Law Comm. P H A Paper Discussion 1:Law Comm. Public Health
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DISCUSSION PAPER NO. 10 REVIEW OF THE PUBLIC HEALTH ACT February, 2012 February, 2012 TABLE OF CONTENTS Introduction .. .. .. .. .. .. .. Scope .. .. .. .. .. .. .. .. 2.1 Parameters of health and public health .. .. .. 2.2 An Overview of the Public Health Act .. .. .. 2.3 Other ancillary statutes to public health . . .. .. 2.4 The national health policy framework . . .. .. 2.5 The International Health Regulations .. .. .. 3. The Public Health Regulatory System . . .. .. .. 3.1 Regulation of health care services in Malawi .. .. 3.2 Comparable Jurisdictions . . .. .. .. .. 3.2.1 Kenya .. .. .. .. .. .. 3.2.2 Botswana . . .. .. .. .. .. 3.2.3 United States of America. .. . .. .. .. 3.2.4 England and Wales. . .. .. .. .. 3.2.5 Canada .. .. .. .. .. .. 3.2.6 Scotland .. .. .. .. .. .. 3.3 Regulation of trainings institutions. . .. .. .. 3.4 Regulation of practice .. .. .. .. .. 3.5 Health financing and health insurance. . . . .. .. 4. Right to Health . . .. .. .. .. .. .. 4.1 The nature of the right to health under international law and policy .. .. .. .. .. .. .. .. 4.2 The nature of the right to health and the Constitution of Malawi 4.2.1 Understanding the right to health in the context of right to life .. .. .. .. .. .. 4.2.2 The right to health in the context of the right to development . . .. .. .. .. 4.3 Rights and duties of health care providers, health professionals, and health care “consumers” .. .. .. .. 5. Public Health and Ethics. . .. .. .. .. .. 5.1 Consent of Medical Procedures . . .. .. .. 5.2 Regulation of Clinical Trials .. .. .. .. 5.3 Confidentiality .. .. .. .. .. .. 6. Control of Use of Human Tissue .. .. .. .. 6.1 The donation of tissue by living persons . . .. .. 6.2 Cadaver donations . . .. .. .. .. .. 6.3 Certification of death of a human being. . . . .. 6.4 Post-mortem examination of human bodies. . .. .. 6.5 Human cloning .. .. .. .. .. .. 7. Disease Prevention and Notification . . .. .. .. 7.1 Disease surveillance or general epidemiological intelligence . . 7.2 Disease prevention measures. . . . .. .. .. 7.3 The nature and purpose of notification of infectious diseases . . 7.3.1 Notification in other jurisdictions. .. . .. .. 1. 2. 1 4 6 6 9 14 17 18 19 19 20 20 20 21 21 21 21 22 23 25 27 27 30 32 34 34 35 35 36 37 38 38 39 39 39 40 41 41 42 43 44 2 February, 2012 7.4 The nature and listing of infectious diseases .. .. 7.5 Sexually transmitted infections . . .. .. .. 7.6 Vaccination . . . .. .. .. .. .. 7.7 Isolation and Quarantine . . .. .. .. .. 8. Environment and Waste . . .. .. .. .. .. 8.1 Sanitation and housing . . .. .. . .. 8.2 Disposal of waste . . .. .. .. .. .. 8.3 Construction and management of public sewers and drainage. . 9. Hospitality, Utility and Public Gatherings .. .. .. 9.1 Public services . .. .. .. .. .. 9.1.1 Water. . .. .. .. .. .. .. 9.1.2 Food . . .. .. .. .. .. .. 9.2 Public Gatherings . . . .. .. . .. 10. Alcohol, Tobacco and Substance Abuse. . .. .. .. 10.1 SAlcohol and public health .. .. .. .. 10.2 Smoking of tobacco as a public health risk. . .. .. 10.3 Substance abuse . . .. .. .. .. .. 11. Public Health Emergency .. .. .. .. .. 11.1 Public health legal preparedness . . .. .. .. 12. Conclusion . . . . .. .. .. .. .. .. References .. .. .. .. .. .. .. .. 45 46 46 48 51 51 53 53 54 54 54 55 56 56 56 57 58 58 58 59 61 February, 2012 3 PREFACE The Law Commission is a public body established under section 132 of the Constitution. The Commission is mandated to review and make recommendations regarding any matter pertaining to the Constitution.1 The Commission also develops new legislation, review all statutory and customary laws in Malawi for the purposes of their systematic development in order to ensure that they conform with both the Constitution and applicable international law. It is further mandated to receive submissions from any person with regard to the laws of Malawi or the Constitution. The findings and recommendations of the Commission are then compiled into reports and, where necessary, the reports include draft legislation and are submitted to Cabinet and Parliament through the Minister of Justice. The Commission is headed by a Law Commissioner who is appointed by the State President on the recommendation of the Judicial Service Commission.2 In the execution of a particular law reform assignment, the Law Commissioner, in consultation with the Judicial Service Commission, empanels a special Law Commission. The Law Commissioner appoints individuals to serve as special Law Commissioners on the basis of their expertise of the subject matter under review.3 A special Law Commission is serviced by programme officers who provide technical legal support to the Commission. In line with its mandate, the Law Commission received a submission from the Executive (through the Ministry of Health) to review the Public Health Act (Cap. 34:01). This Discussion Paper is intended to act as a guide and working paper for the review process. The Paper is in no way trying to limit the discussion and issues to only those identified here and neither are the proposals for reform conclusive. The research methodology for this Discussion Paper was largely qualitative and mainly used desk research involving internet and library search for data collection. This Paper has been prepared by Chikosa Silungwe and Francis Ekari M’mame; law reform officers at the Law Commission. 1 Section 135 (h) of the Constitution 2 Section 133 (a) of the Constitution 3 Section 133 (b) of the Constitution 4 February, 2012 1. INTRODUCTION A healthy population is crucial for a country for a number of reasons. First, there is a correlation between a healthy population and increased productivity which in turn may lead to economic growth. Second, the human and material resource investment to a national health care programme may be less onerous. This may translate to surpluses in a national economy. Third, while a healthy population is desirable, if not essential, for a country’s economic growth, inherent economic inequality in the society negatively affects the overall health profile of a country’s population. The observation here is important because the relationship of “health” and the “economy” is symbiotic. The nature of the interventions in “health” or the “economy” will positively or negatively influence the outcome in each sector. Programmatic interventions to ensure a healthy population in a country may be in at least one of, or a combination of, three ways: health population programmes, medicine-based health interventions, and public health-based programmes. At this point, we will narrate the nature of the three interventions in a fleeting manner. Health population programmes are expansive and include a broad range of factors that influence the health of a population such as the environment, social status, and resource availability and allocation. Medicinebased health interventions entail a number of health care practices that relate to the prevention and treatment of illness. It is not as expansive as health population programmes. Public health-based programmes may be described as those programmes initiated by the State to prevent or combat diseases with a focus on the community (and not necessarily an entire national community) as opposed to individualized care. It must also be noted that what is common to the three sets of interventions highlighted here is the need for synergy between what may termed “medical” and “non-medical” factors in order to achieve a healthy population. Indeed, the combination of medico-scientific, socio-economic, political and cultural factors have an impact on a healthy population. These factors can be addressed through law, policy or both. In this paper, we discuss the Public Health Act and other related matters. This means that this paper will primarily look at the public health-based interventions towards a healthy society in Malawi. It is important, at the outset, to highlight the health profile of the country”s population. In 2010, the National Statistical Office in partnership with the Ministry of Health published a report on a national representative sample survey, the 2010 Malawi Demographic and Health Survey. The primary objective of the 2010 Report is to provide “up-to-date information on fertility levels; nuptiality; sexual activity; fertility preferences; awareness and use of family planning methods; breastfeeding practices; nutritional status of mothers and young children; early childhood mortality; maternal mortality; maternal and child health; malaria; awareness and behaviour regarding, HIV/AIDS and other sexually transmitted infections; and HIV prevalence.4 The data collection had an unweighted response rate of 97 per cent. 4 National Statistical Office and Ministry of Health, Malawi Demographic and Health Survey (NSO: Zomba and ICF Macro, Calverton, Maryland, 2010). February, 2012 5 The general conclusion to be made from the Report is that significant challenges remain on fertility levels; nuptiality; sexual activity; fertility preferences; awareness and use of family planning methods; breastfeeding practices; nutritional status of mothers and young children; early childhood mortality; maternal mortality; maternal and child health; malaria; awareness and behaviour regarding HIV/AIDS and other sexually transmitted infections; and HIV prevalence, and these need to be addressed through a combination of State-led legal and policy interventions. Put another way, the health profile of the Malawian population remains dismal.5 There has been a number of policy interventions aimed at addressing some of the challenges within the health sector in the country. For example, the draft National Health Policy notes that the country’s epidemiological profile is characterized by a high prevalence of communicable diseases including malaria, tuberculosis, and HIV and AIDS-related diseases; a high incidence of maternal and child health problems; an increased burden of non-communicable diseases such as cancer (in a wide range of forms), diabetes, hypertension and other cardiovascular diseases.6 While there have been quite a number of policy efforts in the health sector, interventions through law have remained stagnant. The main statute which comes close to addressing health problems in Malawi is the Public Health Act. However, it is deficient in several aspects. Firstly, the law, as it stands, fails to keep pace with scientific developments regarding public health issues. For example, even though small pox was declared that it is no longer a threat by the 33rd World Health Assembly in Geneva, Switzerland on 8 May, 1980, the Act still provides for vaccination against small pox. Secondly, the Act is old. It came into force on 29 July, 1948. We must clarify one point here. The fact that a law is old does not necessarily mean it is a bad law. However, in the case of the Public Health Act, the law has been overtaken by developments at the international law and policy levels. Certainly from a legal perspective, the Act lags behind modern legal standards. Thirdly, the Act fails, in many ways, to comply with the Constitution. Since the Act came into force in 1948, it predates the Constitution which came into force in 1994. Some of the provisions are not in line with the Constitution. This raises the issue of the validity of some provisions of the Act and immediately triggers the need to review the Act for its constitutionality. Fourthly, the Act does not clearly provide criteria for the exercise of the powers conferred on the various authorities under the Act. This jeopardizes the implementation and enforcement of public health law and policy. For example, the powers of the various authorities under the Act are important in testing, examination, immunization, isolation and quarantining of individuals. The provisions on the exercise of powers under the Act are, in many instances, couched in very broad language. It is not clear whether the power is given to the 5 Ministry of Health, draft National Health Policy 6 From Parts 3 through 7 of the Public Health Act 6 February, 2012 State generally or to local authorities. The lack of clarity leads to ineffective implementation and enforcement of public health law and policy. Finally, the specific provisions on infectious diseases,7 sexually transmitted infections 8 and disease-specific provisions 9 are broad and often overlapping. The Act does not also adequately provide for the imposition of minimum standards for solid and liquid waste management, including human excreta; hazardous and health care waste management; minimum legal standards for the operation of funeral parlours, businesses that supply or prepare food, shops, supermarkets and market places; and issues of food hygiene, to mention a few. In light of the deficiencies with the Public Health Act that have been highlighted above, the Paper proceeds as follows: First, it locates public health discourse within the broader discipline of health. This informs the discussion on the scope of a public health law. The discussion also covers an overview of the Public Health Act and related statutes, and national and international legal or policy instruments on public health. Second, the Paper looks at regulatory issues in public health. This centres on the role of local and central governments, regulation of health care services, health financing and health insurance, among other things. Third, the paper looks at the right to health. The analysis here seeks to establish the nature of the right to health, if at all, under Malawi law. Fourth, the Paper looks at the relationship between public health and ethics. This discussion considers such issues as consent to medical procedure, regulation of clinical trial, and confidentiality of medical information. The Paper also discusses, in series, control of use of “human tissue’; disease prevention and notification; the environment and waste management; public health matters relating to hospitality, utility and public gatherings; alcohol, tobacco and substance abuse; the enforcement and implementation regime of a public health law; and public health emergency. Where possible, the paper makes tentative conclusions that may enrich deliberations of the special Law Commission on the review of the Public Health Act as they meet in plenary. 2. SCOPE In this part, we look at the parameters of health and public health; an overview of the Public Health Act and related statutes; the national health policy framework; and the International Health Regulations. 2.1 Parameters of health and public health We limit the discussion on the parameters of health and public health to law and policy. Despite the three programmatic interventions namely, health population programmes, medicine-based health interventions, and public 7 From Parts 3 through 7 of the Public Health Act 8 Part 8 of the Public Health Act 9 Part 7 of the Public Health Act February, 2012 7 health-based programmes, we also proceed on the basis that public health law and policy is a sub-set of health law and policy generally. The delineation of the parameters of health and public health to law and policy is important for pragmatic reasons. Beyond the socio-economic, political and even cultural incentives of a healthy population, the World Health Organization understands “health” as the “state of physical, mental and social well-being and not merely the absence of disease or infirmity”.10 This understanding of “health” is broad and all-encompassing and is also dependent upon the fullest co-operation of individuals and States.11 Even where the parameters are limited to law and policy, health law and policy covers issues of medicine, child health, women’s health, men’s health, health and safety in workplaces, abortion, mental health and public health issues, to mention a few. The general understanding of health law and policy is that focuses on the relationships that exist generally, among providers in healthcare industry and its patients; and the delivery of health care services. Indeed a question may be posed: Why should a State legislate for health? The World Health Organization points out that “governments have a responsibility for the health of their peoples which can be fulfilled only by the provision of adequate health and social measures.”12 We now turn to public health law and policy: First of all, public health is understood to mean the science and art of promoting health, preventing disease, and prolonging life through the organized efforts of the State and society.13 Public health as an academic field is highly varied and encompasses many academic disciplines. Some of these disciplines are: behavioural sciences; health education; biostatistics; emergency medical services; environmental health; epidemiology; global health law and policy; maternal and child health; nutrition; public health laboratory practice; public health policy and public health practice. Further, public health as a social and political concept aims at improving health, prolonging life and improving the quality of life among whole populations through health promotion, disease prevention and other forms of health intervention.15 Public health mainly focuses on three core areas: prevention of diseases; prolonging life, and organized community efforts against diseases. These areas in the end aim at addressing the sanitation of the environment; the control of communicable infections; the education of the individual in personal hygiene; the organization of medical and nursing services for the early diagnosis and 10 Constitution of the World Health Organization, Basic Documents, Official Document No. 240 (Washington, 11 12 13 14 15 1991). The Constitution of WHO was adopted at the International Health Conference held in 1946 in New York, where it was signed by the representatives of sixty-one States (the “WHO Constitution”) As above See footnote 9 http://www.merriam-webster.com/dictionary/public%20health (accessed on 6 May, 2011) As above Health Promotion Glossary, WHO/HPR/HEP/98.1. WHO, Geneva, 1998. http://www.who.ch/hep (accessed on 6 May, 2011) 8 February, 2012 preventive treatment of disease; and the development of the social machinery to ensure every person a standard of living adequate for the maintenance of health.16 The key functions of public health agencies are assessing community health needs and marshalling the resources for responding to them, developing health policy in response to specific community and national health needs, and assuring that conditions contributing to good health, including high quality medical services, safe water supplies, good nutrition, an unpolluted atmosphere and environment that offer opportunities for exercise and recreation are available to the individuals.17 Public health law provides the framework within which the State and civil society operates in order to achieve a healthy community. The framework outlines the powers and duties of the State and its partners such as health care providers. These powers and duties are, however, subject to the rights of the individuals in the community.18 There is a quasi-symbiotic relationship of cosmopolitan dignity and liberal, individual autonomy. In other words, there is a constant balancing of the demands of the community, on the one hand, and those of the individual, on the other, in health promotion and disease prevention. The prime objective of public health law and policy is to pursue the highest possible level of physical and mental health in the community. Public health law can be said to be ambulatory since it follows the emergence of diseases; and also the scientific breakthroughs as they emerge. Lawrence Gostin highlights several themes that emerge from his definition of public health law: State power and duty; coercion and limits on State power; State’s partners in the “public health system”; the focus on the community; health promotion; and the role of the State, civil society and the community in disease prevention. Hence, public health law and policy has the following characteristics: (a) State: Public health programmes are the primary responsibility of the State. The central and local governments have a critical role in the enforcement and implementation of public health programmes. (b) Community: Public health focuses on the community as opposed to the individual. (c) Services: Public health deals with the provision of public health services rather than personal medical services. It focuses more on community-wide assistance programmes like epidemiological investigations, surveillance activities such as reporting and partner notification services, and health inspections of food servers, lodging providers etc. Thus, public health deals with services geared towards the community good and not necessarily improvement of the health of an individual. 