released, the ABPI says the manifesto will have strong industry support and that it has long argued for the need to make running trials with the NHS more efficient and accessible, speeding up recruitment and giving more people a chance to participate in clinical trials and access the innovative treatments they offer. It is hoped that sponsors may feel more confident in the UK’s infrastructure to run clinical trials if these changes are implemented . ABPI chief executive Richard Torbett said: “During its campaign, Labour was right to single out the UK’s life sciences sector as a critical partner for their plans to deliver positive change and economic growth. A strong industry-government partnership will be vital to ensure that we continue to discover breakthrough medical innovation in the UK and ensure NHS patients are among the first people in the world to benefit from the latest medicines and vaccines. “The new government now needs to hit the ground running and rapidly set out a clear, detailed plan for what the government will do in the coming weeks and years to address persistent inequalities in access to medicines and vaccines, as well as unlock our sector’s true growth potential.” “If sponsors can see a change in the approach and see that it’s getting easier to get clinical trials off the ground, then I see no reason why they shouldn’t come back,” Andersen explains. “In terms of licensing UK is still a very strong nation and is part of the Horizon Europe programme . In the UK you have some of the biggest life science facilities in Oxford, Cambridge, and London. A general change in about the business climate as well will have an impact as businesses need to see a stability and some sort of certainty and predictability and that things are actually being carried out and not just said in a manifesto.” Charlotte Harpin, Partner in the health and life sciences team at UK and Ireland law firm Browne Jacobson, said: “Commitments to speeding up the clinical trials process by embracing technology and standardising documentation will be welcomed by the life sciences industry and should help to attract new investment and market entrants. “With the current system being sometimes difficult to navigate, particularly for new entrants to the clinical trials landscape, simplification appears to be a sensible policy. However, while there are some potential quick fixes that could be implemented – for instance, enabling clinical trial sign-up via the NHS app – the development of standardarised contract documentation and further streamlined governance will likely take longer. Establishing a clear responsibility for taking this forward will be key in order to realise these ambitions quickly.”