Health Regulations in the Health Emergency Declared for COVID-19

ARTICLE
Health Regulations in the Health Emergency Declared for COVID-19
October 15, 2020
Health Regulations in the Health Emergency Declared for COVID-19

National Regulations:

Argentine Congress:

  • Law No. 27,548 - Declares of National Interest and creates the Program for the Protection of Healthcare Personnel in view of the COVID-19 Pandemic (06/08/2020).
  • Law No. 27,549 - Special Benefits to Healthcare Personnel, Armed Forces, Security Personnel and others in view of the COVID-19 Pandemic (06/08/2020).
  • Law No. 27,553 - Allows the prescription and dispensation of medicines through Electronic or Digital Prescriptions (08/11/2020).
  • Law No. 27,554 - Declares of national interest and creates the National Campaign for Blood Plasma Donation of Patients Recovered from COVID-19 (08/11/2020).

 

The Argentine Executive (the “PEN”, after its acronym in Spanish), Ministers’ Cabinet Office (the “JGM”, after its acronym in Spanish), National Migration Department (the “DNM”, after its acronym in Spanish) and Ministry of Interior:

  • PEN Decree No. 297/2020 - Social, Preventive and Mandatory Isolation (03/19/2020).
  • JGM Regulation No. 429/2020 - Incorporation of activities and services exempted from complying with the “social, preventive and mandatory isolation” (03/20/2020).
  • PEN Decree No. 300/2020 - Differential Treatment for Health Employers (03/20/2020).
  • PEN Decree No. 301/2020 - Oxygen Therapy (03/20/2020).
  • JGM Regulation No. 432/2020 - Covid-19 - Ministry of Health Mobile App (03/23/2020).
  • DNM Regulation No. 1771/2020 - Covid-19 - Ministry of Health Mobile App – Compulsory (03/26/2020).
  • PEN Decree No. 315/2020 – Incentive funds for the effective service provision (03/27/2020).
  • PEN Decree No. 317/2020 - Export permit (03/29/2020).
  • Ministry of Interior Regulation No. 48/2020 – Personal Certificate for Movement – COVID-19 Emergency (03/29/2020).
  • PEN Decree No. 325/2020 – Social, preventive and mandatory isolation – Extension (03/31/2020).
  • JGM Regulation No. 446/2020 – Certificate of Authorization for Circulation – Emergency COVID-19 (04/01/2020).
  • PEN Decree No. 333/2020 – Import Duties Extra-zone (04/02/2020).
  • PEN Decree No. 355/2020 – Social, preventive and mandatory isolation – Extension (04/11/2020).
  • JGM Regulation No. 490/2020 – Expansion of exempt activities and services (04/11/2020).
  • National Disability Agency (AND) Regulation No. 77/2020 – Regulation of JGM Regulation No. 490/2020 (04/13/2020).
  • PEN Decree No. 408/2020 - Social, preventive and mandatory isolation – Extension (04/26/2020).
  • JGM Regulation No. 3/2020 - Creation of the database denominated COVID-19 Ministry of Health (05/06/2020).
  • PEN Decree No. 459/2020 - Social, preventive and mandatory isolation – Extension (05/11/2020).
  • PEN Decree No. 493/2020 – Social, preventive and mandatory isolation – Extension (05/25/2020).
  • PEN Decree N. 520/2020 - Social, preventive and mandatory isolation – Extension (06/08/2020).
  • PEN Decree No. 576/2020 – Social, preventive and mandatory isolation – Extension (06/29/2020).
  • PEN Decree No. 605/2020 - Social, preventive and mandatory isolation – Extension (07/18/2020)
  • PEN Decree No. 617/2020 - Mercosur Common Nomenclature - Modification to the list of critical health supplies (07/27/2020).
  • PEN Decree No. 641/2020 - Social, preventive and mandatory isolation – Extension (08/02/2020). PEN Decree No. 677/2020 - Social, preventive and mandatory isolation – Extension (08/16/2020).
  • PEN Decree No. 714/2020 - Social, preventive and mandatory isolation – Extension (08/30/2020)
  • PEN Decree 747/2020 - Regulation of Law No. 27,548 "Program of Protection to the Health Personnel against the Coronavirus Pandemic COVID-19" (09/16/2020).
  • PEN Decree 754/2020 - Social, preventive and mandatory isolation – Extension (09/20/2020).
  • PEN Decree 787/2020 – Incentive funds for the effective service provision – Extension (10/5/2020).
  • PEN Decree 792/2020 – Social, preventive and mandatory isolation – Extension (10/12/2020).

 

National Ministry of Health (MoH)

  • MoH Regulation No. 568/2020 - Regulation of the Decree No. 260/2020 (03/14/2020).
  • MoH Regulation No. 619/2020 - Provision of resources to the Emergency and Assistance Fund, and to the Single Reimbursement System (03/20/2020).
  • MoH Regulation No. 627/2020 - Instructions for Isolation and Social Distancing (03/20/2020).
  • Joint Regulation No. 1/2020 of the MoH and the Ministry of Productive Development - Coronavirus (COVID-19) - Critical Healthcare Supplies (03/21/2020).
  • MoH Regulation No. 680/2020 – Inclusion of COVID-19 disease to the legal regime of mandatory disease reporting set forth by Law No. 15.465 (03/31/2020).
  • MoH Regulation No. 681/2020 - Authorization of pharmacies with authorized laboratories to manufacture hand sanitizer and insect repellent products (03/31/2020).
  • MoH Regulation No. 695/2020 - Manufacturing companies, distributors, non-invasive mechanical fans’ manufacturers cannot deliver items without previous authorization from MoH (04/01/2020).
  • MoH Regulation No. 696/2020 - Authorization of exceptional nature for the prescription of medication available only by prescription, excluding narcotic drugs, via text message or messages through web message applications, email or fax, within the framework of the social, preventive and mandatory isolation (04/01/2020).
  • MoH Regulation No. 781/2020 - Suspension of Applications in the Public Healthcare Insurance Providers Registry and in the Private Healthcare Insurance Providers Registry (04/18/2020).
  • MoH Regulation No. 783/2020 - Creation of the Strategic Plan to Regulate the Use of Plasma from Patients Recovered from COVID-19 with Therapeutic Purposes (04/18/2020).
  • MoH Regulation No. 908/2020 - Ethical and Operational Guidelines for the Accelerated Ethical Review of Human Research Related to COVID-19 (05/12/2020).
  • MoH Regulation No. 943/2020 – “Solidarity" Randomized Clinical Trial (05/21/2020).
  • MoH Regulation No. 987/2020 - Approval of the National Healthcare Personnel Protection Plan - COVID-19 Pandemic Implementation Framework (06/08/2020).
  • MoH Regulation No. 1,117/2020 - Creation of the COVID19 Pandemic Committee on Ethics and Human Rights (06/29/2020).
  • Joint Regulation No. 2/2020 of the Ministry of Education and the MoH – Creation of the Universities for the COVID-19 Emergency Program (07/15/2020).
  • MoH Regulation No. 1284/2020 - Exceptional financial support for healthcare insurance providers (07/28/2020).
  • MoH Administrative Decision No. 1721/2020 - Acquisition of vaccines to generate acquired immunity against COVID-19 (09/18/2020).

MoH Regulation No. 1541/2020 - Inclusion of obesity within the diseases related to the term "risk group" of Decree 260/2020 (09/23/2020)

  • MoH Regulation No. 1643/2020 - Limitation of the inclusion of obesity to classes II and III considered within the diseases related to the term "risk group" of Decree 260/2020 (10/06/2020).

 

Superintendence of Health Services (“SSS”, after its acronym in Spanish)

  • SSS Regulation No. 233/2020 - Public Service Areas - Reduced Scheme (03/17/2020).
  • SSS Regulation No. 234/2020 - Extension of certificates of the National Registry of Public Healthcare Insurance Providers (03/20/2020).
  • SSS Regulation No. 235/2020 - Extension of certificates of the National Registry of Healthcare Providers (03/25/2020).
  • SSS Regulation No. 269/2020 – Health Insurance Agents and Private Healthcare Insurance Providers Registration in Distance Processing Platform (03/27/2020).
  • SSS Regulation No. 281/20202 – Adopting relevant measures to ensure medication provision by the Health Insurance Agents (04/02/2020).
  • SSS Regulation No. 282/2020 – Recommendation on the implementation and promoting the use of tele-assistance and/ or tele-consultations (04/02/2020).
  • SSS Regulation No. 309/2020 – Daughters and Sons of Affiliates – Incorporation (04/09/2020).
  • SSS Regulation No. 365/2020 – Extension of the validity term of SSS Regulation No. 233/2020 (04/18/2020).
  • SSS Regulation No. 629/2020 - Appointment of Members of the Superintendence of Health Services Advisory Council (07/15/2020).
  • SSS Regulation No. 729/2020 - Extension of the registration period in the National Registry of Healthcare Providers (07/29/2020).
  • SSS Regulation No. 1212/2020 – Creation of the Technical Commission for the Purchase of Medicines, Supplies and Devices (10/01/2020).

 

National Agency of Medicines, Food and Medical Technology (“ANMAT”, after its acronym in Spanish)

  • ANMAT Communique No. 2/2020 - Bioequivalence Studies (03/20/2020).

 

National Unified Central Institute for Ablation and Implant Coordination (“INCUCAI”, after its acronym in Spanish)

  • INCUCAI Regulation No. 67/2020 - Extension of Credentials (03/20/2020).
  • INCUCAI Regulation No. 1/2020 - Extension of term included in INCUCAI Regulation No. 67 (04/18/2020)
  • INCUCAI Regulation No. 129/2020 - Extension of INCUCAI Regulations No. 67/2020 and No. 1/2020 (06/22/2020).
  • INCUCAI Regulation No. 180/2020 – Extension of INCUCAI Regulations No. 67/2020 (08/21/2020).
  • INCUCAI Regulation No. 211/2020 - Extension of INCUCAI Regulations No. 67/2020 (09/24/2020).

