Public health law and tuberculosis control in Europe

Public Health (2007) 121, 266 273 www.elsevierhealth.com/journals/pubh Original Research Public health law and tuberculosis control in Europe R.J. Coker a,, S. Mounier-Jack a, R. Martin b a Department of Public Health and Policy, London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, UK b Centre for Research in Primary and Community Care, University of Hertfordshire, College Lane, Hatfield, Hertfordshire AL10 9AB, UK Received 12 May 2006; received in revised form 10 October 2006; accepted 15 November 2006 Available online 5 February 2007 KEYWORDS Law; Europe; Tuberculosis; Policy Summary Background: Tuberculosis control is an important public health challenge in many European countries. Law is an important tool that policy-makers can draw upon to support control efforts and, according to the World Health Organization, represents a tangible expression of political commitment and will. Despite this, little national research, and even less cross-national comparative research, has been conducted to describe and analyse legislative approaches to tuberculosis control. Methods: We conducted a survey of 14 European countries to identify, describe, map and analyse legislative tools used to support tuberculosis control. Results: We found a wide range of legislative models. Legal measures available to nation states, such as compulsory examination, compulsory screening, compulsory detention, compulsory treatment and compulsory vaccination, vary widely in both scope and number. We identified a typology of legal frameworks, from the most authoritarian to the least restrictive. It seems likely that the application of some laws might not withstand scrutiny under the European Convention for the Protection of Human Rights and Fundamental Freedoms. Conclusions: Harmonization of legislative response to infectious diseases, based upon sound evidence, may be necessary if collaborative efforts in support of infectious disease control, as envisaged in the new International Health Regulations, are to be most effective and are to reflect more appropriately a globalized 21st century world. & 2006 The Royal Institute of Public Health. Published by Elsevier Ltd. All rights reserved. Corresponding author. Tel.: +44 020 79272926; fax: +44 020 76127812. E-mail address: richard.coker@lshtm.ac.uk (R.J. Coker). 0033-3506/$ - see front matter & 2006 The Royal Institute of Public Health. Published by Elsevier Ltd. All rights reserved. doi:10.1016/j.puhe.2006.11.003

Public health law and tuberculosis control in Europe 267 Introduction In 1993, the World Health Organization (WHO) described tuberculosis as a global emergency, recommending the strengthening of national TB control programmes and the widespread adoption of the short course directly observed therapy strategy (DOTS), a five-component strategy that includes political commitment. 1 In 2001, WHO stated that, a crucial expression of political will is to have in place up-to-date legislation on communicable disease control and, on the basis of that legislation, to adopt regulations which apply the principles and provisions of that legislation to TB control. 2 In 2002, 404 628 cases of tuberculosis were notified in the 52 countries of the WHO European region, equivalent to a rate of 46.2/100 000, increasing from 35/100 000 in 1995. In 2002, rates in the east were 97/100 000, in the central region of Europe 54/ 100 000, whilst in western Europe 14/100 000. 3 A fundamental function of government is public health protection. 4,5 This requires formulation and implementation of public health policies in order to prevent diseases such as tuberculosis, underpinned by legal regulation authorizing public health interventions. As such, public health law, that is the legal powers and duties of the state to assure the conditions for people to be healthy and the limitations on the power of the state to constrain the autonomy, privacy, liberty, proprietary, or other legally protected interests of individuals for protection or promotion of community health is an important component of the state s armamentarium. 6 In the case of tuberculosis, governments have traditionally focused on preventing transmission of disease by controlling the movement of infected persons. Yet at the heart of public health law is a tension between individual rights and public health security. As Pinet noted in 2001, legislation must protect public health and as well safeguard the legal rights of individuals. 2 Authorities may address disease control by persuasion through health promotion, they may create incentives to support people and agencies to implement public health measures, or they may compel individuals and institutions to conform to a set of behavioural standards or practices. 6 To this end, nations have developed legislative frameworks that describe the rights and duties of individuals, agencies or institutions, and that define the sanctions the state may impose if individuals or bodies are non-compliant. Health legislation, therefore, defines a framework that permits the regulation of prevention and control of communicable diseases, and creates the administrative tools that facilitate the control of those diseases. (In addition to these legislative frameworks, a body of policy framed within the constitutional powers of the state but not formally enacted also addresses communicable disease control. 