16 Nuffield Council on Bioethics, ‘Public Health: Ethical Issues’ (Cambridge Publishers, 2007) 17 As above 18 Gostin, L.O., ‘A Theory and Definition of Public Health Law’ http://www.ucpress.edu/blog/178/a-theory- and-definition-of-public-health-law/ (accessed on 6 May, 2011) February, 2012 9 (d) Coercion: Public health possesses the power to coerce the individual for the protection of the community, and thus does not rely on the near individual ethic of voluntarism, that is, issues of vaccination and quarantine. Health law and policy, and more specifically, public health law and policy involves the State, civil society, law and policy in order to achieve a common good, which in this case is the attainment of a healthy population through health promotion and disease prevention. The quest for the common good is also tempered with the respect for autonomy, privacy and the libertarian interests of the individual. 2.2 An Overview of the Public Health Act The Public Health Act is the main statute which makes provisions for public health issues. The Act is divided into sixteen parts: (a) Parts I and II (Interpretation of Terms; and Administration) Part I deals with interpretation of terms, while Part II deals mainly with administrative matters. The Minister responsible is given powers to direct inquiries in relation to any matters concerning public health in any place.19 The Act in the first Part further provides for general duties to local authorities in handling issues of public health;20 and how the responsible Minister can proceed when hearing public health complaints against a local authority.21 The second Part introduces into the public health set-up, Board of Governors of assisted hospitals. The Board is established by the Minister. (b) Part III (Notification of Infectious Diseases) Part III is concerned with notification of infectious diseases. It commences by giving a list of the numerous infectious diseases which are notifiable.22 The Part also lays down, in detail, the duties of heads of dwellings like family houses23, schools24 and medical practitioners25 with regard to the notification of a case of infectious disease which comes to their notice. This Part makes it an offence to fail to give notice or certificate of the occurrence of the infectious disease.26 This Part also gives power to the Minister to make regulations for the notification of infectious diseases.27 19 20 21 22 23 24 25 26 27 Section 6 of the Act Section 7 of the Act Section 8 of the Act Section 11 of the Act Section 1 3 (a) of the Act Section 13 (b) of the Act Section 13 (c), (d) & (e) of the Act Section 13 (2) of the Act Section 14 of the Act 10 February, 2012 (c) Part IV (Prevention and Suppression of Infectious Diseases) Part IV is concerned with the prevention and suppression of infectious diseases. Medical officers are given powers to enter and inspect any premises where there is reasonable suspicion to believe that such premises have a person who is suffering or has recently suffered from any infectious disease.28 Where the medical officer has certified that a premise or a place harbours infectious diseases, and that the cleansing, disinfection or destruction of the premises would contain infection, a local authority shall proceed giving notice to the occupier of the intended solution.29 Further, the local authority shall not compensate any person whose premises has been destroyed in order to prevent the spread of an infectious disease30, but shall provide means of infection31 and conveyances for the carriage of persons suffering.32 The local authority is given powers to remove to hospital or any place any person suffering from an infectious disease where such person is a serious risk. The said procedures shall be done at the expense of the local authority.33 Section 22 makes it an offence where one exposes persons or articles liable to convey infectious disease. There are also penalties for failure to disinfect a vehicle which carried a patient34 and also letting infected houses.35 The Part also places a duty on any person letting a house to give true information that the said house had within six weeks previously, accommodated a person suffering from any infectious disease; the failure to provide such information one would be liable to a fine.36 Occupiers of buildings are required to report to a local authority of every death from an infectious disease.37 It is an offence where an occupier keeps any dead body of a person who has died of an infectious disease in a room where food is kept, eaten or prepared; or keeps the said body for more than twenty-four hours in any room other than a mortuary.38 Further, it is an offence to remove any dead body of a person who has died of an infectious disease except to a mortuary or for purposes of immediate burial.39 Local authorities are placed with a duty to remove and bury bodies of destitute persons and of unclaimed bodies.40 In addition, the Minister may make rules applicable to all infectious diseases as specified.41 28 Section 16 of the Act 29 Section 17 of the Act 30 Section 19 of the Act 31 Section 19 of the Act 32 Section 20 of the Act 33 Section 21 of the Act 34 Section 23 of the Act 35 Section 24 of the Act 36 Section 25 of the Act 37 Section 26 (1) of the Act 38 Section 26 (2) of the Act 39 Section 26 (3) of the Act 40 Section 28 of the Act 41 Section 29 of the Act February, 2012 11 (d) Part V (Special Provisions Regarding Certain Formidable Epidemic or Endemic Diseases) Part V is concerned only with certain formidable epidemic or endemic diseases, mainly smallpox, plague, cholera, yellow-fever, cerebro-spinal meningitis, typhus, sleeping sickness or human trypanosomiasis and any other disease declared by the Minister.42 This Part gives power to the Minister to declare an infected area as such and make rules for prevention of the disease.43 Local Authorities are given powers to see to the execution of all rules made.44 (e) Part VI (Prevention of Introduction of Infectious Diseases) This Part contains provisions on the prevention of the introduction of infectious diseases (from those people coming) into Malawi. The Minister is given powers to enforce precautions at the borders of Malawi. This can be done through regulating, restricting or prohibiting the entry into Malawi of people, animals, articles or things from any specified country.45 This Part also gives powers of removal of all infected persons arriving in Malawi by railway train or other vehicle46; and also that such infected people may be put in isolation or under surveillance.47 The Part empowers Medical Officers of Health to board trains and other vehicles entering Malawi to inspect passengers with a view to identifying cases of infectious disease, and if such cases are found, to take necessary remedial staps. (f) Part VII (Smallpox) This Part deals with smallpox disease, and mainly issues to do with vaccination against it. It is a required by law that every child born in Malawi, has to be vaccinated after six months and within twelve months from birth so long as the child is fit to be vaccinated.48 (g) Part VIII (Venereal Diseases) This Part deals with venereal diseases such as syphilis, gonorrhoea, gonorrhoeal ophthalmia, soft chancre, lymphogranuloma inguinale, ulcerating granuloma and any other disease that may be declared by the Minister.49 It is an offence, where a person, with knowledge that he is suffering from a venereal disease, continues working in any capacity handling the care of children; requiring the handling of food intended for consumption; or of food utensils.50 42 43 44 45 46 47 48 Section 30 of the Act Section 31 of the Act Sections 32 & 33 of the Act Section 38 (1) of the Act Section 39 of the Act Section 40 of the Act Section 45 of the Act provides that those people not fit to be vaccinated have to be certified as such by any public vaccinator. The said certificate shall be in force for six months only, but renewable for successive periods of six months until the public vaccinator shall deem the person fit for vaccination. 49 Section 53 of the Act 12 February, 2012 It is also an offence to publish, exhibit or circulate any advertisement or statement intended to promote the sale of any medicine, appliance or article for the alleviation or cure of any venereal disease or disease affecting the generative organs or functions, or of sexual impotence or of any complaint or infirmity arising from or relating to sexual intercourse.51 This, however, excludes publications by or under the authority of the Secretary for health, or by any local authority or public hospital or any public body or person or society in the discharge of its lawful duty for the advancement of medical science. It is an offence where one wilfully or by culpable negligence infects any other person with a venereal disease.52 (h) Part IX (Sanitation and Housing) This Part tackles sanitation and housing issues. It prohibits nuisance53 and places duties on local authorities to maintain cleanliness and prevent nuisances.54 Local authorities also have a duty to prevent or remedy danger to health arising from unsuitable dwellings by taking all lawful, necessary and reasonable practicable measures.55 Thus, local authorities can take those who do not obey orders to court;56 put on sale by public auction any matter or thing removed in abating any nuisance;57 and also demolish unfit buildings.58 Further, the Minister is accorded power to make rules regarding inspection of land, construction of buildings, keeping of animals and also control of houses used as lodging.59 (i) Part X (Conservancy, Sewerage and Drainage) This Part provides that a local authority may within its district and also, subject to the prior approval of the Minister without its district, construct and maintain a public sewer and also construct sewage disposal works.60 Every owner and occupier of any premises or private sewer has a right to have his drains or private sewer connected to the public sewers61, so long as he has given notice to the local authority.62 All new buildings are required to make satisfactory provision for drainages63 and latrines.64 Local authorities are supposed to notify the owner of the building to make satisfactory provision for drainages and latrine accommodation, if ever the same are absent.65 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 Section 54 (1) of the Act. It is also an offence to the employer, as per section 54 (2) Section 55 (1) of the Act Section 57 of the Act Section 59 of the Act. As to what constitutes nuisance, the same has been exhaustively provided for in section 62 of the Act Section 60 of the Act Section 61 of the Act Section 66 of the Act Section 69 of the Act Section 71 of the Act Section 75 of the Act. See also Section 76 for provision of standards regarding construction of buildings. Section 79 of the Act Section 83 of the Act Section 86 of the Act Section 87 of the Act Section 88 of the Act February, 2012 13 (j) Part XI (Prevention and destruction of mosquitoes) This Part deals with preventive measures to do away with mosquitoes, the causative agent of malaria. The Part declares that all breeding places of mosquitoes are nuisances.66 It also provides that all yards should be kept free from any item which may retain water and can therefore breed mosquitoes. It is an offence to keep such items.67 The Act also requests all households to make sure that all overgrown bush and long grass is cleared;68 and also that wells are be covered.69 It further requires that all cesspits should be screened to the satisfaction of a medical officer70; and that all mosquito larvae should be destroyed71 for it is an offence where the said larvae are found in the premises of any person.72 (k) Part XII (Protection of foodstuffs) This Part provides that all buildings meant for the storage of foodstuffs for trade purposes should be constructed in a manner that they are protected against rats, vermin and pollution.73 The Part also makes it an offence where a person sleeps in any kitchen or room in which foodstuffs for sale are prepared or stored.74 (l) Part XIII (Water and food supplies) Local Authorities have a duty, under this Part, to take all lawful, necessary and reasonably practicable measures for preventing any pollution dangerous to health of any supply of water which the public within its district has a right to use and does use for drinking or domestic purposes.75 Further, the Act prohibits the sale of food in tainted, adulterated, diseased or unwholesome state76, and it gives power to any health worker or local authority or any person duly authorised to seize such food.77 It is an offence to put on sale such unwholesome food.78 The Minister is also given powers to make rules regarding inspection of dairy stock of animals intended for human consumption; taking and examination of milk, dairy produce, meat and the removal of animals suspected of being diseased or unwholesome for human consumption; veterinary inspection of dairy stock; etc.79 Further, the Minister has powers to specify by order, standards of quality, composition and condition, and minimum standards, in respect of any foodstuffs, goods or other articles.80 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 Section 89 of the Act Section 96 of the Act Section 97 of the Act Section 98 of the Act Section 99 of the Act Section 100 of the Act Section 101 of the Act Section 102 of the Act Section 103 of the Act Section 104 of the Act Section 105 of the Act Section 106 of the Act Section 108 of the Act Section 102 of the Act Section 109 of the Act Section 110 of the Act 14 February, 2012 (m) Part XIV (Cemeteries) The Minister has powers to select, allocate and appoint and to notify in the Gazette sufficient and proper places to be used for burial of dead bodies. It is obligatory, where such cemeteries or crematoria exist to bury or cremate the dead in such cemeteries or crematoria.81 (n) Part XV (General) This Part provides general provisions. It is illegal for one to occupy a basement without permission.82 It is also required that all lodging houses should be regulated and inspected.83 Likewise all private hospitals, nursing homes and maternity homes.84 The Minister of Health is given general powers for the inspection, sampling, examination of vaccines, vaccine lymphs, sera and similar substances imported into or manufactured in Malawi and intended to be used for the prevention or treatment of human diseases.85 (o) Part XVI (Miscellaneous Provisions) This Part lays out provisions regarding court notices, summons and also provisions regarding legal capacity and general operational powers. 2.3 Other ancillary statutes to public health The statutes are related to public health. The list is not exhaustive at this stage: (a) Environment Management Act (Cap. 60:02) The Act makes provision for the protection and management of the environment, the conservation and sustainable utilization of natural resources and for matters connected therewith and incidental thereto.86 The Act criminalizes some of the actions which can amount to public health hazards such as improper management of hazardous materials87 and emission of pollutants into the environment.88 (b) The Anatomy Act (Cap. 34:03) The Act came into force on 1 April 1991; repealing the Human Tissue Act. The Act provided for the donation and use of bodies, or parts of bodies, of deceased persons for educational, scientific, research, therapeutic or diagnostic purposes. 81 82 83 84 85 86 87 88 Section 113 (1) of the Act Section 120 of the Act Section 121 of the Act Section 122 of the Act Section 126 (1) of the Act See the long title to the Environment Management Act Section 66 (a) of the Environment Management Act Section 67 of the Environment Management Act February, 2012 15 (c) Town and Country Planning Act (Cap. 23:01) The Act provides that the Minister responsible, through Councils, has powers to approve or disapprove all building plans. The Public Health Act, however, places a duty on local authorities to prevent or remedy danger to public health arising from unsuitable accommodation. It provides that the Minister has the power to make rules regarding, among other things, the inspection of land, the construction of buildings and to control the letting of houses. (d) Waterworks Act (Cap. 72:01) The Act has provisions to do with operation of water-borne sewerage sanitation.89 The Act provides that water boards have the overall responsibility to provide water. The Public Health Act places that duty in the hands of local authorities. Part III of the Public Health Act states that local authorities must take all lawful, necessary and reasonably practicable measures for preventing any pollution dangerous to health of any supply of water which the public within its district has a right to use and does use for drinking or domestic purposes.90 Much as the Waterworks Act is more recent than the Public Health Act, did not expressly the former spell it out that it was transfering the duties of local authorities regarding water supply to water board. (e) Control and Diseases of Animals Act (Cap. 66:02) The Act makes provisions for the control and diseases of domestic animals. The Act provides that all diseased animals should be separated and notification of the disease should be able to the nearest inspector or police officer. It also gives powers to the Minister to make rules regarding the prevention and control of diseases of animals. In Part XIII of the Public Health Act, the Minister has powers to make rules regarding, among other things, the removal of animals suspected of being diseased or unwholesome for the purpose of human consumption. Similarly, under Part IX of the Public Health Act, the Minister has power to make rules regarding the keeping of animals. (f) Malawi Bureau of Standards Act (Cap. 51:02) The Act provided for standards to be followed by producers. It therefore establishes a board, named Malawi Bureau of Standards which has the mandate to check that standards of products are suitable for consumption by producers. Part XIII of Public Health Act empowers the Minister to specify, by order, standards of quality, composition and condition, and minimum standards in respect of foodstuffs, goods or other articles. 89 See Part V of the Waterworks Act 90 Section 105 of the Public Health Act 16 February, 2012 (g) Occupational Safety, Health and Welfare Act (Cap. 55:07) Section 68 (1) of the Act provides that the occupier of any workplace who believes or suspects, or has reasonable ground for believing or suspecting, that any case of industrial disease as set out in the Second Schedule to the Act has occurred in the workplace, shall forthwith send written notice of such case to the Director of Occupational Health, Safety and Welfare. (h) Prisons Act (Cap. 9:02) The Act has provisions for cleanliness of prisons; notification of illness; sick prisoners including their isolation where recommended by a medical officer; disposal of a dead body in the interest of public health; medical inspection of prisons, sanitation and cooking facilities; and vaccination. (i) Noxious Weeds Act (Cap. 55:07) The Act provides for a duty to clear noxious weeds. It also prohibits the throwing of a noxious weed or its seed into any river or stream. (j) Meat and Meat Products Act (Cap. 67:02) The Act has the Meat Inspection Regulations. It lists down diseases which if found will lead to a rejection of specified parts of the carcass, and diseases which if found will lead to a rejection of the entire carcass (if the same has been slaughtered or is being offered for human consumption). (k) Milk and Milk Products Act (Cap. 67:05) There are regulations under the Act which require, among other things, that: Dairy premises must, at all times, be in a clean and sanitary condition; milk for human consumption which is on a dairy plant premises must be kept in a fluid state separate from all other milk and cream; all dairy plant equipment must, at all times, be thoroughly cleaned after use with hot water or suitable detergents; all premises for distribution of milk must, at all times, be kept in a clean and sanitary condition; and milk, cream and other dairy products shall not be stored in any place where they may be exposed to any condition that may compromise their quality. (l) Local Government Act (Cap. 22:01) Section 103 of the Act provides that the Council may make by-laws for the of the whole or any part of the local government area or, as the case may be for the prevention and suppression of nuisances therein and for any other purpose. (m) Pharmacy, Medicines and Poisons Act (Cap. 35:01) The Act provides for the establishment of the Pharmacy, Medicines and Poisons Board, the registration and disciplining of pharmacists, pharmacy February, 2012 17 technologists and pharmacy assistants, the training within Malawi of pharmacists, pharmacy technologists and pharmacy assistants, the licensing of traders in medicines and poisons and generally for the control and regulation of the profession of pharmacy in Malawi. (n) Medical Practitioners and Dentists Act (Cap. 36:01) The Act provides for the establishment of the Medical Council of Malawi; the registration and disciplining of medical practitioners and dentists; the licensing of private practice of medical practitioners and dentists; the regulation of training within Malawi of medical personnel and generally for the control and regulation of the medical profession and practice in Malawi. The Act has the following subsidiary legislations: Medical Practitioners and Dentists (Specialist Register) (Qualifications) Rules; Paramedicals and Allied Health Professionals (Training) Rules; Paramedicals and Allied Health Professionals (Private Practice) Regulations; Medical Imaging (Private Practice) Regulations; Medical Laboratories (Private Practice) Regulations; Medical Practitioners and Dentists (Private Practice) Regulations; and Medical Practitioners and Dentists (Registration and Miscellaneous Fees) Regulations. (o) Nurses and Midwives Act (Cap. 36:02) The Act provides for the establishment of the Nurses and Midwives Council of Malawi; the registration and disciplining of nurses and nursing technicians; the licensing of private practice; the regulation of education and training of nurses and nursing technicians and generally for the control and regulation of the nursing profession and practice in Malawi. 