MARCH 31, 2020

Ministry of Health Resolution No. 680/2020.

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Life Sciences Department Report | Ministry of Health Resolution No. 680/2020

Dear Sir or Madam,

On March 30, 2020 the Ministry of Health of Argentina (Ministerio de Salud de la Nación) issued the Resolution No. 680/2020, published at the Official Gazette on March 31, 2020 (“Resolution”), by means of which it incorporates the disease COVID-19 in all of its stages, from the suspicion of a case to the follow up of its evolution, to the legal regime of diseases of mandatory notification, established by Law No. 15,465, its amendments and complementary.

Law No. 15,465, of 1960, establishes as mandatory the notification of the cases of certain diseases listed in such law. This notification obligation is mandatory for Healthcare Professionals that become aware of any such disease.

With the incorporation provided for in the Resolution, the Healthcare Professionals, among which the laboratory professional performing the tests to confirm the disease is included, have the obligation to notify the Sanitary Authority of all cases of COVID-19 in all of its stages, including the suspicion of such disease.

In this regard, we hereby provide you with this executive summary with the most relevant remarks of the Resolution:

• Notifications must be made through the platform of the National Health Surveillance System (“SNVS” by its acronym in Spanish) provided by the Ministry of Health of the Nation, with the parameters established in that platform.

It should be clarified that all registered users with access to the SNVS platform were designated by the health authorities of the different jurisdictions, trained by the National Ministry of Health and certified, so that centralizing the notifications there also allows for appropriate traceability of the cases and a more effective safeguard on sensitive information, in accordance with Law No. 25,326 on the Protection of Personal Data.

In fact, the Resolution orders to notify all users registered in the SNVS that, in their capacity as obligated subjects, they must observe the provisions established by Law No. 25,326 on the Protection of Personal Data.

• Section 3 of the Resolution, reinforcing the provisions of sections 4 and 12 of Law No. 15,465 regarding the subjects obliged to notify, clarifies that the subjects obliged to notify the cases of COVID-19 reaches:

(i) Physicians assisting patients in public or private health facilities;
(ii) Professionals from public or private laboratories that study samples of suspected, probable, confirmed, and discarded cases;
(iii) The respective authorities of public or private laboratories and health establishments;
(iv) The respective provincial and municipal health authorities.

Although they are not obligated subjects, epidemiologists who, in collaboration or assistance to the health institutions in which they carry out their activity, carry out epidemiological investigation tasks in relation to COVID-19 cases, may also make the notifications.

Section 4 of the Resolution establishes that the obligation to notify is jointly and severally between the obligated subjects.

The obliged subjects indicated in (iii) and (iv) must guarantee that the obliged subjects indicated in (i) and (ii) send the notifications to the SNVS in a timely manner and when, for justified reasons, the latter cannot carry out the timely and proper notifications, they must urgently notify the reporting entities indicated in (iii) and (iv) in order for them to send the notifications to the SNVS.

• The Resolution also approves the “Guide for Epidemiological Surveillance of COVID-19” and the “Instructions for Notification of COVID-19 in the SNVS”, which we attach to this report for your knowledge. The subjects obliged to notify must do so in accordance with the provisions of said guide and instructions.

• In order to be updated on what a suspected case of COVID-19 is, obligated subjects should consult the institutional website of the Ministry of Health in order to periodically confirm the definition and update of “suspected case” and the recommendations for health teams on approaching cases and contacts.

• The obliged subjects will have five days to make, complete, update or adapt the notifications of COVID-19 cases corresponding to cases dated prior to the entry into force of the Resolution, provided that they have not yet been informed to the SNVS according to the guidelines. approved in the Resolution

• The Resolution will enter into force upon its publication in the Official Gazette.

Annexs:
Anexo I: Guía para la vigilancia epidemiológica de COVID-19.
Anexo II: Instructivo para la notificación de COVID-19 en el SNVS.

Should you require any further information on this matter, please do not hesitate to contact us.

Sincerely,

Ana Andrés