In this Artificial Intelligence newsletter, you will find the following news:
- Federal Council of Pharmacy approves Resolution on Digital Health and Artificial Intelligence
- STJ Restricts Anvisa’s authority in pharmaceutical advertising
Federal Council of Pharmacy approves Resolution on Digital Health and Artificial Intelligence
Recently, the Federal Council of Pharmacy (CFF) published Resolution No. 10/2024, which regulates the pharmacist’s duties within the scope of Digital Health and Artificial Intelligence. Here are the key points of the Resolution:
Digital health
- Pharmacists are prohibited from assuming technical responsibility for pharmacies, clinical analysis laboratories, industries, or other establishments, organizations, laboratories, or sectors of any nature in a non-face-to-face manner.
- Pharmacists are only allowed to use Software as Medical Devices (SaMD) that are registered with the CRF, have a responsible technical pharmacist, and are represented in the country.
- The duties of pharmacists in digital health include:
- Promoting ethics and safety in Digital Health products and services.
- Staying updated on technological innovations and regulations.
- Ensuring that information on digital platforms is accurate and compliant with guidelines.
- Guiding patients on Digital Health services.
- Participating in the evaluation and selection of Digital Health technologies.
- Prescribing Digital Health products and services in compliance with current legislation.
Artificial intelligence in digital health
- Pharmacists are authorized to use artificial intelligence (AI) as a support tool in professional areas and to actively participate in the development of artificial intelligence at all stages;
- The use of artificial intelligence by pharmacists must comply with ethical principles, clinical safety, and the protection of patients’ personal data;
- The duties of pharmacists in the context of AI include:
- Ensuring that AI systems used are validated for clinical use.
- Staying updated on the capabilities, limitations, and innovations in AI applied to health.
- Ensuring that AI does not replace clinical judgment but serves as a support for the pharmacist’s decision-making.
- Leading and collaborating on research regarding the use of AI in pharmaceutical practice, focusing on efficacy, effectiveness, and safety.
- Developing guidelines for the implementation of AI in pharmaceutical practice.
Software as a Medical Device with digitial medicine, digiceutical or digitial therapeutic purposes
- The Resolution defines digital medicine, digiceutical, or digital therapeutic as Software as a Medical Device (SaMD) intended to treat, manage, or prevent diseases or disorders, which operate independently or in conjunction with medications and are regulated and/or registered by the National Health Surveillance Agency (Anvisa);
- Pharmacists are authorized to use and prescribe SaMD for digital medicine, digiceutical, or digital therapeutic purposes;
- Legal entities that provide SaMD must have established representation in the country, be registered with the CRF of the state where they are headquartered, and must necessarily have a technical director pharmacist or a responsible technical pharmacist.
- The duties of pharmacists in the context of SaMD include:
- Ensuring that they are prescribed and regulated in accordance with Anvisa’s regulations;
- Ensuring that their use complements, but does not replace, clinical judgment and personal interaction in the patient care process;
- Developing protocols and guidelines for effective integration into pharmaceutical practice, ensuring an ethical and responsible approach.
STJ Restricts Anvisa’s authority in pharmaceutical advertising
On August 14, the 1st Panel of the Superior Court of Justice (STJ), when ruling on Special Appeal No. 2.035.645, established new limitations on the role of the Brazilian Health Surveillance Agency (Anvisa) regarding the regulation of pharmaceutical advertising.
The panel, in a unanimous decision, determined that Anvisa’s role must be strictly limited to the enforcement of Federal Law 9.294/1996, which regulates pharmaceutical advertising. Rapporteur Regina Helena Costa emphasized that the Agency does not have the normative power to impose restrictions or limitations on economic agents’ commercial pharmaceutical advertising activities through its own acts, especially when such regulatory acts conflict with the provisions of the aforementioned law.
The decision was made after Anvisa filed a Special Appeal against a ruling by the 5th Panel of the Federal Regional Court of the 1st Region (TRF1), which had determined that the Agency exceeded its normative power by enacting Resolution 96/2008. This resolution establishes guidelines for advertising, publicity, information, and other practices related to the promotion or commercial dissemination of medications.
According to the rapporteur, among the powers delegated to the Agency, as per item XXVI of Article 7 of Federal Law No. 9,782/99 (which establishes Anvisa), Anvisa would only have the authority to “control, monitor, and supervise, from a health legislation perspective, the advertising and publicity of products subject to health surveillance.” It does not have the authority to issue regulations on this matter, which is why the illegality of RDC No. 96/2008 was emphasized.
Despite the decision, the 1st Panel recognized the important role of Anvisa in controlling public health policies, as well as the commendable initiative of the entity, and ordered that the National Congress and the Ministry of Health be informed about the decision so that they can work together to improve the applicable legislation.
