A broad review of the main legal areas governing medicinal product development, approval and market access, in the context of MAPPs, was undertaken - except any potential impact of MAPPs on Intellectual Property and Regulatory Exclusivity Rights that will be analysed by D3.06 working group, within Work Package 3. The two documents should be read and understood together.
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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.
The objective of D2.07 was to provide an overview of which tools and systems are available at the national level to guide the appropriate use of medicinal products in EU Member States. This report looks at all tools/systems for guiding appropriate use at the national level, even if these may not be directly applicable in the context of a MAPPs-type pathway.
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.
Podcast: “The Regulatory Needs of MAPPs – What are the Evidence Requirements to Make Adaptive Pathways Work in Practice?”.
On 25 October 2017, ADAPT SMART had a discussion with François Meyer, Advisor to the President & International Affairs at the French National Authority for Health (HAS), Solange Corriol-Rohou, Senior Director Global Regulatory Affairs & Policy, Europe at AstraZeneca Global Medicines Development, Elin Haf Davies, CEO of Aparito and Stefan Lange, Deputy Director at IQWiG, moderated by Richard Barker, Director, CASMI.
Webinar Report: “Implementing Real World Data to Make Adaptive Pathways Work” On 18 October 2017, the ADAPT SMART consortium presented a webinar hosted by the Estonian Ministry of Social Affairs. The webinar was the final event of eHealth week, an international conference occurring as part of Estonia’s Presidency of the European Council, and discussed [...]
25 Oct 2017 8:00 AM – 26 Oct 2017 3:30 PM CET Radisson Blu Steinentorstrasse 25 4001 Basel Switzerland
18th October 2017, 15.15-16.15 CET Adaptive Pathways (or Medicine Adaptive Pathways to Patients (MAPPs)) potentially provide a tool to place new, innovative medicines into the market for those patients at greatest unmet need. This webinar will discuss how Eastern European countries are implementing Real World Data tools that can be used to provide the data infrastructure needed to make Adaptive Pathways work.
EMA answers to questions from industry partners in the ADAPT SMART consortium regarding the EMA Adaptive Pathways pilot project
EMA answers to questions from industry partners in the ADAPT SMART consortium regarding the EMA Adaptive Pathways pilot project Response: Adaptive Pathways is a concept that seeks to foster access to beneficial treatments for the right patient groups at the earliest appropriate time in the product life-span in a sustainable fashion. In so [...]
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