The ongoing kava ban in Germany has become a significant legal and diplomatic struggle, as detailed in a recent interview with Dr. Mathias Schmidt by The Fiji Times. Initially established in June 2002, this ban enforced by the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) now centers on market authorization for kava products, following a ruling against BfArM’s sustained blockade. This situation has persisted for 24 years, resulting from eight liver toxicity cases in Switzerland linked to kava-containing medications from Germany.
Dr. Schmidt is urging the Fijian government and Pacific nations to engage with Germany’s Minister of Foreign Affairs for assistance. He anticipates that BfArM may seek to involve the European Union’s Pharmacovigilance Risk Assessment Committee (PRAC) to reinforce its stance against kava, despite existing court rulings that challenge such actions.
He expressed concern about the fatigue among German pharmaceutical companies, stating they have been involved in this battle for over two decades without significant financial return. The number of companies fighting for kava markets has dwindled from 12 to just two, making the legal expenses harder to sustain.
Dr. Schmidt recommends using diplomatic channels to apply pressure at the governmental level, preferably through the Ministry of Foreign Affairs rather than the Ministry of Health, which has been less responsive. He believes that leveraging the recent court ruling could motivate meaningful discussions on reversing the ban.
In discussing the kava products entering Germany, Dr. Schmidt noted that they were previously imported in root form and transformed into medicinal products, contrasting with the ongoing kava consumption in places like the UK. He emphasized that should Germany lift its ban, it might pave the way for other EU nations to reconsider their stances. However, he cautioned that the perception of Germany’s regulatory decisions heavily influences other countries’ policies regarding kava.
Addressing concerns about consistent quality standards, Dr. Schmidt outlined that establishing reliable testing and compliance frameworks is crucial for any future kava exports to Europe. He highlighted the need for traceability and adherence to international standards to ensure product quality.
In his concluding remarks, Dr. Schmidt reiterated two critical messages: exert diplomatic pressure to advocate for kava’s market reintegration and prepare growers to document quality standards, moving beyond mere assertions of quality to reproducible and transparent evidence.
The last companies persistently advocating for kava are Harras Pharma in Munich and MIT Company in Northam, Australia.