Transcript Bulgaria

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: BCB promotes the development and application
of bioethics in Bulgaria, including medical ethics, research
ethics, animal ethics, ethics of biotechnology and
agricultural ethics
 Activities
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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/indexEN.htm
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 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 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 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.
 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 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 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
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 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 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 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:
(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 - 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 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
 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
10
http://www.nchi.government.bg/Xrevizia.html
 Maria Radeva, Bulgarian Health Care System
http://www.stenobooks.com/knigi/medicinska%20literatura/2/ra
deva-zdr.sistema/index.html
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
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 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, 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.
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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 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
Thank You!
E-mail: [email protected]