Drug Information Journal
, Vol. 45, pp. 541–550, 2011 • 0092-8615/2011Printed in the USA. All rights reserved. Copyright © 2011 Drug Information Association, Inc.
Peter J. Pitts, Center for Medicine in the PublicInterest (email: firstname.lastname@example.org).
Peter J. Pitts
Center for Medicine in thePublic Interest
Mary Baker, MBE
President, EuropeanFederation of Neurological Associations; Vice President,European Brain Council,United Kingdom
In the last 50 years the average life span hasincreased by 10 years, largely due to advance-ments in pharmaceutical drug development, primarily within the developed world. What willdrive this over the next 50 years?Improved patient access to drugs is a critical goal for all stakeholders in drug discovery, de-velopment, and delivery. However, drug accesslevels for patients continue to decrease, drivenby, for example, stricter regulatory policies,lower R&D output, stronger payer cost pres-sures, and a complex legal environment. Giventhe importance of health and well-being, itis critical for stakeholders to better under-stand these hurdles and develop high-impactsolutions that signicantly increase patient ac-cess to new medicines. While pharmaceuticalcompanies have had some limited success inovercoming R&D hurdles, a multistakeholder holistic approach is necessary to develop para-digm-changing solutions. A meeting of 12 distinguished health care ex- perts was convened on January 26–27, 2010,in London, UK, to address this issue. The par-ticipants included government regulators,health care policy experts, industry leaders,health economists, health care attorneys, pa-tient advocates, and academics. The primaryobjectives of the meeting were to further under-stand the hurdles to patient access and to de-velop high-impact global solutions. Topics dis-cussed included the following:• The nature of the problem• Initiatives currently underway• Insights on the challenges and barriers thatinhibit patient access to new and innovativemedicines• Prioritizing ideas to facilitate meaningfulstrategies for expediting patient access tonew medicines• A potential path forward for implementing the priority ideas from the meeting Five of the ideas that were discussed are as fol-lows:1. A nonprot, independent, patient-drivendrug assessment agency to provide an ap- praisal of risks versus benets of new drugsto both individuals and the society as awhole, unbiased by nonclinical measure-ments such as the quality adjusted life year (QALY)2. An academic institute of regulatory scienceto drive research into the discipline of drug regulation3. A new Asia-Pacic panregional regulatoryagency to provide centralized regulatorysupport4. Better sharing of data within the pharma-ceutical industry (eg, safety databases, ge-nomic and small-molecule libraries, negativeoutcomes) directly, or potentially through government bodies5. Enhanced use of private-public partnershipsin new product development building onlearning from organizations such as the Billand Melinda Gates Foundation, the FDACritical Path Initiative, the Innovative Med-icines Initiatives, and the Cardiac SafetyResearch Consortium.
The column reviews important discussion and in-sight emerging at the meeting, and is intended asa call to action highlighting the importance of improved global patient access to new medicines.The rst two of the ideas just described wereviewed as top priority based on feasibility and potential impact.
Expediting Patient Access to New Medicines:A Call to Action, London, January 26–27, 2010
Innovation is at the heart o humankind’s well-being and a driving orce behind impressive im-provements in the standard o living. Over thepast 50 years the advent o new medicines hasbeen a key driver o signifcant increases in lieexpectancy and quality. While oten invented inclose collaboration between academic and in-dustrial scientists, these drugs were mostly de-veloped and commercialized by the pharma-