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Harnessing Regulation as a Competitive Lever: Strategy at the Intersection of Market Access, Pricing and Antitrust Exposure
Once viewed as a defensive, compliance-driven function, regulatory engagement is increasingly being integrated into broader corporate strategies for long-term product protection. In the context of MFN initiatives and intensifying commercial pressures, regulatory tools are becoming an important strategic lever for shaping market entry and influencing pricing dynamics, bringing regulatory activity into closer alignment with IP, competition and commercial decision-making.
Using FDA citizen petitions as a case study, this session will examine how often underutilised regulatory mechanisms can be deployed to influence market access and shape competitive positioning, and explore how these engagement tools intersect with IP strategy and antitrust risk.
- How are companies using regulatory tools, such as FDA citizen petitions, to complement IP strategy and support long-term product protection?
- To what extent can regulatory mechanisms be deployed to influence generic market entry without crossing the line into anti-competitive conduct?
- How does the timing and sequencing of regulatory interventions dictate competitive outcomes and antitrust exposure, particularly in the context of generic and biosimilar entry?
- How do regulatory strategies that influence competitive entry translate into pricing dynamics and broader market access outcomes?
- How are regulators, courts and competition authorities assessing and responding to the use of regulatory tools, such as citizen petitions?
Using FDA citizen petitions as a case study, this session will examine how often underutilised regulatory mechanisms can be deployed to influence market access and shape competitive positioning, and explore how these engagement tools intersect with IP strategy and antitrust risk.
- How are companies using regulatory tools, such as FDA citizen petitions, to complement IP strategy and support long-term product protection?
- To what extent can regulatory mechanisms be deployed to influence generic market entry without crossing the line into anti-competitive conduct?
- How does the timing and sequencing of regulatory interventions dictate competitive outcomes and antitrust exposure, particularly in the context of generic and biosimilar entry?
- How do regulatory strategies that influence competitive entry translate into pricing dynamics and broader market access outcomes?
- How are regulators, courts and competition authorities assessing and responding to the use of regulatory tools, such as citizen petitions?
Speakers
