Legislation and enforcement
Overview
Legislation is key to effective tobacco control. It institutionalizes and makes binding a country's commitment for tobacco control, creates focus for tobacco control activity and regulates private and public conduct in ways that voluntary measures cannot.
The enactment of legislation has its challenges. These include a lack of awareness by policy-makers and the public of the serious harms caused by tobacco use and exposure to second-hand smoke; the lack of human, technical and other capacity, infrastructure and resources; and continuing opposition of the tobacco industry and its affiliates and allies. It is important to counter this opposition. Success requires strong and continual political commitment throughout the life of the legislation. Furthermore, the success of a legislation will depend on its effective implementation, enforcement and compliance mechanisms, supported by financial and technical resources, as well as educational and awareness raising strategies to ensure public support.
The WHO Framework Convention on Tobacco Control (WHO FCTC) now has more than 170 Parties, representing more than 85% of the world's population, As with any other treaty, the WHO FCTC confers legal obligations on its Parties — that is, on the countries (and the European Union) that have formally become Parties to it. With this impetus, many countries are in the process of developing and strengthening their tobacco control legislation and ensuring effective mechanisms for enforcement.
In addition to information provided in the WHO FCTC's guidelines, countries can draw upon best practice legislative and regulatory examples from other countries, adapting them to meet their own varying national systems and needs. WHO and its partners have also developed a number of resources that can be accessed from WHO web sites and other sources.
The importance of legislation
Overview
Legislation is at the heart of an effective tobacco control program. Any comprehensive tobacco control program requires the drafting and adoption of legislation and the introduction of regulations. A society’s laws are the most solemn and formal articulation of its values; they recognize, reinforce and give permanence to a society’s norms. When a government imposes a comprehensive ban on smoking in all public places, for example, it not only protects the public in general, but also declares the will of the society for a smoke free environment.
Further, legislation serves to institutionalize a tobacco control program. In contrast to the ad hoc and intermittent initiatives that might be undertaken by a health ministry or other government office in the absence of legislation a program grounded in comprehensive legislation (1) helps to ensure programmatic continuity as officials, governments and government priorities change over time. With comprehensive approaches to tobacco control, legislation helps to integrate the diverse components of a multifaceted program (2). Importantly, it typically establishes a national focal point for activities relating to tobacco control and mobilizes public resources and institutions in support of the program. It may be that for political and other reasons, some countries prefer enactment of separate legislative instruments covering various aspects of tobacco control. Other countries may prefer to adopt laws in the form of binding rules, resolutions, regulations or orders pursuant to an existing legal authority vested in an agency as is the case with the National Agency of Sanitary Surveillance (ANVISA) in Brazil(3). It may also be that some countries choose to adopt policy instruments without legal force. However, examples of tobacco control programs grounded in a comprehensive legislation in Norway, South Africa, Brazil, India, Australia, Canada, Ireland, Thailand and New Zealand show the importance countries attach to legislation as the core tool for tobacco control (4).
References
(1)Blanke & Costa E Silva, Tobacco Control Legislation: An introductory Guide, WHO 2004, at page 49
(2) Id
(3) The Resolutions and Rules passed by ANVISA are legally binding rules, having the force and quality of law and with sanctions attached for their violation. Article 7 of Law 9.782 endows ANVISA with a broad legislative authority to pass health legislation include that of tobacco control.
(4) Article 4 of the WHO FCTC requires adoption of comprehensive strategies for tobacco control.
