BURLINGTON, Mass., May 30, 2013 /PRNewswire/ -- Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that several barriers impede market access but the regulatory landscape in Argentina is changing and attractive opportunities exist for multinational pharmaceutical companies. After first adopting new guidelines for biological products, biosimilars, enfermedades poco frecuentes (rare diseases) and blood products of biological origin, Argentina then established the first 50 tecnologias sanitarias emergentes (emerging health technologies) for catastrophic diseases. The intent is to use health technology assessment in cost-effectiveness analyses and decision making but the operational processes needed to meet these goals are not yet transparent or well-developed.
The Argentina: Market Access Tracker service finds that in 2013, the Argentine government added more than 200 additional drugs to the National Drug Traceability System, which track all drugs listed in the Registro de Especialidades Medicinales (Register of Medical Specialties), and will require that agents of the National Health Insurance must certify the authenticity and traceability of drugs submitted for reimbursement. In addition, new reimbursement requirements from the Sistema Unico de Reintegro (Uniform Reimbursement System) have been established for catastrophic diseases, which are those diseases of low incidence and high economic impact that require long term treatment.
The findings also reveal that the research-based pharmaceutical industry continues to exert pressure on Argentina to strengthen the country's intellectual property protection and enforcement. Patent backlogs and approval delays, lack of regulatory data protection and new guidelines that restrict the scope of patent eligible subject matter for biopharmaceutical inventions are cause for concern.
"In our new commercialization outlook, we have identified 16 key factors that are important for pharmaceutical market access in Argentina. Latin America is quite diverse with many different cultures, regulatory systems and markets but despite significant market access barriers, multinational companies interested in this region will likely want to include Argentina in their basket of growth markets," said Decision Resources Analyst Lulu Pickering, Ph.D. "The Argentine pharmaceutical market accounts for about 13 percent of the Latin American pharmaceutical market, making it an important target for multinationals interested in the LATAM region of about 600 million people."
About Market Access Tracker
Market access is critical to a drug's commercial success, but it presents many challenges as payers are increasing prelaunch and post-marketing obstacles, causing the market access environment to be in constant flux. Market Access Tracker's timely analysis of key events in emerging and mature markets, regular webinar updates and access to our team of experts will equip biopharmaceutical companies with the insight they need to evaluate the implications of the latest changes for their business and to assess the commercial outlook in each market.
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SOURCE Decision Resources