Presentation (CTI)

OBJECTIVES: Many countries introduced spending caps on pharmaceuticals. While this policy may improve short-term cost control, it favors silos budgeting approach and undermines market launch in Europe, should the possible associated paybacks be included in the MFN cross-reference pricing system. No evidence review of its impact on research, development and production (RDP) localization has been carried out so far. This paper aims at covering this information gap through a systematic literature review.
METHODS: Two independent investigators conducted a literature search on Pubmed, Scopus and Web of Science from inception to April 2026, through four sets of keywords, reflecting the dimensions of interest, and specific inclusion and exclusion criteria. As from preliminary research a lack of evidence on our specific research question emerged, the content eligibility criteria were broadened, considering studies that have generally investigated the determinants of RDP investments allocation. Discrepancies were discussed by the two authors to reach a consensus.
RESULTS: 20904 records were retrieved. After removing duplicates, abstract and full text screening 39 articles were identified (25 and 14 from primary selection and citations respectively). The review highlighted a lack of evidence that correlates spending caps on pharma with RDP allocation. Beyond incentives and efficiency of trial systems, a tough price control and unstable/unpredictable/uncertain (i.e. not structured) market access regulation may have an impact on RDP investments allocation.
CONCLUSIONS: There is no direct evidence on the impact of spending caps on pharmaceuticals on RDP investments allocation yet. Notwithstanding, policy makers and payers should consider the indirect effects of these caps on variables that may influence this location, namely the impact of associated paybacks on actual prices and a non-structured and top-down (i.e. without any interaction with the stakeholder) definition of the spending caps.