Masterarbeit

Chancen und Risiken aktueller Entwicklungen der Arzneimittelzulassung mit Blick auf HMPC-Monographien

Stefan Läer (2025)

Zusammenfassung/Summary

Sprache: Deutsch/Language: German

Various types of medicinal plant monographs have been known for centuries, but it was only through modern laboratory methods in the recent past of human history that the systematic research and extraction of herbal ingredients and active substances became possible.

Since 2004, the monographs of the Committee on Herbal Medicinal Products (HMPC) of the European Medicines Agency (EMA), which are intended to improve the harmonisation of phytopharmaceutical standards in the EU, have played a globally respected role. Like the entire field of regulatory affairs, the authorisation of phytopharmaceuticals is subject to constant change. As part of this master’s thesis, the opportunities and risks of current developments were therefore identified and analysed with a particular focus on the HMPC monographs.

The first focus of the work was to examine the potential impact of the planned reform of the EU pharmaceutical legislation, in particular the revision of Article 10a of Directive 2001/83/EC, which currently permits a bibliographic application for marketing authorisation (well-established use, WEU), on the authorisation of phytopharmaceuticals and the use of HMPC monographs. The methods used were a literature search and requests for statements from professional societies, regulatory authorities and patient representatives. The results of the research and survey are discussed with special consideration of the aspects of therapeutic safety, ethics, costs and availability.

Due to the newly created Article 13 of the new draft directive, the industry fears that applicants for a medicinal product for which a reference medicinal product already exists on the market will in future have to submit a generic or hybrid application instead of a WEU application, which would be associated with greater effort and therefore higher costs for companies. The German Federal Institute for Drugs and Medical Devices (BfArM) also expects – despite all the uncertainty – a decline in WEU applications and an increase in generic applications, but no impact on the efficacy and safety of phytopharmaceuticals. If the draft comes into force, the decline in WEU applications, which are popular with industry, could also have negative consequences for the use of HMPC monographs and the European herbal medicinal product market. Particularly against the background of medicine shortages, there is a risk of weakening the supply of high-quality phytopharmaceuticals to patients. The objectives of the reform would be thwarted in this respect. At the same time, the additional clinical trials required could be a burden for patients from an ethical point of view. The work is limited in particular by the lack of statements from patient representatives.

Another focus of the work was researching, analysing and discussing the opportunities and risks of the idea of a potential extension of HMPC monographs to non-herbal medicinal products with regard to therapeutic safety, ethics, costs and availability. In this context, the question should also be answered for which non-herbal medicinal products efficacy and safety monographs modelled on the HMPC model would be potentially suitable.

As HMPC monographs have proven to be a safe and globally recognised model for the authorisation of phytopharmaceuticals for over 20 years, the risks of a potential extension of the model to non-herbal medicinal products would be manageable. In a pilot project, the model would be suitable for well-known chemically defined medicinal products. The standard authorisations (“Standardzulassungen”) of chemically defined medicinal products in Germany could also serve as a model for a modern, unbureaucratic and at the same time safe medicinal product authorisation at EU level. For manufacturers of proven chemically defined medicinal products, a simplified authorisation at EU level would be a great opportunity to improve the supply of patients with cost-effective and safe medicinal products without the burden of additional studies, particularly in view of the current medicine shortages and other burdens.

The thought experiment is limited by the lack of data on the costs of new monographs, which would also have to be updated at regular intervals.

Seiten/Pages: 54

Annexes: 2, Seiten/Pages: 11