The Argentine Congress passed Law No. 27.573 declaring of public interest the research, development, manufacture, and acquisition of vaccines for coronavirus, within the health emergency framework established by Law No. 27.541.
For this purpose, the Congress ruled on three key issues to facilitate and promote the access to coronavirus vaccines in vast numbers and in short time in Argentina.
First, the Congress authorized and empowered the National Ministry of Health to conclude contracts. Further, the Ministry was entitled to sign all the previous and subsequent administrative acts aimed at the effective compliance of these, to modify their terms, and to include clauses in accordance with international market standards. The powers and authorizations established in the law will be in force during the sanitary emergency declared by the Congress.
Within this regulation, the Ministry is entitled to include in such contracts:
- Clauses deferring jurisdiction in favor of foreign arbitral and judicial courts waiving its sovereign immunity defense exclusively in respect of claims which may arise in that jurisdiction and in relation to such acquisitions. However, this waiver shall not imply any waiver of the immunity of the Argentine Republic in respect of the execution of certain goods mentioned in the law.
- Clauses establishing conditions of economic indemnity with respect to compensation and other pecuniary claims related to and in favor of those participating in the research, development, manufacture, provision and supply of the vaccines, with the exception of those originating from fraudulent maneuvers, malicious conduct or negligence on the part of the aforementioned subjects.
- Confidentiality clauses or agreements in accordance with the international market standards, Laws on Access to Public Information, on Patients' Rights, and concordant, complementary, and amending regulations. The scope of such clauses will be determined by supplementary regulations and should include the vaccine composition, as well as certain provisions outlined in the respective agreements.
Second, the government stipulated exemptions for the payment of import duties and any other tax, levy, contribution, rate or customs or port duty, of any nature or origin, including the value added tax, as well as from the constitution of a previous deposit for vaccines and disposables imported by the Ministry of Health, to ensure the supply of vaccines to generate acquired immunity against COVID-19. The same treatment will be given to any vaccine that may be acquired by the provinces and the City of Buenos Aires. These exemptions shall be applied to the imports of the goods mentioned therein for the exclusive use of the National Ministry of Health and the provincial health ministers.
Last, and pursuant to Decree 287/2020 and supplementary regulations, vaccines must be directly acquired by the National Ministry of Health. The National Ministry of Health shall also decide on the approval within a maximum term of thirty (30) days, prior to their use in the target population. The filing should be carried out through an emergency and summary procedure, with the due support of clinical and bioethical evidence which should clearly demonstrate the quality, safety and efficacy of the vaccines.
All contracts signed by the Ministry of Health should be afterwards submitted to the Social Action and Public Health Commission of the Deputies Chamber and the Health Commission of the Senate to guarantee full compliance with confidentiality clauses. For the same reason, all the contracts concluded should be sent to the National General Audit Office.