Regulatory trends in drug pricing and market access in Argentina

Ana Andrés
Beccar Varela, Buenos Aires
aandres@beccarvarela.com

Introduction

Given the longstanding financial constraints faced by Argentina’s healthcare system and the country’s ongoing economic fluctuations, issues related to drug pricing and market access continue to be highly relevant to the local market and a matter of continuing debate. More recently, these discussions have been driven by major advances in medicine that have led to the development of innovative therapies, such as biological drugs, gene therapies and precision medicine, treatments that are typically extremely expensive and, therefore, are difficult for patients to access, and which healthcare insurance providers, otherwise known as healthcare payers, are often reluctant to reimburse or cover.

Argentine healthcare system and coverage

Argentina’s healthcare system is a complex network involving multiple stakeholders with diverse interests and different levels of regulation. Broadly speaking, the system comprises three subsystems: public, private and social security.

The public subsystem, whether national or provincial, provides healthcare coverage to individuals with no other coverage. The private sector consists of private companies, so-called prepaid medicine companies, offering coverage to those who pay for such services. The social security sector includes national and provincial healthcare insurance entities (obras sociales) and the National Institute of Social Services for Retirees and Pensioners, with beneficiaries including workers whose contributions fund such services, as well as retirees and pensioners.

To define the minimum healthcare services that payers must provide, the Mandatory Medical Programme (El Programa Médico Obligatorio or PMO) was introduced in the early 2000s. The PMO is a basic benefits package, referred to by the courts as the minimum service floor, that all healthcare payers are required to cover. It includes various medications, studies, analyses and treatments.

Additionally, specific laws mandate coverage for treatments, medications and studies related to particular conditions, such as HIV, cystic fibrosis and rare diseases.

Drug pricing and market access

As a general rule, pharmaceutical companies are free to set the prices of their products based on their own drug pricing and market access strategies.[1]

However, drug pricing and market access involve more than merely setting a price that allows for research and development (R&D) cost recovery or revenue maximisation. It is essential that patients can access these medications; otherwise, medicinal products will not be sold and patients will not reap the benefits.

To that end, laboratories typically enter into agreements with various healthcare insurance providers to offer discounts to the beneficiaries of those payers for certain products. These agreements stipulate the terms for discounts on medications and in regard to reimbursement processes.

In the case of major payers, such as the National Institute of Social Services for Retirees and Pensioners and the Buenos Aires province social security provider (IOMA), these agreements are negotiated through industry chambers that represent pharmaceutical companies.

Outside of these agreements, some medications or treatments are not usually covered by payers, who argue that the treatments are not included in the PMO or in their benefit plans. This also applies when treatments involve medications not yet registered in Argentina, but that are available in countries with high regulatory standards, particularly in the case of orphan drugs.

Pharmaceutical companies marketing high-cost medications often attempt to negotiate special pricing agreements with payers to ensure patient access, but these agreements tend to be highly complex and specific and are not always successfully concluded. During these negotiations it is crucial for laboratories to demonstrate the value of the product to payers and its cost efficiency.

When a payer refuses to cover a prescribed treatment or drug, patients often resort to the courts through the use of expedited legal proceedings, known as amparos. These processes aim to ensure swift resolutions and are typically based on the constitutional right to health, requesting that a judge orders the payer to cover the cost of the prescribed treatment.

This legal pathway enables patients to access medications or treatments that would otherwise be prohibitively expensive.

Health technology assessment and CATPROS

The other side of this equation involves health technology assessment agencies.

Since 2018, Argentina has had a National Commission for Health Technology Assessment and Clinical Excellence (La Comisión Nacional de Evaluación de Tecnologías Sanitarias y Excelencia Clínica or CONETEC), which was initially created under the Ministry of Health via Resolution 623/2018.[2] In 2023, CONETEC was re-established by Decree 344/2023[3] as a decentralised agency under the Secretariat for Healthcare Access. Its role is to evaluate health technologies and issue evidence-based recommendations for their adoption, removal, use, funding and coverage, taking into account ethical, medical, economic and social dimensions.

While these recommendations are addressed to the healthcare system as a whole, to facilitate the definition in regard to which technologies should be included in the public healthcare system or covered by public/private healthcare insurance providers, such recommendations are only binding on the national Ministry of Health and its decentralised agencies, and not on other actors involved in the healthcare system.

Also, in 2023, in response to the increasing number of health-related legal claims, the Technical Advisory Council for Judicial Health Proceedings (Consejo de Asistencia Técnica para Procesos Judiciales de Salud or CATPROS) was created by Decree 468/2023.[4] CATPROS is a permanent advisory body that intervenes only at a judge’s request and produces non-binding reports. Its aim is to provide updated, objective technical information in cases involving claims for innovative drugs, treatments or health technologies for the treatment of rare diseases, in support of judicial decision making.

The current outlook

In recent years, various bills have been introduced in the National Congress of Argentina to establish an autonomous national health technology assessment agency, distinct from CONETEC. However, no official debates have taken place in this regard.

Recently, the national government announced[5] its intention to create, in light of the absence of congressional approval for such a health technology assessment agency, the National Agency for the Evaluation and Financing of Health Technologies (Agencia Nacional de Evaluación de Financiamiento de Tecnologías Sanitarias or ANEFiTS), which would replace both CONETEC and CATPROS.

According to the government’s official statement, the new agency would be responsible for evaluating new drugs, devices, diagnostic tools and other health-related procedures to determine, based on scientific rigor, which technologies are safe, effective and efficient, the appropriate timing and method of their use and the benefits they offer, before initiating the product registration process. Although the enabling decree has not yet been published, and the scope of the new agency remains unclear, the government has stated that it will work in coordination with the National Administration of Drugs, Food and Medical Devices (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica or ANMAT) on the matter.

The agency is expected to consider not only clinical outcomes in its cost–benefit analyses, but also factors such as quality, efficacy, safety, efficiency, equity and the ethical, medical, economic and social value of new technologies. This announcement has generated both uncertainty and anticipation across the pharmaceutical industry, which awaits the official decree to better understand the potential implications for drug pricing and market access.

Conclusion

The potential creation of a new national health technology assessment agency represents a significant shift in Argentina’s regulatory landscape and could become a turning point for the pharmaceutical industry. Although its regulatory framework and operational scope have yet to be defined, closely monitoring its development will be key to aligning market access strategies with a more structured and evidence-based decision-making environment.

Notes