AmCham warns that HZZO’s proposed regulation imposes administrative and financial burdens that may delay patient access to innovative drugs. It criticizes the requirement for a drug to be reimbursed in 10 EU countries as discriminatory. Concerns are also raised about undefined guidelines for cost-effectiveness analysis, increasing documentation costs, and lack of secure digital platforms. AmCham recommends withdrawing the draft and initiating a transparent and inclusive process with all relevant healthcare stakeholders.