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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."

Explore this issue:

  • Creating a platform for multi-country, multi-stakeholder engagement on strategic questions of drug development

    Medicine developers can focus their investments in new medicines better and develop the right data for informed assessments, if they can consult during the development process with the institutions that will assess and evaluate the new drugs, as well as with the patients who stand to benefit. A set of pilots recently validated a balanced and structured process for doing this. The challenge now is to sustain this forum to ensure that the benefits provided will continue to be available to healthcare innovators, patients, and health systems.

  • Pilots of multi-country, multi-stakeholder consultations in drug development: from proof of concept to tangible benefits

    A set of pilots have validated the benefits of multi-country, multi-stakeholder consultations in drug development. Tapestry and healthcare leaders co-designed the pilot consultations to reduce the risks of drug development and to increase its responsiveness to health system needs. Through six medicine-specific consultations involving the EMA, HTAs, budget holders, patients and clinical experts, the pilot consultations improved the focus of development programs and increased clarity regarding the value of new treatments.

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