When Things go wrong: is Whistleblowing an Option?
"Whistleblowing is the act of telling the authorities or the public that the organisation you are working for is doing something immoral or illegal." This is the definition in the Collins English Dictionary. In the United States of America, the False Claims Act1 encourages whistleblowing to report evidence of non-compliance or fraud. Whistle-blowers are even rewarded for their efforts for example with monetary compensation and protection from retribution. In the EU such a common law does not exist but obligations2 are placed on the Wholesaler or Manufacturer to immediately inform the Competent Authority or the Marketing Authorisation Holder of any medicinal products they identify as falsified or suspect to be falsified. If the company does not do so, authorities expect that the Qualified Person (QP) would carry out such communications. Of course, the primary legal responsibility of the QP is to certify batches of Medicinal Products. "However, the wider technical, ethical and professional obligations in terms of patient safety, quality and efficacy must also be considered". This statement was in the focus of a presentation given by MHRA's Martine Powell3 at the 13th QP Forum in November 2018 in Prague.
Martine Powell pointed out that QPs should have a good working relationship with their competent authority, and not only during site inspections. In certain situations outside of inspections, a QP might wish and need to contact the respective agency or inspectorate for clarifications or further advice.
Recommendation
Berlin, Germany4/5 December 2024
Root Cause Analysis
Sometimes QPs must ensure that authorities are made aware of manufacturing and/or testing difficulties which may cast doubt on the certification of batches or even might require a product recall. To support this, the European Medicines Agency (EMA) has published Policy/00724 (effective from March 2017). The focus of this document is to give guidance on how to handle information provided by external sources concerning EMA activities on the authorisation, supervision and maintenance of human and veterinary medicinal products. Key sections and aspects of this document are:
- Confidentiality: EMA must protect against any unauthorised disclosure or access of personal data.
- EMA expects that the disclosure of the information by external sources is made in the public interest, in good faith and on reasonable grounds.
- EMA will endeavor that all suspicions of problems regarding medicinal products for public and veterinary health are examined by the competent authority.
- EMA will seek to work closely with institutional partners such as other national and international partners.
In her talk, Martine Powell introduced MHRA's procedure of handling notifications of issues. She clearly pointed out that the UK MHRA "promotes an open reporting culture as an essential pillar of an effective quality system". To support this, MHRA has established a dedicated and confidential reporting process5 which can be used by employees, ex-employees or even third-party employees of a company or organisation in question. After receiving such a report, MHRA will review the information and evaluate the risk and impact "to both the quality of the product and patient safety". This might then lead to a number of different actions, which could include for example a "For Cause" inspection.
Other regulatory bodies in the EU should have a similar approach and you should contact the supervisory authority in the respective member state for further details.
How to deal with critical observations made in an audit?
During her talk, Martine Powell asked the more than 250 QPs in the audience how they would react if during an audit of a contract manufacturer critical observations were made. Of course it is expected that the respective observations will be risk assessed and at least reported to management with the potential consequence to remove the contract acceptor from the list of approved suppliers.
But the question was "is there an obligation to inform your regulatory body of your concerns?"
About one third of the delegates were sure that this is the case whereas the others were not really sure what to do. However, the expectation of the MHRA is "yes!". Especially in the case of a potential patient impact also for other materials manufactured at this site and/or where the incidence may result in a recall or in a restriction in the supply of the product. This does not necessarily have to be a "Whistleblower" situation. For such a case, the MHRA has an "Interim Compliance Report" document that allows sites to notify the agency of any significant changes or issues.
Recommendation
22/23 January 2025
HPLC Data Integrity - Live Online Training
In her summary, Martine emphasised that the "reporting of issues is not meant to be an ethical dilemma but a positive and responsible action to ensure and support robust assurance systems and cultures that will mitigate the potential for GMP violations. Because prevention is better than a cure!"
Author:
Wolfgang Schmitt
... is Operations Director and organises and conducts courses and conferences on behalf of the ECA Academy in the areas QA, GMP
and GDP.
Source:
1 False Claims Act (FCA), 31 U.S.C. §§ 3729 - 3733
2 See Directive 2011/62/EU amending Directive 2001/83/EC
3 Martine Powell is a GMDP Inspector within the Inspectorate, Enforcement and Standards (IE&S) Division of the UK Medicines & Healthcare Products Regulatory Agency MHRA
4 EMA's handling of information from external sources disclosing alleged improprieties concerning EMA activities related to the authorisation, supervision and maintenance of human and veterinary medicinal products (EMA/283205/2013)
5https://www.gov.uk/guidance/contact-mhra#whistleblower-referrals; contact: whistleblower@mhra.gov.uk
