More than five years after dealing with harmonised decision-making in the Handbook “How to regulate?”, we now re-visit the topic of this article in a more analytical way. We present six key components for a strategy leading to more harmonised decision-making (A). These key components can be integrated into an operational action plan and workflow. Continue reading How to harmonise decision-making of authorities and conformity assessment bodies?
Category Archives: All Articles
Referring to standards: never think there is no further alternative
In particular for technical sectors, regulators tend to refer to international or national standards as a means to set up requirements. This article examines some risks and downsides of (classic) direct and specific referencing, a referencing that makes the standards mandatory (A.). Furthermore it presents a matrix that can be used to generate dozens or hundreds of alternative techniques of referencing that avoid these risks and downsides and describes in more details a few favourite techniques (B.). Continue reading Referring to standards: never think there is no further alternative
Attributing legal personality to nature as an effective means for protection
Nature is increasingly being recognised as a holder of rights both in legislation and in court judgements. The relationship between regulations and nature has usually been one of protection, where regulations focus on prohibiting or regulating activities that pose threats to nature. This howtoregulate article explores the burgeoning regulatory landscape attributing legal personality to nature and suggests other regulatory requirements to strengthen the governance and administrative structure supporting legal personhood of nature. Continue reading Attributing legal personality to nature as an effective means for protection
Using regulation to ensure the well-being of children
Scientific evidence shows that child well-being investment pays off, particularly in early childhood, as those children become adolescents and those adolescents become adults who do well. Such adults have higher employment and earnings, better health, and lower levels of welfare dependence and crime rates than those adults who did not have such investment as children. Regulations, be they legislation or delegated rules, are a critical feature of any state seeking to ensure the well-being of children because it organises in a systematic way the responsibilities, enforcement, the budget and services that allow children to thrive. This howtoregulate explores good examples of child well-being laws from around the world. Continue reading Using regulation to ensure the well-being of children
Regulating online safety and tackling online harms
When Tim Berners-Lee invented the World Wide Web in 1990, he envisaged a decentralised environment of free exchange of ideas and information. Fast forward to 2019, almost 30 years later, and that online environment has been polluted by disinformation, manipulation, harassment and privacy breaches. The growth of online pollution has prompted various regulatory responses such as the European Union’s General Data Protection Regulation1, Germany’s Network Enforcement Act2, Australia’s Abhorrent Violence Amendment Bill3 and California’s Consumer Privacy Act4, each one responding to an online safety problem. In a world first, however, the UK has signalled it will regulate online safety in a single and coherent way, including creating a statutory duty of care for online safety. This howtoregulate article will analyse the UK’s regulatory approach outlined in its April 2019 Online Harms White Paper, which is open for public consultation until July 2019, and propose ways to improve on regulatory enforcement of online safety. Continue reading Regulating online safety and tackling online harms
Three new approaches to enforcement of product legislation
Classic product legislation currently reaches its limits in several ways. One is 3D-printing which has been the topic of a separate article1. But the main issue is that the many control systems, be they pre-market or post-market oriented, tend to fail in front of an ever increasing number of economic operators and products and rather decreasing resources of state authorities. This article explores three novel approaches. These approaches can and should be used to complement the classic pre- and post-market verification. Some of them might even become alternatives thereto. Continue reading Three new approaches to enforcement of product legislation
Life after death: regulating posthumous reproduction
Regulating posthumous reproduction raises a myriad of bioethical, social, legal and administrative issues, all of which are important in any drafting of regulation on the topic. Very few jurisdictions researched in this howtoregulate article had complete legislation that regulated well the issues that arise from the retrieval of reproductive tissue postmortem and subsequent posthumous use of such tissue. In some jurisdictions researched, the applicable legislation was somewhat dated in comparison to the advances made in artificial reproductive technology (ART) treatment that push the boundaries of the legal parent. This howtoregulate article explores how jurisdictions have regulated posthumous reproduction, citing examples of regulation where they existed and proposing areas requiring clarity. Continue reading Life after death: regulating posthumous reproduction
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 diseases1 and 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 pathogens3 to 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
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?