Masterstudiengang "Drug Regulatory Affairs"


Die Packungsbeilage als Instrument der Verbraucherinformation im Wandel der Zeit ***

Stephanie Pick (Abschlußjahr: 2008)

Eine Übersicht zur Entwicklung der Gebrauchsinformation und weiterer Möglichkeiten der Verbraucherinformation durch die pharmazeutische Industrie in Deutschland.

Language: German

For some years, the package leaflet (PIL) has been under discussion in the regulatory and social environment. On the one hand, the package leaflet represents a way to inform the patient or the consumer respectively, whereas on the other hand it is a means of fulfilling the duties as pharmaceutical entrepreneur with respect to product liability according to § 84 of German Drug Law.

The current discussions primarily deal with the possibilities and methods to improve readability of the PILs, for instance by consultations with target patient groups and by using the test results of so-called readability testing to improve the style and the understanding of the content of the PIL. As this topic has already been discussed in the context of different master theses, the intention of the present thesis is to show the development of the package leaflet for medicinal products for human use in Germany in the last 50 years and to describe the changes resulting from the different revisions and amendments of the German Drug Law and several other national regulations and recommendations, but also with regard to the ongoing changes in the European regulatory environment.

By means of analysing examples of different medicinal products, the development of the package leaflets as well as changes in content and structure are shown. For comparison, examples of package leaflets of medicinal products that were on the German market in the 1950s, i.e. prior to the first German Drug Law, are also analysed. Based on the analysis of the examples, package leaflets can be considered to be emerging documents.

Furthermore, this master thesis deals with the option to add additional leaflets or further information to the official package leaflets (Weitere Angaben). In this context, reference is made to different examples (medicinal products currently or previously marketed in Germany) as well.

The present work is completed by a summary of the possibilities that are in place to inform patients and consumers about medicinal products, about the underlying illness and to give them appropriate background information. The national and European legal backgrounds such as EU regulation 2001/83/EC (as amended) and its precursors, the German HWG, UWG and other voluntary rules and provisions, are described as well in this regard.

As this master thesis shows, the (regulatory) requirements regarding the package leaflet in Germany have changed in the last 40 to 50 years. However, both the requirement of a certain format and content of the package leaflet in the EU as well as the standardisation of distinctive text passages (e.g. excipients, standard terms etc.) are generally to be appreciated, as they enable consistent information of the patients/ consumers in the European Union.

The changes to the structure and the different ways of presenting information (questions instead of mere information), as well as a more descriptive and patient friendly way to include information in the PIL show that there is a completely new picture of the consumer and that the demands and needs of the patients have changed in the past 50 years. Nowadays, patients are informed more detailed about their illness and the medicinal products they have to take. They do not only know the positive effects but are also aware of the side effects and risks associated with medicinal products in general and specifically the ones prescribed to them.

Apart from the information given in the PIL, further information can be provided to the public by the pharmaceutical entrepreneur or by other parties, such as health authorities, other institutes, (industry or patient) associations, health insurances etc. by different means, such as internet, magazines and books or other kind of media. It is out of question that there is a need for more information regarding underlying diseases, adjunctive therapies or supportive measures. In this context, a European working group has shown that information must be validated as otherwise one cannot rely on the information provided mainly by the world-wide-web.

However, as the boundaries between information and promotion of medicinal products often overlap, for further information about medicinal products to be provided to patients/ consumers, it should be always bore in mind that it depends on the wording if these materials are classified as promotional material or mere information only.

In summary, it can be said that there is a number of laws, regulations, and voluntary provisions to be followed in the context of informing patients and consumers about medicinal products. The requirements regarding the package leaflet or other materials used for patient information will surely be adapted in future as they had been adapted in the last 50 years.

Pages: 115, Annexes: 4, pages : 119