M/XDRM/XDR--TB AND THE LAW:TB AND THE LAW:

South African ContextSouth African Context

Professor Adriano G Professor Adriano G OrsiniOrsini--DuseDuse

Chair, Academic Head and Chief SpecialistChair, Academic Head and Chief Specialist

Department of Clinical Microbiology and Infectious DiseasesDepartment of Clinical Microbiology and Infectious Diseases

School of Pathology of the NHLS & University of the School of Pathology of the NHLS & University of the Witwatersrand, Johannesburg, South AfricaWitwatersrand, Johannesburg, South Africa

Background to South African Background to South African

situationsituation�� HIV pandemic & spiraling epidemic of TB, with HIV pandemic & spiraling epidemic of TB, with

associated associated ↑↑ in M/XDRin M/XDR--TBTB

�� Collectively throughout all 9 SA provinces, among Collectively throughout all 9 SA provinces, among highest #s of XDRhighest #s of XDR--TB worldwideTB worldwide

�� MDRMDR--TB accounts for ~3% of all TB cases (TB accounts for ~3% of all TB cases (±± 6000 6000 MDRMDR--TB cases documented a year)TB cases documented a year)

�� Strong public health interventions are required to protect Strong public health interventions are required to protect highlyhighly--susceptible, as well as immunesusceptible, as well as immune--competent, competent, individuals who are at high riskindividuals who are at high risk

�� Defaulting [>30% d/t long duration of Rx, S/E of antiDefaulting [>30% d/t long duration of Rx, S/E of anti--TB TB drugs, prolonged hospitalization], treatment failures, etc. drugs, prolonged hospitalization], treatment failures, etc. => chronic M/XDR=> chronic M/XDR--TB failures & pose serious PH riskTB failures & pose serious PH risk

THE THE STATUS QUOSTATUS QUO

[Hospitals had] “become the

gates which lead to death”

Thomas Lightfoot (1850): London

Medical Times

Sunday Times headlinesSunday Times headlines

Tuberculosis: An Infection Tuberculosis: An Infection

Control PerspectiveControl Perspective

�� Community to HospitalCommunity to Hospital

�� Nosocomial transmissionNosocomial transmission�� patientpatient--toto--patientpatient

�� patientpatient--toto--HCWHCW

�� Hospital to Community:Hospital to Community:

�� Intrafamilial spread in 4 families of MDRIntrafamilial spread in 4 families of MDR--TB from patients treated at Sizwe HospitalTB from patients treated at Sizwe Hospital

Woolf M, 1988, Presented at ID Congress, Sandton, South AfricaWoolf M, 1988, Presented at ID Congress, Sandton, South Africa

Tuberculosis: An Infection Tuberculosis: An Infection

Control PerspectiveControl Perspective

�� Nosocomial transmissionNosocomial transmission::

�� patientpatient--toto--patient:patient:Sacks L, et al. Comparison of Outbreak and NonSacks L, et al. Comparison of Outbreak and Non--outbreakoutbreak--related MDRrelated MDR--TB Among HIVTB Among HIV--Infected Patients Infected Patients in a SA Hospital. CID 1999;29:96in a SA Hospital. CID 1999;29:96--101101

�� patientpatient--toto--HCW:HCW:Balt E, et al. Nosocomial transmission of TB to HCWs in Balt E, et al. Nosocomial transmission of TB to HCWs in Mpumalanga. SAMJMpumalanga. SAMJ

Wilkinson D, et al. Nosocomial transmission of TB in Wilkinson D, et al. Nosocomial transmission of TB in Africa documented by RFLP. Transactions of Royal Africa documented by RFLP. Transactions of Royal Society of tropical Medicine and Hygiene 1997;91:318Society of tropical Medicine and Hygiene 1997;91:318

The issuesThe issues

�� Outbreak responses REACTIVE rather than Outbreak responses REACTIVE rather than

PROACTIVEPROACTIVE

�� Surveillance systems WEAK. Delay in outbreak Surveillance systems WEAK. Delay in outbreak

detection detection --> increased cases, increased loss of > increased cases, increased loss of

lives. Costs (direct + indirect) inestimablelives. Costs (direct + indirect) inestimable

�� Education, staffing, infrastructure and political Education, staffing, infrastructure and political

support often neglectedsupport often neglected

�� INFECTION CONTROL OFTEN NOT INFECTION CONTROL OFTEN NOT

PRIORITISED !PRIORITISED !

