Consensus Statement on the Outcome of the European Herbal Health Products Summit – Which Way Forward?

Abstract

Herbal medicinal products are a vital part of the healthcare system in Europe and beyond. Being predominantly sold as non-prescription medicines in pharmacies, they are very popular with patients, physicians, and pharmacists and are therefore an important part of self-medication. Interest in this sector has recently gained momentum, reflecting the ongoing revision of the general pharmaceutical legislation and the recent discussion on nutrition and health claims on foods based on the implementation report of Regulation (EC) No 1924/2006 by the European Parliament [1]. Therefore, on 20th February 2024, the Society for Medicinal Plant and Natural Product Research (GA), in collaboration with the German Pharmaceutical Industry Association (BPI) and the German Medicines Manufacturersʼ Association (BAH, now Pharma Deutschland), hosted an in-person summit in Brussels entitled ‘European Herbal Health Products Summit – Which way forward?ʼ. The summit featured a wide range of speakers, including policymakers, regulatory authorities, industry representatives, and academic experts. It was divided into several sessions covering topics such as the future and relevance of herbal medicinal products in the EU, the revision of the EU pharmaceutical legislation, and the resulting impact on herbal medicinal products. Furthermore, the discussions delved into the “Health Claims Regulation” – the European Parliamentʼs implementation report and the related regulatory challenges of herbal medicinal products at an EU level. This consensus paper summarises the current status and provided recommendations to pave the way for future strategies to ascertain the continued use of herbal medicinal products as an important therapeutic option for patients.

Keywords

herbal medicinal products - herbal medicines - botanicals - EU pharmaceutical legislation - health claims

• References

• 1 Implementation report on Regulation (EC) No 1924/2006 on nutrition and health claims made on foods: European Parliament resolution of 18 January 2024 on the implementation of Regulation (EC) No 1924/2006 on nutrition and health claims made on foods (2023/2081 (INI)); P9 TA(2024)0040. Accessed on 30th September 2024 at: https://www.europarl.europa.eu/doceo/document/TA-9-2024-0040_EN.html
• 2 Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. OJ L 311, 28. 11.2001, 67–128. Accessed on 30th September 2024 at: https://eur-lex.europa.eu/legal-content/en/TXT/?uri=CELEX%253A32001L0083
• 3 Personal communication of Thomas Heil, Vice-President at IQVIA Germany, as part of his presentation at European Herbal Health Products Summit on 20th February 2024 in Brussels, Belgium.
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• 6 Susanna Tenhunen, Health Claims made on foods, Findings on the implementation and application of Regulation (EC) No 1924/2006, European Parliamentary Research Service, PE 747.456 – September 2023. Accessed on 30th September 2024 at: https://www.europarl.europa.eu/thinktank/en/document/EPRS_STU(2023)747456
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• 8 Guidelines on the details of the various categories of variations, on the operation of the procedures laid down in Chapters II, II a, III and IV of Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products and on the documentation to be submitted pursuant to those procedure. OJ C 223, 2.8.2 013, 1–79. Accessed on 30th September 2024 at: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%253A52013XC0802%252804%2529