A continuation of yesterday’s interview with Dr. Mathias Schmidt addresses the ongoing kava ban in Germany, which has persisted since 2002. The situation has evolved from a safety and efficacy debate into a prolonged legal battle for market authorization against the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM). Despite a recent court ruling challenging BfArM’s stance, the deadlock is likely to continue, fueled by the agency’s insistence on upholding a decision rooted in eight liver toxicity cases linked to kava extracts.
With legal options nearly exhausted, Dr. Schmidt urges the Fijian government and other Pacific nations to reach out to Germany’s Minister of Foreign Affairs for assistance. He anticipates BfArM may seek further justification for its position, potentially creating more delays. He expressed concerns that pharmaceutical companies are becoming fatigued after 24 years of fighting for kava’s reauthorization, with only two companies remaining in the struggle.
Dr. Schmidt emphasizes the need for diplomatic engagement, suggesting that Fiji’s governmental contacts should target the German Ministry of External Affairs to explain the prolonged wait for the reversal of the ban confirmed by the recent court ruling. He believes that drawing attention to the ongoing situation could prompt a reevaluation from German authorities.
He also outlined how kava entered Germany in medicinal forms, noting that its consumption as a drink primarily occurs in the UK, pointing to potential collaboration with the UK as a strategic move to reopen dialogues with European stakeholders.
The broader implications of Germany’s ban extend to the entire EU, where other regulatory bodies await Germany’s lead before reconsidering their own positions. Dr. Schmidt pointed out that quality control in kava production needs improvement to meet EU standards, and growers must prepare for rigorous documentation and inspections if the product is to be reintroduced to the market.
In closing, he reiterated two critical messages: the need for diplomatic pressure on Germany and the importance of ensuring that kava growers are ready to meet quality standards through transparent and reproducible practices. The two companies still pursuing kava authorization are identified as Harras Pharma in Munich and MIT Company in Northam, Australia.