REGULA Initiative. Noncommunicable disease risk factors in the Americas: Considerations on the Strengthening of Regulatory Capacity

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RGULA Initiative Noncommunicable disease risk factors in the Americas: Considerations on the trengthening of Regulatory Capacity Technical Reference Document ummary

2 NONCOMMUNICABL DIA IN TH AMRICA Distribution of causes of mortality in the Americas, 2012 Noncommunicable diseases Communicable, maternal, perinatal, and nutritional disorders xternal causes of morbidity and mortality Noncommunicable diseases (NCDs) are the leading cause of morbidity, mortality and premature mortality in the Americas. In 2012, NCDs caused 79% of all deaths, and 35% of all NCD deaths were in people between 30 and 70 years old. Cancer, cardiovascular diseases, diabetes and respiratory diseases were responsible for 77% of NCD deaths in 2012 in the Americas. Medical care for people with NCDs will cost lowand middle-income countries about U$21.3 trillion in economic losses over the next two decades, equivalent to the gross domestic product of these countries in 2013. Probability (%) of premature death from NCDs in adults age 30 to 69 years in the Americas, by country. 2010 Guyana Trinidad & Tobago Haiti Brazil Nicaragua Paraguay Bolivia Argentina Cuba l alvador Jamaica Uruguay Honduras Mexico Venezuela Belize Dominican Republic Bahamas Barbados Guatemala United tates Panama uriname Chile Colombia Costa Rica cuador Netherlands Antilles Canada Peru 0 5 10 15 20 25 30 35 40 Percentage ource: PAHO Regional Health Observatory, 2014. ight out of ten premature deaths were caused by NCDs in 2012. Four Risk Factors: unhealthy diet, tobacco use, harmful use of alcohol and physical inactivity U$ 21.3 trillion in economic losses in low- and middle-income countries over the next two decades

3 HUMAN-MAD PIDMIC Four human-made risk factors are directly related to the increase in NCDs: Unhealthy diet Physical inactivity Tobacco use Harmful use of alcohol These factors are related to: Growing availability and affordability of unhealthy products Poorly regulated expansion of global marketing of unhealthy products Intensive advertising and promotion High cost and difficult access to healthy food Lack of consumer awareness of the harmful effects of these four risk factors

4 INTRNATIONAL AGRMNT TO RDUC MORTALITY FROM NCD 2011. The United Nations General Assembly adopts the Political Declaration of the High-level Meeting on the Prevention and Control of Noncommunicable Diseases, emphasizing primary prevention through legislative and regulatory measures to address risk factors. 2013. In the WHO Global Action Plan for the Prevention and Control of Noncommunicable Diseases 2013-2020, WHO Member tates commit to a 25% reduction in premature mortality from NCDs by 2025. o This plan includes five targets related to risk factor control: 1. Halt the rise in diabetes and obesity 2. A 30% reduction in salt intake 3. A 10% reduction in harmful use of alcohol 4. A 10% reduction in the prevalence of insufficient physical activity 5. A 30% reduction of tobacco use 2014. The overall goal of the PAHO Regional Plan of Action for the Prevention and Control of Noncommunicable Diseases for 2014-2019 is to reduce avoidable mortality and morbidity, minimize exposure to risk factors, increase exposure to protective factors, and reduce the socioeconomic burden of these diseases by taking multisectoral approaches that promote well-being and reduce inequity within and among the Member tates. The strategic lines of action relate to: a) strengthening and promoting multisectoral policies and partnerships for NCD prevention and control; b) reducing the prevalence of the main NCD risk factors and strengthening protective factors; c) improving the coverage, equitable access, and quality of care for the four main NCDs (cardiovascular disease, cancer, diabetes, and chronic respiratory diseases); and d) strengthening NCD surveillance and research. A 25% reduction in the risk of premature mortality from NCDs by 2025 Halt the rise in diabetes and obesity A 30% reduction in salt intake A 10% reduction in harmful use of alcohol A 10% reduction in the prevalence of insufficient physical activity A 30% reduction of tobacco use

