Tag Archives: regulation

Patented medicines: how to determine and curb prices?

Profit from sales of medicines is incentivizing pharma companies to further invest in research and innovation, which is undoubtedly in public interest. Profit is evidently linked to prices. Prices of patented medicines are exponentially rising around the world. As a result, there is an increase in public expenditure and diminution of access to medicines across all income groups of countries. Hence there is a conflict between two public interests: innovation on one hand and affordability on the other.

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Whistleblowers: protection, incentives and reporting channels as a safeguard to the public interest

Whistleblowing has become a dynamic regulatory field. Several jurisdictions have recently opened public consultations in this relation. They recognise the need to protect the good faith whistleblower disclosing alleged wrongdoing to ensure, in fine, the respect of the public interest.

This article presents international framework on whistleblowing (Part I.), model laws (Part II.), national reference regulation (Part III.) and national regulation which is commendable for specific aspects (Part IV.).

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Robots: no regulatory race against the machine yet

From autonomous cars, robotised hotel complexes to surgical and companion robots, the technology of robotics have well advanced. However, have the regulatory measures followed with the same pace? We believe that it has not evolved fast enough. At present, only South Korea has adopted a law that specifically governs the sector of robotics whilst other jurisdictions still struggle how to address immense technological advancements and the related challenges from a legal perspective. Continue reading Robots: no regulatory race against the machine yet

Transplantation of organs and human tissues

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

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