This Article is set in the background of the consequences of the WTO’s prescriptions on patenting of life-saving medications which has largely contributed to the morphing of patents on life-saving medication into a luxury. Remarkably, there has been a transformation of the role of patents in the context of pharmaceutical innovation into a strategic business tool leading to a larger interest in creation and sustenance of regulatory rights. The biggest global development in this area is an increased effort to strengthen exclusivity using regulatory protections for all chemicals, and even, biologics, involved in all stages of drug development. Consequently, pharmaceutical companies have expertly navigated this confluence of patents with regulatory data protection to leverage themselves in a manner effectively creating high protection and financial rewards for what materials that could otherwise be susceptible for generic competition. This Article concerns itself with the regulatory regime that effectively provides for exclusivity of clinical trial data. The focus of the Article will be on how and why data exclusivity works for the pharmaceutical industry to promote and/or protect market exclusivity globally. Thus, the Article examines what data exclusivity is, the international trade obligations relating to providing data exclusivity, and the impact of the data exclusivity obligations on access to medication issues, with a specific focus on developing countries while keeping the U.S. regime as the vantage point to examine these issues. The Article outlines how the data exclusivity regime can operate in parallel with the patent regime to add a layer of protection for the data, thus adding to the protection regime for chemical or biologic data. In doing so, this Article will address some of the more controversial issues that have arisen globally with reference to data exclusivity within the larger access to medication debate.'Payers’ experiences with confidential pharmaceutical price discounts: A survey of public and statutory health systems in North America, Europe, and Australasia' by Steven G. Morgan, Sabine Vogler and Anita K. Wagner in (2017) 121(4) Health Policy 354-362 comments
Institutional payers for pharmaceuticals worldwide appear to be increasingly negotiating confidential discounts off of the official list price of pharmaceuticals purchased in the community setting. We conducted an anonymous survey about experiences with and attitudes toward confidential discounts on patented pharmaceuticals in a sample of high-income countries. Confidential price discounts are now common among the ten health systems that participated in our study, though some had only recently begun to use these pricing arrangements on a routine basis. Several health systems had used a wide variety of discounting schemes in the past two years. The most frequent discount received by participating health systems was between 20% and 29% of official list prices; however, six participants reported their health system received one or more discount over the past two years that was valued at 60% or more of the list prices. On average, participants reported that confidential discounts were more common, complex, and significant for specialty pharmaceuticals than for primary care pharmaceuticals. Participants had a more favorable view of the impact of confidential discount schemes on their health systems than on the global marketplace. Overall, the frequency, complexity, and scale of confidential discounts being routinely negotiated suggest that the list prices for medicines bear limited resemblance to what many institutional payers actually pay.
'Payments by US pharmaceutical and medical device manufacturers to US medical journal editors: retrospective observational study' by Jessica J Liu, Chaim M Bell, John J Matelski, Allan S Detsky and Peter Cram in (2017) 359 BMJ comments
Journal editors play a crucial role in scientific discourse. Editors triage new manuscript submissions and decide on those that warrant external review. For manuscripts that undergo external assessment, editors typically synthesise comments and decide which papers will be published. Based on concerns about lapses in integrity and unintentional bias associated with industry funding authors are now required to comprehensively report financial relations with industry to editors early in the publication process. However, compared with author conflict of interest, editorial conflict of interest has been infrequently studied.
For authors, publication in top tier journals plays a crucial role in obtaining grant funding and career advancement. For industry, publication in high impact journals bestows academic prestige and global attention to research and may speed regulatory approval, boost sales, and increase stock price. Journal editors wield enormous power; they are the individuals who determine a substantial amount of the content and conclusions of what appears in their journals, including article selection, article content, and which articles have accompanying editorials. Despite efforts to improve transparency, the peer review process often seems opaque to those on the outside.
In recent years, journal editors have responded to concerns by publishing more information related to the publication process, including authors’ financial disclosures (eg, International Committee of Medical Journal Editors (ICJME) authorship forms), study protocols, statistical codes, and even source data. Certain journals have moved to an open review process in which external peer review critiques, editorial comments, and author responses are published online to maximise transparency of the review process.
Improvements notwithstanding, the inner workings and decision making processes of editors remain a mystery to readers, authors, and the public. Authors have been expected to disclose financial relations using ICMJE conflict of interest forms at most reputable journals since 2010; however, financial disclosure requirements for editors remain highly variable. Professional societies such as the ICMJE, the World Association of Medical Editors (WAME), and the Committee on Publication Ethics (COPE) have published recommendations on editorial conflicts of interest. However, only 30-50% of high impact biomedical journals have clear editorial conflicts of interest policies in place.
Even when journals have editorial policies for conflicts of interest, studies estimate that only 12% of journals have published such policies and only 30% of policies have clear requirements for editorial recusal. Such lack of standardisation could create a perception that editors fail to adhere to the very conflicts of interest requirements they have appropriately developed for authors.
As part of the Affordable Care Act the US Centers for Medicare and Medicaid Services (CMS) have made available all payments by pharmaceutical and medical device manufacturer to doctors and other clinicians publicly available through the Open Payments database. We used this database to examine industry payments to journal editors at 52 influential US medical journals during 2014.
Their finding was
Of 713 eligible editors, 361 (50.6%) received some (>$0) general payments in 2014, and 139 (19.5%) received research payments. The median general payment was $11 (£8; €9) (interquartile range $0-2923) and the median research payment was $0 ($0-0). The mean general payment was $28 136 (SD $415 045), and the mean research payment was $37 963 (SD $175 239). The highest median general payments were received by journal editors from endocrinology ($7207, $0-85 816), cardiology ($2664, $0-12 912), gastroenterology ($696, $0-20 002), rheumatology ($515, $0-14 280), and urology ($480, $90-669). For high impact general medicine journals, median payments were $0 ($0-14). A review of the 52 journal websites revealed that editor conflict of interest policies were readily accessible (ie, within five minutes) for 17/52 (32.7%) of journals.
The conclusion is
Industry payments to journal editors are common and often large, particularly for certain subspecialties. Journals should consider the potential impact of such payments on public trust in published research.