2.4 The national health policy framework The Ministry of Health has over the years developed policies aimed at issues addressing public health. The following are some of the policies: (a) Infection Prevention and Control Policy, 2004 This Policy outlines the broad principles of infection prevention and control for health care facilities. It was developed by the Malawi Ministry of Health in accordance with international evidence-based information to protect patients, staff and the general public from health care facility acquired infections. (b) National Quality Assurance Policy, 2005 This Policy was developed after it was discovered that Malawi’s health delivery systems are faced with a number of problems in the provision of quality services. The policy put into place mechanisms to define, measure and improve the quality of health services at all levels within the health sector. The main purpose of the policy is to give broad guidance in the establishment and implementation of quality assurance and quality 18 February, 2012 management in all health care facilities serving the population of Malawi, both public and private, such that quality assurance and improvement activities are the integral part of health care delivery. The policy reinforces and complements the implementation of health sector reforms, especially the implementation of the Essential Health Package, and other public health policies. (c) National Care of the Carer HIV and AIDS Workplace Policy, 2005 This Policy is aimed at preventing the transmission of HIV and other infectious diseases in the health care setting; providing support for health care workers caring for AIDS patients; providing care and support for health workers infected with HIV; and also assisting informal health workers to prevent contracting HIV during home or hospital care of relatives suffering from AIDS related illnesses and delivery of HIV-infected pregnant women in the home. (d) Health Information System: National Policy and Strategy, 2003 This Policy is aimed at recognising how health information plays an integral part in national health system. (e) National Sexual and Reproductive Health Rights (SRHR) Policy, 2009 This Policy is aimed at providing a framework for the provision of accessible, acceptable and affordable comprehensive SRHR services to all women, men, and young people of Malawi through informed choice to enable them attain their reproductive rights and goals safely. 2.5 The International Health Regulations The International Health Regulations (the “IHR”) are an international legal instrument that was adopted by the fifty-eighth World Health Assembly on 23 May, 2005 and entered into force on 15 June, 2007. The IHR are binding on 194 countries across the globe, including all the member States of the World Health Organization. The IHR aim at disease prevention with an international crossborder public health risk. However, the IHR also ensure that there is no unnecessary interference international traffic and trade. The IHR incorporate a number of innovations:91 (a) there scope is not limited to a specific disease or manner of transmission; (b) State Parties are obliged to develop minimum core public health capacity; (c) State Parties are obliged to inform the World Health Organization of events that may constitute a public health emergency of international concern as defined under the Regulations; 91 http://www.who.int/features/qa/39/en/index.html, (accessed on 20 May, 2011) February, 2012 19 (d) World Health Organization can take into account unofficial reports of public health risks and verify the reports with a State Party concerned; (e) the Regulations provide the procedure for the determination of a “public health emergency of international concern” by the Director General of World Health Organization; (f) protection of the human rights of persons and travellers; and (g) the establishment of focal points for urgent communication between World Health Organization and State Parties. 3. THE PUBLIC HEALTH REGULATORY SYSTEM 3.1 Regulation of health care services in Malawi Health care services in Malawi are regulated by the Ministry responsible for health at different levels. There are three levels of health care: the tertiary level (involving referral, central or teaching hospitals); the secondary level (involving district hospitals); and the primary level (involving health centres, clinics or dispensaries). The Public Health Act, or any law for that matter, is not clear on the hierarchy of public health administration and management in Malawi. The Public Health Act, for example, makes reference to the “medical officer of health” who has been defined as the Secretary for health and has powers over some of the (public) health issues. The Ministry of Health has a Principal Secretary appointed under section 93 (2) of the Constitution.92 There is no further statutory structure beyond the Constitution or is there a cross reference to the Public Health Act. All the other health officers are appointed subject to the provisions of the Public Service Act (Cap. 1:03). Further, the Public Health Act has subsidiary legislation on hospital advisory committees made by the Minister under section 143 of the Act. There are Hospital Advisory Committee Rules for Queen Elizabeth Central, Zomba General, Lilongwe General, Dowa District, Kasungu District, Rumphi District, Salima District and Chitipa District Hospitals. Under the said Advisory Committee Rules, there is provision for the office of Medical Superintendent of Health for each district. This office is equivalent to the position of Hospital Director. The law is not clear as to what ought to be done to those hospitals with no advisory committees. Beyond the Hospital Advisory Committee Rules, the Public Health Act creates a complex public health regulatory system in Malawi. The Act vests powers in the Ministers responsible for health, local government and land matters respectively depending on the issue at hand. It is not clear from the Act which authority takes the lead in cases of public health-related risks and the responses that ought to be put in place to stem such risks. 92 Section 93 (2) of the Constitution provides that ‘every government department shall be under the supervision of a Principal Secretary, whose office shall be a public office, and who shall be under the direction of a Minister or Deputy Minister’. 20 February, 2012 The Public Health Act, for example, provides that local authorities have a duty to take all lawful, necessary and, under its special circumstances, reasonable and practicable measures for preventing any infectious disease.93 Although the local authorities have powers to deal with an outbreak of a communicable disease, the lack of minimum guidelines leads to the absence of a coordinated response to such an outbreak. Furthermore, as such outbreaks are not designated as an emergency, there is no provision for the deployment of emergency health care workers. The Occupational Safety, Health and Welfare Act creates a clearer hierarchy on the exercise of the powers under that Act. The Act establishes the office of the Director of Occupational Safety, Health and Welfare.94 The Director deploys inspectors who are mandated by law to enter, inspect and examine at all reasonable time any place which is reasonably believed to be a workplace and in which there is reasonable cause to believe that explosives or inflammable materials are stored or used. The inspectors are subordinates of the Director and report to that office. The clear line of authority is important for efficiency. 3.2 Comparable Jurisdictions 3.2.1 Kenya The Kenya Public Health Act establishes the Central Board of Health which consists of the Director of Medical Services, a sanitary engineer, a secretary, and such other person or persons not exceeding six as are appointed from time to time by the Minister.95 The Director serves as the chairperson of the Board and three of the other members must be medical practitioners. The Board has powers to prevent and guard against the introduction of infectious diseases into Kenya from outside; to promote public health and the prevention, limitation or suppression of infectious, communicable or preventable diseases within Kenya; to advise and direct local authorities in regard to matters affecting public health; to promote or carry out researches and investigations in connexion with the prevention or treatment of human diseases; to prepare and publish reports and statistical or other information relative to public health; and generally to carry out, in accordance with directions, the powers and duties in relation to the public health conferred or imposed by the Kenya Public Health Act.96 3.2.2 Botswana In Botswana, section 4 of the Public Health Act provides for the appointment of health officers or other officers by the Minister as may from time to time be necessary to carry out the purposes of the Act. This is subject to the provisions of the law governing the public service in that country. 93 94 95 96 Section 7 of the Public Health Act Section 72 of the Occupational Safety, Health and Welfare Act Section 3 of Public Health Act of Kenya Section 10 (2) of Public Health Act of Kenya February, 2012 21 3.2.3 United States of America In the United States of America, there is appointed a Surgeon General of the United States, who is the operational head of the Public Health Service Commissioned Corps. A Surgeon General designate is nominated by the President and confirmed by a majority vote by the Senate. The Surgeon General is the leading authority on matters of public health in the United States federal government. The incumbent is the overall head of the Public Health Service Commissioned Corps, a 6,000-member Commissioned Corps of the United States Public Health Service; a cadre of health professionals who are on call 24 hours a day, and can be dispatched by the Secretary of Health or the Assistant Secretary for Health in the event of a public health emergency. The Surgeon General’s office also periodically issues health warnings. The commonest of such warnings are the labels found on all tobacco products” packages and alcoholic beverages respectively sold in the United States.97 3.2.4 England and Wales In the United Kingdom, the equivalent of the Surgeon General is the Chief Medical Officer. The officer is a qualified medical doctor whose specialty is in public health and in the health of communities, rather than health of individuals.98 There are four Chief Medical Officers that appointed to serve each one of the four governments of the Union: Her Majesty’s government, the Welsh government, the Scottish government, and the Northern Irish government. 3.2.5 Canada In Canada, the Public Health Act empowers the Minister to appoint a duly qualified medical practitioner as Chief Health Officer. This appointed officer is given a duty to supervise the administration and enforcement of the Act.99 There are also other officers who are appointed under the direction of the Chief Health Officer. 3.2.6 Scotland In Scotland, the Public Health Act of 2008 replaced many of the powers available to local authorities and which relate directly to infected people and assigned them to health boards. A health board is responsible for the public health concerns of a larger area than local authorities. The Act places a duty on each health board to prepare plans relating to the protection of public health in its area as the board considers appropriate. In preparing a plan, a health board must consult the relevant local authority. The plan must be prepared in accordance with guidance from the Scottish Ministers, and can be incorporated within any other plan which the health board is required to prepare under any other enactment. There is a duty on the health board which prepares the plan to publish it, either as 97 See: <http://www.surgeongeneral.gov/> (accessed on 20 October, 2011) 98 See: <http://www.dh.gov.uk/en/Aboutus/MinistersandDepartmentLeaders/ChiefMedicalOfficer/About TheChiefMedicalOfficerCMO/DH_4103960 > (accessed on 21 October, 2011) 99 Section 2 of the Public Health Act of Canada 22 February, 2012 a stand-alone document, or as part of any other plan in which it is incorporated. The health board is empowered to vary any plan prepared. Section 3 of the 2008 Act places a duty on health boards to designate a sufficient number of persons for the purpose of exercising certain functions relating to public health under the Act and other enactments in each health board area. Persons designated under this section are to be known as “health board competent persons”. Subsection (4) provides that the Scottish Ministers may, by regulations, prescribe the persons or classes of person who may be designated as health board competent persons; the qualifications, training and other requirements to demonstrate competency which they must meet; and any other matters relating to the terms and conditions of such a designation as the Scottish Ministers consider appropriate. The regulations may provide that certain functions of health board competent persons may be carried out only by those with particular qualifications, training or other prescribed competencies. Similarly to section 3, section 5 of the 2008 Act places a duty on local authorities to designate a sufficient number of persons for the purpose of exercising certain functions relating to public health under the Act and other enactments, in each local authority area. Persons designated under this section are to be known as “local authority competent persons”. Further, the Scottish Ministers may, by regulations, prescribe the persons or classes of person who may be designated as local authority competent persons; the qualifications, training and other requirements to demonstrate competency which they must meet; and any other matters relating to the terms and conditions of such a designation as the Scottish Ministers consider appropriate. The regulations may provide that certain functions of local authority competent persons may be carried out only by those with particular qualifications, training or other prescribed competencies. 3.3 Regulation of trainings institutions The Medical Practitioners and Dentists Act establishes a Training Committee and the Medical Council of Malawi. The Committee has the following functions: (a) to advise the Council on all matters relating to the education and training requirements of medical and related personnel in Malawi; (b) to satisfy itself and the Council that the curricula in every teaching institution in Malawi in the medical field are such that graduates will have a sufficient basic knowledge for the practice of their profession or calling; and (c) to satisfy itself and the Council in such other matters as may be vested in it by the Council in relation to the supervision of other aspects of medical education and training.100 In relation to the training of health professionals, the Medical Council of Malawi has powers to approve: (a) teaching hospitals; 100 Section 41 of the Medical Practitioners and Dentists Act February, 2012 23 (b) medical and dental schools; (c) a basic medical education curriculum; (d) a post-graduate medical education; (e) the basic medical qualification of persons to be registered as medical practitioners or dentists; (f) registration of medical practitioners and dentists as consultants after approving their post-graduate qualifications; and (g) such other matter of training as may be within its competence under this Act or as may be expedient for the purposes and objects of this Act.101 The Medical Council may institute and issue degrees, diplomas and certificates of competence for any class of medical personnel trained or employed at an approved institution in Malawi other than medical practitioners, dentists and personnel of a class for which there is established a separate examining or qualifying authority. Degrees, diplomas or certificates of competence of the College of Medicine of the University of Malawi are also instituted with the approval of the Council.102 Section 45 of the Nurses and Midwives Act (Cap. 36:02) establishes the Education and Examination Committee. The Nurses and Midwives Council may not institute diplomas or certificates of competence to nurses and nursing technicians. However, it has powers to approve__ (a) teaching hospitals; (b) nursing schools; (c) a basic nursing education curriculum; (d) post basic nursing education curriculum; (e) the basic qualification of persons to be registered as nurses or nursing technician; and (f) such other matter of training as may be within its competence under the Act or as may be expedient for the purposes and objects of the Act.103 3.4 Regulation of practice Medical practice in Malawi is regulated by two pieces of legislation: the Medical Practitioners and Dentists Act and the Nurses and Midwives Act. The Medical Practitioners and Dentists Act is concerned mainly with the establishment of the Medical Council of Malawi; the registration and disciplining of medical practitioners and dentists; the licensing of private practice of medical practitioners and dentists; the regulation of training within Malawi of medical 101 Section 43 of the Medical Practitioners and Dentists Act 102 Section 44 of the Medical Practitioners and Dentists Act 103 Section 47 of the Nurses and Midwives Act 24 February, 2012 personnel and generally for the control and regulation of the medical profession and practice in the country. The Act establishes the Medical Council of Malawi which is the sole registering authority and with the following powers: (a) to assist in the promotion and improvement of the health of the population of Malawi; (b) to control and to exercise authority affecting the training of persons in, and the performance of the practices pursued in connexion with, the diagnosis, treatment or prevention of physical or mental defects, illnesses or deficiencies in human beings; (c) to exercise disciplinary control over the professional conduct of all persons registered under this Act and practising in Malawi; (d) to promote liaison in the field of medical training both in Malawi and elsewhere and to promote the standards of such training in Malawi; (e) to advise the Minister on any matter falling within the scope of this Act; and (f) to communicate to the Minister any information acquired by the Council relating to matters of public health.104 Further, the Council has the following powers: (a) to remove any name from any register or, subject to such conditions as the Council may impose, restore it thereto; (b) to appoint examiners and moderators, conduct examinations and approve certificates, and charge such fee in respect of such examinations and certificates as may be prescribed; (c) to approve of institutions in Malawi for the training of medical and related personnel; (d) to acquire, hire or dispose of property, and borrow money on the security of the assets of the Council or accept and administer any trust or donation; (e) to consider any matter affecting the medical, dental or psychology professions and make representations thereon to the Minister or take such action in connexion therewith as the Council considers necessary; (f) upon application by any person, to recognize any qualifications held by that person (whether such qualifications have been obtained in Malawi or elsewhere) as being equal, either wholly or in part, to any prescribed qualifications, whereupon such person shall, to the extent to which the qualifications have been so recognized, be deemed to hold such prescribed qualifications; (g) to perform such other functions as may be prescribed or assigned to the Council by the Minister; and 104 Section 10 of the Medical Practitioners and Dentists Act February, 2012 25 (h) generally, to do such things as the Council deems necessary or expedient to achieve the objects of the Medical Practitioners and Dentists Act.105 The Act further establishes a disciplinary committee within the Council which has the function to inquire into an allegation of conduct that a registered person: (a) has been guilty of improper or disgraceful conduct or conduct which, when regard is had to the profession or calling of that person, is improper or disgraceful; or (b) is grossly incompetent or has performed any act pertaining to his profession or calling in a grossly incompetent manner.106 Section 61 of the Act recognises