The information required to register a medicine may be the subject of an exclusivity period, which can delay the availability of generic medicines by impeding competition from other suppliers and thus, maintain high medicine prices. The length of exclusivity periods and the types of technologies covered varies. Countries face constant pressure to provide this during negotiations of trade agreements. What is the justification behind data exclusivity? And what are its impacts?
Reed Beall will present a study, which reviewed the pre-market development times for all new drugs approved in the US over the past decade. The study concluded that there is no evidence showing that developing biologic drugs takes more time as compared to other drugs despite claims pushing for longer exclusivity periods for biologic drugs.
Mayra Vásquez and Miguel Cortés will present a study that examined the impacts of data exclusivity 10 years after its introduction in Colombia. The study observed an extra cost of US$ 412 million in medicines expenditures and found that providing data exclusivity did not lead to faster entry of novel products in Colombia, which is another argument used to justify the provision.
Speakers
- Reed Beall, Assistant Professor, Cumming School of Medicine & O'Brien Institute for Public Health, University of Calgary, Canada
- Mayra Vásquez, Pharmaceutical Chemistry, MSc Political Studies, International Consultant in Pharmaceutical Policy and Medicines prices, President National College of Pharmaceutical Chemists of Colombia
- Miguel E Cortés G., Pharmaceutical Chemist, MSc Public health advisor, Specialist in international drug price referencing, UNOPS (United Nations Office for Project Services)
Event materials
- Presentation: Impact of Data Exclusivity on Medicines in Colombia
- Presentation: Pre-Market Development Times for Biologic Versus Small-Molecule Drugs
- Q&A Session with the Participants
- Pre-market development times for biologic versus small-molecule drugs, 2019
- Impact of 10 Years of Data Exclusivity in Colombia, IFARMA, 2012, Full report in Spanish, (Abstract in English)