The Government of Ecuador continues working for the second debate of the Organic Health Code bill. As consequence, the Government has issued a draft of the Code in order to receive feedback from any interested party.
The Organic Health Code aims to unify health regulations in a single body, repealing more than 400 legal provisions. In terms of intellectual property, the draft establishes the power to grant compulsory licenses on protected patents for medications and medical devices for human use that are of public interest for the treatment of disease, covering only product patents and leaving aside process patents. Regarding regulatory matters, it establishes standards that detail requirements for labeling, and the obligation to obtain registration or sanitary notification for certain products.
