Letter to the MJM

Dear MJM, It was a delightful experience to read the print copy of the McGill Journal of Medicine. Our previous experience of your journal was through your website. We congratulate the student team on producing an extremely professional journal. The paper and the print quality are comparable to the best journals in the world. The 9.2 issue carried a good collection of articles from various areas of medical science. We especially liked the Commentary article 'Who do I serve?'. The feature reviews in the special forum on Reflections by Neuroscientists were interesting. Being medical students and clinical pharmacologists from a developing country, we were especially interested in the article by Junaid Subhan on ‘’TRIPS agreement and public health. In Nepal, the domestic pharmaceutical industry is rapidly developing and some manufacturers have obtained the WHO Good Manufacturing Practice (GMP) certification. However, domestic manufacturers meet only about 50% of the country's requirements and the rest is met by imports from India, Bangladesh and China. India became TRIPS compliant in 2005 and Nepal yet has few years to do so. The author has given a very lucid elucidation of WTO and TRIPS. A major drug manufacturer in South Asia and the world is India. As Indian medicines are imported into Nepal, India also influences the Nepalese market. Before 2005, India did not allow molecules to be patented and only allowed process patents. Molecules introduced into the Indian market by one company could be manufactured by another company using a different process without infringing on the patent. This kept drug prices low and medicines were affordable to the vast majority. A downside, however, was that innovator companies were reluctant to introduce new molecules into the Indian market. Post 2005, new molecules are introduced faster into the Indian market and many Indian multinationals are investing heavily on research and development of new molecules. Compulsory licensing, as suggested by the author, may help in making essential medicines available at a low cost in the developing world. Parallel importing is also another good strategy to ensure access. India, China and Brazil are the major generic manufacturers that have provided cheap antiretrovirals and anti-TB drugs to other developing and even to developed countries. We basically agree with the author that the term 'essential medicines' should be defined within TRIPS. The change in the definition of essential medicines may be a good strategy. However, as rightly said by the author, companies may concentrate more on drugs which are strongly protected by patents and on which they will get a greater return on investment. This has already happened and tropical diseases and diseases of the developing world were neglected. Recently a number of initiatives like Medicines for Malaria Venture (MMV), the Drugs for Neglected Disease Institutive (DNDi) and the Global Alliance for TB Drug Development (based on public-private partnerships) have been started to encourage research and development of medicines for diseases of developing countries. Looking at the history of product patents in India, a long product patent may not by itself be an incentive for an innovator company to concentrate on developing a product. This had happened with molecules like ciprofloxacin and roxithromycin. Indian companies had also created copies of Sildenafil citrate. Restricting process patents only to essential medicines may be a good idea in principle. Again however, the Indian example tells us that the innovator company may enjoy protection only for a very short period of time. We personally think it is much more difficult to develop and test a new molecule while is is much easier to manufacture an already introduced molecule using a different technique. Placing restrictions on the second developer may be a good idea in principle. However, the practical details will require a lot of work. We congratulate the author on a well-written article and for exploring a possible means of balancing the interests of the innovator companies and the public health needs of developing countries. This is an area of debate. Medical students and doctors, we believe, should have at least a broad idea about TRIPS, patent protection, and its likely effects on the cost and availability of medicines.