Irish MEP Harkin pits ANH against European Commission and EFSA
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By the ANH Team
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On 23rd June 2010, Dr Verkerk went to meet and debate with leading figures from the EC and EFSA responsible for the European regulations. Also in attendance were MEP’s, their assistants and some stakeholders. The title of the debate was “Towards a scientifically and legally rational regulatory approach to natural health products in Europe”
Basil Mathioudakis, head of the food law unit for the EC went first. His talk focused largely on the ‘what’ of the situation and none of the ‘how’ or ‘why’
Next came Professor George Kass, senior scientific officer with EFSA and a member of the Unit on Food Additive and Nutrient Sources Added to Food (ANS Panel). He focused only on the ‘how’
Dr Verkerk's talk looked at how the regulations are going to impact the natural health sector, and took a big picture view of the EU legislation. He focused on 3 main areas; the proposal to harmonise maximum levels of vitamins and minerals, the not-fit-for-purpose licensing system for traditional medicinal herbs, and the wayward health claims process
After all three talks had been delivered there was a Q&A session. This turned out to be less exciting than expected as Mr Mathioudakis and Prof Kass seemed to be ‘avoiding the exploding bomb’
At the end of the discussion came one pearl of a comment from Mr Mathiuodakis. He said, “The laws are as they are now but in 15 or 20 years time, the next generation may have a different legal framework.”
On Wednesday 23rd June, Dr Robert Verkerk, ANH-Intl’s executive and scientific director, entered the lion’s den. In the den, he faced leading figures in both the European Commission and the European Food Safety Authority (EFSA) that are responsible for the rash of European regulation that is putting at risk the ability of 500 million Europeans to manage their health through natural means.
The occasion of this unusual coincidence of views was a lunchtime seminar convened by Irish (North West constituency) independent Member of the European Parliament (MEP), Marian Harkin. The debate’s title, “Towards a scientifically and legally rational regulatory approach to natural health products in Europe” ensured that polarised viewpoints would be aired. The audience in Brussels was a mix of other MEPs, their assistants and a sprinkling of stakeholders who were there because of their concerns over their futures as consumers, retailers or distributors of natural health products.
The European Commission’s case
After opening the seminar, Ms Harkin handed over to Mr Basil Mathioudakis, who heads up the food law unit at the European Commission. Mr Mathioudakis has been the key official responsible for the European Commission’s legislative proposals affecting natural health for over a decade. He’s been not only the key figure in the Commission that stakeholders and member states have been dealing with, he’s also been the primary European representative at committee meetings of the Codex Alimentarius. For many, he epitomises all that’s wrong with the EU’s approach to law-making in the area of healthy foods and supplements.
Mr Basil Mathioudakis, head of the food law unit at the European Commission [photo: European Parliament]
Not surprisingly, Mr Mathioudakis’ talk centred around the ‘what’ of the situation, with a specific focus on food supplements. There was no attempt to explain ‘how’ the legislation had come into being. An even greater omission was the failure to explain ‘why’ this complex framework of legislation affecting natural health was needed.
Download Mr Mathioudakis’ PowerPoint slides presented at the meeting.
Almost certainly, nothing new was learned by any person present and the key questions on the minds of so many, such as when the Commission’s proposals for maximum levels would be issued, or why the scientific substantiation requirements for health claims were set so impossibly high, were left untouched.
The European Food Safety Authority’s case
Then it was over to Professor George Kass, senior scientific officer with EFSA and a member of the Unit on Food Additive and Nutrient Sources Added to Food (ANS Panel). His academic affiliation has most recently been the University of Surrey in the UK. Given the topic of the debate, to say that Prof Kass’ presentation was toothless and unremarkable would be an understatement.
As you’ll see, Prof Kass focused only on the ‘how’. And to be frank, so many of us already know all that we want to know about the ‘how’. What we really want to know more about is the ‘why’. Why, for example, does EFSA consistently red light health claims for natural products yet green light as safe genetically modified foods? Why does EFSA require a level of proof, via human clinical studies, for a beneficial health relationship that’s on par with the proof of efficacy required from clinical studies used to get a drug licensed? (How many clinical trials on the consumption of broccoli and carrots have you seen?) Taking another example, why does EFSA not take into account the vast differences in hazard profile of different molecular forms of micronutrients when determining Upper Safe Levels for vitamins and minerals. This latter issue has been the subject of two recent ground-breaking scientific papers by ANH’s Robert Verkerk. While Prof Kass admitted to Dr Verkerk prior to the start of the meeting that he’d read the papers, amazingly, he made no attempt to consider any of the issues raised. Another ‘why’, perhaps? And most certainly another black mark against EFSA’s widely touted transparency policy.
