The UK arm of German herbal medicine manufacturer, Schwabe, along with the British Herbal Medicine Association (BHMA), are the principle actors of the SHMC, which, frustrated by the lack of policing of food supplements it believes should obtain EU herbal medicine registrations or be stripped from the market, has campaigned in Westminster and Whitehall for enforcement action.
Academics who have written similar letters airing similar concerns have been accused by the Alliance for Natural Health (ANH) of being in league with pharma players like Schwabe, something the only named academic to date, the University of Reading’s Elizabeth Williamson has categorically denied.
Dick Middleton, PhD, Schwabe technical director and head of the campaign that will “go public” in London in January, told this publication the campaign acted independently and had not actively encouraged any academics to write to politicians or anyone else, despite similarities in letters written by him, the SHMC and professor Williamson.
“We have not deliberately gone out to enlist academics, there has been no inducement from us,” Dr Middleton said. “But I have spoken at meetings and people are aware of my views and many have contacted me.”
Professor Williamson has been researching herbal medicines for 30 years and rejected the idea the EU regulation in question – the Traditional Herbal Medicinal Products Directive (THMPD) – favoured larger herbal medicine makers like Schwabe.
“I know all the main UK herbal companies, and I knew MedicHerb, before Schwabe bought the company, and even then it was registering its products,” she told NutraIngredients this morning.
“I am not on the payroll of any of them and anyone can check that using the Freedom of Information Act. I would only make the point that all these documents are in the public domain and have been widely circulated.”
“I thought it was a BHMA campaign…”
Professor Williamson said the existence of the campaign was widely known among herbal academics.
“I thought it was a BHMA campaign to be honest, and most of the BHMA are also involved with the industry in some way.”
The backdrop to the debate is the reluctance of the UK regulator the Medicines and Healthcare products Regulatory Agency (MHRA) to do what the SHMC would like it do – it argues on grounds of safety and quality – and remove products like black cohosh and St John’s wort from the market if they don’t hold THMPD registrations.
Nervous
That reluctance is being blamed on the European Court of Justice (ECJ) which has delivered verdicts about garlic and other herbs that have, the SHMC argues, made it difficult for the MHRA to enforce the THMPD because the court has refused to draw a clear line between the two categories.
“The ECJ decisions are making the MHRA nervous about its ability to determine whether products are medicines or not," said Middleton. "What was the purpose of the MHRA and the British government investing so much money into the THMPD registration system if they are not going to enforce it?”
The MHRA said it was investigating at least nine cases but gave no timeline for when those investigations might conclude.
Deal breaker
Middleton’s sentiment was backed by BHMA chief, Simon Mills, who said the MHRA inaction was a slap in the face for those that had invested the money into THMPD registrations, of which Schwabe has 18.
“There were investments made under an understanding of how the regulation would be policed,” Mills said. “But now it seems there is a duel business plan, the deal has been broken, because all the encouragement from the MHRA was that there would be no other way to market. Companies wouldn’t have invested that money if they had of known it would be policed like this. But the ECJ decisions have muddled everything.”
Groups like the ANH say the Directive is too costly and discriminates against herbal traditions like Chinese and Ayurvedic medicines. Robert Verkerk, PhD, its chief and scientific officer, said of the expectation the MHRA would undertake more enforcement action: “It’s even possible that there had been some kind of gentleman’s agreement that this was going to happen.”
The group said in a statement on Friday where it suggested professor Williamson and other academics were doing the SHMC's bidding that, “The Directive does not give the MHRA power to interfere in products regulated by food law, such as botanical food supplements. There is also little evidence for the fact that herbal products pose a significant risk to public health.”
It added: “Standing to gain the most from a regulatory clampdown on botanicals, we propose, are the largely German phytopharmaceutical companies who have spent huge wads of cash on registering their products under the herbal Directive.”