the practice of the African (traditional) system of therapeutics by any person in Malawi so long as the performance by a person practising any African system of therapeutics of any act is not dangerous to life. The Nurses and Midwives Act is concerned mainly with the establishment of the Nurses and Midwives Council of Malawi; the registration and disciplining of nurses and nursing technicians; the licensing of private practice; the regulation of education and training of nurses and nursing technicians and generally for the control and regulation of the nursing profession and practice in the country. The Nurses and Midwives Council has almost the same functions as those of the Medical Council of Malawi. The disciplinary procedures are also the same. The Act also recognises the African (traditional) system of nursing or midwifery by any person in Malawi so long as the performance by a person practising any African system of nursing or midwifery of any act is not dangerous to life. 3.5 Health financing and health insurance Health financing aims at providing the resources and economic incentives for the operation of a health care system. It is one of the key determinants of health system performance in terms of equity, efficiency, and health outcomes.107 Health financing involves the basic functions of revenue collection, pooling of resources, and purchase of interventions.108 The World Health Assembly on 25 May, 2005 resolved and urged member States to ensure that health-financing systems include a method for prepayment of financial contributions for health care with a view to sharing risk among the population and avoiding catastrophic health care expenditure and impoverishment of individuals as a result of seeking such care. Health financing support in Malawi is done by the Government through budgetary allocations and also through 105 Section 11 of the Medical Practitioners and Dentists Act 106 Sections 47 and 50 of the Medical Practitioners and Dentists Act 107 http://www.ncbi.nlm.nih.gov/books/NBK11772/ (accessed on 1 December, 2011) 108 As above. Revenue collection is how health systems raise money from households, businesses, and external sources. Pooling deals with the accumulation and management of revenues so that members of the pool share collective health 26 February, 2012 support from donor partners. Under section 143 (2) (e) of the Public Health Act, the Minister is empowered to make rules regarding fixing of fees. These fees are provided in a schedule to the Public Health (Government Hospital) (Fees) Rules. The fees were promulgated in 1998 under Government Notice 15 of 1998. It is not clear whether the fees are being enforced at all. For some time now, the Government has been providing some essential health care interventions for free. These interventions, under what is known as the Essential Health Package, relate to thirteen “health” conditions which have been prioritized as the most critical and common conditions requiring urgent treatment responses at all times. The conditions include the so-called “diseases of poverty’, namely, diarrhoea, acute respiratory infections (ARIs), cholera, malaria and communicable and non-communicable diseases. In order to implement the Essential Health Package, the Government and other major stakeholders, including Christian Health Association of Malawi (“CHAM”) developed and subscribed to a programme of work. This programme of work provides a framework for supporting and implementing activities contained in the Essential Health Package. The agreement to finance was formalised under the Sector Wide Approach (“SWAp”) with external donors. The current Essential Health Package runs from 2011 to 2016. Despite all these efforts, better health care services are still not accessible to every person at all levels in Malawi. Adequate health financing still remains a major challenge to the extent that a number of State-run health care facilities such as hospitals or clinics lack adequate drugs and other essentials for the delivery of quality health care. Beyond health financing, another key component to access to health care is health insurance. Health insurance is a medical cover taken out by an individual or group of individuals against the risk of incurring medical expenses. By estimating the overall risk of health care expenses among a targeted individual or group, an insurer can develop a routine finance structure, such as a monthly premium or payroll tax, to ensure that money is available to pay for the health care benefits specified in the insurance agreement. Heath insurance comes in two models: a national insurance (NI) system and a social insurance (SI) system. An NI system imposes a burden on government budgets; while an SI system is funded by mandatory payroll deductions from those in formal or semi-formal employment. A lot of countries in Europe have opted for the SI system. In Malawi, health insurance is a matter of choice 109 and it is regulated generally by the Insurance Act 110 and the Finance Services Act. risks, thereby protecting individual pool members from large, unpredictable health expenditures. Prepayment allows pool members to pay for average expected costs in advance, relieves them of uncertainty, and ensures compensation should a loss occur. Pooling coupled with prepayment enables the establishment of insurance and the redistribution of health spending between high– and low–risk individuals and high– and low–income individuals. Purchasing refers to the mechanisms used to purchase services from public and private providers. 109 For example, there are health insurance schemes that are administered by Medical Aid Society of Malawi (‘MASM’) and a South African firm, Momentum Health. Other organisations, like the University of Malawi, have their own medical care schemes for their employees. 110 Cap. 47:01 February, 2012 27 Rule 2 (2) of the Public Health (Government Hospitals) (Fees) Rules makes a recognition of medical insurance schemes. 4. RIGHT TO HEALTH In this part, we analyze the nature of the right to health under Malawi law. We pose two questions: What is the nature of the right to health under international law and policy? What is the nature of the right to health under Malawi law; with specific focus on the Constitution? We will also look at the wider issue of the rights and duties of health care providers, health professionals, and health care “consumers” respectively. 4.1 The nature of the right to health under international law and policy It is important that the discussion on the right to health is located within the debates on the universality, justiciability and practicality of economic, social and cultural rights. Economic, social and cultural rights are contested because they require positive obligations on the part of the State for their realization. On the other hand, what are described as civil and political rights require a negative obligation - non-interference - on the part of the State. The arguments for the nonenforceability of economic, social and cultural rights proceed as follows: The rights are not universal because they cannot be enjoyed by everyone in a jurisdiction. This re-enforces the argument that these rights are also not fully recognized. Second, a large body of scholarship has historically questioned whether economic, social and cultural rights are justiciable, that is, whether they can be enforced in a court of law. Third, the question of practicality of economic, social and cultural rights is raised because they are resource-dependent.111 Hence, there is a Kantian-like objection to economic, social and cultural rights in the sense that since they are supposedly not cosmopolitan they cannot be enforced as human rights. This is a conceptual argument. Second, there is a more ideological argument advanced by the likes of Cass Sustein. The argument states that economic, social and cultural rights must be rejected because they are an intrusion to the free market.112 In the post-Cold War period, the general consensus is that there is no conceptual difference between civil and political rights and economic, social and cultural rights. The divisibility of rights, their hierarchy and indeed there categorization into generation is misplaced.113 Indeed, a number of largely, liberal democratic constitutions have emerged in the post-Cold War that recognize economic, social and cultural rights.114 Some constitutions recognize these rights as “principles of State policy’; others as “fully justiciable rights”; and yet others adopted a “mixed model” of recognition, that is, State policies and fully justiciable rights.115 111 See Chirwa, DM, Human Rights under the Malawian Constitution (Cape Town: Juta, 2011), pp 255–279 112 See Sustein, C, ‘Against Positive Rights’ (1993) 2 (1) East European Constitutional Review 35 in DM Chirwa, above, 257 113 See for example Baxi, U, The Future of Human Rights (Delhi: Oxford University Press, 2002) 114 See Chirwa, footnote 111, 258 115 As above 28 February, 2012 The right to health is an economic, social and cultural right. How has this right fared under international law and policy? A healthy life is arguably the basic starting point of the enjoyment of every human right. The state of health is in itself universally acknowledged as a basic human right. This is the case because the enjoyment of the right to health is a necessary condition of the enjoyment of all other human rights. Every human being is entitled to the enjoyment of the highest attainable standard of health conducive to living a life in dignity. The realization of the right to health may be pursued through numerous, complementary approaches, such as the formulation of health policies, or the implementation of health programmes developed by the World Health Organization or the adoption of specific legal instruments.116 The right to the highest attainable standard of health is a human right recognized in international human rights law. Article 25 (1) of the Universal Declaration of Human Rights (“UDHR”) states, “Everyone has the right to a standard of living adequate for the health of himself and of his family, including food, clothing, housing and medical care and necessary social services.” The International Covenant on Economic, Social and Cultural Rights (“ICESCR”), in Article 12 provides, 1. The State Parties to the present Covenant recognize the right of everyone to the enjoyment of the highest attainable standard of physical and mental health. 2. The steps to be taken by the State Parties to the present Covenant to achieve the full realization of this right shall include those necessary for: (a) The provision for the reduction of the stillbirth rate and of infant mortality and for the healthy development of the child; (b) The improvement of all aspects of environmental and industrial hygiene; (c) The prevention, treatment and control of epidemic, endemic, occupational and other diseases; (d) The creation of conditions which would assure to all medical service and medical attention in the event of sickness. The Committee on Economic, Social and Cultural Rights, in General Comment Number 14, laid out “underlying determinants of health”, as being the component of the right to health. These include: safe drinking water and adequate sanitation; safe food; adequate nutrition and housing; healthy working and environmental conditions; health-related education information; and gender equality. The Committee further notes that “the notion of the highest attainable standard of health” in Article 12.1 of the ICESCR takes into account both the individual’s biological and socio-economic preconditions and a State”s available resources”.117 116 General Comment No 14 of 2000 by the Committee on Economic, Social and Cultural Rights (‘CESCR’) on “the right to the highest attainable standard of health” (Article 12 of the International Covenant on Economic, Social and Cultural Rights) 117 As above February, 2012 29 Universal recognition of the right to health was further confirmed in the Declaration of Alma-Ata on Primary Health Care, 1978, in which States pledged to progressively develop comprehensive health care systems to ensure effective and equitable distribution of resources for maintaining health. They reiterated their responsibility to provide for the health of their populations, “which can be fulfilled only by the provision of adequate health and social measures.”118 Additionally, the right to health is recognized, among others, in Article 5 (e) (iv) of the International Convention on the Elimination of All Forms of Racial Discrimination of 1965; Articles 11 (1) (f) and 12 of the Convention on the Elimination of All Forms of Discrimination against Women of 1979; and in Article 24 of the Convention on the Rights of the Child of 1989. At the regional level, Article 16 of the African Charter on Human and Peoples” Rights (“ACHPR”) of 1981 guarantees right to health; so does Article 14 of the Protocol to the ACHPR on the Rights of Women in Africa, and Article 14 of the African Charter on the Rights and Welfare of the Child. Thus, some groups or individuals, such as children, women, persons with disabilities or persons living with HIV and AIDS, should be given special attention in relation to their right to health. These groups of people face specific hurdles resulting from biological or socioeconomic factors, discrimination and stigma. As such, States are encouraged to adopt positive measures to ensure that specific individuals and groups are not discriminated against. States have the primary obligation to protect and promote human rights emanating from both international customary law and international human rights treaties. Through their ratification of human rights treaties, State parties are required to give effect to human rights within their jurisdictions. Article 2 (1) of the ICESCR states that States have the obligation to progressively achieve the full realization of the rights under the Covenant. This is an implicit recognition that States have resource constraints and that it takes time to implement the treaty provisions. States, at a minimum, must show that they are making every possible effort, within their available resources, to better protect and promote all rights under the Covenant. The Committee on Economic, Social and Cultural Rights set out the following as core minimum obligations towards the realization of the right to health: (a) the right of access to health facilities, goods and services on a non-discriminatory basis, especially for vulnerable or marginalized groups; (b) access to the minimum essential food which in nutritionally adequate and safe; (c) access to shelter, housing and sanitation and an adequate supply of safe drinking water; 118 WHO, Declaration of Alma–Ata, International Conference on Primary Health Care, Alma-Ata, USSR, 6 to 12 September, 1978 30 February, 2012 (d) the provision of essential drugs; (e) equitable distribution of all health facilities, goods and services. 4.2 The nature of the right to health and the Constitution of Malawi Under the Constitution, there is no provision that expressly states that there is a right to health that is justiciable and enforceable in the jurisdiction. The Constitution takes a mixed model approach to economic, social and cultural rights. For example, the following economic, social and cultural rights are explicitly recognized under the bill of rights: the right to family protection;119 the right to education;120 the rights to culture and language;121 the right to property;122 the right to economic activity;123 the right to labour;124 and the right to development.125 Under the Constitution, the right to health is only recognized as principle of State policy.126 Section 13 of the Constitution provides that “the State shall actively promote the welfare and development of the people of Malawi by progressively adopting and implementing policies and legislation aimed at achieving”, among other things, health as a key national goal. The State is required to “provide adequate health care, commensurate with health needs of Malawian society and international standards of health care.”127 However, the right to health - as a principle of State policy - is “directory in nature”.128 The implication of the right to health as a principle of State policy is that it raises questions of justiciability. Can an aggrieved person take the State to court for violation of his or her right to health? There is a drought of litigation on economic, social and cultural rights in Malawi courts. However, where these rights have been before the courts for determination, the position is that where there is expression provision of a right, the State is bound by the right and the right is judicially enforceable. This is the position in Gable Masangano v. Attorney General & Others.129 It is not clear how the Malawi courts would consider an economic, social or cultural right that is only implicitly recognized under the Constitution. We will discuss the right to health in the context of the right to life and the right to development respectively below. Beyond recognition and the attendant issue of justiciability that arises, economic, social and cultural rights also bring out the challenges of enforcement. These relate to availability of resources to ensure persons fully enjoy their economic, social and cultural rights. In South Africa, for example, the right to 119 120 121 122 123 124 125 126 127 128 129 Section 22 of the Constitution Section 25 of the Constitution Section 26 of the Constitution Section 28 of the Constitution Section 29 of the Constitution Section 44 of the Constitution Section 30 of the Constitution Section 13 (c) of the Constitution As above Section 14 of the Constitution Constitutional Case Number 15 of 2007 (unreported) February, 2012 31 health is embedded in the Constitution as one of the economic, social and cultural human rights. The right to health in South Africa is not a principle of national policy.130 However, this position has not meant that economic, social and cultural rights are easily enforced in that country. Indeed, as a mirror image at the international level, economic, social and cultural rights, even in jurisdictions where they are fully recognized often have to contend with the minimum core principle. The minimum core principle in relation to economic, social and cultural rights entails that for a State to fail to meet her minimum core obligations under international human rights law she must demonstrate that all efforts were focussed on using all of her resources towards the realization of the right in question. The argument available cannot be that there are no resources. It can only be that despite the provision of the resources available, a person has not fully enjoyed the right in question. Put another way, a State is exonerated if she shows that even though she provided the resources available to her, the right could not be fully enforced. On this basis, the decision of the South African Constitutional Court in Soobramoney v. Minister of Health (KwaZulu -Natal)131 may be faulted for taking an overly administrative law train of thought as opposed to a minimum core approach. The Constitutional Court placed more weight on the budgetary constraints facing the local authority than on the steps the local authority took to meet the requirement of a right to health in the case of the applicant. In a different case - Minister of Health and Others v. Treatment Action Campaign & Others132 - the same court ordered the State to provide Nevirapine, a drug that significantly reduces the incidence of mother-to-child transmission of HIV at birth, to all pregnant mothers in South Africa. Here, the court placed more emphasis on the minimum core approach than on the purely administrative assessment of availability of resources. Beyond the minimum core principle, there is the requirement of “progressive realization” at international human rights law. CESCR General Comment Number 3 states that a State Party to the CESCR must move with speed, regardless of its national wealth, towards the realization of economic, social and cultural rights. At the African region level, the African Commission on Human and Peoples” Rights (“ACHPR”) in Purohit and Moore v. The Gambia,133 has held, 130 Section 27 of the South African Constitution provides, “(1) Everyone has the right to have access to– (a) health care services, including reproductive health care; (b) … (c) … (2) The State must take reasonable legislative and other measures, within its available resources, to achieve the progressive realisation of each of these rights. (3) No one may be refused emergency medical treatment.” 