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 PUBLIC HEALTH – HORIZONTAL Slavojka Šuković Adviser 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 Risk assessment

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  Strategies  Constitution of Montenegro  Strategy for Health Care Development in Montenegro until 2020  Law on Health Care  Law on Health Insurance  Law on Rights of Patients  Other laws of Montenegro  Master Plan Development for Health Care in Montenegro 2010-2013  Reforms of Health Care System  Risk assessment Chapter 28: CONSUMER AND HEALTH PROTECTION

4. M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Relevant Acquis Treaty on the European Union EU strategy »Together for health: strategic accession to the EU 2008-13« 32011D0281 (EUR-Lex: 01.40) 2011/281/EU: Commission Decision of 16 May 2011 amending Decision 2009/146/EC as regards the replacement of members of the Scientific Committees by members from the Pool of scientific advisors set up by Decision 2008/721/EC (OJ L 129, 17.5.2011, p. 15–16) 32007D0708 (EUR-Lex: 15.20.30) 2007/708/EC: Commission Decision of 31 October 2007 amending the list of experts appointed as members of the Scientific Committees in the field of consumer safety, public health and the environment and the prolongation of their term of office (OJ L 287, 1.11.2007, p. 25–28) 32004D0210 (EUR-Lex: 15.20.30) 2004/210/EC: Commission Decision of 3 March 2004 setting up Scientific Committees in the field of consumer safety, public health and the environment (Text with EEA relevance) (OJ L 66, 4.3.2004, p. 45) Chapter 28: CONSUMER AND HEALTH PROTECTION Chapter 28: Consumer and Health Protection

5. 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 as of 2007 Law on health care (“Official Gazette of RoM", no. 39/04 and “Official Gazette of MNE", no 14/10)39/04 14/10 Law on health insurance (“Official Gazette of RoM", no. 39/04 and “Official Gazette of MNE", no. 14/12)39/0414/1 Law on rights of patients (“Official Gazette of MNE", no. 40/10)40/10 Law on health care of patients (“Official Gazette of MNE", no. 25/10)25/10 Law on medicines (“Official of MNE", no. 56/11)56/1 Law on medical devices (“Official Gazette of RoM", no. 79/04 and “Official Gazette of MNE", no. 53/09)9/04/ Law on contributions of compulsory social insurance („Official Gazette of MNE", no. 13/2007, 79/2008, 86/2009, 78/2010 and 14/2012)13/200779/200886/200978/201014/2012 Law on inspection supervision (“Official Gazette of RoM", no. 39/2003 and “Official Gazette of MNE", no. 76/2009)39/200376/2009 Law on health inspection („Official Gazette of MNE", no. 79/08) Chapter 28: CONSUMER AND HEALTH PROTECTION Chapter 28: Consumer and Health Protection

6. M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Pharmaceutical Institution „MONTEFARM“ Agency for Pharmaceuticals and Medical Devices of Montenegro, Doctors’ Chamber of Montenegro Pharmaceutical Chamber of Montenegro Directorate for Inspection Supervision (health – sanitary inspection) Private health institutions not included in the Network of health institutions NGOs Chapter 28: CONSUMER AND HEALTH PROTECTION Chapter 28: Consumer and Health Protection Institutional Framework

7. M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Strategies Health Care Policy in Montenegro until 2020, Health Care Development Strategy in Montenegro until 2020, as of 2003 Master Plan for Development of Health Care in Montenegro for the period 2010-2013 Strategy for Optimization of Secondary and Tertiary Level of Health Care with the Action Plan for Implementation National Strategy for Rare Diseases in Montenegro 2013-2020 and the Action Plan for 2013-2020, with the Budget for 2013-2016 National Strategy on Control of Bacterial Resistance to Antibiotics 2012- 2016 Chapter 28: CONSUMER AND HEALTH PROTECTION Chapter 28: Consumer and Health Protection

8. M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Strategies Chapter 28: CONSUMER AND HEALTH PROTECTION Chapter 28: Consumer and Health Protection National Strategy to prevent harmful use of alcohol and alcohol-related disorders in Montenegro 2013-2020 National Strategy for Improvement of Health Care Quality and Safety of Patients, with Action Plan 2012-2017 Strategy for Improvement of Health of Employees and Safety at Work in Montenegro 2010-2014, with Action Plan for Implementation Strategy for Integration of persons with disabilities in Montenegro 2008 - 2016 National Strategic Response to HIV/AIDS in Montenegro 2010-2014 Strategies are published on the webpage of the Ministry of Health www.mzd.gov.mewww.mzd.gov.me Strategy for scientific-research activity of Montenegro (2008-2016)

9. M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Constitution of Montenegro It is stipulated by the Article 69 of the Constitution of Montenegro that everyone shall have the right to health protection. A child, a pregnant woman, an elderly person and a person with disability shall have the right to health protection from the public revenues, unless this right is exercised on some other grounds. Chapter 28: CONSUMER AND HEALTH PROTECTION Chapter 28: Consumer and Health Protection

