Kept in the dark: Scotland rejects “sunshine” legislationBMJ 2019; 364 doi: https://doi.org/10.1136/bmj.l1379 (Published 29 March 2019) Cite this as: BMJ 2019;364:l1379
- Joseph S Ross, associate professor
In February, the Scottish government formally rejected a petition to introduce legislation that would have created a searchable record of all payments to healthcare professionals from the pharmaceutical and medical device industries.1 “Sunshine” legislation has been enacted elsewhere, including in the US, Australia, and Japan, and there are voluntary efforts in the UK, Germany, and Canada. The decision is a lost opportunity for Scottish citizens to have transparent information on the financial relationships between industry and their doctors and other healthcare professionals.
In the US, the Physician Payment Sunshine Act was enacted in 2009 as part of the Affordable Care Act and mandated drug and medical device manufacturers to start reporting all payments to physicians and teaching hospitals from August 2013.2 Disclosures are made available to the general public through a searchable website. The information includes direct and indirect payments for research, consulting, and advisory board service as well as payments in kind such as food, travel, and gifts; manufacturers must declare the value of the payment and the marketed products associated with it. In 2018, the US passed the Fighting the Opioid Epidemic with Sunshine Act, which will require manufacturers also to report payments made to advance practice nurses and physician assistants, beginning in 2022.
The Physician Payment Sunshine Act was the culmination of decades of growing concern over the influence of financial payments on the medical profession. Many of these concerns were summarised in a 2009 report by the Institute of Medicine which concluded that the primary goals of medicine—improving health by providing beneficial care to patients, conducting valid research, and offering excellent medical education—were at risk of being compromised by the undue pursuit of financial gain or other secondary interests posed by conflicts of interest.3 Without question, some financial links are beneficial to patients and to medicine. However, others may be improper, and it was expected that greater transparency would curtail these.
Unclear effects on behaviour
Whether sunshine legislation has reduced improper relationships is uncertain. In 2014, the first full year of reporting in the US, 11.3 million general payments to physicians and teaching hospitals totalling $2.7bn (£2bn; €2.4bn) were disclosed; these figures were largely unchanged in 2017: 10.7m general payments totalling $2.8bn. Similarly, no substantial changes were observed in research payments: 730 000 totalling $4.2bn in 2014 and 603 000 totalling $4.6bn in 2017. Moreover, evidence that patients use this information is uneven. One study showed that 65% of patients visited a physician who had received an industry payment during the previous 12 months, yet only 12% knew that payment information was publicly available and only 5% knew whether their doctor had received payments.4 In contrast, testimonials from patients suggest that these financial relationships erode trust and that public disclosure is needed.5
Seeing the light
Although greater transparency may not by itself curtail potentially improper relationships, sunshine legislation has provided other clear benefits to the medical profession. Journal editors, peer reviewers, and readers of the medical literature have been able to use the database to verify the disclosures of authors of research studies, commentaries, review articles, and guidelines. This ensures that all financial links between article authors and industry are transparently disclosed and that they can be considered when interpreting the study’s design or the article’s conclusion. Journalists and government agencies, such as the Center for Program Integrity, have also used the database to identify payments that violate antikickback and False Claims Act statutes.6 The independent, non-profit news organisation ProPublica used the database to investigate industry payments to physicians for promotional speaking, poor enforcement of conflict of interest policies by medical schools, and payments received by physicians accused of professional misconduct.7
In addition, the data have enabled investigation of associations between payments and prescribing. Studies have consistently found that physicians who received payments from the drug industry, even for small amounts, were more likely to prescribe branded medications associated with the payments than lower cost generics.891011 For example, we examined prescribing of oral anticoagulants and non-insulin diabetes drugs among Medicare beneficiaries in different areas, determining that one additional payment in a region was associated with roughly 100 additional days’ prescribing of the branded medication rather than an alternative.9
Scotland’s formal rejection of the petition to introduce sunshine legislation is a lost opportunity to have full transparent information on the financial links between industry and healthcare professionals. Other nations currently relying on voluntary reporting should consider mandating disclosure. Although there is no way to identify payments that are more concerning or suggestive of influence, efforts are needed to promote the use of the information by professional organisations and patients, not just journal editors, journalists, and government agencies, to ensure that sunshine legislation is as effective as possible in curtailing potentially improper relationships.
Competing interests: JR has received research support through Yale University from Medtronic, the FDA, the Centers of Medicare and Medicaid Services, and the Blue Cross Blue Shield Association in the past three years. He receives research support through Yale University from Johnson and Johnson to develop methods to share clinical trial data and from the Agency for Healthcare Research and Quality, the National Heart, Lung and Blood Institute, and the Laura and John Arnold Foundation to establish the Good Pharma Scorecard at Bioethics International and to establish the Collaboration for Research Integrity and Transparency at Yale.
Provenance and peer review: Commissioned, not externally peer reviewed.