The following is a continuation from an interview conducted by The Fiji Times with Dr. Mathias Schmidt regarding the ongoing kava ban in Germany. Since the original ban was imposed in June 2002, attempts to lift the ban by the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) have faced significant obstacles. What began as a safety and efficacy issue has developed into a long-standing struggle for market authorization as BfArM continues to reject kava. Although a recent court ruling in Germany has gone against BfArM, the situation appears destined to prolong, be it through legal channels or via BfArM’s determination to maintain its decision from over 20 years ago, rooted in eight liver toxicity cases reported in Switzerland linked to kava extract.
With legal options nearly exhausted, Dr. Schmidt urges the Fijian government and other Pacific nations to contact Germany’s Minister of Foreign Affairs for assistance.
In the interview, Dr. Schmidt expressed concerns that BfArM might seek input from the Pharmacovigilance Risk Assessment Committee (PRAC) at the EU level, potentially leading to new arguments against kava. He criticized this approach, highlighting the previous court ruling that forbids such arbitrary actions.
Dr. Schmidt voiced worries over the pharmaceutical companies in Germany, who after years of battling for kava market authorization are growing weary. The number of companies involved in the fight has dwindled from 12 to just two, heightening the risk that they may abandon the effort entirely due to lack of profitability.
He emphasized the importance of leveraging the momentum from the recent court ruling to apply diplomatic pressure on Germany. Dr. Schmidt recommended that the Fijian government reach out to Germany’s Ministry of External Affairs, specifically Minister Annalena Baerbock, to convey the urgency of the situation and advocate for the lifting of the ban.
He pointed out that the EU might not fully understand the political context behind the kava ban, having relied on Germany’s prior reputation for thoroughness and well-considered decisions. Dr. Schmidt believes educating the EU on the matter could be pivotal in moving forward.
When discussing how kava was originally imported into Germany, he clarified that it came in the form of roots, which were then turned into medicinal products, with no drinking of kava occurring in Germany at that time.
Dr. Schmidt also addressed the significance of Germany’s stance on kava for the rest of the EU. If Germany lifted its ban, it could open doors for other EU nations to consider revising their positions. He noted that while Germany wasn’t a major market for kava, its prohibition heavily influences other countries’ decisions to follow suit.
He expressed concern about the quality control of kava production in the Pacific, acknowledging BfArM’s position given inconsistent standards. However, Dr. Schmidt believes that establishing a quality control system in the Pacific is feasible, advocating for adherence to CODEX standards, the establishment of testing labs, and compliance with HACCP protocols.
He concluded the interview with two key takeaways: first, the need for diplomatic pressure to push for change; and second, the necessity for growers to prepare robust quality documentation to support kava’s re-entry into European markets.
The two companies still advocating for kava are Harras Pharma in Munich and MIT Company in Northam, Australia.