Advances in Pharmaceutical Market Integration in Mercosur and Other Latin American Countries

Abstract

This paper reviews the developments in the pharmaceutical sector in the MERCOSUR countries which have resulted from the renewed efforts of economic integration in Latin America. MERCOSUR refers to the “Mercado Común del Sur, “ the common market that has been under development since 1991 by Argentina, Brazil, Paraguay, and Uruguay. In MERCOSUR the underlying principles for harmonization of pharmaceutical legislation and regulations are that there is no centralized approval system (a pharmaceutical product needs to be registered at the national level before it can be marketed in a country) and that requirements and procedures for registration should be the same in all countries.

By the end of 1995, the MERCOSUR countries had adopted common good manufacturing practice (GMP) guidelines for production of large parenteral solutions and an inspection guide, a common guide for inspection of production facilities of pharmaceutical products, common requirements for production facilities for pharmaceutical ingredients and raw materials, an inspection guide for raw materials’ production facilities, common guidelines on GMP and quality control of blood products, and a strategy for the transition period stretching until 1999.

It is concluded that the opening of markets has already brought not only adoption of GMP standards but general movement toward clearly defined technical requirements for the registration of products. This will strengthen national regulatory systems and consumer protection. The harmonization process will strive to reach international standards, with the World Health Organization (WHO) and the International Conference on Harmonization (ICH) as references. Multinational companies will review their production policies and plant locations. National companies will review their portfolio of products looking for specific “niches” in the pharmaceutical market; and they will need to be prepared for increased competition from foreign companies. Further concentration of the domestic industry is likely to occur.