 

National Agri-food Health and Quality Service (“SENASA”, after its acronym in Spanish)

  • SENASA Regulation No. 295/2020 - Extension of permits and registrations (03/28/2020).
  • SENASA Regulation No. 344/2020 - Digital Media Monitoring and Control Program (05/04/2020).

 

Ministry of Productive Development:

  • Ministry of Productive Development Regulation No. 132/2020 – Creation of the Program to Support the National Productive System in the department of Medical Equipment and Medical and Sanitary Supplies and Technological Solutions within the framework of the Coronavirus Pandemic COVID-19 (04/01/2020).

 

City of Buenos Aires Regulations:

  • Government of the City of Buenos Aires Decree No. 1/2020: Decrees the Sanitary Emergency in the area of CABA (03/17/2020).
  • Government Control Agency (AGC, after its acronym in Spanish) Regulation No. 165/2020: Suspension of deadlines and filing of pending administrative proceedings (03/19/2020).
  • Joint Regulation No. 15/MJGGC/20: Establishes the mandatory use of protective equipment that covers the nose, mouth and chin. Ban on the marketing of masks N95 to any individual who cannot demonstrate to be a health service professional or personnel (04/13/2020).
  • Ministry of Health Regulation No. 998/20: Approves the Teleconsultation Program within the City of Buenos Aires (04/21/2020).
  • Ministry of Health Regulation No. 1,506/20: Exempts from liability insurance all research aimed at evaluating the efficacy and safety of convalescent plasma in patients infected with COVID-19 (07/13/2020).
  • Ministry of Health Regulation No. 1,958/2020: Creates the Plan for the Promotion and Support of Research in COVID-19 in the City of Buenos Aires (08/27/2020).
  • Legislature Law No. 6,322: Creates the Plan for Accompanying Patients in an End-of-Life Situation during the Health Emergency declared by the COVID-19 pandemic (08/27/2020).

 

National Regulations:

Argentine Congress

On June 8, 2020, the Argentine Congress enacted Law No. 27,548, which declares of national interest the protection of the life and health of the Argentine health system personnel and the workers and volunteers who perform essential activities and services during the health emergency caused by the COVID-19 pandemic.

Furthermore, this law creates the Program for the Protection of Healthcare Personnel in view of the COVID-19 Pandemic, which will be mandatory for all medical, nursing, management and administration, logistics, cleaning, gastronomy, and ambulance personnel, among others, who provide services in health facilities where practices are carried out for the care of suspected cases, the taking of samples and tests, and/or the care and treatment of COVID-19, regardless of the responsible person and the legal form of the facility.

The enforcement authority has the following obligations: (i) to establish mandatory protocols for the protection of health personnel, practice guidelines for the management and use of supplies to minimize the risk of transmission when dealing with suspected cases, taking samples and testing, care and treatment of patients with COVID-19; (ii) to coordinate with provincial and municipal jurisdictions and with the Superintendence of Health Services to provide mandatory training for all personnel involved; (iii) to coordinate mandatory trainings with companies, universities, unions, and civil organizations.

Finally, article 7 of the law provides for the duty to set forth protection protocols and training aimed at preventing the spread of the disease of those individuals involved in essential activities and services with exposure to COVID-19.

On June 8, 2020, Law No. 27,549 was enacted, which aims to provide Special Benefits to Health Personnel, Armed Forces, Security Personnel and others in view of the Covid-19 Pandemic.

Among the special benefits we find: (i) the exemption from Income Tax, from March 1, 2020 and until  September 30, 2020, of the accrued compensations for compulsory on-call medical services (active or passive) and overtime, and any other concept that is specifically and additionally settled by virtue of the health emergency caused by the COVID-19; and (ii) the granting of an ex gratia pension for life to worker’s family members whose deaths occurred in the period from March 1 to September 30, 2020 as a result of having had COVID-19.

On August 11, 2020, Law No. 27,553 on Electronic or Digital Prescriptions (Law on Electronic or Digital Prescriptions), was enacted.  It establishes that the prescription and dispensation of medicines, as well as any other medical, dental or other health professionals’ prescription legally authorized to prescribe in the respective fields of health care and pharmaceutical care (public and private), may be written in electronic or digital prescriptions and signed in handwritten, electronic or digital form. It also provides for the possibility of using health teleassistance platforms throughout the national territory, in accordance with the provisions of Law No. 25,326 on the Protection of Personal Data and Law No. 26,529 on Patients’ Rights.

With respect to the implementation of electronic and digital signatures in electronic or digital prescriptions and/or in the digital registers or files that pharmacies must keep, the Law states that these signatures, and other technical requirements associated with them, must comply with the provisions of the legislation in force, in particular Law No. 25,506 on Digital Signatures. In this sense, the Law on Electronic or Digital Prescriptions modifies point 7 of Article 19 of Law No. 17,132 on the Art of Healing, which regulates the practice of medicine and other health-related professions, in order to explicitly contemplate electronic or digital prescriptions. Along the same lines, the Law on Electronic or Digital Prescriptions updates the terms of Law No. 17,818 on Narcotics, Law No. 19,303 on Psychotropics, Law No. 23,277 on the Professional Practice of Psychology and Law No. 17,565 on the Practice of Pharmacy.

As for the health teleassistance platforms, the Law on Electronic or Digital Prescriptions states that its application will be extended to any of these platforms used in Argentina. However, the law is clear that teleassistance may only be developed for practices specifically authorized for such purpose by the Enforcement Authority (an authority to be determined by the PEN, which will coordinate its actions with the competent authorities of each jurisdiction).

Finally, the Law on Electronic or Digital Prescriptions stipulates that the enforcement authority will be responsible for the custody of the databases connected with the electronic systems of electronic or digital prescriptions and with the electronic systems of health teleassistance platforms. Likewise, the enforcement authority will have the obligation to outline the criteria for authorization and access control to such databases, and to guarantee the strict compliance with the Law on Personal Data Protection, among other regulations.

On the same August 11, 2020, Law No. 27,554 was enacted, which declares the national public interest of the voluntary donation of blood to obtain plasma from patients recovered from COVID-19, for the treatment of patients who require it according to the protocols in force authorized by the enforcement authority. It also establishes the creation of a National Campaign for the diffusion and promotion of the voluntary donation of blood plasma, from patients recovered from COVID-19, throughout the national territory, within the framework of the "Strategic Plan to Regulate the Use of Plasma from Patients Recovered from COVID-19 for Therapeutic Purposes".

Likewise, the creation of the National Registry of Patients Recovered from COVID-19 plasma donors is established, whose information must be safeguarded in compliance with Law No. 25,326 on Personal Data Protection.

 

Argentine Executive (PEN), Ministers Cabinet Office (JGM) and National Migrations Directory (DNM):

On  March 19, 2020, PEN Decree No. 297/2020 was published, providing for the “social, preventive and mandatory isolation” of every individual living in the country or staying in it temporarily from March 20 to 31 of the year 2020, which may be extended for the period considered necessary.

Decree No. 297/2020 was adopted in the context of the declaration of the pandemic issued by the World Health Organization (WHO), the Health Emergency extended by Decree No. 260/2020 and its amendment, and in view of the evolution of the epidemiological situation, in relation to COVID-19, to protect public health in the context of the health emergency.

For the food and health areas, the Decree No. 297/2020 specifically provides that:

  • Only those individuals who are complying with the social, preventive and mandatory isolation will be able to carry out the minimum and indispensable displacements to supply themselves with cleaning articles, medicines and food.
  • The following services and activities are exempted from social, preventive and mandatory isolation in food and health areas (Section 6):
  • Health personnel;
  • Wholesale and retail supermarkets and grocery stores;
  • Pharmacies;
  • Food industries, their productive chain and inputs, personal hygiene and cleaning; medical equipment, medicines, vaccines and other sanitary supplies;
  • Activities related to agricultural and fisheries production, distribution and commercialization; and
  • Home delivery of food, medicines, hygiene and cleaning products and other necessities.

Employers must guarantee the hygiene and safety conditions set forth by the MoH to preserve their workers’ health.

Thus, compulsory isolation is extended to every individual living in the country or temporarily staying in it, and not only for the cases covered by Section 7 of Decree No. 260/2020, which includes (a) those with the status of "suspected cases" (a person who has a fever and one or more respiratory symptoms (cough, sore throat or difficulty in breathing) and who also has a travel history to "affected areas" in recent days or has been in contact with confirmed or suspected cases of COVID-19; (b) those who have medical confirmation of having contracted COVID-19; (c) "close contacts" of persons described in subparagraphs (a) and (b) above, as determined by the corresponding authority; (d) those arriving to the country having transited through "affected areas"; and (e) those arriving to the country within the past 14 days having transited through "affected areas".

At the same time, JGM Regulation No. 429/2020 published on March 20, 2020 set forth the inclusion in the list of certain activities and services declared as essential in the emergency, which are excepted from the compliance with the “social, preventive and mandatory isolation" and the prohibition of movement, to the following activities and services related to health and food areas (among other activities):

  • Industries that carry out continuous processes which its interruption implies structural damage to production lines and/or machinery may request authorization from the Secretariat of Industry, Knowledge-Economy and External Commercial Management.
  • Hotels affected by the emergency health service. The medical assistance provision must be guaranteed to the individuals who are staying in these hotels.
  • Restaurants, prepared meals and fast food stores may sell their products through home delivery services, subject to the specific protocol established by the health authority. Under no circumstances may they provide services with personal attention to the general public.

Section 3 of Regulation No. 429/2020 clarifies that "Food Industries", referred to in section 6.12 of Decree No. 297/2020, should be understood as those industries that make up the value and input chain of the productive sectors of food and beverages, personal hygiene and cleaning, medical equipment, medicines, vaccines and other sanitary inputs.

