Conference coverage: how can Latin America remain competitive in R&D?
Investigacion Clinica Latam
I recently attended the 2nd Partnerships Clinical Trials Latin America Congress held in Sao Paulo, Brazil. One of the main topics addressed was How can Latin America remain competitive in a Global Market place? It seems to be clear that Latin America has a great opportunity to keep growing in the research and development (R&,D) field and that the pharma industry needs to take this as an advantage. However there are a few challenges to overcome so that the region can stay competitive.
“It seems to be clear that Latin America has a great opportunity to keep growing in the research and development field”
In a previous post that I wrote with Dr. Ruben Gennero, we discussed Latin America´s place within R&,D and we mention some of the challenges Latin America faces, what I would like to mention in this post are some key factors to overcome these challenges according to discussions at the conference and to my own personal opinion.
One of the main key factors that Latin America needs to solve in order to remain competitive is the rigid regulatory environment that circles it. The region deals with a lack of predictability that makes it extremely difficult to plan ahead and this is not helpful in an industry where time matters so much. The other factor that makes the regulatory environment a problem for the region is not harmonizing the regulatory process between the different countries. This means that any pharma industry that wishes to perform research in Latin America needs to go through as many regulatory processes as the number of Latin American countries it wants to include in the trial. The pharma company then needs to decide which of the countries will be the more cost effective. If the region finds a way to harmonize the process then it would give the industry a broader choice of countries because the regulatory process would be the same for all.
“One of the main key factors that Latin America needs to solve in order to remain competitive is the rigid regulatory environment that circles it.”
In 2005 the Documento de las Américas was developed at the IV Panamerican Conference for the Harmonization of the Pharmaceutical Regulations by a committee integrated by the different Latin American countries however this document is not being used. The pharma industry needs to be aware of the existence of this document and find a way to sit together with the regulatory agencies of the different Latin American countries in order to try and implement it so that eventually the region harmonizes the regulatory process.
A second key factor that the region needs to be aware of if it wants to continue growing in the R&,D field is the need for investigator education. Latin America has prepared physicians and health care professionals very well but the research education is still missing. There is a need for medical schools to get involved in clinical research and create awareness about the importance of clinical research amongst young physicians so that they get prepared to be excellent research professionals that take part of the whole research process and not only physicians who do clinical trials. If medical schools get involved with clinical research the advantages are going to be not only for the pharma industry but also to the educational system and the country in general. The more involved medical schools get, there will be more basic research in the country leading to more clinical research, more job openings, more money entering the economy and therefore economic growth. So as we can see this would be a win-win situation.
Another strategy that the pharma industry needs to foster in order for Latin America to remain competitive is the development of new research sites. The pharma industry needs to invest in the development and preparation of new high quality sites that enrol patients always complying with Good Clinical Practices. Increasing the number of high quality sites will increase the number of available patients therefore making Latin America more attractive.
“…pharma industry needs to be aware of the existence of this document…”
An even better strategy would be to increase the number of phase 1 units. The region has the potential and the population to perform phase 1 trials and therefore it should be developed. This would broaden the R&,D spectrum of the region and it would give Latin America more strength in the clinical trials market. Developing phase 1 units requires the appropriate training and infrastructure which can be given by joining different stakeholders like medical schools, the pharma industry, private and public hospitals. If we manage to work together, Latin America can develop top quality research sites like the Brazilian Clinical Research Institute or the Clinical Research Unit of Hospital Austral in Argentina.
As we can see, and as was concluded in Partnerships Clinical Trials Latin America, Latin America has a brilliant future in the clinical research market but there are several key factors to bear in mind if the region wants to remain competitive. Being aware of these challenges allows a correct approach to the region, so that all the potential that the region has to offer can be fully exploited therefore allowing Latin America to not only be competitive but even become a leader in the R&,D market.
The next piece in this series can be viewed here.
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How can Latin America remain competitive in a Global Market place?