Argentina

Despite slowing growth in the sector due to economic problems and the COVID-19 pandemic, Argentina’s pharmaceutical market still ranks third in Latin America in terms of overall size, thus presenting an attractive opportunity for global industry players. However, multinational manufacturers face strong competition from robust Argentine competitors, which hold over 50 percent of the market share.

In Argentina, healthcare and medicines are delivered through a fragmented combination of systems that include the public sector, the private sector, and workers’ unions, all overseen by the Ministry of Health (MINSAL). Despite the government’s guarantee of universal coverage, there is no single governmental payer or roadmap to deliver medicines and health services. Considering the array of different parties with which to negotiate reimbursement, learning to “tango” with the Argentinian healthcare system can appear to be an overwhelming challenge.

Argentina’s Payer Stakeholders

There are three main payers that make up the system. The Ministry of Health’s Superintendent of Health Insurance (SSS) is responsible for overseeing national social and healthcare services and private health coverage.

    1. El Estado – The Argentine government (el Estado) covers approximately 36 percent of the population who otherwise would not possess health coverage. Services include vaccines, primary care, medicines, clinical studies, hospitalization, surgery, and other procedures. Coverage for both acute and chronic conditions ranges from 25 percent to 40 percent.
        • Certain programs within the government-run system, including “Remediar” (Remedy), cover 100 percent of medicines, as do funds that focus on specific pathologies.
    2. Obras Sociales (OS) – This union-backed health insurance for workers is co-financed by employers and employees. 64 percent of the Argentinean population is covered under OS plans, national, provincial-level coverage, and PAMI (National Institute of Social Services for Retirees and Pensioners), the largest health insurer for elderly people of Latin America.
          • Depending on the specific case, medicines are reimbursed under the OS programs at either 40, 70 or 100 percent, depending on the specific case and medical need.
    3. Prepago – Private payers, including individuals and companies, which comprise 13 percent of the population via different health plans offered by insurers. The top five private plans cover approximately 60 percent of this “pre-paid” (or prepago) market segment.
          • 56 percent of total private spending goes into prepayment (typically monthly).

The Programa Médico Obligatorio (PMO, or Compulsory Medical Program) establishes the basic health services that Obras Sociales and Prepago sectors must guarantee under law.

The remainder is paid at point-of-service via co-insurance. Recent economic problems in Argentina have led to citizens favoring plans with low premiums and prepay, but much higher out-of-pocket expenditures should they get sick. This has further exasperated existing public health concerns in the country as patients try and avoid treatment to avoid high co-pays for public insurance and potentially high out of pocket expenditures for private insurance.

Important Points to Keep in Mind

Under the Ministry of Health, the National Administration for Medication, Disease and Medical Technology (ANMAT) is the national regulatory agency that approves new medicines. In addition, local jurisdictions can dictate their own specific requirements for approval alongside the national regulations.

ANMAT REVIEW PROCESS 

While the synthetic drug evaluation process can take on average 80-180 days, the biologic drug registration process can last up to 210 business days. In the case of specialty medicines or when a drug is imported from a country with high safety standards, an abbreviated registration process can be used. After a product is approved, the company must seek reimbursement with the fragmented health systems independently. ANMAT provides health technology assessment (HTA) documentation to guide agencies’ decision-making on certain drugs and devices from a cost-effectiveness perspective, but these documents are not mandatory.

REIMBURSEMENT/FUNDING PROCESSES

Reimbursement processes vary according to the payer and can take between 60-120 business days to process.*

*Reimbursement timelines: 120 business days for public funding decision, 45-60 days for OS insurance, and 30-45 days for private insurance funding decision.

Implications for Industry

The fragmented schemes that make up the Argentine health system often result in payers denying the appropriate or desired level of reimbursement for certain prescription drugs. In this case, the appeals process can include court action, in a manner like Argentina’s neighbor, Brazil. In addition, Argentinean law provides limited patent protection, and requires that drugs be marketed under generic names based on the principal ingredient, making it difficult to introduce branded innovative products into the market.

Due to the recent economic environment and inefficient administration, the Argentinean government has delayed making payments owed to manufacturers. This causes industry to raise drug prices, which impacts the payers who are unable to afford innovation. As a result, legislation has been drafted in Parliament to establish a new HTA agency. In 2018, CONETEC (National Commission for the Evaluation of Health Technologies) was created to carry out evaluations and issue recommendations to the health authority on the incorporation, form of use, financing and coverage policies of health technologies. While CONETEC falls under the Ministry of Health, it is comprised of a diverse range of government and institutional stakeholders, as well as patient associations. The reports and recommendations of this commission are available to the public. CONETEC can intervene as a consulting body in any instance where issues related to these issues are discussed, including judicial processes.

Argentina’s varied and diverse pathways to market access and reimbursement are too challenging to tackle with just one strategy, and thus your value communication story and strategy must be designed to reach multiple stakeholders.

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