On the basis of alleged liver toxicity of kava (Piper methysticum) extracts, the marketing authorizations of kava extract-containing products were suspended and withdrawn in Germany through 3 regulatory decisions, the last one adopted in 2007, of the Bundesinstitut fuer Arzneimittel und Medizinprodukte (“BfArM”), the German regulatory authority responsible for the monitoring of risks related to medicinal products. A number of other European Countries followed Germany and imposed similar measures. As a result, imports of kava from Samoa, Fiji, Tonga, and Vanuatu to the European Community virtually stopped after having reached a peak in 2000. The commercial impact of the measures taken against kava-containing products has been devastating to the traders and the economies of the Pacific Islands communities, with estimated losses of over 200 million USD per year for the producers of the 4 above-mentioned Pacific Island states alone.
In the years following the German decision to ban kava products, the focus of the debate was primarily on toxicology. Many theories have been exchanged, but despite all efforts, toxicity of “noble kava” (high quality kava acceptable for daily drinking in the countries of origin) has never been demonstrated. After years of debating details of case reports and no progress to be seen, the situation regarding causal attribution of hepatotoxicity is still unresolved. A final decision still has not been taken by the German authorities. (Note: German administrative procedures require administrative appeals by the manufacturers as a pre-condition to take the case to court. In the case of an appeal the German authorities either have the choice to re-confirm their decision and thus finalize it—at the same time opening the way for legal appeals. In the case of kava, all new decisions had involved substantial changes, which again necessarily had to lead to administrative appeals. It is as yet unclear whether the forth coming decision will now be unchanged and thus final, or whether once again changes will be introduced.)
In the past 7 years kava producers had to accept that debates about risk are not essentially scientific in nature. Even toxicological data cannot rule out remaining doubts. This situation called for a different approach. Recently the Germany measures have been examined for inconsistencies with rules of the World Trade Organization (WTO). In cooperation with the TradeCom facility (a European Union [EU]-funded economic liaison between the Pacific Island states and the EU), a delegation of South Pacific kava producers from the International Kava Executive Council (IKEC) visited Europe between October 20 and October 29, 2008. The aim of this mission was to discuss the international trade ramifications of the kava case with the political representatives of the South Pacific Islands, the European Commission and, most importantly, the German Ministry of Health, the Ministry of Economics and Technology, and the Ministry of Economic Cooperation and Development. The potential involvement of WTO makes the kava issue an international question rather than an isolated problem under German responsibility.
A major goal of the meeting with the German ministries was to discuss the requirements expected from the German authorities as proof of safety of kava. Despite multiple calls for more data, the authorities have never defined the exact type and amount of data to be produced in order to allow BfArM to lift the ban. A promising outcome of the meeting was the decision to have a working meeting with BfArM and the German drug manufacturers, which should take place as soon as possible. IKEC expressed its expectation to be given a clear and detailed list of studies to be performed. However, such a “to-do list” would clearly have to take various issues into account:
• The already existing data on kava: Kava preparations should not be treated as a new, completely unknown entity.
• The time frame in which the studies could reasonably be performed: As kava is one of the few commodities of the South Pacific, the devastating economic situation will not improve until a scientific or legal solution for the kava situation is found.
A detailed list might finally allow planning ahead and seeking the proper cooperation for funding. IKEC places some hope on a potential involvement of the German Federal Ministry for Economic Cooperation and Technology and Development, among others.
An outcome of the meetings is that IKEC (in cooperation with the Pacific ambassadors) has drawn up a 2-year road map to undertake the following steps through a continuous consultative process among IKEC and the Pacific Island Governments with Germany and the European Commission:
1. Legal. IKEC will continue to work closely with the TradeCom Facility to pursue and seek legal advice in relation to international trade negotiations such as EPA (Economic Partnership Agreements with non-EU countries) and Doha (WTO trade negotiations named after Doha, Qatar, where the initial meeting took place), WTO consultations, and WTO dispute settlement procedures.
2. Scientific. IKEC will continue to facilitate the collection of scientific data and the undertaking of research to meet the requirements of BfArM as well as to support its various applications for alternative kava registrations. Assistance will be sought through the ACP-EU Trade Facility (the economic liaison of the EU for the African-Caribbean-Pacific countries) and the German Pharmaceutical Industry as well as its other counterparts to move this important aspect forward. The list of BfArM’s expectations shall be made public in order to allow international scientists to contribute to the solution of the kava question.
3. Alternative Registrations of Kava. IKEC will facilitate the preparation of the registration of kava in Europe under alternative options, such as the following regulatory categories and corresponding criteria:
• well-established herbal medicinal product;
• traditional herbal medicinal product;
• food/beverage; and
• Geographical indication (GI) protected commodity (e.g., Pacific noble kava-such as the French Champaign Case) in Europe. To this end, IKEC will consider becoming a member of oriGIn, an international network for geographical indications in the marketing of plants with defined origin and quality.
4 Strengthening and Supply Capacity Preparation. IKEC and its partners such as the EU-ACP Centre for the Development of Enterprise (CDE) will continue its work on quality control assurance and quality control standards for the Pacific kava-producing countries. This work will not only focus on meeting quality standards when the restrictions are removed on the kava trade, but it will also cater to preparing the Pacific Island kava-producing countries to meet requirements under the various registration options listed above. IKEC will also seek assistance for institutional strengthening and organizational establishment to manage and drive these processes and strategies.
Conclusions
Although the situation with kava is probably not about to change within the next 2 years, there is hope that constructive discussions with BfArM might finally allow scientists to perform studies according to the then-disclosed expectations of the German regulatory authorities.
— Mathias Schmidt, PhD
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