Safety and Quality of Generic Drugs: A Never Ending Debate Fostered by Economic Interests?

A generic medicine is a pharmaceutical product intended to be interchangeable with the originator, manufactured without a licence from the innovating company and marketed after expiry of a patent or other exclusivity rights [1]. In principle, a generic medicine should be marketed without a commercial brand name, under the International Non-proprietary Name (INN). However, the definition of generic medicine is not always precise, as it is still more a commercial than a legislative concept in many countries. Copies of branded drugs have been marketed for decades in many countries; however, laws in the last century such as the Hatch-Waxman Act in the US, have made it much easier and cheaper to bring a new generic drug to market without undermining its quality, safety and efficacy. In Europe, an abbreviated procedure—the abridged application defined by directive 87/21/EEC—is permitted under certain circumstances, therefore generic manufacturers merely have to prove that their drugs have the same active ingredients and perform in the same way as the branded drugs. The first article [2] of this supplement confirms that the regulatory definition of generics is still inconsistent and piecemeal throughout the world. To warrant the full inter-changeability of generics with originators, their definition should include the requirements for bioequivalence. Unfortunately , important differences in the terms used for generic drugs, such as similars, copies, branded generic products, etc., are still found among countries worldwide. These differences and inconsistencies can challenge the trust of local people and must be addressed and recognised, particularly in developing countries. The second article [3], focused on the Chinese market (one of the most important in the world), shows a very important example of the problems raised by the lack of a clear cut definition of generics in the biggest developing country. It describes a confusing array of drug categories and a lack of quality assurance for generics that could easily be avoided by copying the regulation of developed countries. A crucial problem for generics is the guarantee on safety and quality of products marketed. Although evidence of bio-equivalence is important, national health authorities should set up mechanisms for checking manufacturing practice by (local and foreign) providers too. However, safety and quality problems should be less of a threat than in the past, at least in developed countries where the few manufacturers (including the ''sister companies'' of some ''big pharma'') in the generics market are definitely interested in avoiding risky practices …