28 septiembre 2017

Another working meeting was held on September 20th to discuss the Executive Branch’s draft bill to amend Law Nº 16.463 regulating medications. This involves an activity spearheaded by the Medeos Group and the National Academy of Medicine, which are discussing the proposal created by Argentina’s National Administration of Drugs, Food, and Medical Technology (Administración Nacional de Medicamentos, Alimentos y Tecnología or ANMAT). The goal is to finish reviewing and rewording the text by the end of November for submission to the ANMAT with consensus from the private sector.

The aim behind the reform of the medications law is based on the understanding that this legislation was out of date and that it was necessary to promote a present-day legal framework (the law dates to 1964) to regulate the sale of medications.

The points that were underscored at the meeting were as follows:

  • Scope of the law
  • Definitions of the law
  • Research stimulus measures
  • Creation of a law of a less regulatory nature

The activity was focused on three work groups:

  • Advertising and Promotion of Medications Workshop and Prescriptions Workshop

The group reviewed three central points from prior meetings and proposed that the scope of the eventual law be delineated. Given the way it is currently worded, it is unclear whether it covers medications, medical products, cosmetics, and fragrances. Generally speaking, the consensus of the group was that the law should cover medications and suggested that the cut-off point be dermato-cosmetic products; this, however, is not inferred from the current wording of the draft bill. ANMAT representatives indicated that the aim is to correct the text to specify that it will not regulate dietary supplements, cosmetics, or fragrances.

The role of electronic prescriptions was also discussed. A recommendation was made for the measure to modify the regulatory framework in effect in order to be able to move forward with this modality.

In addition, the focus turned to prescriptions that use generic names. It was understood that it is necessary for health care professionals to be able to use commercial names for drugs.

  • Regulation Workshop, Quality Workshop, and Dispensary Workshop

This group’s task focused on the definitions stipulated in the draft bill. It maintained that these are not clear and that they must be organized. The group will continue to work on the definitions. Participants in this discussion will submit proposals for definitions for the text’s glossary.

The need to add clarity to the legislative framework to safeguard the quality, safety, and efficiency of the drugs in circulation was also mentioned.

  • Research Workshop

The work focus from earlier meetings was followed. A proposal was made for the ANMAT to approve the research development plans. It was indicated that the figure of New Research Products should be promoted and that all research should be endorsed by the ANMAT as the authority for implementation.

In addition, a list of the types of research for specialty pre- and post-marketing was created.