The first article in this two-part series appeared in the June 15 issue of GEN. It examined the challenges and opportunities associated with Brazil, Mexico, and Colombia. This article picks up from where the other left off, providing insight into the unique aspects of the pharmaceutical markets in Chile, Peru, and Argentina.
While each of these countries has a relatively small population as compared to Brazil or Mexico, they have a growing GDP per capita. Moreover, as Figure 1 illustrates, these three counties have become hot spots for clinical trials in the region.
As part of the Latin American region, these three counties have gained increased international attention due to a number of important changes in their regulatory processes with respect to pharmaceutical products and conducting clinical trials. As their importance in the region, and indeed the world, continues to grow, so too does the importance of understanding the advantages and obstacles to be found there.
Although Chile is a relatively small country in the region, the Chilean pharmaceutical market is the sixth largest in Latin America. However, the domestic pharmaceutical industry in Chile benefits from a number of various protectionism measures by the Chilean government. That characteristic notwithstanding, pharmaceutical expenditures in the country are expected to increase in the long run, partially due to the introduction of several health-related reforms as well as TRIPS-related patent protection measures.
It is also worth noting that the pharmaceutical industry in Chile is led by domestic companies. Moreover, domestic manufacturers are expected to transition away from copy generic products toward the production of branded pharmaceuticals (through licensing from multinational companies). However, domestic producers in Chile have traditionally relied substantially on imported raw materials. While quality-control standards in Chile continue to mature, Chilean exports of pharmaceuticals are relatively low and limited to the Andean region.
Chile has been considered among Latin America’s more successful countries in terms of economic performance. With an aging population on par with larger markets in the region (Figure 2), Chile is ripe for growth in the pharmaceutical sector. Indeed, in 2006 the Chilean pharmaceutical market was $1.3 billion and posted a growth rate of 9%. To put this in perspective, Brazil, a country that has typically received wider attention in the region, had a smaller growth rate of only 5% and per capita spending of $70 as compared to $82 per capita in Chile.
The pharmaceutical market in Chile is regulated by the Ministry of Health, which is responsible for formulating and setting health policies for the country. To that end, one of its functions is to "exercise stewardship of the health sector." Additionally, this is the regulatory agency that receives, reviews, and approves new drug registrations.
As in Brazil and Argentina, Chile offers incentives to pharmaceutical companies to register generic products by discounting the registration application fees for generics. While the cost of registering an original pharmaceutical product in 2003 was $1,300, the fee is reduced to $800 for generics and biosimilars. In either case, however, drug registration in Chile can take anywhere from eight months to a year. This time frame for regulatory approval is considerably longer than in many other countries in Latin America.
In order for a pharmaceutical company to receive import authorization in Chile, the process can take anywhere from 14 to 21 weeks. Because the application is required to be in Spanish, document translation is a necessary first step, which may take two to three weeks to complete. In the next phase of the registration process, the applicant makes a submission to the Institutional Review Board (IRB) and the Ethics Committee.
In Chile, the regional ethics committee that must approve the application prior to its submission to the Ministry of Health is the Comite de Etica Cientifico (CEC). Submission to and approval by the IRB and CEC can take six to ten weeks, and this time frame may be longer depending on the CEC’s volume of work at that time.
Once an applicant has received IRB and CEC approval, the dossier is submitted to the Ministry of Health for review. The Ministry of Health review, approval, and drug import authorization typically takes just four to six weeks to complete, after which time the import process takes place. Namely, this includes the drug use and distribution authorization, which takes an estimated two weeks. Collectively, the estimated time line that a pharmaceutical company can expect for drug registration in Chile is approximately 14 to 21 weeks.