Better than bilateral trade agreements: unilateral recognition of approvals / certificates and approval / certification hubs

This article analyses the regulatory tool “unilateral recognition of foreign product or service approvals or certificates”. This tool might in the future play a crucial role in favour of international trade. Furthermore, this article shows how jurisdictions, by applying extremely stringent approval or certification criteria on an optional basis, could become approval / certification hubs, to the benefit of many other jurisdictions and their own. Continue reading Better than bilateral trade agreements: unilateral recognition of approvals / certificates and approval / certification hubs →

Analysing legislation

The Handbook “How to regulate?” has been developed to train law-makers in administrations and parliaments. But it can also be used as analytical tool. One of the author’s readers, François Mestre, analysed a regulation by applying categories of the Handbook in a slightly modified way.

Reference rules of procedure

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 →

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 →