European pharma expects regulatory compliance challenges
pharmafile | November 18, 2010 | News story | Sales and Marketing | CRM, Cegedim Dendrite, Transparency Directive, regulatory compliance, transparency
European pharma companies will face major challenges over the next three years implementing new regulatory legislation and compliance requirements, according to a new report.
CRM solutions firm Cegedim Relationship Management found that 93% of surveyed companies agreed compliance would be a major hurdle, but almost as many (83%) agreed transparency guidelines could improve the industry’s reputation, if followed correctly.
The report highlighted data identification, consistency and quality as the major challenges in project implementation and compliance governance processes, along with new regulations such as the UK Anti-Bribery Act.
Bill Buzzeo, Cegedim’s VP and general manager for Global Compliance, said: “It came as no surprise to learn that the greatest concern is the changing compliance landscape and how this will affect daily processes and the image of the industry as a whole.
“Life Sciences companies need a way to respond to a rapidly evolving industry that is presented with stiffer regulatory requirements in addition to extreme competitive pressures and market access challenges.”
According to Cegedim’s research, 75% of respondents say their company is either excellently equipped (31%) or well equipped (42%) to comply with the transparency regulations as they exist today.
Three-quarters of those polled believed Europe will follow the US’s lead when it comes to promotional spending curbs and declarations of their activities. It is likely these will continue to come though a fragmented series of self regulatory rules, rather than the highly-enforced centralised environment seen in the US.
Cegedim questioned 117 people for its 2010 European Trends in Aggregate Spend, Transparency, and Disclosure report. Over 80% were from pharmaceutical companies and the functions represented included marketing, sales, management and compliance.
Brett Wells
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