New Law on Vaccines Intended to Generate Acquired Immunity against COVID-19

The Argentine Congress passed the Law on Vaccines Intended to Generate Acquired Immunity against COVID-19. 
 
On October 29, 2020, the Argentine Senate passed Law No. 27.573, governing Vaccines Intended to Generate Acquired Immunity against COVID-19, which the Argentine Executive later enacted through Decree No. 872/2020.
 
Law No. 27,573 declares of public interest the research, development, manufacture and acquisition of vaccines intended to generate acquired immunity against COVID-19.
 
The purpose of the Law is to confer to the Argentine Executive, through the National Ministry of Health (MoH), the  necessary powers and authorizations in agreements to acquire vaccines against COVID-19, in light of the pandemic declared by the WHO, and in the context of the Health Emergency declared by Law No. 27,541 and Decree No. 260/20.
 
Within its conferred powers, the MoH may include in vaccine acquisition agreements the following clauses:
 
Clauses that establish the change of venue to foreign arbitration and judicial courts (section 2). However, it stipulates that under no circumstances may the change of venue be made in favor of or include third parties who are residents of Argentina.
 
Clauses that establish the waiver of the sovereign immunity defense with respect to any claims that may arise in such jurisdiction and in connection with such acquisition. Such waiver does not imply surrendering Argentina’s immunity with respect to certain assets and goods, such as: (i) the Argentine Central Bank reserves, (ii) public domain assets in the national territory, (iii) private domain assets belonging to Argentina  (iv) assets inside and outside the national territory which provide an essential public service, and (v) taxes and/or royalties owed to Argentina, and Argentina’s right to collect them, among others (sections 2 and 3).
 
Clauses that set forth conditions of patrimonial indemnity regarding compensations and other pecuniary claims related to and in favor of those who participate in the research, development, manufacture, provision and supply of vaccines, except for those resulting from fraudulent maneuvers, malicious conduct or negligence by the aforementioned individuals (section 4).
 
Confidentiality clauses or agreements consistent with the international market of vaccines against COVID-19, in compliance with Law No. 27,275 on Access to Public Information, Law No. 26,529 on Patient’s Rights, as amended and complemented (section 4).
 
In addition, the Law authorizes the MoH to subscribe all prior and subsequent administrative acts to their effective compliance, and to include other clauses consistently with the international market of vaccines against COVID-19, for their acquisition (section 5).
 
On the other hand, the Law sets forth that imported vaccines and disposables that are intended to ensure coverage of such vaccines, will be exempt from paying: (i) import duties, (ii) taxes, fees, contributions, rates or customs or port duties, (iii) value added tax, and (iv) constitution of previous deposits. Such vaccines and disposables will be imported (a) by the MoH, (b) on behalf of the MoH, (c) by the PAHO Revolving Fund, or (d) exclusively for the MoH. This section will apply to the vaccines that may eventually be acquired by the provinces and the City of Buenos Aires (section 6).
 
Acquirers of vaccines regulated by this Law shall have the duty to submit them to the National Agency of Medicines, Food and Medical Technology for its intervention. The MoH must determine within a maximum period of 30 days whether the vaccines should be granted approval. In this sense, due to the exceptionality of the pandemic, competent bodies are authorized to carry out the emergency approval of the vaccine, provided it is duly supported by scientific and bioethical evidence that allows verifying its safety and efficacy.
 
The agreements entered into by the MoH for such purpose must be submitted to the National General Audit, and to the authorities of the Social Action and Public Health Commission of the Argentine Congress.
 
Finally, it establishes that the powers and authorizations conferred by this Law shall remain in force throughout the sanitary emergency, declared by Law No. 27.541 and extended by Decree No. 260/20.

Marval O’Farrell Mairal