10. M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Strategy for Health Care Development in Montenegro Until 2020 ( Adopted In 2003) General objectives of the healthcare policy: Prolongation of life span Improvement in quality of life in regards to health Reduction of differences in state of health Insurance against financial risk Chapter 28: CONSUMER AND HEALTH PROTECTION Chapter 28: Consumer and Health Protection

11. M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Law on Health Care SCOPE AIM PRINCIPLES Chapter 28: CONSUMER AND HEALTH PROTECTION Chapter 28: Consumer and Health Protection

12. M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Health Care Priority health care measures Public interest in the area of health care Health care measures related to work and working environment Rights and obligations of citizens in the implementation of health care Health care implementation Maintaining of medical documentation and records Health care of foreigners Chapter 28: CONSUMER AND HEALTH PROTECTION Chapter 28: Consumer and Health Protection

13. M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Health Activity and Health Institutions Levels of health activity Types of health institutions Founding of health institutions Bodies, organization, working hours and means for work of health care institutions Chapter 28: CONSUMER AND HEALTH PROTECTION Chapter 28: Consumer and Health Protection

14. M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Health Workers and Health Associates Skill training and capacity building of health workers Licenses Chambers Chapter 28: CONSUMER AND HEALTH PROTECTION Chapter 28: Consumer and Health Protection

15. M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Quality of Health Care and Control of Quality of Professional Performance Upgrading of the quality of health care Control of the quality of professional performance – supervision – penal provisions Chapter 28: CONSUMER AND HEALTH PROTECTION Chapter 28: Consumer and Health Protection

16. M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Regulations for Implementation of the Law Rulebook on specific conditions and method of obtaining title of Primarius Rulebook on specific conditions for performance of auxiliary work by health care workers in network of health care institutions Decision on network of health care institutions Rulebook on working hours in health care institutions Rulebook on specific conditions, duration, method of performing residency and taking the professional exam, plan and program of practice and training for apprentices- health workers and health associates with high education Chapter 28: CONSUMER AND HEALTH PROTECTION Chapter 28: Consumer and Health Protection

17. M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Regulations for Implementation of the Law Rulebook on specific conditions for performance of health care activities in hospitals and health resorts Rulebook on specific conditions in terms of standards, norms and methods of exercising the right to primary health care either through a chosen team of doctors or one chosen doctor Rulebook on lease of premises, equipment and other means necessary for performance of dentistry Rulebook on conditions that must be fulfilled by pharmacies, in terms of space, necessary staff and medical technical equipment Decree on provision of medicines and medical means Chapter 28: CONSUMER AND HEALTH PROTECTION Chapter 28: Consumer and Health Protection

18. M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Regulations for Implementation of the Law Rulebook on conditions, criteria and procedure for approval of specializations Rulebook on specializations Rulebook on scope of measures of specific health care of the employed Rulebook on continuous education and evaluation method in all types of capacity building of health workers Rulebook on content and method of maintaining registry of work licenses and licenses based on practice and forms of licenses for graduated pharmacists Chapter 28: CONSUMER AND HEALTH PROTECTION Chapter 28: Consumer and Health Protection

19. M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Regulations for Implementation of the Law Decision on form and content of health card for refugees and internally displaced persons Decision on method of recording refugees and internally displaced persons Decision on form and content of medical forms Rulebook on method and procedure of implementation of external supervision over professional performance of health institutions and measures for removal of determined inadequacies Decision on participation of insured persons in health care expenses Chapter 28: CONSUMER AND HEALTH PROTECTION Chapter 28: Consumer and Health Protection

20. M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Law on Health Insurance SCOPE AIM PRINCIPLES Chapter 28: CONSUMER AND HEALTH PROTECTION Chapter 28: Consumer and Health Protection

21. M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Compulsory Health Insurance Rights within the compulsory insurance right to health care rights to the wage compensation during temporarily incapability for work right to compensation for travel expenses related to the use of health care Chapter 28: CONSUMER AND HEALTH PROTECTION Chapter 28: Consumer and Health Protection

22. M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Funding Of Compulsory Health Insurance Compulsory health insurance 1) contributions for compulsory health insurance 2) donations 3) funds based on conventions 4) compensation of damage Voluntary health insurance Chapter 28: CONSUMER AND HEALTH PROTECTION Chapter 28: Consumer and Health Protection

23. M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Regulations for Implementation of the Law Decision on specified List of medicines which are prescribed and dispensed charging the Health Insurance Fund Rulebook on criteria for entering into contracts on providing health care and method of paying for health care services Rulebook on method of work, composition and authorizations of the second instance panel of doctors Rulebook on indications and utilization of medical rehabilitation at medical institutions performing specialized rehabilitation Rulebook on method and procedure of exercising the right to medical- technical devices Chapter 28: CONSUMER AND HEALTH PROTECTION Chapter 28: Consumer and Health Protection

