In 2005, a small delegation (myself included) of the European Fine Chemicals Group (EFCG) met with the deputy head of the cabinet of Commissioner Kyprianou (the then Commissioner responsible for health and consumer protection). Our mission was simple — we were there to raise a red flag.

We were concerned that substandard APIs were a growing problem and, in our opinion, the root-cause lay in break-neck globalization and rogue players taking advantage of the virtual absence of effective oversight on European laws governing minimum quality standards. We were given 20 minutes, by which time it was made abundantly clear to us that we must be from another planet. We were told that all was well, and that "in the EU the architecture of quality of medicines is firmly based around the Qualified Person and that there is no such issue of substandard APIs in the EU". In several other meetings with the Commission and with the EMEA, we were looked at with disbelief and almost horror every time we raised the spectre of noncompliance as a deliberate business strategy. In between the lines we could read "how can the EU's API industry sink so low as to try to make up for its lost competitiveness by scare-mongering".

Living in the past

Most regulators still live in the 20th century. During the last 25 years, Europe — with the explosion of off-patent medicines — has moved from being the cradle of the pharmaceutical industry, and the dominant player in the fermentation and synthesis of APIs, to a hasbeen; fermentation has virtually disappeared from Europe and the EU API industry is only thriving because of innovators and because of the US market where tough hurdles set up by the FDA separate the wheat from the chaff.