Position statement

Detention of patients with extensively drug-resistant tuberculosis (XDR-TB).
Position Statement by the South African Medical Research Council (SAMRC)

In the context of extensive local and international comment on the contentious issue of detention of patients with XDR-TB in South Africa, the South African Medical Research Council (SAMRC) wishes to state that:

• Enforced hospitalisation/quarantine of patients with XDR-TB is only justifiable as a last resort; after all reasonable voluntary measures to isolate individual patients have failed.  Key to restriction of patient rights is the assurance that all of the criteria of the Siracusa Principles (http://www1.umn.edu/humanrts/instree/siracusaprinciples.html) have been met, and that restrictions are limited in duration and subject to review and appeal.  These criteria are:

• The restriction is provided for and carried out in accordance with the law;
• The restriction is in the interest of a legitimate objective of general interest;
• The restriction is strictly necessary in a democratic society to achieve the objective;
• There are no less intrusive and restrictive means available to reach the same objective;
• The restriction is based on scientific evidence and not drafted or imposed arbitrarily, ie. in an unreasonable or otherwise discriminatory manner.

Current health legislation in SA empowers authorities to detain patients with infectious diseases until the disease no longer poses a public health threat, thereby allowing quarantine restrictions to be enforced for a limited period.  Herein lies the dilemma: many XDR-TB patients may have untreatable disease and confinement would have to be until death or, conceivably, could be indefinite.  From a human rights perspective prolonged isolation could, without sufficient procedural safeguards, violate several SA Constitutional rights and international human rights law.

• Quarantine of patients has to be preceded by lawful procedure.  Adequate isolation facilities must be provided and appropriate airborne infection control measures implemented in such facilities.  Available treatment must be offered to patients, on a voluntary basis.  Suitable counseling of and visitation rights for family members of patients would be appropriate. 

• Enforced treatment of XDR-TB patients, even under quarantine conditions, represents a most severe invasion of an individual’s right to freedom and security of the person.  Given the toxicity of XDR-TB treatment, potentially severe drug side effects, a low success rate of treatment, and the reduced life expectancy of XDR-TB patients, there is no sufficiently strong legal justification for coerced treatment. 

• The threat of an uncontrollable XDR-TB epidemic fuelled by HIV, should urge policy makers, public health authorities, researchers and funders to spend the necessary time, energy and financial resources addressing the problem as a national priority in SA.

Rationale

The global emergence of extensively drug-resistant tuberculosis (XDR-TB) is a stark reminder of the failure of public health systems to control TB, an infectious disease that is easily diagnosed and treated.  Prevention of XDR-TB is straight-forward if health systems ensure, as a first priority, that individuals suspected of having TB have universal access to rapid diagnosis, appropriate treatment, and adequate support systems to ensure treatment completion, based on the International Standards for Tuberculosis Care (http://www.who.int/tb/publications/2006/istc_report.pdf) and encompassing patient rights and responsibilities as outlined in the Patient Charter for Tuberculosis Care (http://www.who.int/tb/publications/2006/istc_charter.pdf).

Aside from the clinical challenges, management of XDR-TB poses a significant challenge to public health practice, especially within the context of HIV, given the effective transmission of XDR-TB to HIV-positive individuals and the consequent extraordinary high mortality reported.  Classical public health interventions for infectious diseases aim to contain infection, often through quarantine or detention of affected individuals.  However, protection of public health always comes at a cost to individual rights, particularly those around freedom and privacy, creating an inherent contradiction in the control of infectious diseases such as XDR-TB.

In liberal democracies, the power vested in public health legislation is generally accepted, ie. the state intervening and limiting individual rights when the unlimited exercise of such rights may result in harm to the greater community, given the ethical and legal obligations of the state to ensure that communities are protected against the consequences of an infectious disease.  It is accepted that fundamental individual rights may legally be limited by a law of general application that complies with the necessary Constitutional safeguards, and public health legislation usually contains substantive provisions that override individual rights in order to prevent serious risk to public health.  Nevertheless, contemporary biomedical ethics put strong emphasis on the rights of the individual and on the principles of autonomy and self-determination, stressing that any limitation must be reasonable and justifiable in an open and democratic society, based on human dignity, equality and freedom, and using the least restrictive measures available to accomplish public health goals. 

