On November 6th 2020, Law No. 27,573 on vaccines designed to generate acquired immunity against COVID-19 (the “Law”) was published in the Official Gazette of the Argentine Republic.
The Law declares the research, development, manufacture and acquisition of the vaccines to be of public interest and authorises the Ministry of Health to include in contracts for the acquisition of vaccines intended to generate acquired immunity against COVID-19 (the “Vaccine”) – clauses that provide for:
- Extension of jurisdiction in favor of foreign arbitration tribunals and judicial courts with a waiver of the sovereign immunity defense (Art. 2)
Article 2 of the Law sets forth that the extension of jurisdiction mentioned above operates exclusively with respect to claims that may arise in that foreign jurisdiction and in relation to purchases made in such jurisdiction. Furthermore, it is established that “…In no case may the extension of jurisdiction be extended or included to third parties resident in the Argentine Republic, whether they are human beings or legal entities, who in all cases retain their right to resort to the local or federal courts of the country for matters arising or deriving from the application of these contracts”.
- Indemnity in respect of compensation and other pecuniary claims related to and in favor of those participating in the research, development, manufacture, provision and supply of the Vaccines (Art. 4)
The Law establishes that the exception to this indemnity with respect to compensation and pecuniary claims are those originated by fraudulent maneuvers, malicious conduct or negligence on the part of the aforementioned subjects.
- Confidentiality clauses or agreements in accordance with the international vaccine market (Art. 4 in fine)
The Law provides that these clauses must be included in the contracts in accordance with Law 27,275 on Access to Public Information, Law 26,529 on Patients’ Rights, and other related regulations, as amended and complemented.
In addition, the Law exempts from the payment of import duties and any other tax, levy, contribution, rate or customs or port duty of any nature or origin, including value added tax, as well as from the constitution of a previous deposit, Vaccines and disposables imported by the Ministry of Health, on behalf of and by order of the Ministry of Health, by the PAHO Revolving Fund or with exclusive destination to the Ministry of Health, which aim at ensuring the coverage of Vaccines. The same treatment will be given to any Vaccines that may be acquired by the Provinces and the Autonomous City of Buenos Aires.
Furthermore, it is established that the purchaser of the Vaccines must submit them to the National Administration of Drugs, Food and Medical Technology (A.N.M.A.T.) and must be authorized by the Ministry of Health, who shall issue the relevant authorizations within a maximum term of thirty (30) days, prior to their use in the target population.
In relation to the approval of the Vaccine and due to the exceptional nature of the pandemic context, the Law authorizes the competent authorities to carry out the emergency approval of the Vaccines covered by this law, with the due support of scientific and bioethical evidence that proves their safety and efficacy.
Finally, the Law clarifies that the powers and authorizations established therein shall be in force jointly with the health emergency declared by Law 27,541 and extended by Decree 260/20, as amended or extended.
This report cannot be considered as legal or any other kind of advice by Allende & Brea.
