Academic journal article Bulletin of the World Health Organization

Multisource Drug Policies in Latin America: Survey of 10 Countries/ Politiques En Faveur Des Medicaments Multisources En Amerique Latine : Enquete Portant Sur 10 pays/Politicas Sobre Medicamentos Multiorigen En America Latina: Encuesta De 10 Paises

Academic journal article Bulletin of the World Health Organization

Multisource Drug Policies in Latin America: Survey of 10 Countries/ Politiques En Faveur Des Medicaments Multisources En Amerique Latine : Enquete Portant Sur 10 pays/Politicas Sobre Medicamentos Multiorigen En America Latina: Encuesta De 10 Paises

Article excerpt

Introduction

An increasing number of pharmaceuticals are available in the world market and yet many people in developing countries do not have access to medicines that can save lives and/or reduce suffering. Financial affordability is the main barrier to access (1-5). In Latin America the cost of medicines has increased at a rate faster than inflation. The number of pharmaceutical units sold in many countries in the region decreased despite increased drug expenditures, confirming that access to medicines has become more difficult (3, 6, 7). To ensure that countries have access to needed medicines at an affordable price, WHO has recommended the use of essential drug lists to guide drug selection, registration and procurement by governments; it has also recommended the implementation of policies to promote the use of generic drugs (4, 8-10). The need to increase the availability of and access to generic drugs has gained visibility with the failure of antiretroviral therapy to reach patients in the developing world (1). In response to these problems and recommendations, many countries in Latin America have recently taken steps to increase the use of cheaper off-patent drugs.

This article reports the result of a survey conducted in June 2003 in several Latin American countries. The aim was to document their pharmaceutical policies. In this paper we present data on the existence of generic or multisource drug policies, the cost and time needed to register the different types of pharmaceuticals, and the incentives used to promote the use of generic or multisource drugs.

Methods

The survey tool was developed by the authors and was based on indicators that the Pan American Health Organization had wanted to use in its pharmaceutical observatory initiative (EC Seoane Vazquez, unpublished data, May 2003). The survey included a combination of 82 qualitative and quantitative questions.

The survey was financed by a US$ 6000 grant from The World Bank as part of an initiative to develop strategies to increase access to affordable medicines in developing countries. The funding was used to meet with survey respondents face to face and to attend meetings at The World Bank's headquarters in Washington, DC. We had less than one month to collect the information and decided to administer as many questionnaires as possible. The questionnaires were administered in person in Chile, Ecuador and Peru by Roberto Lopez Linares. Questionnaires were administered by email to respondents in Argentina, Brazil, Bolivia, Colombia, Costa Rica, Nicaragua and Uruguay.

Email respondents had a maximum of 10 days to complete the questionnaire and provide supporting documentation. Survey respondents included at least one person working in the national drug regulatory agency and/or one expert on pharmaceutical policies in each country. We had at least two respondents per country except in Brazil where we had only one respondent; thus there were 22 respondents in total.

Data were gathered during the second and third week of June of 2003, except in the case of Brazil from which information was obtained in January 2004. The information collected in the questionnaire was complemented with information obtained from archival documents and the web sites of the regulatory agencies (most of them located within the ministries of health) of the countries studied.

The definitions used in the survey (Table 1) were offered by a group of experts convened by The World Bank and, as will be discussed, we found these definitions to be inappropriate and that their use limited the possibility of making comparisons across countries. For our purposes a generic product had to be bioequivalent to the proprietary (original) drug. WHO uses the term multisource. According to WHO guidelines, multisource pharmaceutical products are pharmaceutically equivalent products that may or may not be therapeutically equivalent. …

Search by... Author
Show... All Results Primary Sources Peer-reviewed

Oops!

An unknown error has occurred. Please click the button below to reload the page. If the problem persists, please try again in a little while.