Court rejects appeal

There is good news once again for kava growers in Samoa and the Pacific.

The Upper Administrative Court in Muenster, Germany, has rejected an appeal by the German Health Authorities and reaffirmed the ruling of the Administrative Court of Cologne in June 2014.

The ruling in question had found that the ban on kava was both unreasonable and unlawful.

Now the most recent decision was confirmed in a statement issued by the International Kava Executive Council (I.K.E.C) Chairman, Tagaloa Eddie Wilson, yesterday.

“The verdict came the very same day, only a few hours after the closing of the session,” the statement said.

“The reasons of the Court will be made available in two to four weeks-time- and until then a clear understanding of the potential consequences for the Pacific Kava Trade.”

For now, Tagaloa is confident that the ruling will stand.

“It is understood that the German Health Authorities still have the right to appeal the decision- however, there is also the possibility they will accept the decision,” he said.

“In short, the Court’s view is that the risk, although minor, was not sufficiently substantiated for the ban on kava. In conclusion, Kava is back to the regulatory status of 2001, thus the ban has been lifted by order of the Administrative Court!”

The ruling of the Administrative Court of Cologne in 2014 said the ban on kava products in Germany did not constitute as being unlawful and inappropriate.

The Court ruled that:

* Mere doubts related to the efficacy of a medicinal product do not justify the withdrawal of marketing authorizations;

* Doubts related to efficacy cannot automatically lead to the conclusion of an overweight of risk in the benefit-risk-ratio;

* Mere hypotheses and assumptions on the causality of adverse events are per se not a justified suspicion;

* The risk must be assessed in the clinical context, especially if the therapeutic alternatives bear a greater risk – this should have been counted in favour of kava;

* The authorities must demonstrate the risk in a reproducible manner. If the risk cannot be clearly corroborated, the withdrawal of marketing authorizations is unlawful:

* The risk of kava has not been clearly demonstrated. Consequently, the benefit-risk-ratio cannot be negative and there is no justification for the withdrawal of marketing authorizations;

* In view of the exposure data the risk does not seem unusually high. The incidence of liver toxicity would have to rated “rare“ or “very rare“;

* BfArM uses duplicate case reports. Quantity of case reports does not replace quality of the assessment; * BfArM never commented on the doubts related to its causality assessment;

* The court doubts that a pattern of liver toxicity can be derived from the data;

* BfArM is wrong to describe the benzodiazepines, buspirone of SSRI as less harmful alternatives to kava.

According to the International Kava Executive Council (I.K.E.C) Scientist, Dr. Mathias Schmidt and Tagaloa - the Kava Industry will start preparations for the modalities for the re-introduction of Kava to the European Market once the German Upper Administrative Court’s reasons become available.

After the 2014 ruling was issued, Tagaloa told the Samoa Observer that the pharmaceutical industry had a vested interest in the herb due to its medicinal properties.

“The pharmaceutical industry actually developed ava products that were eventually used,” he said.

“At the time of the ban there were about 1.5 million people in Germany alone who were on an ava prescription.

“So you can imagine that – that is 1.5 million in Germany alone, and the world was catching on, the U.S. was a big market.”

However, according to the I.K.E.C. website the herb was banned BfArM due to a few reported cases of sever hepatotoxicity, which were possibly related to the intake of ava products.

But with the court overturning BfArM’s decision, Tagaloa said he was excited about the doors this could open for the ava market.

“We are excited because we have been there and done it,” he said. “Even though it is going to be hard work re-establishing it we have been there and done it. And we have also learned from the lessons now.

“So there are some big plusses in the sense that we have learned from that.

“So now we are going to put in place the proper procedures and processes to ensure that quality control to ensure the right (types of ava) are propagated and grown.

“And there is a lot of work being done. So hopefully with this news we can get the farmers to grow. But at least we know that this market opportunity is there.”