I am a public health professional representing the organization Center for Health Policies and Studies (PAS), an NGO working in policy analysis and research in health in Moldova. In June 2012 we became aware of the intention of the government to change patent legislation by introducing data exclusivity as an additional IPR measure in addition to TRIPS provisions and started to inquire as to the origins of this initiative.
The Republic of Moldova, a country in the Eastern European region, has started in 2011 the process of confidential negotiations for Deep and Comprehensive Free Trade Agreement with the European Union (EU). In these negotiations the EU requires the Republic of Moldova to introduce in the national legislation data exclusivity as a new form of protection of intellectual property for the maximum period of 11 years (8+2+1). There was first round of negotiations where Moldova has opposed introduction of data exclusivity because of the impact on price of drugs, but the official answer of DG trade was that EU interpretation of unfair commercial use is in line with TRIPS agreement.