Pharmaceutical Safety: A Study in Public and Private Regulation

The purpose of the project is to identify whether the major drug safety issues that gave rise to litigation in Europe during the past 40 years since pharmaceutical regulation was introduced were identified by litigation or by the regulatory system. That issue is central to current debate on comparing the effectiveness of public and private systems, and of ex ante and ex post controls, on influencing corporate behaviour, and in particular on the European debate over class actions and collective redress. This study builds on research carried out previously on the major litigation cases that occurred in England and Wales prior to 2001.

Since the mid-1960s, the EU has put in place sophisticated regulatory systems that control the entire lifecycle of a medicinal product and also modern liability systems. Cases that have given rise to major litigation should be a good proxy for the occurrence of major safety issues with medicinal products. But where litigation has occurred, a comparison can also be made over whether the all-important signal that a safety issue may have occurred with a drug originated from the regulatory system, or from the liability system, or in some other way.

If the safety signal emanated from the liability system, it might indicate some measure of failure in the regulatory system, and an argument in favour of a widespread ex post liability-based policy on enforcement. In contrast, if the safety signal emanated from the regulatory system, it would tend to indicate that that approach is operating effectively, or in any event is more effective than the liability system, and hence a liability regime may be refocused on delivering compensation rather than on a regulatory function.

By attempting to examine the histories of all major litigation involving medicinal products in Europe in the past 40 years, it should be possible to gain an overview between the above two opposing policy regimes. If there were to be a clear result in favour of either a regulatory or liability approach, that would have important lessons for policy in the objectives, design and prioritisation of both systems of control. As well as being a significant contribution to scholarship, this research should inform debate over regulation of medicines, sustainability and enhancing economic competitiveness, and have implications for policy on pre-emption and liability systems.

Major Questions Examined:

The object of this project is to study how regulation and enforcement works in the pharmaceutical sector.

1. What major litigation has occurred in EU jurisdictions concerning pharmaceutical liability issues?
2. Where did the safety signal that was raised in relation to the medicine concerned come from - medical usage, the medical or healthcare professions, the    pharmacovigilance system or the litigation system?
3. What were the outcomes of the litigation, where these have been concluded?
4. What regulatory consequences followed?
5. Hence, what conclusions are to be drawn between the effectiveness of (a) public and private enforcement mechanisms, (b) deterrence and other compliance policies, (c) ex ante regulatory and ex post liability policies?