Medicines and vaccines can deliver major gains in prevention and treatment, yet access is often delayed or uneven once products exist. Bottlenecks arise across a linked sequence of steps, where barriers in one phase can cascade into shortages, higher costs and reduced availability at the point of care. The Innovation Development and Access Pathway (IDAP) frames access as an end-to-end route from early research and development through regulatory approval and then through listing, reimbursement, procurement and health service delivery. By presenting access as a pathway rather than a single decision, the framework clarifies how incentives, regulation, financing and system capacity interact to shape whether patients receive medicines and vaccines in appropriate volumes and without avoidable delay.
Incentives and Research Capacity Influence What Is Developed
IDAP describes research and development (R&D) as long, expensive and uncertain. Bringing one new medicine or vaccine from initial discovery to regulatory approval takes 10-15 years on average, with an average cost of USD 2.6 billion (EUR 2.4 billion) when failures are included. Attrition is high, with one or two out of every 10,000 compounds synthesised in laboratories progressing through all stages required to reach the market, equivalent to 0.01% or 0.02%. Despite this, the global pipeline remains sizeable, with over 12,700 medicinal products in development.
The pathway highlights that investment incentives are uneven. Economics can be insufficient to attract investment for products sold mainly in lower-income countries, including those addressing malaria, tuberculosis and neglected tropical diseases. Similar constraints arise where demand is unpredictable, including antimicrobial resistance (AMR) and preparedness against future pandemics, which can deter private investment needed for late-stage trials, regulatory work and manufacturing capacity. IDAP points to mechanisms intended to de-risk development, including product development partnerships and advance market commitments. It also emphasises that countries with stronger clinical research ecosystems, supported by infrastructure and a clear link to access pathways, can enable more inclusive trials and support faster adoption of therapies that better reflect population needs.
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Regulatory Requirements Can Extend Timelines and Constrain Supply
Regulatory approval and life cycle management are presented as essential to assuring quality, safety and effectiveness, including oversight after registration. IDAP also underlines that requirements need to be proportionate, since excessive or duplicative processes can add time and cost that delay access. Limited institutional capacity, fragmented processes and divergent national requirements are described as persistent constraints.
The pathway provides examples of procedural requirements that can slow registration. Post-approval updates can be delayed where local rules are not aligned with international standards, contributing to backlogs and additional workload for regulators and companies. IDAP notes that post-approval changes may trigger further sampling requirements, creating additional delays and potential supply disruption.
Supply resilience is also affected where some countries require separate registration for each manufacturing site for the same product, reducing flexibility to shift production when demand changes or disruptions occur. Registering multiple sites under a single licence, in line with World Health Organization (WHO) guidance, is presented as supporting more resilient supply. Regulatory reliance, where authorities leverage assessments and approvals from trusted regulators, is described as a route to reducing timelines and limiting duplicative, country-specific requirements.
Listing, Reimbursement and Delivery Drive Point-of-Care Access
After market authorisation, IDAP links access to listing, clinical guidance, procurement and payment or reimbursement, followed by delivery through health services. Listing may be managed through multilateral or regional organisations, national public authorities, private healthcare authorities, hospitals or pharmacies. The WHO Essential Medicines List (EML) is presented as a reference point for resource-limited settings, while national Essential Medicines Lists (nEMLs) and clinical guidelines are framed as pivotal for consistent uptake.
IDAP highlights slow updating and limited coverage of recently launched products. None of the nEMLs reviewed included more than 21 recently launched products, and more than half were updated before 2019. Reimbursement is positioned as critical to reducing out-of-pocket (OOP) spending and supporting universal health coverage (UHC), yet coverage for newer products is limited in many low-and middle-income countries (LMICs). Only one-third of recently launched products were included in public reimbursement systems in any of the LMICs studied, and only 13% were reimbursed in more than one country. More established products were reimbursed at higher rates, with two countries covering about 50%. Health technology assessments (HTAs) are described as increasingly used in reimbursement and procurement decisions and as needing adequate resourcing, transparency and regular updating, with attention to clinical outcomes, quality of life and broader economic impact.
Distribution and service capacity then shape affordability and availability. IDAP describes supply chain deficiencies as major barriers, with private supply chains adding costs usually paid by patients and fragmented public supply chains contributing to stockouts. Markups and taxes are presented as material drivers of affordability pressures, with a study across 35 countries finding distribution markups plus taxes adding up to 187% of ex-factory prices. Service delivery constraints include shortages in equipment, diagnostics and workforce, and unreliable infrastructure such as water, electricity and telecommunications. Financing is positioned as foundational, with more than 140 countries in 2022 investing less than 5% of gross domestic product (GDP) and less than 15% of national budgets into health, affecting potentially over 80% of the world’s population, while reductions in official development assistance (ODA) increase pressure on domestic resource mobilisation.
IDAP presents access as a pathway in which barriers can accumulate from early development through to delivery. Long timelines, high attrition and uneven incentives influence what is developed, while regulatory requirements can extend approval and slow post-approval updates, affecting supply resilience. After authorisation, slow updating of nEMLs, limited reimbursement for recently launched products and constraints in procurement and supply chains can delay uptake and sustain OOP spending. The framework clarifies where regulatory, financing and operational pressures intersect and where aligned action across the pathway can influence timely, reliable access for patients.
Source: IFPMA
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