Clinical trials in Sri Lanka: new Act at the behest of the pharmaceutical industry?

Abstract

Clinical trials are defined as studies involving human participants, with the intervention being selected by the investigator (1). The intervention can be related to a new drug or device, or a new indication for an already approved drug or device. The intervention can also relate to different healthcare options, eg the trial may be aimed at comparing the management of a particular illness in the hospital to its management in the community.The state regulatory body for drugs in Sri Lanka is the Cosmetics Drugs and Devices Regulatory Authority (CDDRA). The CDDRA's permission is required for the registration and import of new drugs. In January 2009, the ministry of health appointed a subcommittee on clinical trials (SCOCT) under the CDDRA. The SCOCT's regulatory approval is necessary for clinical trials. The SCOCT requires ethical approval by a recognised ethics review committee (ERC). Further, according to the regulations, registration in the primary World Health Organization clinical trial registry network is mandatory. The clinical trial registry, which is in the premises of the Sri Lanka Medical Association, is the only such registry in the country.Recently, bureaucrats in the health and the finance ministries, as well as a few academics, have been pushing for a new Act on clinical trials (2). This paper highlights the various loopholes in this draft Act and describes how it may give the pharmaceutical companies opportunities to circumvent its provisions and exploit patients. The clinical trial industry has been perceived by these Faustian treasury economists as a magnet for foreign currency. The draft Act reflects an insouciant attitude to the patient's welfare and the free health system, which is unique to Sri Lanka. There were no consultations with the public or the stakeholders when this Act was drafted, and its provisions have still not been made known to academics, ERCs and the public.