PD14 A New Equitable Biomedical Research And Development Model: Preliminary Findings From A Pilot Study Applying VALIDATE Value Methods

Abstract

Introduction

The public health areas without commercial value continue to be underserved, while those of high profit for industry will not be sustainable for much longer. We hypothesize that the lack of equity and efficiency in the biomedical research and development system is mainly due to a pharma-led short-term profit orientation that ignores the values of other relevant stakeholders.

This pilot study reached some consensus on the principles of a co-created biomedical research and development process based on the preferred supplier (PS) model, which proposes a public health procurement system prioritizing business with companies fulfilling the “4 Share” criteria of priorities, risks and rewards, results, and outcomes to ensure that health needs are met.

Methods

A constructive health technology assessment, which included VALues In Doing Assessments of health TEchnologies (VALIDATE) methodology, was used to analyze the values and dissent of a pilot sample of ten global key informants. The methodology comprised qualitative techniques such as an online preliminary survey, in-depth semi-structured interviews, and a Delphi survey to reach a joint construction by reconstructing the stakeholders’ interpretive frames and applying an adaptation of the Richardson model to contested values.

Results

There was consensus on combining efficiency and social justice norms by incentivizing diseases affected by market failure due to small subpopulations (e.g., rare diseases), low availability to pay, restricted use (e.g., antibiotics), and difficulty demonstrating results (e.g., Alzheimer’s disease). Stakeholders mainly agreed on the PS 4 Share principles, highlighting the need for price to be linked to impact modulated by tracked research and development costs and investments, as proposed by the PS model. More market incentives such as push, and especially pull incentives (market access), should be included. The PS model should be cause-solution oriented, promote open-disruptive innovation, and guarantee fast patient access.

Conclusions

The PS model achieved multistakeholder consensus for desirability (values) and plausibility (shifting incentives). Stakeholders pointed out the need to apply health technology assessment to further develop the model and pilot it in the European Union with the NextGenerationEU.