New Drugs, Fair Prices Managing the Pharmaceutical Innovation Ecosystem for Sustainable and Affordable New Medicines

New Drugs, Fair Prices addresses the important question of how we might get the innovative new medicines we need at prices we can afford. Today, this debate is impassioned but sterile. One side calls for price controls, discounting their impact on investment in innovation. The other points to miraculous new therapies, disregarding their affordability and social inequity. This polarized argument creates more heat than light, threatening the social contract between the industry and society on which pharmaceutical innovation depends. This ground-breaking book takes a wholly new perspective on the issue and raises the debate to a more informed and productive level. Drawing on interviews with more than 70 experts across the pharmaceutical innovation world and combining a diverse literature from scientific, political, economic and business domains, it describes how a sustainable and affordable supply of new medicines is possible only by balancing pharmaceutical innovation’s complex, adaptive ecosystem. By considering how each of the ecosystem’s seven habitats work and interact with the others, it makes a comprehensive set of recommendations for achieving that ecosystem balance. The core message of New Drugs, Fair Prices is important to anyone who ever has needed or will ever need a medicine: we can have a sustainable supply of new medicines that are both innovative and affordable if we manage the pharmaceutical innovation ecosystem intelligently.

Preface: Writing with Intent Acknowledgements Balancing Tomorrow with Today Precis How important a question is this? How American a question is this? First, do no harm. What might change put at risk? Does pharmaceutical innovation have a problem? Where does this leave us? A New Paradigm for a Wicked Problem Precis Why did the drug pricing debate become so sterile? Are we looking at drug pricing the wrong way? What is the case for the ecosystem paradigm? What is the pharmaceutical innovation ecosystem? What does the ecosystem perspective imply for the affordability debate? The pharmaceutical innovation ecosystem is fragile The pharmaceutical innovation ecosystem can only be managed systemically How can we resolve our dilemma? The Discovery Habitat Precis What is the discovery habitat and who inhabits it? What does a healthy PIE require of the discovery habitat? Is the discovery habitat capable of supporting a healthy PIE? How can we improve the discovery habitat? Will this be enough? The Innovation Habitat Precis What happens in the innovation habitat and who inhabits it? What does a healthy PIE require of the innovation habitat? Is the innovation habitat capable of supporting a healthy PIE? How can we improve the innovation habitat? Will this be enough? The Coalition Habitat Precis What happens in the coalition habitat and who inhabits it? What does a healthy PIE require of the coalition habitat? Is the coalition habitat capable of supporting a healthy PIE? How can we improve the coalition habitat? Will this be enough? The Value Habitat Precis What happens in the value habitat and who inhabits it? What does a healthy PIE require of the value habitat? Is the value habitat capable of supporting a healthy PIE? How can we improve the value habitat? Will this be enough? The Pricing Habitat Precis What happens in the pricing habitat and who inhabits it? What does a healthy PIE require of the pricing habitat? Is the pricing habitat capable of supporting a healthy PIE? How can we improve the pricing habitat? Will this be enough? The Competition Habitat Precis What happens in the competition habitat and who inhabits it? What does a healthy PIE require of the competition habitat? Is the competition habitat capable of supporting a healthy PIE? How can we improve the competition habitat? Will this be enough? The Patient Habitat Precis What happens in the patient habitat and who inhabits it? What does a healthy PIE require of the patient habitat? Is the patient habitat capable of supporting a healthy PIE? How can we improve the health of the patient habitat? Will this be enough? Breaking Ground, Raising the Debate Precis Where are we now? Breaking ground on a PIE for the future Raising the debate Index

Brian D. Smith is an academic, author and advisor who has worked in and studied the life sciences sector for over 40 years. He has published over 300 books, papers and articles and worked with most of the world’s leading pharmaceutical companies.