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Feature

Clinical trials in Argentina

Posted on: 06 Oct 05
Clinical trials in Argentina

Summary

There is considerable pharmaceutical industry involvement in clinical research in Argentina. the country represents a major Latin American market and has one of the region's most advanced healthcare systems.

Although the current operating environment has presented pharmaceutical companies with difficulties, the healthcare infrastructure in Argentina is considered to be one of the more sophisticated in Latin America and this has helped maintain the interest of companies in using it as a location for clinical research. All of Argentina’s provinces have an organized network of hospital and outpatients services (1). The country’s position as a leading Latin American market means that most international companies are well-represented.


 


Ongoing interest in clinical research


In 1998, a survey revealed that 3% of the economically active population in Argentina worked in the healthcare sector (1). Despite the strain on working conditions that the recent economic problems caused, Argentina still has a relatively large medical community, with there being around 300 physicians per 100,000 of the population (2). In comparison, Brazil has around 205 physicians per 100,000 of the population and Mexico about 150 physicians per 100,000 of the population (2).


 


Argentina’s medical community has been actively involved in clinical research for a number of years. This longstanding interest has been extremely beneficial for pharmaceutical companies, as it has created a pool of potential investigators who are enthusiastic about participating in international studies. Many physicians are involved in educational programs to increase their knowledge of clinical research and this has helped drive interest in clinical research in Argentina.


 


For example, La Sociedad Argentina de Investigación Clínica (the Argentinian Society of Clinical Research – SAIC) was founded by 7 physicians in 1960, but its membership has now grown to over 400 (3). The SAIC carries out a range of educational activities for its members and also runs a Committee of Ethics that provides members with guidance and also evaluates their clinical research projects (3).


 


Industry involvement


There is considerable pharmaceutical industry involvement in clinical research in Argentina, and this presents a potentially large customer base for CROs. The Argentinian outsourcing market is characterized by domestic, regional and international CROs.


 


Local pharmaceutical companies have a limited ability to compete against their multinational rivals and many tend to concentrate on generics rather than invest in innovative R&D. Not surprisingly, as clinical trials in Argentina can be run to international GCP standards, multinational pharmaceutical companies are currently responsible for most of the investment in this area. Pfizer Argentina alone is estimated to be responsible for 13% of the clinical studies approved by Argentina’s regulatory body, La Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT) (4).


 


It has been estimated that between 1994 and 2000, over 700 clinical trials were approved by ANMAT (4). ANMAT maintains an active interest in ensuring that clinical trials are run to legal standards and carries out regular inspections of clinical trial sites (5). It requires documented evidence that all people involved in a particular clinical study have been suitably trained (5).


 


Outlook


The recovery of Argentina’s economy will be important if there is to be further pharmaceutical industry investment in clinical research. Yet despite the economic problems Argentina’s clinical trial professionals remain positive that the country is a good location for international drug development. SAIC has noted that the financial difficulties in the country have impacted on the ability of its members to engage in clinical research, but it believes that Argentina’s base remains strong as about half of its membership continues to regularly publish their scientific work (3).


 


Recent reports suggest that the Argentinian pharmaceutical market is recovering. In an IMS Health survey of 30 pharmaceutical companies, only two suffered a drop in 2004 sales when compared to figures for 2003 (6). This should further boost the confidence of international companies to become more actively involved in the country.


 


References



  1. Anon (2005). Pan American Health Organization. http://www.paho.org

  2. Anon (2004). Global Atlas of the Health Workforce. http://www.who.int/globalatlas/

  3. Anon (2004). La Sociedad Argentina De Investigacion Clinica. http://www.saic.org.ar/

  4. Anon (2005). Dirección Medica - Investigación Clínica. Pfizer Argentina. http://www.pfizer.com.ar

  5. Anon (2005). Newsletter Nº 7 - June 15, 2005. Blanchard and Associates newsletter. http://www.blanchardyasociados.com.ar/Boletines/Ingles/Boletin_050615.htm

  6. Rumeau G (2005). Argentina: El Consumo De Medicamentos Ya Recuperó Los Niveles De 2000. El Cronista (Argentina). Boletin Farmacos. 24 February 2005. http://www.boletinfarmacos.org

Dr Faiz Kermani

Last updated on: 27/08/2010 11:40:18

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