The donation and transplantation of human organs, tissues and cells is a complex domain that touches on questions of health, law and ethics. These questions are intrinsically connected. Thus, it demands a stringent regulation by public authorities so as to prevent serious health risks and eventual abuses of the consent given by the donor. Furthermore, the increased demand for organs combined with the globalisation has prompted the phenomena of organ trafficking and “transplant tourism”. These phenomena require additional regulation, ideally at global level. Continue reading Transplantation of organs and human tissues
Category Archives: Sector Specific
Who is a refugee? Regulatory approaches.
When regulating the domain of asylum, it is advisable to build on existing international criteria or to make use of specific regional instruments. We examine these in the first part of this article (I.) Furthermore, we present here some national regulations with different degrees of complexity that can serve as reference (II.). Moreover, we highlight some particular provisions that might be of interest to regulators (III.). Finally, we analyse in more detail the proposal of the European Commission for a “Qualification Regulation” (IV.). Continue reading Who is a refugee? Regulatory approaches.
Regulation against money laundering and financing of terrorism
This article presents international benchmarks (I.), national reference regulation (II.) and particular aspects that can be covered (III.).
Continue reading Regulation against money laundering and financing of terrorism
Countering unfair lobbying
It is natural and basically good that interest groups inform regulators on facts, concerns, and alternative solutions. However, lobbying can also go over the top, torpedoing good governance. This article investigates what can be done to counter unfair or disproportionate lobbying. Continue reading Countering unfair lobbying
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
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