The holder of a licence for activities with blood or labile blood products must appoint a person who is responsible for haemovigilance in accordance with Article 28 para. 1 of the Medicinal Products Licensing Ordinance (MPLO, SR 812.212.1). This obligation applies particularly to manufacturers of labile blood products, i.e. specifically the blood transfusion services.
Art. 65 para. 4 of the Therapeutic Products Ordinance (TPO, SR 812.212.21) requires institutions which use labile blood products to set up a quality assurance (QA) system for the use of labile blood products in keeping with the current state of medical science and technology. According to this definition, this applies to all institutions which perform transfusions of labile blood products, and hospitals and doctors’ practices in particular. These institutions designate a person who is responsible for fulfilling the reporting duty (referred to below as the RPHv).
According to Art. 28 para. 2 MPLO, this person must be a doctor and must have the necessary professional knowledge. This person has an obligation to report adverse drug reactions in accordance with Art. 61 and 65 TPO (Art. 28 para. 3 MPLO). The responsibility of RPHv begins with the establishment of haemovigilance processes in their institutions and observance of the following legal provisions: obligation to notify in accordance with Art. 59 TPA, obligation to record in accordance with Art. 39 TPA, and obligation to archive in accordance with Art. 40 TPA.
Responsible Persons for Haemovigilance should ideally manage or be actively involved in the QA operations of the respective institution or institutions. They have access to information relevant to incidents, can mandate investigations and can take actions to optimise the transfusion process.
Swissmedic may also recognise persons with other professional qualifications as RPHv, provided they possess sufficient knowledge and experience. While RPHv do not need to be employees of the company, their responsibilities must in all cases be defined in writing (Art. 28 para. 4 and 5 MPLO). Recognition of this kind may be considered, for example, if the institution has a transfusion committee. The RPHv must also have access to the relevant data at all times so that these can be sent to Swissmedic or so that related questions can be answered.