country-illustration-argentinaRxTitle

Argentina

The pharmaceutical market in Argentina is expected to triple between 2012 and 2020, thus presenting an attractive opportunity for global industry players. Despite this, 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

Ministry of Health’s Superintendent of Health Insurance (SSS) is responsible for overseeing the three fragmented payers that make up the system:

1. El Estado – The Argentine government (el estado) covers approximately 40 percent of the population who otherwise would not possess health coverage. Services include vaccines, primary care, medicines, clinical studies, hospitalisation, surgery and other procedures. Coverage for both acute and chronic conditions ranges from 25 percent to 40 percent.

  • Certain programmes 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. 32 percent of the Argentinean population is covered under national OS plans, with 15 percent of citizens receiving provincial-level coverage, and eight percent covered under a special plan for retirees.

  • Depending on the specific case, medicines are reimbursed under the OS programmes at either the 40 percent, 70 percent or 100 percent level depending on the specific case and medical need.

3. Prepago – Private payers, including individuals and companies, which comprise eight percent of the population via one of 150 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 remainder is paid at point-of-service via coinsurance. Recent economic problems in Argentina have led to citizens favouring plans with low premiums and prepay, but much higher out-of-pocket expenditures in the instance that they do get sick. This has further exasperated existing public health concerns in the country as patients try and avoid treatment to avoid their 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 (120 BUSINESS DAYS)

  1. Applicant files new drug submission with ANMAT
  2. Director of Drug Evaluation completes evaluation of dossier for safety, efficacy and quality
  3. Legal Department conducts evaluation, ensures evidence of commercialisation, reviews Certificate of Pharmaceutical Product
  4. Technical Secretariat conducts provision check
  5. Dispatch Department assigns date and number to Provision
  6. ANMAT approves and grants market authorisation

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 (30-60 BUSINESS DAYS*)

1. Applicant sends funding request to the appropriate payer

2. Processes diverge:

a. Public health payer negotiates with sponsor
b. National Health Maintenance Organisations negotiate with applicant
c. Provincial Health Maintenance Organisations negotiate with applicant
d. For retirees, the Programa de Atención Médica Integral (PAMI) negotiates with applicant
e. Private insurance payer negotiates with sponsor

3. Payer authority makes funding decision

*Allow 45-60 business days for public funding decision, 30-45 days for OS (social) insurance, and 30 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 similar to 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 by 2018. 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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