Vaccines Act To Generate Immunity Acquired Against Covid-19 Provisions - Updated Standard

Original Language Title: LEY DE VACUNAS DESTINADAS A GENERAR INMUNIDAD ADQUIRIDA CONTRA EL COVID-19 DISPOSICIONES - Texto actualizado de la norma

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LAW OF VACUNAS AGAINST COVID-19

Law 27573

Provisions.

The Senate and Chamber of Deputies of the Argentine Nation assembled in Congress, etc. sanction with force

Law:

LAW OF VACUNAS AGAINST COVID-19

Article 1 - Determine the investigation, development, manufacture and acquisition of vaccines for the generation of immunity acquired against COVID-19 in the framework of the health emergency established by law 27,541 and extended by decree 260/20, its amendment and complementary regulations, under the pandemic declared by the World Health Organization (WHO) in relation to the said disease.

Article 2 - Provide the national executive branch, through the Ministry of Health, to include in the contracts it concludes and in the supplementary documentation for the acquisition of vaccines aimed at generating immunity acquired against COVID-19, in accordance with the special procedure regulated by article 2°, paragraph 6, of Decree 260/20, its amendment and administrative decision 1,721/20, clauses establishing the extension of jurisdiction in favour of the foreign and judicial tribunals.

In no case may the extension of jurisdiction be extended or understood to third parties residing in the Argentine Republic, whether human or legal persons, who in all cases retain their right to go to the local or federal courts of the country for matters arising from the application of these contracts.

Article 3 - The waiver to oppose the defence of sovereign immunity, in accordance with Article 2 of the Constitution, shall not imply waiver of any respect for the immunity of the ARGENTINA REPUBLIC in relation to the execution of the following assets:

(a) Any property, reservation or account of the BANCO CENTRAL DE LA REPUBLIC ARGENTINA;

(b) Any property belonging to the public domain located in the territory of the ARGENTINA REPUBLIC, including those covered by articles 234 and 235 of the National Civil and Commercial Code;

(c) Any property located within or outside Argentine territory that provides an essential public service;

(d) Any property (in the form of cash, bank deposits, securities, third-party obligations or any other means of payment) of the ARGENTINA REPUBLIC, its government agencies and other governmental entities related to the execution of the budget, within the scope of articles 165 to 170 of Law No. 11.672, Permanent Budget Complementary (t. or 2014);

(e) Any asset achieved by the privileges and immunities of the 1961 Vienna Convention on Diplomatic Relations and the 1963 Vienna Convention on Consular Relations, including, but not limited to property, establishments and accounts of the Argentine missions;

(f) Any asset used by a diplomatic, governmental or consular mission of the ARGENTINA REPUBLIC;

(g) Taxes due to the ARGENTINA REPUBLIC and its rights to collect them.

(h) Any property of a military nature or under the control of a military authority or defence agency of the ARGENTINA REPUBLIC;

(i) Any property that forms part of the cultural heritage of the ARGENTINA REPUBLIC; and

(j) Any asset that integrates the Argentine Integrated Previsional System Sustainability Guarantee Fund (Decree No. 897/07 and Decree No. 2103/08).

(Article replaced by art. 1 Decree No. 431/2021 B.O. 3/7/2021. Watch: from the day of publication in the OFFICIAL BOLETTER.)

Article 4 - Provide the NATIONAL EXECUTIVE POWER, through the Ministry of Health, to include in the contracts it concludes and in the supplementary documentation for the acquisition of vaccines for the generation of immunity acquired against COVID-19, in accordance with the special procedure regulated by Decree No. 260/20, its amendment and Administrative Decision No. 1721/20, provisions establishing conditions of compensation related to the origin of pecuniary claims

Please refer to the NATIONAL EXECUTIVE PODER, through the Ministry of Health, to include clauses or confidentiality agreements in line with the international market for vaccines aimed at generating acquired immunity against COVID-19, in accordance with the Nros Acts. 27,275, Access to Public Information, 26,529, Patient Rights, Clinical History and Informed Consent and Concordant, Complementary and Modifying Standards.

(Article replaced by Article 2 of the Decree No. 431/2021 B.O. 3/7/2021. Watch: from the day of publication in the OFFICIAL BOLETTER.)

