Modifications to the general health regime

Section 264 of the Decree abolishes Law No. 27.113, which declared as national and strategic public interest the activity of laboratories of public production, dedicated to the research and production of medicines, raw materials for medicines, vaccines, supplies, and medical devices.

Law No. 27.113 aimed to promote the activity of public production laboratories, which are those belonging to the national, provincial or municipal state, to the City of Buenos Aires, to the armed forces, or to state-managed university institutions. Additionally, through Law No. 27.113, the National Agency of Public Laboratories (ANLAP) was created. Among its functions were designing public policies for research and public production of medicines, raw materials for medicine production, vaccines, supplies, and medical devices, as well as their distribution in the healthcare system.

Section 265, on the other hand, abolishes Decree No. 743/2022, through which a maximum cap of a 90% increase in relation with the Average Taxable Remuneration of Stable Workers (RIPTE) was set, for the fees of Private Healthcare Insurance contracts paid by users. This cap was established for a period of eighteen (18) months, from February 1, 2023.

Moreover, Decree No. 473/2022 established that as of January 1, 2023, Private Health Insurance companies were obliged to offer their users identical coverage plans to those they had at the time of the issuance of Decree No. 743/2022, without co-payments (with some additional considerations).

 

Prescribing drugs by their commercial name is now prohibited

Section 266 eliminates the possibility of prescribing medications by their commercial names. The Decree substitutes Section 2 of Law No. 25.649, titled "Promotion of the Use of Medicines by their Generic Name."

The new text of Section 2 establishes that all medical prescriptions must be made exclusively using the generic name of the medication, followed by the pharmaceutical form, dosage/unit, and details of the concentration level.

The previous wording of Section 2 allowed the inclusion of the commercial brand name of the medication on the prescription, alongside the generic name. In such cases, upon the consumer's request, the pharmacist was obliged to substitute the prescribed medication's brand name for a less expensive one. This mechanism is currently repealed, as prescribing using the commercial name of the medication is now forbidden.

Modifications to the regulatory framework of Private Healthcare Insurance (Law No. 26,682)

Section 267 of the Decree abolishes Sections 5.g), 5.m), 6, 18, 19, 25.a), and 27 of Law No. 26.682, known as the "Regulatory Framework of Private Healthcare Insurance Providers."

• Subsection 5.g) authorized the Ministry of Health of the Nation, through the Superintendence of Health Services (SSS), to approve and review the fees of Private Healthcare Insurance contracts. Subsection 5.m) authorized the SSS, in the event of a healthcare insurance provider's bankruptcy, closure, or cessation of activities, to transfer the health coverage of its affiliates to another insurance provider with similar health coverage and fees.
• The repeal of Section 6 eliminates the Permanent Commission that had been created as a coordinating body for the functions established in Law No. 26.682.
• Section 18 stipulated that the SSS should set the minimum mandatory fees to be charged by public and private providers to ensure their efficient performance.
• Section 19 mandated that Private Healthcare Insurance providers must adopt, as an obligation, the contract models established by the SSS to formalize their contracts with users.
• Section 25.a) established the payment of an annual fee by different entities as one of the sources of financing for the objectives of the Law.
• Lastly, Section 27 established an advisory body called the Permanent Concertation Council, composed of representatives of the parties involved (Ministry of Health of the Nation, SSS, users, providers, among others). This advisory body has been abolished.

Additionally, Section 268 incorporates Section 30 bis into Law No. 26.682, stating that the law shall only apply to voluntary affiliates who have a relationship with an insurer outside the scope of Law No. 23.660 of "Public Healthcare Insurance Application Regime."

Finally, Section 269 substitutes Section 17 of Law No. 26.682. In its previous wording, Law No. 26.682 authorized the SSS to oversee and ensure the reasonableness of the fees for the service plans, approving increases when appropriate. This provision has been abolished, leaving only the possibility for service providers to set differential prices for coverage plans at the time of contracting, based on the user's age group, with a maximum variation of 3 (three) times between the price of the first and last age group.

 

Modifications to the regulatory framework of Public Healthcare Insurance (Law No. 23.660)

Section 270 of the Decree extends the Public Healthcare Insurance Providers Applicable Regime to all entities covered by Law No. 26.682 "Regulatory Framework of Private Healthcare Insurance Providers" (i.e., private healthcare insurance companies, cooperatives, mutual associations, civil associations, and foundations whose total or partial purpose is to provide prevention, protection, treatment, and rehabilitation of human health to users).

Section 271 substitutes Section 2 of Law No. 23.660. Under the new regulations, different types of entities will be subject to specific legal regimes.