5 CHANG TH DFAULT TO MAK HALTHY BHAVIOR TH AIR CHOIC While education and calls for personal responsibility are essential to reduce NCDs and obesity, they are not enough. In order to change the environmental and social determinants of NCDs, interventions are needed that rely less on promoting healthy choices by individuals and more on changing the defaults to make healthy behaviors the easier choice. In order to reduce exposure to NCD risk factors, three courses of action are necessary: promotion, clinical prevention and regulation. The focus here is on regulation, an essential public health function that has enormous potential for improving health and preventing premature deaths and suffering. There are achievable, highly cost-effective measures that address these risk factors by changing environmental and social conditions, and encourage healthy behaviors in a sustainable and widespread manner. Legislative and regulatory action is required to implement these measures in various areas. The WHO Global Action Plan for the Prevention and Control of Noncommunicable Diseases 2013-2020 identifies several highly cost-effective interventions or best buys, which include population based measures on diet, tobacco use, harmful use of alcohol and physical inactivity, as well as clinical preventive measures related to cardiovascular disease, diabetes and cancer. Risk factor/ disease Tobacco use Harmful use of alcohol Diet and physical inactivity Cardiovascular diseases and diabetes Cancer Highly Cost-ffective Interventions 1 Interventions that require government regulation are boldfaced Reduce affordability of tobacco products by increasing tobacco excise taxes Create by law completely tobacco smoke-free environments in all indoor workplaces, public places, and public transport Warn people of the dangers of tobacco and tobacco smoke through effective health warnings and mass media campaigns Ban all forms of tobacco advertising, promotion, and sponsorship Regulate commercial and public availability of alcohol Restrict or ban alcohol advertising and promotions Use pricing policies such as excise tax increases on alcoholic beverages Reduce salt intake Replace trans fats with unsaturated fats Implement public awareness programs on diet and physical activity Promote and protect breastfeeding Drug therapy (including glycemic control for diabetes mellitus and control of hypertension using a total risk approach) and counseling to individuals who have had a heart attack or stroke and to persons with high risk ( 30%) of a fatal or non-fatal cardiovascular event in the next 10 years Acetylsalicylic acid (aspirin) for acute myocardial infarction Prevention of liver cancer through hepatitis B immunization Prevention of cervical cancer through screening (visual inspection with acetic acid [VIA] or Pap smear [cervical cytology] if very cost-effective) linked with timely treatment of precancerous lesions ource: WHO, Global tatus Report, 2015. The implementation of these interventions encourages prevention at all levels: Primary: by lowering the prevalence of risk factors in the population econdary: by reducing risk for the large population already affected by NCDs Tertiary: by reducing relapses and preventing the occurrence of other NCDs in those already affected. 1 This refers to policy options identified as best buys in the WHO Global Action Plan for the Prevention and Control of Noncommunicable Diseases 2013-2020. Best buys means very cost-effective options, for example, those that generate an extra year of healthy life for a cost that falls below the average annual income or gross domestic product per person. Regulation has been identified as one of the main strategies for addressing NCD risk factors. trengthening this public health function is supported by international agreements that need to be fulfilled.

6 RGULATION: AN NTIAL FUNCTION OF PUBLIC HALTH Protecting the population from certain risks is a core role of the tate, and regulation is the tool for doing so. Regulation refers to action by legislative bodies and executive action by government agencies, which unlike the delivery of services, aims to correct market failures or modify widespread social practices that have an impact on public health. In other words, it seeks to effect change through the enforcement of laws or regulations that are outside the traditional scope of health systems. Regulation involves: Working with other spheres of government (conomy, Finance, Agriculture or Transportation) Adopting multisectoral approaches trengthen capacity in local and national governments Generate political will INUFFICINT RGULATORY CAPACITY Compliance with international agreements or resolutions related to the regulation of NCD risk factors has been insufficient due to deficient implementation, enforcement, documentation, and/or evaluation at the national level. Regulatory capacity is still very limited in many countries of the Region. The overlap of governmental institutions with authority to regulate consumer products such as tobacco, alcohol, and food can hinder effective regulation from the standpoint of health, a problem compounded by lobbying, opposition, and lawsuits from stakeholders with private economic interests. Regulatory capacity should be developed and fostered as part of the institutional framework of health systems and governments. The legal framework and health-related regulatory capacity should also be strengthened at the national level. The government necessarily plays the lead implementation role in regulatory action. This role is more effective when there is a clear legal framework that is part of a political and technical process of governance that acts effectively to balance competing interests while protecting the greater good of society, including the health of the population. The trategic Plan of the Pan American Health Organization 2014-2019 cites low regulatory capacity at the national level as a risk for the control of NCDs, which in turn allows the tobacco, alcohol, processed food, and sugary beverage industries to interfere and hinder progress in the countries.

7 COMPONNT OF HIGH-QUALITY RGULATORY PROC They follow a systematic process (see figure) They have a mechanism for: o holding technical consultations o promoting social participation o defending health rights o supporting communication. They have a transparent and well-established regulatory and legislative process to reduce the risks of manipulation They address the prevention of corruption and conflicts of interest from the outset, avoiding a concentration of the power throughout the process. These elements are embedded in the regulatory institution s design, financing, and operation. The participation of civil society, academia, and the ombudsman is essential in an open consultation process that promotes the protection of public health. xposure Risk assessment Hazard identification Health promotion (1) Choice of regulatory path (2) Rule design/review of draft Product characterization Trade planning/land use conomic/fiscal tools (taxes/incentives) Implementation Compliance? Risk analysis Risk management Risk regulation Rule standard making Rule implementation nforcement Monitoring & evaluation LGAL FRAMWORK Risk characterization Clinical prevention (4) Revision and rule adoption (3) Publication for public consultation Marketing restriction Laboratory assessment Authorization, licensing, registration Inspection Noncompliance? Warnings anctions valuation of process valuation of impact U R V I L L A N C C I V I L O C I T Y / R A R C H R / O M B U D M A N Translated and adapted from the original version in panish

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