Navigating impact: the Regulatory Institute’s influential journey in 2023

In 2023, the Regulatory Institute left an indelible mark on global public health, undertaking impactful initiatives that will save lives of countless individuals across the globe.  Recognising the pivotal role of European legislation and its far-reaching influence on other countries, we seized the opportunity presented by the proposed new European Union (EU) Medicines Directive by submitting comments aimed at enhancing its efficiency and closing inherent loopholes. Our well-thought-out comments and amendment proposals were addressed to ministries and specialised institutions across all EU member states, yielding positive feedback from more than six countries1. Notably, our insights seemed to resonate with the Health Committee of the EU Parliament, garnering positive responses from the committee rapporteurs and providing us the chance to further explain our comments with a rapporteur’s assistant.

The Regulatory Institute also played a certain role in the development of the WHO’s new international instrument designed to prevent pandemics, the so-called WHO CA+. In response to the initial drafts, we submitted comments resumed here and two draft protocols complementing the instrument. Among others, we addressed the aspect of laboratory safety which was initially quite underdeveloped, and fortunately was slightly improved over time. To suggest further elements for the instrument, we also published our own model law on pandemic prevention. Undertaking our largest outreach campaign to date, our team disseminated the model law and the two draft protocols to all WHO member countries globally. Our proposals were welcomed by some of the INB members, the body shaping the final version of the WHO CA+. Positive feedback from 10 countries2 strengthens our belief that our contributions might enhance the WHO CA+ contracting parties in their implementation of the future instrument within domestic legislations, potentially leading to the preservation of millions of lives.

We continued promoting our model laws, particularly those pertaining to emergency management, artificial intelligence, internet relationships and virtual worlds and the regulation of tobacco, alcohol, and cannabis. These model laws were also referred to in targeted recommendations to countries developing or revising laws in the respective fields. For example, we made submissions to the specialised institutions in India working on the Digital Personal Data Protection Act that referred to our model law on artificial intelligence. We also referred to this model law in submissions made to legislators from Australia, Bolivia, the United States and the United Kingdom on similar topics. Being aware of the alarming effects of addictive consumer products on global health, we pursued our annual campaigns to enhance the current legislation aiming to control the use of these products. We also shared our comments on Hong Kong’s public consultation on Tobacco Control Strategies besides responding to South Africa’s public consultation on Tobacco Products and Electronic Delivery Systems Control Bill.  

Beyond these four sectors, we shared proposals and comments on bills discussed in different regions of the world. Specifically, we offered support to the Business and Trade Department of the United Kingdom’s Government by engaging in the Product Safety Review consultation. Concurrently, we contributed to the proposed EU non-road mobile machinery regulation via the European Parliament. We made a submission to China’s public consultation on the Law on the Prevention and Control of Infectious Diseases. Earlier this year, we proudly contributed to South Africa’s National Council on Gender-Based Violence and Femicide Bill as well as Australia’s public consultation on aged care regulation. 

Our commitment to disseminating regulatory knowledge took new strides. In addition to articles and model laws, we recorded an audio / video introduction to our Handbook “How to regulate?” which can serve as self-standing introductory online-training. It will soon be available on our website.

Our founder published in the Review of the Commonwealth Association of Legislative Counsel an article presenting our model laws which also argues in favour of a modernised way of producing regulation. We published two further articles of his on our website, one calling for a more rational selection of topics to be regulated and another one countering the general belief that “less regulation” is good for business.

As it turned out to be even more complicated than thought, we could not commit to our plan to publish the third model law foreseen for 2023, our model law on animal protection. It will be published for public consultation in January 2024. Its final publication is now planned for March 2024. It contains three times as many regulatory elements than the best national animal protection law or model law so far. It will therefore provide countries the possibility to bring their animal protection law to another level.

Aiming to cover all the regions of the world, our team has expanded with a new representative for South America and the Carribeans. Moreover, our founder, Manfred Kohler, serves since the end of 2023 as our chief consultant.

What else is planned for 2024? 

We envisage a model law on public tendering, with special focus on mining rights and infrastructure work. Moreover, we are researching further topics to be covered by model laws. For this, we welcome suggestions. 

In terms of methodology of law-making, we will investigate what ChatGPT, Gemini and other Large Language Models can do for us to ensure that all elements needed for an effective pursuit of the legislators’ policy goals are in the respective drafts. Do not hesitate to contact us if you are interested in this particular topic. We look for testimonies from other law-makers using Large Language Models and we provide early-on insights into our findings in return.

1.Belgium, Czech Republic, Luxembourg, Netherlands, Romania, and Spain.                                      2.Brazil, Cabo Verde, Canada, Costa Rica, Iraq, Philippines, Switzerland, Tajikistan, United Kingdom,     and Vanuatu.

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