The topic of “a needs-driven approach for pharmaceutical innovation” was brought on the Agenda of the EPSCO Council on June 13th 2023 at the request of the members of the Beneluxa initiative (Belgium, the Netherlands, Luxembourg, Austria and Ireland).
In a patient-centred healthcare system, research and development should be driven by needs of patients and of the society as a whole. However, as things stand today, private investments in R&D tend be aimed towards the highest expected return on investment; and regulatory incentives and financial support for R&D are still mainly supply driven.
The Beneluxa members propose to think of new systems, allowing for a change in business models. Models that focus more on real needs rather than on supply. This requires a life cycle approach and a clear, joint message as to which therapeutic interventions have the greatest health benefits for society as a whole.
The EU has a crucial role in this, through its important research funding programs, as well as through regulatory incentives. We believe that these leviers should be used in a more targeted way to better address the public health needs in the EU.
Beneluxa members urge for applying a needs-driven approach to pharmaceutical innovation:
- We call for a common approach to identify unmet needs at EU level
- We call for a dialogue on an evidence-based operationalisation of the definition of unmet needs in the EU pharmaceutical legislation
- We invite Member States to provide predictability to healthcare developers as to health interventions addressing high unmet needs they intend to include in their benefit package
- We welcome Member States in a discussion on a voluntary coordinated approach to needs driven reimbursement systems
- We invite Member States to engage in a dialogue on shifting toward a needs driven pharmaceutical model
Link to the full note: pdf (europa.eu)
Link to the EPSCO meeting: Employment, Social Policy, Health and Consumer Affairs Council - Consilium (europa.eu)
Last update: 21 June 2023