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Jun 15, 2010 (Vol. 30, No. 12)

Opportunities & Challenges in Latin America

Guidelines on Tapping the Potential That Exists in This Emerging Market

  • Colombia

    Certainly, with respect to its size alone, Colombia does not hold the same importance as Brazil or Mexico. By most accounts, it would rank fifth in terms of how large its pharmaceutical market is, behind Mexico, Brazil, Argentina, and Venezuela. Nevertheless, with a market for pharmaceuticals that was worth US$1.8 billion in 2006, and a growth rate of 5%, the Colombian market is nothing to sneeze at.

    Indeed, Columbia has become, perhaps somewhat unexpectedly, a destination for clinical trials. The regulation of clinical trials in Colombia is entrusted to the Instituto Nacional de Vigilancia de Medicamentos y Alimentoa (INVIMA). While the 17- to 21-  week time frame for approval presents a longer timeline than what is found in Mexico, it is still considerably shorter than the length of time that the process requires in Brazil. The key initial documents consist of the protocol, ICF, IB POA, and an insurance policy for the Colombian sites.   

    Although it is required that the protocol for each site be approved by IRBs, once the IRB approves the protocol for the first site, it can be submitted for INVIMA to approve. INVIMA must then be notified of additional sites. Once a company has approval from INVIMA, it can request an import license for the study drug and other supplies.

    In contrast to the challenges that protocols with a placebo arm present in Brazil, there are no such special concerns with placebo-controlled studies in Colombia as long as it is approved by ECs.

    On the other hand, the clinical trials regulation in Colombia presents its own set of challenges. In particular, a new resolution was introduced in 2008 that requires GCP and a certification of institution by INVIMA in order for a company to be able to conduct clinical research. Consequently, all protocols that are submitted to INVIMA for approval will need to also include a copy of the submission of a certification plan. 

    Putting aside the potential for conducting clinical trials in Colombia, the pharmaceutical market, in general, is also ripe with possibilities. Since the 1930s, when the pharmaceutical industry in Colombia essentially consisted of just three local manufacturers and ten foreign subsidiaries, the Colombian pharmaceutical market has developed and blossomed. Today, the domestic industry is considered relatively well developed although rather fragmented. This market fragmentation itself can be seen as a source of opportunity for companies entering Colombia.  

    Also worth bearing in mind, as with most other countries in Latin America, the time and cost associated with registering a pharmaceutical product in Colombia, both with respect to new, as well as similar or generic pharmaceuticals, is significantly lower than in the U.S. or Europe. New drugs take six months to register, while similar and generic drugs can be registered in merely three months.

    However, although the pharmaceutical market in Colombia holds a great deal of appeal, there are also challenges to entering and operating in this market that a pharmaceutical company ought to be aware of when considering doing business there.

    One challenge is the high incidence of under-the-counter sales in pharmaceuticals in Colombia. Additionally, counterfeit products make up about 2–3% of the pharmaceutical market value. This particular issue, however, may become less of a concern in the future; the prevalence of counterfeit pharmaceuticals is decreasing in Colombia thanks to the adoption of good manufacturing practices.

  • Conclusion

    The emerging countries reviewed in this article are economic powerhouses with large populations, large resource bases, and large markets. To a lesser or greater extent, no major player in the pharmaceutical industry can ignore the importance of these economies, and those of Latin America in particular.

    As many Latin American countries attempt to extend healthcare to larger portions of the population, public spending on pharmaceutical products by these governments can be expected to grow; there remains significant unfulfilled demand that represents an attractive opportunity for pharmaceutical companies. In fact, despite the cost-containment efforts by the governments of a number of Latin American countries, the simultaneous efforts to expand access to medicine means that these sorts of opportunities will not be going away any time soon.

    Each of the markets highlighted here feature unique attributes that must be identified and understood when entering or operating in that particular country. This will remain to be true for at least the foreseeable future, since efforts at regional (or for that matter, global) harmonization have had limited success. Therefore, at least for the meantime, the regulatory schemes in Latin America differ among the countries, although many have certainly come along a great deal in their own rights respectively.

    The pharmaceutical industry, much like all sectors of business today, is no longer a localized endeavor. Today, more than ever, globalization plays a vital strategic role in the undertakings of pharmaceutical companies.

    As transnational borders become less and less important, the pharmaceutical industry is expanding its reach beyond already established markets. Certainly, Latin America is a region that has precisely this kind of untapped potential. Once pharmaceutical companies are able to effectively maneuver within the regulatory landscape of these key Latin American countries, the pharmaceutical markets there will surely evolve even further.


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