Tuesday, 17 July 2018

42nd Sitting of the European Integration Committee

At the sitting held on 17 July, the members of the European Integration Committee considered, in principle, the Bill on Human Cells and Tissues, Bill on Human Organ Transplantation and the Bill amending and modifying the Law on Psychoactive Controlled Substances.


The Bill on Human Cells and Tissues was presented by Dr Vesna Rakonjac, acting head of the Biomedicine Directorate, who said that the bill falls within Chapter 28 and as such contains all the recommendations from the European directives concerning the field. She added that it is an umbrella law to be followed by a number of by-laws focusing on the EU directives in more detail.

The existing law was only partially harmonized with the directives and the newly proposed Bill is adjusted to seven European directives, guidelines and regulations, Rakonjac said. The Bill covers the 2004 directive concerning the standards of quality and safety for human cells and tissues, 2006 directive concerning the donation, procurement and testing of human cells and tissues and the 2006 directive concerning responses to unwanted developments in the process of procurement, storage and distribution of cells and tissues, said Rakonjac. She added that the Bill contains inspection guidelines and that a biomedicine inspection is to be set up staffed by trained and licenced inspectors. The Bill also covers all the 2015 directives concerning the technical conditions for cell and tissue storage, quality standards and standards for imported cells and tissues.

Following a debate the Committee members accepted the Bill in principle, by majority vote.

Dr Vesna Rakonjac, acting head of the Biomedicine Directorate, also presented the Bill on Human Organ Transplantation, which, like the one discussed before it, falls within Chapter 28 and is and as such fully harmonized with the all the European directives in the field. The 2010 directive concerns the quality and safety of organs intended for transplantation and defines the opening of hospital banks or donor hospitals. The directive hinges on the principle of self-sufficiency for one’s citizens which will, after it is achieved, make it possible for Serbia to become member of Eurotransplant. The 2012 directive concerns information procedures for the exchange of human organs between the Eurotransplant member states.

Following a debate the Committee members accepted this Bill as well, in principle, by majority vote.

Assistant Minister of Health Dr Dragana Vujicic presented the Bill amending and modifying the Law on Psychoactive Controlled Substances which, she said, also needs to be passed to enable the implementation of EU regulations. The Council of Europe provided assistance in the form of expert consultations in the drafting of the Bill and the amendments concern the inclusion of new psychoactive substances, the legislative framework for the establishment of a monitoring centre with an HQ at the Ministry of Health, an early warning system and system of transportation of seized substances, sampling and storage of samples.

The Committee members accepted the Bill in principle, by majority vote

The sitting was chaired by Committee Deputy Chairperson Elvira Kovacs, and attended by the following Committee members and deputy members: Olivera Pesic, Dusica Stojkovic, Zvonimir Djokic, Dragan Veljkovic, Vera Jovanovic, Tanja Tomasevic Damnjanovic, Aleksandar Stevanovic, Miljan Damjanovic, Zarko Micin and Dr Muamer Bacevac.


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