Entities covered in subsections c), d), and h) of Section 1 will function as non-state public law entities, with legal, financial, and administrative individuality and will have the status of a legal subject, within the scope established by the Civil and Commercial Code of the Nation for legal entities; entities mentioned in subsections a), e), and f) will operate with administrative, accounting, and financial individuality and will have the status of a legal subject as defined by Section 148 of the Civil and Commercial Code of the Nation.

Entities mentioned in subsection b) will maintain their administrative, accounting, and financial modalities according to the laws that originated them.

Section 272 modifies the wording of Section 3 of Law No. 23.660. Previously, that Section applied only to Public Healthcare Insurance Providers. The new wording includes "all entities mentioned in Section 1", thus extending its application to entities regulated by Law No. 26.682.

Section 273 substitutes Section 4 of Law No. 23.660. Previously, that Section applied only to Public Healthcare Insurance Providers. In the new version, all entities from Section 1 are included, extending its application to entities regulated by Law No. 26.682. Additionally, some aspects of the documentation to be submitted are modified.

Section 274 abolishes Section 5 of Law No. 23.660, which stipulated that Public Healthcare Insurance Providers must allocate a minimum of 80% of their gross resources to providing health care services to their beneficiaries established by the insurance. Section 5 also established inter-jurisdictional obligations for revenue redistribution.

Section 275 replaces Section 6 of Law No. 23.660. Previously, that Section applied only to Public Healthcare Insurance Providers. The new wording includes all entities from Section 1, extending its application to entities regulated by Law No. 26.682.

Section 276 replaces Section 7 of Law No. 23.660, hence replacing ANSSAL with the SSS as the body empowered to issue mandatory resolutions for entities, exclusively concerning their condition as Healthcare Insurance Agents.

Section 277 replaces Section 8 of Law No. 23.660. Previously, that Section applied only to Public Healthcare Insurance Providers. The new wording includes all entities from Section 1, thus extending its application to entities regulated by Law No. 26.682.

Section 278 substitutes the last paragraph of Section 9 of Law No. 23.660, replacing the National Directorate of Public Healthcare Insurance Providers with the SSS as the body empowered to authorize the inclusion of ascendants or descendants by consanguinity (dependents) of the main beneficiary, to the coverage plan.

Section 279 replaces subsection e) of Section 10 of Law No. 23.660 regarding seasonal workers who receive coverage during periods of inactivity. This coverage will cease when, due to another work contract, the worker becomes a main beneficiary according to the terms of Section 8 of the Law.

Section 280 of the Decree abolishes Section 10. f) of Law No. 23.660. This provision had already fallen into disuse, for it established that individuals who had to fulfill mandatory military service were not required to make contributions, without losing their coverage.

Section 281 substitutes Section 11 of Law No. 23.660. Previously, that Section applied only to Public Healthcare Insurance Providers. The new wording includes all entities from Section 1, thus extending its application to entities regulated by Law No. 26.682.

Section 282 of the Decree substitutes Section 12. h) of Law No. 23.660. Previously, that Section applied only to Public Healthcare Insurance Providers. The new wording includes all entities from Section 1, thus extending its application to entities regulated by Law No. 26.682.

Section 283 substitutes Section 15 of Law No. 23.660. The new wording replaces ANSSAL with the SSS as the body with powers of supervision and control over Public Healthcare Insurance Providers.

Section 284 substitutes Section 19 of Law No. 23.660. According to the new wording, employers, as retention agents, must deposit their contributions together with the contributions that should have been withheld from their personnel within fifteen (15) consecutive days from the date when the remuneration should be paid to the entity selected by the beneficiary and through the corresponding mechanism of the agency responsible for founds collection.

Section 285 incorporates Section 19 bis into Law No. 23.660, which establishes that when entities receive additional contributions beyond those provided in subsections a) and b) of Section 16 (the 6% contribution by the employer and the 3% contribution by the worker), they must deposit 20% to the Solidarity Redistribution Fund.

Section 286 substitutes Section 21 of Law No. 23.660, replacing the National Directorate of Public Healthcare Insurance Providers with the Superintendence of Insurance of the Nation. The latter will be in charge of supervising and verifying the obligations arising from the law, and its inspectors and officials will have the powers and attributions assigned by law to the inspectors and officials of the National Directorate of Pension Collection.

Section 287 replaces the first paragraph of Section 23 of Law No. 23.660. The current wording refers not only to Public Healthcare Insurance Providers but also to entities in general. It stipulates that any funds corresponding to them must be deposited in banking institutions and be exclusively allocated to providing benefits and fulfilling obligations, as well as covering administrative operational expenses.

