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 Milica Golubović Advisor Ministry of Health milica.golubovic@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 RARE DISEASES

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  National Strategy for Rare Diseases in Montenegro 2013- 2020  Institutional Framework 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 32010D0728 (EUR-Lex: 15.30 / 01.40) Commission Decision of 27 July 2010 on the appointment of the members of the European Union Committee of Experts on Rare Diseases set up by Decision 2009/872/EC (Dec. 2010/C 204/02) (OJ C 204, 28.7.2010, p. 2–5) Council Recommendation of 9 June 2009 on a European Action in the field of rare diseases - Rec. 2009/C 151/02 32009D0872 (EUR-Lex: 15.30 / 01.40) 2009/872/EC: Commission Decision of 30 November 2009 establishing a European Union Committee of Experts on Rare Diseases (OJ L 315, 2.12.2009, p. 18) 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 National Legislation CONSTITUTION OF MONTENEGRO LAW ON HEALTH CARE (“Official gazette of RoM“, no.39/2004, „Official gazette of Montenegro”, nos.14/2010 and 40/2011) LAW ON HEALTH INSURANCE (“Official gazette of RoM“, NO.39/2004, “Official gazette of Montenegro“, no.14/2012) NATIONAL STRATEGY FOR RARE DISEASES IN MONTENEGRO 2013- 2020 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 Chapter 28: CONSUMER AND HEALTH PROTECTION National Strategy for Rare Diseases in Montenegro 2013-2020 Montenegro and Rare Diseases There is no standardised approach to rare diseases in Montenegro. Additional obstacle is a lack of appropriate registration and unified monitoring of rare diseases at national level, insufficient organisation and connection of all segments in dealing with persons suffering from rare diseases. Another problem is insufficiently raised awareness, of both professional and general public concerning the importance of rare diseases and their influence on heath and quality of life.

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 BUDGET FOR RARE DISEASES Significant financial investments GLOBAL OBJECTIVE Global objective of the Strategy for Rare Diseases in Montenegro Main objectives of the Strategy Chapter 28: CONSUMER AND HEALTH PROTECTION

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 Priorities Provision of epidemiological data on rare diseases and establishing of National Registry of Rare Diseases. Integrated approach to discovering, diagnostics, prevention and social integration of persons with rare diseases and their families. Improvement of prevention of rare diseases with genetic origin, by organisation of extensive “screening” programmes. Improvement of prevention of rare diseases with genetic origin, by introducing new diagnostical technologies and promotion of facilitated access to genetic information and counseling. Increase of professional qualifications of medical specialists for adequate discovering and eary diagnostic of rare diseases. Drafting of guidelines and criteria for establishment of National Reference Centre for Rare Diseases. Forming of National Reference Centre for Rare Diseases. Raising of awareness of professional and general public on importance of rare diseases and their influence on healt of population. Definition and provision of financial framework for rare diseases. Support and cooperation of NGOs of patients and families with rare diseases. Establishment of international professional cooperation in the field of registration, monitoring, diagnostics, treatment and research of rare diseases. 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 Chapter 28: CONSUMER AND HEALTH PROTECTION The Country population Medical specialists Non-governmental organisations Target Group

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 Programme Activities Establishment of the National Council for Rare Diseases (NCRD) within the Ministry of Health Tasks of the NCRD Criteria for forming of the list of rare diseases Preparation of studies on establishment of the Reference National Centre for RD in Montenegro Establishment of RNCRD with setting up of multidisciplinary network of national institutions and experts for rare diseases Tasks of RNCRD Setting up and implementation of the National Registry for RD Improvement of prevention and diagnostics of rare diseases, congenital anomalies and genetic predispositions/tendencies. Improvement of control and supervision of the overal treatment congenital diseases and those with genetic origin. Upgrading of knowledge and professional capacities of medical specialists in the field of early prevention, diagnostics, therapy and rehabilitation of patients with rare diseases. Promotion of integrated approach in implementation of programmes of prevention, diagnostics, treatment and social inclusion of patients with rare diseases and their families Organisation of national public campaigns for raising of general and professional awareness on importance of rare diseases Cooperation and support of NGO and organisations of patients Establishment of efficient regional and international cooperation 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 Management and Coordination of the Program Activities Supervision and evaluation of implementation of the Strategy and Action Plan for Rare Diseases shall be performed by the National Council for Rare Diseases, including the inter-sectoral coordination of all activities in the field of overal treatment of rare diseases in Montenegro. Implementation of the National Strategy for Rare Diseases shall be carried out by the RNCRD. 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 Institutional Framework Diagnostic and research centres and laboratories at tertiary level Centre for medical genetics and immunology with the cabinet for clinical genetics and genetic counseling and information and multidisciplinary professional consilia Services in health care institutions, departments of gynecology and obstetrics, maternity hospital and department of neonatology in general hospitals and Clinical Centre of Montenegro Team of national experts and researchers in the field of rare diseases Doctors of medicine and other medical experts in the primary health care Ministry of Health, Health Insurance Fund, Ministry of Labor and Social Welfare, Ministry of Education and Ministry of Science; NGO and association of patients with rare diseases. Chapter 28: CONSUMER AND HEALTH PROTECTION

13. Thank you for your attention. QUESTIONS?