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Παρασκευή 17 Φεβρουαρίου 2012

Survey Results From Life Sciences Executives on Regulatory Compliance Trends in Europe


Cegedim Relationship Management released its second annual industry survey report of Europe’s key decision makers, 2011 European Trends in Aggregate Spend, Transparency and Disclosure, which provides a comparative analysis of current trends and challenges in Life Sciences compliance between 2010 and 2011. According to surveyed pharma, biotech and medical device executives, organizations are committed to achieving operational compliance but find incomplete data and internal system inefficiencies as their greatest challenges.


The UK Bribery Act and Foreign Corrupt Practices Act (FCPA) are not the only regulations transforming pharma in Europe. France recently adopted legislation similar to the US Patient Protection and Affordable Care Act (which includes the “Sunshine Provisions”), and the Netherlands is set to soon launch increased transparency rules. Companies now face a multi-national shift towards improved aggregate Health Care Provider (HCP) spend reporting clarity that raises the bar even higher and, in turn, increases the potential for a breach in compliance.
Key European Industry Trends Towards Operational Compliance
Comparisons between 2010 and 2011 results show that more European companies are enforcing corporate standards for spending on HCPs, with 76% of 2011 respondents saying their policies apply to all external partners and internal data, up from 62% in 2010. Further, compliance professionals are more confident in their companies’ ability to meet transparency requirements, with 87% of 2011 participants saying their ability to comply is Good or Excellent, an increase from 73% in 2010. 64% of those polled in 2011 indicated that implementing a unique spend data reporting and disclosure solution is “absolutely a requirement.” However, 44% of the 2011 respondents reported that their companies are currently satisfying existing reporting and disclosure requirements with spreadsheets and other manual process, up a surprising 22% from 2010.
Europe’s Most Pressing Drivers for Change
Data errors and system shortcomings are key obstacles in 2011, which may be linked to a considerable rise in inefficient reporting mechanisms. Specific difficulties include struggling to connect a unique identification to HCPs from expense reports (52%); incomplete spend and customer information (43%); and overall system/process shortcomings (42%).
“Europe is at a pivotal moment as it approaches an enforcement model increasingly similar to the US,” explained Bill Buzzeo, Vice President of Global Compliance Solutions at Cegedim Relationship Management. “Companies are making essential strides at self-enforcement, but according to the 2011 survey, most respondents are reliant on inefficient manual and Excel spreadsheet reporting mechanisms. These companies should consider the robust capabilities of an automated Aggregate Spend Transparency solution in order to transform the administrative duty of compliance into a competitive business strategy.”
The survey was conducted in November and December of 2011 by Cegedim Relationship Management, the leading global provider of regulatory compliance, customer relationship management, healthcare data, and marketing solutions to the Life Sciences industry.