Comprehensive tobacco control measures
Comprehensive tobacco control measures require steps to restrict the conduct of tobacco companies and other private and public businesses. Private businesses include places of employment, wholesalers and retailers of tobacco products etc. For example, a tobacco control programme may seek to regulate workers’ health through a ban on smoking in public places and workplaces. Such steps can be taken only through legislation. Only through legislation can a government mobilize the resources necessary to counteract tobacco manufacturers and sellers, including tobacco taxes and duties, as well as requirements that manufacturers display government-approved warning messages on tobacco packets. However, there are challenges to the development of legislation for tobacco control. These include:
- Lack of awareness by the public on health and other hazards posed by tobacco;
- Limited capacity, expertise, commitment and funding for implementation of tobacco control programmes and strategies including legislative implementation;
- Powerful opponents --- the tobacco industry has continued to undermine tobacco control legislation and other policies around the world; and,
- Uncertain political will. Political will for tobacco control can be uncertain depending on the changing political landscape in each country.
Fortunately, recent developments have favoured the adoption of effective legislation for tobacco control, adapted to each country’s particular social, cultural and political circumstances:
- Overwhelming scientific evidence has firmly documented the effects of tobacco use and exposure on health;
- Abundant research has documented the effectiveness of recommended tobacco control legislative strategies;
- Compelling research by the World Bank, the World Health Organization and academic experts has refuted economic arguments against tax increases and other legislative measures;
- Litigation has exposed the efforts of multinational tobacco companies to conceal the truth about tobacco use and to undermine public health efforts around the world;
- Countries in every region of the world have gained hard-won experiences with tobacco control legislation, allowing others to advance quickly based on those experiences;
- Global public awareness of the health effects of tobacco use and the conduct of tobacco companies has increased sharply in recent years;
- Spurred partly by the negotiations of the WHO FCTC, nongovernmental organizations from many countries and in a worldwide network have mobilized around support for strong legislative proposals;
- The WHO FCTC negotiations have raised international understanding of tobacco control and galvanized the political will for action in many countries.
Together, these developments offer support for the enactment of comprehensive national legislation, even in countries with no history of stringent tobacco control.
The legislative process
Overview
Before commencing a legislative scheme for tobacco control, it is necessary to understand the basic forms of laws and some characteristics that distinguish the varying governmental and legal systems. Statutes, in some jurisdictions referred to as Acts of Parliament or Act, bylaws or ordinances are usually created by national or sub-national legislative bodies.(Statutes have advantages; they are binding and enforced by various mechanisms and their legal force is limited only by constitutional restrictions or judgements of superior courts of law.) They remain in force until repealed or overturned by competent courts of law.
Tobacco control legislation can take varying forms. These include national legislation, sub-national legislation, administrative regulations, constitutional law and court-made law. WHO proposes the promulgation of comprehensive tobacco control legislation. This will also support effective implementation of the WHO FCTC and ensure the adoption of a public health evidence-based tobacco control measures. Article 5 of the WHO FCTC also favours the adoption of comprehensive legislative tobacco control measures. The various forms of legislation are discussed hereunder;
National Legislation: National legislation is most often used around the world and has advantages (5). These vary among countries, depending on the distribution of power among different levels of government and the form of electoral representation. National tobacco control laws in Thailand, South Africa, New Zealand, Norway, and Ireland are some examples of strong and comprehensive legislation.
Advantages of national legislation for tobacco control include the following:
- National law applies to the whole country with uniformity, consistency and maximum effect. The national legislature will usually have broader competence to enact a comprehensive tobacco control law than a sub-national legislature.
- In some cases, resources for developing legislation are more available at the national level than at the sub- national level. This is partly because some aspects of tobacco control such as advertisement bans or product regulation require a level of enforcement funding and technical expertise that can be found only at the national level.
- A national problem like tobacco requires a national legislative response.
References
(5) Blanke & Costa E Silva, Tobacco Control Legislation: An introductory Guide, WHO 2004, at page 62, stating that 91 countries had enacted such laws in 1993
The forms of legislation for tobacco control
Sub-national Legislation: despite the preference for national legislation by most countries, (6) and with its advantages as discussed in the paragraph above, there are also distinct advantages of sub- national legislation. Where regional or local governments of a country are willing to develop legislation, and not the national authorities, it may be easier for those regions to develop sub-national legislation. Sub-national lawmakers may even be less influenced by industry pressures.(7) Local legislation may, in fact, achieve the long-term goal of tobacco control. Some states, provinces and municipalities in countries such as Brazil, Canada and the United States have developed effective sub-national laws for tobacco control, for example, in the area of smoke-free public places and workplaces, among others.
