Panama: New Medicine Law
On February 1st, 2024, Law 419/2024 (hereinafter “the Law”) was issued, “which regulates medicines and other human health products and the public procurement of medicines, other human health products, health supplies, medical devices and equipment, and dictates other provisions.”
This law regulates, in general, the manufacture, quality control, sanitary registration, importation, marketing, distribution, acquisition, and information and advertising of products for human health, such as (i) finished medicines, (ii) pharmaceutical specialties, (iii) psychotropic and narcotic drugs, (iv) biological products, (v) drugs developed by genetic engineering, (vi) dietary supplements with therapeutic properties, (vii) homeopathics, (viii) phytopharmaceuticals, (ix) radiopharmaceuticals, (x) medicinal gases, (xi) chemical precursors for medicinal use, (xii) cosmetics, (xiii) pesticides for domestic and public health use, (xiv) antiseptics, (xv) disinfectants for hospital use, (xvi) hygiene products, (xvii) personal hygiene products, and finally, other products related to the health of human beings, except products for veterinary use, which are excluded from this regulation
One of the objectives of the law is to supervise products that reach the consumer with high quality standards and to implement strategies that ensure more accessible prices, also giving the consumer access to the price list of medicines, in an effective and timely manner.
The Law includes all the regulations of the sanitary registry of medicines, its requirements, and the obligation to obtain it for all the products mentioned in Law 419. Additionally, the National Directorate of Pharmacy and Drugs has been granted the power to publish all applications for sanitary registries so that third parties can oppose to the granting of said registrations, additionally.
The Law also seeks to strengthen the local pharmaceutical industry by giving the local producer a differential price advantage of up to five percent (5%) compared to the foreigner producer in public bidding processes and supply contracts with the State.
In addition, the Health Authority may create platforms, applications or technological tools that offer information to consumers on the prices of medicines and the pharmacies where they can be obtained. Private pharmacies must provide and keep updated the information required to feed the database of the website that is available, as well as the respective platform, application, or technological tool.
According to the Law, it is mandatory to inform the consumer about the products, how to use them and the relevant warnings.
Pharmaceutical products that have a sanitary registration, authorized to be sold without a prescription, may be advertised. In addition, any advertisement must be truthful, taking care that the facts are not misrepresented and that it does not lead to error or confusion.
Title VI of the Law regulates everything related to the public procurement of medicines, other human health products, health supplies, medical devices, and medical equipment. It includes (i) the notification and publication of the call for public bids, (ii) the structure of the statement of charges, (iii) requirements for the acquisition of medical devices, and the types of public bids, (a) agile procurement, (b) public bidding, (c) minor procurement, (d) bidding for best value, etc. including the exceptional and special contracting procedure, as well as other relevant topics in public procurement
A relevant aspect of the new legislation is the creation of the National Medicines Observatory of Panama which has the purpose to develop scientific studies and monitor the marketing of medicines to strengthen their supply, traceability, and safety as well as transparency that allows, among others, to measure the national market behavior vis-à-vis the international market.
At Arias we have a team of expert advisors on the issues regulated by the Law. Therefore, do not hesitate to contact us if you require more information: regulatorio-arias@ariaslaw.com
Authors:
Yuri Moreno - Partner in Arias Panama
Estefanía Guardia - Associate in Arias Panama
The information provided by ARIAS® is presented for informational purposes only. This information is not legal advice and is not intended to create, and does not constitute, an attorney-client relationship. Readers should not act upon this information without seeking advice from professional advisers.