Electronic or Digital Prescriptions Law.
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Healthcare & Life Sciences Department Report | Electronic or Digital Prescriptions Law
Dear Sir or Madam,
By means of Decree No. 664/2020, published in the Official Gazette on August 11th, 2020, the Executive Power enacted Law No. 27,553, on “Electronic or Digital Prescriptions”, which was approved by the National Congress on July 23rd (the “Law”).
The Law has two great – and highly expected- purposes. On the one hand, it is established that the prescription and dispensing of medicines, as well as any other prescription may be written and signed through handwritten, electronic, or digital signatures, in electronic or digital prescriptions in the national territory.
On the other, it is established that health teleassistance platforms may be used throughout the national territory, in accordance with the personal data protection law and the patient rights law.
Prescriptions
Regarding electronic or digital prescriptions, the provisions apply to any prescription, whether medical, dental, or other health care professionals legally empowered to prescribe, both for the public and private sectors.
It is also clarified that the medicines thus prescribed must be dispensed at any pharmacy in the national territory, pharmacy services of health establishments and establishments belonging to the health sector authorized for this purpose.
In order to harmonize the provisions of the Law with current regulations, the Law modifies subsection 7 of Article 19 of Law No. 17,132 – a law that regulates the practice of medicine, among others – incorporating the possibility of formulating handwritten, electronic or digital prescriptions and signed in handwritten, digital or electronic form. In addition, it establishes that in the event that the prescriptions are written electronically, the signature and other technical and legal requirements must be in accordance with current legislation. In case of using the digital signature, it must comply with the provisions established in Law No. 25,506 on digital signature.
In addition, the Law makes the following modifications or additions to the current legislation:
(i) It modifies Article 9 of Law No. 17,565 (Pharmacy Law), and provides that prescriptions in paper or digital format, corresponding to legally restricted dispensing and dispensing under a filed prescription, must be kept for a period of no less than three (3) years (making this period coincide with the limitation period for liability for damages provided for in the Civil and Commercial Code).
(ii) It incorporates into Article 10 of Law No. 17,565 (Pharmacy Law) the requirement that pharmacies also keep the digital records or files approved by the health authority, that the competent authority deems pertinent. Also, it provides that in the event that the books are kept electronically, the signature and technical and legal requirements must comply with the current legislation and with what the competent authority establishes in this regard.
(iii) It incorporates Article 21 bis to Law No. 17,818 (Narcotics Law), indicating that in the event that the prescriptions mentioned in that law are written electronically, or in case the mandatory records are kept electronically, the signature and other technical and legal requirements must comply with the current legislation and with what the enforcement authority establishes in this regard.
(iv) It incorporates Article 18 bis to Law No. 19,303 (Law on Psychotropics), which provides that in the case of prescriptions written electronically, the signature and technical and legal requirements must be adapted to the current legislation and to what the enforcement authority establishes in this regard.
Teleassistance
Regarding teleassistance, to receive it, it incorporates Article 2 bis into Title I of Law N ° 17,132, which enables the modality of teleassistance for the practice of medicine, dentistry and collaboration activities thereof, guaranteeing the patient’s rights; and it establishes that teleassistance can be developed only for the practices authorized for this purpose, according to protocols and platforms approved for it by the enforcement authority.
In the same regard, it extends Article 3 of Law No. 23,277 (Practice of Psychology-Law) establishing the possibility of the psychologist and/or interdisciplinary teams to develop the exercise of their activity through teleassistance platforms previously empowered to this effect and authorized by the enforcement authority, according to protocols and platforms approved by it, guaranteeing the patient’s rights.
Enforcement Authority
The Law’s enforcement authority will be established by the National Executive Power, which must coordinate its actions with the corresponding jurisdictional authorities, as well as with the institutions that have competence in these matters. These authorities will be in charge of:
• Defining the necessary timeframes to achieve full digitalization in prescription and dispensing of medicines, all other prescriptions, and regulate the use of health teleassistance platforms. PAMI must be summoned by the enforcement authority in order to collaborate in the regulations issued for this purpose.
• Regulating the development and/or adaptation of existing electronic systems and regulate their implementation to use electronic or digital prescriptions and health teleassistance platforms.
• Supervising the electronic or digital prescription systems and the health teleassistance platform systems, having to guarantee the custody of the virtual professional assistance, prescription, dispensing, and archiving databases.
• Establishing the criteria for authorization and control of access to the indicated databases and guarantee the normal operation and strict compliance with the Law on Protection of Personal Data and Patient Rights, as well as any other current regulations on the matter.
Other General Provisions
Both the Digital or Electronic Prescription, as well as the Teleassistance must contemplate:
• The compliance with all current regulations that regulate the medicines marketing chain, including the requirements set forth for the traceability of these and the handwritten, electronic or digital signature requirements.
• The issuance of certificates for the patients of the teleassistance, prescription and dispensing, by computerized means or printing of said certificates.
• The possibility of the pharmacist of blocking when there is a manifest error in the prescription.
All electronic or digital prescription and health teleassistance platform that meet technical and legal requirements are valid according to the current legislation not modified by this law.
The provinces and the Autonomous City of Buenos Aires are invited to adhere to the Law and it is established that the Executive Power shall regulate the Law within a hundred twenty (120) days as of its promulgation.
Should you require any further information on this matter, please do not hesitate to contact us.
Sincerely,
Ana Andrés
aandres@beccarvarela.com