The innovation development and access pathway: A holistic approach to accelerating access to innovative medicines and vaccines

Innovative medicines and vaccines have transformed healthcare around the world, extending life expectancy and improving quality of life. These achievements are the result of sustained investment in scientific research, pharmaceutical innovation, and close collaboration between public and private stakeholders across the entire value chain - from product development to implementation planning and patient access.

Yet, too often, innovative medicines and vaccines do not reach the people who need them in a timely way and in appropriate volumes, facing barriers and impediments at critical stages of drug development and health system delivery. This is particularly acute in lower-resource settings. To address this, it is important to establish a shared understanding of the end-to-end pathway for health products - from the laboratory to a person in need at the point of care - with particular focus on identifying the barriers that hinder access, and to propose a way forward.

In this paper, we share the perspective of the innovative pharmaceutical industry on key elements of the innovation and access ecosystem in which we operate, in order to build a common understanding and identify opportunities for collaboration. We outline the key stages that any medicine or vaccine must navigate from the laboratory to people at the point of care globally.

We describe this process as the "Innovation Development and Access Pathway" (IDAP).

We recognize that specific steps and relevant stakeholders will vary between countries and product or market archetypes. However, most medicines and vaccines follow four common phases:

• Research & Development (R&D) and the innovation ecosystem
• Regulatory processes, product registration and life cycle management
• Listing, treatment guidelines, procurement and payment or reimbursement
• Health service delivery to patients, including distribution, supply chain, workforce capacity, diagnostics or referral networks, treatment, and follow-up

Focusing on the end-to-end pathway highlights critical bottlenecks. This approach helps illustrate where different stakeholders' accountabilities may lie along the development-to-delivery chain, recognizing that delays or bottlenecks at any point can prevent timely access for people, resulting in preventable mortality, poorer clinical outcomes, and increased costs to healthcare systems and society.