1. M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Working Group for Chapter 28 – Consumer and Health Protection Bilateral screening: Chapter 28 PRESENTATION OF MONTENEGRO Brussels, 15-16 April 2013

2. Chapter 28: Consumer and Health Protection Slavojka Šuković Advisor The Ministry of Health slavojka.sukovic@mzd.gov.me M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Chapter 28: CONSUMER AND HEALTH PROTECTION BLOOD, TISSUES, CELLS AND ORGANS

3. Chapter 28: Consumer and Health Protection M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Contents  Relevant Acquis  National Legislation  Institutional Framework  Law on Blood Provision  The Removal and Transplantation of Human Body Parts for the Purposes of Medical Treatment Act  Law on Infertility Treatment with Assisted Reproductive Technologies Chapter 28: CONSUMER AND HEALTH PROTECTION

4. Chapter 28: Consumer and Health Protection M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Relevant Acquis 32002L0098 (EUR-Lex: 15.30) Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC (OJ L 33, 8.2.2003, p. 30–40) 32004L0033 (EUR-Lex: 15.30) Commission Directive 2004/33/EC of 22 March 2004 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards certain technical requirements for blood and blood components (OJ L 91, 30.3.2004, p. 25–39) 32011L0038 (EUR-Lex: 15.30) Commission Implementing Directive 2011/38/EU of 11 April 2011 amending Annex V to Directive 2004/33/EC with regards to maximum pH values for platelets concentrates at the end of the shelf life (OJ L 97, 12.4.2011, p. 28–29) 32005L0061 (EUR-Lex: 15.30) Commission Directive 2005/61/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards traceability requirements and notification of serious adverse reactions and events (OJ L 256, 1.10.2005, p. 32–40) Chapter 28: CONSUMER AND HEALTH PROTECTION

5. Chapter 28: Consumer and Health Protection M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Relevant Acquis (continued) 32005L0062 (EUR-Lex: 15.30) Commission Directive 2005/62/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards Community standards and specifications relating to a quality system for blood establishments (OJ L 256, 1.10.2005, p. 41–48) 32004L0023 (EUR-Lex: 15.30) Directive 2004/23/EC of the European Parliament and the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells (OJ L 102, 7.4.2004, p. 48–58) 32006L0017 (EUR-Lex: 15.30) Commission Directive 2006/17/EC of 8 February 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells (OJ L 38, 9.2.2006, p. 40–52) Chapter 28: CONSUMER AND HEALTH PROTECTION

6. Chapter 28: Consumer and Health Protection M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union 32006/L0086 (EUR-Lex: 15.30) Commission Directive 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells (OJ L 294, 25.10.2006, p. 32–50) 32012L0039 (EUR-Lex: 15.30) Commission Directive 2012/39/EU of 26 November 2012 amending Directive 2006/17/EC as regards certain technical requirements for the testing of human tissues and cells (OJ L 327, 27.11.2012, p. 24–25) 32010D0453 (EUR-Lex: 15.30) 2010/453/EU: Commission Decision of 3 August 2010 establishing guidelines concerning the conditions of inspections and control measures, and on the training and qualification of officials, in the field of human tissues and cells provided for in Directive 2004/23/EC of the European Parliament and of the Council (OJ L 213, 13.8.2010, p. 48–50) Chapter 28: CONSUMER AND HEALTH PROTECTION Relevant Acquis (continued)

7. Chapter 28: Consumer and Health Protection M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union 32010L0053 (EUR-Lex: 13.10.30.20 / 15.20.30) Directive 2010/53/EU of the European Parliament and of the Council of 7 July 2010 on standards of quality and safety of human organs intended for transplantation (OJ L 207, 6.8.2010, p. 14) 32012L0025 (EUR-Lex: 15.30) Commission implementing Directive 2012/25/EU of 9 October 2012 laying down information procedures for the exchange, between Member States, of human organs intended for transplantation (OJ L 275, 10.10.2012, p. 27–32) Council Conclusions on organ donation and transplantation (2012/C 396/03) Chapter 28: CONSUMER AND HEALTH PROTECTION Relevant Acquis (continued)

8. Chapter 28: Consumer and Health Protection M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union National Legislation  Constitution of Montenegro (2007)  Law on Blood Provision (“Official gazette of MNE", no. 11/07)11/07  Rulebook on Conditions for Collection, Treating and Processing of Human Blood, Blood Components and Derivatives (“Official gazette of FRY", no. 36/94)  Order on Hygiene and Technical Measures to be Taken by Business Organisations Dealing with Production and Distribution of Blood and Blood Derivatives („Official gazette of SFRY“ no. 28/67 and 31/68)  The Removal and Transplantation of Human Body Parts for the Purposes of Medical Treatment Act (“Official gazette of MNE", no. 76/09)76/09  Rulebook on Manner, Procedure and Medical Criteria for Determining Death of Persons Whose Body Parts May Be Taken for Transplantation for Purposes of Medical Treatment (“Official gazette of MNE", no. 48/12). Chapter 28: CONSUMER AND HEALTH PROTECTION

