Evaluating the regulatory system
Evidence for the innovation crisis in pharma
In recent years, there has been much discussion about the dearth of innovation in the pharmaceutical industry. Across the globe, regulators and international organizations such as WHO have expressed concerns about the declining output of the pharmaceutical industry pipeline. These concerns focus both on the decline of the total number of New Chemical Entities (NCEs) released into the major markets, and the many real public health needs of the population that are not addressed by new medicines. Within the European Union, these concerns have been complemented by fears about deterioration in the relative competitiveness of the European pharmaceutical industry.
This project looked at the data presented on several measures on industry-sector performance such as innovativeness of new medicines, sales, employment, labour productivity, and R&D investment. For each of these, three questions were answered. First, what measures were used in some of the leading European reports on competitiveness in the pharmaceutical sector, and how relevant were these measures? Second, might a re-assessment using data that became available since the publication of the report show that the evidence used was misleading or more mixed than the singular policy conclusions? Third, what kind of variables should be collected for future reports that focus on the issue of the relative productivity of pharmaceutical research in the US and EU to provide a meaningful groundwork for assessing the current state of affairs and identifying future actions?
Results
- Did the U.S. eclipse European pharmaceutical research productivity? An analysis of major reports as searchlights in the fog (report)
- Light DW, Lexchin JR. Pharmaceutical research and development: what do we get for all that money? In: BMJ, 2012; 344: e4348. (journal publication)
- Light DW. Global drug discovery: Europe is ahead. In: Health Affairs, 2009; 28(5): w969-w977. (journal publication)