Regulatory Reforms
/ Argentina
An insight into upcoming regulatory reforms affecting Argentinian pharma. Prepared in association with Marval, O’Farrell & Mairal, a leading global law firm, this is an extract from The Pharma Legal Handbook: Argentina, available to purchase here for GBP 119.
1. Are there proposals for reform or significant change to the healthcare system?
There are no proposals for reform or significant change of the healthcare system in the short term. Nonetheless, due to the COVID-19 pandemic, several new regulations and laws have passed. A proposal for a significant change to the healthcare system is Bill No. 0101-S-2020 on telehealth, already approved by the Senate. Such bill seeks to promote the provision of medical assistance services to the population through telemedicine networks that allow remote patient care. It establishes a regulatory framework for consultations by electronic means to improve people’s accessibility to the system and the quality of care, avoiding unnecessary or prohibited transfers, even after the COVID-19 pandemic.
The new telemedicine law will cover, if approved by both Chambers, all agents and providers of the National Health Insurance System and prepaid medicine companies, who will have to adapt their medical assistance services.
In this context, in March 2022 the Ministry of Health issued the Telehealth Good Practices that shall apply to virtual medical visits at the public, private and social security sector (MoH Regulation No. 581/2022).
Creation of the Argentine Health Technology Agency (AGNET)
The creation of the AGNET is a very sensitive issue for the local pharmaceutical industry since it will ultimately be the body that determines through certain studies which medicines, medical devices, procedures, etc., will be incorporated into the set of benefits for their financing and/or coverage (currently, under CONETEC’s scope).
The bill No. 0002-S-2022 specifically establishes that AGNET may intervene and will be the consulting body at judicial proceedings where health issues are discussed.
The creation of the AGNET is currently at Congress for review (it was filed on March 2022).
2. When are they likely to come into force?
There is no specific date for these laws to come into force. The voting date for these bills has not been appointed yet.
