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BMI SYSTEM held in London on the 29th of November a seminar on the new transparency regulations in Europe (EFPIA Code) and in the UK (ABPI Code), and their impact on the pharmaceutical industry. The seminar was organized in partnership with Compliance Hub (consulting firm specialized in the codes of practice). The event was held in the premises of the French Trade Commission at Piccadilly Circus; it was attended by participants from the pharmaceutical industry, medical device industry, biotechnology and consultants specializing in regulatory affairs. Both presentations addressed the main trends for transparency in the life science industry, the direct impact on the pharmaceutical industry and the set-up of processes within companies to computerize these same processes in order to comply with local and global requirements.

From January 2013, UK based pharmaceutical companies have to publicly disclose their financial relationships their donations and grants to healthcare organisations, their donations to patient groups, the sponsorship of healthcare professionals and the use of consultants. For the moment the amounts declared are aggregated and no individual name has to be declared; the amounts and the number of HCPs having received any support are to be disclosed. However, according to the EFPIA board, from 2016 all the names and detailed support shall be publicly disclosed.

With this aim in mind, it is very important for UK Pharma companies to be able to aggregate all their expenditures from all the different IT systems (CRM, Excel files…) and from all the services in the company (sales, marketing, compliance…). Even if it is not yet mandatory to display the names of HCPs, the risk associated to disclose information about a person not concerned is too high for companies not to undertake an integrated approach allowing to link the concepts of Governance, Risk-Management and Compliance. American and other European countries (France is first) have already set regulations for a nominative approach to transparency, thus a corporate involvement is necessary for a global reporting strategy, but at the same time countries keep some specificity and local processes are needed.

 

What is the solution to these new issues of Transparency?

There is no easy answer to this question since there cannot be one global solution for such a huge process. However transparency should not be seen as a burden for pharmaceutical companies but as an opportunity to show their commitment in this global trend. Worldwide regulations, like the Sunshine Act or the Bribery Act, will enforce these concepts; but it would be a mistake to think that all markets are the same and inside a global strategy there is a need to take into account each affiliate’s local requirements and processes. Thus the solution must be able to address local specificity within an international approach.

 

Compliance Hub website: here

 

If you need more information on transparency, or if you want to receive the presentations given on the day of the seminar, please contact Sylvain Hubert (s.hubert@bmi-system.com).

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