International comparison of pharmaceutical industry payment disclosures in the UK and Japan: implications for self-regulation, public regulation, and transparency.

BACKGROUND: Self-regulation of payment disclosure by pharmaceutical industry trade groups is a major global approach to increasing transparency of financial relationships between drug companies and healthcare professionals and organisations. Nevertheless, little is known about the relative strengths and weaknesses of self-regulation across countries, especially beyond Europe. To address this gap in research and stimulate international policy learning, we compare the UK and Japan, the likely strongest cases of self-regulation of payment disclosure in Europe and Asia, across three dimensions of transparency: disclosure rules, practices, and data. RESULTS: The UK and Japanese self-regulation of payment disclosure had shared as well unique strengths and weaknesses. The UK and Japanese pharmaceutical industry trade groups declared transparency as the primary goal of payment disclosure, without, however, explaining the link between the two. The rules of payment disclosure in each country provided more insight into some payments but not others. Both trade groups did not reveal the recipients of certain payments by default, and the UK trade group also made the disclosure of some payments conditional on recipient consent. Drug company disclosure practices were more transparent in the UK, allowing for greater availability and accessibility of payment data and insight into underreporting or misreporting of payments by companies. Nevertheless, the share of payments made to named recipients was three times higher in Japan than in the UK, indicating higher transparency of disclosure data. CONCLUSIONS: The UK and Japan performed differently across the three dimensions of transparency, suggesting that any comprehensive analysis of self-regulation of payment disclosure must triangulate analysis of disclosure rules, practices, and data. We found limited evidence to support key claims regarding the strengths of self-regulation, while often finding it inferior to public regulation of payment disclosure. We suggest how the self-regulation of payment disclosure in each country can be enhanced and, in the long run, replaced by public regulation to strengthen the industry's accountability to the public.

A 'patient-industry complex'? Investigating the financial dependency of UK patient organisations on drug company funding.

We examined the minimum extent of dependency of UK patient organisations on pharmaceutical industry funding using drug company disclosure reports and patient organisation financial accounts from 2012 to 2016. We used linear regression to explain the overall share of industry funding ('general dependency') and top donor funding ('company-specific dependency') in organisations' income. Predictors included patient organisations' goal; having members and volunteers; geographical scope of activity; headquarter location; expenditure/income ratio; and disease area. The prevalent low levels of general dependency (IQR, 0.1%-6.0%) and company-specific dependency (IQR, 0.1%-4.3%) made a widespread capture of patient organisations unlikely, though only if one excludes the possibility of significant payment under-reporting. However, organisations with considerably higher dependency than others might be more prone to co-optation by industry. Of the 398 organisations, 18 (4.5%) and 8 (2.0%) had general and company-specific financial dependency over 50%, respectively. However, the shares of outliers exceeding the third quartile plus 1.5 times IQR were 51 (12.8%) and 56 (14.1%) for each dependency type. Certain characteristics including activity profile (advocacy) or indicating limited access to resources (remote location) made organisations vulnerable to developing financial dependency. Future research should examine both financial and non-financial links between the two sides and their impact on patient organisations' activity.

Comparing pharmaceutical company payments in the four UK countries: a cross-sectional and social network analysis.

OBJECTIVES: To examine the characteristics of pharmaceutical payments to healthcare and patient organisations in the four UK countries. Compare companies spending the most; types of organisations receiving payments and types of payments in the four countries. Measure the extent to which companies target payments at the same recipients in each country and whether it differs depending on the type of recipient. DESIGN: Cross-sectional comparative and social network analysis. SETTING: England, Scotland, Wales, Northern Ireland. PARTICIPANTS: 100 donors (pharmaceutical companies) reporting payments to 4229 recipients (healthcare organisations and patient organisations) in 2015. MAIN OUTCOME MEASURES: For each country: payment totals and distribution; average number of common recipients between companies; share of payments to organisations fulfilling different roles in the health ecosystem and payments for different activities. RESULTS: Companies prioritised different types of recipient and different types of activity in each country. There were significant differences in the distribution of payments across the four countries, even for similar types of recipients. Recipients in England and Wales received smaller individual payments than in Scotland and Northern Ireland. Overall, targeting shared recipients occurred most frequently in England, but was also common in certain pockets of each country's health ecosystem. We found evidence of reporting errors in Disclosure UK. CONCLUSIONS: Our findings suggest a strategic approach to payments tailored to countries' policy and decision-making context, indicating there may be specific vulnerabilities to financial conflicts of interest at subnational level. Payment differences between countries may be occurring in other countries, particularly those with decentralised health systems and/or high levels of independence across its decision-making authorities. We call for a single database containing all recipient types, full location details and published with associated descriptive and network statistics.