In addition, on March 20, 2020 the PEN issued the following Decrees:

Decree No. 300/2020 set forth a differential treatment for employers in health-related activities with respect to employer contributions to the Argentine Integrated Social Security System (“SIPA”, after its acronym in Spanish) and to the Tax on Credits and Debits to Bank Accounts and other Transactions.

The Decree establishes, for a period of 90 days, a 95% reduction in the rate provided for in Section 19 of Law No. 27,541 corresponding to employer contributions on the payroll for the SIPA, created by Law No. 24,241.

Among the activities contemplated in Annex I of Decree No. 300/2020, we find the following: 

  • Public healthcare insurance providers and health insurance services (including private healthcare insurance providers and mutual healthcare insurance providers);
  • Hospital services;
  • Outpatient services provided by physicians and dentists;
  • Diagnostic and treatment practice services;
  • Integrated consultation, diagnostic and treatment services; and
  • Emergency and transfer services, among others.

Decree No. 301/2020 establishes that exports of goods included in the customs tariff code of the MERCOSUR Common Nomenclature (9019.20.10.: oxygen therapy equipment, its parts and accessories) must apply for an export permit to be issued by the Ministry of Production Development with the necessary intervention of the Ministry of Health.

On the other hand, on March 24, 2020, the JGM issued Regulation No. 432/2020, providing that any individual who arrived the country within the last (14) days, and for those who do so in the future, must use the Mobile Application "Covid-19 Ministry of Health" (the App).

In this sense, the DNM is empowered to require those returning from abroad to use the App prior to entering the country. Those who have agreed to use the App and cannot complete the form due to technical issues at the time of entry into Argentina must complete the form within twelve (12) hours from their entry. Those who arrived from abroad and agreed to use the App, must download it and keep it active for a minimum period of fourteen (14) calendar days from its activation.

In addition, on March 26, 2020, the DNM issued Regulation No. 1771/2020 implementing Regulation No. 432/2020, and establishing that those arriving to the country must adhere to and use the App for a minimum period of fourteen (14) days since they arrive.

On  March 27, 2020, Decree No. 315/2020 was published, granting professional, technical, auxiliary and dependent workers who provide face-to-face and effective healthcare services in public, private and social security institutions involved in the management of cases related to the COVD-19 pandemic, the payment of a non-remunerative incentive fund for the effective provision of services. The allocation will consist of the payment of five thousand Argentine pesos (ARS 5,000) for the tasks performed in the months of April, May, June and July and will be paid by the National State.

Such payment will be subject to the effective provision of services. Healthcare workers who are paid by more than one employer will only receive the incentive from one of their employers.

The Decree defines the term worker as someone who is under an employment contract in the private or public sector or under other contractual forms, as long as the provision of the service presents the characteristic of continuity, either under the figure of the location of services, internships, scholarships, residences or professional practices.

On Sunday March 29, 2020, Decree No. 317/2020 was published, establishing that exports of goods included in the customs tariff code of the MERCOSUR Common Nomenclature listed in Annex I of the Decree must apply for an export permit to be issued by the Ministry of Production Development, with the necessary intervention of the Ministry of Agriculture.

Among the products included we can find: (i) paracetamol; (ii) hand sanitizer; (iii) disposable gloves, such as those used in healthcare assistance; (iv) non-woven fabric masks, of the type used by surgeons in operations; (v) infusion pump; (vi) portable ventilator, etc.

The measure will be in force from the day of its publication and will remain in force as long as the Health Emergency declared by Law No. 27,541, extended by Decree No. 260/2020, lasts.

On the same Sunday, Ministry of the Interior Regulation No. 48/2020 was published in the Official Gazette, implementing the "Individual Certificate for Movement - Emergency COVID-19" (CUHC, after its acronym in Spanish) for any person who falls under the cases provided for in Section 6 of Decree No. 297/2020 and Sections 1 and 2 of Administrative Decision No. 429/2020, as well as those exceptions to "social, preventive and mandatory isolation" that may be set forth in the future.

The CUHC will be personal and non-transferable and must be processed through the "Trámites a Distancia" system (TAD) (https://tramitesadistancia.gob.ar/) for the purpose of displaying the CUHC and the Identity Card (“DNI”, after its acronym in Spanish) at the request of the competent authority when driving or walking through the streets.

Those persons who must travel in cases of force majeure are exempted from processing and carrying this CUHC (Section 6, paragraph 6, of Decree No. 297/2020). In such cases, the exception must be accredited by means of reliable documentation that evidences the force majeure event.

Once the information has been validated, the CUHC will be issued and will be valid for a period of seven (7) calendar days, which may be renewed.

Through the PEN Decree No. 325/2020, published on March 31, 2020, the validity of Decree No. 297/2020 was extended up to and including April 12, 2020.

On the other hand, on April 1 2020, the JGM Regulation No. 446/2020 was published which establishes that, from April 6, 2020 the document to validate the situation of those included within the exceptions listed in Section 6 of the Decree No. 297/2020, its amending  and supplementing provisions and in the Regulation No. 429/2020, as well as those implemented in the future, will be the “Certificate of Authorization for Circulation – Emergency COVID-19”, adopted by Regulation No. 48/2020 from the Ministry of the Interior, the certificate will be valid for the same term the social, preventive and mandatory isolation lasts.

On April 2, 2020 PEN Decree No. 333/2020 was published, it established an Extra-zone Import Duty (“D.I.E.” after its acronym in Spanish) of 0% for certain merchandise (medical products, home sanitary products, etc.) listed in Annex I.

In addition, the Decree exempts the import transactions of covered goods from paying the statistical rate.

On the evening of April 11, 2020, PEN Decree No. 355/2020 was published, which extends up to and including April 26, 2020, the validity of Decree No. 297/2020, extended at the same tie by the Decree No. 325/2020, with the amendments contained in Section 2 of the latter. It is mandated that the Decree is public policy and is valid since its publication in the Official Gazette.

Furthermore, it establishes the competence of the Chief of the Cabinet of Ministers in his capacity as Coordinator of the “Unity of General Coordination of the Integral Plan for the Prevention of Events of Public Health of International Importance”, with prior intervention of the national sanitary authority, and upon request of Provinces’ Governors or the Head of Government of the Autonomous City of Buenos Aires, of exempt from complying with the “social, preventive and mandatory isolation” and the circulation ban, to the staff involved in certain activities and services, or individuals who reside in specific and defined areas, providing that the following circumstances are met:

  • The Governor or the Head of Government of the Autonomous City of Buenos Aires requires so in writing, with prior intervention and consent from the highest local sanitary authority, in line with the current epidemiological situation
  • Along with the written request, is the pertinent operating protocol, complying with the national and local sanitary and security recommendations and instructions.

However, on the same date the JGM Regulation No. 490/2020 was published. It broadens the list of exempt activities and services in the terms of Section 6 of Decree No. 297/2020 regarding sanitary policies to:

  • The circulation of people with disabilities and those on the autism spectrum, to perform brief excursions in the vicinity of their residency, together with a family member or a cohabitating partner. In this case, the assisted individual as well as their companion must carry their DNI and the Disability Certificate or the medical prescription where the diagnose and the requirement to going out is specified, which can be produced digitally.
  • The professional services provided at home for people with disabilities and those on the autism spectrum. The professionals must carry a copy of the DNI of the individual being treated and the Disability Certificate, or the relevant medical prescription with the requirements specified in the previous clause.

The circulation of the individuals comprised by the Regulation must be limited to the strict compliance of the exempt activities and services. The above-mentioned cases are exempt from applying for the Certificate of Authorization for Circulation – Emergency COVID-19. The effective date will be the date it is published in the Official Gazette.

On April 13, 2020, the National Disability Agency (the “AND”, after its acronym in Spanish) Regulation No. 77/2020 was published which regulates the JGM Regulation No. 490/2020 setting the following criteria:

 

Circulation of people with disabilities:

They will be allowed to go out briefly as long as they do not show symptoms compatible with COVID-19 (fever, sore throat, cough and/or shortness of breath), or who fall into the following categories: a) Being 60 years or older b) Having chronic respiratory illnesses, obstructive pulmonary disease, congenital emphysema, bronchopulmonary dysplasia, bronchiectasis, cystic fibrosis and moderator severe asthma; c) Having heart disease, heart failure, coronary disease, valve disease and congenital cardiopathies; d) Having immune deficiency; e) Having diabetes, chronic kidney failure or expectations of entering dialysis in the following six months; f) Pregnant women; g) Any other circumstance that the health authority defines in the future.

They will be able to go out on the public highway respecting the social distance of one and a half meters (1.5 m) with respect to the rest of the passers-by, with a single companion, family member or cohabitant, if they need it, for short walks, not o more than 500 meters from their residence, according to the following schedule: a. On Mondays, Wednesdays and Fridays, those people with disabilities, whose last ID number is 1, 2, 3, 4 and 5; and b. On Tuesdays, Thursdays and Saturdays, those people with disabilities, whose last ID number is 6, 7, 8, 9 and 0.

In all cases, the Disability Certificate (“CUD”, after its acronym in Spanish) must be carried on paper or digital photo, or the time of update if it has expired; as well as the DNI.

 

Professional services rendered at home for people with disabilities:

Only those services that are strictly necessary, cannot be postponed, and that do cannot be carried out in virtual mode. It will not be possible to utilize  this type of benefits if the person who will receive it, one or some of their cohabitants, or the respective professional, has symptoms of COVID-19 or is reached by any of the circumstances described in Section 2 of this Regulation. This limitation extends in case someone living with the patient shows symptoms. During the performance of the services, the health recommendations in force for the prevention of COVID-19 must be complied with.                                                                                                                                   

On April 26, 2020, PEN Decree 408/2020 was published in the Official Gazette, which extended the validity of Decree 297/2020 (which was extended by Decree Nos. 325/2020 and 355/2020 and their complementary regulations), until May 10, 2020 inclusive.

