Pharmaceutical companies in Europe have spent almost two years preparing for the first disclosure of transfers of value, after the publication of the new Code of Ethics of EFPIA regulating transparency in the sector. Here are a few steps worth noticing:
Change and the timeframe for adaptation have represented great challenges for pharma companies. The new regulation impacts their business processes directly, as well as the information systems supporting them. In addition, adaptation to the new regulatory environment has impacted both the tools used in back and front offices, which means an extra effort to coordinate the adaptation of different information systems that are not always compatible.
Once pharma companies have adapted their business processes, company policies and information systems to carry traceability of all transfers of value, here are the next steps.
Data Quality Control
Firstly, it is necessary to control the quality of the data to be disclosed.
This preliminary validation prior to disclosure is very important, in order to ensure the relevance of the information and avoid:
- HCP and HCO duplicates
- Errors in the unique identification of the recipients of transfers of value
- Missing information
- Data inconsistencies
Beyond recorded information, it is important to control every document related to transfers of value: contracts, agreements, invoices, invitation lists…
Pre-disclosure & privacy consent
After performing data quality controls, pharma companies can then inform recipients of the relevant transfers of value to be disclosed.
This “Pre-disclosure” phase is highly recommended in order to prevent claims from HCPs. Moreover in some countries, pharma companies must collect the HCP or HCO consent to disclose information.
Nonetheless, this enables pharma companies to anticipate conflicts, apply modifications and manage withdrawals when needed, before the actual disclosure.
Finally, once transfers of values are disclosed, pharma companies will have one last challenge to meet. They must be prepared to handle potential claims from HCPs and HCOs affected by disclosure, to react quickly and to be able to trace both modification requests and corrections.
The proper management of this process will be key during the first weeks following disclosure. Pharma companies must provide adequate resources and information systems to respond to a possibly high volume of requests.
In conclusion, although pharma companies have adapted to the new regulatory environment, they still have a very important role to play in this final stretch towards transparency to ensure the highest quality of disclosed data and the proper management of all the risks it entails.