24. M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Regulations for Implementation of the Law Rulebook on method and procedure of referring the insured abroad for medical treatment Rulebook on composition, type of education and work of the first instance panel of doctors Rulebook on method and procedure of exercising the right to temporary working disability and exercising the right to wage compensation during the period of working disability Rulebook on specific conditions and method of exercising certain rights within the compulsory health insurance Decree on scope of rights and standards of health care within the compulsory health insurance Chapter 28: CONSUMER AND HEALTH PROTECTION Chapter 28: Consumer and Health Protection

25. M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Law on Protection of Patients RIGHTS OF PATIENTS: Right to free choice of medical doctor or a dentist Right to information and notification Right to self-decision (free choice) Right to insight into medical documentation Right of a patient to refuse to be an object of scientific research and examination Right to different professional opinion Right to privacy and confidentiality Right to prompt health care Right to objection Right to compensation of damage Right to voluntary discharge from a health institution Chapter 28: CONSUMER AND HEALTH PROTECTION Chapter 28: Consumer and Health Protection

26. M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Other Laws Law on Health Care of Patients Law on Medicines Law on Contributions for Compulsory Social Insurance Law on Inspection Supervision Law on Health Inspection Chapter 28: CONSUMER AND HEALTH PROTECTION Chapter 28: Consumer and Health Protection

27. M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Instrument of the health care policy which gives directions to development of the health system, starting from the achieved level of implemented reforms Follows guidelines of the healthcare strategy of the European Union »Together for health« a strategic approach to the EU for the period 2008- 2013 Aimed for efficient, rational and sustainable development of the health care system in accordance with the universal values, goals and instruments of development of the health care system Puts an emphasis on reform of secondary and tertiary level of the health care Chapter 28: CONSUMER AND HEALTH PROTECTION Chapter 28: Consumer and Health Protection MASTER PLAN 2010-2013

28. M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union VISION To build an accessible, quality and long-term sustainable health care system, with a citizen at the centre of the system and with strengthened individual awareness and responsibility for consequences of decisions on personal health and health of others. MISSION Creating conditions for promoting health in all policies for all in Montenegro, in order to safeguard and improve the health of the population of Montenegro. Chapter 28: CONSUMER AND HEALTH PROTECTION Chapter 28: Consumer and Health Protection Master Plan Guidelines

29. M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union 1.Completed all the activities related to primary health care reform, on the whole territory of Montenegro 2.Established a Network of health institutions, as a geographical distribution of capacities of public health care institutions and concessionaires 3.Defining a mandatory package of services for secondary and tertiary health care 4.Introduced transparent systems of patients classification as a basis to change the system of financing, i.e. charging according to seriousness and complexity of diseases 5.Strengthened a specialist-hospital activity, acute and non-acute hospital treatment and transferred activities into hospitals 6.Introduced an additional offer in the area of voluntary health insurance and public-private partnership 7.Implemented a comprehensive palliative care development programme at the national level 8.Introduced national and international clinical guidelines, and established clinical guides, standards, protocols and codes of conduct based on scientific evidence 9.Number of personnel at the secondary and tertiary health care planned according to the citizens’ needs, which will be defined by national priorities, number of patients and covered gravitational areas Chapter 28: CONSUMER AND HEALTH PROTECTION Chapter 28: Consumer and Health Protection Master Plan Guidelines

30. M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Primary level of health care Dentistry health care Information system Reform of secondary and primary health care level Chapter 28: CONSUMER AND HEALTH PROTECTION Chapter 28: Consumer and Health Protection Reforms of the Health System

31. M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union MINISTRY OF HEALTH HEALTH INSURANCE FUND OF MONTENEGRO Network of health institutions: 1)Public health institutions: – 18 public health centers – 7 general hospitals – 3 specialist hospitals – CLINICAL CENTER OF MONTENEGRO – INSTITUTE OF PUBLIC HEALTH OF MONTENEGRO – BUREAU FOR TRANSFUSION OF BLOOD OF MONTENEGRO – BUREAU FOR EMERGENCY HEALTH CARE 2)Private health institutions with which the Health Insurance Fund has concluded a contract on providing of health care arising from compulsory health care Chapter 28: CONSUMER AND HEALTH PROTECTION Chapter 28: Consumer and Health Protection Institutional Framework

32. M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Faculty of Medicine Clinical Center of Montenegro – Center for science, Medical Board, Ethical Committee Institute of Public Health – Ethical Committee Ministry of Science – Council for Scientific and research activity Chapter 28: CONSUMER AND HEALTH PROTECTION Chapter 28: Consumer and Health Protection Risk assessment

33. Thank you for your attention. QUESTIONS?