21/08/2012 AL 21/08/2012 AL Case No Country Mandate(s) Summary of the allegation transmitted Reply OTH 10/2012 Other Health; Alleged negative impact of article 9 of the draft Deep and Comprehensive Free Trade Agreement (DCFTA), currently being negotiated between the Republic of Moldova and the European Union, on access to medicines in the Republic of Moldova. According to the information received, article 9 of the draft DCFTA contains a ―TRIPS-plus‖ provision on data exclusivity, according to which manufacturers of generic medicines would allegedly not be able to refer to clinical test results of originator drugs for a maximum period of eleven years with potentially negative impact on the ability of major segments of the population in Moldova to afford a range of medications, including antibiotics, antiretrovirals and medicines for the treatment of tuberculosis and cancer. Allegedly the provision will ensure a monopoly by manufacturers of originator drugs and that manufacturers of generic drugs will be unable to enter the market and provide cheaper alternatives to originator drugs for a maximum period of eleven years. MDA 4/2012 Republic of Moldova Health; 29/10/2012 Alleged negative impact of article 9 of the draft Deep and Comprehensive 13/11/2012 Free Trade Agreement (DCFTA), currently being negotiated between the Republic of Moldova and the European Union, on access to medicines in the Republic of Moldova. According to the information received, article 9 of the draft DCFTA contains a ―TRIPS-plus‖ provision on data exclusivity, according to which manufacturers of generic medicines would allegedly not be able to refer to clinical test results of originator drugs for a maximum period of eleven years with potentially negative impact on the ability of major segments of the population in Moldova to afford a range of medications, including antibiotics, antiretrovirals and medicines for the treatment of tuberculosis and cancer. Allegedly the provision will ensure a monopoly by manufacturers of originator drugs and that manufacturers of generic drugs will be unable to enter the market and provide cheaper alternatives to originator drugs for a maximum period of eleven years. A/HRC/22/67 84 Date Type

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