6 ) This paper describes research that maps and analyses legislative tools used to support tuberculosis control in 14 countries from the WHO European region, and discusses the extent to which their application might withstand scrutiny under the European Convention of Human Rights. Methods A piloted structured questionnaire was designed to collect data on national legislative frameworks. The themes covered were drawn from the model WHO legislative framework and included compulsory screening, examination, vaccination, treatment, exclusion from specified activities, isolation and detention. Individuals with expertise in both public health and public health law were identified through formal and informal public health, academic, and legal networks including Eurosurveillance, and the Global Exchange for Population Health Law. In April 2004, we sent the questionnaire to identified individuals with expertise in communicable disease control and public health law in 28 countries of the WHO European region (Table 1). European Union states were selected because individuals with public health legal expertise within those states were more readily identified. In addition, we selected countries on the basis of the representative nature of their legal systems, epidemiological patterns, and their sociopolitical context. The questionnaire was distributed by both e-mail and post. Questionnaires were followed up with reminder e-mails and phone calls to encourage response. Results Responses were received from 14 countries, representing 56% of the population of the WHO European region. Most non-responders came from the European Union. The results are summarized in Table 1. Compulsory screening Legislation authorizes compulsory screening for tuberculosis in seven countries. In all these

268 R.J. Coker et al. Table 1 Legal compulsory measures for each country (ranked by number of control measures). Country Response to questionnaire Screening Examination Treatment Detention Vaccination Isolation on the grounds of exposure Exclusion from activities Number of control measures TB notification rate (2004) Spain b N N N N N N N 0 15 France N N N N Y N Y 2 8.9 Germany N Y N Y N N N 2 8 Israel N N N Y N N Y 2 7.9 the Netherlands Y Y N N N N N 2 8.3 Finland Y N Y N N N Y 3 6.4 Poland N N Y N Y N Y 3 24.6 England Y Y N Y N N Y 4 12.7 a Estonia N Y Y Y Y N N 4 44.5 Hungary Y N Y N Y N Y 4 24.5 Switzerland Y Y Y Y N N N 4 8.2 Czech Republic N N Y Y Y N Y 5 10.3 Norway Y Y Y Y N Y Y 6 6.6 Russia Y Y Y Y Y N Y 6 105.9 The following countries were unable to supply data: Denmark, Italy, Lithuania, Romania, Latvia, Greece, Slovakia, Austria, Sweden, Romania, Bulgaria, Belgium, Malta And Luxembourg. The source of TB notification rates was EuroTB 2004. a Notification rate for the UK. b Including the autonomous region of Catalonia. Subsequent to submission, peer review and revision, it was brought to our attention that under The Netherlands Infectious Diseases Act 1999, Article 14, a major has power to have a person admitted to a hospital for isolation immediately if he is suffering from tuberculosis, subject to a list of conditions. It has been noted elsewhere that a lack of public health law expertise has resulted in a limited understanding of public health powers. Insufficient clarity regarding the scope and role of public health laws on the part of policy makers and public health consultants was found to have contributed to the spread of SARS in Hong Kong (The Hong Kong Legislative Council, Report to the Select Committee to Inquire into the Handling of SARS 2004). The building of capacity in public health law is essential if the application of public health powers is to be effective.

Public health law and tuberculosis control in Europe 269 countries, the body authorized to apply for the screening order is the public health agency. A combination of public health agencies and governmental bodies including immigration offices are authorized to issue the screening order. Orders may be issued either in response to the occurrence of a tuberculosis epidemic or as part of routine compulsory periodic screening of specific populations. Screening of professionals whose work brings them into contact with children and screening of healthcare workers occurs in several countries, notably those from the former Soviet Union (FSU). Five countries have legislated for screening of migrants (Switzerland, Norway, France, England, and the Netherlands). Records of screening orders are retained in five countries and collated nationally in four. Compulsory medical examination Seven countries sanction compulsory medical examination. In these cases, either the patient s own doctor or a public health officer applies for an order. A court order is specifically required in two countries (England and Russia), while in five the authority to issue an order lies with public health authorities or government agencies. The right to appeal an examination order is codified in three countries (Switzerland, Norway and the Netherlands). Examination orders may be issued where there is suspicion of infectious tuberculosis or concern that a threat to public health exists. Records of orders issued are retained in most countries, but only in Russia are they collated nationally. Compulsory treatment Eight states sanction compulsory treatment, including all five respondent states that had been part of the FSU as well as three western European states. In most states the patient s own doctor or the public health agency applies for a compulsory treatment order, and orders are issued in most states by the local public health agency. In three countries (Russia, Estonia and Poland) orders are issued by a court (in Russia the public health agency also has the authority to issue orders). There is no codified appeal procedure in Russia, Estonia or Hungary. In six countries, justification of a compulsory treatment order is dependent upon a patient s refusal to submit to treatment and/or a determination that an individual poses a public health threat. In several countries, prevention of the development of drug resistance or prevention of the spread of drug resistant tuberculosis is a rationale for compulsory treatment. Where principles are defined, the duration of compulsory treatment is determined by assessment of infectiousness and/or the public health threat. Compulsory treatment may be sanctioned in hospital, or less commonly in patients homes or in outpatient facilities. Records are kept in all countries and collated nationally in two countries. Detention Eight countries sanction detention in either an institution or at home. Of these, five also sanction compulsory treatment whilst three (England, Germany and Israel) do not. In most cases it is the public health agencies that apply for a detention order; in all cases, courts are responsible for issuing the order. Norway is an exception