Section 288 of the Decree substitutes the first paragraph of Section 24 of Law No. 23.660. Previously, that Section applied only to Public Healthcare Insurance Providers. The new wording includes all entities, thus extending its application to entities regulated by Law No. 26.682.

Section 289 substitutes Section 25 of Law No. 23.660 and eliminates the National Directorate of Public Healthcare Insurance Providers created by the law in its original version. Its functions are now under the scope of the SSS.

Section 290 of the Decree substitutes Section 26 of Law No. 23.660. According to the new wording, the SSS will aim to promote, coordinate, and integrate the activities of entities not subject to the National Health Insurance System Law. It will also act as a supervising body for administrative and accounting aspects of Public Healthcare Insurance Providers. Originally, these functions were within the scope of the National Directorate of Public Healthcare Insurance Providers.

Section 291 substitutes Section 27 of Law No. 23.660. The Decree does not modify the powers provided to the implementing authority, but adjusts the wording by replacing the National Directorate of Public Healthcare Insurance Providers with the SSS.

Section 292 incorporates Section 28 bis into Law No. 23.660, stating that, despite the Decree including all entities regulated by Law No. 26.682 as entities covered by Law No. 23.660, the sanction regime of Law No. 26.682 will still apply to them.

Section 293 substitutes the last paragraph of Section 40 of Law No. 23.660. With the new wording, the trustee will be appointed by the Ministry of Health of the Nation upon the proposal of the SSS. Previously, the proposal was made by ANSSAL.

Finally, Section 294 abolishes Section 42 of Law No. 23.660. Section 42 established that the functions and attributions outlined for the National Directorate of Public Healthcare Insurance Providers would be assumed by the National Institute of Public Healthcare Insurance Providers (INOS) until the Law No. 23.660 was regulated and the new organization began operating.

 

Modifications to the National Healthcare Insurance System

Section 295 of the Decree amends the last paragraph of Section 2 of Law No. 23.661 "National Health Insurance System". With the current wording, entities included in subsection i) of Law No. 23.660 (that is, all entities within Section 1 of Law No. 26.682), are considered insurance agents.

Furthermore, Section 296 replaces Section 5. a) of Law No. 23.661. Previously, the insurance covered all beneficiaries contemplated in the "Public Healthcare Insurance Providers Law". With the new wording, it refers to all beneficiaries included in Law 23.660.

Section 297 replaces Section 15 of Law No. 23.661 and expands the reference to natural insurance agents, mentioning not only Public Healthcare Insurance Providers but also all entities included in Law No. 23.660 (including those incorporated by Section 1, subsection i).

Additionally, Section 298 of the Decree substitutes Section 17. a) of Law No. 23.661. The new wording refers to entities included in Law No. 23.660 and not to the "Public Healthcare Insurance Providers included in the Public Healthcare Insurance Law".

Section 299 of the Decree substitutes the last paragraph of Section 17 of Law No. 23.661, regarding the National Registry of Insurance Entities. It establishes that registration will enable the agent to allocate the resources destined for health benefits, as provided for in Law No. 23.660. Previous wording referred to the allocation to health benefits as provided by the “Public Healthcare Insurance Law”.

Furthermore, Section 300 of the Decree replaces Section 21.a) of Law No. 23.661 and establishes that, to ensure the benefits stipulated in the Law, the system will rely on the coverage of benefits that the entities included in Law No. 23.660 must provide to their beneficiaries.

Lastly, Section 301 replaces Section 22.a) of Law No. 23.661, concerning the funds that will comprise the Solidarity Redistribution Fund. The Decree states that the resources mentioned in Law No. 23.660 and its amendments are included as a source of financing.

 

Modifications to the Traceability and Technical Aptitude Verification Regime for Active Medical Devices.

Section 302 of the Decree abolishes Sections 6, 7, 8, and 11 of Law No. 26.906, which established the following:

• Section 6 established that the regulatory authority should define the identification mechanism to allow the enablement of active medical devices in use in public and private health establishments in our country.
• Section 7 stipulated that jurisdictional health authorities should issue the certification of enablement for active medical devices and their corresponding renewals, in accordance with the technical verification requirements determined.
• Section 8, concerning the warranty period, excluded the corresponding technical verification for the renewal of equipment under warranty, when their manufacturers could certify that their operating characteristics were ensured during that period. It also established that the Biomedical Technology Services could impose tests and verifications of active medical products even within the warranty period.

