GenMed – 010: A Workshop on Generic Medicines

This report outlines the content of a one-day workshop on Generic Medicines that was held at KIST Medical College, Lalitpur, Nepal on 13th December 2010, which was attended by 32 delegates from different institutions in Nepal, including pharmacists, pharmacologists and medical doctors. Right medicine, right patient, right dose, right frequency and duration, right information and right monitoring are conditions to be fulfilled for the rational use of medicine (RUM). The World Health Organization (WHO) defines generic medicine as ‘a pharmaceutical product, usually intended to be interchangeable with the innovator product, marketed after the expiry of patent or other exclusivity rights’. Economic factors, supportive legislation and regulation, public and professional acceptance and quality assurance are key enabling factors promoting use of generics. Increased patent protection for medicines and removing process patents is a key feature of new trade agreements and newer medicines for diseases like HIV/AIDS, tuberculosis and infectious diseases are likely to be more expensive. The Medicine and Therapeutics Committee (MTC) can play a key role in promoting generic medicine use in institutions. Nepal being among the Least Developed Countries (LDCs) need not provide patent protection for medicines until 31st December 2015. Only a few ‘true’ generics are available in Nepal and there is huge cost variation in the price of different branded generics. Clinicians have concerns about the quality of medicines in general, substitution of poor quality brands by pharmacists and about therapeutic substitution. Generics have to meet the same regulatory requirements and be bioequivalent to reference preparations assuring their quality