Kava’s Legal Battle: Will Germany Lift the Ban?

The ongoing legal struggle surrounding the kava ban in Germany continues to be a significant concern, as discussed in an interview between The Fiji Times and Dr. Mathias Schmidt. The prohibition, implemented in June 2002 by the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), initially focused on safety and efficacy issues. However, the situation has evolved into a battle for market authorization amidst BfArM’s persistent rejections of kava.

Despite a recent court ruling in Germany that questioned BfArM’s decision, many believe that the challenges will persist, whether in the legal arena or through the agency’s steadfast refusal to reverse a decision stemming from a few liver toxicity cases linked to imported kava extracts.

With the legal options nearly exhausted, Dr. Schmidt urged the Fijian Government and other Pacific nations to seek assistance from Germany’s Minister of Foreign Affairs. He expressed concern that BfArM might use the European Union’s Pharmacovigilance Risk Assessment Committee to label kava as dangerous, potentially prolonging the absence of market authorization.

Dr. Schmidt highlighted the frustration among German pharmaceutical companies, which have been advocating for over two decades, often at significant financial cost. Many of them are questioning the viability of continuing the fight, given the lack of profits from kava. He emphasized the importance of diplomatic efforts, advocating for the Fijian Government to engage with German officials, particularly those interested in maintaining strong bilateral relations, such as Foreign Minister Annalena Baerbock.

He also mentioned that while the situation in Germany influences the broader EU stance on kava, it is essential for stakeholders to recognize that Germany’s ban is based on outdated and arbitrary decisions. Dr. Schmidt encourages a collaborative approach, including potential outreach to the UK, where kava consumption is still common.

In addressing quality concerns tied to kava exports from the Pacific, Dr. Schmidt noted that enhancing testing capabilities and establishing proper quality control protocols are critical for meeting EU market standards. He reinforced the necessity for growers to prepare for inspection and documentation to prove the quality of their products.

For those still fighting for kava authorization, Dr. Schmidt identified two remaining companies: Harras Pharma in Munich and MIT Company in Northam, Australia. He concluded by reiterating the importance of both diplomatic pressure and the preparedness of growers to document and maintain quality standards for any future return of kava to European markets.

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