This decree sets forth that provincial governors may exempt certain activities and services from compliance with the "social, preventive and obligatory isolation" and circulation prohibitions, with regards to the personnel involved in those activities and services, in Departments or Municipalities within their jurisdictions, subject to the approval of the local health authority. In order to set in place an exception, the following epidemiological and health requirements must be met in the corresponding jurisdictions:

  • The doubling time of confirmed cases of COVID-19 must not be less than fifteen (15) days. This requirement will not be required if, due to the small or null number of cases, the aforementioned calculation cannot be made.
  • The health system must have sufficient and adequate capacity to respond to potential health demand.
  • There must be a positive evaluation by the health authorities regarding the socio-sanitary risk in relation to the population density of the geographic area involved.
  • The proportion of people exempted from social isolation, preventive and compulsory, may not exceed fifty percent (50%) of the total population of the Department or Municipality, as appropriate.
  • The Department or Municipality included in the measure must not be defined by the national health authority as those “with local transmission or agglomeration”.

When an exception is authorized, an operating protocol that complies with national and local health and safety recommendations and instructions must be previously implemented. Once the exemption is established, the measure must be reported immediately to the MoH.

The following activities and services may not be included as an exception:

  • Face-to-face classes at all levels and all modalities.
  • Public and private events: social, cultural, recreational, sports, religious and of any other nature that involves the attendance of people.
  • Shopping centers, cinemas, theaters, cultural centers, libraries, museums, restaurants, bars, gyms, clubs and any public or private space that involves the attendance of people.
  • Intercity, inter-jurisdictional and international public passenger transport.
  • Tourism activities;

The exceptions may not be made in urban agglomerates with more than five hundred thousand (500,000) inhabitants.

On May 6, 2020, Regulation No. 3/2020 of the JGM was published in the Official Gazette, creating the database denominated "COVID-19 Ministry of Health". This database will receive from its users’ data related to their health conditions through a self-assessment proposed by the COVID-19 Ministry of Health Application, related to the symptoms of COVID19, to obtain useful information within the framework of the pandemic.

On May 11, 2020, Decree No. 459/2020 was published in the Official Gazette, which extended until May 24, 2020 the term of the social, preventive and mandatory isolation, declared by Decree No. 297/20, a term which was further extended by Decrees No. 325/20, 355/20 and 408/20. Likewise, it extends for the same term, the validity of all the complementary regulations issued regarding "social, preventive and compulsory isolation".

Among its provisions, it enabled Municipalities with up to 500,000 inhabitants and provided that they are not part of urban agglomerations whose population exceeds that number, with new exceptions to the compliance with the "social, preventive and mandatory isolation" and the prohibition of movement in order to authorize industrial, service or commercial activities.

For Municipalities with more than 500,000 inhabitants or forming part of urban agglomerations with a population exceeding that number, the Governors of Provinces may only provide for further exceptions to compliance with the "social, preventive and mandatory isolation" and the prohibition of movement for the purpose of authorizing industrial, service or commercial activities, when the protocol for the operation of such activities is included in the "Annex of Protocols authorized by the national health authority".

Throughout the Metropolitan Area of Buenos Aires, the Governor of the Province of Buenos Aires and the Head of Government of the Autonomous City of Buenos Aires may request the Chief of Cabinet of Ministers, in his capacity as Coordinator of the "General Coordination Unit of the Comprehensive Plan for the Prevention of Public Health Events of International Importance", to authorize new exceptions to comply with the "social, preventive and mandatory isolation" and to the prohibition of movement for the purpose of authorizing industrial, service or commercial activities.

On May 25, 2020, PEN Decree 493/2020 was published in the Official Gazette, which extended Decree No. 297/20 until June 7, 2020 inclusive, which was extended by Decrees Nos. 325/20, 355/20, 408/20 and 459/2020. Likewise, it extends for the same term, the validity of all the complementary regulations issued regarding social, preventive and mandatory isolation".

By means of Decree No. 520/2020, published on  June 8, 2020 in the Official Gazette, the PEN set forth the measure of "social, preventive and mandatory distancing" for all persons residing or transiting in the urban agglomerations and in the districts and departments of the Argentine provinces as long as the following epidemiological and health parameters are positively verified: (i) the concerned health system has sufficient and adequate capacity to respond to health demand; (ii) the urban agglomeration, department or district is not defined by the national health authority as having 'Community transmission' of SARS-CoV-2 and (iii) the time for doubling confirmed cases of COVID-19 is not less than 15 days. This measure will be mostly in force in most provinces, allowing for greater flexibility in circulation and permitted activities. 

On the other hand, it sets forth that Decree No. 297/20, which establishes "social, preventive and mandatory isolation", extended by Decrees Nos. 325/20, 355/20, 408/20, 459/20 and 493/20, will remain in force exclusively for persons residing or transiting in the urban agglomerations, departments and districts of the Argentine territory that do not positively meet the epidemiological and health parameters mentioned in the previous paragraph. Among the urban agglomerations are the AMBA and some provincial districts.

On June 29, 2020, PEN Decree 576/2020 was published in the Official Gazette. It extends until June 30 the measures established in Decree 520/2020 and its complementary regulations and maintains the social, preventive and mandatory isolation set forth by Decree 297/2020 and its complementary norms, from July 1 to 17 for certain urban agglomerations.

This regime establishes measures of social distancing, preventive and mandatory for all individuals residing or transiting in the urban agglomerations, departments and districts of the Argentine provinces as long as the following epidemiological and health parameters are positively verified:

  • The health system must have sufficient and adequate capacity to respond to the health demand.
  • The urban agglomeration, department, or district should not be defined by the national health authority as having sustained "community transmission" of the SARS-CoV-2 virus.
  • The doubling time of confirmed cases of COVID-19 should not be less than 15 days.

The locations reached by these measures from the day of its publication includes: (i) Catamarca, (ii) Chubut, (iii) Córdoba, (iv) Corrientes, (v) Entre Ríos, (vi) Formosa, (vii) Jujuy, (viii) La Pampa, (ix) La Rioja, (x) Mendoza, (xi) Misiones, (xii) Salta, (xiii) San Juan, (xiv) San Luis, (xv) Santa Cruz, (xvi) Santa Fe, (xvii) Santiago del Estero, (xviii) Tierra del Fuego, (xix) Tucumán, (xx) Neuquén except the city of Neuquén, and (xxi) Río Negro except the department of General Roca .

It also establishes social, preventive and mandatory isolation measures,for the following locations: (i) AMBA, (ii) Chaco, (iii) General Roca, Río Negro, and (iv) City of Neuquén, Neuquén.

On July 18, 2020, PEN Decree No. 605/2020 was published in the Official Gazette, extending until August 2, 2020 the measures of social, preventive and mandatory isolation and social distancing, preventive and mandatory.

The locations reached by the measures of social distancing, preventive and mandatory include: (i) Catamarca, (ii) Chubut, (iii) Córdoba, (iv) Corrientes, (v) Entre Ríos, (vi) Formosa, (vii) La Pampa, (viii) La Rioja, (ix) Mendoza, (x) Misiones, (xi) Salta, (xii) San Juan, (xiii) San Luis, (xiv) Santa Cruz, (xv) Santa Fe, (xvi) Santiago del Estero, (xvii) Tierra del Fuego, (xviii) Tucumán, and (xix) all Chaco departments with the exception of the San Fernando department.

It also establishes social, preventive and mandatory isolation measures, for the following locations: (i) AMBA, (ii) Jujuy and (iii) the San Fernando department within Chaco.

On July 27, 2020, PEN Decree 617/2020 - Mercosur Common Nomenclature was published in the Official Gazette, which replaces the Annex of Section 1 of Decree No. 317/20, as amended by Decree No. 405/20, with a new list of goods.

This new list incorporates to the list of supplies provided for in the aforementioned Decree No. 405/20, ethyl alcohol, denatured, with a water content of less than or equal to 1% by volume and Diagnostic reagents, among others; and the following health supplies are deleted from the list: aluminium hydroxichloride, propyl alcohol, isopropyl alcohol, preforms suitable for the manufacture of bottles by blowing, diagnostic ultrasonic equipment, transducers (probes) of ultrasonic scanning equipment, azithromycin or its salts, colchicine, chloroquine, ivermectin and hydroxychloroquine.

On August 2, 2020, PEN Decree No. 641/2020 was published in the Official Gazette, which extends from August 3 to August 16 inclusive, the measures of social distancing, preventive and mandatory; adding new restrictions such as the prohibition of social or family events in closed spaces and in people's homes, in all cases and whatever the number of people attending, except for the cohabiting group. In addition, it maintains the measures of social, preventive and mandatory isolation.

The locations reached by the measures of social distancing, preventive and mandatory include: (i) Catamarca, (ii) Chaco (iii) Chubut, (iv) Córdoba, (v) Corrientes, (vi) Entre Ríos, (vii) Formosa, (viii) La Rioja, (ix) Mendoza, (x) Misiones, (xi) Neuquén, (xii) Río Negro, (xiii) Salta, (xiv) San Juan, (xv) San Luis, (xvi) Santa Fe, (xvii) Santiago del Estero, (xviii) Tucumán, (xix) La Pampa, except the departments of Atreucó, Catriló, Capital and Toay, (xx) Santa Cruz, except the department of Güer Aike, (xxi) Tierra del Fuego, except the department of Río Grande and (xix) all departments of the province of Buenos Aires not included in the AMBA.

It also establishes social, preventive and mandatory isolation measures, for the following locations: (i) AMBA, (ii) Jujuy, (iii) Departments of Atreucó, Catriló, Capital and Toay of La Pampa, (iv) Department of Güer Aike, Santa Cruz and (v) Department of Río Grande, Tierra del Fuego.On Sunday, August 16, 2020, PEN Decree No. 677/2020 was published in the Official Gazette, which extends from August 17 to August 30 inclusive, the measures of social distancing, preventive and mandatory. It adds new exceptions to the fulfillment of the social, preventive and mandatory isolation and to the prohibition to circulate, for people affected to certain commercial activities and services of the City of Buenos Aires and some municipalities of the Province of Buenos Aires; also certain activities are authorized such as the theaters, museums and libraries, within the City of Buenos Aires.