there the responsible physician at regional level makes the order. Four countries have codified appeals procedures, which can be initiated by the detainee or by the public health agency. Orders for detention are dependent upon proof of infectious tuberculosis (five countries). Detention can be ordered because of refusal to undergo treatment in six countries. Only Russia allows exceptions to detention on health grounds (acute or chronic illnesses that could result in exacerbation of the state of health during the detention). Police enforce the order in all countries, with hospital staff also responsible for enforcement in half. Detention takes place in hospital in all countries, and prisons are also used in three (Switzerland, Russia and Israel). Two countries (Israel and Germany) specify predetermined principles limiting the duration of detention either when the detainee is no longer infectious or when treatment is completed. Records of detention are kept in five countries and collated nationally in two countries. Compulsory vaccination Of the 10 countries where vaccination against tuberculosis is advocated, vaccination is compulsory in six, principally focused upon infants and healthcare workers. Only in Poland is a penalty attached to non-compliance with legislation. In France non-compliance with the vaccination law results in exclusion from school for children. In no country is vaccination required for the purpose of travel or residency. The law provides a mechanism for compensation for vaccine damage in two countries where vaccination is compulsory (France and Poland) and in three countries where it is not

270 (Spain, England and Norway). In practice, in England compensation is rarely awarded because the burden of proof of causation demanded is high. 4 Where vaccination is compulsory, exemptions from compulsory orders may be made on grounds to include HIV infection. Compulsory quarantine Only one country, Norway, authorizes the isolation of individuals on grounds of exposure to tuberculosis. Exclusion from specified activities In nine countries the law sanctions exclusion from certain activities or professions (principally healthcare, teaching, and the food industry) on grounds of tuberculosis. Surveillance Notification is compulsory in all countries and all have central registers. Discussion Legislative frameworks for tuberculosis control in our sample of European countries vary considerably. No two countries legislation has the same set of compulsory measures for preventing and controlling tuberculosis. The number of identified compulsory measures varies from zero in Spain to a maximum of six in Russia and Norway. Overall, each category of compulsory control measures is authorized in more than half of the countries, while compulsory preventative-oriented measures defined by compulsory vaccination and/or compulsory screening are enforced in a minority of countries. Many countries have two or three compulsory tuberculosis control measures. Russia and Norway (six each), Czech Republic (five), Hungary (four), Estonia (four) and Switzerland (four) display a more robust legal framework. Of note, more authoritarian models tend to be found in countries situated in Eastern Europe and in countries that are still outside the European Union. All countries apart from the Netherlands, France and Spain apply either compulsory treatment or compulsory detention or both. Those countries that do not envisage mandatory treatment or detention are usually proponents of a more preventive targeted legislative framework, granting routine or compulsory vaccination, compulsory or targeted screening, and possibly compulsory medical examination. There are some similarities between countries in terms of which body is authorized to apply for a compulsory order. However, models are widely divergent on the power to issue an order, with some countries resorting to the court to issue the order while others leave their appointed administrative public health or local authorities to do so. Even for more drastic measures like compulsory detention or treatment, the order is issued by the court in a minority of countries (England, Russia, Estonia and Poland) essentially those in eastern Europe plus England. There appears to be little correlation between the nature of the legislative framework and the epidemiological situation of the country, nor between historical patterns of tuberculosis and the historical framing of legislative approaches. Relatively high tuberculosis notification rates are recorded in both countries that have a large number of compulsory measures and those that do not. Countries situated in eastern Europe do have a greater range of powers, but these are more likely related to their Soviet history rather than the contemporary epidemiological position. Some patterns between respondents can be discerned. First, all countries possess a surveillance system that requires notification of tuberculosis through a central registry. Second, an underlying principle behind compulsory examination is the suspicion of infectious tuberculosis in six of the seven countries that authorize compulsory examination. Third, in six countries refusal to comply with treatment may prompt compulsory treatment. Fourth, exemptions from compulsory orders are extremely limited in all countries, with only Russia and Switzerland offering possible exemptions from compulsory measures on the basis of health or age. The geo-political variation in the legal models is notable. The new migrant population is the subject of at least one compulsory control measure in almost all of western Europe (Switzerland, Germany, the Netherlands, Norway, France and England), while none of the eastern European countries include any specific provision related to this population group. Legislation reflects wider political considerations as well as differences in migration patterns and epidemiological trends in tuberculosis. 7 9 Legislative models R.J. Coker et al. Although we cannot identify a common broad European legislative framework to control tuberculosis, there appear to be several different families of legislative models in the region.

