New Electronic or Digital Prescriptions Law

Law No. 27,553 on Electronic or Digital Prescriptions (the “Electronic or Digital Prescriptions Law ”), which will enter into force on August 19, 2020, provides that the prescription and dispensation of medicines, as well as any other medical or dental prescriptions or prescriptions from other legally authorized healthcare professionals to prescribe in the respective fields of healthcare and pharmaceutical care (public and private), may be written as electronic or digital prescriptions and signed with handwritten, electronic or digital signatures. Law No. 27,553 also establishes the possibility of using healthcare tele-assistance platforms throughout the Argentine territory, in accordance with Law No. 25,326 on the Protection of Personal Data ("Data Protection Law") and Law No. 26,529 on the Rights of the Patient.

With respect to the implementation of electronic and digital signatures on electronic or digital prescriptions and/or on the digital records or files that pharmacies must keep, the  Electronic or Digital Prescriptions Law states that these signatures, and other technical requirements associated with them, must comply with the provisions of current legislation, in particular with Law No. 25,506 on Digital Signatures ("Digital Signatures Law").

In this regard, the Electronic or Digital Prescriptions Law amends section 19, subsection 7, of Law No. 17,132 on the Art of Healing (hereinafter, "Law 17,132"), which regulates the practice of medicine and other health-related professions, in order to explicitly provide for electronic or digital prescriptions.

Similarly, the Electronic or Digital Prescriptions Law updated the terms of Law No. 17,818 on Narcotics, Law No. 19,303 on Psychotropic Drugs, Law No. 23,277 on Practice of Psychology and Law No. 17,565 on the Practice of Pharmacy.

As regards healthcare tele-assistance platforms, the Electronic or Digital Prescriptions Law stipulates that its application will be extended to any of these platforms used in the Argentine territory. However, the law is clear in that tele-assistance may only be performed in connection with practices specifically authorized for such purpose by the Enforcement Authority (an authority to be determined by the Argentine Executive, and which will coordinate its actions with the competent authorities of each jurisdiction).

Together with the provisions on electronic or digital prescriptions and healthcare tele-assistance platforms, the Electronic or Digital Prescriptions Law entails a series of obligations regarding the necessary modernization and digitalization process associated with these technological advances. In consequence, it provides that the Enforcement Authority must regulate the development and/or adaptation of electronic systems in order to enable the use of electronic or digital prescriptions and healthcare tele-assistance platforms. The Electronic or Digital Prescriptions Law also calls upon the Enforcement Authority to define, by the means of specific regulation, the timeframes required to achieve the total digitalization of the prescription and dispensation of medicines and all other prescriptions, and to regulate the use of healthcare tele-assistance platforms.

In addition, it should be noted that the technologies expressly incorporated by the Electronic or Digital Prescriptions Law (i.e., both electronic or digital prescriptions and healthcare tele-assistance platforms) involve the processing of personal data concerning health; data which, according to section 2 of Data Protection Law, are of a sensitive nature. Under Data Protection Law, public or private healthcare institutions and professionals related to the health sciences may collect and process personal data regarding the physical or mental health of their patients, but in order to do so such institutions and professionals must respect professional secrecy and must implement technical and organizational measures to guarantee the security and confidentiality of the patients’ personal data so as to avoid the data’s adulteration, loss or unauthorized treatment, among other obligations contained in Law 25,326.

In this respect, the Electronic or Digital Prescriptions Law also sets forth that the Enforcement Authority is responsible for the custody of the databases associated with the electronic systems of electronic or digital prescriptions and healthcare tele-assistance platforms. Likewise, the Enforcement Authority is responsible for outlining the criteria pertaining to the access to such databases, and for ensuring strict compliance with Data Protection Law, among other regulations.