AGNESE ALICIA MARIEL
Congresos y reuniones científicas
Título:
MEDICINAL PLANTS AND PHYTOTHERAPEUTIC MEDICAMENTS REGULATIONS IN MERCOSUR: COMPARATIVE ANALYSIS
Autor/es:
NUÑEZ MONTOYA S; ORTEGA G; CABRAL PÉREZ M; BIRRI M; VALLEJO M; PETTENATI E; DEL VITO L; GARCIA COUTO A; BELLE BRESOLIN T; CECHINEL FILHO V; VIEIRA PC; KUZE RATES S; HEINZEN H; DEGEN R; LUGO G; AGNESE AM
Lugar:
Rosario
Reunión:
Encuentro; Segunda Reunión Internacional de Ciencias Farmacéuticas (RICIFA); 2012
Institución organizadora:
UNR
Resumen:

Introduction

According to the World Health Organization (WHO), 80% of world population uses traditional medicine to treat their primary health care needs. The traditional treatment is based above all on the use of extracts or active principles of plants. 1

WHO has promoted the scientific study of plants used in ethnomedicine, on the basis that would eliminate unsafe practices and promote only those that was safe and effective. 2

As many cultures in the world, the use of medicinal plants (MP) is specially developed in our continent. Indeed, the countries that form the MERCOSUR have a rich tradition in the use of MP, ancestrally inherited and culturally significant.

In recent decades took place in contemporary societies a tendency to "return" to the natural. The urban population tended to consume native or foreign plant species in several ways: by the false belief that natural is harmless, strongly influenced by advertising, by tradition, snobbism, or because people are looking for results not found in conventional medicine, among others. At the same time began to be marketed PM in masse, to fill a market niche not satisfied. World markets were invaded by PM, they were sold out of control, demands and rules. The magnitude of this commercial activity was not minor: this sector was responsible for a global market of $ 21.7 billion per year.

Which is the associated problem to this situation? Clearly, the proliferation of sales without authorization, without hygienic conditions, safety or quality controls. In many cases the MP were marketed with a different identity to that proclaimed. They were also marketed with pharmacological activity recommendation, or also ?fashions? from other countries were imposed. Extracts or different preparations of plants were sold at the same conditions to those mentioned for MP.  The lack of specific regulations allowed manufacturers and importers to impose their own requirements, were these appropriated or not.

That was a world tendency that had however, diverse reactions in the States control level. In some countries the Sanitary Authorities took the situation as a problem and started elaborating regulations to give a regulatory framework to the related sanitary problems.

Within the framework of the Project ?Plantas Medicinales y Medicamentos Fitoterápicos, situación actual en el MERCOSUR?, belonging to the Project ?Apoyo al Programa de Movilidad MERCOSUR en Educación Superior. Línea Prioritaria 2, Convocatoria de propuestas EuropeAid/130695/M/ACT/R06, Contrato de Subvención N° 20?; having as reference the Directive 2001/83/CE of the European Parliament and Council (on the community code relating to medicinal products for human use), and its  amending (Directive 2004/04/CE, as regards traditional herbal medicinal products), a group of MERCOSUR universities leaded by the Universidad Nacional de Córdoba, proposed as an objective to develop a comparative analysis among the current regulations on the subject matter in MERCOSUR and in those of the European Union.

 

Methodology:

 

To fulfill the objective, a strategy of qualitative type was used as a methodology to face the arisen problems. Research Documental Techniques were developed.

Results:

From the situation diagnosis in relation to the current regulations in the MERCOSUR, it can be stated that in Uruguay there is a total lack of regulations in relation to PM and Phytotherapic medicaments (PhyM); to the present any regulation has been approved in relation to those subjects.

Conclusions:

In view of the dissimilarity in the current regulations, the lack of them in Uruguay and the precarity in Paraguay, the conformed university net will work by virtue of its educational Mission and as a part of the previously mentioned Project in favor to collaborate in the harmonization of the policy framework existent in the MERCOSUR by means of elaborating a document that will be presented to the different countries Ministeries with the conclusions reached.