Public health law and tuberculosis control in Europe 271 The first model could be described as authoritarian since it is based on the enforcement of a high number of compulsory control measures (Russia, Estonia, Switzerland and Norway). All four countries have at least three compulsory measures including compulsory examination, detention and treatment, but also include upstream measures of prevention including compulsory vaccination or screening. Only Estonia is a member of the European Union. The soviet legacy clearly informs Russian and Estonian approaches. It may be that the political imperatives that have ensured Norway and Switzerland remain outside the European Union, including a homogeneous cultural identity and an enthusiastic embracing of conformity, provide insights into the legislative models of these countries. 7 The second moderate model is based on the enforcement of predominantly compulsory control measures without recourse to prevention powers such as compulsory vaccination or population screening. These include England, Germany and Israel. The Czech Republic, Hungary, Poland and Finland, likewise, have fewer sanctions at their disposal than the authoritarian model but have either compulsory vaccination, screening or exclusionary practices. The third model, what might be termed a preventive model, is based mainly on compulsory provisions that are oriented towards preventive measures, including screening, medical examination and/or vaccination, rather than compulsory treatment or detention. This model includes France and the Netherlands. The fourth model is that illustrated by Spain, where no compulsory measures exist. This last model, a laissez faire model, presupposes a tacit confluence of social and individual interests and is based on a consensual social contract. 10 Limitations Most non-responders to our questionnaire came from western Europe, within the European Union. Whilst this may have potentially introduced bias, the epidemiological picture of non-responders is similar to that of other countries in the Union and the legal traditions, we believe, are similar. The reasons for non-response probably relate to an inability to identify individuals with expertise in the public health functions of tuberculosis control and with knowledge of public health law. This lack of a coherent, network of public health legal capacity in Europe is an issue we have highlighted elsewhere. 11 Scrutiny under the European Court of Human Rights and evidence-based policy The European Court of Human Rights was established under the European Convention for the Protection of Human Rights and Fundamental Freedoms, which currently has 45 state signatories from the European region, including all member states of the European Union. The Convention has significant implications for public health interventions and offers a framework to examine the legitimacy of legal sanctions. The Convention facilitates challenge of legal powers by means of judicial review and litigation for damages in countries that are signatories to the Convention, where compulsory powers are not administered in accordance with Convention rights. 12 The Convention includes specific provisions that strengthen individual rights such as the right to life (article 2), the right not to be subjected to inhuman and degrading treatment (article 3), the right not to be deprived of one s liberty arbitrarily (article 5), and the right to a private and family life (article 8). Whilst, in common with other human rights instruments, the Convention allows compulsory measures that restrict human rights where public health is threatened, sanctions must be proportionate, nondiscriminatory, and not be applied arbitrarily. Moreover, interventions must be authorized by law and the processes of application of powers must ensure, under article 6, the right to a fair and public hearing including a right of appeal. 13 Achieving a balance between the threat posed to public health and the recognition of individual rights is challenging. Interventions must be in response to a pressing public health need, be proportional to this social aim and be no more restrictive than necessary to achieve the intended purpose. 2,6 The removal of liberty is perhaps the most profound sanction the state can impose on an individual in the service of public health; yet three countries in our survey, the Czech Republic, England, and Estonia, do not have a codified right of appeal for detained individuals. We have argued previously that if public health powers that provide no procedures for appeal were to be challenged, it is likely that such powers would be judged unlawful. 12 14 Not only does detention of individuals with tuberculosis raise due process concerns in some jurisdictions, the imposition of detention also raises questions about the evidence base that underpins such a policy. Any coercive intervention requires that the evidence base in support be scrutinized.