Article 5 - Provide the national executive branch, through the Ministry of Health, to subscribe, in the contracts that it concludes pursuant to the procedure regulated by this law, to all previous and subsequent administrative acts aimed at the effective implementation of these acts, to modify their terms, and to include other clauses according to the international market of the vaccine for the prevention of COVID-19 disease, with the aim of making the acquisition of them.

Article 6 - Explain the payment of import duties and any other tax, tax, contribution, rate or customs or port tariff, of any nature or origin, including the tax on the aggregate value, as well as the constitution of pre deposit, to the vaccines and disposable imported by the Ministry of Health, by account and order of the Ministry of Health, by the PAHO Revolving Fund or with exclusive purpose to the Ministry of Health.

Identical treatment will receive vaccines that may eventually acquire the provinces and the Autonomous City of Buenos Aires.

Article 7: The exemptions established in Article 6 shall apply to the imports of the goods mentioned there for the exclusive use of the Ministry of Health of the Nation and the ministries of health of the provinces and the Autonomous City of Buenos Aires, starting from the publication in the Official Gazette of this Law.

Article 8: The acquisition of vaccines to generate acquired immunity against COVID-19, subject to this law, must present them to the National Administration of Medicines, Food and Medical Technology (A.N.M.A.T.) for the purpose of the intervention of its competence and must be authorized by the Ministry of Health, who shall be issued within a maximum period of thirty (30) days, prior to its use in the target population.

Article 8° bis.- Please refer to the COVID-19 Reparation Fund for the purpose of the payment of compensation to human persons who have suffered harm in physical health, as a direct result of the application of the Cowskin to generate acquired immunity against COVID-19 and with the scope of this Act.

(Article 3 of the Decree No. 431/2021 B.O. 3/7/2021. Watch: from the day of publication in the OFFICIAL BOLETTER.)

Article 8° ter.- All human persons who had been provided with a vaccine against COVID-19 in the national territory shall be potential beneficiaries, provided under contracts of supplies signed under this law by the Ministry of Health of the Nation or the jurisdictions adhering to this COVID-19 Reparation Fund regime, under article 12 bis of this Act.

Access to restitution will only require proof of the existence of the damage and its causal link with the vaccine by preponderance of the evidence, without the need to attribute another factor of liability to any of the potential agents of the damage.

In the case of death, the following persons shall be entitled to compensation:

(a) Children and girls equally;

(b) In the absence of children, parents and parents by equal shares;

(c) The surviving spouse, provided that he or she had not been found separated or de facto separated on the day of disappearance or death.

The surviving spouse is with the beneficiaries and beneficiaries established and established in subparagraphs (a) and (b) and shall be entitled to receive the same part as them and/or them, in respect of the total benefit;

(d) The surviving survivor, provided that he had lived in a public, notorious, stable and permanent nature.

The surviving person or the surviving partner meets the beneficiaries and the beneficiaries established and established in subparagraphs (a) and (b) and shall have the right to receive the same part as them and/or them in respect of the total benefit.

(Article 4 of Article 4 Decree No. 431/2021 B.O. 3/7/2021. Watch: from the day of publication in the OFFICIAL BOLETTER.)

Article 8° quater.- Scope of compensation. Compensation from the Fund for the total and permanent death or physical incapacity of the injured person or the injured person shall be equal to DOSCIENTAS CUARENTA (240) times the minimum retirement of SIPA. Compensation for damages that do not cause total or permanent physical incapacity shall be assessed directly in proportion to this amount in accordance with the percentage of incapacity determined by the medical commissions provided for in article 8° sexies.

(Article 5 of the Decree No. 431/2021 B.O. 3/7/2021. Watch: from the day of publication in the OFFICIAL BOLETTER.)

Article 8° quinquies.- The Ministry of Health, with the intervention of the National Commission for Security in Vaccinations, shall establish the general criteria for the determination of the causal relationship on the basis of the preponderance of the evidence, between the application of the vaccine and the damage reported, and those necessary for the determination of the extent of the damage.

(Article 6 of the Decree No. 431/2021 B.O. 3/7/2021. Watch: from the day of publication in the OFFICIAL BOLETTER.)

