The ongoing battle against Germany’s kava ban continues to frustrate advocates, with Dr. Mathias Schmidt emphasizing the need for diplomatic intervention from the Fiji government and other Pacific nations. Since the ban was first implemented by the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) in June 2002, efforts to secure market authorization for kava have faced significant obstacles. The initial focus on safety concerns has transitioned into a prolonged struggle against BfArM, which has consistently blocked the product despite a recent court ruling against its actions.
Dr. Schmidt shares his concerns that BfArM may resort to other tactics, such as seeking an opinion from the European Pharmacovigilance Risk Assessment Committee (PRAC), which could further complicate the situation. He believes pharmaceutical companies in Germany, which have faced nearly 24 years of legal challenges, are becoming weary of the ongoing fight and may eventually withdraw if they don’t see profitable opportunities.
In light of the recent court ruling, Dr. Schmidt urges the Fijian government to reach out to Germany’s Ministry of Foreign Affairs to advocate for a reevaluation of the ban, as the issue has yet to be resolved despite the court’s findings. He suggests utilizing diplomatic channels to apply pressure, as the EU’s initial alignment with Germany’s stance may stem from misconceptions about the nature of the ban and its underlying issues.
Historically, kava entered Germany in its raw form, processed into medicinal products, while kava consumption has continued elsewhere, notably in the UK. Dr. Schmidt notes that lifting Germany’s ban might not automatically change the EU’s position, but it could pave the way for new discussions about regulatory compliance across Europe.
Quality assurance remains a critical aspect of reintroducing kava to the EU market. Dr. Schmidt advocates for improved testing capabilities within the Pacific islands to meet necessary standards and ensure traceability in production processes. He stresses the importance of preparing growers for the scrutiny they will face regarding product quality.
Dr. Schmidt concludes with two key messages: the need for diplomatic pressure to be applied by Pacific governments and the importance of growers being prepared with comprehensive quality documentation. Two companies, Harras Pharma in Munich and MIT Company in Northam, Australia, remain committed to the fight for kava’s market authorization.