The health of the population requires a pharmaceutical industry with the capacity to comply with the demanding regulations and strict supervision by the health authorities of each country.
To adequately address these challenges, they require a strategic ally of a legal nature, but with accredited competencies in pharmacosanitary matters. This is the case of lawyer Olga Torres, partner of the LatinAlliance law firm, who since 2000 has developed her professional practice specialized in the industry. Her experience led her to work as an advisory lawyer for Sanitary Registries for research and development houses of international prestige. Her position has been key to the firm's growth and she now serves as Director of Sanitary Registries for Central America. In addition, she advises on the protection of test data and patent rights for innovative products.
The lawyer Torres points out, who with more than 25 years of experience have worked with the main pharmaceutical research and development houses in the world, such as GlaxoSmithKline, Eli Lilly, Pfizer, Merck & Co., Sanofi, Janssen among a few that we can mention. “We do it in the countries of Guatemala, Honduras, El Salvador, Nicaragua and Costa Rica. It constitutes a strategic division within our law firm”.
It is an industry that requires sanitary registrations that are not exempt from challenges. “There are various complexities and challenges in this sector. From the regulatory aspects and registration of new molecules in the health authority, to the insertion in the basic table and the subject of tenders for the purchase by the different government entities. But the biggest challenge is found in the constant changes in the requirements demanded by the health authorities of each of the countries, although we are currently governed by the RTCA (Central American Technical Regulations), that is, each authority adjusts said regulations to their country. and this makes it difficult for the laboratory to prepare an adjusted dossier for each country. However, as specialists in this matter, they are advised and guided so that the work is efficient and effective to execute.
Even, the firm must overcome difficulties related to the fact that the industry is moving faster than the legislation, which is why legal loopholes are produced. It indicates that the legislation in most countries is concise, lagging far behind in issues such as the case of "orphan" products, differential treatment of biotechnological products, new molecules, drug surveillance, etc... But pharmaceutical companies also face, in certain countries, to a bureaucratic structure that has not wanted to modernize, affecting the industry in general and the population that requires innovative, highly effective products.
Added the challenge of getting the logs on time. The influencing factors are varied: stricter requirements, lack of budget in some of the Ministries and lack of personnel in many of the health authorities, the time for the evaluation of a registry is around eight months. Long time for the pharmaceutical industry that annually schedules the launch of its new products. At the same time, it delays the access of quality medicines to the population and the doctor to a specific treatment.
PROGRESS AND CHALLENGES IN THE REGION
“LatinAlliance's experience for more than 25 years allows us to affirm without any doubt that El Salvador is the country that has evolved the most in recent years. It repealed a 1959 law and promoted a new one in 2012 where everything related to ensuring accessibility, registration, quality, availability, efficiency and safety of medicines and cosmetic products was updated. The one that faces the most challenges is Nicaragua since, although it is a country subscribed to the RTCA, it has its own requirements that are not regulated if they are not requested from the laboratory and users at their discretion.”
NEW OPPORTUNITIES FOR THE INDUSTRY
The pharmaceutical industry for which LatinAlliance works is an industry rich in opportunities. It is constantly acquiring new business divisions, which allows them to be highly competitive. Some have expanded their portfolios to include generic products, while others are targeting specific therapeutic areas. Given that in our region there is limited access to the research product, where 48% is acquired by the pocket of the population and the public sector with 52%, the pharmaceutical industry constitutes and will continue to constitute an important sector for Central America, of which the quality of health of our population is greatly benefited.