New Health Regulations Passed

1. Law No. 27,553 on Electronic or Digital Prescriptions.

 

This new law aims to establish that the prescription and dispensing of medicines, and any other prescription, may be in writing and signed by means of handwritten, electronic or digital signatures, and that healthcare teleassistance platforms may be used throughout the Argentine territory in accordance with Law No. 25,326 on the Protection of Personal Data (Personal Data Protection Law) and Law No. 26,529 on Patient’s Rights (Patient's Rights Law).

This new law amends and complements:

(i)   Law No. 17,132 on the Art of Healing, which regulates the practice of medical professions and other health-related professions (Law on Medical Practice);

(ii)  Law No. 23,277 of the Psychology Professional Practice;

(iii) Law No. 17,565 of the Pharmacy Practice (Law on Pharmacy Practice);

(iv) Law No. 17,818 on Narcotics (Law on Narcotics); and

(v)  Law No. 19,303 on Psychotropics (Law on Psychotropics).

 

The following highlights of the new law should be mentioned:

• Section 2 bis is incorporated to the Law on Medical Practice, enabling the modality of remote assistance for the practice of medicine, dentistry and associated activities. Teleassistance may be performed only for practices authorized for that purpose, in accordance with protocols and platforms approved by the enforcement authority;

 

• Section 19 (obligations of the healthcare professionals), subsection 7 of the Law on Medical Practice is amended as follows: "Prescribe or certify in handwritten, electronic or digital prescriptions which must contain the following information in national language: name, surname, profession, license number, address, telephone number, and e-mail, if applicable. Only technical titles or qualifications registered with the competent enforcement authority may be advertised and under conditions to be regulated. Prescriptions and/or prescriptions must be formulated in the national language, dated and signed in handwritten, electronic or digital form. If they are electronically featured, the signature and other technical and legal requirements must be in accordance with the legislation in force. If a digital signature is used, it must comply with Law 25,506 on digital signatures, adhering to the regime and being issued by a certifying authority.";

 

• Section 9 of the Law on Pharmacy Practice is amended as follows: "In pharmacies, the dispensation of drugs, medicines or medicinal specialties is in accordance with the following forms as established by current legislation or as determined by the health authority: 1. Legally restricted dispensation; 2. Dispensation under filed prescription; 3. Dispensation under prescription; and 4. over the counter dispensation. Prescriptions corresponding to points 1 and 2 must be kept in paper or digital format for a period of not less than three (3) years, after which they may be destroyed or deleted, prior communication to the health authority.”; and

 

• Section 10 of the Law on Pharmacy Practice is amended to read as follows: "The following records or digital files authorized by the health authority must be kept in pharmacies: (a) prescriptions; (b) control of narcotics; (c) control of psychotropic drugs; (d) inspections; (e) other records or digital files that the competent authority deems relevant. These must be approved by the health authority. They must be kept in legible form and without leaving any blank spaces, without altering the order of the entries of the prescriptions dispensed and without amendments or erasures. The health authority may authorize another prescription copying system, provided that it ensures that the entries are unalterable. If these books are kept electronically, the signature and other technical and legal requirements must comply with the legislation in force and with what is established by the corresponding authority, ensuring the inalterability of the records".

 

Medicines prescribed by means of electronic or digital prescriptions must be dispensed in any pharmacy, healthcare institution pharmacy service and any healthcare facility authorized for this purpose in accordance with the provisions of the Law on Pharmacy Practice and Law No. 25,649 on Prescription of Drugs by their Generic Name.

The new legislation establishes that existing electronic systems must be developed and/or adapted and regulate their implementation in order to use electronic or digital prescriptions, and healthcare teleassistance platforms, all of which must be regulated by the enforcement authority in accordance with what the Argentine Executive establishes in a timely manner and the agencies determined by each jurisdiction (Section 4). The agencies in each jurisdiction will be responsible for the supervision of the electronic prescription systems and healthcare teleassistance platforms, and must guarantee the custody of the virtual professional assistance, prescription, dispensation and filing databases. They are also responsible for establishing the criteria for authorization and control of access to these databases and ensure the normal operation and strict compliance with the Protection of Personal Data Law, Patients' Rights Law and other regulations in force in the field.

In addition, Law No. 27,553 sets forth that the referred to systems must contemplate compliance with all the regulations in force governing the entire commercialization chain of medicines, including the requirements for traceability of medicines and the handwritten, electronic or digital signature. It must also provide for the issuance of a record of teleassistance, prescription and dispensation for patients, by computer or printing of this record and the possibility of the pharmacist of blocking the prescription when there is a manifest error in such prescription, so that the prescriber can review, cancel or reactivate it as appropriate. Finally, the new Law No. 27,553 also modifies the Law on Narcotics and Law on Psychotropics to enable electronic or digital prescriptions for drugs regulated by those laws.

The enactment of this law will strengthen the path initiated through the implementation of the National Digital Health Strategy 2018-2024, the National Telehealth Plan and the First Recommendation for the Use of Telemedicine, among others, which seek to consolidate a health system that allows for better quality and broader access.

 

2. Law No. 27,554 on National Campaign of Blood Plasma Donation from Patients Recovered from COVID-19

This new law aims to promote voluntary blood donation for the collection of plasma from patients recovered from COVID-19 for the treatment of patients who require it. The law creates the "National Registry of Plasma Blood Donors of Patients Recovered from COVID-19", which will be in accordance with the provisions of Law No. 22,990 of Blood. Those patients recovered from COVID-19 who are plasma donors and are employees, will receive a 2-day special paid leave for each plasma donation they make and will be recognized as "Outstanding Solidarity Citizens of the Argentine Republic.”

 

3. Law No. 27,552 on Fight against Cystic Fibrosis of Pancreas or Mucoviscidosis

This new law declares the fight against cystic fibrosis of pancreas or mucoviscidosis to be of national interest and establishes a legal regime of protection, healthcare attention, work, education, rehabilitation, social security and prevention for people with cystic fibrosis of pancreas or mucoviscidosis.

Healthcare insurance agents (public and private healthcare insurance providers, as well as all those agents that provide medical insurance services to their affiliates), will have the obligation to provide 100% coverage of treatments, medicines, dietary and nutritional supplements, medical equipment, treatment kits, rehabilitation therapies, transportation and all those treatments that are indicated by physicians and that are needed by people who have such disease. The law also included all the procedures and practices in the Mandatory Medical Program (PMO, after its acronym in Spanish).

However, Law No. 27,552 was partially enacted through Decree No. 662/2020 of the Argentine Executive, with some of its articles being observed, the most important being the following:

(i)  Section 6, since it prohibits the substitution and/or modification of medicines prescribed by the healthcare professional by the private or public healthcare insurance provider and the public health sector, since this section differs from the criteria established by Law No. 25,649 on Prescription of Drugs by their Generic Name.

(ii) Section 7 which establishes that once the diagnosis of the person with cystic fibrosis of the pancreas or of the mucoviscidosis is confirmed by the competent authority, they will be granted a Unique Certificate of Disability "which will be for life". This article is observed since in Argentina unique certificates of disability are not granted at once and permanently, in no case and with respect to any disease, because the beneficiary of the same is not necessarily subject to that condition for life.