The locations reached by the measures of social distancing, preventive and mandatory are: (i) Catamarca, (ii) Chaco (iii) Chubut, (iv) Córdoba, (v) Corrientes, (vi) Entre Ríos, (vii) Formosa, (viii) La Pampa, (ix) Mendoza, (x) Misiones, (xi) Neuquén, (xii) Río Negro, (xiii) San Juan, (xiv) San Luis, (xv) Santa Fe, (xvi) Tucumán, (xvii) Jujuy, except for the departments de Manuel Belgrano, Ledesma, El Carmen and San Pedro (xviii) La Rioja, except for the departments de Capital and Chamical (xix) Salta, except for the department of General José de San Martín, (xx) Santiago del Estero, except for the departments of Capital and Banda, (xxi) Santa Cruz, except for the department of Güer Aike, (xxii) Tierra del Fuego, except for the department of Río Grande, and (xxiii) all departments of the province of Buenos Aires not included in the AMBA.

It also establishes social, preventive and mandatory isolation measures for the following locations: (i) AMBA, (ii) Departments of Manuel Belgrano, Ledesma, El Carmen and San Pedro de Jujuy, (iii) Department of Güer Aike, Santa Cruz, (iv) Department of Río Grande, Tierra del Fuego, (v) Departments of Capital and Chamical, La Rioja, (vi) Department of General José de San Martín, Salta, and (vii) Departments of Capital and Banda, Santiago del Estero.

On August 30, 2020, PEN Decree No.  714/2020 was published in the Official Gazette, which extends from August 31 to September 20 inclusive, the measures of social distancing, preventive and mandatory. The Decree authorizes the local tourist activity of the Iguazú and Iberá National Parks, and the authorization for the activity developed by psychologists in the thirty-five (35) districts of the Province of Buenos Aires that conform the AMBA.

Furthermore, this decree authorizes social gatherings of up to ten (10) people in public spaces or open-air public access, provided that the respective distancing measures are followed, and the protocols of the provincial and national health authorities are strictly observed. It also establishes that the accompaniment of patients during hospitalization, in their last days of life, may be authorized.

The locations reached by the measures of social distancing, preventive and mandatory are: (i) Catamarca, (ii) Chaco (iii) Chubut, (iv) Córdoba, (v) Corrientes, (vi) Formosa, (vii) La Pampa, (viii) Mendoza, (ix) Misiones, (x) Neuquén, (xi) San Luis, (xii) Santa Fe, (xiii) Tucumán, (xiv) Entre Ríos, except for the cities of Paraná, Colonia Avellaneda, Oro Verde, San Benito and Gualeguaychú , (xv) Jujuy, except for the departments of Manuel Belgrano, Ledesma, El Carmen, Palpalá and San Pedro, (xvi) La Rioja, except for the departments of Capital and Chamical, (xvii) Río Negro, except for the cities of Bariloche and Dina Huapi and the department of General Roca, (xviii) Salta, except for the department of General José de San Martín and Orán, (xix) San Juan, except for the department of Caucete, (xx) Santa Cruz, except  for the city of Río Gallegos, (xxi) Santiago del Estero, except for the departments of Capital and Banda, (xxii) Tierra del Fuego, Antártida and Atlántico Sur islands, except for Río Grande and Tolhuin, (xxiii) all the departments of the Buenos Aires province, except for the department of General Pueyrredón and all the included in the AMBA.

It also establishes social, preventive and mandatory isolation measures for the following locations: (i) AMBA, (ii) Department of General Pueyrredón, Buenos Aires, (iii) Cities of Paraná, Colonia Avellaneda, Oro Verde, San Benito and Gualeguaychú, Entre Ríos, (iv) Departments of Manuel Belgrano, Ledesma, El Carmen, Palpalá and San Pedro de Jujuy, (v) Departments of Capital and Chamical, La Rioja, (vi) Cities of Bariloche and Dina Huapi and the department of General Roca, Río Negro, (vii) Departments of General José de San Martín and Orán, Salta, (viii) Department of Caucete, San Juan, (ix) City of Río Gallegos, Santa Cruz, (x) Departments of Capital and Banda, Santiago del Estero, and (xi) Departments of Río Grande and Tolhuin, Tierra del Fuego, Antártida and Atlántico Sur islands.

On September 16, 2020, PEN Decree No. 747/2020 was published in the Official Gazette, which approves the regulation of Law No. 27,548 on the "Program for the Protection of Health Personnel from the Coronavirus Pandemic COVID-19". It is established in annex I of this decree, the duty of healthcare facilities to comply with the recommendations and guidelines developed and published by the enforcement authority, specifically those related to the organization of care in facilities and the recommendations on personal protective equipment, ensuring its provision. Furthermore, it mentions that the enforcement authority will be the MoH, through the Secretariat of Health Quality.

On Sunday, September 20, 2020, PEN Decree No. 754/2020 was published in the Official Gazette, which extends from September 21 to October 11 inclusive, the measures of social distancing, preventive and mandatory. In addition, it maintains the measures of social, preventive and mandatory isolation.

The locations reached by the measures of social distancing, preventive and mandatory are: (i) Catamarca, (ii) Chaco (iii) Chubut, (iv) Córdoba, (v) Corrientes, (vi) Entre Ríos (vii) Formosa, (viii) La Pampa, (ix) Mendoza, (x) Misiones, (xi) Neuquén, (xii) San Juan (xii) San Luis, (xiii) Santa Fe, (xiv) Tucumán, (xv) Jujuy, except for the departments of Manuel Belgrano, Ledesma, El Carmen, Palpalá, Yavi, Susques, Rinconada and San Pedro, (xvi) La Rioja, except for Capital, (xvii) Río Negro, except for the cities of Bariloche and Dina Huapi and the department of General Roca, (xviii) Salta, except for the department of General José de San Martín, Cerrillos, Rosario de Lerma, General Güemes, La Caldera, Orán and Capital, (xix) Santa Cruz, except for the city of Río Gallegos, (xx) Santiago del Estero, except for the departments of Capital and Banda, (xxi) Tierra del Fuego, Antártida and Atlántico Sur islands, except for Río Grande, and (xxii) all the departments of the Buenos Aires province, except for the departments of Pueyrredón, Bahía Blanca, Tandil and all those included in the AMBA.

It also establishes social, preventive and mandatory isolation measures for the following locations: (i) AMBA, (ii) Departments of General Pueyrredón, Bahía Blanca and Tandil, Buenos Aires, (iii) Departments of Manuel Belgrano, Ledesma, El Carmen, Palpalá, Susques, Yavi, Rinconada and San Pedro, Jujuy, (iv) Department of Capital, La Rioja, (v) Cities of Bariloche and Dina Huapi and the department of General Roca, Río Negro, (vi) Departments of General José de San Martín, Cerrillos, Rosario de Lerma, General Güemes, La Caldera, Orán and Capital, Salta, (vii) City of Río Gallegos, Santa Cruz, (viii) Departments of Capital and Banda, Santiago del Estero, and (ix) Departments of Río Grande de Tierra del Fuego, Antártida and Atlántico Sur islands.

On October 5, 2020, PEN Decree No. 787/2020 was published in the Official Gazette, extending the payment of the incentive fund to health personnel established in Decree 315/2020, for a period of 3 monthly and consecutive periods. As previously provided, health workers who receive remuneration from more than one employer will only receive the incentive for one of their jobs. Payment remains subject to the effective provision of in-person, health-related services in public, private and social security care institutions engaged in and dealing with cases related to COVID-19 pandemic.

On Monday, October 12, 2020, PEN Decree No. 792/2020 was published in the Official Gazette, which extends from October 12 to October 25, the measures of social distancing, preventive and mandatory. In addition, it maintains the measures of social, preventive and mandatory isolation, except for those that prohibited in person classes in schools. In this sense, it allows the resumption of classes and non-school educational activities.

The locations reached by the measures of social distancing, preventive and mandatory are: (i) Catamarca, (ii) Corrientes, (iii) Entre Ríos, (iv) Formosa, (v) La Pampa, (vi) Misiones, (vii) Chaco, except for the departments of San Fernando, Comandante Fernández, Mayor Luis Jorge Fontana and Chacabuco, (viii) Chubut, except for the departments of Biedma and Escalante, (ix) Córdoba, except for the departments of Capital, Santa María, Punilla, Colón, Tercero Arriba and General San Martín, (x) Jujuy, except for the departments of Manuel Belgrano, Ledesma, El Carmen, Palpalá, Yavi, Susques, Rinconada and San Pedro (xi) La Rioja, except for Capital and Chilecito, (xii) Mendoza, except for the departments of Capital, Luján de Cuyo, Las Heras, Maipú, Guaymallén, Godoy Cruz, Tunuyán and Tupungato, (xii) Neuquén, except for the cities of Neuquén, Plottier, Centenario, Senillosa, Cutral Có, Plaza Hiuncul and Zapala, (xiii) Río Negro, except for the cities of Bariloche and Dina Huapi, and the department of General Roca, (xiv) Salta, except for the departments of Cerrillos, Rosario de Lerma, General Güemes, La Caldera and Capital, (xv) San Juan, except for the departments of Rawson and Capital, (xvi) San Luis, except for the department of General Pedernera, (xvii) Santa Cruz, except for the cities of Río Gallegos, El Calafate and Caleta Olivia, (xviii) Santa Fe, except for the departments of Rosario, La Capital, General López, Caseros, Constitución, San Lorenzo, Las Colonias and Castellanos, (xix) Santiago del Estero, except for the departments of Capital and Banda, (xx) Tierra del Fuego, Antártida and Atlántico Sur islands, except for Río Grande, (xxi) Tucumán, except for the department of Capital, and (xxii) all the departments of Buenos Aires, except for General Pueyrredón, Bahía Blanca, Tandil, San Nicolás and all those included in the AMBA.

