EU Directive 2001/83/EC describes in Article 52 :
« Member States shall ensure that the duties of qualified persons referred to in Article 48 are fulfilled, either by means of appropriate administrative measures or by making such persons subject to a professional code of conduct. »
Until recently, EU rules provided no further details on how such an ethical dimension is defined and ensured.
That’s why the European QP Association (EQPA) decided to publish a supplementary chapter in the « EQPA Code of Practice for QPs – Duties and Responsibilities for Qualified Persons in the EU » entitled « Ethics for the Qualified Person – A Professional Code of Conduct ». This code is intended to define the ethical dimension for QPs and may be further used as a reference. This document is available on the web page of EQPA.
Key is that we must always ensure that patients are protected and that all medicinal products meet the appropriate requirements for compliance, safety, quality and efficacy. The following ethical duties have been defined by EQPA (for more details, please refer to the EQPA document):
Always put the patient at the first place ! The motif of your action should be based on a risk assessment, considering the most ideal benefit of the patient at the lowest risk to the patient. Whenever you are in doubt, a batch should not be certified.
Avoid any fraud or negligence and act in accordance with the law. It is important for the QP to take an independent position and to avoid placing himself/herself under any obligation to any person or organisation that might inappropriately try to influence him/her. Financial or material benefits should not influence the decisions of the QP. The QP must feel comfortable with the knowledge about the products to be released. Because the QP depends on many colleagues, a collegial relationship with other QPs, and different functions/organizations is a must
Decisions are based on legislation, official guidance, scientific facts and quality risk management principles. The QP has interest in keeping abreast of new developments in science, technology, legislation and official guidance that may impact his/her work.
As a QP you take full responsibility for your decisions, therefor you should not take decisions which may compromise compliance, quality, safety, or efficacy of the product batch.
A QP takes his/her decisions in an open and transparent manner. This means you do not withhold any information, you can explain your decisions clearly, and you provide proper documentation of your decisions.
This needs no explanation : always act truthful.
Qualified persons lead by example and should challenge poor quality behaviour wherever it occurs. They should address shortcomings and – when necessary – take the first step.
As stated by Eudralex Volume 4, Annex 16 : «Any QP involved in the certification, or confirmation of a batch must have detailed knowledge of the steps for which they are taking responsibility. The QPs should be able to prove their continuous training regarding the product type, production processes, technical advances and changes to GMP ». The QP needs to be confident about the quality of the product. When more knowledge is required, the QP should consult other experts.
Qualified persons take necessary steps to prevent corrupt practices and professional misconduct. The QP has the duty to inform the senior management, who needs to ensure that appropriate corrective measures are taken.
The qualified person is the official contact for the national competent authorities, and should therefor establish a good working relationship with regulatory inspectors. In cases were departure from professional, ethical, and technical standards cannot be counterbalanced, the QP should contact the appropriate authority to mutually settle the issue(s).
Try to be consistent in your decisions and be conservative with risk taking. The decision is built on a comprehensive assessment and is based on different perspectives. It is important to consider other people’s arguments and views.
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