BMI SYSTEM held in London on the 20th of September a seminar on the newly introduced Bribery Act and its impact on the pharmaceutical industry. The seminar was organized in partnership with Pritchard Engelfield (Solicitors) and 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. The various presentations addressed the provisions of this Act, 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 the Bribery Act requirements.
The Bribery Act affects companies doing business in the UK (even if they are not based in the UK). It strengthened the provisions on passive bribery, active bribery and the facilitation payments that are now prohibited. So far the SFO (Serious Fraud Office), which manages the implementation of the Act, has not actively started proceedings because it favors a collaborative approach with businesses in order to curb corruption. For the pharmaceutical industry, it brings a new set of rules that already existed in most the national codes of practice, but with a compelling extraterritorial aspect which implies a greater control of third parties (suppliers, employees, customers …) in all subsidiaries.
One of the keys to ensure compliance with this new law is documenting all your relationships with third parties as well as monitoring the ones between employees and other individuals or organizations (suppliers / customers). The Bribery Act requires implementing “adequate procedures”, in other words a company cannot be held responsible if the SFO considers that all possible measures were taken to prevent corruption. For the pharmaceutical industry, these procedures correspond to rules of transparency that already exist in some countries and the SFO said to be sensitive to the fact that, according to the ABPI, British laboratories publicly declares their relationships with third parties (health professionals).
Implementation of the Bribery Act as well as other regulations concerning transparency, affects at the same time issues of governance, regulatory compliance and risk management. This is why an integrated approach called GRC (Governance, Risk Management & Compliance) is particularly adapted, for the global vision it provides, to the management of processes covered by this law. A GRC platform should enable to trace, validate and easily publish all financial relationships between a pharmaceutical company and health professionals. In order to prevent risks, this approach should allow a better anticipation of non-compliances by focusing on proactive validation of relationships with health professionals, on the reconciliation of actual expenditures compared to planned expenditures and on the identification and treatment of potential noncompliance. The Bribery Act is just one example of extraterritorial rules that apply to companies in different countries to promote transparency. These provisions are specific to each country, but they represent different facets of a global problem that encourages pharmaceutical companies to promote a comprehensive and integrated regulatory compliance.