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Patient Rights in Bulgaria: de jure and de facto Assya Pascalev, Ph. D. , Patient Rights in Bulgaria: de jure and de facto Assya Pascalev, Ph. D. , Executive Director Yordanka Krastev, M. D. , Ph. D. , Fellow Bulgarian Center for Bioethics 27 January, 2009

Bulgarian Center for Bioethics § Founded in 2004 in Sofia § NGO § Mission: Bulgarian Center for Bioethics § Founded in 2004 in Sofia § NGO § Mission: BCB promotes the development and application of bioethics in Bulgaria, including medical ethics, research ethics, animal ethics, ethics of biotechnology and agricultural ethics § Activities • • Research and scholarship Expert advice and consulting Education and training in all areas of bioethics Discussions, symposia, meetings, round tables, seminars and workshops § URL: http: //www. bio-ethics. net/EN/index. EN. htm

Patient Rights in Bulgaria - de jure: 1. Regulations of patient rights in Bulgaria: Patient Rights in Bulgaria - de jure: 1. Regulations of patient rights in Bulgaria: § Bulgarian Constitution § Health Act 2004 - SG No. 70/10. 08. 2004, effective 1. 01. 2005, supplemented, SG No. 46/3. 06. 2005, amended and supplemented, SG No. 76/20. 09. 2005, effective 1. 01. 2007, SG No. 85/25. 10. 2005, effective 25. 10. 2005 § The National Framework Contract (2008 edition) § Health Insurance Act 1998. State Gazette, No. 70/1998. Amended State Gazette, No. 93/1998; 153/1998; 62/1999; 65/1999; 67/1999; 69/1999; 110/1999; 113/1999; SG 1/2000; 64/2000; 41/2001; 1/2002; 54/2002, 74/2002, 107/2002, 8/2003 § Health Care Establishment Act 1999 State Gazette, No. 62/1999. Amended State Gazette, No. 113/1999; 36/2000; 65/2000; 108/2000; 51/2001; 28/2002; 62/2001

Patient Rights in Bulgaria - de jure: Regulations of patient rights (cont’d): § Medicinal Patient Rights in Bulgaria - de jure: Regulations of patient rights (cont’d): § Medicinal Products in Human Medicine Act, State Gazette No. 31/13. 04. 2007, amended, SG No. 19/22. 02. 2008, Judgment No. 5/10. 07. 2008 of the Constitutional Court of the Republic of Bulgaria – SG No. 65/22. 07. 2008, amended and supplemented, SG No. 71/12. 08. 2008, effective 12. 08. 2008 § Transplantation Law for Organs, Tissues and Cells § Bulgarian Codex of Professional Ethics 2000, State Gazette, No. 79/2000 § Preventive Medicine Act № 39 of 16 Nov. , 2004

Patient Rights in Bulgaria - de jure: 2. Rights granted explicitly: § by the Patient Rights in Bulgaria - de jure: 2. Rights granted explicitly: § by the Bulgarian Constitution: • universal right to state health insurance • free access to health care • free health care • protection from compulsory treatment

Patient Rights in Bulgaria - de jure: 2. Rights granted explicitly (cont’d): § by Patient Rights in Bulgaria - de jure: 2. Rights granted explicitly (cont’d): § by the National Health Insurance Fund (NHIF): • free choice of a general practitioner (GP) who has a contract with the Regional HIF - de facto limited in the rural areas • accessible, timely and good-quality medical and dental care included in a basic package guaranteed by the RHIF budget de facto limited for minorities and marginalized citizens • solution to problems within the competency of NHIF - de facto bureaucratized and biased to the medical profession • awareness - de facto limited public education on patient rights and lack of debate on important issues pertaining to health care • participation in the management of NHIF through their representatives • second opinion • protection of the rights of health-insured citizens: reception rooms in the NHIF Central Office, in RHIF and in the municipal offices (citizens can receive up-to-date information and can file complaints of violations) - conflict of interests

Patient Rights in Bulgaria: 3. Implementation and Enforcement of Patient Rights in Bulgaria. § Patient Rights in Bulgaria: 3. Implementation and Enforcement of Patient Rights in Bulgaria. § National body in charge: National Health Insurance Fund - reception rooms - National Information Responsibilities Centre for Patient Rights & - NHIF hot line (services 10 lines) - NHIF web site for consultations - site is in Bulgarian and English: www. nhif. bg