On the other hand, Section 303 incorporates Sections 5.1 and 5.2 into Law No. 26.906, which establish that the Regulatory Authority will determine the active medical devices authorized for use in the country. Active devices that have not been authorized by the Regulatory Authority cannot be used. Furthermore, users of active medical devices must inform the Regulatory Authority of the installation and use of such devices. Additionally, the Regulatory Authority will determine the requirements and procedures for the use of active medical devices and reserve the right to audit their compliance.

Section 304 substitutes Section 9 of Law No. 26.906. Only the reference to 'the certificate of enablement' of active medical devices is modified, replaced by an 'authorization for use.'

Likewise, Section 305 substitutes Section 15.f) of Law No. 26.906 concerning the functions of the Biomedical Technology Service, which included providing advice regarding the installation, start-up, and maintenance of services associated with medical equipment and their optimal performance. The new wording keeps that function, but clarifies that this task´s objective will be to meet the technical specifications established by the regulatory authority.

Finally, Section 306 substitutes Section 16 of Law No. 26.906. Among the functions of the regulatory authority, it includes the power to authorize active medical devices for use throughout the country (subsection a) and to define the conditions of use for each authorized medical device (subsection b). The task of promoting the creation of a Repair and Maintenance Services Registry is now eliminated.

 

Modifications to the electronic or digital prescription regime: elimination of handwritten prescription and other previsions.

The whereas of Presidential Decree No. 70/2023 emphasizes the need to reduce costs associated with health services amid the crisis in the healthcare system, aiming to directly enhance benefits for the general population.

In relation to Law No. 27.553 on Electronic or Digital Prescriptions, the Decree highlights the need of its reformulation to fully transition to the use of electronic prescriptions. This change aims to increase industry efficiency, minimize expenses, and consequently enhance competitiveness in the market.

In that sense, Section 307 of the Decree substitutes Section 1 of the Electronic or Digital Prescription Law, so that the prescription and dispensing of medications, as well as any other form of prescription, must be exclusively carried out through duly authorized electronic platforms, in accordance with Law No. 25.326 on Personal Data Protection and Law No. 26.529 on Patient Rights.

Section 310 modifies Section 19.7 of Law No. 17.132 on the Rules for the Practice of Medicine, establishing that medical professionals can only prescribe using exclusively the generic name of the drug or its common international denomination (in correlation with Section 265 of the Decree).

Section 308 substitutes Section 3 of Law No. 27.553, and the new wording establishes that the National Executive Branch will determine the necessary deadlines to achieve complete digitalization in the prescription and dispensing of medications, as well as in any other form of prescription. These deadlines cannot be extended beyond July 1, 2024. Additionally, the use of telehealth platforms in healthcare will be regulated.

Finally, Section 309 substitutes Section 13 of Law No. 27.553. In this manner, the reference to handwritten signatures in the prescription and dispensing of medications is eliminated, limiting it to electronic or digital signatures concerning their traceability throughout the medication supply chain.

 

Regulation of the right of choice regarding Public Healthcare Insurance Providers

The Section 311 of the Decree substitutes Section 13 of Decree 504/1998. The previous wording of Section 13 required that workers remain for at least one (1) year in the Public Healthcare Insurance system corresponding to the branch of their activity before being able to exercise the right to choose a change or provider. With the new wording of Section 13, workers will be able to exercise the right to choose an Insurance Provider without the obligation to wait for one (1) year.

On the other hand, Section 312 substitutes Section 14 of Decree No. 504/1998. The previous wording of Section 14 demanded that affiliates who had exercised the right to choose a change remain for a minimum of 1 (one) year in the chosen Public Healthcare Insurance Agency in order to exercise the right of choice again. The new wording of Section 14 establishes that the Regulatory Authority will determine the minimum time for which affiliates must remain in the chosen Public Healthcare Insurance Agency, which can never be more than one (1) year.

Principio del formulario

Modifications to the legal framework for the practice of pharmaceutical activity and the authorization of pharmacies, wholesalers and herbalist shops.

Section 313 of the Decree substitutes the first and second paragraphs of Section 1 of Law No. 17.565 ("Pharmacy Law"). The new wording of Section 1 establishes that the preparation of prescriptions, dispensing of drugs, medicines, and pharmaceutical specialties requiring prescriptions can only be carried out in authorized pharmacies. This obligation does not seem to extend to products that do not require a prescription for delivery, such as over-the-counter medications.

Additionally, section 314 adds a last paragraph to Section 2 of Law No. 17.565, which provides the possibility for pharmacies to be created under any legal form permitted by current legislation.

Section 315 replaces Section 4 of Law No. 17.565, eliminating the requirement to obtain prior authorization from the health authority for the partial or total transfer of a pharmacy, and the accreditation through registration of the contract in the Public Registry of Commerce.

