Żaneta Zemła-Pacud, Associate Professor, Institute of Law Studies, Polish Academy of Sciences, Warsaw, Poland

• ContentsRegulatory protection in the pharmaceutical and life scienceindustries: an introduction ixPART I Regulatory protection for medicinal products1 Introduction to the regulation of market authorisation formedicinal products 2 Data and market exclusivity for reference medicinal products 3 Regulatory exclusivities and rewards for paediatric products 4 Regulatory protection for orphan drugs PART II Reform of the EU pharmaceutical regulation5 The EU Pharmaceutical Strategy and the context of theongoing reform 6 Revision of the regulatory protection for reference medicinalproducts 7 Revision of the regulatory protection for paediatric medicines 8 Revision of the regulatory protection for orphan medicinalproducts 9 Transferrable vouchers for new antimicrobial medicines 10 Regulatory data protection for repurposed medicinal products PART III Regulatory exclusivities as a part of the legal protectionfor intellectual property in life sciences11 Regulatory protection in different sectors of the life sciences 12 Exclusivity versus confidentiality of regulatory data 13 Regulatory protection in the light of TRIPS 14 Regulatory exclusivities in the EU: their legal categorisationunder civil law Bibliography

‘This book is a timely and important contribution to the scholarship and practice of intellectual property and pharmaceutical law. With clarity and depth, it brings to light an often-underexplored yet increasingly pivotal element of the life sciences innovation ecosystem: regulatory exclusivities. While patents and supplementary protection certificates have long dominated discourse around innovation incentives, this work reveals how regulatory data protection and market exclusivity have come to play an equally, if not more, decisive role in determining when generic competition can enter the market.

Żaneta Zemła-Pacud, Associate Professor, Institute of Law Studies, Polish Academy of Sciences, Warsaw, Poland

• ContentsRegulatory protection in the pharmaceutical and life scienceindustries: an introduction ixPART I Regulatory protection for medicinal products1 Introduction to the regulation of market authorisation formedicinal products 2 Data and market exclusivity for reference medicinal products 3 Regulatory exclusivities and rewards for paediatric products 4 Regulatory protection for orphan drugs PART II Reform of the EU pharmaceutical regulation5 The EU Pharmaceutical Strategy and the context of theongoing reform 6 Revision of the regulatory protection for reference medicinalproducts 7 Revision of the regulatory protection for paediatric medicines 8 Revision of the regulatory protection for orphan medicinalproducts 9 Transferrable vouchers for new antimicrobial medicines 10 Regulatory data protection for repurposed medicinal products PART III Regulatory exclusivities as a part of the legal protectionfor intellectual property in life sciences11 Regulatory protection in different sectors of the life sciences 12 Exclusivity versus confidentiality of regulatory data 13 Regulatory protection in the light of TRIPS 14 Regulatory exclusivities in the EU: their legal categorisationunder civil law Bibliography

‘This book is a timely and important contribution to the scholarship and practice of intellectual property and pharmaceutical law. With clarity and depth, it brings to light an often-underexplored yet increasingly pivotal element of the life sciences innovation ecosystem: regulatory exclusivities. While patents and supplementary protection certificates have long dominated discourse around innovation incentives, this work reveals how regulatory data protection and market exclusivity have come to play an equally, if not more, decisive role in determining when generic competition can enter the market.

Żaneta Zemła-Pacud, Associate Professor, Institute of Law Studies, Polish Academy of Sciences, Warsaw, Poland

• ContentsRegulatory protection in the pharmaceutical and life scienceindustries: an introduction ixPART I Regulatory protection for medicinal products1 Introduction to the regulation of market authorisation formedicinal products 2 Data and market exclusivity for reference medicinal products 3 Regulatory exclusivities and rewards for paediatric products 4 Regulatory protection for orphan drugs PART II Reform of the EU pharmaceutical regulation5 The EU Pharmaceutical Strategy and the context of theongoing reform 6 Revision of the regulatory protection for reference medicinalproducts 7 Revision of the regulatory protection for paediatric medicines 8 Revision of the regulatory protection for orphan medicinalproducts 9 Transferrable vouchers for new antimicrobial medicines 10 Regulatory data protection for repurposed medicinal products PART III Regulatory exclusivities as a part of the legal protectionfor intellectual property in life sciences11 Regulatory protection in different sectors of the life sciences 12 Exclusivity versus confidentiality of regulatory data 13 Regulatory protection in the light of TRIPS 14 Regulatory exclusivities in the EU: their legal categorisationunder civil law Bibliography

‘This book is a timely and important contribution to the scholarship and practice of intellectual property and pharmaceutical law. With clarity and depth, it brings to light an often-underexplored yet increasingly pivotal element of the life sciences innovation ecosystem: regulatory exclusivities. While patents and supplementary protection certificates have long dominated discourse around innovation incentives, this work reveals how regulatory data protection and market exclusivity have come to play an equally, if not more, decisive role in determining when generic competition can enter the market.