9. Chapter 28: Consumer and Health Protection M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union National Legislation  Rulebook on Form, Contents and Procedure of Giving Consent for Transplantation of Human Body Parts for the Purposes of Medical Treatment (“Official gazette of MNE", no. 35/12)  Rulebook on the Procedure of Giving and Contents of the Consent for Removal of Human Body Parts from the Body of Dead Donor and Way of Identification of the Consent Giver (“Official gazette of MNE", no. 24/12)  Rulebook on Procedure of Giving and Contents of the Consent for Removal of Human Body Parts From a Living Donor (“Official gazette of MNE", no. 58/11)  Rulebook on the Procedure of Collection, Storage and Use of Haematopoietic Stem Cells (“Official gazette of MNE", no. 56/12)  Law on Infertility Treatment with Assisted Reproductive Technologies (“Official gazette of MNE", no. 74/09)74/09 PREPARATION OF NEW LAW AND COMPLETE ADOPTION OF EU REGULATIONS FOR BLOOD IS IN PROGRESS. Chapter 28: CONSUMER AND HEALTH PROTECTION

10. Chapter 28: Consumer and Health Protection M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Institutional Framework Ministry of Health Transfusion Instutute of Montenegro Red Cross of Montenegro Clinical Centre of Montenegro Public health care institutions that possess the decision of the Ministry to perform the ART procedures Private health care institutions, with which the Healt Insurance Fund has concluded the Agreement on Providing Health Services from the Obligatory Health Insurance and which are included in the network of health care institutions Private health care institutions, with which the Healt Insurance Fund has not concluded the Agreement on Providing Health Services from the Obligatory Health Insurance and which are not included in the network of health care institutions Health Insurance Fund of Montenegro Administration for Inspection Affairs Agency for Medicines and Medical Devices of Montenegro Chapter 28: CONSUMER AND HEALTH PROTECTION

11. Chapter 28: Consumer and Health Protection M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Constitution of Montenegro Article 69 of the Constitution of Montenegro stipulates that everyone shall have the right to health protection. A child, a pregnant woman, and elderly person and a person with disability shall have the right to health protection from public revenues, if they do not exercise this right on some other grounds. Chapter 28: CONSUMER AND HEALTH PROTECTION

12. Chapter 28: Consumer and Health Protection M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Law on Blood Provision SUBJECT MATTER AND PURPOSE OF THE LAW ORGANISATION AND COMPETENCY OF THE BLOOD TRANSFUSION INSTITUTE BLOOD QUALITY AND SAFETY 1. Blood collection 2. Blood testing, storage and distribution 3. Blood traceability 4. Use of Blood DATA PROTECTION SUPERVISION PUNITIVE PROVISIONS Chapter 28: CONSUMER AND HEALTH PROTECTION

13. Chapter 28: Consumer and Health Protection M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Removal and Transplantation of Human Body Parts for the Purposes of Medical Treatment Act Manner and procedure of removal of human body parts from a living or dead donor Conditions for performance of procedures of human body parts removal and transplantation Conditions which health care institutions have to meet Other issues relevant for the procedure of removal and transplantation of human body parts for the purposes of medical treatment Removal and transplantation of human body parts for the purposes of medical treatment shall be carried out: 1)in accordance with relevant professional standards of medicinal science and with respect to the ethic principles, 2)only when it is medically justified, 3)if that is the only possible way of treatment, and under the conditions laid by this Law 4)after medical investigations and other treatment methods were conducted, based on which it has been determined that the procedure represents welfare for the recipient, and according to medical criteria an acceptable health risk for the donor and that the success of intervention can be predicted with probability 5)only in health care institutions which meet conditions concerning premises, staff and equipment 6)by taking all standard measures and activities in order to prevent risk from transferring of transmissible or any other disease to recipient and to avoid influences to preservation of body parts for transplantation. Data on donor and recipient of body parts are a professional secret Chapter 28: CONSUMER AND HEALTH PROTECTION

14. Chapter 28: Consumer and Health Protection M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Subject Matter, Purpose and Principles of the Law Procedure of removal and transplantation of human body parts shall be carried out with application of the principles: 1)of acceptance, i.e. consent of both recepient and donor 2)of donation for the sake of treatment 3)of uncommercial donation 4)of anonymity of donor and recepient Popularisation of the procedure of donating of body parts Chapter 28: CONSUMER AND HEALTH PROTECTION

