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Intellectual property rights is the most commonly used term to describe the framework of incentives and rewards that encourage and protect innovation, driving research and development investments to areas of unmet medical need. Pharmaceutical incentives and rewards deliver access to today’s medicines and investment into the cures of tomorrow for patients who need them.

This framework of measures such as patents, supplementary protection certificates and regulatory data protection are the foundations on which innovation is built. They provide companies researching and developing new medicines the certainty that if a medicine makes it to the market, it will be protected from unfair competition for a limited period time. This is what they need to invest in the long, complex and risky process of delivering new medicines to patients, to healthcare systems and to society and what paves the way for low-cost generics to be used by healthcare systems.

A comprehensive suite of incentives is needed to foster the development of solutions to patients’ unmet needs and turn basic science into medicines. They have enabled the research and development of today’s medicines and will lead to tomorrow’s cures.

With over 7000 medicines in development, the system is working: it enables a pipeline of this scale despite the high risk of failure. These new treatments will continue to change patients’ lives; slowing disease progression, avoiding illness and reducing overall costs for healthcare systems. This exciting new wave of medical innovation and the products it will bring would simply not exist without pharmaceutical incentives and rewards.

The pharmaceutical incentives regime is a complex ecosystem that takes into account the realities of biopharmaceutical innovation and societal needs. Changing any part of the pharmaceutical incentives and rewards framework risks undermining the innovation process that patients, healthcare systems and society are relying on to address the challenges they face.

About the incentives reviewIn the Council conclusions of 17 June 2016 on strengthening the balance in the pharmaceutical systems in the EU and its Member States, Member States invited the Commission to prepare an evidence-based analysis of the impact of pharmaceutical incentives on innovation, availability and accessibility of medicinal products, including generic products.

This review will mainly take the form of an economic study to be conducted by Copenhagen Economics for the European Commission in the course of 2017, with the support of Member States.  

The study shall analyse the actual use by pharmaceutical companies of incentives & rewards mechanisms (patents, Supplementary Protection Certificates and their extension for paediatric medicines, Regulatory Data Protection and orphan market exclusivity) as well as both their overall and specific economic impact on the entire product lifecycle, from innovation to accessibility.