Generic medicines are not substandard medicines

Sir—Carol Adelman and Jeremiah Norris (Dec 22/29, p 2174), who work for the industry-funded Hudson Institute, advocate the use of patented drugs, pointing to what they say are risks associated with generic drugs. They confuse generic drugs with old, substandard, ineffective, and counterfeit drugs. Generic does not mean old. The 1996 World Trade Organisation (WTO) Agreements mandate all member countries to provide 20-year patent protection for medicines. Before that date, however, many countries (including Spain, Finland, and India) thought of medicines as too important to subject to market monopolies and exempted them from patentability. All drugs in these countries could, therefore, be generic. This situation is still true for countries that have not implemented the WTO Agreements. Drug quality is important. Medecins sans Frontieres advocates for improved quality surveillance. We support WHO’s efforts to assist countries by assessing quality of many technically complicated pharmaceutical products, including the prequalification of generic antiretroviral suppliers. Generic does not, however, mean unsafe or ineffective, just as patented does not necessarily mean safe and effective. Most medicines on the WHO Model Essential Drugs List are generic. Many vital patented drugs are excluded from the list because they do not meet the affordability criteria. For drug resistance and treatment adherence, generic companies may be in a better position to provide effective treatments by producing certain combinations and formulations that brand companies cannot or will not produce. Counterfeiting is a separate issue referring to the deliberate and fraudulent mislabelling of medicines for identity or source. Counterfeiting mostly concerns expensive branded drugs. The only consistent practical difference between generic and patented drugs is their price. Because market monopolies drive prices up, generic agents are less expensive. The price of patented drugs is a barrier to access to medicines for many diseases that are common in less-developed countries. Access to AIDS medicines has increased strikingly in some countries through the use of generic drugs. Affordable, high-quality, generic alternatives exist for many diseases causing substantial mortality and morbidity in the less-developed world (eg, trachoma, kala-azar, and cryptococcal meningitis), which, if the right prohealth policies are implemented, could be used to increase access in all countries in need. Introduction of market competition through parallel importation (competition between branded drugs) or compulsory licence (competition with generic drugs) is an important way to lower drug prices in a sustainable way. The Brazilian government, for example, has used extensive generic production and the threat of compulsory licensing to reduce the price of AIDS drugs. The declaration at the WTO meeting in Doha in November, 2001, which states clearly that countries can rightfully overcome patents, should encourage other countries to implement and use a compulsory licensing system for expensive drugs they deem essential in their health-care system. Drug quality, safety, and effectiveness are matters of great concern. So is lack of access to essential medicines in the developing world. It is essential for millions of people that the latter is not limited by confusing and bias concerns over the former.