272 Under what circumstances are restrictions on human rights justified? The 1984 Siracusa Principles, a set of principles under which departure from the 1966 International Covenant on Civil and Political Rights is recognized, frame the just restriction or limitation of human rights. These principles determine that any restriction must be in accordance with the law, legitimate, and necessary. The action must be the least restrictive alternative that is reasonably available, and its application must not be discriminatory. Gostin has argued, applying the principles to public health interventions, that before coercion is justifiable, the risk posed should be demonstrable, the effectiveness of proposed interventions should be demonstrably effective, and the approach should be cost-effective. 6 In addition, he argues that any sanctions should be the least restrictive necessary to achieve the purpose, and that policy should be fair and non-discriminatory. To our knowledge none of the legal interventions advocated in support of tuberculosis control, either through the WHO model legislation framework or the legal tools at the disposal of public health authorities in the countries surveyed, have been examined rigorously with these principles in mind. Indeed, what research has been conducted is often contradictory. 7,8,15 Novel approaches are needed to determine the potential impact of legal interventions, such as by means of modelling, in order to evaluate interventions in ways that capture the complex environment in which they apply. 16,17 As increasingly those concerned with disease control search for new tools to address the spread of tuberculosis and seek to learn from the experiences of others, the benefits and costs of adopting legal responses drawn from other jurisdictions need to be understood. The recent approval of the new international health regulations (IHR) by the World Health Assembly in 2005, and the demands upon member states to ratify the IHR by 2007, provide the WHO with broader scope and greater leverage with implications beyond the European region in the control of infectious diseases. The new IHR impose upon WHO and member states greater responsibility to provide security against the international spread of disease. 18 If the new IHR result in WHO rules and practices being incorporated into national legislative frameworks, greater harmonization of legislative approaches across WHO member states seems likely. In Europe, surveillance is already more consistent following the establishment of the communicable diseases network in 1999. There is opportunity for coherent collaborative exercises in communicable disease control through the newly created European Centre for Disease Control. All European countries are confronted to a varying degree with the challenges of a resurgence of TB linked to enhanced migration, as well as the threat of multidrug-resistant TB and an increase in HIV TB co-infection. Ideally, a pan-european approach to tuberculosis control will be rooted in an evidence base. Such an evidence base should inform the framing and application of public health legal interventions, and any newly drafted public health interventions must be cognizant of the demands of the European Convention on Human Rights. Acknowledgements We are grateful to all collaborators who completed questionnaires. References R.J. Coker et al. 1. World Health Organization. TB a global emergency. Geneva, Switzerland: World Health Organization; 1994. 2. Pinet G. Good practice in legislation and regulations for TB control: an indicator of political will. Geneva, Switzerland: World Health Organization; 2001. 3. EuroTB (InVS/KNCV) and the national coordinators for tuberculosis surveillance in the WHO European Region. Surveillance of tuberculosis in Europe. Report on tuberculosis cases notified in 2002. Saint-Maurice, France: Institut de Veille Sanitaire; 2004. 4. Dute J. Affected by the tooth of time: legislation on infectious diseases control in five European countries. Med Law 1993;12:101 8. 5. Gostin LO. Public health law in a new century: part II: public health powers and limits. JAMA 2000;283:2979 84. 6. Gostin LO. Public health law: power, duty, restraint. Berkeley, Los Angeles, London: University of California Press; 2000. 7. Coker RJ. From chaos to coercion: detention and the control of tuberculosis. New York, USA: St. Martin s Press; 2000. 8. Coker R. Migration, public health and compulsory screening for TB and HIV. Asylum and Migration Working Paper 1. London, UK: Institute for Public Policy Research; 2003. 9. Coker R, Bell A, Pitman R, Hayward A, Watson J. 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Public health law and tuberculosis control in Europe 273 14. Coker RJ. The law, human rights, and the detention of individuals with tuberculosis in England and Wales. J Public Health Med 2000;22:263 7. 15. Coker RJ. Public health impact of detention of individuals with tuberculosis: systematic literature review. Public Health 2003;117:281 7. 16. Bird SM, Brown AJ. Criminalisation of HIV transmission: implications for public health in Scotland. BMJ 2001;323: 1174 7. 17. Coker R, Atun R, McKee M. Untangling Gordian knots: improving tuberculosis control through the development of programme theories. Int J Health Plann Manage 2004; 19:217 26. 18. Gostin L. International infectious disease law: revision of the World Health Organization s International Health Regulations. JAMA 2004;291:2623 7.