By GIRISH MALHOTRA, PE, President, EPCOT Intl.
Affordability of HIV/AIDS drugs is critical for the well-being and survival of patients, especially in underdeveloped countries. Companies have done an excellent job of inventing the necessary drugs. Initially, the patients who were not covered under healthcare programs could not afford them.
Even those who were covered, food for the family and drug for an individual (1) became an excruciating choice. Companies in the developing countries took it upon themselves to commercialize processes that had lowered their manufacturing costs i.e. a lower selling price. Thus, the availability and affordability became possible to many in many countries.
Various governments and non-profit organizations (notably the U.S. government, Médecins Sans Frontières’, the World Health Organization, and the Clinton, and Bill & Melinda Gates foundations) have done an excellent job of making the necessary drugs available for the needy. However, in a slow economic environment, governments and foundations are facing funding challenges that could make availability of the necessary drugs an uphill task (2, 3). The need for these drugs has not gone away and is not going away.
How do we make the drugs more affordable? Is there a solution?
The answer to the query posed above is “yes!” and it comes from lowering the manufacturing cost. Using the best manufacturing technologies, along with the best business practices e.g. supply chain rationalization, economies of scale, better chemistry and improved execution, can lower the manufacturing cost of the needed drugs by 20 to 40 percent from the lowest selling prices listed at http://utw.msfaccess.org/drugs (4).
The cost reduction claim may seem to be large, but is not out of the realm of possibilities. Any cost reduction, i.e. lower selling price, is worth the effort. Anyone who is familiar with chemical processes and cost accounting can reverse (5) calculate factory costs within the ± range of the actual costs. A thorough review of the chemistry, process equipment, current practices, economies of scale and supply chain (6, 7) would be needed to develop better costs. Such review, along with creativity and innovation, can lead to the development and execution of the best and lowest cost process. Quality can be built in the process. Profits could also increase.
Abovementioned reviews and practices are a common practice in the chemical, petrochemical and other chemicals-related industries, but have not been practiced in the pharmaceutical manufacturing, which includes the manufacture of the active ingredients and their formulation to a dose. If done right, the saving could be higher. Best technology would also facilitate and simplify regulatory compliance.
If we are able to lower the cost of the needed drugs, pressures on the funding governments and the foundations could be reduced. It is possible that lower prices would extend coverage. It would be a win-win and lessons learnt could be used to lower costs of other drugs also.
What’s your take? Please feel free to comment below!
Malhotra, Girish: Drug Prices: Food vs. Medicine - A Difficult Choice for Some June 16, 2011
MSF Report: Funding shortages threaten advances against HIV/AIDS, political promises will fall short accessed October 18, 2012
Malhotra, Girish: Drugs for Infectious Diseases, Funding and Opportunity December 11, 2011
Médecins Sans Frontières’ Untangling the Web of Antiretroviral Price Reductions: 15th Edition accessed October 18, 2012
Malhotra, Girish: Neglected Tropical Disease (Infectious Diseases) Drugs: What are they telling us about Innovations! March 7, 2012
Malhotra, Girish: Chemical Process Simplification: Improving Productivity and Sustainability February 2011
Malhotra, Girish: Chapter 4 “Simplified Process Development and Commercialization” in "Quality by Design-Putting Theory into Practice" co-published by Parenteral Drug Association and DHI Publishing© February 2011