Vol VII, Issue 4
Date of Publication: October 28, 2022
From a public interest perspective, the most important policy shift in the regulation of medicines in the 21st century is improved transparency. Until recently, the scientific evidence that companies provided to regulators to support approval of medicines for marketing was largely considered “confidential business information”, kept secret from researchers, clinicians, patients, and the public. This confidential information has included full reports of clinical trials testing treatment effectiveness. Policy shifts to open this body of scientific evidence to public scrutiny are a major advance, allowing independent researchers to re-analyse trials based on full unfiltered reports. Several of these re-analyses have led to profound shifts in the understanding of benefits and harmful effects of medicines. A second major win for public interests has been in uncovering not just the science but also the financial links between pharmaceutical companies and clinicians, through legally mandated company reporting in the United States (US) and in several European countries. Other countries, including the UK, are considering similar legislation , and self-regulatory industry reporting systems exist throughout the European Union and in Australia and the UK.
Copyright and license
©Indian Journal of Medical Ethics 2022: Open Access and Distributed under the Creative Commons license ( CC BY-NC-ND 4.0), which permits only non-commercial and non-modified sharing in any medium, provided the original author(s) and source are credited.