�� Whose responsibility is it? And accountability?Whose responsibility is it? And accountability?

PrinciplisticPrinciplistic ethical conflicts emerge ethical conflicts emerge

giving rise to ethical & legal dilemmasgiving rise to ethical & legal dilemmas

�� InfringementsInfringements of not only the patientof not only the patient’’s s autonomyautonomy, but also of individuals including , but also of individuals including HCWs at high risk of acquiring the diseaseHCWs at high risk of acquiring the disease

�� Beneficence & nonBeneficence & non--maleficencemaleficence: rationale for : rationale for treating patients is good, but how can no harm treating patients is good, but how can no harm be done if some drugs are either painful when be done if some drugs are either painful when administered &/or linked with toxic S/Esadministered &/or linked with toxic S/Es

�� Justice: Justice: (i) resource allocation to a man(i) resource allocation to a man--made made problem, and (ii) exposure of unsuspecting problem, and (ii) exposure of unsuspecting individuals to a potentially lifeindividuals to a potentially life--threatening threatening diseasedisease

South African legal frameworkSouth African legal framework�� The Constitution of the Republic of South Africa Act 108 The Constitution of the Republic of South Africa Act 108

(1996) is supreme law of the nation (1996) is supreme law of the nation –– all legislation, all legislation, including that relevant to PH including that relevant to PH –– must be contextually & must be contextually & legally aligned with the Bill of Rightslegally aligned with the Bill of Rights

�� Bill of Rights (Chapter 3 of the SA Constitution) defines Bill of Rights (Chapter 3 of the SA Constitution) defines rights of all South Africans & affirms values such as rights of all South Africans & affirms values such as human dignity, equality, autonomy (which includes human dignity, equality, autonomy (which includes informed consent), selfinformed consent), self--determination & freedom determination & freedom –– these these must be respected, protected & enforced by the Statemust be respected, protected & enforced by the State

�� However, and potentially conflicting with the SA However, and potentially conflicting with the SA Constitution, are public health interventions, within the Constitution, are public health interventions, within the current SA legal framework aimed at containing serious current SA legal framework aimed at containing serious PH hazards such as M/XDRPH hazards such as M/XDR--TB TB

�� The Bill of Rights spells out the parameters within which The Bill of Rights spells out the parameters within which the DoH is required to operatethe DoH is required to operate

�� Effective PH procedural safeguards within existing Effective PH procedural safeguards within existing legislation are lackinglegislation are lacking

SA Legislation pertaining to rights of SA Legislation pertaining to rights of

HCWs & allied health practitionersHCWs & allied health practitioners

�� OHS Act 85 of 1993 and its HBA OHS Act 85 of 1993 and its HBA

regulations (21 December 2001)regulations (21 December 2001)

�� Compensation of Occupational Injuries Act Compensation of Occupational Injuries Act

130 of 1993130 of 1993

�� Employment Equity Act 55 of 1998Employment Equity Act 55 of 1998

�� Labour Relations Act 66 of 1995Labour Relations Act 66 of 1995

�� Basic Conditions of Employment Act 75 of Basic Conditions of Employment Act 75 of

19971997

SA: The rights of HCWs & allied SA: The rights of HCWs & allied

health professionalshealth professionals

�� TB (& therefore M/XDRTB (& therefore M/XDR--TB) listed occupational TB) listed occupational diseasedisease

�� Employer has a legal responsibility to provide Employer has a legal responsibility to provide safe measures or alternative employment for safe measures or alternative employment for HCWs (e.g. HIVHCWs (e.g. HIV--infected) infected) atat greater risk to greater risk to acquire TB in workplaceacquire TB in workplace

�� HBA regulations clearly spell out responsibilities HBA regulations clearly spell out responsibilities of both Employer and Employee to take all of both Employer and Employee to take all measures to limit & control exposures to measures to limit & control exposures to dangerous biological agentsdangerous biological agents

The Healthcare WorkerThe Healthcare Worker

�� Administrative, infrastructural & other Administrative, infrastructural & other controlscontrols�� Legal rightsLegal rights

