The High Level Regional Meeting on Intellectual Property Policies to Facilitate Access to Medicines was organized by the South Centre and the Caja Costarricense de Seguro Social (Costa Rican Social Security Fund, CSS), in San José, Costa Rica, from 2 to 4 October 2019. It was attended by representatives of the ministries of health, trade, foreign affairs and intellectual property offices of El Salvador, Guatemala, Honduras, Nicaragua, the Dominican Republic and Cuba.
The meeting enabled public policymakers in Central America to establish specific objectives related to making use of the flexibilities in the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) to ensure the supply of affordable medicinal products and medical equipment to the population.
Dr. Dennis Angulo Alguera, Vice Minister of Health of Costa Rica, affirmed the need for countries to strengthen their capacities in the area of intellectual property and public health. This will allow them to "continue the fight on access to medicines, establishing innovative procedures that allow the price of medicines to be in relation to the wealth of the countries and that they enter the public health systems according to their effectiveness”, said Dr. Angulo Alguera.
Dr. Román Macaya Hayes, Executive President of CSS, reiterated the need to promote adequate access to medicines. In his welcome remarks, Dr. Macaya described the challenges in Costa Rica. Showing a series of data on Costa Rica, Dr. Macaya illustrated major health concerns such as the aging trend of the population, the impact of chronic degenerative diseases, the increasing demand of the population (today better informed) for biosimilars, the judicialization of health and the excessive costs of treatments.
Dr. Carlos Correa, Executive Director of the South Centre, highlighted the need to reconcile intellectual property (IP) protection and access to medicines. He stressed that the meeting was organized with a practical approach and attentive to the particularities of the region. The policy space for countries was constrained not only by the TRIPS Agreement, but also by free trade agreements. He said that "the diversity of representatives from various institutions present in this room supports the overall objective of the meeting: to create coherence between public policies on IP and access to medicines".
During his presentations Dr. Correa said that the granting of patents is justified when there is real innovation. However, the patent system has been distorted in some countries whereby patents are granted on trivial developments which are not really innovative that unjustifiably restrict access, he said.
Dr. Correa also elaborated on the different strategies employed to artificially extend the length of patent protection beyond 20 years, such as ‘evergreening’, that is, seeking patent protection for incremental improvements for already existing drugs and their derivatives. He explained how patent applications on polymorphs, salts, formulations, combinations, isomers, new indications and Markush claims are being made by the pharmaceutical industry with astute legal drafting. Dr. Correa also discussed the effects of patenting of isolated genes.
Dr. Germán Velásquez, Special Adviser on Health and Policy of the South Centre, said that the dialogue is a very big step towards agreed solutions for the countries of the region. "I believe that if Central America and the Caribbean come together, a lot of progress can be made in international negotiations. This is a long-term project and we are going to continue supporting the region," said Dr. Velásquez.
Dr. Velásquez highlighted the current challenges in the area of biological products, which are products manufactured from living organisms or contain components of living organisms, and constitute now an important class of medicines. Countries have difficulties in ensuring access to these products because of their high costs, in some cases due to restrictive regulatory measures that unduly limit competition of biosimilars. He said that improving guidelines to facilitate access to biosimilars must be the priority for countries. He also noted that the World Health Organization (WHO) is failing the mandate to revise its stringent 2009 guidelines for evaluation of biosimilars.
The Guatemalan Vice-Minister of Health, Dr. Alvar Frank Pérez, said that it is very important to create and promote health promotion organizations that reproduce collective reactions in order to learn how to negotiate with powerful pharmaceutical companies and define acceptable price conditions for access to medicines in the region.
Dr. Marjorie Obando, Director of pharmacoepidemiology at the CSS, noted that the strategy is to achieve intersectoral communication. "We have to be in one line looking to improve patient access to medicines. It is something possible, achievable and it is a commitment of all the participant countries; from the economics, foreign affairs, ministries of justice, social security institutions and ministries of health’s points of view" said Dr. Obando. She emphasized the importance of public policy coherence on the issue of medicines, strengthening joint purchases at the regional level, especially those of high cost medicines, associated with the entry of generic drugs and accredited biosimilars.