It also establishes social, preventive and mandatory isolation measures for the following locations: (i) AMBA, (ii) Departments of General Pueyrredón, Bahía Blanca, San Nicolás and Tandil, Buenos Aires, (iii) Departments of San Fernando, Comandante Fernández, Mayor Luis Jorge Fontana and Chacabuco, Chaco, (iv) Departments of Biedma and Escalante, Chubut, (v) Departments of Capital, Santa María, Punilla, Colón, Tercero Arriba and General San Martin, Córdoba, (vi) Departments of Manuel Belgrano, Ledesma, El Carmen, Palpalá, Susques, Yavi, Rinconada and San Pedro, Jujuy, (vii) Departments of Capital and Chilecito, La Rioja, (viii) Departments of Capital, Luján de Cuyo, Las Heras, Maipú, Guaymallén, Godoy Cruz, Tunuyán and Tupungato, Mendoza, (ix) Cities of Neuquén, Plottier, Centenario, Senillosa, Cutral Có, Plaza Hiuncul and Zapala, Neuquén, (x) Cities of Bariloche and Dina Huapi, and the department of General Roca, Río Negro, (xi) Departments of Cerrillos, Rosario de Lerma, General Güemes, La Caldera and Capital, Salta, (xii) Departments of Rawson and Capital, San Juan, (xiii) Department of General Pedernera, San Luis, (xiv) Cities of Río Gallegos, El Calafate and Caleta Olivia, Santa Cruz, (xv) Departments of Rosario, La Capital, General López, Caseros, Constitución, San Lorenzo, Las Colonias and Castellanos, Santa Fe, (xvi) Departments of Capital and Banda, Santiago del Estero, (xvii) Department of Río Grande, Tierra del Fuego, Antártida and Atlántico Sur islands, and (xviii) Department of Capital, Tucumán.

 

Ministry of Health (MoH):

On March 14, 2020, MoH Regulation No. 568/2020, which regulates the DNU No. 260/2020, was published in the supplement of the Official Gazette.

It states that the obligatory measures and the recommendations issued by the MoH must be applied by the entities of the National Public Administration. In addition, those restrictive measures that require the intervention of other jurisdictions and entities that constitute the Federal Public Administration, these entities must dictate the regulations to immediately enforce such measures.

The MoH will also determine which services and resources are essential to address the health emergency caused by COVID-19 (Coronavirus), in order to be considered in subsequent sectoral regulations.

In addition, the following Regulations were issued on March 20, 2020:

  1. MoH Regulation No. 619/2020: extends the provisions of Sections 3 and 4 of Decree No. 251/2019 (Reassignment of Funds for Universal Health Coverage) for a period of two years, for the purpose of continuing to provide resources to the Emergency and Assistance Fund and the Single System of Reimbursement (SUR, for its Spanish acronym) administered by the SSS.
  2. MoH Regulation No. 627/2020 regulates the indications for social, preventive and mandatory isolation, explaining the risk groups.

The following are considered to be risk groups: (i) people with chronic respiratory diseases; (ii) people with heart diseases; (iii) people with diabetes; (iv) people with chronic kidney failure on dialysis or with expectations of entering dialysis in the next six months; (v) people with an immunodeficiency disease [Congenital, functional or anatomical asplenia and severe malnutrition, HIV depending on status (< 350 CD4 or detectable viral load), persons on immunosuppressive medication or high dose steroids]; (vi) cancer patients and transplant recipients: with oncohematological disease up to six months after complete remission, with solid organ tumor under treatment or transplanted from solid organs or hematopoietic precursors; and (vii) persons with Disability Certificate.

This Regulation also set forth the issue of transport crews to and from the affected areas, establishing that transport crews to and from countries considered as affected areas must remain in social isolation in the hotel or their homes, as the case may be, according to the instructions detailed in Annex I of the Regulation, clarifying that, once  social isolation is fulfilled, they will be exempted from completing the 14-day period of compulsory isolation provided in Section 7 of Decree No. 260/2020, as long as they do not present symptoms, to continue their work activity due to the need for the service. With regard to passengers in transit, the rule states that passengers who have remained "in transit" in countries considered as affected areas are exempted from the mandatory isolation provided for in Section 7 of Decree No. 260/2020 upon entering the country (it is understood that persons "in transit" are those who made a stopover in one of the countries considered as affected areas, and never left the area of the terminal where they were, having complied with social distancing measures and having not been in contact with sick persons).

Finally, the Regulation stipulates that in order to make effective the work licenses arranged by the competent authorities in the framework of the health emergency of the COVID-19, and to protect the confidentiality of the patient, the medical personnel may indicate the use of these licenses with the sole mention that the workers are considered to be a risk group or by the sectorial regulation that has defined "risk group".

On Saturday, March 21, 2020, Joint Regulation No. 1/2020 of the MoH and the Ministry of Productive Development was published in the Official Gazette, which establishes in Annex I the critical health supplies needed to mitigate the spread of COVID-19. These inputs may be expanded or replaced by order of the MoH and the Ministry of Productive Development, according to the requirements of the circumstances.

At the same time, it encourages the companies that participate in the production chain of health inputs to increase the production, distribution and commercialization of these inputs up to the maximum of their installed capacity, and to arbitrate the means to ensure their distribution and provision to the population and healthcare facilities, the latter having priority to acquire them.

It sets forth an information regime for these companies through which, every 5 days, they must inform the Health Authority and the Secretariat of Domestic Trade of the Ministry of Productive Development, the amount of goods produced, the amount of goods marketed and the recipients of these sales operations. They must also inform their production plan for the next three (3) months.

The list of critical health inputs are namely: (i) equipment (ventilators, infusion pumps, hospital beds, oxygen tubes, etc.); (ii) protective elements (latex gloves, surgical mask, disinfectant detergent, alcohol gel, etc.); and (iii) medicines (amoxicillin, azithromycin, budesonide spray, cephalexin, dexamethasone, loratadine, ibuprofen, meprednisone, paracetamol, among others).

The provisions of the Joint Regulation must be controlled in accordance with the procedures and sanctions provided for in the Supply Law No. 20,680 (Ley de Abastecimiento) and its amendments.

The Regulation came into force the day after its publication and will be in force for 90 calendar days, which can be extended after analyzing the state of the health emergency and depending on the time needed to rehabilitate the shortage situation.

On Tuesday, March 31, 2020, MoH Regulations No. 680/2020 and 681/2020 were published in the Official Gazette. MoH Regulation No. 680/2020 incorporates COVID-19 disease into the legal regime of mandatory disease reporting, set forth by Law No. 15,465, in all its stages, from the suspected case to the monitoring of its evolution.

Such notification must be made under the individual notification procedure with immediate frequency (twelve hours) and the following subjects must comply with it: (i) physicians who assist patients in public or private healthcare facilities, (ii) professionals from public or private laboratories who study samples of suspected, probable, confirmed, and discarded cases, (iii) the corresponding authorities of public or private laboratories and healthcare facilities, and (iv) the corresponding provincial and municipal health authorities. Finally, the Regulation sets forth that under the terms of Section 6 and 12 of Law No. 15,465, the obligation to notify cases of COVID-19, their evolution and epidemiological investigation, is joint and several among all obligated subjects.

MoH Regulation No. 681/2020 instructs pharmaceutical professionals to cooperate in the prevention of the Coronavirus COVID-19, Dengue and Zika; and authorizes pharmacies with authorized laboratories to manufacture and stock up to 5 kilograms of hand sanitizer and 5 kilograms of insect repellent products to rationally meet dispensing requirements. This authorization must be extended for the time the health emergency lasts.

In the early hours of April 1, 2020, MoH Regulations No. 695/2020 and 696/2020 were published in the Official Gazette:

  1.   MoH Regulation No. 695/2020 establishes that the manufacturing, distribution or marketing companies of invasive mechanical ventilators may not deliver units without prior express authorization from the MoH, in accordance with the provisions of a federal distribution criteria, the evolution of the pandemic of COVID-19 and the infrastructure available in health care establishments in the public, private, social security sectors, establishments of the Armed Forces, Security, and state Universities.
  2. MoH Regulation No. 696/2020 exceptionally authorizes the medication prescription contained in Lists III and IV of Law No. 19.303, of medication for patients with cancer treatment or patients with treatment of chronic non-communicable diseases (ECNT), as well as any other medicine that is used under prescription, excluding narcotic drugs, via text message or messages through web message applications, email or fax, within the framework of the social, preventive and mandatory isolation provided by Decree No. 297/2020.

On April 17, 2020, MoH Regulation No. 781/2020 was published in the Official Gazette. This regulation suspends the registration of new Health Insurance Providers, during the period of public health emergency, in the Public Healthcare Insurance Providers Registry and in the Private Healthcare Insurance Providers Registry. It also suspends all the procedures that are currently in progress for the same purpose or procedures for extension of territorial scope of action.

On April 18, 2020, MoH Regulation No. 783/2020 was published in the Official Gazette. This regulation created the Strategic Plan to Regulate the Use of Plasma in Patients Recovered from COVID-19 for Therapeutic Purposes.  Furthermore, the Regulation requires from the jurisdictional health authorities to define the Regional Centers of Hemotherapy and/or Intrahospital Blood Banks that will be responsible for the collection of plasma from patients recovered from COVID-19.

On May 12, 2020, MoH Regulation 908/2020 was published in the Official Gazette. It approves the Ethical and Operational Guidelines for the Accelerated Ethical Evaluation of Investigations on Human Beings related to COVID-19. The objective of the approved guidelines is to orient the investigation ethics committees and the health authorities of the different jurisdictions in the development of operational procedures for an accelerated evaluation of investigation projects related to COVID-19.