�� Responsibility of Healthcare Facility Responsibility of Healthcare Facility Administrator to:Administrator to:�� Educate StaffEducate Staff

�� Offer VCT for HIV: inform of risks & provide Offer VCT for HIV: inform of risks & provide optionsoptions

�� Staff monitoringStaff monitoring

�� Building design (engineering controls) Building design (engineering controls) –– ID highID high--risk areasrisk areas

�� Provide appropriate PPE & handwashingProvide appropriate PPE & handwashing

SA: The rights of HCWs & allied SA: The rights of HCWs & allied

health professionalshealth professionals�� HCW counseling about risks of working with TB and M/XDRHCW counseling about risks of working with TB and M/XDR--TB TB

patients, taking all necessary precautions, right to work in a spatients, taking all necessary precautions, right to work in a safe afe workplace, understanding the substantially increased risks if thworkplace, understanding the substantially increased risks if they ey are/become HIV +veare/become HIV +ve

�� VCT should be offered but not compulsory VCT should be offered but not compulsory –– if HIV +ve HCW wants if HIV +ve HCW wants to be transferred to a safer working environment, to be transferred to a safer working environment, optionoption provided to provided to do sodo so

�� Disclosure of HCW HIV status is Disclosure of HCW HIV status is voluntaryvoluntary & must be held in & must be held in strictest of confidencestrictest of confidence

�� Compensation claims can be lodged in terms of COIDA where TB Compensation claims can be lodged in terms of COIDA where TB presumed to be contracted during working hours & in workplace inpresumed to be contracted during working hours & in workplace inwhich significant exposures are deemed to have taken placewhich significant exposures are deemed to have taken place

�� HCWs contracting TB through work cannot be dismissed on the HCWs contracting TB through work cannot be dismissed on the basis of either incapacity or expiry of paid sick leave: a fair basis of either incapacity or expiry of paid sick leave: a fair procedure, validity of which will be tested on a caseprocedure, validity of which will be tested on a case--byby--case basis in case basis in our courts, must be followedour courts, must be followed

Current legal framework regarding rights of Current legal framework regarding rights of

the community the community vs. vs. those of the patientthose of the patient

�� State required ethically and by law to protect State required ethically and by law to protect communities from being exposed to, and acquiring, communities from being exposed to, and acquiring, potentially dangerous IDspotentially dangerous IDs

�� Health Act Health Act ‘‘empowersempowers’’ PH authorities to implement PH authorities to implement interventions to contain those IDs that are a PH threat interventions to contain those IDs that are a PH threat BUT these must be carefully balanced with rights of the BUT these must be carefully balanced with rights of the patient as an individual. Furthermore, in SA Constitution patient as an individual. Furthermore, in SA Constitution provision is made for restriction of individual rights under provision is made for restriction of individual rights under strict circumstancesstrict circumstances

�� Constitutionally, however, all South Africans are entitled Constitutionally, however, all South Africans are entitled to a safe and healthy environment, including right to be to a safe and healthy environment, including right to be protected from infectionprotected from infection

Current legal framework regarding rights of Current legal framework regarding rights of

the community the community vs. vs. those of the patientthose of the patient

�� Ethical & PH dilemmas include:Ethical & PH dilemmas include:�� Issues of disclosure of an individualIssues of disclosure of an individual’’s M/XDRs M/XDR--TB status to close TB status to close

contacts & the communitycontacts & the community

�� Infectious patients continuing employmentInfectious patients continuing employment

�� Discharge of chronic infectious patients back into the communityDischarge of chronic infectious patients back into the community

�� PH authorities are constitutionally required to operate PH authorities are constitutionally required to operate within the context of the Bill of Rightswithin the context of the Bill of Rights

�� Violations of individual patient rights include violation of Violations of individual patient rights include violation of rights to: (i) freedom & security of person, (ii) life, (iii) rights to: (i) freedom & security of person, (ii) life, (iii) healthcare services & emergency medical treatment, (iv) healthcare services & emergency medical treatment, (iv) privacy, (v) justice, and (vi) those that, consequent to privacy, (v) justice, and (vi) those that, consequent to enforced hospitalization and isolation, impact on human enforced hospitalization and isolation, impact on human dignity, freedom of movement & residence, and freedom dignity, freedom of movement & residence, and freedom of trade, occupation and from enforced detentionof trade, occupation and from enforced detention

