As part of the ADAPT SMART Work Package 3, the D3.04 workstream was tasked to analyse the specific views and uncertainties of stakeholders facing MAPPs, and identify enablers to manage and reduce them.
Enablers of decision making in an adaptive environment: managing uncertainties and disengagement (D3.03)
This report identified that the terminology surrounding disengagement from MAPPs needs further clarification as interchangeable terminology such as, ‘exit strategy’, ‘withdrawal’, or ‘disinvestment’ holds different meanings and different implications to different stakeholders.
Managed Entry Agreements for Pharmaceuticals in the Context of Adaptive Pathways in Europe (D3.05 & D3.07)
This review reports the findings of activities undertaken by the ADAPT-SMART consortium to identify enablers and explore the suitability of managed entry agreements for adaptive pathways products in Europe.
Work-stream D3.09 has explored some general ethical and legal issues that may arise through the introduction of the MAPPs concept, the implications for each stakeholder – in particular, patients and healthcare professionals (HCP) – and any liability change or shift between stakeholders and ethical considerations of prescribing control.
Within the ADAPTSMART consortium, the remit of work-stream D3.08 has been to explore general ethical and legal issues that may arise through the introduction of the MAPPs concept, the implications for each stakeholder - in particular, patients and healthcare professionals (HCP), and what recommendations could be made to mitigate against identified issues. Specific legal issues relating to intellectual property law are the subject of another ADAPTSMART work-stream and are not discussed here.
Impact of adaptive licencing and adaptive access on Intellectual property and regulatory exclusivity right periods (D3.06)
A broad review of the rules governing IP and RER as they are today, and with respect to MAPPs, was undertaken in the context of the following 4 scenarios deemed likely to occur with MAPPs: (i) Stand-alone MA (i.e. single indication only); (ii) MA with subsequent indications with the same compound, i.e. indication 1, subsequently followed by indication 2; (iii) MA under exceptional circumstances or conditional approval that subsequently gets approved for ‘full’ MA; and (iv) MA (full, conditional, or exceptional MA) that subsequently is revoked / suspended from a regulatory perspective. Any direct legal impact of MAPPs were assessed along with an exploration of several perceptual issues pertaining to the incentives of adopting and using MAPPs from an IP and RDP perspective.
Decision points in current vs. future processes by stakeholder groups, and resource implications for a roadmap for implementation (D3.02)
The introduction of a new concept introduces new dynamics to which the involved stakeholders need to adapt. When considering the feasibility and practicalities of being involved in an adaptive pathway to medicines – which includes multi-stakeholder interactions, iterative cycles of development and assessment, and long term real-world data (RWD) collection – each stakeholder must have a clear understanding of their remit (current or new), the type of input requested from them (advice or decisions), and the appropriate resources needed.
Joint workshop: Patient uncertainties and exploring the ethical and legal considerations of MAPPs (D3.04 & D3.08)
In order to continue the instructive discussions of the ADAPTSMART programme of work, on January 17th 2017, the ADAPT SMART consortium hosted a multi-stakeholder workshop on ‘Patient uncertainties and exploring the ethical and legal considerations of MAPPs’, bringing together two work streams - D3.04 and D3.08. This workshop comprised of 40 representatives including; European regulators, Health Technology Assessment (HTA) bodies, the pharmaceutical industry, patient organizations, health care professionals, and academics
Workshop: The Impact of Adaptive Pathways and Adaptive Access on Intellectual property and Regulatory exclusivity rights (D3.06)
On April 12th 2017, the IMI ADAPTSMART consortium hosted a multi-stakeholder workshop. Twenty-two representatives attended, including: medicine developers, independent IP and regulatory lawyers, payers, academics and policy makers.
Joint workshop: tools and systems used for prescription control & the ethical and legal aspects of adaptive decision making (D2.07 & D3.09)
On the 17th of January 2017, as part of its Annual Meeting, the ADAPT SMART consortium hosted a multi-stakeholder workshop on ‘Tools and systems used for prescription control and the ethical and legal aspects of adaptive decision making’. The topic of this workshop related to two different deliverables: D2.07 (focused on prescription control) and D3.09 (focused on ethical and legal aspects of adaptive decision making).