Challenges as an information officer

Role of the information officer in accordance with Section 74a of the German Medicinal Products Act (AMG)

The role of the information officer in accordance with Section 74a of the German Medicinal Products Act (AMG) is varied and demanding. For pharmaceutical companies, this person is responsible for providing correct and legally compliant information about medicinal products. Many legal requirements and regulations must be complied to provide patients, healthcare professionals and the public with correct and comprehensive information.

The most important focal points and associated challenges are:

Legally compliant handling of the German Therapeutic Products Advertising Act and the German Act against Unfair Competition

The information officer must ensure that a pharmaceutical company's entire public image complies with the provisions of the German Drug Advertising Act (HWG) and the German Act against Unfair Competition: this applies to advertising measures, the website, and the sales force for medicinal products. The aim is to prevent misleading advertisement. One challenge is to recognize the subtle differences between permitted and unauthorized advertisement. Caution is required when presenting the efficacy, safety, and quality of medicinal products, as violations can have serious legal consequences.

Science-based advertisement for healthcare professionals

Advertisement for prescription-only medicines is subject to specific regulations. Here, advertising measures must only be placed with healthcare professionals, such as medical doctors, pharmacists, and nurses. The information officer must ensure that the advertisement is scientifically sound and factually correct. It is crucial that the standardized information, such as summary of product characteristics and package leaflets, as well as information in specialist journals, at congresses or in the form of product brochures, meets scientific standards and takes current data into account. One challenge here is to design effective advertisement without overstepping the legal boundaries.

Public advertising

Advertising aimed at the public is even more strictly regulated. The information officer must ensure that the advertising is neither misleading nor incomplete and does not make any unauthorized medical claims. Advertisement must be understandable to laypeople and must not raise false expectations. It can be particularly difficult to formulate comprehensible and appealing advertising messages that still fulfil all legal requirements.

Responding to medical enquiries

The information officer is also responsible for responding to medical enquiries from patients, medical doctors and pharmacists in a legally compliant manner. These enquiries as a so-called PULL element (information that is actively sought or requested by the enquirer) must be answered precisely, evidence-based, and quickly. The information officer must have comprehensive knowledge of product information and the current scientific literature. The challenge is to communicate medical facts clearly and comprehensibly while ensuring that the information is complete, correct and that recurring enquiries are answered consistently.

Summary of product characteristics and package leaflets

Summary of product characteristics (SmPC) and package leaflets (PL) are key sources of information for healthcare professionals and patients. For package leaflet, the content of the SmPC must be rephrased in a manner that is comprehensible to non-experts without losing scientific accuracy. The information officer must ensure that this standardized information is precise, up-to-date and regularly revised to reflect the latest scientific findings. Changes to these texts must be adopted promptly and correctly in accordance with authority requirements. This requires close co-operation with other departments within a pharmaceutical company.

Mandatory disclosures

Mandatory statements include information that must be incorporated in the advertisement of medicinal products, such as warnings and the indication for use. The use and content of mandatory texts is prescribed by law and must be strictly adhered to. The information officer must ensure that they are correctly and completely integrated into all advertising measures. The challenge is to integrate these often-extensive texts into the advertising without diluting the message or making it unattractive.

Conclusion

The role of information officer under the AMG requires a wide range of knowledge and skills, from legal expertise to medical-scientific understanding and communication skills. The challenges are varied and demanding, as they require constant engagement with changing legal frameworks, scientific findings and co-operation with all departments involved in a pharmaceutical company. Only through careful and continuous work can the information officer ensure that all information and advertising measures fulfil the legal requirements and at the same time reach the target groups effectively.