131 1998 (1) SA 765 (CC) (S.Afr.) 132 2002 (5) SA 703 (CC) (S.Afr.) 32 February, 2012 “(M)illions of people in Africa are not enjoying the right to health maximally because African countries are generally faced with the problem of poverty which renders them incapable to provide the necessary amenities, infrastructure and resources that facilitate the full enjoyment of this right. Therefore, having due regard to this depressing but real state of affairs, the African Commission would like to read into Article 16 the obligation on part of States parties to the African Charter to take concrete and targeted steps, while taking full advantage of its available resources, to ensure that the right to health is fully realized in all aspects without discrimination of any kind.” The South African Constitutional Court in Republic of South Africa & Others v. Grootboom & Others has held that “progressive realization” entails that “accessibility should be progressively facilitated: legal, administrative, operational and financial hurdles should be examined and, where possible, lowered over time.”134 Finally, the idea of reasonableness may be used as a measure of whether a State is meeting its obligations towards economic, social and cultural rights. A State Party may have deliberate policies in place towards the attainment of economic, social and cultural rights but may still fall short if those policies are unreasonable. For instance in Grootboom, even though the State had policies in place to address lack of housing in poor community, the Cape High Court found the policies unreasonable since they did not take into account short term needs such harsh weather conditions prevalent in the case. The South African Constitutional Court has gone to state that the reasonableness test must be balanced with the comprehensiveness test, that is, “policies must be wellcoordinated and comprehensive so as not to exclude a significant section of the people or those in desperate circumstances, or to neglect a particular right.”135 4.2.1 Understanding the right to health in the context of right to life Keep in mind that the Constitution adopts a mixed model approach in the recognition of economic, social and cultural rights. The right to health is recognized as one of the principles of national policy under section 13 (c) of the Constitution. In this part, we discuss the nature of the right to health in the context of the right to life. Are the constitutional provisions so far discussed adequately robust to make the State liable for infractions relating to public health? Let us look at India. The Federal Constitution of India does not expressly provide for a right to health. Just like the Malawian Constitution, health is provided as one of the directive principles of State policy.136 Indian jurisprudence has developed an expansive 133 African Commission on Human and People‘s Rights, Communication No. 241/2001, Sixteenth Activity Report 2002–2003, Annex VII 134 See para 45 of the judgment 135 Chirwa, footnote 111, 277 136 Section 47 of the Indian Constitution provides, “The State shall regard the raising of the level of nutrition and the standard of living of its people and the improvement of public health as among its primary duties and, in particular, the State shall endeavour to bring about prohibition of the consumption except for medicinal purposes of intoxicating drinks and of drugs which are injurious to health.” See http://www.issuesinmedicalethics.org/114hl123.html (accessed on 10 June, 2011) February, 2012 33 interpretation of the right to life to include the right to health and the right to a clean environment. Article 21 in the Indian Constitution provides for protection of life and personal liberty.137 The Indian Supreme Court has held that the right to live with human dignity, enshrined in Article 21, derives from the directive principles of State policy and therefore includes protection of health.138 Further, it has also been held that the right to health is integral to the right to life and the Indian Government has a constitutional obligation to provide health facilities.139 Similarly, it is possible to construe the right to health within the right to life under the Malawian Constitution. Section 16 of the Constitution provides for the right to life. It states, “Every person has the right to life and no person shall be arbitrarily deprived of his or her life: Provided that the execution of the death sentence imposed by a competent court on a person in respect of a criminal offence under the laws of Malawi of which he or she has been convicted shall not be regarded as arbitrary deprivation of his or her right to life.” The proviso to the right to life is only linked to the circumstances where death sentence is pronounced a person. However, there is need to define the right against to life in a higher sense. Committee on Civil and Political Rights (“CCPR”) in its General Comment Number 6, noted that “the right to life has been too often narrowly interpreted. The expression “inherent right to life” cannot properly be understood in a restrictive manner, and the protection of this right requires that States adopt positive measures.” The Committee considered that “it would be desirable for States parties to take all possible measures to reduce infant mortality and to increase life expectancy, especially in adopting measures to eliminate malnutrition and epidemics.”140 In this respect, the right to life takes on a more unrestrained conception that goes beyond the instantaneous “ending-oflife’. Finally, and in the context of the expansive interpretation of the right to life, human rights are also premised on the notion of human dignity.141 Under international human rights instruments, the assertion of the inherent right to life of every human being is accompanied by an assertion of the legal protection of that basic human right and of the negative obligation not to arbitrarily deprive one’s life.142 The negative obligation is accompanied by the positive obligation to take all appropriate measures to protect and preserve human life. Taken in its wide and proper dimension, the fundamental right to life comprises the right of every 137 The wording of Article 21 is that “no person shall be deprived of his life or personal liberty except according to procedure established by law.” Bandhua Mukti Morcha v. Union of India 1984 AIR SC 802 State of Punjab v. Mohinder Singh Chawla (1997) 2 SCC 83 Emphasis added Kamchedzera G & Banda C, ‘Dignified Rural Living, the right to development, multiparty politics and legislation in Malawi’, (2009) 25 South Africa Journal on Human Rights, 73 142 UN Covenant on Civil and Political Rights, Article 6 (1); European Convention on Human Rights, Article 2; American Convention on Human Rights, Article 4 (1); African Charter on Human and Peoples’ Rights, Article 4 138 139 140 141 34 February, 2012 human being not to be deprived of his life- right to life and the right of every human being to have the appropriate means of subsistence and a decent standard of life. In this way, the right to life is as much about the preservation of life (through the absence of death) as it is about the right to dignified living.143 4.2.2 The right to health in the context of the right to development Section 30 of the Constitution provides for the right to development. The provision states, “(1) All persons and peoples have a right to development Right to and therefore to the enjoyment of economic, social, cultural and political development and women, children and persons with disabilities in particular shall be given special consideration in the application of this right. (2) The State shall take all necessary measures for the realization of the right to development. Such measures shall include, amongst other things, equality of opportunity for all in their access to basic resources, education, health services, food, shelter, employment and infrastructure. (3) The State shall take measures to introduce reforms aimed at eradicating social injustices and inequalities. (4) The State has a responsibility to respect the right to development and to justify its policies in accordance with this responsibility.” It should be noted that the Constitution recognizes that access to, among other things, health services, is one of the necessary measures for the realization of the right to development. The World Health Organization and the Office of the Human Rights Commissioner have also adopted this development policyunderstanding of the right to health. The international bodies construe the right to health as an inclusive right that includes the right to safe drinking water and sanitation, safe food, adequate housing and nutrition, safe working environment, health-related information and education, and gender equality; as an entitlement to ethical medical practice and treatment, and functional public health and health care facilities.144 Indeed, scholars such as Danwood Chirwa note that in jurisdictions where the right to health is only recognized as a principle of State policy, it is useful to locate the right to health within the right to development. Chirwa argues that the “equality of opportunity” standard espoused in section 30 (2) of the Constitution is the benchmark for claims for the enforcement of economic, social and cultural rights such as the right to health.145 4.3 Rights and duties of health care providers, health professionals, and health care “consumers” In this part, “health care provider” refers to a facility such as a hospital; “health professional” refers to the personnel in the medical, nursing and other allied professional fields and “health care consumer” refers to potential and actual 143 Kamchedzera & Banda (n 139) 144 See World Health Organisation and Office of the Human Rights Commissioner, Fact Sheet Number 31 145 Chirwa, footnote 111, 265–268 February, 2012 35 patients. While there are minimum standards that are expected in relation to each category, by and large, the rights and duties that apply to each category are influenced by the municipal laws of the particular country, the nature of the health care that is provided, the field of expertise of the professional, and the nature of health care services. The Ministry of Health has developed a charter on the rights and responsibilities of patients and health service providers. The charter provides that a patient has the right to access to health care according to the patient”s need; right to be cared for by a competent health worker; the right to access medicines, vaccines and other pharmaceutical supplies of acceptable standards; and also the right to prompt emergency treatment. The patient also has rights to choice and second opinion; adequate information and health education; informed consent or refusal of treatment; participation or representation; respect and dignity; guardian; privacy and confidentiality; safe environment; and fair administrative remedy. On the health professional; the charter provides that the worker has rights in relation to access to equipment and supplies; continuing education; respect and dignity; working hours and rest; occupational health and protection; professional practice; and right to fair administrative remedy. The rights above have also responsibilities. A patient must ensure that he or she is conducting himself or herself in a manner that does not interfere with the rights or well being of other patients and health professionals. He or she also has the responsibility to accept all the consequences of his or her own informed decisions; and also must provide health professionals with relevant and accurate information for diagnostic treatment, rehabilitation or counselling purposes. The health professional has responsibilities to conduct his duties in the best of the patient; and comply with all ethical requirements among others. There are no similar provisions on the rights and duties of health care providers developed by the Ministry of Health in its charter or at all. 5. PUBLIC HEALTH AND ETHICS 5.1 Consent to Medical Procedures Consent to medical procedures plays an extremely important role in the context of health care provision. The concept of consent operates as a unifying principle through health care law. It represents the legal and ethical expression of the human right to have one”s autonomy recognized and respected. Once a person has been adjudged that they require health care services they are a patient. However, before any service is actually administered on that person, there is need for his or her consent. For consent to be legally effective, a patient must be able to understand the nature and purpose of the treatment, and must be able to weigh the risks and benefits of it.146 There is need for the patient to possess the capacity to make a choice on the basis of his or her understanding, 146 Per Lord Brandon in F v West Berkshire Health Authority [1989] 2 All ER 545 36 February, 2012 and be able to communicate that choice. The aim of determining competence is to categorize patients into two classes- those whose voluntary decisions must be respected by others and accepted as binding; and, those whose decisions may be set aside. The incompetent patient seeking health care services will thus effectively be denied any right of autonomy. When can treatment be imposed without getting consent from the patient? Paternalists have argued that good health and physical comfort are preferable to ill health and physical discomfort: a patient will thus be happier treated than untreated.147 Paternalism is usually understood to mean the interference of the State or an individual with another person, against their will, and justified by a claim that the person interfered with will be better off or protected from harm. The case for imposed treatment can also be couched in social terms. Illness is costly to the community and the individual is not entitled to refuse treatment which may minimize that cost. Thus, when an unconscious patient is admitted to hospital, the casualty officer may argue that his or her consent could be implied or presumed on the grounds that if he or she were he or she would probably consent to his or her life being “awake” saved in this way. Criminal and civil law recognize circumstances in which acting out of necessity legitimates an otherwise wrongful act. The basis of this doctrine is that acting unlawfully is justified if the resulting good effect materially outweighs the consequences of adhering strictly to the law. In the present context, the doctor is justified, and should not have criminal or civil liability imposed upon him, if the value which he seeks to protect is of greater weight than the wrongful act he performs - that is, treating without consent. However, a doctor cannot, “take advantage” of unconsciousness to perform procedures which are not essential for the patient”s survival. Others have argued that, ideally, coercive policies should not be implemented without political mandate or authorization. Lack of such legitimization would render the interventions incompatible with the largely liberal democracies today. They would also be undesirable from a more technical public health perspective, as opposition to the measures is likely to be strong, especially in personal areas such as food or sexual behaviour. The justification and feasibility of public health policies therefore depends heavily on their having a mandate.148 5.2 Regulation of Clinical Trials Clinical trials are regulated under the Pharmacy, Medicines and Poisons Act. Section 42 (1) of the Act defines a clinical trial as an investigation or series of investigations consisting of the administration of one or more medicinal products of a particular description by, or under the direction of, a medical practitioner or dentist to his patient where there is evidence that medicinal products of that description have effects which may be beneficial to the patient in question and the 147 Mason, JK and McCall Smith, RA, Law and Medical Ethics, (5th edn., Butterworths, London, 1999) 148 Nuffield Council on Bioethics, ‘Public Health: Ethical Issues’ (Cambridge Publishers, 2007) February, 2012 37 administration of the medicinal product is for the purpose of ascertaining to what extent the product has any other effects whether beneficial or harmful. The Act also makes it an offence, in section 42 (2), where a person, in the course of a business carried on by him sells or supplies any medicinal product; procures the sale or supply of any medicinal product; and procures the manufacture or assembly or for the manufacture or assembly of any medicinal product for sale or supply for the purpose of a clinical trial. The Act sets out that persons supposed to conduct clinical trials should be holder of a product licence, issued by the Pharmacy, Medicines and Poisons Board, which authorizes the clinical trial in question, or they do it to the order of the holder of such a licence, and, in either case, they do it in accordance with that licence. Further the clinical trial certificate should be one issued to the persons conducting the trial and it certifies that, subject to the provisions of the certificate, the licensing authority has authorized the clinical trial in question and that a certificate is for the time being in force and the trial is to be carried out in accordance with that certificate.149 Thus, in Malawi, it is the Pharmacy, Medicines and Poisons Board, which issues clinical trial certificates. However, if we are to define clinical trials broadly, the term may not only cover inception of medicine. What would be done where medical product involves introducing a new surgical technique? Would this too be subject to special regulation, or be within the ambit of the Board? In England, before a clinical trial is undertaken, it is standard practice for the trial to be referred to a research ethics committee for its approval. The revision of the law in this area may consider developing regulations protects people taking part in the trials, like students; and even those who have been offered inducements to participate in the trials. 5.3 Confidentiality The relationship of a health professional and patient is a fiduciary one, that is, it is creates trust and confidence enforceable at law. Medical law and ethics has settled the principle that a health professional cannot reveal information on a patient which he or she obtained in the course of the discharge of his or her professional duty. The principle has developed in light of the right to privacy under human rights law. However, there are exceptions to the rule of medical confidentiality which have been developed due to the peculiar circumstances of each country. In Malawi, it is not apparent under the Medical Practitioners and Dentists Act or the Nurses and Midwives Act that matters of confidentiality are dealt with as a matter of law. Anecdotal evidence confirms that medical confidentiality forms part of the ethics curricula during the training of health professionals in the country. Jurisdictions such as the England and Wales or the United States have developed elaborate rules that allow disclosure of information on road traffic 149 See sections 42 (2) and (3) of the Pharmacy, Medicines and Poisons Act 38 February, 2012 infractions; crime investigation, particularly gunshot and knife wounds; serious communicable diseases; or insurance, employment or similar purposes.150 6. CONTROL OF USE OF HUMAN TISSUE 6.1 The donation of tissue by living persons Tissue is defined as any human tissue including any human flesh, organ, bone, body fluid or derivative of any human tissue.151 In this paper, human tissue refers organs and parts of organs, cells and tissue, sub-cellular structures and cell products, blood, gametes (sperm and ova), embryos and fetal tissue. The starting point here is the understanding that no person is deemed capable of consenting to his being killed or seriously injured. The Anatomy Act provides that removal of tissue from bodies of living persons may be only for educational, scientific research, therapeutic or diagnostic purposes.152 The Act further provides that in cases of removal of tissue from bodies of living persons, such removal shall only be done where such a person or his or her spouse or close relative has granted consent. In case where the person is a minor or a person with mental disability, the consent of a parent, guardian or close relative (who is not a minor) is required.153 At common law, the legal requirements necessary for a valid consent may vary between the two types of procedure: therapeutic and non-therapeutic. As regards therapeutic procedures, there are two levels of consent. There must be explicit consent to the nature and purpose of any proposed intervention. Thereafter, the degree of information concerning possible risks associated with the treatment, which the doctor must disclose, so as to make the consent informed and thus valid, is what a reasonable doctor would disclose. In certain circumstances, for example, if a patient is extremely anxious, a doctor may decide not to inform the patient about certain risks associated with a particular treatment. Where the procedure is non-therapeutic, the two levels of consent do not apply and there is no scope for medical discretion. Consent, in this latter instance, must be explicit and all relevant information must be provided. Thus, when removal of tissue takes place in a non-therapeutic context, for example, from a volunteer in a research project, not only must the removal be for a purpose which the law permits, that is, it must be in the public interest, but it must also be consented to explicitly and on the basis of all appropriate information.154 It is an offence where a person sells or buys a tissue removed from the body of a living person.155 Further, no person is allowed, for gain or profit, to supply to any person for educational, scientific, research, therapeutic or diagnostic 150 151 152 153 154 155 See the General Medical Council of England’s list of ethical guidance available at http://www.gmcuk.org/guidance/ethical_guidance/confidentiality.asp (accessed on 19 January, 2012); and also the Privacy Rule under the Health Insurance Portability and Accountability Act of 1996 Section 2 of the Anatomy Act Section 11 of the Anatomy Act As above Nuffield Council on Bioethics, ‘Human Tissue: Legal and Ethical Issues’ (1995), 59 Section 16 of the Anatomy Act February, 2012 39 purposes, or any other purpose whatsoever, tissue removed from the body of living person.156 6.2 Cadaver donations The Anatomy Act regulates the conduct of an “anatomical examination”157 in circumstances where a deceased person has bequeathed his or her body for such a purpose. The Act provides that any person, if he or she wishes, can make a declaration to have his body after his death be examined anatomically. This can be made either in writing signed by him or her or orally in the presence of two or more witnesses during the illness from which he or she died.158 The Act also provides that any medical practitioner may, with the prior approval of a close relative of the deceased person or, in case where a close relative is not known, the police, carry out a post-mortem examination on the body of a deceased person before its burial or examination in order to establish the cause of death. The provisions of the Anatomy Act do not clearly state what the tissues from the dead body can be used for, as opposed to the tissues from a living person which are said to be for educational, scientific research, therapeutic or diagnostic purposes. Section 131 of the Penal Code makes it an offence where any person without lawful authority in that behalf disinters, dissects, or harms the dead body of any person. It is an offence where a person sells or buys the body of a deceased person or a tissue removed from the body of a deceased person.159 Further, no person is allowed, for gain or profit, to supply to any person for educational, scientific, research, therapeutic or diagnostic purposes, or any other purpose whatsoever, tissue removed from the body of a deceased person.160 The revision of the law on this point ought to consider reconciling the provisions of the Anatomy Act and the Penal Code, and also to provide for the manner of the lawful use of tissue from dead persons. 