EMA itself ensures compliance with current legislation and regulations on medicinal products, the agency recognizes that its own activity cannot cover all the cases of irregularities and declinations that raise during medicines development and marketing. Recently, EMA published an official policy on reporting of such imperfections by “external sources”. “External source” is defined as any other source than EMA staff member who reports facts pointing to the existence of improprieties.
In layman’s terms, EMA officially declared its will to receive denunciations from pharma companies (and others involved in pharma business and R&D) on each other. On the other hand, the Agency understands that such reporting may affect the reputation of informers. That’s why new policy also grants confidentiality to the informer.
This rule is effective immediately (from March 17th, 2017). From now on, any suspected, presumed or alleged improprieties concerning EMA activities on the authorization, supervision or maintenance of human and veterinary medicinal products, whether intentional or not, can be anonymously reported and will lead to the conduct of investigations.
If the allegations concern a centrally authorized medicine, EMA will coordinate the investigation which may lead to regulatory action. If the allegations concern a nationally authorized medicine, EMA will inform national regulator of EU Member State. Moreover, if a fraud is suspected, EMA will inform European Anti-Fraud Office.
Such policy could possibly become a powerful weapon in competition between industry members since the only suspicion is sufficient to create additional issues for another market member. A concern may be raised, that the implementation of this policy will slow down medicinal products development and marketing, but on the other hand it can force the market players to follow the rules strictly and support a higher quality of medicines in the EU.