- All > Medicine Information and Evidence for Policy > Medicines Policy
- All > Public Health, Innovation, Intellectual Property and Trade > Research and Development (R&D) - Innovation and Financing
- Keywords > access to medicines
- Keywords > health priorities
- Keywords > medicines policy
- Keywords > medicines strategy
- Keywords > pharmaceutical gaps
- Keywords > pharmaceutical innovation
- Keywords > pharmaceutical research - priorities
- Keywords > policy - priority issues
- Keywords > priority diseases
- Keywords > priority medicines
(2013; 28 pages)
Chapter 8 aims to provide an overview of the main tools that can stimulate pharmaceutical innovation with a focus on achieving public health objectives. The focus is in particular on those topics addressed in Chapter 8 of the 2004 Report (then titled "New Approaches to Promoting Innovation"). All topics from the 2004 Report are covered here, but the structure of this chapter is different and the scope has expanded. More specifically, a new section has been added on patient and citizen participation in priority setting. This topic was not a major part of the previous report, but there have been many developments in this area that warrant a separate section. Additionally, the focus on research priorities has been strengthened compared to the 2004 Report.
The structure of this chapter can be seen as the sequential steps from drug development to use in clinical practice. This approach has been chosen to highlight key developments in the field while not being exhaustive.
Chapter 8.1 focuses on public-private collaborations, a topic that has grown in importance since the previous report and which can assist in priority setting for early stage innovation, development and also systems improvement. Chapter 8.2 addresses the regulatory system related to market authorization and focuses on research priorities that can support current developments in the field. Chapter 8.3 on pricing and reimbursement policies has this same perspective: it identifies research priorities that can fuel current discussions about new tools and methods for setting pricing and reimbursement levels that recognize and incentivize innovation. Chapter 8.4 focuses on the opportunities that exist in the area of electronic health records (EHR) to capture the use of medicines and outcomes in clinical practice. With the increasing use of databases and new tools for analysis, this is an especially promising area that will impact on all areas covered in Chapters 6, 7 and 8.
Finally, Chapter 8.5 addresses the role of patients and citizens in priority setting. Although ways in which patients and citizens can play an optimal role in priority setting are still being explored, the movement towards more patient and citizen involvement is strongly supported. It is, however, still a field in which several research questions need to be answered.
It should be emphasized that there are many cross-links between the sections in Chapter 8 (for example, real-life data plays an increasingly important role in drug development, regulation, and pricing and reimbursement) and other chapters of this report (e.g. different disease areas in Chapter 6). Therefore, they should be viewed in conjunction. In several places these cross-links have been highlighted.