BELOW is a continuation from yesterday’s published interview between The Fiji Times and Dr Mathias Schmidt on the ongoing kava ban by Germany. Since the initial ban in June 2002, the legal battle to free kava from the iron grip of the Bundesinstitut für Arzneimittel und Medizinprodukte (German Federal Institute for Drugs and Medical Devices or BfArM) has become an impossible fight. What initially began as a ban heavily steeped in safety and efficacy considerations has now morphed into a fight for market authorisation for kava against BfArM’s continuous blocking of kava. Despite the recent ruling in Germany against BfArM’s actions, the issue is expected to drag on, if not in the courts, through BfArM’s relentless persistence in upholding a decision it made over 20 years ago that has its roots in eight liver toxicity cases reported in Switzerland linked to kava extract-containing medications imported from Germany.
With the legal avenue almost exhausted, Dr Schmidt is calling on the Fiji Government and governments in the Pacific to reach out to Germany’s Minister of Foreign Affairs for help.
FT: You were saying BfArM will find something else to bring up against kava?
Dr Schmidt: What I’m expecting them to do that would be the logical thing for them (BfArM) is they could address the so-called Pharmacovigilance Risk Assessment Committee (PRAC) and that committee is again at the European Union (EU) level. If they address them, they can get a good paper saying kava is dangerous and you have to withdraw the marketing authorisations. If that happens, of course I will, as I did the last time, again raise the question of whether they have read their own piece of paper in Europe as they did last time and there is already a court ruling that’s telling them you’re not allowed to do that kind of stuff.
You cannot simply write something and say it comes from a superior agency in Europe if you have written it yourself.
So I’m afraid that’s going to happen and it can buy them some more time. But what I’m more afraid of is by now, the (pharmaceutical) companies in Germany, they are tired. They have been fighting for more than 20 years. It started in 2000 and we are now in 2024, so 24 years of fighting for market authorisations. They have spent so much money on the lawyers and they’re coming to a point where they say: “we’re not earning any money from kava, so why should we continue?”. They’re continuing because they’re saying, ok, if kava comes back, we may have a marketing advantage because we’ll be the only ones who can sell kava products in the market. That’s one thing. The other thing is we want to avoid BFARM using the same kind of approach to any other medicinal product. That was what they tried to do in the beginning of the process in the early 2000. They tried to do the same thing with other plants as well but it was (not successful) so kava was a fight for other medications, not for kava itself specifically. So what they tried to do was to avoid trouble with other medications by fighting for kava. So if kava comes back, nice, because the market is there. But if the whole thing is prolonged…we started out with 12 companies and now we’re down to two. With 12 companies, you could distribute the cost of the lawyer to 12 companies, now we can distribute the cost only to two companies and it’s common sense that if you don’t earn any money on that, why should you? So I’m having some anxiety over that because it looks like at some point, they will simply give up and then the situation will remain as it is.
Diplomatic pressure
Dr Schmidt: And for me, my conclusion is we should use the impetus we now have from the German court case which is quite recent to put some pressure on Germany from the exterior, from Fiji for example. Just using the contacts on the political level, that the Fijian Government should contact the German Government, not necessarily the Ministry of Health because these guys, you cannot talk to them — but the Ministry of External Affairs. That one is interested in having good relations to Fiji and right now, it would be Ms Annalena Baerbock (Germany’s Foreign Minister) and I think she might be interested in hearing that.
So that is something that should come from the highest levels of the government in the South Pacific region, make contact with them, talk to them and explain them the situation that we have been waiting for 24 years now, that a wrong decision, as confirmed by the court in Germany, is still not reversed – and why. Because there is no reason to keep up that ban.
FT: So you’re suggesting we use diplomatic channels to try to persuade the German authorities to look into the matter?
Dr Schmidt: Use the diplomatic pressure on Governmental level, not necessarily on the Ministry of Health but on the Ministry of Foreign Affairs and developmental agencies. Or the European Union. That’s also possible. Because I think the EU isn’t aware of the situation. The EU followed the German ban in 2001 because Germany was known to be very thorough and Germany is known to take very well considered decisions but in the case of kava, it was not the case. In that case it was an arbitrary decision and still people do not know about that.
I’ve been talking to scientists in many European countries and they were not aware that it was a political issue and not a scientific one.
FT: In what form was kava coming into Germany at the time?
Dr Schmidt: It was coming in the form of roots and transformed into medicinal products in Germany. There was no kava drinking in Germany during that time. But there is kava drinking still in the UK because the Fijian military in London drink quite a lot of kava and maybe it would be a good idea to contact UK over that. UK is no longer in the EU but they still have a standing in the EU and that may be a backdoor to come back into negotiations with stakeholders in Europe on the political level, by showing them that if UK has come around, why can’t Germany?
FT: How important is Germany’s stand on kava in relation to the rest of the EU? If they lift the ban tomorrow, will the rest of the EU do that same?
Dr Schmidt: No, because that’s a long process. What happens is if the product came back to the German market, that would be the door open to other regulatory authorities in Europe and tells them: look, Germany has finally understood but the risk is minor, so why can’t we bring kava back. So that would open new discussions. But now, everyone is saying: Germany still has its ban and they must be banning it for a reason so we must also ban. That’s it.
If you talk to Vincent Lebot in Vanuatu for example, he always says: why are we all looking to Germany because Germany was never a huge market — they imported a relatively small amount of kava. Yes, he’s right. But the problem is everyone is looking to Germany and as long as Germany is blocking, everyone else is saying well, as long as Germany is blocking, we are blocking too. So the solution unfortunately is in Germany.
Unfortunately the South Pacific, especially Vanuatu, has never really done anything against exports of Tudei kava. And they still have the problem. I’ve been telling them for the past 24 years stop that, see that you have the good quality and then you have all the justification to say: “we don’t do anything wrong, please accept that.”
FT: We can also understand BFARM’s position given the lack of consistent quality standards or control in the Pacific’s kava growing countries. So how do you make sure you have quality products entering the EU markets or the German market?
Dr Schmidt: That would not be too much of a problem because you have the specifications, you have the CODEX standards, you have analytical methods, of course not in the South Pacific except maybe in Suva, at the University of the South Pacific. But there are no labs in place for doing the testing. By the way, when I was there (in Fiji) the last time in 2015, that was exactly the topic. It was about how can to introduce capacity for testing in place. It’s difficult. You also need HACCP protocols — the Hazard and Critical Control Point analysis. That is something you need if you want to bring kava into the European market because they will ask for it and there will be inspections, there will be people coming over to say, ok if we are using that for food or for medicinal purposes, we have to make sure the kava has been produced according to some standards. So you need the traceability from the field down to the product and that means people cannot overlook how you’re storing the material, how you’re transporting it, how you’re drying it, is there any possibility that something wrong can be mixed in, that mold formation happens or whatever, so, it can be done but it has never been solved. But the growers must simply be aware that if kava comes back into Europe, that’s the first question they will be asked, so that’s something they need to be prepared for.
FT: Your key message?
Dr Schmidt: Two messages: One: Apply diplomatic pressure and the second message is: make your growers aware that they need to prepare for quality documentation. Just saying we have good quality is not enough. You have to have it at a reproducible transparent form.
FT: What are the names of the two companies hanging on to the fight?
Dr Schmidt: The names of the two companies are: Harras Pharma in Munich and the other one is called MIT Company in Northam Australia. These are the two companies still in the race.
