SUMMARY MINUTES OF THE HERBAL MEDICINES ADVISORY COMMITTEE MEETING HELD ON WEDNESDAY 21ST JULY 2021
From: Medicines and Healthcare products Regulatory Agency [18/01/2022]
TRADITIONAL HERBAL REGISTRATIONS
The Traditional Herbal Medicines Directive (Directive 2004/24/EC) was published on 30 April 2004. Products which were legally on the UK market on 30 April 2004 were not required to comply with the Directive until 30 April 2011. This meant that where an unlicensed herbal remedy sold under Section 12(2) of the Medicines Act had transitional protection, by April 2011 it must have had either a traditional herbal registration or a marketing authorisation or it must have been removed from the market. This transitional protection did not apply to any products placed on the UK market at any time from 30 April 2004 on wards.
HERBAL MEDICINAL PRODUCTS COMMITTEE (HMPC)
The Committee on Herbal Medicinal Products (HMPC) was established in September 2004, replacing the CPMP Working Party on Herbal Medicinal Products. The Committee was established in accordance with Regulation (EC) No 726/2004 and Directive 2004/24/EC, which introduced a simplified registration procedure for traditional herbal medicinal products in EU Member States.The HMPC’s activities aim at assisting the harmonisation of procedures and provisions concerning herbal medicinal products laid down in EU Member States, and further integrating herbal medicinal products in the European regulatory framework.As part of these objectives, the HMPC provides EU Member States and European institutions its scientific opinion on questions relating to herbal medicinal products. Other core tasks include the establishment of a draft ‘Community list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products’, as well as the establishment of Community herbal monographs.The Committee noted the meeting reports from the Herbal Medicinal Products Committee (HMPC) meeting held in March and May 2021.
PHARMACOVIGILANCE ISSUES
Adverse reaction reports suspected to be associated with herbal medicines received through the Yellow Card scheme
The Committee were informed that between 1 March 2021 and 30 June 2021, the Yellow Card Scheme received 75 new reports which included a herbal ingredient as a suspect drug. These 75 reports had not previously been presented to the Committee.Of these,67 cases were associated with medicinal herbal products. The Committee was presented with a summary of these 67 cases which were discussed.The remaining 8 herbal reports received since the last meeting were suspected to be associated with products which are classified as licensed medicines (2), contained non-herbal ingredients (6) and therefore were not within the remit of the Committee.The Committee were provided with information about the overall reporting rate of suspected adverse reactions compared to previous years. It was noted that the overall level of reporting had almost doubled in 2021 compared with 2020 over the 6 months to June 2021. The increase in reporting in 2021 may reflect a general increase in reporting to the Yellow Card scheme which is believed to be due to increasing awareness of the scheme as a result of the national vaccine campaign. The proportion of reports received from patients remained high, including reports from patients submitted by the Traditional Herbal Registration (THR) Holders. THR holders submitted the majority (74%) of reports in 2021. The trend for a decrease in the proportion of serious cases noted in 2019 continues to be observed in 2020 and 2021.Many of the cases received were recognised adverse reactions, or first cases for the particular adverse reaction. The Committee agreed that no new safety signals had been identified.The Committee noted the majority of reports for products indicated to aid sleep and anxiety. The Committee considered that this may reflect individuals seeking over the counter medication for these conditions during the pandemic when it may be more difficult to access healthcare professionals.The committee recommended that product information for valerian be updated to include the side effects of abdominal pain, abdominal cramps, vomiting, diarrhoea and nausea.
July Drug Safety Update newsletter article reminding patients and healthcare practitioners to submit Yellow Cards for herbals and homeopathic medicines
The Committee were advised of the recent publication of a Drug Safety Update article for herbals and homeopathic medicines (volume 14, issue 12: July 2021: 2). The aim of the article was to remind healthcare professionals to report Yellow Cards for suspected reactions associated with herbal and homeopathic medicines in the UK and to remind patients that they should check that a product is licensed. The Committee heard that Drug Safety Update is sent to a wide range of healthcare professionals, subscribers, and targeted stakeholder organisations.
Butterbur article
The Committee were updated on the action taken by the MHRA in response to an article published promoting the use of Butterbur (Petasites hybridus).
The MHRA has previously published a safety alert advising consumers not to take unlicensed. But Butterbur herbal remedies following reports of Butterbur products being associated with cases of liver toxicity and this advice remains unchanged.PAPERS/OTHER ITEMS The Committee received a presentation by a member titled “Herbal medicine what’s next: a review of the current status of herbalists”. The Committee were also given brief presentations on the MHRA response during COVID-19. The MHRA delivery plan 2021-2023 published in July 2021 Procedural Items. The Committee completed its usual procedural business including the need to observe the confidentiality of the meeting, to declare interests, apologies, announcements. No interests were declared. A list of Members who attended the meeting is at Annex A.Medicines and Healthcare Products Regulatory Agency staff may be present for all or part of the meetings or for specific items.The meeting started at 10:03 and finished at 12:37.
The next meeting is scheduled for Wednesday 13th October 2021.
