With the participation of the US FDA, Health Canada and representatives from Mexican, Argentine, Peruvian, Brazilian and Ecuadorian agencies and PAHO, the pharmaceutical regulation policy model in the country was revealed by the Deputy Minister of Health at Invima’s twentieth anniversary.
Bogotá, DC, February 13, 2015. In the framework of the V Meeting of National Regulatory Authorities of Regional Reference (ARNR), organized by the National Institute of Food and Drug Surveillance (Invima), the Deputy Minister of Public Health and Provision of Services outlined the process set forth by the pharmaceutical price regulation policy in Colombia which was well received by the Andean Community, representatives of the US FDA, Health Canada, agencies of Brazil, Argentina and the participation of the Pan American Health Organization.
Fernando Ruiz said that the social appropriation of safety, quality and efficacy are not necessarily given by having refined definitions and standards.
He said “the past two years we have had to operate under a nonexistent pharmaceutical policy and have implemented the pharmaceutical price regulation policy where the country decided to tackle the problem of technological pressure of medications and their transformation within a market system with incentives towards generating income.”
He added that Colombia has limited resources and spends 6.5 percent of GDP on health with great needs; all these technological pressures had to be addressed. “We laid out the pharmaceutical price regulation policy which generated controversy among pharmaceutical and other sector agencies such as hospitals and insurance.”
However, he explained “later the associations regarded it as a transparent and understandable policy in its implementation by the different agencies in the market. This has been an important breakthrough in pharmaceutical health policy.”
He insisted that another aspect to highlight refers to biotech drugs. “Colombia spent approximately 2.8 trillion pesos in 2011 in biotech drugs through recoveries, which was nearly 10 percent of total spending on health and we decided to prepare a regulation on the subject of biotechnology.”
He explained that the entry of biosimilars was more controversial than the pharmaceutical price regulation. “We really felt alone as a country while facing the pressure of national and international actors but the balance between the country’s public health and the integrity of the system was complex and it required a thorough analysis from the point of view of political economy. However, after a year we consider it a successful process and today the model of the Colombian system is a different reality.”
In his speech, Fernando Ruiz acknowledged the role of Invima, which became a strategic agency for Colombia. “This is an organization that not only covers pharmaceuticals but also food and trade relations with the country. It has turned 20 because it has reached an important technical level, with great challenges for the future. But also worth noting is director Blanca Elvira Cajigas’s efforts” he said.
