Center For Health Policies and Studies

Negative Impact of Data Exclusivity on Access to Medicines


In the current negotiations for Deep and Comprehensive Free Trade Area Agreement, the European Union (EU) requires the Republic of Moldova to introduce in the national legislation data exclusivity as a new form of intellectual property protection. Data exclusivity would allow pharmaceutical companies to hold exclusive rights over their clinical test data for a defined period of time. In essence, this measure ensures the exclusive right and market monopoly of originator drugs for a maximum of 11 years and the European Union promotes this measure to return initial investments that lead to discovering an innovative pharmaceutical entity. To support its position, the European Union brings several arguments that are discussed below in this document.