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 USD 99.

1. Are there proposals for reform or significant change to the healthcare system?

TRANSPARENCY LAW (SIMILAR TO US SUNSHINE ACT)

A bill on transparency in the relationship between the pharmaceutical and medical devices industry and physicians was submitted in Congress. The purpose of this law is to provide patients with information regarding possible conflicts of interest that may affect the therapeutic decisions adopted by their physicians when prescribing products and treatments.

According to this bill, the manufacturers, importers and distributors of medical, biological and pharmaceutical products that grant and/or deliver goods, services, benefits or prizes susceptible of pecuniary valuation to physicians within the scope of the Argentine Republic, will need to report said situation to the health authority – Ministry of Health of the Nation – in order to give it due publicity.

CREATION OF THE ARGENTINE HEALTH TECHNOLOGY AGENCY (AGNET)

The imminent creation of the Argentine Health Technology Assessment Agency (AGNET after its acronym in Spanish) is a very sensitive issue for the local pharmaceutical industry since it will ultimately be the body that determines through certain studies and evaluations what medicines, medical devices, procedures, etc., will be incorporated into the set of benefits covered under the mandatory medical plan (PMO).

In addition, this rule specifically establishes that AGNET will be the consulting body in judicial proceedings where health issues are discussed.

Unusually the creation of the AGNET is proposed within the Labor Project Reform’s bill, which is currently at Congress for review.

2. When are they likely to come into force?

Both bills are currently under the analysis of the Congress and it would be reasonable to expect that these bills will be analyzed and voted on during 2018.