Administrative regulations: these are rules or decrees made by administrative agencies of government, acting on the basis of authority delegated to them by the legislative body. This form of law is important especially in legislating areas requiring technical expertise and also in implementation of specific aspects of provisions of a Statute. The scope of an agency's legal authority and the procedural steps for adopting such rules determines the effectiveness of this legislative approach. In many countries, the Parliaments authorize the Minister responsible for Health to promulgate administrative regulations for health matters including tobacco control.
Constitutional law: this is the highest and most fundamental form of law in most countries. It limits the powers of legislatures and administrative bodies and constitutions are more stable and change infrequently. While Constitutions may not offer a direct avenue for tobacco control, guarantees of right to health, life and obligation on the government to protect the public interest can support tobacco control. However, constitutional guarantees such as free speech may be interpreted by the tobacco lobby to undermine legislation. Despite this, Constitutional law has been successfully used in India and Uganda to promote tobacco control.
The role of courts- court- made law: courts make law through judicial review and case decisions. These define legal rights and powers in ways that may determine legal rights and powers for tobacco control, particularly in countries with powerful judiciaries. Generally, the power of judicial review is exercised by national courts but this may vary from country to country. Depending on the legal tradition, the rulings of the supreme judicial body may serve as binding precedents in future. Courts also make case law. In common law legal systems, entire fields of law are governed by decisions of court in individual cases. In many jurisdictions, legal actions based on theories of negligence, deception and other aspects of manufacturer liability are in the realm of common law, making common law (case law) a critical component of litigation against tobacco manufacturers by injured smokers. Hence in common law legal systems, the principles and rules pronounced in earlier cases have binding force on later cases.
References
(6) Ibid
(7) Jenny White and Lisa A. Bero, Public Health Under Attack: The American Stop Smoking Intervention Study (ASSIST) and the Tobacco Industry, February 2004, Vol 94, No. 2 | American Journal of Public Health 240-250
Other key issues relating to the legislative process
Capacity building
National capacity building in the form of human, financial, technical and political will is essential for success of a legislative scheme. The designation of a focal point for tobacco control is key, as well as the work of champions committed to moving the legislative agenda. Article 5 of the WHO FCTC stresses the importance of establishing the institutions to further tobacco control in each country. The importance of funding, training, dissemination and evaluation of information are all key aspects of capacity building. More specifically, the importance of scientific and other evidence to support tobacco control will need to be disseminated. The civil society as well as the broad public institutions and the general public will need to be mobilized through a designed communications strategy by the originators of the legislation.
Strategic choices for development of legislation
A country will need to assess its preparedness before embarking on a legislative scheme. The assessment may need to cover the political environment and sustainability of support for the legislation. An important choice is whether to pursue a comprehensive legislation for tobacco control or proceed step by step, adding the components of the programme overtime. Comprehensive legislation has proven successful in many countries that have pursued this option, for example, Norway, Poland, South Africa and Thailand. However, where political impediments inhibit the development of comprehensive legislation, it is possible to commence by incremental legislation such as tax increases, smoke-free public and work places or warning labels. (8) Sometimes, countries may need to weigh the options of pursuing national or sub-national legislation. Furthermore, statutory law may be used for tobacco control legislation but could be complemented by administrative regulations usually adopted by the Minister or government official empowered to do so.
Pre-emption: This concept is based on the idea that a national government possesses a country's law making authority and can prevent or strip the law-making powers of subordinate units of government through express or implied legal powers. In countries with federal governmental systems, the tobacco companies have actively supported legislation that prohibits lower level legislative authorities from enacting regional or local legislation that would be stronger and supersede national legislation. For example, pre-emption arguments were used to invalidate tobacco control legislation in State of Massachusetts in the United States and in the State of New South Wales in Australia.