Article 8° sexies.- Competition. The medical commissions provided for in article 51 of Act No. 24,241 shall be responsible for the processing of the claim. They shall, to the extent of their compatibility, apply the rules provided for in Act No. 24.557 and the other rules governing their performance. The National Security Commission in Vacunas will act as a technical consultation body. Your views will be binding.

What is issued by the medical commissions shall be judicially revised before the Federal Appeals Chamber with a seat in the jurisdiction of the domicile of the person seeking the compensatory recognition. In the Autonomous City of Buenos Aires, the National Appeals Chamber will be competent in the Federal Administrative Dispute.

(Article 7 of the Decree No. 431/2021 B.O. 3/7/2021. Watch: from the day of publication in the OFFICIAL BOLETTER.)

Article 8° septies.- Payment effect. Payments made by the Fund set out in article 8° bis shall have an extinct effect on any emerging obligation of the facts described in article 8° quinquies and must be considered to be made by any agent who may be responsible for the damage, without this generating a right on the part of the Fund or the National State to obtain the repetition of the paid, except in case of dolo.

(Article 8 of the Decree No. 431/2021 B.O. 3/7/2021. Watch: from the day of publication in the OFFICIAL BOLETTER.)

Article 8° octies.- Prescription. The claim for compensation provided for in article 8° quater prescribes the THREE (3) years. The computation of the limitation period begins to run from the fact that the damage caused by the COVID-19 Cowskin was known or may have been known.

(Article 9 of the Decree No. 431/2021 B.O. 3/7/2021. Watch: from the day of publication in the OFFICIAL BOLETTER.)

Article 8° nonies.- Constitution of the Fund. The fund should be made up of an amount equal to UNO COMA VEINTICINCO BY CIENTO (1.25 %) of the FCA value (Free Carrier, according to Incoterms 2020) by doses of the vaccines supplied. The National Executive will regulate its form of constitution, form of financing and other aspects necessary for its proper functioning. Once constituted, the Ministry of Health shall act as implementing authority.

(Article 10 of the Decree No. 431/2021 B.O. 3/7/2021. Watch: from the day of publication in the OFFICIAL BOLETTER.)

Article 8° decies.- In the event that the Fund ' s resources were insufficient to meet its obligations, the debtor would be the National State.

(Article incorporated by art. 11 Decree No. 431/2021 B.O. 3/7/2021. Watch: from the day of publication in the OFFICIAL BOLETTER.)

Article 9 - In the framework of the Health Emergency established by law 27,541 and extended by decree 260/20, its amendment and complementary regulations, under the pandemic declared by the WORLD HEALTH ORGANIZATION (WHO) in relation to COVID-19, authorize, by the exceptionality of the pandemic context, the competent organisms to carry out the emergency approval of the vaccines subject to scientific evidence, and to ensure the safety of the vaccines.

Article 10.- Contracts under this Act shall be referred to the General Audit of the Nation for the purposes of respecting the confidentiality clauses that may be included therein, in accordance with article 4 of the Act, paragraph 2.

Article 11. Contracts under this Act shall be referred to the authorities of the Commission for Social Action and Public Health of the Honourable Chamber of Deputies of the Nation and of the Health Commission of the Honourable Senate of the Nation for the purposes of respecting the confidentiality clauses that may be included therein, in accordance with article 4 of the Act, paragraph 2.

Article 12.- The powers and authorizations set forth in this Act shall be effective as long as the sanitary emergency declared by law 27,541 and extended by decree 260/20, or the regulations extending it.

Article 12 bis.- Invite the Provinces and the Autonomous City of Buenos Aires to join the Regime provided for in Articles 8° bis to 8° decies of this Law.

(Article incorporated by art. 12 Decree No. 431/2021 B.O. 3/7/2021. Watch: from the day of publication in the OFFICIAL BOLETTER.)

Article 13.- This law will begin to govern from the day of its publication in the Official Gazette of the Argentine Republic.

Article 14.- Contact the National Executive.

IN THE SESSION OF THE ARGENTINE CONGRESS, IN GOOD AIRES, TO THE VETH DAYS OF THE OCTOBER OF THE YEAR DOS MIL VEINTE.

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CLAUDIA LEDESMA ABDALA DE ZAMORA - SERGIO MASSA - Marcelo Jorge Fuentes - Eduardo Cergnul

e. 06/11/2020 No. 53687/20 v. 06/11/2020