Department of General Practice, RCSI University of Medicine and Health Sciences, Dublin, Ireland.
Department for Health, University of Bath, Bath, UK.
Health Policy. 2024 Nov;149:105155. doi: 10.1016/j.healthpol.2024.105155. Epub 2024 Sep 13.
Pharmaceutical companies spend hundreds of millions of pounds on marketing/R&D-related payments annually to healthcare organisations and healthcare professionals. UK pharmaceutical industry self-regulatory bodies require member companies who sign up to their code of conduct to publish details of their payments. They are also required to publish the methodologies underlying these payments, namely methodological notes. This study aimed to analyse UK pharmaceutical companies' methodological notes and their adherence to the Association of the British Pharmaceutical Industry code of conduct and other relevant guidance. We conducted a content analysis of methodological notes for the years 2015, 2017 and 2019 and assessed companies' adherence to self-regulatory bodies' requirements and recommendations for methodology disclosure. Overall, 90 companies made payment disclosures in all three years, publishing 269 methodological notes. We found gaps in adherence to self-regulatory requirements. Only 3 (3.3 %) companies provided clear information for all self-regulatory body recommendations and regulations in all of their notes. Companies also varied in their approaches to important areas. For example, of the 244 notes with clear information on VAT management, 36.1 % (N = 88) included VAT, 30.3 % (N = 74) excluded VAT, and 33.6 % (N = 82) had multiple rules for VAT. There was evidence of widespread non-adherence to self-regulatory requirements. This suggests flaws with self-regulation and a need for greater enforcement of rules or consideration of a publicly mandated disclosure system.
制药公司每年在营销/研发相关支付方面花费数亿英镑给医疗机构和医疗保健专业人员。英国制药行业自律机构要求签署其行为准则的成员公司公布其支付款项的细节。他们还被要求公布这些款项所依据的方法,即方法说明。本研究旨在分析英国制药公司的方法说明及其对英国制药工业协会行为准则和其他相关指导的遵守情况。我们对 2015 年、2017 年和 2019 年的方法说明进行了内容分析,并评估了公司遵守自律机构对方法披露的要求和建议。总体而言,90 家公司在所有三年都进行了支付披露,共发布了 269 份方法说明。我们发现遵守自律要求存在差距。只有 3 家(3.3%)公司在其所有说明中为所有自律机构建议和法规提供了明确的信息。公司在重要领域的方法也存在差异。例如,在 244 份明确说明增值税管理信息的说明中,36.1%(N=88)包含增值税,30.3%(N=74)排除增值税,33.6%(N=82)有多种增值税规则。有证据表明广泛存在不遵守自律要求的情况。这表明自律存在缺陷,需要加强规则的执行或考虑采用强制性公开披露制度。