Regulatory costs will rise, fines will increase, expert warns

“It feel like we are driving at 100km per hour in the fog without being able to find the brakes,”​ was how co-founder of economic publication 8 Monthly Barometer, Thierry Malleret, described the current landscape to delegates at Partnerships in Clinical Trials (PCT) yesterday.

The forces that will shape the business world of tomorrow are playing their part in blurring decision makers in all industries, with evidence of this effect already in place in the pharma world, Malleret told the room.

“The fiscal outlook will make well-being mandatory,”​ he said, with the first mechanism in place to deal with the economic crisis being to regulate more. “The trend of over-regulation is already apparent in many spheres and this will increase.”​

He added the pharma world would feel this in the form of increased regulatory and compliance costs, with fines becoming common-place. Just this year, he said, fines in the clinical trial worl stood at $10.6bn in the US alone.

Interdependence affecting India​

The Financial Times reported Monday​ 157 previously approved clinical trials in India have been suspended due to discrepancies over numbers of deaths​ in the industry, and this, Malleret said was evidence of the times we are living in.

No longer can a company be dependent of the industry as a whole and malpractice by one firm will have lasting repercussions across the board, he argued, as is the case in India.

Velocity and Transparency​

The velocity of the industry was also addressed with the cost of sequencing genomes used as an example of how rapidly things are changing. The first genome to be sequenced cost $3bn, he said, but by 2009 it had dropped to $100,000 with the cost expected to be $1,000 by 2014.

Furthermore, post Edward Snowden, transparency has become a critical issue with implications that will affect future business. “Everything is visibke to everyone,”​ he said, and industry must realise this.

Private Equity warning​

In a Q&A session, Malleret was asked whether the recent spate of investment by private equity firms in contract research organisations (CROs – see PRA and RPS’s merger​, Bracket​, or PPD​, as examples) was a sign of the times.

“Many private equity firms don’t give a toss but only do it for financial gain,”​ he said. Such behaviour was characteristic of how speculation is affecting industry, but – he warned – inherent of the collateral damage the current climate is causing.