Chilean Pharma: Exploring Beyond Copper - Pharmaceutical Executive


Chilean Pharma: Exploring Beyond Copper

Pharmaceutical Executive

Maria Teresa Valenzuela, Director of the Publich Health Institute (ISP)
Leading today's healthcare reform is Minister of Health, Jaime MaÑalich, who is determined to iron out the inefficiencies of the healthcare system to reflect the rest of the country's economic and political achievements. "A major issue for our healthcare system is related to the structure and quality of health institutions, including hospitals and regulatory entities," he asserts. Two main entities on the Ministry's radar are the Public Health Institute (ISP), the regulatory agency for the pharmaceutical industry, and the National Supply Center (CENABAST) that is the public purchasing entity and distributor for all public hospitals and clinics—the pharmaceutical industry's de facto biggest purchaser. A recent audit of CENABAST conducted by advisory firm PWC, brought to light the severe inadequacies of the institution and the desperate need for a professionalization of its activities. Minister MaÑalich explains that "the underlying problem is that CENABAST does not have the adequate facilities and capacity to handle the logistics required to supply the system appropriately. We are therefore proposing to delegate this responsibility to the private sector by having pharmaceutical laboratories deliver directly to hospitals and clinics." Initiatives such as this will save the government millions of dollars in health expenditures that will allow for the coverage of higher quality treatments under the GES plan, therefore narrowing the gap between private and public healthcare options. Other proposals in the pipeline include the liberalization of OTC products that today are, paradoxically, kept behind the counters and sold only in pharmacies, as well as the creation of a National Pharmaceutical Agency (ANAMED) that will be solely charged with the registration and regulation of pharmaceutical products—a task that today is overseen by the overwhelmed and underbudgeted ISP. The director of the ISP, Maria Teresa Valenzuela, echoes the need for drastic change and stresses that "the key area for this new administration is the search for quality in all possible aspects—from administrative management up to the most detailed analysis of technical processes". For Valenzuela this also means improving protocols and approval of clinical trials, as well as enhancing the bioequivalence capabilities of the institution by "supporting the accreditation of three new centers of bioequivalence in the country in partnership with three major academic institutions".

Maximiliano Santa Cruz, National Director of the National Institute of Industrial Property
As regards the old tales of Chilean imitators violating patents, the National Institute of Industrial Property (INAPI) has been at the forefront in setting the record straight. Chile is one of the countries in the world that has signed on to the most free trade agreements, including one with the United States and an Association Agreement with the European Union. Maximiliano Santa Cruz, national director of INAPI, admits that Chile "committed to several obligations in these treaties, many of them impacting directly on the pharmaceutical sector, such as extending the protection of patents in case of delays which we are already running in INAPI and ISP." Part of his institution's efforts to optimize patent regulation includes a direct partnership with the national police's "IP brigade" in charge of IP enforcement and national customs agencies. With such proposals already rolling, Santa Cruz is bold enough to proclaim that "INAPI is going to be the best IP agency in Latin America in the future."


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