Unethical pharmaceutical marketing:a common problem requiring collective responsibility

Shai Mulinari and Piotr Ozieranski argue healthcare professionals and organisations should respond more forcefully to unethical marketing and support stronger regulatory actio

Divergent spender: State‐societal and meso‐organisational mechanisms in the containment of public spending on pharmaceuticals in a liberal capitalist democracy

For two decades, New Zealand has been placed consistently at the foot of OECD rankings for state expenditure on pharmaceuticals. In this article, we explore New Zealand's containment of pharmaceutical spending as a ‘divergent’ case of pharmaceutical policy in a liberal democracy. To elucidate the likely institutional mechanisms and interests behind this phenomenon, we conducted a case study of New Zealand's drug reimbursement policy. In doing so, we derived sensitising concepts from major accounts of pharmaceutical policymaking (Corporate Bias Theories and Reputational Theory) and theories of the western state (Historical Institutionalism and Corporate Domination Theory). Drawing on 28 expert interviews and documentary analysis, we identified three main mechanisms of spending containment. First, New Zealand's state bureaucracy use pricing strategies that rely on a spending containment strategy coordinated by bureaucratic managers. Second, these managers shape the policy preferences of expert committees involved in scientific drug assessment. Third, on a meta-level, conditions for spending containment are enabled by the judicial-legislative arena. As such, we find support for Historical Institutionalism and Reputational Theory and more limited support for Corporate Bias Theory and Corporate Domination Theory. Our explanation posits further conceptual linkages between the macro/societal and meso-organisational theoretical levels

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

Disclosure of Pharmaceutical Industry Funding of Patient Organisations in Nordic Countries: Can Industry Self-Regulation Deliver on its Transparency Promise?

Pharmaceutical companies regularly fund patient organisations. It is important for patient organisations’ credibility that there should be transparency regarding this financial support. In Europe, the pharmaceutical industry promises to deliver transparency through self-regulation, as opposed to legally binding provisions, but self-regulation’s effectiveness is contested. We compared the industry’s transparency of funding in four Nordic countries that, given their general reputation for high transparency, offered a critical test of self-regulation’s ability to deliver on its transparency promise. For 2017–2019, we compared: national rules regarding funding disclosure; disclosure practices as evidenced by the availability, accessibility, and format of company transparency reports; and disclosure data, including payment descriptions and sums. Transparency problems differed in kind and magnitude between countries. In Norway and Finland, unlike in Sweden and Denmark, data on funding were difficult to access and analyse, and sometimes seemed incomplete or missing. We explain that a key factor allowing for country differences is the freedom given to a country’s pharmaceutical industry trade associations to form self-regulatory rules, provided they do not fall below the weak European-level minimum requirements. Transparency could be improved by aligning rules and practices with the FAIR data principles: i.e., corporate disclosures should be findable, accessible, interoperable, and reusable

Advancing international comparison of pharmaceutical industry funding of patient advocacy: Focus on Denmark

Pharmaceutical industry funding of patient organizations raises ethical challenges related to patient engagement in healthcare due to fears of commercial agendas influencing patient advocacy and creating industry-driven inequalities across patient organizations. We contribute to an international body of knowledge on patient organization–industry relations by analyzing all payments reported by companies in Denmark over a six-year period, 2014–2019. We performed descriptive analyses calculating the number, value, and distribution of payments for various units of analysis: all companies and patient organizations; individual companies and patient organizations; and the broader disease area (e.g., cancer) and narrower disease (e.g., breast cancer). Fifty-one companies reported paying €8,826,916 to 84 patient organizations. As in previously studied countries, the funding was dominated by a relatively small number of funders and recipients, and commercially high-profile diseases attracted most of the funding. Nevertheless, our study also highlighted the arguably concerning dominance of one company in Denmark, both at the level of overall funding and in funding specific patient organizations, during a time of great policy contention surrounding one of its drugs, the world’s top-selling medicine; i.e., switching patients to cheaper biosimilars to save big money for the healthcare system. Patient organizations have reasons to rethink some collaborations with companies, especially during policy contentions, and governments should ensure equitable funding to counteract risks posed by the concentration of industry funding

Drug company payments to General Practices in England: cross-sectional and social network analysis

Although there has been extensive research on pharmaceutical industry payments to healthcare professionals, healthcare organisations with key roles in health systems have received little attention. We seek to contribute to addressing this gap in research by examining drug company payments to General Practices in England in 2015. We combine a publicly available payments database managed by the pharmaceutical industry with datasets covering key practice characteristics. We find that practices were an important target of company payments, receiving £2,726,018, equivalent to 6.5% of the value of payments to all healthcare organisations in England. Payments to practices were highly concentrated and specific companies were also highly dominant. The top 10 donors and the top 10 recipients amassed 87.9% and 13.6% of the value of payments, respectively. Practices with more patients, a greater proportion of elderly patients, and those in more affluent areas received significantly more payments on average. However, the patterns of payments were similar across England’s regions. We also found that company networks–established by making payments to the same practices–were largely dominated by a single company, which was also by far the biggest donor. Greater policy attention is required to the risk of financial dependency and conflicts of interests that might arise from payments to practices and to organisational conflicts of interests more broadly. Our research also demonstrates that the comprehensiveness and quality of payment data disclosed via industry self-regulatory arrangements needs improvement. More interconnectivity between payment data and other datasets is needed to capture company marketing strategies systematically

Accessibility and quality of drug company disclosures of payments to healthcare professionals and organisations in 37 countries: A European policy review

Objectives: To examine the accessibility and quality of drug company payment data in Europe.Design: Comparative policy review of payment data in countries with different regulatory approaches to disclosure.Setting; 37 European countries.Participants: European Federation of Pharmaceutical Industries and Associations, its trade group and their drug company members; eurosfordocs.eu, an independent database integrating payments disclosed by companies and trade groups; regulatory bodies overseeing payment disclosure.Main outcome measures: Regulatory approaches to disclosure (self-regulation, public regulation, combination of the two); data accessibility (format, structure, searchability, customisable summary statistics, downloadability) and quality (spectrum of disclosed characteristics, payment aggregation, inclusion of taxes, recipient or donor identifiers).Results: Of 30 countries with self-regulation, five had centralised databases, with Disclosure UK displaying the highest accessibility and quality. In 23 of the remaining countries with self-regulation and available data, disclosures were published in the portable document format (PDF) on individual company websites, preventing the public from understanding payment patterns. Eurosfordocs.eu had greater accessibility than any industry-run database, but the match between the value of payments integrated in eurosfordocs.eu and summarised separately by industry in seven countries ranged between 56% and 100% depending on country. Eurosfordocs.eu shared quality shortcomings with the underlying industry data, including ambiguities in identifying payments and their recipients. Public regulation was found in 15 countries, used either alone (3), in combination (4) or in parallel with (8) self-regulation. Of these countries, 13 established centralised databases with widely ranging accessibility and quality, and sharing some shortcomings with the industry-run databases. The French database, Transparence Santé, had the highest accessibility and quality, exceeding that of Disclosure UK.Conclusions: The accessibility and quality of payment data disclosed in European countries are typically low, hindering investigation of financial conflicts of interest. Some improvements are straightforward but reaching the standards characterising the widely researched US Open Payments database requires major regulatory change

The whistleblowing drama behind Astellas's suspension from the ABPI

The Japanese drug company Astellas has had its knuckles rapped for wrongdoing four times in less than three years. Now Deborah Cohen, Shai Mulinari, and Piotr Ozieranski reveal fresh claims about the treatment of an employee who offered to help it clean up its ac

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

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$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$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$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