Patient Rights in Bulgaria : 3. Implementation (cont’d). § NGO’s and patient advocacy groups Patient Rights in Bulgaria : 3. Implementation (cont’d). § NGO’s and patient advocacy groups by disease Bulgarian Association for Protection of Patients’ Rights http: //www. patient. bg/main. php? act=content&rec=27 Bulgarian Helsinki Committee /www. bghelsinki. org/index. php? module=home&lg=en

Patient Rights in Bulgaria - Problems and Challenges : § Strong tradition of medical Patient Rights in Bulgaria - Problems and Challenges : § Strong tradition of medical paternalism § Inadequate citizen education and awareness § Lack of strong democratic traditions § Young civil society § Little emphasis on individual autonomy and selfdetermination § Lack of hospital ethics committees, advocates and health ombudsman for patient concerns - limits EC Right 13 § Lack of accessible, speedy and efficient legal recourse - EC Right 14

Patient Rights in Bulgaria - Violations : § Lack of adequate resources for health Patient Rights in Bulgaria - Violations : § Lack of adequate resources for health care - EC Right 2 § Discrimination of minorities (Roma) and disease types - see WHO Report on Bulgaria, 2007, Reports by Bulgarian Helsinki Committee and Amnesty International on mental health patients EC Rights 1 & 2

Patient Rights in Bulgaria - Violations : BHC Website: “…After the launch of the Patient Rights in Bulgaria - Violations : BHC Website: “…After the launch of the campaign, the Bulgarian authorities decided to close down the institution in Sanadinovo, notorious for its cage for human beings in the yard, and announced its plans to close down the institution in Dragash Vojvoda, where 22 men - or a striking 15% of the resident population had died over a 15 month period (January 2001 - March 2002). ” The Social Care campaign of BHC is carried out with Amnesty International and Mental Disability Rights International.

Patient Rights in Bulgaria - Violations : § Lack of meaningful informed consent ECR Patient Rights in Bulgaria - Violations : § Lack of meaningful informed consent ECR 4 § Privacy and confidentiality issues - ECR 6 § Lack of respect for the patient’s time ECR 7

Patient Rights in Bulgaria - Access to Health Care Records : Regulated by the Patient Rights in Bulgaria - Access to Health Care Records : Regulated by the HEALTH ACT, Articles 27 & 28 Article 27: (1) Health information includes the personal data and any other information contained in medical prescriptions, instructions, protocols, certificates and other medical documentation. (2) Medical and healthcare establishments, RHC, RIPHPC, medical doctors, dentists, pharmacists and other medical specialists, as well as non-medical specialists with higher non-medical education working in the national healthcare system shall collect, process, use and store health information.

Patient Rights in Bulgaria - Access to Health Care Records (cont’d) : Article 28: Patient Rights in Bulgaria - Access to Health Care Records (cont’d) : Article 28: (1) Health information may be disclosed to this parties in any of the following cases: 1. the treatment of the person continues at another medical establishment; 2. there exists a threat to the health or life of other persons; 3. it is necessary for identifying a human corpse of for establishing the reasons for the death; 4. it is necessary for the needs of the state health control to prevent epidemics or the spread of infectious diseases;

Patient Rights in Bulgaria - Access to Health Care Records (cont’d) : Article 28 Patient Rights in Bulgaria - Access to Health Care Records (cont’d) : Article 28 - cont’d: 5. it is necessary for the needs of medical expert activities and the social security scheme; 6. it is necessary for the needs of medical statistics or medical research, having deleted the data identifying the patient; 7. it is necessary for the needs of the Ministry of Health, the National Health Information Centre, NHIF, RHC, RIPHPC, and the National Statistical Institute. (2) In the cases under Paragraph 1, Item 2, the information shall be disclosed upon notification of the person concerned. (3) The persons under Article 27, Paragraph 2 shall ensure the protection of the health information they keep against unauthorised access.