6.3 Certification of death of a human being The medical profession has reached consensus as to the point of death, and this paper shall not labour itself defining the same. However, there may be instances where a person is said to be dead by ordinary persons who have no medical training. These declarations of death arise where a person has died in the care of ordinary persons in their homes. It is important that the law should make provision that a medical doctor or similarly qualified person should certify the death of a person to avoid instances where people may be buried alive. 6.4 Post-mortem examination of human bodies A post-mortem examination is a detailed study of a body after death. It is also known as an autopsy. Post-mortem examinations are carried out by 156 157 158 159 160 As above Anatomical examination is defined to include dissection of a body Section 3 of the Anatomy Act Section 16 of the Anatomy Act As above 40 February, 2012 pathologists (medical professionals who specialize in the diagnosis of disease after death and identifying the causes of death).161 Post-mortem examinations are carried out for two main reasons: (a) If the cause of a death is unknown, or when a death happens unexpectedly or suddenly, it is referred to a coroner who orders a postmortem examination. By law, coroners’ post-mortem examinations can take place without the consent of the family.162 (b) At the request of the family of a deceased person in order to provide information about illness and cause of death. In these cases consent should be obtained from the deceased’s family. 6.5 Human cloning Human cloning is the creation of a genetically identical copy of a human. Human cloning may be divided into two categories: reproductive cloning and therapeutic cloning. In reproductive cloning, the cloned embryo is implanted in a woman”s uterus, where it potentially results in pregnancy and the birth of a cloned human being. Therapeutic cloning, on the other hand, allows scientists to create an abundant source of stem-cells for research purposes.163 In general, there is a consensus among legislators and scientists that reproductive cloning, which poses a large number of safety and ethical concerns, should be banned. Far less agreement, however, exists where therapeutic cloning is concerned. Proponents of therapeutic cloning contend that the process of extracting stem cells from cloned human embryos is essential for researching new therapies and developing cures for debilitating or life-threatening diseases like Alzheimer”s and Parkinson”s disease. Opponents, however, argue that creating cloned human embryos for research purposes unethically treats human life as a commodity and contend that destroying embryos in order to extract stem cells is tantamount to murder.164 The General Assembly on 8 March, 2005 adopted the United Nations Declaration on Human Cloning, by which member States were called on to adopt all measures necessary to prohibit all forms of human cloning inasmuch as they are incompatible with human dignity and the protection of human life.165 Some jurisdictions, like some states of the United States of America, have banned human cloning completely. In view, of the developments around human cloning elsewhere, there ought to be a legal and policy intervention in Malawi to deal with this current, albeit controversial, scientific phenomenon. 161 http://www.hta.gov.uk/licensingandinspections/sectorspecificinformation/postmortem.cfm (accessed on 10 162 163 164 165 December, 2011) Section 12(1) of the Inquests Act (Cap. 4:02) http://www.policyarchive.org/handle/10207/bitstreams/3734.pdf (accessed on 22 December, 2011) As above http://www.un.org/News/Press/docs/2005/ga10333.doc.htm (accessed on 22 December, 2011) February, 2012 7. 41 DISEASE PREVENTION AND NOTIFICATION 7.1 Disease surveillance or general epidemiological intelligence Disease surveillance in respect of public health means the systematic and continuous collection, collation and analysis of data for public health purposes and the timely dissemination of public health information for assessment and public health response as necessary. In order to combat the ever-present threat of infectious diseases, an efficient and robust health care system needs to have in place a sensitive epidemiological surveillance system to detect the occurrence of diseases and be able to take effective preventive and control measures rapidly. The IHR requires that each State Party should assess events occurring within its territory. Further, each State Party shall notify World Health Organisation, by the most efficient means of communication available, by way of the National IHR Focal Point, and within 24 hours of assessment of public health information, of all events which may constitute a public health emergency of international concern within its territory in accordance with the decision instrument, as well as any health measure implemented in response to those events. If the notification received by World Health Organisation involves the competency of the International Atomic Energy Agency (“IAEA”), World Health Organisation shall immediately notify the IAEA. Following a notification, a State Party shall continue to communicate to World Health Organisation timely, accurate and sufficiently detailed public health information available to it on the notified event, where possible including case definitions, laboratory results, source and type of the risk, number of cases and deaths, conditions affecting the spread of the disease and the health measures employed; and report, when necessary, the difficulties faced and support needed in responding to the potential public health emergency of international concern. Rapid and appropriate response to emerging infectious diseases depends primarily on efficient surveillance systems at national, regional and global levels. Globally, the World Health Organisation coordinates surveillance systems. Public health systems are faced with challenges where outbreak information gets disseminated more rapidly by the media, NGOs and the private sector, bypassing public health sources and increasing the pressure for rapid information from public health authorities at all levels. There is need therefore to learn how to address this new information-sharing environment for the only viable response would lie in the rapid verification of information and increased transparency for information related outbreaks or even rumoured outbreaks. Surveillance effort therefore, requires multiple skills including epidemiology, infectious diseases, public health, laboratory, field experience, telecommunication and information management. It also requires multiple partnerships among the World Health Organisation, ministry responsible for health, private sectors, NGOs and the media; this is termed integrated surveillance. The World Health Organisation provides standards and norms for 42 February, 2012 country systems to ensure regional and global consistency of surveillance data. It is important that the multi-purpose local human resources in an integrated surveillance system undergo field epidemiology training. The first priority of a surveillance system at all levels is epidemic response capacity to ensure that surveillance information provided by the system can be effectively and rapidly used for action. Epidemic preparedness and response are primarily a matter of organisation rather than important resources. A core of experienced professionals in field epidemiology can rapidly conduct outbreak investigations provided than administrative arrangements. 7.2 Disease prevention measures The control of different infectious diseases involves an extensive range of interventions. These may depend on the nature of the disease, how easily it is transmitted, the mode of transmission, the infectious period, the incubation period (i.e. the time from infection to the appearance of clinical disease), the population at risk, and the severity of its clinical manifestations. Many infections are relatively mild and often self-limiting, and although they may cause significant minor morbidity and be a major burden to the health services, they are not a major threat to population health.166 Public health measures are needed when outbreaks and epidemics of new existing diseases occur. Such measures may involve controlling non-human sources of infection, such as birds, livestock, mosquitoes, or flooding, and reducing the risk of disease transmission by infected humans. In order for measures to be implemented effectively, strategies for infection control often incorporate disease surveillance, testing and monitoring. There are so many measures under the Act which are introduced to control infectious diseases. In order for measures to be implemented effectively, strategies for infection control often incorporate disease surveillance, testing and monitoring. Methods for preventing infected people from transmitting an infectious disease and controlling the occurrence of infectious diseases vary. People are in some cases required to comply with travel restrictions.167 Under the Public Health Act, local authorities are provided with a duty to prevent or remedy danger to health arising from unsuitable dwellings by taking all lawful, necessary and reasonable practicable measures.168 To that effect, local authorities are given a duty of constructing and maintaining public sewers169 which every owner and occupier of any premises or private sewer has a right to have his drains or private sewer connected to the said public sewers170, so long as he has given notice to the 166 Nuffield Council on Bioethics, ‘Public Health’, 70 167 Section 38 of the Public Health Act empowers the Minister to regulate, restrict or prohibit the entry into Malawi of any person or of persons of any specified class or description or from any specified country, locality or area for the purpose of preventing the introduction of any infectious disease 168 Section 61 of the Public Health Act 169 Section 79 of the Public Health Act 170 Section 83 of the Public Health Act February, 2012 43 local authority.171 Further, all new buildings are required to make satisfactory provision for drainages172 and latrines.173 Under the Public Health Act, as a way of preventing the breeding of mosquitoes, all households are requested to clear all overgrown bush and long grass.174 The Act further requests that all cesspits should be screened to the satisfaction of a medical officer175; and that all mosquito larvae should be destroyed.176 It is an offence for mosquito larvae to be found in the premises of any person.177 7.3 The nature and purpose of notification of infectious diseases An infectious disease has been defined as any disease which can be communicated directly or indirectly by any person suffering therefrom to any other person.178 Infectious diseases in humans are caused by a wide range of disease agents including viruses, bacteria, fungi and protozoa (single-celled organisms including amoebae). They vary widely in their ability to be transmitted in human populations, and different infections are transmitted by different means. The means of spread include: (a) airborne and aerosol, for example, measles, influenza and tuberculosis; (b) food or water, for example, typhoid, cholera, hepatitis A; (c) close contact, for example, scabies, impetigo, MRSA (methicillinresistant Staphylococcus aureus); (d) sexual intercourse, for example, gonorrhoea, syphilis, Chlamydia, HIV; (e) blood, for example, hepatitis B and C, HIV; (f) insect vectors, for example, malaria, plague; and (g) from an animal to a human being (zoonoses), for example, rabies, avian influenza. The Public Health Act provides that the following are notifiable infectious diseases: anthrax; blackwater fever; cerebro-spinal meningitis or cerebro-spinal fever; cholera; diphtheria or membranous croup; dysentery (bacillary); encephalitis lethargica); enteric or typhoid fever (including paratyphoid); erysipelas; hydrophobia or human rabies; influenza; measles; plague; acute primary pneumonia; acute anterior poliomyelitis; acute polioencephalitis; puerperal fever (including septicaemia, pyaemia, ceptic pelvic cellulitis or other serious septic condition occurring during the puerperal state); relapsing fever; scarlet fever or scarlatina; sleeping sickness or human trypanosomiasis: smallpox 171 172 173 174 175 176 177 178 Section 86 of the Public Health Act Section 87 of the Public Health Act Section 88 of the Public Health Act Section 98 of the Public Health Act. Under section 99, it is a requirement that wells should be covered. Section 100 of the Public Health Act Section 101 of the Public Health Act Section 102 of the Public Health Act Section 4 of the Public Health Act 44 February, 2012 or any disease resembling smallpox; all forms of tuberculosis which are clinically recognizable apart from reaction to the tuberculin test; typhus fever; whoopingcough and yellow fever. This list can be expanded to include new diseases as necessary.179 The Act places a duty on heads of dwellings like family houses180, schools181 and medical practitioners182, to report to relevant authorities of the infectious disease discovered. The Act provides that every person who is required to give a notice or certificate of the occurrence of the infectious disease, but fails so to do, commits an offence.183 The Act also gives powers to the Minister to make regulations for the notification of infectious diseases.184 The Medical Practitioners and Dentists (Private Practice) Regulations made under the Medical Practitioners and Dentists Act, requires every licensee to report immediately upon treating any person for, or identifying any person as having any of the following notifiable diseases at his private practice: cholera; typhoid fever; meningitis; tuberculosis; acute poliomyelitis; rabies; trypanosomiasis: measles: acute placid paralysis; viral haemorrhagic fever; plague (Bubonic or Pneumonic); and shigellosis.185 7.3.1 Notification in other jurisdictions In England and Wales, the statutory requirement for notification of infectious diseases was first established in London in 1891 when cholera, diphtheria, smallpox and typhoid had to be reported by the head of the family or the landlord to the local authority. Nowadays, doctors in England and Wales have a statutory duty under public health legislation to notify the relevant officer of the local authority of suspected cases of around 30 infectious diseases, including, for example, measles, mumps, rabies and smallpox. In addition, childminders, day care centres and schools that cater for children under eight years old are required to notify the Office for Standards in Education, Children”s Services and Skills (“Ofsted”) of any cases of notifiable diseases and of food poisoning affecting two or more children. Two main purposes of the notifiable disease system are for the rapid detection of outbreaks and epidemics and for the implementation of measures to control such outbreaks by local public health officials. Some of the information relating to each notification is passed on, in an anonymousized form, to the Health Protection Agency for England and Wales and the Information Services Division (“ISD”) in Scotland for evaluation at a national level. Notifiable disease schemes exist in a lot of countries, and internationally, under the guidance of the World Health Organization. The diseases included in 179 Section 12 of the Public Health Act gives power to the Minister to declare any other disease as the case 180 181 182 183 184 185 may be, notifiable. Section 13 (a) of the Public Health Act Section 13 (b) of the Public Health Act Section 13 (c), (d) & (e) of the Public Health Act Section 13 (2) of the Public Health Act Section 14 of the Public Health Act Regulation 20 of the Medical Practitioners and Dentists (Private Practice) Regulations February, 2012 45 each country are usually revised periodically, but, for example, at present, in New Zealand there around 50 such diseases and in the USA around 60, with some variations between states in the USA. Under the IHR, a few diseases considered to have a “serious public health impact” (smallpox, poliomyelitis caused by wildtype poliovirus, human influenza caused by a new subtype, and SARS) must additionally be reported to World Health Organization. So too must any other cases of infectious diseases deemed to constitute, under WHO definitions, a “public health emergency of international concern”.186 7.4 The nature and listing of infectious diseases The Public Health Act gives out a list of infectious diseases and also power to the Minister to declare any disease as a notifiable infectious disease. Out of the diseases which have been listed out, only smallpox has special provisions in the Act. Smallpox, however, was declared defeated by the 33rd World Health Assembly in Geneva, Switzerland on 8 May, 1980. Malaria, though not listed as a notifiable disease, has provisions to do with prevention and destruction of mosquitoes.187 The Act has also special provisions for certain formidable epidemic or endemic diseases in Part V. These diseases are smallpox, plague, cholera, yellow fever, cerebro-spinal meningitis, typhus, sleeping sickness or human trypanosomiasis and any other disease which the Minister may by notice declare to be a formidable epidemic or endemic disease.188 It has been argued that public health law should stop the separate classifications for communicable diseases. The argument is that having uniform standards, in public health statute, based upon the degree of risk, the cost of efficacy of the response, and the burdens on human rights, would lend clarity and coherence to public health interventions.189 It might be proper sometimes to make specific provisions addressing specific diseases for the sole reason that different diseases pose different risks of transmission. However, these specific laws may pose problems. Firstly, rigid classifications can frustrate attempts to deal effectively with diseases that do not fit neatly into any category. Secondly, classification of diseases often determines whether those entrusted with the power to curb the threats are able to exercise compulsory public powers. Third, disease classification reflects stereotypes associated with sexually transmitted (venereal) diseases. Section 54 of the Act prohibits employing any person who is suffering from a sexually transmitted disease. The section further makes it an offence to employ such a person. However, section 20 on the Constitution prohibits discrimination against any person on any ground. 