Access to medicines and legal pathways affecting competition in pharmaceutical markets of South America


To make possible the competition in the pharmaceutical market promotes the availability of medicines. The Pan-American Health Organization commit countries of the region to promote policies of generic medicines trough their availability, quality, use and acceptability, as a comprehensive set of actions to make c

ompetition possible for prices in the pharmaceutical market (PAHO, 2004). Apart from the various fields related with the market exclusivity granted to via patent medicines, there are mechanisms that exceed the efforts from various national authorities of the countries of the region in order to give priority to the needs of public health and to the regional pharmaceutical policy above another type of interest.

Some countries in the region have incorporated into their norm-setting strict guidelines for the assessment of medicines patents requests; in particular Argentina embodied the “guidelines for the assessment of patent applications related with pharmaceutical inventions” established by Professor Carlos Correa of the University of Buenos Aires.  On the other hand, the resolution REMSAA XXXVI/511 recommended the adoption of guidelines for countries of the Andean Sub region in 2017. Some of these recommendations have guided the training of evalua

tors for medicines patents requests for several years. These guidelines establish criteria related to treatment methods, claims, as well as clarifications on the nature of active pharmaceutical ingredients. An on-going review explore different ways and institutions that can take account of these guidelines of public health in South American countries, and identifies various commercial and legal mechanisms currently used to maintain market exclusivity for certain pharmaceutical products.

Part of these mechanisms link national medicines agencies function with areas such as the use of the evidence that supports the features of efficacy and safety of medicines, not necessarily related to patents, recognized  as test prove data, where owners can claim a period of exclusivity.  Another area known as “linkage” demand t

he consent of national intellectual property authorities on health assessment processes carried out national medicines agencies, this stage beyond a communication interinstitutional commits time and resources to actions not aligned with the interests of public health protection. Other mechanisms link areas responsible for regulation of markets to attend demands of possible anti-competitive practices.

In addition, there are trade agreements which usually include issues like the period of duration of the patent, or data protection of medicines licensing, as well as compensation for delays in the procedure of assessment of patent applications.  Countries such as Chile and Colombia have incorporated specific conditions related to the free trade agreements with the United States. Finally, national intellectual property authorities have signed bilateral agreements with each other to promote exchange and allowing the application of accelerated achievement of patents, known as “patent prosecution highway”. Under this figure the evaluators can make use of assessment documents from other authorities.  While the World Intellectual Property Organization defines this possibility as bilateral agreements, some South American countries signed a multilateral agreement among its authorities called PROSUR. This regional system of cooperation among nine South American countries (Argentina, Brazil, Chile, Colombia, Ecuador, Paraguay, Peru, Suriname and Uruguay) was created in 2009 as a common platform for the exchange of information on requests for patents. In 2016 these countries signed a memorandum of understanding that establishes that the industrial property system users who have submitted a patent application in any of the countries of PROSUR, may have the benefit of request to any of the other countries the use of the respective study. It is important to state that Brazil declares the exception of the use of this route in the case of medicines, and countries such as Bolivia, Guyana and Venezuela have not incorporated this type of mechanism.

Chronologically the implementation of such judicial mechanisms has led to South American countries to go a long way in about two decades. During this period in countries such as Brazil, Colombia, Chile and Peru have established processes to allow the use of flexibilities to the TRIPS agreement. These countries have sought a fair and equal access to immunosuppressant medications and antivirals among others. For its part, Ecuador in its internal law made viable the possibility that these alternatives would be of legitimate and clear use in situations of interest in public health. To date these efforts have not allowed an effective fair access to medicines in question.

Trade barriers to regional pharmaceutical sovereignty

It seems that schemes which sought to compensate for novelty and inventive efforts have ended to affect the possibility of having health accessible alternatives; on the other hand, have led to the exclusivity of markets for pharmaceutical products which even are not the most relevant to the current needs in health.  Conversely, pharmaceutical innovation has dimmed over the past ten years, as describes it to the South Centre on the appointment of a recent publication 2018.

The priority of the protection of the interests of public health, access to medicines and pharmaceutical regional sovereignty demands a balance in the field of intellectual property rights and market restrictions.


Author: Ángela Acosta, especialista en Medicamentos y Tecnologías de la salud