Patient Rights in Bulgaria - Access to Health Care Records (cont’d) : Regulations in Patient Rights in Bulgaria - Access to Health Care Records (cont’d) : Regulations in case of death? § Euthanasia and PAS illigal § Very limitted use of advance directives (living wils and proxy designation) - living wils only available and required of cancer patients with 6 mos. life expectancy treated under NHIF - problematic restriction (arbitrary) and requirement (undue pressure, too late) § Designation of proxy or a surrogate possible but enforcement is uncertain because there are no specific legal provisions - surrogates chosen by others (doctor, family) among relatives § BCB initiatives on advance directives: § National Conference in June 2008 (Position Statement) § participation in the European Science Foundation project on European advance directives

Access to Health Care Records Language Issues : § Documents are in Bulgarian § Access to Health Care Records Language Issues : § Documents are in Bulgarian § Latin is used for diagnosis and desciptions (“CA” for cancer, not the Bulgairan “rak”) § Interpretation from Bulgarian can be arrnaged but: • there are no interpreters in the hospitals • not clear how promptly can be arranged • who pays?

Translation of Medical Terms : § National Centre of Health Informatics, Bulgaria – ICD Translation of Medical Terms : § National Centre of Health Informatics, Bulgaria – ICD 10 http: //www. nchi. government. bg/Xrevizia. html § Maria Radeva, Bulgarian Health Care System http: //www. stenobooks. com/knigi/medicinska%20 literatura/2/ra deva-zdr. sistema/index. html

Quality Standards for Health Care: WHO Report Bulgaria: Health system review, Health systems in Quality Standards for Health Care: WHO Report Bulgaria: Health system review, Health systems in transition, Vol. 9 No. 1 2007 § The quality of medical care - one of the most significant health care delivery problems; the most difficult to analyse § Lack of quality monitoring in Bulgaria § There is no quality management system encompassing quality criteria and standards, quality assurance, medical protocols and/or reference quality overviews § Development is lagging behind in management: the quality of contracts, the monitoring of services, expenditure; and fraud prevention

Quality Standards for Health Care: WHO Report Bulgaria: Health system review, Health systems in Quality Standards for Health Care: WHO Report Bulgaria: Health system review, Health systems in transition, Vol. 9 No. 1 2007 Efforts to improve the quality of care in BG since the start of the health reforms: • introduction of financial incentives for providing better care • the creation of new responsibilities for existing agencies to control and monitor • better training for health and allied health professionals • payment of health personnel is now performance-based • 2004 Health Act provided for: 1) the establishment of a Registry of health professionals to be developed by the Ministry of Health and 2) the introduction of medical standards for certain professions

Quality Standards for Health Care: WHO Report Bulgaria: Health System Review, Health Systems in Quality Standards for Health Care: WHO Report Bulgaria: Health System Review, Health Systems in Transition, Vol. 9 No. 1 2007 § Disparities in health care quality between rural and urban areas - low quality of services in rural areas due to the lack of efficient communication lines, equipment and the condition of hospitals § Health institutions: § hospital accreditation by the Accreditation Council at the Ministry of Health introduced in 2003 § some hospitals have the ISO 2001: 2000 international certificate

Quality Standards for Health Care cont’d: Bulgaria: Health system review, Health systems in transition, Quality Standards for Health Care cont’d: Bulgaria: Health system review, Health systems in transition, Vol. 9 No. 1 2007: “Such initiatives have not been as successful and well received owing to the fact that there are currently no real incentives for rewarding high quality care, as the accreditation system is not linked to differential payments from the NHIF, which in certain circumstances may decrease the incentives for providing the best care for the patient. ” Example: Referrals for preventive care in obstetrics and gynecology for ovarian and cervical cancer. § limited number of referrals allowed per GP § GP’s fined for exceeding allotted referrals § violation of ECR § makes no financial sense - prevention less costly then acute therapy § How are referral needs predicted?

Regulations of Cross-Border Health Care in Bulgaria: European Health Insurance Card (2003) • right Regulations of Cross-Border Health Care in Bulgaria: European Health Insurance Card (2003) • right to urgent and emergency treatment of Bulgarian citizens within EU if they participate in NHIF • covers medications • the patient must had made uninterrupted payments to the NHIF or must have filed a declaration for absence from the country

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