Ms. Carolina Gómez, Founder of the think tank Medicines, Information and Power at the National University of Colombia and former Director of medicines of the Ministry of Health of Colombia, made a presentation on joint negotiations based on the experience of Colombia in the case of Hepatitis C. Presenting data and a historical sequence of events in Colombia, Gomez explained the purchase process of Sofosbuvir. She also presented her perspectives on how to promote access to biosimilars, sharing Colombia's regulatory experience in this area in which she was involved. The issue is of increasing relevance as the largest margin of expenditure comes from the purchase of biological medicines.
The president of the IFARMA Foundation of Colombia, Dr. Francisco Rossi, considers that it is necessary to know the laws very well, review the existing agreements and use international resources to change the current reality of the high cost of medicines. "The Ministries of Health and the institutions dedicated to Social Security are concerned that there should be a good supply of products and that information about the real costs incurred from public sector and private firms for R&D should be accessible. More transparency is needed because there are many abuses, including exorbitant prices, that the pharmaceutical industry tries to justify using arguments that are not true and are manipulated," said Dr. Rossi.
For Dr. Rossi, there is a need to continue to question the arguments of the pharmaceutical industries about the real costs of developing new medicines and put in place measures so that the public policy objectives of having quality medicines at reasonable prices are met.
Ms. Thamara Romero, Senior Programme Officer of the South Centre emphasized the importance of allowing entry of biosimilars, in the context of prohibitive prices for biologicals. She also explained the exceptions to the exclusive rights acquired by a patent holder once it is obtained, and analyzed cases of abuse of exclusive rights and the remedies available under national and international law.
Ms. Judit Rius Sanjuan, from the United Nations Development Programme (UNDP), gave a legal overview of the Dominican Republic-Central America Free Trade Agreement (CAFTA-DR Agreement). In particular, she mentioned some provisions included in the agreement that are not in the TRIPS Agreement (TRIPS plus), which reduce the policy space of the Central American countries to protect public health, such as data exclusivity and patent linkage. Compared to other free trade agreements, CAFTA was signed without sufficient evaluation of its possible impact, said Rius.
Mr. Vitor Ido, Programme Officer of the South Centre, explained that competition law was another important tool to promote access to medicines. There was ample space in international law for States to apply competition policies with a view to guaranteeing and promoting access to medicines, he said. Ido noted that in many jurisdictions including the United States and the European Union, there were several cases of control of anti-competitive practices in the pharmaceutical sector.
Dr. Lesly Karel Franco of the Dominican Republic's Ministry of Health said that "the collaboration between public health authorities and industrial property offices must be clear and must lead to the use of flexibilities to ensure adequate access to medicines. In addition, IP legislation and health regulations must be reviewed because they could generate restrictions when buying drugs.”
Meanwhile, Dr. Veronica Lopez Moreno of the Nicaraguan Ministry of Health said that they will review the national legislation that impacts on access to medicines to make it an effective tool for achieving their public health objectives. "We are going to strengthen the inter-institutional relationship to facilitate access to medicines. We will develop more knowledge and work to eliminate barriers that hinder access to medicines for the population," said Dr. López Moreno.
At the conclusion of the event, participants presented a roadmap in which they identified priority national and regional actions to facilitate access to medicines and the best use of TRIPS flexibilities.
At the national level, policy makers identified the need to improve the coordination mechanisms between institutions, and to provide more capacity building for patent examiners. They also identified as a priority to update the guidelines for patent examination in chemistry, pharmacy and biotechnology. They also assured to work towards strengthening the drug procurement system.
At the regional level, policy makers recommended promoting joint cooperation initiatives among Central American and Caribbean countries to implement the TRIPS flexibilities. They also supported establishing new regional mechanisms to regulate the drug market and the strengthening of existing regional cooperation mechanisms, including joint drug purchases. They expressed interest in using parallel imports as a mechanism to reduce prices.
The representatives of the industrial property offices proposed establishing a network of experts on patent examination to exchange on technical issues relating to the patentability criteria for new technologies.
In summary, the participants noted that the use of TRIPS flexibilities will contribute to eliminate barriers that prevent countries from providing medical products and treatments at accessible prices to the population.
Author: Thamara Romero is Senior Programme Officer of the Health, Intellectual Property and Biodiversity (HIPB) programme of the South Centre.