186 World Health Assembly (2005) International Health Regulations (2005), available at: http://www.who.int/ csr/ihr/IHRWHA58_3-en.pdf (accessed on 13 April, 2011) 187 Section 96 through 102 of the Public Health Act 188 Section 30 of the Public Health Act 189 Gostin L.O., et al., ‘Improving state law to prevent and treat infectious disease’. http://www.milbank.org/ 010130improvinglaw.html (accessed on 13 April, 2011) 46 February, 2012 7.5 Sexually transmitted infections Sexually Transmitted Infections (STIs) or Sexually Transmitted Diseases (STDs) (and also referred to as venereal diseases under the Public Health Act) mean diseases that are contracted and transmitted by sexual contact, caused by microorganisms that survive on the skin or mucus membranes, or that are transmitted via semen, vaginal secretions, or blood during sexual intercourse.190 Under the Act, any person, while knowing that he is suffering from any STI in a communicable form, accepts or continues in employment shall be guilty of an offence.191 The employer shall also be guilty of an offence if he employs a person with an STI.192 The other issue under this head concerns scenarios when a person with an STI continues to engage in dangerous sexual or needle sharing behaviours. There are no provisions on what could be done in this scenario. The law as provided now seems to give public health officials coercive powers on contagiousness rather than risk behaviour. 7.6 Vaccination Generally, vaccination can mean the administration of antigenic material (a vaccine) to stimulate adaptive immunity to a disease. Vaccination is a type of control measure employed in the fight against some diseases. It has over the years been considered as the most effective method of preventing infectious diseases. It involves treating healthy person with an intervention derived from (or similar to) a particular infectious disease agent. The purpose is to induce an immune response in order to gain immunity to the disease in the future. The WHO estimates that vaccination programmes averted over two million deaths worldwide in 2002.193 The incidences of diseases such as tetanus, measles, hepatitis B and polio have been greatly reduced by vaccination programmes worldwide, and smallpox has been eradicated.194 Usually there are two main types of vaccination strategies. The first one is that aimed at protecting vulnerable subgroups. Here, vaccines are given to members of selected population groups, such as those who have a high risk of infection or who are particularly vulnerable to serious consequences arising from the infection, i.e. health personnel. The second type is the population-wide vaccination which is aimed at achieving “herd immunity’. Here vaccines are given to a large proportion of the population, usually during childhood. The “herd effect” occurs when a sufficiently large proportion of a population is vaccinated, such that the chance of the disease being passed between unvaccinated people is reduced to a minimum. 190 191 192 193 http://www.medterms.com/script/main/art.asp?articlekey=11545 (accessed on 26 April, 2011) Section 54(1) of the Public Health Act Section 54(2) of the Public Health Act World Health Organization (2005) Fact sheet No. 288: Immunization against diseases of public health importance, available at: www.who.int/mediacentre/factsheets/fs288/en/index.html. (accessed on 9 June, 2011) 194 As above February, 2012 47 Immunization against vaccine-preventable diseases is said to be essential to reaching Millennium Development Goal 4 on reducing under-five mortality by two thirds by 2015. This is because millions of children die from diseases that can be prevented through vaccines.195 There is normally the issue of consent which arises in children. Children are a vulnerable group and a decision whether to vaccinate them or not can have so many implications in their healthy life. In this scenario, it is important that concerned personnel focus on the best interest considerations. Decisions that are not in the best interest of the child can be overridden. The Public Heath Act provides for vaccination issues in the Smallpox provisions under Part VII.196 As noted above, smallpox was declared a dead disease in 1980. Under the Act, it is compulsory that every child born in Malawi, should be vaccinated against smallpox after six months and within twelve months from birth unless such child is unfit.197 The Minister has power under the Act to declare by a Notice in the Gazette any area to be a compulsory vaccination area, every unprotected person, and parent or guardian of every unprotected child, shall make sure that his child has been vaccinated within the period specified.198 The Ministry of Health, following international health standards set by WHO, has introduced several vaccines on children. Children are routinely vaccinated for diphtheria, tetanus, whopping cough, polio, tuberculosis, some types of meningitis and measles. Below is the Immunization and Vitamin A Supplementation Schedule: AGE VACCINE PROTECTED DISEASE At birth or first contact At birth up to 2 weeks At 6 weeks BCG OPV 0 OPV1,DPT-HepBHib1 and PCV1 Tuberculosis Polio Polio, Diphtheria, Tetanus, Pertusus, Hepatitis B, Heamophilus Influenza, Pneumonia, Otitis media, meningitis At 10 weeks OPV 2, DPT-HepBHib2 and PCV2 Polio, Diphtheria, Tetanus, Pertusus, Hepatitis B, Heamophilus Influenza, Pneumonia, Otitis media, meningitis 195 World Health Organization, 2011 10 facts of immunization, available at: http://www.who.int/features/ factfiles/immunization/en/, (accessed on 9 June, 2011) 196 Section 42 of the Public Health Act defines vaccination as the introduction into the skin of smallpox vaccine virus contained in pure and tested vaccine lymph. 197 Section 43 of the Public Health Act 198 Section 44 of the Public Health Act 48 February, 2012 At 14 weeks OPV 3, DPT-HepBHib3 and PCV3 Polio, Diphtheria, Tetanus, Pertusus, HepatitisB, Heamophilus Influenza, Pneumonia, Otitis media, meningitis At 19 months Measles Measles First contact (15 - 45 years and pregnant women) At 4 weeks after TT1 At 6 months after TT2 At 1 year after TT3 At 1 year after TT4 At 6 months and every 6 months up to 59 months Within 2 weeks of delivery TT1 Tetanus TT2 TT3 TT4 TT5 Tetanus Tetanus Tetanus Tetanus Vitamin A (Children) Vitamin A (Postnatal Mothers) Most times, vaccination against an infectious disease is compulsory. The only circumstance under the Act where a person cannot be vaccinated against smallpox (though generally here) is where he has been declared unfit and a certificate to that effect issued. The US Supreme Court handed down a 7-2 decision in the case of Jacobson v Massachusetts199 that upheld the right of states to enact compulsory vaccination laws. In asserting that there are “manifold restraints to which every person is necessarily subject for the common good,” the Court took a firm position on one of the most challenging constitutional dimensions of public health. It also set the terms for what would eventually emerge as a core question at the heart of public health ethics. 7.7 Isolation and Quarantine The IHR define isolation as separation of ill or contaminated persons or affected baggage, containers, conveyances, goods or postal parcels from others in such a manner as to prevent the spread of infection or contamination. Quarantine, on the other hand, means the restriction of activities or separation from others of suspect persons who are not ill or of a suspect baggage, containers, conveyances or goods in such a manner as to prevent the possible spread of infection or contamination. 199 197 US 11 (1905) February, 2012 49 Under the Public Health Act, public health authorities are permitted to confine persons with active infectious diseases. The confinement can also be effected on persons who are suspected to have had contact with any person suffering from an infectious disease. However, the quarantine provisions are not clearly stated and rarely exercised. Generally, isolation has been said to be a necessary method in the prevention of tuberculosis. It is no doubt that medical interventions are important in the prevention or control of the spread of infectious diseases, but they can also interfere with civil liberties such as bodily integrity and freedom of conscience. Public health law provides that an individual’s liberty can be restricted where an individual’s decisions or actions potentially endanger the health of others. Recently, there have been issues of infectious diseases attacking a large number of people due to the complexity of the disease; or where such a disease has been artificially introduced i.e. in cases of bio-terrorism. For the Public Health Act dwells on issues of sanctions and quarantine of those suspected of suffering from communicable and infectious diseases; the same is a complete disregard for and violation of human rights. Sections 18 and 19 of the Constitution provide for the inviolability of right to personal liberty and dignity of all persons, respectively. Article 1 of the UDHR states that “all human beings are born free and equal in dignity and rights.”200 Further, Article 3 of the UDHR provides that “everyone has the right to life, liberty and security of person.”201 Article 9 of the UDHR warns that “no one shall be subjected to arbitrary arrest or detention.” Article 10 of the UDHR provides that “everyone has the right to freedom of movement and residence within the borders of each State.” Indeed, under Malawi law, section 39 (1) of the Constitution provides that “every person shall have the right of freedom of movement and residence within the borders of Malawi.” Further, Article 23 of the UDHR states that everyone has the right to work, to free choice of employment’. The ideas of quarantine, the restriction of activity, and the prohibition from work of specified persons, as provided in the Public Health Act do not sit well with the ideas of liberty and dignity, for example under the Constitution. However, the UDHR clearly indicates that rights principles are not absolute and must be construed in a wider context. For example, Article 29 states: (1) Everyone has duties to the community in which alone the free and full development of his personality is possible. (2) In the exercise of his rights and freedoms, everyone shall be subject only to such limitations as are determined by law solely for the purpose of securing due recognition and respect for the rights and freedoms of others and of meeting the just requirements of morality, public order and the general welfare in a democratic society. 200 Art 1 Universal Declaration of Human Rights 201 Art 3 Universal Declaration of Human Rights 50 February, 2012 The rights established in the UN International Covenant on Civil and Political Rights (“ICCPR”) are similar to the UDHR and are also modified by Article 4 in times of public emergency: In a time of public emergency which threatens the life of the nation and the existence of which is officially proclaimed, the States Parties to the present Covenant may take measures derogating from their obligations under the present Covenant to the extent strictly required by the exigencies of the situation, provided that such measures are not inconsistent with their other obligations under international law and do not involve discrimination solely on the ground of race, colour, sex, language, religion or social origin.202 Individual provisions are also qualified. For example, Article 12 (1) of UDHR provides that “everyone lawfully within the territory of a State shall, within that territory, have the right to liberty of movement and freedom to choose his residence.”203 This is followed by the qualification in Article 12 (3) that the right is subject to laws “necessary to protect national security, public order, public health or morals or the rights and freedoms of others, and are consistent with the other rights recognized in the present Covenant.” The requirements of public health, allow the curtailment of individual liberty rights. There is however a liberal approach which was propounded by John Stuart Mills as one way to start thinking about resolving the tension between the promotion of public health and the protection of individual freedoms. This is in the famous “harm principle” found in the essay “On Liberty” and it states: “The object of this Essay is to assert one very simple principle, as entitled to govern absolutely the dealings of society with the individual in the way of compulsion and control, whether the means used be physical force in the form of legal penalties, or the moral coercion of public opinion. That principle is, that the sole end for which mankind are warranted, individually or collectively in interfering with the liberty of action of any of their number, is self-protection. That the only purpose for which power can be rightfully exercised over any member of a civilized community, against his will, is to prevent harm to others. His own good, either physical or moral, is not a sufficient warrant. He cannot rightfully be compelled to do or forbear because it will be better for him to do so, because it will make him happier, because, in the opinions of others, to do so would be wise, or even right. These are good reasons for 202 Article 4 of the UDHR does not apply to the following of the Declaration: Article 6 on inherent right to life, Article 7 on torture or to cruel, inhuman or degrading treatment or punishment, Article 8(1) & 8 (2) on slavery and servitude, Article on 11 imprisonment for debt, Article 15 on retrospective penalties, Article 16 on the right to recognition as a person under the law, and 18 the right to freedom of thought, conscience and religion. In Malawi, section 45 (3) (c) provides that rights can be derogated during a state of emergency in cases of war, threat of war, civil war or a widespread natural disaster, only strictly for the protection and relief of those people in the disaster area. 203 Likewise, section 39(1) of the Malawi Constitution provides that ‘Every person shall have the right of freedom of movement and residence within the borders of Malawi.’ February, 2012 51 remonstrating with him, or reasoning with him, or persuading him, or entreating him, but not for compelling him, or visiting him with any evil, in case he (does) otherwise. To justify that, the conduct from which it is desired to deter him must be calculated to produce evil to someone else. The only part of the conduct of any one, for which he is amenable to society, is that which concerns others. Over himself, over his own body and mind, the individual is sovereign.”204 The Nuffield Council on Bioethics report on Public Health: Ethical Issues suggests that Mills” principle is introduced in public health not to suggest that it provides a satisfactory answer to all the questions that arise in the context of public health. Nor does it commit us to the wider theoretical framework in which it was set out, or to claim that harm to third parties is always a sufficient legitimisation of coercion. Rather, it is used to illustrate that, even in an approach that seeks to ensure the greatest possible degree of individual liberty and the least possible degree of State interference, there is a core principle according to which coercive, liberty-infringing State intervention is acceptable: where the purpose is to prevent harm to others.205 8. ENVIRONMENT AND WASTE 8.1 Sanitation and housing House can be said to be the usual residential home of an individual or family. Housing is one of the important components for a dignified life. The association between housing conditions and physical and mental ill-health has long been recognized. In fact, there are a broad range of specific elements relating to housing that can affect health outcomes. These include: (a) agents that affect the quality of the indoor environment such as indoor pollutants (for example, asbestos, carbon monoxide, radon, lead, moulds and volatile organic chemicals); (b) cold, damp, housing design or layout (which in turn can affect accessibility and usability of housing), infestation, hazardous internal structures or fixtures. (c) factors that relate more to the broader social and behavioural environment such as overcrowding, noise sleep deprivation, neighbourhood quality, infrastructure deprivation (that is, lack of availability and accessibility of health services, parks, stores selling healthy foods at affordable prices), neighbourhood safety and social cohesion; and (d) factors that relate to the broader macro-policy environment such as housing allocation, lack of housing (that is, homelessness, whether without 204 Mills JS (1859) ‘On liberty’, p.13 quoted in Nuffield Council on Bioethics (2007), Public Health: Ethical Issues 205 Nuffield Council on Bioethics (2007), Public Health: Ethical Issues, 16 52 February, 2012 a home or housed in temporary accommodation), land tenure, housing investment, and urban planning.206 The Public Health Act prohibits causing a nuisance or perpetuating a nuisance on any land or premises. An owner, occupier or a person in charge of the land or premises in question commits an offence if the nuisance is in fact injurious or dangerous to health.207 Nuisance mainly causes extreme annoyance on both housing and health. This can include a number of situations such as noise nuisance, sewage leaks from septic tanks, dilapidated or sub-standard houses or other buildings, dust from building works, and foul smells from animals, both living and dead. Nuisance as a branch of the law of torts is most closely concerned with the protection of the environment. Nuisances are divided into public and private. A public nuisance is a crime, while a private nuisance is only a tort. At common law, public nuisances include such diverse activities as carrying on an offensive trade, keeping a disorderly house, selling food unfit for human consumption, obstructing public highways and holding an ill-organized music festival. In recent years, it has been noted that funeral ceremonies are conducted right in the middle of public access roads especially in the high density areas of Lilongwe, Blantyre, Zomba and Mzuzu; heavy articulated trucks are being parked in residential areas; and sometimes beer bashes take place in public access roads. All these, in the absence of clear legal or policy direction, constitute nuisances. The Public Health Act places duties on local authorities to maintain cleanliness and prevent nuisances.208 Local authorities have a duty to prevent or remedy danger to health arising from unsuitable dwellings by taking all lawful, necessary and reasonable practicable measures.209 Thus, local authorities can take those who do not obey orders to court;210 put on sale by public auction any matter or thing removed in abating any nuisance;211 and also demolish unfit buildings.212 Further, the Minister is accorded power to make rules as regarding inspection of land, construction of buildings, keeping of animals and also control of houses let in lodging.213 There have been a few of the rules made by the Minister. Much as the Public Health Act is rich in this area, and that there are rules made, there is still lack of enforcement. Some provisions promulgated under Part IX of the Public Health Act and the relevant subsidiary legislation are also outdated.214 206 Taske Nichole and others, ‘Housing and public health: a review of reviews of interventions for improving 207 208 209 210 211 212 213 214 health,’ (2005) http://www.nice.org.uk/niceMedia/pdf/housing_MAIN%20FINAL.pdf (accessed on 23 September, 2011) Section 59 of the Public Health Act Section 60 of the Act Section 61 of the Act Section 66 of the Act Section 69 of the Act Section 71 of the Act Section 75 of the Act. See also Section 76 for provision of standards regarding construction of buildings. The Public Health (Construction of Trading Stores) Rules came into force in 1932. There are also the Public Health (Minimum Building Standards for Traditional Housing Areas) Rules which target traditional housing in urban areas, but there has been lack of enforcement on the same. February, 2012 53 8.2 Disposal of waste There are no clear provisions on disposal of waste in the Public Health Act. The Environment Management Act, however, provides that the Minister, on the recommendations of the Environment Management Council, may, by regulations published in the Gazette, control the management, transportation, treatment and recycling, and safe disposal of waste and for prohibiting littering of public places.215 Local authorities are given power to promulgate such rules or formulate such measures as are necessary to regulate the collection, transportation and safe disposal of waste by local authorities.216 The Environment Management Act provides that no person shall handle, store, transport, classify or destroy waste other than domestic waste, or operate a waste disposal site or plant, or generate waste except in accordance with a licence issued by the Minister on the advice of the Council.217 The Environment Management (Waste Management and Sanitation) Regulations require every local authority to prepare a waste management plan for the area of its jurisdiction. The plan has to include the type of waste generated by area; management of each type of waste generated; and resources required for managing