Government Signs Bioequivalence Decree
BMI View: The legislation on bioequivalent drugs is an important step in bring ing high quality medicines to the Chilean market and eventually reduc ing the country ' s medical spending. The tightened bioequivalent regulations will boost genuine medicine sales and force similares out of the market. I t will also help to bring local drugmakers up to international standard s , and in the long term, improve their competitiveness in the domestic and regional markets. Indian drugmakers and other Latin American firms with products which have been held to tougher bioequivalent standards in the international market will benefit from the legislation immediately.
The Chilean President, Sebastián Piñera, along with Health Minister, Jaime Mañalich, and Deputy Finance Minister, Julio Dittborn, has signed a supreme decree on bioequivalent medicines and given authority to the National Medicines Agency (ANAMED) to approve the drugs. The government stated that the new legislation aims to facilitate access to bioequivalent drugs in Chile and reduce medicine prices. The president has planned to increase the number of approved bioequivalent drugs to 3,000 over the next four years. The Institute of Public Health in Chile (ISPCH) will be responsible for the certification of bioequivalence through ANAMED.
The Chilean government has been determined to improve the accessibility of bioequivalent drugs: in October 2011, ISPCH signed an agreement with Brazil's ANVISA to increase the number of bioequivalent drugs in Chile. As a result, all products guaranteed as bioequivalent by ANVISA are recognised by ISPCH. This is the first agreement signed by ISPCH with a foreign medicine agency. ISPCH reported that 324 drugs had to meet bioequivalence standards by 16th February 2012. Of these, 235 products, equal to 72.5% of the total, had already responded to ISPCH by October 2011. ISPCH had also issued 120 bioequivalence-related infractions by October 2011.
BMI believes that the new legislation will help to bring bioequivalent drugs to the Chilean market and invariably reduce the price as a wider group of drugmakers enter the market. However, due the complex nature of bioequivalence, drug companies require considerable biopharmaceutical experience to produce and market their products in this comparably well-regulated country. It is reported that there were only ten products certified as therapeutically equivalent by July 2010 in Chile. Nevertheless, ISPCH believes that national producers should make an effort to meet bioequivalence standards.
Currently, ISPCH has 12 companies authorised to perform bioequivalence studies in Chile: Andrómaco, Bagó, Bioeq, Davis, Garden House, Instituto Sanitas, Laboratorio de Investigaciones Farmacológicas y Toxicológicas (IFT), LabChile, Medipharm, Mintlab, Recalcine and Saval. Additionally, ISPCH has certified a number of companies to perform bioequivalence studies in Argentina and Brazil.