Company: GIFLF
Filing Date: 2025-04-11
Form Type: 20-F
Source: 0001104659-25-034245
Chunk: 141

Company: Grifols SA
Filing Date: 2025-04-11
Form: 20-F
Item: Item 4
Chunk 141
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 regulatory approval for commercial sale may suffer if the government and third-party payors fail to provide adequate coverage and reimbursement. Existing and future legislation could limit payments for our existing products or for drug candidates that we are developing, including possibly permitting the federal government to negotiate prices directly with manufacturers. This increasing emphasis on managed care in the United States has increased and will continue to increase the pressure on pharmaceutical pricing. For a discussion of certain risks related to reimbursement and pricing, see Item 3 of this Part I, “Key Information—D. Risk Factors—Risks Relating to the Healthcare Industry—United States Healthcare Reform may adversely affect our business.”

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European Union Pharmaceutical Pricing and Reimbursement
Our operations in the E.U. are subject to regulations that affect the pricing and market access of our products. The governments of E.U. Member States are able to regulate the price of pharmaceutical products through cost containment measures applied to national healthcare systems. As such, over the last decades, governments in the E.U. Member States have been introducing severe Health Economics and Outcomes Research (“HEOR”) criteria, a multidisciplinary field that studies the economic, clinical and societal impact of healthcare interventions, to limit increases in costs, particularly with respect to innovative prescription drugs. 
These HEOR criteria are being applied by Health Technology Assessment (HTA) organizations on a country basis, a process that evaluates the effects and impacts of health technologies and interventions to inform policy and decision-making in healthcare, and include cost-effectiveness analysis, budget impact models and added clinical benefits versus existing marketed (or in development) drugs being used as benchmarks for comparison to appraise the value proposition and determine the price and reimbursement levels. E.U. Member States are also seeking to limit healthcare expenditure by passing legislation and health policies to impose mandatory rebates for pharmaceutical products and financial claw-backs to the pharmaceutical industry. We expect that E.U. Member States will continue to pursue actions to reduce healthcare expenditures in the upcoming years.
Pricing and Reimbursement in Other Countries
Many countries around the world have been taking steps to control healthcare costs, particularly as they relate to prescription drugs. For example, in Asia, pharmaceutical pricing and reimbursement regulations vary significantly across countries, reflecting diverse healthcare infrastructures and economic conditions. In China, the government has implemented several reforms to control drug prices and improve access. The National Healthcare Security Administration (“NHSA”) oversees the centralized procurement of drugs, which has led to significant price reductions for many medications. In India, the National Pharmaceutical Pricing Authority (“NPPA”)