Palabras clave: bioequivalencia, agencia nacional de medicamentos

One of the most important challenges in modern medicine relates to efficiency. In times of costs spiraling upwards and hardships in funding the health care systems, effectiveness is not enough – you also have to be cost effective, i.e., effective at the lower cost. Unfortunately, the most oft used tool to determine efficiency, the market, has shortcomings in medicine due to skewed information. There are information asymmetries between supplier and buyer, or there may not be enough information to base the decision-making process.

In order to overcome this difficulty, pharmacoeconomics was developed, a discipline that relates costs to health outcomes, compares programs and treatment options, and seeks the lowest cost/effectiveness coefficient for any given option. This discipline has proven itself of great utility since one of the most significant expenditures in modern medicine is drug acquisition, both by institutions and individuals. However, these economic assessments may turn out relatively useless if the drug being assessed was actually substituted by another one, as occurs when changing an innovative drug with a generic formulation, or one generic form by another.

In these cases, bioequivalence studies are useful. The purpose of these studies is to determine whether two drugs that are chemically equivalent also prove to be kinetically equivalent. More to the chase, bioequivalence attempts to ascertain whether a drug that is being considered as a substitution of another one, is able to reach maximum blood concentration in a group of healthy volunteers, within the same maximum time and with the same area under the concentration versus time curve (in this case, “same” is said to indicate a difference not greater than 20% with respect to the reference drug). If this is the case, then both drugs are said to be bioequivalent and therefore exchangeable.

Why is it not possible to infer this conclusion only from chemical equivalence? Because the manufacturing process of drugs and the excipients that are used, together with the raw materials of the active principle, may alter drug kinetics, which is why kinetics must be measured in order to be compared. Why don’t we use the clinical effect of drugs as an equivalence criterion? Of course this could be the definitive criterion. The problem is that conducting this type of comparison entails clinical trials with all of the associated costs and hassle, and secondly, because the trial would have to be conducted in subjects with specific conditions that could alter the drug kinetics thereby making comparisons difficult. This is the reason why for several decades bioequivalence studies have been deemed to be the best proxy to clinical comparison, since they allow specific variables to be isolated and compared, and at reasonable costs.

Due to all of these considerations, the announcement of the creation of a National Drug Agency in Chile is good news. Its mission will be, among other things, to assess the bioequivalence of several drugs that are currently marketed in Chile. This long-expected initiative is a significant step in the direction of determining efficiency since now it will be possible to establish which drugs are actually exchangeable. The next step is to conduct the economic assessment and cost minimization studies, making it possible to conclude that the cheaper drug will also be the most efficient one.

Not only is this the correct sanitary approach, it also will provide more information and make pharmaceutical markets more transparent.

Article Information Sheet
Title: Chilean Government Announced Creation of a National Drug Agency
Citation: Biagini L. Chilean government announced creation of a national drug agency. Medwave 2011;11(07).
Submission date: 07/06/2011
Acceptance date: 10/06/2011
Publication date: 01/07/2011
Origin: commissioned
Type of review: internally peer-reviewed
Final decision to publish: Editor-in-Chief

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