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.
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
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
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.