A pharmaceutical policy is a health policy formulated and driven by governments designed to deal with the development, access and use of medications within a health care system. Effective patent laws form part of a pharmaceutical policy and the two should work together to deliver safe and accessible drugs.
This has often not been the case though, as governments especially those in poor countries, sometimes blame big pharmaceutical companies for being profit-conscious and often obstruct the production of generics which are usually far cheaper. Big pharma have responded that the cost of research and development of new brands is so high that patent laws ought to be strong in protecting their inventions so they can recover costs and have the incentive and means to work on new discoveries.
Following India’s Supreme Court’s dismissal in April, 2013 of Swiss pharmaceutical giant Novartis AG’s appeal for a patent for its cancer drug imatinib marketed as Glivec, some drug manufacturing firms have lamented that the ruling is a disincentive for the development of new brands and discovery of effective treatment options. This ruling has implications for the future of the relationship between pharmaceutical policy and pharmaceutical companies not only in India but in many poor nations. But in all the discourse, the health of the patient should be paramount. The reason is simple – not all of us may work for or own shares in a big pharma company or be formulating policy in government but sure enough all of us fall sick at one point in time. In sickness, our aim is common – get a pill and get well. That pill should be accessible and for poor people this is often a miracle.
Governments should provide incentives for innovation and new drug discovery. According to its Fact Sheet New Drug Development Process, The California Biomedical Research Association indicates that on average, it costs a company US$359 million to develop a new drug from the research lab to the patient. This is expensive. Governments could offer tax incentives to companies to enable them retain more earnings towards R&D.
Patent laws should be flexible to encourage production of generics. Creating room for unnecessary patent extensions often means that drugs would continue to be expensive. Commenting on the India’s Supreme Court ruling on the Novartis case, The Lancet explained that, in its branded form, Glivec costs about US$2,600 a month. The generic version is available in India for around $175 per month. The Court decision means generic drug makers can continue to sell copies of the drug at a lower price in India. (The Lancet, Volume 381, Issue 9874, Page 1263, 13 April 2013).
Government’s pharmaceutical policy should create a business friendly atmosphere to enable drug companies to innovate and invent new drugs. The accessibility and future of cheap drugs for the world’s poor however lies in generics and both governments and big pharma should work together to make this happen.
- The CBRA website: http://ca-biomed.org/news-and-programs/reporters.aspx
- The Lancet, Volume 381, Issue 9874, Page 1263, 13 April 2013
- Fact Sheet New Drug Development Process, The California Biomedical Research Associa.