Key takeaway messages
- BMS is committed to minimizing the impact of drug shortages on patients and supports ongoing and balanced discussions with regulatory authorities and policymakers to address both anticipated and unanticipated drug shortfalls. To help ensure that patients have access to the medicines they need, BMS invests systematically in policies and processes to reduce the risk of product shortages. Since drug shortages usually result from complex interactions among many stakeholders, we believe careful consideration should be given to new regulations in this area to ensure a balanced and appropriate approach.
- BMS is committed to timely notification of drug shortfalls and working with regulatory authorities to maintain treatment options and limit shortages. In deciding what should be reported, we believe balance needs to be achieved in terms of an appropriate notification process. We support the appropriate use of national data repositories for monitoring inventory levels and identifying potential and actual shortages, as understanding the root cause of shortages is critical to addressing them.
- BMS supports efforts by regulatory authorities to look for ways to help reduce drug shortages by expediting re-inspections of plants, shortening the process for approving modified product specifications that can address shortage issues, and working through various raw material issues that could impact the industry.
- BMS encourages governments and payers to ensure appropriate reimbursement for essential medicines. This includes supporting market stability and sustainability, and implementing predictable and sustainable reimbursement and demand estimation policies that facilitate production planning. This also includes implementing tendering regulations that avoid extreme single-winner, price-only situations that create supply risk in the medium-term.