A recent position paper published by IFPMA, the International Federation of Pharmaceutical Manufacturers and Associations, proposed a new comprehensive, end-to-end approach to the development and approval of medicines and vaccines, known as the Innovation Development and Access Pathway (IDAP). The proposal also seeks to align policies, incentives, and stakeholders throughout the entire R&D process. It is based on the identification of four common phases applicable to all product types, regardless of the specificities encountered in different countries or among various stakeholders.
The analysis has been commissioned by IFPMA to IQVIA to identify critical bottlenecks and barriers that slow patient access to innovative treatments, particularly in lower-resource settings. The resulting integrated pathway would avoid siloed steps and ensure better alignment of science, predictable regulatory and HTA processes, financing, and tailored country-level implementation.
Common steps across different local contexts
The four core areas identified by the IDAP model include R&D activities within the innovation ecosystem and regulatory activities related to product registration and lifecycle management. Countries differ significantly in clinical research infrastructure and data ecosystems, which can affect the ability to conduct early-stage trials. Suggested common activities could include the targets’ identification and validation, and the generation of proof-of-concept data in early discovery. Demonstrating safety and efficacy remains the primary goal of clinical development. According to the IDAP model, this could be achieved through phased trials with adaptive design, supported by biomarker development and the availability of a pivotal data package as the final output.
At the regulatory level, the maturity of local pathways may vary, for example, in the implementation of reliance mechanisms and harmonised reviews to speed the process and reduce the time-to-market. Rolling submissions, reliance and/or recognition, and accelerated pathways are suggested tools to achieve marketing authorisation. HTA early dialogue and cost-effectiveness modelling could help establish the value and reimbursement terms across different countries.
As for patient access, the IDAP pathway focuses on listing to help countries prioritise products that meet population needs within their specific health system structure. Other important elements of the framework at this level include treatment guidelines, payment and reimbursement policies, and procurement. Market-access mechanisms, such as inclusion in national formularies, vary widely across countries, while value-based procurement and HTA are processes more typical of high-income settings.
The final common area concerns the delivery of health services, including the scale-up of manufacturing, cold supply chains and logistics, the availability of a trained workforce, diagnostics and increased use of point-of-care solutions. This area is affected by differences in public health insurance coverage, the robustness of the supply chain and workforce capacity.
Based on these considerations, the IDAP does not propose a one-size-fits-all solution, but instead emphasises the need for clear policy alignment, accountability and data-driven, quantitative measurement of implemented actions.
Key enablers to align policies
The IDAP framework also identifies key enablers across the core areas: when integrated at the national and regional levels, they should help accelerate access to innovation. These enablers should also serve as focal points for stakeholders to be considered during negotiations and reforms of existing frameworks.
For R&D and innovation ecosystems, incentive mechanisms should include advanced market commitments to support investment in high-need and commercially challenging areas. Incentives and technology diffusion should be balanced by a robust legal and IP framework. Clinical research structures would be needed to ensure local trial capacity and evidence generation, while access to data would avoid duplication of efforts.
In the regulatory domain, harmonisation would again reduce duplication and heterogeneity in decisions. Improved regulatory reliance would enable countries to trust assessments by other regional authorities without the need to relocate the full review. The IDAP vision suggests adaptive regulatory pathways, including conditional approvals and rolling reviews, to achieve rapid authorisation. Standardised core data sets and endpoints for priority disease areas may be other useful tools to facilitate cross‑jurisdictional comparability.
The lists of essential medicines and clinical guidelines should be dynamically updated to reflect the evolution of the disease burden and advances in the scientific and technological domains. Therapeutic value and payments should be aligned through value-based procurement, depending on the country.
Finally, healthcare systems should be strengthened through increased funding, new infrastructure, and improved logistics. Sustainable access programmes should consider innovative payment models and capacity building to ensure long‑term access.
Typical friction points and how to address them
IFPMA identifies several points that may cause friction between stakeholders. Misaligned expectations regarding the evidence provided are a typical example, with regulators and HTA bodies sometimes requesting different endpoints and data from those provided. Early multi-stakeholder scientific advice and joint evidence planning would help harmonise requirements and reduce duplication of studies. This process should be supported by the availability of national and regional coordination platforms for early stakeholders’ dialogue.
HTA and regulatory expertise might be strengthened by the creation of twinning, training, and regional centres of excellence. In the HTA domain, the IDAP vision also suggests creating clear, published decision criteria for regulators and HTA bodies, and using data-sharing agreements to balance the confidentiality of commercial information with public health needs.
On the other side of the lifecycle pathway, access may be hindered by the high prices characterising breakthrough products, compared with the often strict budgets of healthcare systems. The IDAP approach suggests using outcome‑based agreements and pooled procurement/regional purchasing to align pricing with the demonstrated value of products while safeguarding the security of supply and budget impact. Annuity payments and risk-sharing agreements are among other possible solutions suggested by the IDAP.
Once on the market, according to IFPMA, the lack of adequate real-world evidence (RWE) is limiting the possibility of reassessing products to expand indications. The expanded use of registries and interoperable data systems, as well as pragmatic trials to better address the relevance to local populations, would be useful under the IDAP approach to generate actionable RWE. This would also support real-time pharmacovigilance and post-marketing surveillance. Healthcare systems could also consider task-shifting and decentralised care models to improve access when specialist capacity is limited.