15. Chapter 28: Consumer and Health Protection M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Removal of Body Parts from a Living Donor  only for the purpose of a medical treatment, provided there is no appropriate body part of a dead donor available or any other form of medical intervention;  only from persons over 18 years of age under condition that that person is capable of work and of making judgment;  if adequate medical examinations and interventions for estimation and reduction of physical and psychic risks for health of the donor are performed prior to removal;  only if according to medical criteria the risk for life and health of the donor is within limits of acceptable and corresponds to expected benefit for the recipient ;  if the donor has given for that intervention his written consent authorized by competent authority;  doctor involved in the removal of body parts has informed the donor about the nature, purpose and course of the procedure, chances for success and usual risks of removal of body parts;  Donor is informed about the right to an independent consultation about the risks to health from a doctor who is not involved in the removal or transplantation of body parts, i.e. who is not a personal physician of the recipient, and about other rights stipulated by this Act. Chapter 28: CONSUMER AND HEALTH PROTECTION

16. Chapter 28: Consumer and Health Protection M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Removal of Body Parts from Dead Donor only if that person as a person of age, capable of work and of making judgment has given written voluntarily consent for this procedure with his personal physician; from an underage dead person for transplantation into other person for the purpose of medical treatment may be performed only with written consent of both parents; after the death of the donor has been established and confirmed in compliance with medical criteria and set procedures. Chapter 28: CONSUMER AND HEALTH PROTECTION

17. Chapter 28: Consumer and Health Protection M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Transplantation of Body Parts Transplantation of body parts may be performed only with written consent of informed recipient of age, capable of work and making judgment. For underage persons and persons over 18 years of age who are not capable of work or of making judgment, consent shall be given by a legal representative, i.e. guardian. Reasons for urgent transplantation of body parts HANDLING OF REMOVED BODY PARTS Chapter 28: CONSUMER AND HEALTH PROTECTION

18. Chapter 28: Consumer and Health Protection M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Health Care Institutions for Removal and Transplantation of Body Parts Removal, transplantation, determining of compatibility, storage and exchange of body parts shall be performed by health care institutions or parts of health care institutions that possess the decision of the Ministry to perform these procedures concerning the premises, equipment and staff Analyses of body parts, before using, shall only be performed in laboratory which meets the conditions regarding application of optimal level of accepted medical standards, premises, staff, technical or other conditions A coordinator shall be appointed in health care institutions, who will be responsible for implementation of procedures of removal and transplantation of body parts Chapter 28: CONSUMER AND HEALTH PROTECTION

19. Chapter 28: Consumer and Health Protection M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Registry and Records Ministry keeps the registry of persons who gave their consent for removal of body parts in case of their death; Health care institutions keep records on personal data on donors and recipients, on each removal and transplantation of body parts, exchange of body parts, successfulness of interventions, possible complications, health condition of donor and recipient after the performed intervention, measures taken to provide quality of performing of interventions and other data in accordance with a special Law; Coordinator shall submit annual reports to the Ministry; SUPERVISION PUNITIVE PROVISIONS Chapter 28: CONSUMER AND HEALTH PROTECTION

20. Chapter 28: Consumer and Health Protection M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Law on Infertility Treatment with Assisted Reproductive Technologies conditions, manner and procedure of infertility treatment of women and men with assisted reproductive technologies; rights to fertilization with the use of ART procedures; donation of gametes; conditions under which the ART procedures are performed in heaht care institutions; supervision over the implementation of the Law other matters relevant for the application of ART procedures elimination of infertility or reduced fertility by using biomedical achievements, after it was determined that the pregnancy cannot be achieved by other ways of treatment treatment also represents retrieving and keeping of men’s spermatozoa or women’s oocyres in cases when according to knowledge and experience of medical science there is a danger of infertility Chapter 28: CONSUMER AND HEALTH PROTECTION

21. Chapter 28: Consumer and Health Protection M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Law on Infertility Treatment with Assisted Reproductive Technologies RIGHT TO TREATMENT WITH APPLICATION OF ART PROCEDURES HEALTH CARE INSTITUTIONS FOR INFERTILITY TREATMENT WITH APPLICATION OF ART PROCEDURES AND ART PROCEDURES 1.Institutions for application of ART procedures 2.ART procedures with gametes 3.ART procedures with gametes of male or female donor HANDLING GAMETES OR EARLY EMBRYOS KEEPING OF SPERMATOZOA, UNFERTILIZED OOCYTES AND EARLY EMBRYOS RECORDS AND REPORTS SUPERVISION PUNITIVE PROVISIONS Chapter 28: CONSUMER AND HEALTH PROTECTION

22. Thank you for your attention. QUESTIONS?