The main objective of this study was to establish a baseline to monitor the public health implications of new Intellectual Property Rights regime and access to drugs. The study was conducted in three phases; a secondary data analysis of existing data bases in the state, private and international establishments; a prescription survey; and a cross sectional survey of knowledge and perceptions of personnel involved in pharmaceutical regulations on IPR.
New Chemical Entities were defined as the medicinal drugs registered with the DRA for the first time in Sri Lanka. During the 5- year period from 2005 to 2009, 70 NCEs were registered at the DRA by 19 pharmaceutical companies. The 70 NCEs were under 36 therapeutic groups according to ATC classification Level 3. Except for four therapeutic groups all other groups had alternative drugs of the same therapeutic group in the Sri Lankan market. Of the NCEs, 24 (34.28%) had competitor brands registered for the initial NCE at the time of this study. One hundred and eight applicants claimed patent rights for 874 (16.47%) chemical compounds and therapeutic claims, from the National Intellectual Property office in Sri Lanka from 2006 up to 2010 March. The patent information of the NCEs was also inquired from the importers of these pharmaceuticals. Official and unofficial information suggested that all the NCEs registered during this period are not patented in Sri Lanka.
A 10% sample of daily prescriptions was selected randomly from a SPC retail outlet. A sample of 1664 prescriptions was included in the study. Total number of prescriptions with NCEs was 151(9.07%). Of the 70 NCEs 22 (31.54 %) appeared in the prescriptions. Percentage cost per prescription for NCEs exceeded 50% for 82 (54.3%) prescriptions with NCEs. Knowledge and perceptions of personnel related to drug regulation was assessed through a self administered questionnaire. It was found that most of the participants were not knowledgeable about the IPR issues on pharmaceuticals.