Pharmaceuticals in Latin America. Pharmaceuticals Policy and Law Vol. 16(3,4)

VALVERDE, J.L.; REAL J.P; PALMA SD

IOS Press

Lugar: Linking ISSN (ISSN-L): 1389-2827; Año: 2014 p. 150

0-0000-0000-0

A region that has undergone big changes in the past few years is Latin America, having dealt with political and economical changing processes that indeed affect all aspects of human development. Recent democratic governments, troubled periods of politics, and a sort of ?youth? in the institutions make Latin America a place with complex nuances to analyze. The pharmacy as an institution, the pharmaceutical profession and the legal and sanitary medicines status are not free from the previous analysis. Public health coverage and quality varies according the country. Primary attention scope and the access to drugs are heterogeneous in this region. In rural areas and in more deprived countries there is no adequate infrastructure and drugs are scarce, however, in countries like Brazil, Cuba, Argentina, Costa Rica, Chile and Mexico, among others, some of the world best hospitals as well as advanced research centres in terms of health concerns are established. Yet access to health is not completely universal, with few exceptions. So it is important to underline that professional associations do not follow a pattern. In general, pharmaceuticals are grouped by provinces, districts and by national groups. However this is different among the countries and there are also chambers or circles that join pharmacies together not owned by pharmacists. This creates an asymmetry of interests among the different associations. The pharmacy models and hence pharmaceutical actions are also different among countries geographically very close. A simple case as such would be to compare the influence of chain pharmacies in countries like Argentina and Chile. In the first country mentioned, despite the strong deregulation occurred in the 90ths, the impact of large corporate surfaces has been relatively low. On the other hand, in Chile and Peru most community pharmacies belong to business groups. Also, in Uruguay, the presence of the pharmacist at community pharmacies is not decisive, and not obliged in practice, it is simply a legal requirement (technical direction) with no health impact. The pharmacy profession deregulation, which implies the logic concentration and the difficulties in the economic survival of independent pharmacist, causes as a result difficulties in provision of specialized pharmaceutical services aimed at disease prevention and health promotion. The aforementioned determines the pharmacy careers degree in Latin America where a lack of uniformity in training students is observed. The latter has an academic logic due to the need to train pharmacists who will only have impact on medicine production (industry) or those who will participate in health processes related to pharmaceutical advice, pharmaceutical care, patient follow up, etc. Added to the above, it is necessary to move towards a unified regulations and policies construction bearing in mind some key aspects: ? Patent laws in line with the current times. ? Introducing and promoting the use of generic medicines. ? Sustainable policies for developing drugs of biological origin and natural products. ? Regional pharmaceutical industry development with an emphasised impact on specific diseases and health problems. ? Design of pharmacoepidemiological studies and rational drug use. ? Evaluate the possibility of creating unified legal standards in the region. ? Conduct cross-sectional studies analyzing the results related to pharmacovigilance in the region. ? Set clear policies related to humans and animals studies resulting in the market introduction of new medicine products. ? Harmonized development of new public laboratories for medicine production, among others. In this context, different countries face the challenge of striking a balance between respecting international patents, their own industrial policies and improving access to health and drugs mainly in the most vulnerable populations. Most patents in the pharmaceutical field cover a small number of new active ingredients and a large number of variants or derivatives (salts, esters, polymorphs, formulations, combinations) of the active ingredients already known. The countries of Latin America should tend to strategies that favour trading or manufacturing of generic products, increasing competition and access to drugs. Governments require more and more capacity to assess the national and international legal frameworks applicable in intellectual property and to participate in negotiations processes in several forums and fields defending the rights of citizens without altering the property right. In this sense the region definitely has a pending account. It is necessary that states contemplate the active policies to promote research and development in the pharmaceutical area. It is imperative also to lay down criteria on public drug production. In many countries of the region industries belonging to governments and that produce drugs are proliferating. There are many questions in this context. What kind of medicines are to be produced? Innovation should be done or just a copy? Orphan drugs should be produced or generic drugs should to regulate overall prices in a given country? Is it necessary to compete with private companies? It is likely that such discussions have already occurred elsewhere in the world and that is why a deeper discussion corner that considers history, events, realities and common interests should be opened to thereby achieve access to drugs to be the focus of government policy in Latin America.The purpose of this monograph is just starting to discuss preliminarily the drug situationin Latin America as an initial contribution to enable progress in better actionsand policies.