Furthermore, it eliminates the obligation to previously notify the health authority of reforms, expansions, temporary or permanent closures, or reopening of pharmacies. Lastly, it removes the last paragraph of Section 4, which stipulated that any pharmacy that remained closed for more than 30 consecutive days would be considered a new entity upon reopening.

Section 316 substitutes Section 6 of Law No. 17.565, incorporating as the first paragraph that pharmacies may operate at the hours they choose without any restriction, with the sole obligation of communicating these hours to the health authority and adhering to the communicated hours.

Section 317 replaces Section 9 of Law No. 17.565, removing "Free Dispensation" as one of the forms of dispensing drugs, medicines, or medicinal specialties in pharmacies.

Additionally, Section 318 replaces Section 10 of Law No. 17.565. According to the previous wording, records (or digital archives) had to be kept for a) prescriptions; b) narcotics control; c) psychotropic control; d) inspections; and e) other records that the authority deemed pertinent. These records had to be kept legibly without leaving blank spaces, altering the order of dispensed prescriptions, or making amendments or erasures.

The current wording replaces this system and mandates that the records be digital. It is established that electronic books, electronic or digital signatures, and other technical and legal requirements must conform to what the enforcing authority establishes, ensuring the immutability of the records.

Section 319 abolished Sections 13, 20, 27, 40, 41, 42, 43, and 44 of Law No. 17. 565, which established the following:

• Section 13 prohibited the installation of optical houses or workshops in pharmacies.
• Section 20 prohibited simultaneously exercising the title of doctor or dentist alongside that of a pharmacist. It also stated that pharmacists holding also the title of biochemist could not work as technical director of a pharmacy, while simultaneously working as technical director of a clinical analysis laboratory. It also prohibited the establishment of medical or dental offices in the pharmacy's premises.
• Section 27 regulated the procedure for the absence of the pharmacy's technical director, which was to be exceptional and temporary. This requirement has been eliminated.
• Section 40 imposed the obligation on wholesalers to maintain books authorized by the health authority. Regarding the repeal of Section 40 of Law No. 17.565, there seems to be a contradiction with Section 325 of the Decree, which keeps Section 40 in force and replaces the last paragraph.
• The abolishment of Sections 41 to 44 repeals the entire regulatory framework of the law applicable to herbalist shops. Consequently, it eliminates the requirement of prior authorization from the health authority, the need for a technical director subject to pharmacy regulations, limitations on advertisements, and the obligation to maintain an inspection´s book.

Section 320 substitutes Section 25 of Law No. 17.565, excluding the prohibition that a pharmaceutical professional be the technical director of more than one pharmacy. In that sense, it establishes that when a pharmaceutical professional is the technical director of more than one pharmacy, they are obligated to oversee the preparation and dispensing of medications in all locations under their charge, signing the prescription book daily after the last dispensed prescription.

Additionally, Section 321 substitutes Section 26 of Law No. 17.565, removing the obligation for the technical director's continuous presence in the establishment, subject to exceptional circumstances. Instead, it establishes that in the absence of the technical director at the pharmacy, the pharmacy may be managed by: a) auxiliary pharmacists, who may dispense medical prescriptions in these cases; or b) dispatch assistants, in which case they can only dispense medical prescriptions with the authorization of the technical director, as stipulated by the regulations.

Moreover, Section 322 substitutes Section 28.d) of Law No. 17.565, excluding the obligation for the technical director to have a plan of the authorized premises in the pharmacy. In the current wording, this requirement is replaced by the obligation to have only evidence of the establishment's authorization.

Lastly, Section 323 substitutes Section 36 of Law No. 17.565, and in the new wording, it removes the prohibition for wholesalers to dispense prescriptions.

Section 324 replaces Section 38.a) of Law No. 17.565. The Decree establishes that the holder of the permit for a wholesaler´s installation and its technical director must ensure that the drugs and products involved in the establishment's activities are exclusively acquired by individuals authorized for their sale and, in turn, only dispensed to pharmacies and laboratories or directly to the public if they also decide to constitute as public retail pharmacies. This inclusion allows the wholesalers the possibility of direct sales to the public if it decides to be established as a retail pharmacy as well.

Finally, Section 325 substitutes the last paragraph of Section 40 of Law No. 17.565. In the previous wording, the books that wholesalers were required to maintain had to be paginated and bound, written in a legible manner, without altering the order of the sales records, and without erasures or scratches. As per the new wording, these books must be electronic, without altering the order of the sales records.