Abstract
Experts in regulatory and HTA agencies are urging the pharmaceutical industry to make more effort to include patients’ perspectives in the medicine development process to further improve the quality and relevance of evidence of effectiveness and value. Indeed, much of the product development activity within companies is geared around meeting goals for regulatory approvals and market access. Therefore, the pharmaceutical industry has an interest in responding to changes in how these agencies consider evidence and make decisions. Many companies make considerable effort to involve patients during the development process as an essential part of improving the overall efficiency of that process. The pharmaceutical industry is benefiting from insights that improve the efficiency of medicine development, while ensuring patient organisations are able to become involved in regulatory and HTA processes. International and national guidelines provide governance to the process and ensure this involvement will occur transparently, without influence and without any overt promotion of specific products (European Federation of Pharmaceutical Industry Associations 2011; Perfetto et al. 2015). This chapter will review the evolution and value of patient involvement in medicine development and assessment processes, discuss legal constraints on communication between the pharmaceutical industry and patients and the importance of patient education and training.
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The author acknowledges the helpful input and advice from Lucy Hickinbotham of Astra Zeneca.
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Grainger, D.L. (2017). Patient Involvement in Medicine Development and Assessment. In: Facey, K., Ploug Hansen, H., Single, A. (eds) Patient Involvement in Health Technology Assessment. Adis, Singapore. https://doi.org/10.1007/978-981-10-4068-9_33
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DOI: https://doi.org/10.1007/978-981-10-4068-9_33
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