A hidden web of policy influence: The pharmaceutical industry's engagement with UK's All-Party Parliamentary Groups.

Our objective was to examine conflicts of interest between the UK's health-focused All-Party Parliamentary Groups (APPGs) and the pharmaceutical industry between 2012 and 2018. APPGs are informal cross-party groups revolving around a particular topic run by and for Members of the UK's Houses of Commons and Lords. They facilitate engagement between parliamentarians and external organisations, disseminate knowledge, and generate debate through meetings, publications, and events. We identified APPGs focusing on physical or mental health, wellbeing, health care, or treatment and extracted details of their payments from external donors disclosed on the Register for All-Party Parliamentary Groups. We identified all donors which were pharmaceutical companies and pharmaceutical industry-funded patient organisations. We established that sixteen of 146 (11%) health-related APPGs had conflicts of interest indicated by reporting payments from thirty-five pharmaceutical companies worth £1,211,345.81 (16.6% of the £7,283,414.90 received by all health-related APPGs). Two APPGs (Health and Cancer) received more than half of the total value provided by drug companies. Fifty APPGs also had received payments from patient organisations with conflicts of interest, indicated by reporting 304 payments worth £986,054.94 from 57 (of 84) patient organisations which had received £27,883,556.3 from pharmaceutical companies across the same period. In total, drug companies and drug industry-funded patient organisations provided a combined total of £2,197,400.75 (30.2% of all funding received by health-related APPGs) and 468 (of 1,177-39.7%) payments to 58 (of 146-39.7%) health-related APPGs, with the APPG for Cancer receiving the most funding. In conclusion, we found evidence of conflicts of interests through APPGs receiving substantial income from pharmaceutical companies. Policy influence exerted by the pharmaceutical industry needs to be examined holistically, with an emphasis on relationships between actors potentially playing part in its lobbying campaigns. We also suggest ways of improving transparency of payment reporting by APPGs and pharmaceutical companies.

Under-reported relationship: a comparative study of pharmaceutical industry and patient organisation payment disclosures in the UK (2012-2016).

OBJECTIVES: To examine the under-reporting of pharmaceutical company payments to patient organisations by donors and recipients. DESIGN: Comparative descriptive analysis of payments disclosed on drug company and charity regulator websites. SETTING: UK. PARTICIPANTS: 87 donors (drug companies) and 425 recipients (patient organisations) reporting payments in 2012-2016. MAIN OUTCOME MEASURES: Number and value of payments reported by donors and recipients; differences in reported payments from/to the same donors and recipients; payments reported in either dataset but not the other one; agreement between donor-recipient ties established by payments; overlap between donor and recipient lists and, respectively, industry and patient organisation data. RESULTS: Of 87 donors, 63 (72.4%) reported payments but 84 (96.6%) were mentioned by recipients. Although donors listed 425 recipients, only 200 (47.1%) reported payments. The number and value of payments reported by donors were 259.8% and 163.7% greater than those reported by recipients, respectively. The number of donors with matching payment numbers and values in both datasets were 3.4% and 0.0%, respectively; for recipients these figures were 7.8% and 1.9%. There were 24 and 3 donors missing from industry and patient organisation data during the entire study period, representing 38.1% and 3.6% of those in the respective datasets. The share of donor-recipient ties in which industry and patient organisation data agreed about donors and recipients was 38.9% and 68.4% in each dataset, respectively. Of 63 donors reporting payments, only 3 (4.8%) had their recipient lists fully overlapping with patient organisation data. Of 200 recipients reporting industry funding, 102 (51.0%) had their donor lists fully overlapping with industry data. CONCLUSIONS: Both donors and recipients under-reported payments. Existing donor and recipient disclosure systems cannot manage potential conflicts of interest associated with industry payments. Increased standardisation could limit the under-reporting by each side but only an integrated donor-recipient database could eliminate it.

Five years of pharmaceutical industry funding of patient organisations in Sweden: Cross-sectional study of companies, patient organisations and drugs.

