Argentina: COVID-19 - Argentina passes law allowing indemnity clauses in contracts with manufacturers of the Covid-19 vaccine

In brief

Argentina is set to join with a new law the list of countries that have approved regulations to favor and accelerate the research, development and acquisition of Covid-19 vaccines. In a recent law approved by the Senate (which has yet to be promulgated by the President), broad and exceptional powers have been granted to the National Executive Power (the "Executive") to negotiate the expedited purchase of such vaccines. The law authorizes to extend jurisdiction in favor of foreign judicial and arbitration tribunals and to agree to indemnities in favor of the entities that have developed or that sell the vaccines to the Executive. In addition, an exceptional procedure for the emergency regulatory approval of such vaccines was enacted.


Contents


In depth

The pandemic has affected the world in multiple ways, and impact on the legal landscape is no exception. Legislators and regulators have had to adopt rapid measures to address the various problems that have arisen and offer the population access to therapies and vaccines quickly guaranteeing, at the same time, safety and efficacy. The Argentine Republic has joined this trend, the most recent example being the passing by the Senate, on October 29, 2020, of a law that grants broad powers to the Executive in its negotiations to acquire vaccines against Covid-19 (“Vaccines”).

The following are some of the most relevant aspects of the law:

Public interest. Declares of public interest the investigation, development, manufacturing and acquisition of vaccines destined to generate immunity from Covid-19.

Extension of jurisdiction, indemnity, confidentiality and other exceptional clauses to buy the Vaccines. The Executive is authorized to purchase the Vaccines through the accelerated purchasing regime approved during the pandemic (Executive Order 260/2020 and related regulations), and is expressly allowed to include various exceptional clauses in the contracts. These clauses are (i) extension of jurisdiction in favor of judicial and arbitration courts abroad, (ii) waivers of the defense of sovereign immunity, (iii) indemnity (except for fraud, malice or negligence) regarding monetary claims related to and in favor of those who participate in the research, development, manufacture, provision, and supply of Vaccines, (iv) confidentiality, and (v) other clauses according to the international market.

Tax exemptions. Exempts from the payment of import duties and any other tax, levy or contribution, of any nature or origin, Vaccines and disposables imported by the Ministry of Health or on behalf and order of the Ministry of Health, the provinces and the City of Buenos Aires.

ANMAT's emergency approval. The National Administration of Drugs, Foods and Medical Devices ("ANMAT") is authorized to carry out the emergency approval of the Vaccines through a summary procedure if certain requirements are met.

Term. The powers and authorizations under the law will be in effect for the duration of the health emergency caused by Covid-19.

Around the world, authorities have taken different approaches and, in general terms, they can be grouped into countries that already had regulations for products approved in emergency situations or countries that are beginning to regulate specific issues of products and vaccines. related to Covid-19 (as is the case of Argentina), or those that, for the time being, have not yet adopted regulations of this type, but have included indemnity clauses in their agreements with the Vaccines manufacturers.

Of particular relevance is the authorization for the Executive to include exceptional clauses (which usually require legislative approval) in the contracts for the purchase of Vaccines, such as extension of jurisdiction, and confidentiality and indemnity. These clauses may pose multiple legal and commercial challenges related to implementation and enforceability, in particular due to the existence of other legal regimes and case law with which they will coexist and which could result in claims or challenges (for example, legislation and jurisprudence regarding access to public information, transparency, patient rights, competition, commercial loyalty, supply and consumer protection).

According to the procedure established in the National Constitution, the President must promulgate or veto the law within 10 days. Although the law does not expressly require it, the Executive could regulate various additional issues not established under the law.

Read alert in Spanish


Copyright © 2023 Baker & McKenzie. All rights reserved. Ownership: This documentation and content (Content) is a proprietary resource owned exclusively by Baker McKenzie (meaning Baker & McKenzie International and its member firms). The Content is protected under international copyright conventions. Use of this Content does not of itself create a contractual relationship, nor any attorney/client relationship, between Baker McKenzie and any person. Non-reliance and exclusion: All Content is for informational purposes only and may not reflect the most current legal and regulatory developments. All summaries of the laws, regulations and practice are subject to change. The Content is not offered as legal or professional advice for any specific matter. It is not intended to be a substitute for reference to (and compliance with) the detailed provisions of applicable laws, rules, regulations or forms. Legal advice should always be sought before taking any action or refraining from taking any action based on any Content. Baker McKenzie and the editors and the contributing authors do not guarantee the accuracy of the Content and expressly disclaim any and all liability to any person in respect of the consequences of anything done or permitted to be done or omitted to be done wholly or partly in reliance upon the whole or any part of the Content. The Content may contain links to external websites and external websites may link to the Content. Baker McKenzie is not responsible for the content or operation of any such external sites and disclaims all liability, howsoever occurring, in respect of the content or operation of any such external websites. Attorney Advertising: This Content may qualify as “Attorney Advertising” requiring notice in some jurisdictions. To the extent that this Content may qualify as Attorney Advertising, PRIOR RESULTS DO NOT GUARANTEE A SIMILAR OUTCOME. Reproduction: Reproduction of reasonable portions of the Content is permitted provided that (i) such reproductions are made available free of charge and for non-commercial purposes, (ii) such reproductions are properly attributed to Baker McKenzie, (iii) the portion of the Content being reproduced is not altered or made available in a manner that modifies the Content or presents the Content being reproduced in a false light and (iv) notice is made to the disclaimers included on the Content. The permission to re-copy does not allow for incorporation of any substantial portion of the Content in any work or publication, whether in hard copy, electronic or any other form or for commercial purposes.