By means of Decree No. 70/2023 the Executive Power declared the public emergency on health matters until December 31, 2025, and introduced various modifications to the Argentine legislation, including relevant reforms in the health regulatory framework, as follows:
- Derogation of Law No. 27,113. By this means the Executive Power derogated the promotion of the activity of public production laboratories, along with the National Agency of Public Laboratories that was created to encourage national drug production.
- Prepaid Medicine and Social Security Funds
a. Prepaid Medicine Companies (“EMP”) have been incorporated into Law No. 23,660 on Social Security Funds, thereby granting them all the rights, obligations, and responsibilities established therein.
b. Following the amendments incorporated into Law No. 26,682 on Prepaid Medicine, the Enforcement Authority will no longer be required to authorize or review the fee rates of EMPs or the contract models with providers.
c. PME and Health Insurance Entities can establish differential prices for benefit plans based on age groups, with a maximum variation of three (3) times between the price of the first and last group.
d. PME can freely set the value of fees for individual voluntary adhesion contracts, without state intervention.
e. Employees could derive their salary contributions to pay for an EMP health plan directly, without the intermediation of a Health Insurance Entity.
f. The obligation foreseen to transfer PME’s associates to other registered providers in case of bankruptcy, closure, or cessation of activities was eliminated.
g. PME’s annual fee payment specified in Article 25 of Law No. 26,682, used to finance the same law, was eliminated.
h. The provision in Law No. 23,660 that set guidelines on how Social Security Funds should manage their funds has been repealed.
i. The Superintendence of Health Services will act as the Enforcement Authority of Law No. 23,660, and will be able to authorize the inclusion of ascendants and/or descendants by blood of primary beneficiaries as beneficiaries, subject to an additional contribution of 1.5% for each of them.
j. Amendments were introduced to Decree No. 504/1998, providing dependent workers the right to choose the Health Insurance Entity, without being obliged to join the Health Insurance Entities of their activity. It also stipulates a minimum affiliation period if changing the insurance agent, which cannot exceed of a calendar year. - Use of Generic Names for prescription of Medicines. Law No. 25,649 on Medicinal Specialties has been amended to require that medical prescriptions or orders must express only the generic name of the medication or international common name, followed by its pharmaceutical form and dose/unit, with the concentration level, without mentioning drug brands. Only authorized pharmacists are allowed for dispensing prescribed medicines.
- Traceability and Verification System for Active Health Medical Devices in Use Various articles of Law No. 26,906 have been repealed, which established the procedure for the approval and renewal of the authorization of active medical devices by the Enforcement Authority, with the aim of streamlining the implementation of medical equipment. It also incorporates the responsibility of users of these medical devices to inform the Enforcement Authority about the installation and use of the active medical devices.
- Electronic or Digital Prescriptions. The amendments to Law No. 27,553 foresee the elimination of handwritten prescriptions, establishing that the prescription and dispensing of medications must be carried out exclusively through authorized electronic platforms, as well as through telehealth platforms that comply with Law No. 25,326 on Personal Data Protection and Law No. 26,529 on Patient Rights. The dispensing of medications through electronic or digital prescriptions must comply with all regulations regarding the commercialization chain and traceability; it must also include a record of telehealth assistance, prescription, and dispensing for the patients. It also incorporates the possibility for pharmacists to implement a block when there is a manifest error in the prescription, so that the prescriber can review, cancel, or reactivate it as appropriate.
- Pharmaceutical Activity, Pharmacy Authorization, Drugstores, and Herbalists. Relevant modifications include:
a. Over-the-counter medicine can be sold outside authorized pharmacies.
b. Over-the-counter medicine can be displayed on pharmacy shelves without requiring personal dispensing by pharmacists.
c. Pharmacies must digitally preserve prescriptions for restricted drugs, legally dispensed drugs, and prescription drugs for a period of at least three (3) years.
d. The prohibition established in Law No. 17,565 against setting up optical shops or workshops in pharmacies, and the establishment of medical or dental offices in or attached to a pharmacy, has been removed.
e. Pharmacists with medical or dental qualifications can practice both professions simultaneously. Pharmacists with a biochemistry qualification can be both Technical Directors of a Pharmacy and Technical Directors of a clinical analysis laboratory.
f. The guidelines established by Law No. 17,565 for Technical Directors in the event of their absence have been repealed; during this period, the operation of pharmacies will be managed by assistant pharmacists and/or dispensing assistants.
g. Several articles of Law No. 17,565 that regulated herbal medicine shops have been repealed, meaning that these entities will no longer need prior authorization from the health authority, their advertisements or promotions will not require a Technical Director, and they will not need to maintain an inspection book authorized by the health authority.
h. Drugstores are now allowed to dispense prescriptions.
