EMA pushes ahead with anti-fraud strategy

The European Medicines Agency’s (EMA) new anti-fraud office is to undertake structured surveys of the European Union (EU) regulator’s staff to ensure they are proficient on anti-fraud and ethics knowledge. The goal is to root out the potential for collusion and corruption – and further anti-fraud training will be organised, depending on the results.

The office is also planning to assess whether its selection and procurement procedures demonstrate sufficient fraud resistance and address any gaps identified.

Meanwhile, this summer, the office is to develop internal processes on reporting and tackling alleged instances of fraud within the pharma sector discovered by agency staff.

EMA’s IT department is also to review access rights to its Document Records Electronic Archive Management (DREAM) and other databases for all users to make sure access to documented software takes account of potential fraud risks.

EMA established an anti-fraud office within its legal department last February to roll out, implement and coordinate the agency’s anti-fraud strategy. It is responsible for identifying and preventing breaches of EMA rules preventing fraudulent collusion between the regulator and the pharma sector, working with EU anti-fraud office OLAF where necessary.

The agency updated its anti-fraud guidance in December 2015. It highlights how the regulator has a close financial relationship with the pharma sector, with industry fees accounting for more than 85% of its annual budget, and 30% disbursed through procurement.

The guidance said: 'The agency will not tolerate fraud, impropriety or dishonesty and will report, without delay, any instance of suspected fraud to OLAF.'