Patient Rights in Bulgaria: de jure and de facto

27 January, 2009

Patient Rights in Bulgaria: Patient Rights in Bulgaria: de jure and de jure and de factode facto

Patient Rights in Bulgaria: Patient Rights in Bulgaria: de jure and de jure and de factode facto

Assya Pascalev, Ph.D., Executive Director

Yordanka Krastev, M.D., Ph.D., Fellow

Bulgarian Center for BioethicsBulgarian Center for Bioethics

Assya Pascalev, Ph.D., Executive Director

Yordanka Krastev, M.D., Ph.D., Fellow

Bulgarian Center for BioethicsBulgarian Center for Bioethics

Bulgarian Center for BioethicsBulgarian Center for BioethicsBulgarian Center for BioethicsBulgarian 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/indexEN.htm

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/indexEN.htm

Patient Rights in Bulgaria - Patient Rights in Bulgaria - de jurede jure::Patient Rights in Bulgaria - Patient Rights in Bulgaria - de jurede 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

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


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

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


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

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


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

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:Patient Rights in Bulgaria: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 Centre for Patient Rights &

Responsibilities

- NHIF hot line (services 10 lines)

- NHIF web site for consultations - site is in Bulgarian and

English: www.nhif.bg

3. Implementation and Enforcement of Patient Rights in Bulgaria.

National body in charge: National Health Insurance Fund

- reception rooms

- National Information Centre for Patient Rights &

Responsibilities

- NHIF hot line (services 10 lines)

- NHIF web site for consultations - site is in Bulgarian and

English: www.nhif.bg

http://www.nhif.bg/

http://www.nhif.bg/

Patient Rights in Bulgaria :Patient Rights in Bulgaria :Patient Rights in Bulgaria :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

3. Implementation (cont’d).

NGO’s and patient advocacy groups by disease

Bulgarian Association for Protection of Patients’ Rights


Bulgarian Helsinki Committee/www.bghelsinki.org/index.php?module=home&lg=en



Patient Rights in Bulgaria - Problems Patient Rights in Bulgaria - Problems and Challenges :and Challenges :

Patient Rights in Bulgaria - Problems Patient Rights in Bulgaria - Problems and Challenges :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 self-

determination

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

Strong tradition of medical paternalism

Inadequate citizen education and awareness

Lack of strong democratic traditions

Young civil society

Little emphasis on individual autonomy and self-

determination

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 :Patient Rights in Bulgaria - Violations :Patient Rights in Bulgaria - Violations :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

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


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.

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.


Lack of meaningful informed consent -

ECR 4

Privacy and confidentiality issues - ECR 6

Lack of respect for the patient’s time -

ECR 7

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 Patient Rights in Bulgaria - Access to Health Care Records :Health Care Records :

Patient Rights in Bulgaria - Access to Patient Rights in Bulgaria - Access to Health Care Records :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.

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 Patient Rights in Bulgaria - Access to Health Care Records (cont’d) :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;

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;



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.

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.



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

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 - Access to Health Care Records - Language Issues :Language Issues :

Access to Health Care Records - Access to Health Care Records - Language Issues :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?

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 :Translation of Medical Terms :Translation of Medical Terms :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/radeva-zdr.sistema/index.html

National Centre of Health Informatics, Bulgaria – ICD 10


Maria Radeva, Bulgarian Health Care System

http://www.stenobooks.com/knigi/medicinska%20literatura/2/radeva-zdr.sistema/index.html



Quality Standards for Health Care: 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

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





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

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


WHO Report Bulgaria: Health System Review, Health Systems in Transition, Vol.9 No.1 2007


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

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 Quality Standards for Health Care cont’d:cont’d:

Quality Standards for Health Care Quality Standards for Health Care cont’d:cont’d:

Bulgaria: Health system review, Health systems in transition, Vol.9 No.12007: “Such initiatives have not been as successful and wellreceived owing to the fact that there are currently no real incentivesfor rewarding high quality care, as the accreditation system is not linked to differential payments from the NHIF, which in certaincircumstances may decrease the incentives for providing thebest 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?

Bulgaria: Health system review, Health systems in transition, Vol.9 No.12007: “Such initiatives have not been as successful and wellreceived owing to the fact that there are currently no real incentivesfor rewarding high quality care, as the accreditation system is not linked to differential payments from the NHIF, which in certaincircumstances may decrease the incentives for providing thebest 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 Regulations of Cross-Border Health Care in Bulgaria:Care in Bulgaria:Regulations of Cross-Border Health Regulations of Cross-Border Health Care in Bulgaria: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

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!Thank You!Thank You!Thank You!

E-mail: [email protected]: [email protected]