To this end, and in the context of the pandemic, Investigations Ethics Committees should ensure that (i) the research does not compromise the response to the health emergency generated by the pandemic, (ii) the research has social value and relevance, (i.e., it responds to the health needs or priorities of affected individuals and communities), (iii) the studies are designed to produce scientifically valid results, (iv) participants are selected fairly when one group is prioritized over another and adequate public and transparent justification is provided for that prioritization, (v) individual informed consent is obtained from participants or their legal representatives, supporters, family members or significant others, unless conditions for exceptions to informed consent are met, and (vi) research results are disseminated, data is shared, and any effective interventions developed or knowledge generated are made available to affected communities, among others.

Operational procedures for health emergencies should address at least the following points: (a) Selection of evaluation members, (b) Pre-selection of external consultants, (c) Submission of evaluation requests, (d) Additional information for review, (e) Meetings and Quorum, (f) Expedited evaluation procedures, (g) Communication of decisions, and (h) Follow-up and monitoring of investigations, among others.

On May 21, 2020, MoH Regulation No. 943/2020 was published in the Official Gazette, appointing Dr. Juan Manuel Castelli as Government Coordinator and Dr. Gustavo Daniel Lopardo as Clinical Coordinator of the "Solidarity" Randomized Clinical Trial for COVID-19.

The designated coordinators will be responsible for: (a) managing all approvals necessary for their proper development; (b) selecting and convening potential centers of collaboration from among major hospitals that already have, or are expected to soon have, a substantial number of hospital admissions of COVID-19 patients; and (c) facilitating local ethical approval on behalf of local centers of collaboration. On June 8, 2020, MoH Regulation No. 987/2020 was published in the Official Gazette, approving the National Healthcare Personnel Protection Plan - COVID-19 Pandemic Implementation Framework.

The main objective of the Plan is to guide healthcare providers in taking actions to prevent COVID-19 infections and the indirect consequences of the pandemic on workers' health. Three strategic aspects are created for this objective: (i) Policies of Consensus, Guidance and Articulation, which aims to promote coordination actions between the MoH and other  jurisdictions, (ii) Policies of Education, Supervision and Awareness, which seeks to develop environments for training, coaching and supervision on real work processes, and (iii) Policies for the Care of Workers, which aims to have a strategy for the communication and detection of risk scenarios and for the support of health personnel and their families.

On June 29, 2020, MoH Regulation No. 1,117/2020 was published in the Official Gazette, creating the Ethics and Human Rights Committee on COVID19 Pandemic. The Committee will have an advisory and consultative character, providing advice to the MoH on the ethical implications of the COVID-19 pandemic for public health. It must limit the performance of its duties to the emergency declared by Decree No. 260 of March 12, 2020.

Joint Regulation No. 2/2020 of the Ministry of Education and the MoH, published on July 15, 2020 in the Official Gazette, created the Universities for the COVID-19 Emergency Program (PUPLEC19, after its acronym in Spanish). The PUPLEC19 seeks, on the one hand, to expand health teams in the face of the pandemic and, on the other, to strengthen the processes of accompanying and assisting the population in the current context of social, preventive and obligatory isolation, especially among the most marginalized groups and in situations of vulnerability. Its main targets are university students from all careers to carry out various support tasks. The PUPLEC19 will have a six-month term from the issuance of the Joint Regulation.

On July 28, 2020, MoH Regulation No. 1284/2020 was published in the Official Gazette, granting exceptional financial support to Health Insurance Agents who had suffered a drop in revenue during the month of June 2020, as compared to the month of March 2020, in order to guarantee the proper functioning of health services during the COVID-19 pandemic, as well as timely and proper payment to healthcare providers, which is essential for the continuity of healthcare for beneficiaries.

On September 18, 2020, MoH Administrative Decision No.1721/2020 was published in the Official Gazette, which establishes a series of general principles that the MoH must comply with in order to carry out the direct acquisition of vaccines to generate acquired immunity against COVID-19. Section 2 lists the principles to which contracts must comply with, specifically: (i) reasonability of the project and efficiency of the contracts to meet the public interest pursued and result, (ii) transparency in the procedures, (iii) publicity and diffusion of the actions, (iv) responsibility of agents and public officers who authorize, approve or manage the contracts, (v) assignment of priority for the criteria of sanitary security, and of efficiency and efficacy in the times of the different developments over economic criteria, and (vi) to ensure that the National Government has, as soon as possible, a sufficient number of doses of vaccines to generate acquired immunity against COVID-19. Furthermore, such administrative decision empowers the MoH to sign the contracts regulated hereby, as well as all the prior and subsequent administrative acts tending to the effective compliance thereof and may include stipulations in accordance with the international market of the vaccine for the prevention of COVID-19 disease. Finally, it should be noted that the established regime will be in force during the COVID-19 pandemic.

On September 23, 2020, MoH Regulation No. 1541/2020 was published in the Official Gazette, which expands the list of diseases related to the term "risk group" of Decree 260/2020, including obesity.

On October 6, 2020, MoH Regulation No. 1643/2020 was published in the Official Gazette, which states that only classes II and III of obesity will be considered within the diseases related to the term "risk group" of Decree 260/2020.

 

Superintendence of Health Services (“SSS”, after its acronym in Spanish)

On March 17, 2020, the SSS issued Regulation No. 233/2020 in response to the pandemic declared by the WHO, stating that from March 17 to April 15, 2020, the public service areas of the SSS will have a reduced scheme to safeguard the health and safety conditions of its employees.

During such period, the SSS must only attend to requirements related to situations of lack of coverage and/or refusal of affiliation by Healthcare Insurance Agents (“ASS”, after its acronym in Spanish) and Private Healthcare Insurance Providers (“EMP”, after its acronym in Spanish) that are of a medical emergency nature and/or involve affiliates with disabilities. The term "medical emergency" is not defined in the Regulation.

In addition, during this period the SSS suspended: (i) the administrative procedural deadlines for appeals by ASS and EMP against regulations issued by the SSS; (ii) the personal or direct access notification of ASS and EMP in all SSS facilities; and (iii) the receipt of judiciary informative requests, except for those requests that expressly include the authorization of non-working days and hours ordered by the intervening court.

Finally, the period of validity is extended until June 30, 2020 for those registrations issued by the National Registry of Healthcare Providers whose expiration had occurred or will occur between January 1, 2020, and April 15, 2020.

On March 20, 2020, SSS Regulation No. 234/2020 was published extending the term of validity of those certificates of authorities issued by the National Registry of Healthcare Insurance Providers of the SSS whose expiration had operated or will operate within the days of January 1, 2020 and April 15, 2020, such extension expiring 30 business days after the publication of the Regulation.

On March 25, 2020, SSS Regulation No. 235/2020 was published, extending the term of the registrations issued by the National Registry of Providers whose expiration had occurred or will occur between January 1, 2020 and April 15, 2020, ending such extension on June 30, 2020.

On March 27, 2020, SSS Regulation No. 269/2020 was published, which requires those ASS and EMP that have not complied with Regulation No. 381/2019 to carry out, within a peremptory term of forty-eight (48 hours), the user registration process at the Distance Processing Platform (“TAD”, after its acronym in Spanish) and communicate the data to the SSS, at the e-mail address tad@sssalud.gob.ar, where they must indicate the CUIT corresponding to the user registration. Regulation No. 381/2019 set forth that all communications and notifications to be made by the SSS with respect to the ASS and the EMP must be made through the TAD Platform. However, as this has not occurred in practice, the SSS continued to notify regulations through postal mail. Given the health emergency, and the impossibility of notification by this means, the SSS encourages these organizations to register their users through the TAD.

During the morning of April 2, 2020, SSS Regulations No. 281/2020 and 282/2020 were published.

i. Regulation No. 281/2020 establishes that, for the period of preventive and mandatory social isolation, the Health Insurance Agents registered in the National Registry of Health Insurance Companies (RNOS) and the Entities registered in the National Registry of entities of Prepaid Medicine, must adopt the pertinent measures to ensure medicine provision for the treatment of chronic diseases to their beneficiary population, ensuring that the delivery exceeds the usual periods, in such a way as to avoid the concurrence of the beneficiaries to the pharmaceutical establishments. For this purpose, all those prescriptions for chronic use medication will be extended, for the period of preventive and mandatory social isolation provided by Decree No. 297/20 and its extensions, if any, and up to 30 days after at its completion.

Likewise, it authorizes the Health Insurance Agents that provide medications for the treatment of chronic diseases, which, in turn, are recognized by the Single Reimbursement System (SUR), to submit the reimbursement requests with a copy of the Last prescription issued by the treating professional.

ii. On the other hand, SSS Regulation No. 282/2020 recommends that, during the period of validity of the of social, preventive and mandatory isolation measure, and any possible extensions that may be provided, the Health Insurance Agents and the Prepaid Medicine Entities must implement and promote the use of tele-assistance and/or tele-consultation platforms, to guarantee essential demand benefits.

On April 9, 2020, the SSS Regulation No. 309/2020 was published, which establishes that all the ASSs and the EMPs must incorporate, provisionally and for a term of up to forty-five (45) days after completion. of the period of social, preventive and compulsory isolation established by Decree No. 297/2020 and its possible extensions, to the children of the registered members born as of February 20, 2020, with the sole accreditation of birth and kinship, by presentation of the Birth Certificate, Birth Medical Certificate issued by the publicly or privately managed healthcare establishment signed by the doctor, obstetrician or health agent authorized for the purpose of having attended the delivery, or any other instrument that, in copy or original, allow to consider, reasonably proven, the occurrence of the birth. It will be exempt from presenting any instrument that proves the birth in the cases in which the ASS or the EMP had covered the delivery of the affiliated mother.

Once the “social, preventive and mandatory isolation” has ended, the affiliated holders must process the child's DNI and present it before the ASS or the EMP to which they belong, up to 45 days after the end of the social isolation, preventive and mandatory. Once this term has expired without the documentation having been presented, the ASS or the EMP may order the provisional suspension of the affiliation of the girl or the boy until the affiliate holder complies with the delivery of the documentation that proves their identity.