Public anxiety coupled with the risk that XDR-TB may rise to epidemic levels in SA is putting increased pressure on government and public health authorities for quarantine of patients and coercive measures to curtail the spread of XDR-TB.  The dual stigma associated with TB and HIV, now compounded by XDR-TB, poses a real risk of driving the XDR-TB problem underground, especially if isolation measures are coercive.  This is a situation that SA can ill afford.

Control of XDR-TB within the context of South African legislation

Current legislation in South Africa allows for public health interventions in order to contain infectious diseases that constitute a threat to public well-being, providing a legal framework against which health authorities may invoke their regulatory responsibility to effectively address public health issues.  The grave public health threat of XDR-TB would, therefore, provide a legal basis for governmental intervention in decision-making of an individual’s health care.  However, health authorities also need to operate within the context of the Bill of Rights enshrined in the Constitution of the Republic of South Africa Act 108 of 1996.  The Constitution forms the supreme law of the Republic of SA while the Bill of Rights in Chapter 3 of the Constitution is the cornerstone of democracy in SA, enshrining the rights of all people and affirming the democratic values of human dignity, equality and freedom, which by law the state must respect, protect, promote and fulfil.

Research by the SAMRC on the legal dilemmas around management of multidrug-resistant TB (MDR-TB) – and conceivingly also XDR-TB - has highlighted potential conflicts between current public health legislation and the SA Constitution, as well as a lack of adequate procedural safeguards within existing laws (http://www.mrc.ac.za/policybriefs/managingTB.pdf).  The relevant provisions of the National Health Act 61 of 2003 and the Communicable Disease Regulations of 1987 have not yet been tested for Constitutional validity, creating a serious dilemma in the need to address XDR-TB using conventional public health intervention strategies such as confinement, coercion, detention and quarantine while protecting individual patient rights.
       
In addition, several other directly applicable sets of legislation remain to be tested within the context of public health legislation, particularly those related to health care worker safety, including:

• The Occupational Health and Safety Act 85 of 1993;
• The Compensation for Occupational Injuries Diseases Act 130 of 1993 and its Hazardous Biological Agent Regulations (21 December 2001);
• The Employment Equity Act 55 of 1998;
• The Labour Relations Act 66 of 1995;
• The Basic Conditions of Employment Act 75 of 1997.

TB is listed as an occupational disease in SA and legislation affords health care workers the legal right to a safe working environment where adequate protection must be provided against infection.  Quarantine of infectious XDR-TB patients, many with virtually untreatable disease, will therefore inadvertently affect the right of health care workers (especially those with compromised immunity) to a safe working environment, especially in settings where appropriate infection control is absent or deficient. 

The XDR-TB dilemma:  public health vs individual rights

Prevention of XDR-TB through improved TB control must be the first priority.  Nevertheless, the Department of Health is also legally required to address XDR-TB appropriately in the interest of protecting public health, while operating within the context of the Bill of Rights enshrined in the Constitution, thereby promoting, respecting and protecting individual rights.  Some of the human rights that would be severely limited, if not violated, by instituting detention of XDR-TB patients include the right to:

• freedom and security of the person;
• human dignity; 
• privacy and confidentiality; 
• freedom of movement and residence;
• freedom of trade, occupation and profession;
• just administrative action (the right to be heard before action is taken);
• equality ( discriminating between those who will be detained and those who will not);
• an environment that is not harmful to health or well-being (particularly health care workers and other patients).

The utilitarian approach, advocating that government policies be directed to provide for the greatest good to the largest component of the population, certainly makes sense from a public health perspective.  Nevertheless, the humanitarian approach in which patient dignity, equality and freedom constitute core values, also needs to be taken into account for management of XDR-TB, a disease that can in large part be traced to the failure of implementation of government policies.  The challenge to all South Africans therefore is to develop an ethically justifiable framework for management of XDR-TB based on sound legal principles.