But perhaps we shouldn’t blame Prof Kass for being so toothless. Maybe he was under instructions from his masters? Was he given strict orders to be as generic as possible? That would explain his generic presentation that made no attempt to justify any of EFSA’s highly controversial and widely contested decisions. Consistent with EFSA’s attempt to limit any ‘ad lib’ elements to its offering, we did hear that senior management at EFSA had great difficulty agreeing who they could release from their Parma quarters, and it was only on the afternoon before the day of the debate that Prof Kass got his release note to come to Brussels. Quite convenient, we suppose, as he also had little time to deliver something more relevant to the subject of the debate.
The Alliance for Natural Health’s case
It was Dr Verkerk’s turn next. Okay, he had a small, theoretical advantage in that the other two had gone before him. But Mathioudakis and Kass weren’t the lions he expected, having missed their opportunity to try and deliver any knock-out blows that would justify their seemingly wayward law-making. Perhaps, as we might expect, there are actually no knock-out arguments that can be levelled against true scientific and legal rationality, the language in which Dr Verkerk so often speaks?
It seemed therefore that ANH’s representative used the time available — plus a few more minutes — to tell an attentive audience how it really was to be at the receiving end of these laws and what the consequences of defective laws on natural health might be downstream.
Download Dr Verkerk’s PowerPoint slides from his presentation.
He focused on the totality of legislation impacting the natural health sector, and the way in which it was already impacting, but worse still — was set to impact — consumers as well as practitioners (the ‘heilpractiker’), health store owners, other retailers and distributors. He took a big picture view that has been so conspicuously absent from the drafting of EU legislation that suffers from the same reductionist approach as the science that guides it.
Dr Robert Verkerk and Ms Marian Harkin [photo: European Parliament]
Verkerk alluded to the way in which drug companies and biotech companies might be influencing governments. But, in the main, he kept his arguments focused to the defective and often contradictory nature of the science and law that comprised the near-complete EU regulatory framework for natural health. The ‘why?’ of what the European Commission and EFSA were up to seemed to scream silently through his presentation. With chronic diseases representing the biggest burden on healthcare systems the world over, why was a regulatory framework being put in place that ravaged the ability of consumers to look after themselves as well as possible through natural means?
In exposing the nonsensical nature of the legal framework that has been proposed by the Commission and supported by EFSA, Dr Verkerk homed in on three main areas: the proposal to harmonise EU-wide maximum levels of vitamins and minerals, the fact that the simplified medicinal licensing system for ‘traditional herbal medicinal products’ which comes fully into force in April 2011 was not fit for purpose and the wayward health claims process that was set to infringe the ability of individuals and companies to inform consumers about the health properties of food and supplement products.
He explained that the EU Nutrition and Health Claims Regulation, will soon ban, EU-wide, any health claim, using the principles embedded in Napoleonic law (‘guilty unless proven innocent’), unless the claim is specifically approved by EFSA. Of the 1000 or so generic health claims already evaluated by EFSA, most have been rejected outright. He said, while this might not be a total disaster for our generation which will continue to recollect information about the health benefits of foods that was learned before the implementation of the regulation, it could be very damaging to the health of future generations. In times gone by, and indeed up until now, it has been our ability to communicate freely with each other that allows us to discriminate between foods that are good or bad for us. Our ancestors used the same system to discriminate between the berries and fruits that would give them the energy and vitality to be physically fit and active, as opposed to those that might kill them.
Removing our ability to communicate about these things, despite ample bodies of credible evidence, amounts to the removal of an invaluable tool that has helped people for millennia to discriminate between healthy and less healthy foods. Millions have become accustomed to consuming particular foods, herbal products and other concentrated sources of nutrients (food supplements) that aim to support specific systems within our bodies. These foods are not drugs in the sense that they block or interfere with metabolic pathways. They, by and large, facilitate metabolic pathways that have become dysfunctional through poor diets and lifestyles, excessive stress or the result of exposure to environmental chemicals. In other cases, dysfunction has yet to set in, but particular body systems benefit from nutritional or botanical support. That’s after all what disease prevention should be all about and it’s so much cheaper for our society to prevent disease than it is to deal with diseases once they have become fully symptomatic.
