Bulgarian Generic Pharmaceutical Association

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BGPharmA is against the applying of double standard to include medicines in the Positive list

2008-12-23

BGPharmA disapproves the proposal, expressed on behalf of the PL Committee, that cheap medicines (eg below two BGN) should not be included in the Positive List.


This would constitute a double standard and discrimination of the cheaper generic equivalents of original medicines and would impact directly on the pockets of the socially most sensitive groups of patients.


BGPharmA participated in a round table, organized by the Health Policy Expert Council to the Ministry of Health, held on 23.12.2008, at 10.00 am, in Grand Hotel Sofia, with the presence of representatives of the Expert Council and the PL Committee.


During the discussion, the PL Committee announced that till 30 December 2008 all applications to the Committee must be opened, and in the absence of documents or in cases of incomplete documents, the Committee will stop the examination. 363 products were revised and only 101 of them were approved. The PL Committee declared that till 30th of January the Positive List will be completed, but it can not enter into force immediately.


By the part of the pharmaceutical industry was expressed concerns about the reduced PL, which could not meet the needs of patients. In addition, it was requested from the Committee to continue to examine all submitted applications, not only the approved to date. Problems such as lack of transparency in the Committee work and difficulties in communication, the supplementation by the Committee of additional requirements, which are not included in any Regulations or in the LAW ON THE MEDICINAL PRODUCTS IN HUMAN MEDICINE, were put forward. The pharmaceutical industry noted that the term for completion of the PL till 30.01.2009 is too short and will lead to problems for both NHIF, and for the hospitals.

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