The European Medicines Agency (EMA) is committed to ensuring that its staff, members of committees and all external contractors pursue the highest standards of honesty, propriety and integrity in the exercise of their duties and has a ‘zero tolerance' approach to fraud.
The Common Approach on decentralised agencies agreed in July 2012 between the European Commission, the European Parliament and the Council of the European Union (EU) requires all European Union agencies to develop a set of anti-fraud measures and proactively communicate them to external stakeholders. Accordingly, EMA has put in place an anti-fraud strategy and a related action plan for the years 2015-16. These are also in line with Article 69 of Regulation EC No 726/2004 establishing EMA, which requires the Agency to combat fraud, corruption and other unlawful activities.
The anti-fraud strategy complements existing policies and procedures such as the EMA code of conduct and EMA’s policy on handling competing interests, thereby reinforcing the Agency’s commitment to the highest standards of integrity.
The overall objective of the anti-fraud strategy is to improve prevention, detection and the conditions for investigation of fraud, in close collaboration with the European Anti-Fraud Office (OLAF), and to pursue adequate deterrence and reparation, with proportionate and dissuasive sanctions.
Fraud is defined in the applicable legal texts as an intentional breach of a rule with the aim of obtaining a gain, which may or not have a direct impact on the financial interests of the EU. It may include misbehaviours that have a reputational impact.
EMA established an Anti-Fraud Office within its Legal Department in February 2015 to coordinate the implementation of the anti-fraud strategy and related action plan. The office aims to strengthen an anti-fraud culture at all levels of the organisation and provides relevant training.
Any EMA staff member or third party can report alleged fraudulent behaviour to the Agency, using the provided template:
After an initial analysis, the Agency will report to OLAF any instance of suspected fraud, which is exclusively competent to investigate such cases.
|Document(s)||Language||Status||First published||Last updated||Effective Date|
|Anti-fraud strategy: November 2014||(English only)||2014-12-22||2015-12-02|
|Decision of the European Agency for the Evaluation of Medicinal Products of 1 June 1999 concerning the terms and conditions for internal investigations into the prevention of fraud, corruption and any illegal activity detrimental to the Communities' interests||(English only)||adopted||1999-06-01|