In a bilateral contact with a development aid agency we learnt that some governments struggle to find a consensus amongst ministries or departments, and this in particular when regulating. If your government is in such a situation, you might wish to check whether the establishment or the amendment of rules of procedure could help. We recommend as a reference the Rules of Procedure of the Czech Republic and the supplementing rules for the Government’s Legislative Council available here.
Liability as regulatory tool
Establishing a legal basis for liability claims or modifying an existing one can deter economic operators or other natural or legal persons from unwished behaviours. To use this instrument, it is necessary to analyse the tort law regime of the respective jurisdiction and to complement or correct it so as to ensure that the unwished behaviour is covered. The following check-list of relevant issues might help regulators in this task. The check-list reflects various tort law traditions. This means, on the other hand, that some of the issues listed below are not relevant in all jurisdictions. Continue reading Liability as regulatory tool
World Bank to launch regulatory advice practice
There are not so many institutions or service providers offering advice for regulators. We found a job advertisement according to which the World Bank is about to launch a comprehensive regulatory advice practice. Continue reading World Bank to launch regulatory advice practice
Drones: national regulations not complete
In this blogpost, we present some reference regulation on drones. As the reference regulation is still anything but complete, we also list the aspects which might be worthwhile being regulated. Continue reading Drones: national regulations not complete
Reference legislation on medicines
Regulators who wish to develop or amend regulation for their respective jurisdiction might wish not to start from scratch, but to learn from other jurisdictions. Therefore we present here some legislation on medicines / pharmaceuticals / drugs of different jurisdictions as models. The models have different degrees of complexity. We start with rather simple models and go up to the quite complex models. Continue reading Reference legislation on medicines
The downside of requiring justifying data
Requesting data as justification for new legislation is useful, but has an important downside. Requesting justifying data can delay or render impossible the new legislation. It can also be extremely costly, bind too much manpower, increase the influence of lobby groups and reduce the choices of political decision-makers. In a view of this downside, it is preferable to establish a pragmatic case-by-case approach that takes account of the situation of the sector in the respective jurisdiction. Continue reading The downside of requiring justifying data
Decentralized 3D-printing: a regulatory challenge
Summary
3D-printing of products in decentralized manufacturing constitutes a regulatory challenge. Normal product legislation will mostly not cover it. Thus there is a regulatory gap. Subject to the risks of the products and their manufacturing, it is worthwhile closing this gap.
If need there is, the gap can be closed by creating specific obligations for the designers of the product, for the owners of print-shops, the manufacturers of 3D-printers and sometimes even for the clients. The regulatory approach presented here can be adapted to atypical cases. It can also be used to cope with:
– devices sold as kits, and
– the marketing of manufacturing instructions for dangerous devices.
Continue reading Decentralized 3D-printing: a regulatory challenge