Recommendations (legal Recommendations (legal –– subject o the use of subject o the use of

lawful procedures, not ethicslawful procedures, not ethics--based) proposed by based) proposed by

the SAMRC the SAMRC WeyerWeyer K et al, K et al, MRC Policy Brief on Managing MRC Policy Brief on Managing

MDRMDR--TB, No.1, January 2006TB, No.1, January 2006

�� Provision for enforced commitment to hospitalization/isolation Provision for enforced commitment to hospitalization/isolation ––seriously infringes on the right to freedom & security of personseriously infringes on the right to freedom & security of person. . Enforced hospitalization justifiable only as a last resort.Enforced hospitalization justifiable only as a last resort.

�� SiracusaSiracusa PrinciplesPrinciples (U.N. Doc.E/CN/.4/1985/4, Annex (1985) (U.N. Doc.E/CN/.4/1985/4, Annex (1985) applyapply

�� Treatment of M/XDRTreatment of M/XDR--TB patients cannot be enforced without TB patients cannot be enforced without patientpatient’’s consent s consent –– invasion of right to freedominvasion of right to freedom, , security of person, security of person, & bodily integrity& bodily integrity

�� Hence, informed consent (written) is required for Rx of M/XDRHence, informed consent (written) is required for Rx of M/XDR--TB TB patientspatients

�� Disclosure of patientDisclosure of patient’’s status (except for notification) is not s status (except for notification) is not permissible permissible –– infringes on patientinfringes on patient’’s confidentialitys confidentiality

�� Termination of Rx by HCW justifiable if: (i) Rx default Termination of Rx by HCW justifiable if: (i) Rx default –– provided provided that individual be heard before such action is takenthat individual be heard before such action is taken, (ii) consent for , (ii) consent for further Rx withdrawn by patient, (iii) negligible chance of further Rx withdrawn by patient, (iii) negligible chance of therapeutic success, (iv) interruption & retherapeutic success, (iv) interruption & re--institution of Rx results in institution of Rx results in unacceptable risk of amplification of M/XDRunacceptable risk of amplification of M/XDR--TBTB

Conclusions 1:Conclusions 1:

�� Emergence of XDREmergence of XDR--TB is a sober reminder of SA TB is a sober reminder of SA public health system to fail to control TBpublic health system to fail to control TB

�� Knowledge needed of existing legislation / Knowledge needed of existing legislation / regulations in each country we operate in before regulations in each country we operate in before appropriate recommendations are madeappropriate recommendations are made

�� PH interventions for IDs, with aim to contain PH interventions for IDs, with aim to contain infection, that have to resort to quarantine or infection, that have to resort to quarantine or detention of affected individuals will come at a detention of affected individuals will come at a cost of individual rights (particularly those cost of individual rights (particularly those concerning freedom and privacy)concerning freedom and privacy)

Conclusions 2:Conclusions 2:

�� Although Constitutional safeguards & PH legislation Although Constitutional safeguards & PH legislation makes provision to overrule individual rights in the makes provision to overrule individual rights in the interest of PH, interest of PH, bioethicistsbioethicists –– often in conflict with legal often in conflict with legal principles principles –– will closely be monitoring & safeguarding will closely be monitoring & safeguarding human rights of individuals in just and open democratic human rights of individuals in just and open democratic societies societies

�� Ethically, utilitarianism will be challenged by the Ethically, utilitarianism will be challenged by the humanitarian approachhumanitarian approach

�� Major challenge in SA is to develop an ethically Major challenge in SA is to develop an ethically justifiable framework for Mx of M/XDRjustifiable framework for Mx of M/XDR--TB that is based TB that is based on sound legal principleson sound legal principles

�� Test cases in South African courts are urgently needed Test cases in South African courts are urgently needed to provide legal guidance that is acceptable within the to provide legal guidance that is acceptable within the context of both public health effectiveness & the context of both public health effectiveness & the individual rights of South Africans individual rights of South Africans

Thank you !Thank you !Thank you !Thank you !Thank you !Thank you !Thank you !Thank you !