Healthcare
Multi-stakeholder consultations in drug development
New medicines can greatly improve patients' quality of life. In some cases, they can mean the difference between life and death. Yet European healthcare systems face a number of challenges in ensuring that patients gain access to the medicines they need:
- Healthcare budgets are under strain.
- Medicine development programs often fail to demonstrate how new drugs are better than existing treatments.
- The various decision-makers that mark the path of a medicine from the laboratory to the patient – including regulators, health technology assessors (HTAs) and budget-holders – often reach different conclusions about whether a medicine should be supported.
Healthcare leaders across Europe believe the drug development process will yield better outcomes for all involved if the various stakeholders are willing to engage in a dialogue with each other. These leaders and the institutions they represent have worked together with Tapestry to create this dialogue early in the drug development process. Some institutions, such as regulatory agencies, have experience meeting one-on-one with medicine developers, while others are doing so for the first time.
Together, they are piloting multi-country, multi-stakeholder consultations in drug development to provide integrated feedback for sponsors on the expected value of a medicine under development and how best to demonstrate that value. The pilots also provide participants with insight into how their peers in other countries and other institutional roles approach critical drug development issues.
Through these pilots, participants are learning how to develop better medicines for diseases such as cancer, type 2 diabetes, Alzheimer's and drug-resistance bacterial infections. They are also creating greater clarity and alignment across constituencies about the evidence needed to evaluate new treatments.
One pilot participant, a budget-holder, explained the importance of this initiative: "There is no way we could address the level of complexity inherent in [these therapeutic areas] without putting together the resources that are here in this room: the regulators, the scientists, the academics in the field. We must really do it together, engaging private to public, public to public and private to private."
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