On April 18, 2020, SSS Regulation No. 365/2020 was published in the Official Gazette, which extended the validity term of the provisions contained in SSS Regulation No. 233/2020 until the end of the "social, preventive and mandatory isolation" provided by Decree No. 297/2020 extended by Decrees Nos. 325/2020 and 355/2020.

On July 15, 2020, SSS Regulation No. 629/2020 was published in the Official Gazette, in which the members of the Advisory Council of the Superintendence of Health Services were appointed, in accordance with the objectives and functions set forth in Decree No. 2,710/12 and by virtue of the health emergency and the recurrent crises of the Health System. The main objective of the Advisory Council will be developing strategic proposals and making non-binding recommendations to promote solutions to the structural problems of the Health System. By means of SSS Regulation No. 729/2020, published on July 29, 2020, the validity term of the registrations issued by the National Registry of Healthcare Providers of the Superintendence of Health Services whose expiration would have operated or will operate between January 1 and September 30, 2020, is extended until December 31, 2020.

On October 1, 2020, SSS Regulation No. 1,202/2020 was published in the Official Gazette, providing for the creation of the Technical Commission for the Purchase of Medicines, Supplies and Devices. Among its main functions are the following: (i) to analyze and evaluate the opportunity, merit and convenience of initiating the processes of drug, supplies and device procurement, (ii) to generate a space for coordination with the ASS, (iii) to supervise the procedures to be completed by the ASS in order to have access to the drugs, supplies and devices that are purchased through mechanisms that unify the procurement management of multiple contracting entities that require the same service, (iv) prepare technical reports on the medicines, supplies and devices that require the consolidated purchasing procedure, and carry out an evaluation of the economic impact within the National Health Insurance System, (v) consolidate a system of indicators and statistics to evaluate the effectiveness of the procedures for joint purchase of medicines, supplies and devices carried out by the SSS, and (vi) formulate proposals to strengthen the procedures to be observed by the ASS.

 

National Agency of Medicines, Food and Medical Technology (ANMAT)

On Friday, March 20, 2020, ANMAT Communique No. 2/2020 was published, extending for a 180-day-period as from March 21, 2020, the obligation to perform the Bioequivalence studies established in ANMAT Communique No. 7/2019. This responds to the global health situation, which increases the demand for various inputs of ANMAT's competence whose import, export and distribution is affected, and aims to ensure the availability of critical inputs and effective health action throughout the country. ANMAT Communique No. 7/2019 required that pharmaceutical companies holding product certificate containing any of the active pharmaceutical ingredients (APIs) included in ANMAT Communique No. 9222/2017 (Acenocumarol, Clopidogrel, Clozapine, Haloperidol, Levothyroxine, Nitrofurantoin, Olanzapine, Quetiapine and Risperidone) should start the filing process for bioequivalence studies in a 180-calendar-day-period starting on September 19, 2019, hence, until March 17, 2020. The same period applied to products that were in the process of being registered in the Registry of Medicinal Specialties (the “REM”, after its acronym in Spanish).

In addition, it also sets forth that the pharmaceutical companies that are holders of medicinal products commercialized and/or in the registration process that have as an ingredient any of the APIs included in the lists of APIs with bioequivalence requirements should comply with the provisions of ANMAT Regulation No. 4132/2012 for all concentrations.

The sanctions for not complying with this regulation implied the cancellation of the registration, without further procedure, by means of the relevant administrative proceedings.

 

National Unified Central Institute for Donation and Transplant Coordination (INCUCAI)

INCUCAI Regulation No. 67 published on March 20, 2020 extends the validity of the terms of expiration of the credentials issued under Law No. 26,928 by the INCUCAI and the Jurisdictional Agencies of Procurement and Transplant, for a period of ninety (90) calendar days as from March 19, 2020.

INCUCAI Regulation No. 1/2020 published on April 18, 2020 established an extension until May 15, 2020 the suspension of the period set forth in Regulation INCUCAI No. 67/2020, for the filing of the procedures related to the licenses granted by the INCUCAI to healthcare facilities, physicians and teams of healthcare professionals.

INCUCAI Regulation No. 129/2020 published on June 22, 2020 extends the validity of the terms of expiration of the credentials issued under Law No. 26,928 by the INCUCAI and the Provincial Agencies of Procurement and Transplant, until August 21, 2020. In addition, it extends the validity of the expiration terms of the licenses granted by the INCUCAI to healthcare facilities, physicians and healthcare professional, until August 21, 2020, in accordance with Law No. 27,447.

INCUCAI Regulation No. 180/2020 published on August 21, 2020, extends the validity of the terms of expiration of the credentials issued under Law No. 26,928 by the INCUCAI and the Provincial Agencies of Procurement and Transplant.

INCUCAI Regulation No. 211/2020 published on September 24, 2020, once again extended the validity of the terms of expiration of the credentials issued under Law No. 26,928 by the INCUCAI and the Provincial Agencies of Procurement and Transplant.

 

National Agri-food Health and Quality Service (SENASA)

On March 28, 2020, SENASA Regulation No. 295/2020 was published, which extended until July 31, 2020 the expiration of the licenses, registrations and permits of i) animal food facilities and companies; ii) wholesale markets, concentration markets, warehouses, dispatch centers, commercial operators, and fruit and vegetable stockpiling; iii) fruit and vegetable packing and refrigeration facilities; iv) facilities for washing and disinfecting reusable plastic containers intended for the packing of fresh fruit and vegetables; and v) authorization for the transport of animal origin products.

The extension does not affect the health and safety conditions of the above-mentioned facilities and transportations. This Regulation entered into force on March 29, 2020.

On May 4, 2020, SENASA Regulation 344/2020 was published, creating the Digital Media Monitoring and Control Program. The objective of the Program is to formalize and put into operation the control system carried out by SENASA within the framework of the faculties conferred by Law No. 27,233 and its Regulatory Decree No. 776/2019. Among the specific objectives of the Program is to ensure the control of the content published on websites that commercialize products, by-products and/or derivatives of animal and vegetable origin.

 

Ministry of Productive Development:

On April 1, 2020, Ministry of Productive Development Regulation No. 132/2020 was published in the Official Gazette, through which the Support Program for the National Productive System in the department of ​​Medical Equipment and Medical and Sanitary Supplies and Technological Solutions in the Framework of the Coronavirus Pandemic COVID-19. This program is intended to assist and finance the public health sector and companies, entrepreneurs and public institutions, within the framework of the health emergency.

The direct beneficiaries of the Program are companies, suppliers of its productive value chain, entrepreneurs, public institutions and other productive units that make contributions in the area of ​​medical and health equipment and supplies, as well as technological solutions and their development and implementation that helps the prevention, diagnosis, treatment, monitoring, control and/or other aspects related to the coronavirus COVID-19.

 

City of Buenos Aires Regulations:

Government of the City of Buenos Aires Decree No. 1/2020

By means of the Decree No. 1/2020, published on March 17, 2020 in the Official Gazette of the City of Buenos Aires (“CABA”, after its acronym in Spanish), a Health Emergency was declared in CABA until June 15, 2020 to adopt the necessary measures to prevent and mitigate the risk of spreading the COVID-19 virus among the population.

 

Government Control Agency (“AGC”, after its acronym in Spanish) Regulation No. 165/2020

On March 19, 2020, AGC Regulation No. 165/2020 was published in the CABA Official Gazette. This regulation provides for the exceptional suspension, for a 60-calendar-day-period, of the legal terms and filings corresponding to administrative proceedings, which have been filed with the AGC, as from the day of its publication.

Furthermore, the public service area is suspended in every public office since the publication in the Official Gazette until March 31, 2020.

 

Joint Regulation No. 15/MJGGC/20

On April 13, 2020 Joint Regulation No. 15/MJGGC/20 was published in the Official Gazette of the city of Buenos Aires. The regulation provides for the mandatory use of protective equipment that covers nose, mouth and chin to enter or remain in commercial premises, in public service units and in public transportation in the area of ​​the Autonomous City of Buenos Aires. Additionally, it prohibits the commercialization of N95 masks to any individual who cannot prove that they are a health service professional or personnel and to legal persons that do not have the purpose of providing that service. This measure will take effect from April 15, 2020.

 

City of Buenos Aires Ministry of Health Regulation No. 998/2020

On April 21, 2020, City of Buenos Aires Ministry of Health Regulation 998/2020 was published in the Official Gazette of the City of Buenos Aires. The regulation creates the Teleconsultation Program within the CABA, whose main objective is to optimize the accessibility, equity and quality of healthcare provided in the CABA Public Health System, providing the necessary means for them to carry out remote care or teleassistance in a timely manner to continue monitoring population health problems that are not linked to Coronavirus.

 

City of Buenos Aires Ministry of Health Regulation No. 1,506/2020

On July 13, 2020, Regulation No. 1,506/2020 of the CABA Ministry of Health was published in the CABA Official Gazette. The Regulation exempts from hiring liability insurance for all research aimed at assessing the efficacy and safety of convalescent plasma in patients infected with COVID-19, provided that it is carried out in healthcare providers belonging to the Government of the City of Buenos Aires and sponsored by the State and/or not privately funded.

 

City of Buenos Aires Ministry of Health Regulation No. 1,958/2020

On August 27, 2020, Regulation No. 1,958/2020 of the CABA Ministry of Health was published in the CABA Official Gazette. This regulation creates the Promotion and Support Plan for research in COVID-19 within the scope of the CABA, whose priority will be those projects that seek to prove safety and efficacy with respect to plasma from convalescent patients, vaccines, immunological treatments and antiviral treatments.

 

City of Buenos Aires Legislature Law No. 6,322

On August 27,2020, Law No. 6,322 of the CABA Legislature was published in the CABA Official Gazette. This law creates the Plan for Accompanying Patients in an End-of-Life Situation during the declared health emergency due to the COVID-19 pandemic. The objective of this plan is to ensure that patients are accompanied, either virtually or in person, by a person of their emotional environment. In addition, the necessary safety, information and support should be guaranteed for the patient and the accompanying person.