Thematic workshop on relationships transparency
Industry – Healthcare professionals – Health Authorities
BMI SYSTEM and the French arm of the law firm Simmons & Simmons LLP presented a thematic workshop on the challenges of the new law wich decree should be passed by the end of the year, called the “French Sunshine Act ,” which complements the existing provisions in the law called “DMOS”.
The “Sunshine Act” was adopted in 2010 in the United States and France is preparing to vote on its version as part of the law to modernize the health system. To establish full transparency in the relationship between pharmaceutical companies and healthcare professionals, the “French Sunshine Act ” could come into effect from the 1st of January 2013, “with need for companies to be able to generate aggregate reports of all the benefits granted to healthcare professionals as of the 1st of January 2012″.
The new regulation provides that all agreements as well as the direct or indirect benefits granted to health care professionals are to be made public. BMI SYSTEM stressed that the implementation of this new regulation must first be based on DMOS processes well defined and robust. In addition, good management of the “French Sunshine Act ” needs to anticipate various possible pitfalls at each stage of the underlying processes DMOS, namely:
– Data collection
– Data validation
– Data aggregation
– The breakdown of expenditure
– Reconciliation between reported hospitality and expenses incurred
– Publication of the conventions and hospitality
– Archiving of records
– The agreement on the amount the physician released
Therefore, with its experience in the computerization of the processes DMOS, BMI SYSTEM has developed its application “NAYA Sunshine Act” in line with “NAYA DMOS” to ensure validation of all information to be published under the “French Sunshine Act “.
About BMI SYSTEM
BMI SYSTEM is the editor of NAYA Compliance, integrated software for management of compliance in the pharmaceutical industry.
Working since 2004, BMI SYSTEM includes within its staff experts in pharmaceutical regulatory affairs nationally recognized. The different modules of the NAYA Compliance solution have been adopted by a significant range of laboratories, making it the leading software in its field.
The module NAYA Sunshine Act, recently developed by BMI SYSTEM, positions itself in the spotlight : the new regulation to come before the end of the year provides for agreements to release and direct or indirect benefits granted by the pharmaceutical industry to health professionals. NAYA Sunshine Act provides the necessary features to comply with this regulatory change, while including indicators for use by sales force and budgetary control.
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