Implementation and enforcement of legislation
Implementation of tobacco control legislation needs to be phased in to smooth compliance by the public. Implementation mechanisms should be complemented by mass media campaigns for awareness raising of public, policy-makers, opinion leaders, enforcement agents and the media.
Aspects of enforcement are crucial without which, a legislation will face implementation challenges. It is also crucial to select the right enforcement authority and mechanism and that varies from country to country. It is important to weigh the pros and cons of using existing legislative enforcement authorities versus the creation of new enforcement authorities and institutions. The enforcing agency should be completely free of any connection to the tobacco industry, competent and sufficiently trained to enforce the legislation effectively, and committed to its success. The enforcement operations may be designed to be undertaken by both a national and local authorities. Partial funding for enforcement could potentially come from fining violators, licensing fees, filing fees, or earmarked tobacco tax revenues. Furthermore, penalties for breach of the legislation need to be tailored to avoid enforcement difficulties and must be serious enough to deter violations but not so excessive as to undermine public support. The procedures used to impose sanctions should meet basic standards of fairness and transparency, and should be consistent with the jurisdiction's legal and constitutional standards of due process of law and procedural fairness.
Compliance monitoring needs to be vigorously enforced. Tools for enforcement monitoring include:
- research and surveillance program to monitor trends and patterns in tobacco use;
- public awareness, epidemiological information and quality of enforcement;
- monitoring mechanisms such as compliance checks and toll-free phone lines for public reporting of violations;
- reporting requirements for tobacco product constituents and additives, as well as industry advertising expenditures;
- inspections, including manufacturing facilities and places of restricted smoking;
- tobacco industry monitoring within the jurisdiction to ensure industry compliance with legislation and other measures;
- and, assessment of fines and or citations issued overtime for non compliance.
However, the best legislation is one that enforces itself, by the public through mass awareness raising that empowers them to support the law and its implementation.
Evaluation of legislation: Evaluation seeks to measure how well a specific law has helped a society to move towards the legislative goals. Process evaluation, includes the evaluation of activities and programmatic experiences and that of immediate programme effects. Outcome evaluation refers to long-term outcomes using essential indicators, recommended indicators and optional indicators. Indicators of success or failure for evaluation purposes include mortality rates, tobacco consumption, smoking prevalence and the prevalence of smoking control policies among others. The success of tobacco control legislation will also depend in part its evaluation, both short term and long-term.
Case studies on enforcement of tobacco control legislation
Brazil
Constitutional context
Federal, state and municipal governments share legislative authority over tobacco control. However, it is at the federal level that Brazil's comprehensive legislation has been implemented
Federal tobacco control laws
A 1999 law created the National Agency of Sanitary Surveillance (ANVISA), which has competence to regulate tobacco. ANVISA has law-making powers.
- Law 10.167/2000, prohibits advertising of tobacco among many other things as well;
- Resolution RDC 46 of 2003 establishes maximum levels of tar, nicotine etc and bans misleading descriptors light, mild etc;
- Resolution RDC 346 of 2003: requires annual registration and listing with detailed information to be included e.g. packaging, incomes etc;
- Resolution RDC 335 of 2004: requires graphic warnings and health messages.
Enforcement structure and operations
The Ministry of Health/ANVISA. The Ministry of Health has responsibility for the administration of the Federal tobacco control legislation. The national tobacco control programme housed at the National Cancer Institute (INCA) also has enforcement responsibility. Furthermore, State and municipal authorities have responsibility for the enforcement of the over 70 (State) and 331 (municipal) laws as well as the federal legislation. The Federal Police, the Judiciary and Federal Revenue Service are also involved in enforcement of tobacco control laws in collaboration and cooperation with ANVISA, the Ministry of Health.
Compliance promotion
Approach used in Brazil included, awareness raising among the public, regulated community and governmental agencies, training and educational materials, development of database, work of NGOs.