BACKGROUND: Many patient organisations collaborate with drug companies, resulting in concerns about commercial agendas influencing patient advocacy. We contribute to an international body of knowledge on patient organisation-industry relations by considering payments reported in the industry's centralised 'collaboration database' in Sweden. We also investigate possible commercial motives behind the funding by assessing its association with drug commercialisation. METHODS: Our primary data source were 1,337 payment reports from 2014-2018. After extraction and coding, we analysed the data descriptively, calculating the number, value and distribution of payments for various units of analysis, e.g. individual companies, diseases and payment goals. The association between drug commercialisation and patient organisation funding was assessed by, first, the concordance between leading companies marketing drugs in specific diseases and their funding of corresponding patient organisations and, second, the correlation between new drugs in broader condition areas and payments to corresponding patient organisations. RESULTS: 46 companies reported paying €6,449.224 (median €2,411; IQR €1,024-4,569) to 77 patient organisations, but ten companies provided 67% of the funding. Small payments dominated, many of which covered costs of events organised by patient organisations. An association existed between drug commercialisation and industry funding. Companies supported patient organisations in diseases linked to their drug portfolios, with the top 3 condition areas in terms of funding-cancer; endocrine, nutritional and metabolic disorders; and infectious and parasitic disorders-accounting for 63% of new drugs and 56% of the funding. CONCLUSION: This study reveals close and widespread ties between patient organisations and drug companies. A relatively few number of companies dominated the funding landscape by supporting patient organisations in disease areas linked to their drug portfolios. This commercially motivated funding may contribute to inequalities in resource and influence between patient organisations. The association between drug commercialisation and industry funding is also worrying because of the therapeutic uncertainty of many new drugs. Our analysis benefited from the existence of a centralised database of payments-which should be adopted by other countries too-but databases should be downloadable in an analysable format to permit efficient and independent analysis.

Evaluating the transparency of pharmaceutical company disclosure of payments to patient organisations in the UK.

Patient organisations contribute to many areas of pharmaceutical policy. In developing their organisational capacity, many turn to financial support from pharmaceutical companies, which may create conflicts of interests. However, the transparency of the industry's self-regulatory approach to the disclosure of payments to patient organisations has evaded scrutiny. Using company reports disclosing payments to UK patient organisations in 2012-2016, we evaluate the transparency of reporting using indicators derived from industry's European patient organisation Code. We found a large proportion of companies did not have any disclosure reports available despite many having made payments, confirmed by comparing with annual financial accounts of patient organisations registered as charities. Where disclosure reports were available, many payments were not adequately described, resulting in large portions of money being disclosed without clarity as to the payment type and purpose. We found companies were clearer regarding whether payments were financial or benefits-in-kind, but transparency was particularly inadequate as to whether it could be determined if payments were indirect or direct and restricted or unrestricted, and almost no companies mentioned the VAT status of payments. Our findings suggest that the industry's self-regulatory approach to transparency has not been working efficiently. We suggest ways for standardising and increasing the precision of information by pharmaceutical companies and advocate for the introduction of a centralised, and easily accessible national-level payment database.

Analysis of Pharmaceutical Industry Payments to UK Health Care Organizations in 2015.

Importance: Drug company payments to health care organizations can create conflicts of interest. However, little is known about such financial relationships, especially outside the United States. Objective: To examine the concentration and patterns of drug company payments to health care organizations in the United Kingdom. Design, Setting, and Participants: This cross-sectional study examined nonresearch payments reported in the industry-run Disclosure UK database. Companies participating in Disclosure UK in 2015 and health care organizations receiving their payments were included in the analysis. The data were analyzed descriptively at the health care organization, payment, and donor levels, considering health care organization categories, payment categories, and companies from February 5 through May 28, 2017, with follow-up checks from June 1 through August 31, 2018. Analysis was conducted from July 10 through December 20, 2018. Main Outcomes and Measures: Share of funding and the Gini index (GI) to measure payment concentration (0 indicates perfect deconcentration [eg, all drug companies provide the same value of payments]; 1, perfect concentration [eg, 1 company provides the entire value of payments]) and median and interquartile range (IQR) to measure payment patterns. Results: A total of 4028 health care organizations received 19 933 payments, worth US $72 110 156.6, from 100 companies. This study identified 11 categories of health care organizations, with 3-public-sector secondary and tertiary care providers, education and research providers, and professional organizations-accumulating 67.2% of funding. The health care organization categories had varying GIs (range, 0.65-0.92), medians (range, $750.3-$45 862.4), and IQRs (range, $389.1-$1843.9 to $3104.4-$199 868.2). Of 4 payment categories, the top category-donations and grants-captured 50.6% of funding. Joint working (collaborative projects with nonindustry partners) had a lower GI (0.64) than other payment categories (range, 0.79-0.84). The median and IQR were the lowest for contributions to costs of events ($366.8; IQR, $229.3-611.3) and highest for joint working ($14 903.7; IQR, $3185.0-34,748.4). The top 10 firms (58.6% of funding) had payments with varying medians (from $366.8 [IQR, $244.5-611.3] to $9781.3 [IQR, $1834.0-48 906.7]). Conclusions and Relevance: Although organizations from across the health care system received funding, the payments were concentrated on a few large donors, payments, and recipients. Different payment and recipient categories had different patterns of payment values, suggesting that the industry has diversified its funding strategies across different parts of the health care system. These results suggest that Disclosure UK requires improved transparency, particularly by including built-in recipient categories, and that organizational conflicts of interest need more policy attention, including disclosure of payments independent of the industry.