Parexel rides clinical trial growth in Peru
These countries sit in-between the “traditional” markets for contract research in the region – Argentina, Brazil and Mexico – and “non-traditional” markets such as Ecuador, Uruguay and Venezuela, explains Graciela Racaro, Parexel International’s director of Latin America operations. The volume of clinical trials in Peru, Chile and Columbia has increased significantly over the past few years, Racaro notes. In Peru, for example, the Ministry of Health approved 74-78 clinical trials per year between 2000 and 2003, whereas in 2007 the number rose to 118 and in the current year 115 trials had been cleared by November. This is partly a function of the new clinical trial legislation enacted in 2006, based on the Declaration of Helsinki and International Conference on Harmonisation standards for Good Clinical Practice. As Racaro comments, Peru “took [clinical trials] very seriously”. But there have also been improvements in infrastructure, with many more trial sites and clinical research associates. Previously, Racaro points out, there was no site infrastructure in most of Peru’s cities. Now, good sites may be found not just in the capital Lima but in other cities such as Arequipa. This is important as 73% of Peru’s 27.9 million population is urban – a ‘mega-city’ trend typical of the Latin American markets. In fact, considerably more of Argentina’s population (90.4%) is concentrated in cities while 85.2% and 76.5% respectively of the Brazilian and Mexican population is urban (in the US the proportion is 81.4%, according to Parexel data). As of 2007 (INEI data), 30.8% or 8.45 million of the Peruvian population could be found in Lima, 6.1% in Piura, 5.9% in La Libertad, 4.3% in Cusco, 4.2% in Arequipa, 4.1% in Lambayeque and 3.2% in Callao. Sheer size The sheer size of the populations in Latin America is another attraction for contract research organisations (CROs) – over 565 million people overall, with 191.8 million in Brazil, 106.5 million in Mexico and 39.5 million in Argentina. Peru is a little further down the scale although, as Racaro observes, it still compares very favourably with other markets for outsourcing in Central and Eastern Europe, such as the Czech Republic and Hungary with populations of around 10 million apiece. The bulk of Peru’s healthcare facilities are, unsurprisingly, located in Lima, where there are some 600 healthcare centres, 140 hospitals and 450 health posts (small clinics). Arequipa, by way of comparison, has just under a hundred healthcare centres, about 20 hospitals and 200 health posts. Across the country, doctors and nurses are relatively thin on the ground compared with the US or some other Latin American countries. Parexel data (sourced from PAHO, year to December 2007) show that Peru has 10 physicians and nine nurses per 10,000 inhabitants, while the US has 22.5 and 78.5 respectively, Mexico 10.4/13.4, Brazil 16.1/5.4 and Argentina 33.4/2.2. Regulatory boost The new regulations governing clinical trials in Peru have been a significant fillip for CROs, offering “really clear rules” not just for licensing and conducting studies but for infrastructure requirements such as making sure there are private and administrative areas at trial sites, Racaro says. There are currently 303 investigation sites registered with the Peruvian Ministry of Health as well as 22 ethics committees. Another benefit is a genuine focus on high-quality support for the trial process, Racaro adds. Peru, like Columbia, maintains an “excellent” website with comprehensive information on local clinical trials. The study approval process is a sequential one, whereby applications must first be cleared by a registered ethics committee then submitted to the Ministry of Health. According to Racaro, the first stage takes three to seven weeks and the second six to eight weeks. Another three or so weeks are needed to obtain an import licence. The whole process adds up to 22-24 weeks, in line with several European countries and less onerous than in Latin American markets such as Brazil and Venezuela, Racaro points out. Inevitably cost savings also come into the equation. In this respect Peru is closer to countries such as Argentina and Chile than the massive Brazilian market, Racaro notes, putting the cost differential at 70-75% of the US or Western Europe. And with the devaluation of the Brazilian currency, savings are now less pronounced in that market. |