For decades, regulators and payers have operated in parallel worlds. Regulators judged safety and efficacy. Payers judged value and affordability. Between them sat a gap large enough to stall innovation. In today’s complex environment, that separation no longer works.
The pace of scientific advancement — from gene therapies to digital diagnostics — is outstripping the ability of traditional systems to evaluate and fund innovation efficiently. When regulatory approval arrives years before payers have the confidence to reimburse, patients wait, markets stall, and innovation loses momentum.
The future depends on closing that gap through structured collaboration.
From Sequential to Parallel Thinking
The old model was linear. A product moved from lab to clinic to regulator to payer, one step at a time. Each agency had its own data requirements and timelines. But when data packages overlap by 80 percent, duplication becomes waste.
A handful of forward-thinking countries are now experimenting with joint scientific advice and parallel review processes. These initiatives bring regulators and payers into early dialogue with developers. They discuss endpoints, comparators, and evidence expectations before trials even start. The result is better-aligned data, faster decisions, and reduced uncertainty.
The challenge is scale. Coordination across multiple agencies, each with its own remit and political context, is complex. But without it, we will continue to penalise innovation with inefficiency.
Managing Uncertainty Together
Most regulatory frameworks are designed for certainty. However, the most thrilling innovations frequently commence with uncertaint, limited groups, new methods, few points of comparison. Regulators may approve these products conditionally, but payers hesitate, fearing budget exposure without long-term data.
Joint models of managed entry can change that. By linking conditional approval with adaptive reimbursement, both sides share responsibility for evidence generation and re-evaluation. In oncology, this approach has already accelerated access to promising treatments while maintaining accountability.
A Culture Shift in Evaluation
Collaboration requires a change in mindset. Regulators must understand health economics. Payers must understand regulatory science. Each must see the other not as a gatekeeper but as a partner in societal value creation.
The key is shared evidence infrastructure — common registries, interoperable real-world data, and transparent outcome reporting. Without shared information, collaboration remains rhetoric. With it, it becomes the foundation of a smarter, faster system.
The Global Opportunity
Cross-border cooperation could also unlock efficiency. The European Medicines Agency’s collaboration with national HTA bodies is an early sign of progress. As emerging markets strengthen their own regulatory capacity, global alignment on evidence standards could reduce duplication and speed patient access worldwide.
The Bottom Line
The future of access depends on partnership. Regulators protect safety. Payers protect sustainability. Between them lies the possibility of balance — if they move from coexistence to co-creation.
Key Takeaways
- Sequential evaluation slows innovation; parallel collaboration accelerates it.
- Shared data and early dialogue reduce duplication and uncertainty.
- Managed entry agreements align regulatory and payer risk.
- A shared evidence culture enables continuous learning.
- Collaboration is not compromise; it is evolution.
Try This
If you work in development or access, identify where payer expectations diverge from regulatory ones in your current portfolio. Propose a cross-functional session to map common evidence needs.
Closing Thought
Share this with colleagues in regulatory or access policy. The future of sustainable innovation depends on how well these two worlds finally meet.
