How to regulate sensitive products when regulatory resources are limited

This howtoregulate article analyses how countries with limited regulatory resources could regulate sensitive products, using the example of medical devices. A key component of regulating such sensitive products is recognising certificates and evaluations from stringent jurisdictions, so that scarce government resources can be focussed on other regulatory activities such as customs control and enforcement. Continue reading How to regulate sensitive products when regulatory resources are limited

Infectious diseases: how to regulate an agile system equipped for the unknown

This howtoregulate article explores the regulation of infectious diseases, an issue of global importance noting that an outbreak from any infectious disease is just a plane ride away. Global climate change has contributed to increases in vector-borne diseasesand zoonotic diseases2, as animals move to populated areas in search of food. The World Health Organisation even has a placeholder for future unknown diseases (Disease X) on its list for determining which diseases and pathogensto prioritise for research. Evidently, effective public health regulations are critical for the effective surveillance, early detection and prevention of infectious diseases. Continue reading Infectious diseases: how to regulate an agile system equipped for the unknown

Regulating Cross Border Services

In today’s globalised world, where markets are increasingly borderless, how does the domestic regulator enforce national objectives in consumer protection, professional standards, taxes and competition? Let’s be honest, it’s not easy to enforce these objectives within the border, imagine across borders, where the language and legal systems are different and, most importantly, there is no own state power of the jurisdiction setting up requirements. Cross-border product enforcement has matured in recent years in line with consumer demand for quality and stricter enforcement through customs and sometimes even postal services. Requirements for cross-border services, however, have been more difficult to enforce due to the variety of channels that services consumers and businesses currently use, particularly digital services. This howtoregulate article focuses on how the regulation of cross-border services could be better enforced so that compliance with service requirements by traders outside of the jurisdiction are similar, or at least not too dissimilar, to those within the regulator’s jurisdiction. Continue reading Regulating Cross Border Services

Not just another tax: how to reflect environmental and social goals in legislation?

Tax legislators, product legislators and service legislators are sometimes confronted with the political wish to integrate environmental or social goals into regulation. This is an understandable wish, well intended. However, the devil is in the detail. We will see in this article where exactly, and how, the devil could possibly be outplayed. Continue reading Not just another tax: how to reflect environmental and social goals in legislation?

Regulating alcohol consumption in the absence of a medically determined safe level

According to The Lancet “alcohol use is a leading risk factor for global disease burden and causes substantial health loss”1. In fact, it is the seventh leading risk factor globally for mortality and disease finding that “the risk of all-cause mortality, and of cancers specifically, rises with increasing levels of consumption, and the level of consumption that minimises health loss is zero”2. These results suggest that alcohol control policies and regulations that have traditionally focused on “responsible” or “safe” alcohol consumption might need to be revised worldwide, refocusing on efforts to lower overall population-level consumption. Some states (eg. Australia) are currently reviewing their alcohol control regime and with The Lancet’s recent publication more jurisdictions are expected to follow. This howtoregulate article examines the international and national alcohol control regulations to determine good regulatory techniques that could assist states’ reviews of existing regulation. Continue reading Regulating alcohol consumption in the absence of a medically determined safe level

Empowerments (Part I): typology

To ensure the good application of law, authorities must have empowerments. However, we have not yet found any systematic presentation of types of empowerments. We aim at closing this gap by this article. We will see that the focus on empowerment permits a new, complementary view on what regulation should contain. This complementary view can be used to double-check whether draft regulation is complete. Continue reading Empowerments (Part I): typology

Report on Artificial Intelligence: Part II – outline of future regulation of AI

This Part II of the howtoregulate Report on Artificial Intelligence presents regulatory approaches for minimising the harms of artificial intelligence (AI), evidently without putting into question the utility of AI. What should regulation of AI look like? The answer to this question depends on the goals of the regulator. As was previously outlined in Part I, much of the goals of states today is to focus on incentivising innovative applications of AI or encouraging break through AI research. We could imagine, however, that the average regulator might also consider such goals as avoiding the risk that AI research or technology leads to the eradication of humankind and reducing other major risks for human beings to the extent that the expected positive effect of AI is not disproportionately hampered. Furthermore, regulators might feel compelled to deal with particular risks linked to specific technological uses. Continue reading Report on Artificial Intelligence: Part II – outline of future regulation of AI

Report on Artificial Intelligence: Part I – the existing regulatory landscape

Artificial intelligence (AI) has been placed front and centre in many countriesʼ economic strategies1, probably unsurprising as AI is one of the defining technologies of the Fourth Industrial Revolution2. Nascent AI regulation around the world today is characterised by soft approaches either aimed at incentivising innovation in the manufacturing or digital sectors or encouraging break through research. The ethical implications of AI are either regulated through specific AI codes in companies concerned with good corporate social responsibility, in research institutes (private or public) concerned with ethical research and innovation or not regulated at all. These AI ethical codes are not formally scrutinised by any public administration, nor are they legislatively required, and so it is difficult to assess the quality and effectiveness of such codes in minimising the negative implications of AI. The purpose of this howtoregulate report is to examine existing AI regulatory landscape (Part I) and present regulatory approaches for minimising the harms of AI (Part II – outline for future regulation of AI), evidently without putting into question the utility of AI. Continue reading Report on Artificial Intelligence: Part I – the existing regulatory landscape

Tobacco control regulations: Combating the world´s leading preventable cause of death

Tobacco remains the leading preventable cause of death in the world today and accounts for around 12% of all adult deaths worldwide (more than 7 million people)1. Its effects are far-reaching and has implications along the supply chain: from the land used to grow tobacco instead of food, often in countries where food security is a concern, to the 63% of children of tobacco-growing families involved in child labour, to the environmental effects of smoke expelled into the air, the bystander and the smoker´s health2. This howtoregulate article focuses on tobacco control regulation and regulation for the emerging tobacco alternative electronic cigarettes. Continue reading Tobacco control regulations: Combating the world´s leading preventable cause of death