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Pharmaceutical Innovation and Access to Medicines

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This report reviews the important role of medicines in health systems, describes recent trends in pharmaceutical expenditure and financing, and summarises the approaches used by OECD countries to determine coverage and pricing. It then highlights current issues for policy makers, such as the increasing prices of new medicines; concerns about the value of spending in some therapeutic areas; challenges in anticipating the arrival of very effective medicines for highly prevalent diseases; sharp price increases in off-patent products; and the apparent misalignment of current incentives for the development of treatments for certain conditions. The report also describes the role of the biopharmaceutical industry in OECD economies, examines the process of pharmaceutical R&D and its financing, and looks at the risks, costs and return from R&D investment for the industry. Examining trends in the industry over time, it shows that productivity of R&D expenditure has declined; that the duration of market exclusivity has remained relatively stable; that new medicines are increasingly being developed for small patient populations; and that the industry as a whole has remained highly profitable for investors. Lastly, the report presents a range of policy options for consideration by policy makers, to support the development of effective and co-ordinated responses to the identified challenges.

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Executive summary

In recent decades, novel medicines have not only improved survival rates and quality of life for many patients around the world, they have also changed the natural history of diseases such as HIV and certain cancers. Anti-retroviral therapies have transformed HIV from a terminal illness to a manageable chronic disease, while the once-daily single tablet regimen has simplified the daily lives of patients. In the last 15 years, the 5-year survival rate for patients with chronic myeloid leukaemia has improved from less than 20% to more than 90%, thanks to the advent of a class of drugs known as tyrosine kinase inhibitors (TKIs). With direct acting anti-virals (DAAs), hepatitis C, once the leading indication for liver transplant, is now curable in more than 90% of treated patients with as little as 8-12 weeks of treatment.

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