In an appearance before the State Council, the Ministry of Health defended its policy regulating the entry of biotechnological medications to the country. In opposition to the arguments posed by international laboratories, this body stated that these measures will result in savings of between $300 billion and $600 billion every year.
The Ministry opposed the cautionary measure requested by the Association of Pharmaceutical Laboratories for Research and Development (Asociación de Laboratorios Farmacéuticos de Investigación y Desarrollo or Afidro) to not apply article 9 of 2014 Decree 1782, which went into effect last August, establishing a new regulation for the entry of biotechnological medications to the country.
The article in question establishes an abbreviated route for the health registry transaction when certain requirements have been met: that the medication’s active ingredient is sufficiently defined (in terms of identity, biological activity, physical chemical properties, and purity), that its safety and efficiency are documented, that its clinical experience is demonstrated, and that there is sufficient pharmacovigilance information available.
Afidro requests the provisional suspension of this article because it considers that all biosimilar products should again undergo clinical trials in patients, which would take decades in each case. The Ministry of Health, on the other hand, defends the abbreviated procedure because it considers that it does not violate the right to health and that it does not place the life of Colombian citizens at risk; it also considers that in accordance with ethical standards of clinical research, experiments involving human beings should not be repeated to demonstrate things that have already been proven.
The abbreviated procedure to register the biotechnological medications can save the health care system between 300 and 600 billion pesos annually, which is a sufficient basis for it to have the support of the Misión Salud organization.