each type of waste in terms of budget and equipment.218 Further to that, a local authority is required to keep records of waste management services in its area of jurisdiction from the point of generation to the point of disposal. The records should include the source; waste type or types; quantities of waste handled; classification of waste; recyclability of the types of waste managed; and recommended disposal methods and mechanisms for monitoring compliance with such disposal methods. General or municipal solid waste may be disposed of at any waste disposal site or plant identified and maintained by a competent local authority or owned or operated by any person licensed to do so under the Environment Management (Waste Management and Sanitation) Regulations.219 An operator of a waste220 disposal site or plant is supposed to keep records in respect of any waste disposed of at the site or plant the source; weight of the wastes; and type of wastes. It is an offence where any person discharges wastes into a site or plant which is unlicensed.221 8.3 Construction and management of public sewers and drainage Part X of the Public Health Act provides that a local authority may within its district and also, subject to the prior approval of the Minister without its district, construct and maintain a public sewer and also construct sewage disposal works.222 Thus again, as observed before, there is lack of implementation though 215 216 217 218 219 220 221 222 Section 37 (1) of the Environment Management Act Section 37 (2) of the Environment Management Act Section 38 of the Environment Management Act Regulation 3 (1) of the Environment Management (Waste Management and Sanitation) Regulations Regulation 11 (1) of the Environment Management (Waste Management and Sanitation) Regulations Regulation 11(2) of the Environment Management (Waste Management and Sanitation) Regulations Regulation 11(3) of the Environment Management (Waste Management and Sanitation) Regulations Section 79 of the Act 54 February, 2012 the Act provides for the construction of sewers. Every owner and occupier of any premises or private sewer has a right to have his drains or private sewer connected to the public sewers223, so long as he has given notice to the local authority.224 However, this has not been the case for the provisions are couched in such a way that the public are not compelled to connect to the public sewers. Regulation 5 of the Environment Management (Waste Management and Sanitation) Regulations provides that a local authority shall operate and maintain a municipal sewage collection system in its area of jurisdiction. The local authorities are also said to be responsible for the collection of the general or municipal solid waste in its area of jurisdiction and this shall be done at such a frequency as to prevent the piling of waste.225 9. HOSPITALITY, UTILITY AND PUBLIC GATHERINGS 9.1 Public services There are certain amenities which require public health protection such as food, water and air. Under the Public Health Act, local authorities have a duty to supply water to the people within their jurisdictions. Further, it is the duty of local authorities to take all lawful, necessary and reasonably practicable measures for preventing any pollution dangerous to health of any supply of water which the public within its district has a right to use and does use for drinking or domestic purposes.226 However, under the Waterworks Act, water boards have the overall responsibility to provide safe drinking water in the country. 9.1.1 Water The Public Health Act provides that every local authority has a duty to take all lawful, necessary and reasonably practicable measures for preventing any pollution dangerous to health of any supply of water which the public within its district has a right to use and does use for drinking or domestic purposes (whether such supply is derived from sources within or beyond its district).227 Local authorities are also responsible for purifying any such supply which has become so polluted, and to take measures (including if necessary, proceedings at law) against any person so polluting any such supply or polluting any stream so as to be a nuisance or danger to health.228 The World Health Organization recognizes that water has a profound influence on human health.229 At a very basic level, a minimum amount of water is required for consumption on a daily basis for survival and therefore access to some form of water is essential for life. However, water has much broader 223 224 225 226 227 Section 83 of the Act Section 86 of the Act Regulation 10(1) of the Environment Management (Waste Management and Sanitation) Regulations Section 105 of the Public Health Act Section 105 of the Public Health Act 228 As above 229 http://www.who.int/water_sanitation_health/dwq/S01.pdf (accessed on 20 May, 2011) February, 2012 55 influences on health and wellbeing and issues such as the quantity and quality of the water supplied are important in determining the health of individuals and whole communities.230 The World Health Organization states further that the first priority must be to provide access for the whole population to some form of improved water supply. However, access may be restricted by low coverage, poor continuity, insufficient quantity, poor quality and excessive cost relative to the ability and willingness to pay. Thus, in terms of drinking water, all these issues must be addressed if public health is to improve. Water quality aspects, whilst important, are not the sole determinant of health impacts.231 It is further stated that the quality of water does, however, have a great influence on public health; in particular, the microbiological quality of water is important in preventing ill health. Poor microbiological quality is likely to lead to outbreaks of infectious water-related diseases and may cause serious epidemics. Chemical water quality is generally of lower importance as the impact on health tends to be chronic long-term effects and time is available to take remedial action. Acute effects may be encountered where major pollution event has occurred or where levels of certain chemicals are high from natural sources, such as fluoride, or anthropogenic sources, such as nitrate. 9.1.2 Food The Public Health Act defines food to mean any article used for food or drink other than drugs or water, but includes ice, and any article which ordinarily enters into or is used in the composition or preparation of human food, and includes flavouring matters and condiments.232 The Act prohibits the sale of food which is tainted, adulterated, disease or in an unwholesome state233, and it gives power to any health worker or local authority or any person duly authorised to seize such food.234 It is an offence to put on sale such unwholesome food.235 The Minister has powers to make rules regarding inspection of dairy stock of animals intended for human consumption; taking and examination of milk, dairy produce, meat and the removal of animals suspected of being diseased or unwholesome for human consumption; veterinary inspection of dairy stock; etc.236 The Minister is also given powers to specify, by order, standards of quality, composition and condition, and minimum standards, in respect of any foodstuffs, goods or other articles.237 There are also the Public Health (Marketing of Infant and Young Child Foods) Rules which apply to all breast-milk substitutes and other designated 230 231 232 233 234 235 236 237 As above As above Section 4 of the Public Health Act Section 106 of the Public Health Act Section 108 of the Public Health Act Section 109 of the Public Health Act Section 109 of the Public Health Act Section 110 of the Public Health Act 56 February, 2012 products whether locally made or imported. The Rules affect the quality, availability and information concerning the use of the breast-milk substitutes. Under the Rules, every manufacturer, importer, wholesaler or retailer of designated products, is supposed to apply annually to the Ministry of Health for registration.238 The Rules also prohibit any form of promotion of any designated product by advertising; distribution of any information or educational material regarding infant or child feeding etc.239 The Rules further provide for labelling of every designated product.240 The Nuffield Council on Bioethics Report on Public Health: Ethical Issues noted that consumer”s choices of food and drink are at least driven by the products available and the way they are promoted, priced and distributed. The Report further noted that although the regulation of industry can be necessary, much can be achieved through industry self-regulation. 9.2 Public Gatherings The Police Act provides for the regulation of assemblies and public demonstrations. The Police law here is restricted to the logistical or operational issues related to assemblies and demonstrations in light of the freedoms of association, expression and assembly under the Constitution. The Police law does not address any public health issues that may arise out of an assembly or a demonstration. There is a need for deliberate legal and policy interventions addressing public gatherings. These gatherings may be political rallies, music or arts festivals, or sporting events. Questions that may arise include: To what extent should the law or policy provide for the minimum standards for washroom facilities; fire exit points; or the maximum capacity for public gatherings on any land or premises? In recent years, it has been noted that there is an increasing need for the provision of washroom facilities in banking halls or shopping malls. The query ought to be: To what extent is the absence of washroom facilities in banking halls or shopping malls a public health risk? 10. ALCOHOL, TOBACCO AND SUBSTANCE ABUSE 10.1 Alcohol and public health The legal and policy interventions related to alcohol consumption focus on the age at which it is legal to consume alcoholic beverages. The health or public health risks have emerged around policy formulation. However, any health or public health risks related to alcohol consumption are yet to be addressed at law in any jurisdiction worldwide. 238 Rule 14 of the Public Health (Marketing of Infant and Young Child Food) Rules 239 Rule 19 of the Public Health (Marketing of Infant and Young Child Food) Rules 240 Part VI of the Public Health (Marketing of Infant and Young Child Food) Rules February, 2012 57 10.2 Smoking of tobacco as a public health risk The philosophy behind the regulation of the smoking of tobacco is best captured in the Foreword to the World Health Organization Framework Convention on Tobacco Control (“FCTC”): The World Health Organization FCTC is an evidence-based treaty that reaffirms the right of all people to the highest standard of health. The World Health Organization FCTC represents a paradigm shift in developing a regulatory strategy to address addictive substances; in contrast to previous drug control, treaties, the World Health Organization FCTC asserts the importance of demand reduction strategies as well as supply issues.241 The World Health Organization FCTC proceeds on the basis that tobacco is an epidemic. In response to this epidemic, State Parties emphasize the fact that persons have a right to health which is understood as the highest attainable standard of health. The FCTC provides for price and tax measures to reduce the demand for tobacco. There a number of non - price measures as well: protection from exposure from tobacco smoke; regulation of the contents of tobacco products; regulation of tobacco product disclosures; and packaging and labelling of tobacco products, to mention a few. The FCTC emerges from this backdrop: Smoking of tobacco kills more than five million people a year - an average of one person every six seconds - and accounts for one in 10 adult deaths. In addition to tobacco use, more than 600 000 non-smokers die from exposure to tobacco smoke in a year. As a result, the tobacco epidemic kills nearly 6 million people per year.242 The World Health Organization reckons that without urgent action, the death toll could rise to more than eight million by 2030. Indeed, up to half of current users will eventually die of a tobacco-related disease.243 In the United States of America, Congress passed the Family Smoking Prevention and Tobacco Control Act which came into effect on 22 June, 2009. This law gives the Food and Drug Administration the power to regulate the tobacco industry. Further, the law imposes new warnings and labels on tobacco packaging and their advertisements, with the goal of discouraging minors and young adults from smoking.244 The interventions in the United States resonate with the policies advocated by the World Health Organization. For instance, World Health Organization states that every person should be able to breathe smoke-free air. As such, there should be smoke-free laws to protect the health of non-smokers which do not harm business and encourage smokers to quit.245 In England and Wales, Parliament passed the Health Act, 2006. The law, among other things, prohibits the smoking of tobacco in public places. The law 241 WHO Framework Convention on Tobacco Control, p. v 242 WHO, Fact sheet No. 339, May, 2011, available at: http://www.who.int/mediacentre/factsheets/fs339/en/ index.html (accessed on 13 June, 2011) 243 As above 244 As above 245 WHO, Fact sheet No. 339, May, 2011, available at: http://www.who.int/mediacentre/factsheets/fs339/en/ index.html (accessed on 13 June, 2011) 58 February, 2012 has made provision for what are called “smoke-free places”.246 Public places here include places of work. A place of work is not limited to a building. It includes “institutional” vehicles used by employees in the course of their duty. 10.3 Substance abuse Substance abuse is the excessive consumption of any substance for the sake of its non-therapeutic effects on the mind or body.247 The technical understanding of substance abuse includes the abuse of controlled drugs and alcohol. The common understanding of substance abuse, however, is limited to abuse of - often - illicit drugs. We will limit the understanding of substance abuse here to the abuse of controlled or illicit drugs. In the public health field, the analysis of substance abuse goes beyond the individual and looks at society, culture and availability. Further, public health considerations criticize the binary of “use” and “abuse” and prefer a range of use, from beneficial use to chronic dependence.248 The Public Health Act does not specifically address substance abuse. The Dangerous Drugs Act (Cap. 35:02) adopts the binary approach - of use versus abuse - and criminalizes possession of listed drugs under the Act. The strategies that a country will put in place in order to deal with substance abuse is often a politically contested exercise which pits policy makers and politicians on one side and the scientific community on the other side. While punitive legislation has been the preferred strategy to deal with substance abuse, there is evidence to show that it has only succeeded in making the global illicit drug trade a lucrative enterprise. The scientific community seems to favour more therapeutical approaches in order to wean abusers from their addictions. 11. PUBLIC HEALTH EMERGENCY 11.1 Public health legal preparedness Public health legal preparedness is a subset of public health law and is defined as the readiness of a public health system (of a community, a national region, the State, or the world community itself) to respond to specified health threats. Public health legal preparedness may also framed as a goal, that is, as the attainment by the public health system of a defined standard of response to conventional dangers and, specifically, to such emerging threats as terrorism, and the next major dangers to follow.249 Public health legal preparedness can be defined as attainment by a public health system of legal benchmarks or standards essential to the preparedness of the public health system.250 246 See Part 1, Chapter 1 of the Health Act, 2006 of England and Wales 247 Andrew S. O’Connor, ‘Substance Abuse and Public Health Policy’, <http://www.cwru.edu/med/epidbio/ mphp439/Substance_Abuse.htm> (accessed on 20 October, 2011) 248 See The Health Officers Council of British Columbia, 2005, A Public Health Approach to Drug Control in Canada 249 Moulton, AD et al. ‘What is Public Health Legal Preparedness’ (2003) Journal of Law, Medicine and Ethics, 31 <http://www2.cdc.gov/phlp/docs/moultonarticle.pdf> (accessed on 21 May, 2011) 250 As above February, 2012 59 Public health legal preparedness has four core elements: laws, competencies, information and coordination. Laws are said to be the starting point for public health legal preparedness. They are the authoritative utterances of public bodies and come in many forms, be statutes, judicial rulings as well as policies of different public bodies.251 At the operational level, public health laws also include such “implementation tools” as executive orders, administrative rules and regulations, memoranda of understanding and mutual aid agreements among localities, states, or nations. The second element is the competencies of the people who serve as the agents of public health legal preparedness. In the public sector these include elected officials, public health professionals, their legal counsel, government agency administrators, judges, law enforcement officials, and others. In the private sector are included medical practitioners, hospital and health plan administrators, community organizations, a wide range of service and advocacy organizations, and their legal counsel. Also important are the researchers, educators, and other scholars who develop the science base for public health legal preparedness and who educate practitioners in public health law. In this context, the term “competencies” refers to the abilities and skills these practitioners should have to access and understand the relevant laws and to actually apply them to given health issues.252 The third core element is information for these agents” use in shaping and applying public health laws. Examples include repositories of public health laws, updates on new enactments and judicial rulings, reports on innovations and public health law “best practices,” and public health law practice guidelines. A surprising finding is how rare such information resources are. With some exceptions, there appear to be few, if any, published manuals on public health emergency law for government and hospital attorneys, “bench books” for judges to brief themselves on evidentiary standards for public health search warrants and quarantine orders, or databases of extant state and municipal public health emergency statutes and regulations.253 The fourth core element is coordination of legal authorities across the multiple sectors that bear on public health practice and policy and across the vertical dimension of local-state-federal-international jurisdictions. Coordination is critical precisely because the public health system is richly multidisciplinary, multi-sectoral, and cross-jurisdictional.254 12. CONCLUSION A number of points may be made regarding the health law and policy, and even more specifically public health law and policy. First, what ought to be the scope of a law in this area? It is pragmatic and prudent to consider the 251 252 253 254 As above As above As above As above at 3 60 February, 2012 development of a series of laws that encompass a health sector of a country. Second, public health law and policy entails at least three key pillars: duty, power and restraint. The following have to be regarded as standard recommendations when it comes to public health law reform.255 First, a public health law should clearly impose the duties of the State to promote health and well-being within the community. In this respect, a clearer articulation of the right to health under the Constitution would the first step towards this objective. If at all, proposes for amendments to the Constitution are to be preferred, the costing of the referendum is inevitable. Keep in mind that amendment to, among others, Chapters III and IV of the Constitution require a referendum. Second, a public health law should clearly confer a hierarchy on the powers and duties for the application of the provisions under the law. This will require better synergetic linkage between central and local governments respectively. And lastly, there is need to maintain the balance, albeit a delicate one, between the common good and individual autonomy. 255 See Gostin, L.O., ‘Public Health Law Reform’, American Journal of Public Health, September 2001, Vol. 91, No. 9, p. 1365 February, 2012 61 References DM Chirwa, Human Rights under the Malawian Constitution (Juta, Cape Town, 2011) LO Gostin and others, “Improving state law to prevent and treat infectious disease” (http://www.milbank.org/010130improvinglaw.html) G Kamchedzera & C Banda, “Dignified Rural Living, the right to development, multiparty politics and legislation in Malawi” (2009) 25 South Africa Journal on Human Rights 73 RE Kapindu, “Policies, Aspirations, or Rights? 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