Enforcement tools
The following are some of the enforcement tools used in Brazil for tobacco control:
- Inspectors are being trained by municipal authorities to enforce local smoke-free laws.
- Penalties: Law Number 6437 of 1977 empowers ANVISA to impose fines on offenders of Federal legislation.
- Litigation is a potential tool of enforcement.
- Self-reporting by the regulated community is often used. For example, under Resolution RDC No 346 of 2003, in order to begin marketing a new brand of tobacco product, manufacturers/importers/exporters are required to file appropriate applications for the listing of each brand of the product with ANVISA. These applications must include, interalia copies of the product’s packaging; the company’s income statements from the previous year; various statements describing the product’s composition, emissions, product characteristics; descriptions of compounds present in the main- and side streams, as well as overall compounds present in the tobacco. In order to renew the listing, the company is also required to annually repeat the process for the first listing.
Canada
Constitutional context
In Canada, federal, provincial and municipal governments share legislative and regulatory authority over tobacco control, and each passes its own legislation and enforces it.
Tobacco control laws
The Tobacco Act, 1997 (as amended), provides for product standards, industry reporting, prohibits youth access to tobacco products, provides for health warnings and messages including graphic picture warnings, and bans misleading descriptors, among others.
Tobacco Act (Amendment) 1998, Bans tobacco advertisement, promotion and sponsorship. A number of Provincial laws governing 63% of Canada's population address smoking in public places among others.
Enforcement structure and operations
Health Canada is the enforcement agency for the Federal tobacco control legislation. The Agency maintains a pool of Inspectors. Regional, municipal and territorial authorities are responsible for the enforcement of the respective laws, by assigning tasks to specific enforcement officers, other authorized officers
The Attorney General of Canada and Department of Justice has responsibility for all federal litigation including those regarding tobacco control. Any decision to prosecute as well as to recover damages on recommendation from enforcement officials rests with the Attorney-General.
Compliance promotion
Enforcement and other authorities have undertaken awareness raising activities among the public, regulated community and governmental agencies. They have also conducted training and developed educational materials, tobacco control information database and facilitated the work of NGOs and research institutions in tobacco control.
Enforcement tools
Commonly used enforcement tools in Canada include, inspections, penalties, litigations and reporting obligations.
South-Africa
Constitutional context
National government and provincial governments share competence in enforcement of the tobacco control legislation. However, overall enforcement framework is laid down at the national level.
Tobacco control laws
The main legislation is the Tobacco Products Control Amendment Act 1999 (No 12), that amends the 1993 Tobacco Products Control Act. It provides for: prohibition of smoking in enclosed public places, strong package warnings and health messages, prohibition of free distribution and gifts of tobacco products, prohibition of sale of tobacco to a person under the age of 16, regulation of vending machines and regulation of the contents of tobacco products. The Act empowers the Minister to promulgate as is necessary on matters relating to the Act. Regulations 974,975,976 and 977 and promulgated by the Minister of Health, elaborate on the specific requirements as provided for under the Tobacco Products Amendment Act, 1999.
Enforcement structure and operations
The Department of Health enforces a ban on smoking in public places, can grant or deny extensions of time for compliance, and can make orders for compliance. In South Africa , the provincial or city health departments have also been involved in enforcement activities. For example, in May 2005, Cape Town inspected 862 premises to ensure compliance; 88% of those surveyed had complied with the legal requirements and those that did not were fined. The Government legal office and the national and provincial police also contribute to the enforcement regime of the legislation.
Compliance promotion
The Department of Health raises awareness among the public, mobilizes owners of restaurants and other public places regarding enforcement, provides training to enforcement personnel and related government departments and produces materials and other information tools.
Enforcement tools
Enforcement tools used in the South African legislation include the use of inspections, fines, compliance reporting by the regulated community. The work of NGOs has also supported enforcement. An example is the maintenance of a hotline for public reporting of violations