Comments to the Second Transitory Complementary Provision of Supreme Decree No. 016-2013-SA

Within the classification of medicaments established by our legislation, we find those belonging to Category 3, which are products that in most cases do not have research clinical trials and which, in turn, present active pharmaceutical ingredient(s) which are neither in the National List of Essential Medicines nor come from countries of high health vigilance.

In this respect, it is worth mentioning that Supreme Decree No. 016-2013-SA, published on December 24, 2013, established in its Second Transitory Complementary Provision the following:

“(…) the owners of the health registration will have a five (5) year time limit counted from the coming into force of this Supreme Decree to support the efficacy and safety of their specialty drugs, according to criteria and actions for the evaluation of and compliance with their efficacy and safety approved by the National Health Authority.

For applications of reregistration of specialty drugs that were authorized before the coming into force of Law Nº 29459 –Law on Pharmaceutical Products, Medical Devices and Health Products -, the National Health Authority, within a sixty-day term will form a work group which will prepare the criteria and actions for the evaluation of and compliance with their efficacy and safety (…).”

Thus, in accordance with said rule, the Authority had a 60-day term to approve the Criteria and Actions for the evaluation of and compliance with the efficacy and safety of specialty drugs.  Nevertheless, said criteria was not issued within the term established by the rule and were just published on September 13, 2016.

Taking into consideration that the five-year term for supporting the efficacy and safety of specialty drugs expires on December 24, 2018 and the fact that the criteria for presenting the required documentation supporting the efficacy and safety of specialty drugs were just published on September last year, the pharmaceutical companies have been seriously affected since they have now a shorter term to implement said criteria.

Moreover, in order to obtain documents supporting the security and efficacy of a pharmaceutical product of category 3, the companies of said sector must previously conduct clinical trials in human beings to determine the clinical, pharmacological and pharmacodynamic effects of one or more research products, all of which takes a five year period of research at least.

Therefore, it is very difficult for the pharmaceutical sector to be able to comply with the term established by the Health Authority in the Second Transitory Provision of Supreme Decree N° 016-2013-SA.