From left to right: Mr Christophe Wolff (Policy Officer, EFSA); Prof George Kass (Senior Scientist, EFSA); Meleni Aldridge (Executive Coordinator, ANH-Intl); Dr Robert Verkerk (Executive & Scientific Director, ANH-Intl); Marian Harkin (Host and MEP, Ireland) and Mr Basil Mathioudakis (head of the food law unit, European Commission) [photo: European Parliament]
It’s worth remembering that health claims are more than advertising slogans designed to sell products on supermarket or health store shelves. They are one of the most important means by which a consumer’s attention is drawn to a given health-giving property of a given product. Extraordinarily, the Nutrition and Health Claims Regulation covers any type of communication, whether verbal, written, graphical or in any other medium, when the claim is linked to any commercial product. As already mentioned, in a commercial sea deprived of information pointing us to the health benefits of products, consumers are surely going to be less likely to be able to discriminate against junk foods and select healthy ones in their place. That wouldn’t be good for our society given the already massive and ever increasing burden placed on healthcare services by chronic diseases. As the World Health Organization makes clear in its 2004 Global Strategy on Diet Physical Activity and Health, the ‘Big 5’ chronic diseases, namely cancer, heart disease, obesity, diabetes and osteoporosis, represent the single greatest burden on healthcare systems worldwide, and these diseases are largely preventable through modified diets and lifestyles.
Speaking of the many hundreds of rejected health claims, Dr Verkerk gave the example of probiotics which have been disallowed any type of beneficial health claim despite ample evidence of their benefit for supporting gastrointestinal health. He also gave the example of glucosamine, that is the number one choice for those wanting to reduce the risk of, or problems caused by, osteoarthritis. But then we know that Sweden and Denmark have already made glucosamine a medicine, so it seems more that coincidental that the large body of scientific evidence showing benefits failed to meet with the criteria set by EFSA and the European Commission for a food supplement health claim. The real problem here is not the lack of evidence, but more that the vast majority of evidence relates to glucosamine’s role in preventing or reducing a disease, namely osteoarthritis. You see, unless company is able to show studies proving the benefits of glucosamine on healthy people, the company, or any other company selling the same ingredient, doesn’t get to be able to make a generic health claim (under Article 13.1 of the regulation)! So, interestingly enough, it is no great surprise that companies have yet to fork out thousands upon thousands to conduct clinical trials on healthy people with no symptoms of, for example, knee osteoarthritis. The concepts, as you can hopefully see, with which EFSA and the Commission are working are preposterous and they need to be changed. The idea seems to be to reserve claims for the realm of pharmaceutical drugs. With consumers being deprived information about the health benefits of foods and supplements, won’t they be encouraged to take pharmaceutical drugs instead? It’s plausible that this is the real ‘why’ behind the whole EU regulatory framework, is it not? And don’t imagine this is only happening in Europe.
Mrs Jill Bell (Irish Association of Health Stores) with other representatives from small businesses [photo: European Parliament]
Dr Verkerk complained adamantly that small businesses had not been adequately represented at the table when legislative proposals were being developed and drafted. During the questions, Mr Mathioudakis predictably disagreed. In fact he said, probably not realising it was a compliment, that the ANH had used up more of the Commission’s time in this area than any of the large businesses and associations it deals with. He may or may not be right. We doubt it to be frank, but we know also that it would be very hard to prove one way or another. But of course, it’s not just about time. It’s about who is actually being listened to, and how the legislation harms or benefits particular sectors. It seems, if Mr Mathioudakis is right, that the backroom deals, in which unelected European Commission officials engage with big business, are done swiftly and efficiently.
The Q & A session
In any debate, the question and answer session that follows the laying out of the different positions is the bit everyone’s waiting for. This particular Q & A session delivered the odd pearl, but it was hardly the hotbed of opposing ideas that one expected. That was largely because Mr Mathioudakis and Prof Kass, quite deliberately we can only presume, chose to avoid engaging with any of the key criticisms raised by Dr Verkerk. In the world of campaigning, we sometimes refer to this strategy, metaphorically, as avoiding the exploding bomb, or, more precisely, trying to do everything possible to stop the bomb exploding.
In fact the only significant point that Mr Mathioudakis chose to contest was a throw away line that Dr Verkerk made about his concern that key implementing measures, such as the setting of maximum permitted levels for vitamins and minerals, may slip though in the “dead of night” or during “vacation periods” with inadequate scrutiny by the European Parliament. Despite the fact that Dr Verkerk responded by saying that this was one concern that he hadn’t established himself, but rather it was one that had been frequently voiced to him by MEPs and MEP assistants in the 8 years he’d been working on these issues in Europe, Mr Mathioudakis didn’t relent. Mr Mathioudakis may not have understood that Dr Verkerk’s use of the term “dead of night” was not literal. It was a metaphor for times when the full Parliament was not present, such as in recess or in holiday periods. It was also a metaphor when the Parliament was snowed with other issues that were taking a huge amount of their attention. Mr Mathioudakis in fact assured everyone that there was a period of 3 months for MEPs to look at, amend or even revoke, the proposed legislative amendments. Dr Verkerk commented later that he’d most recently heard the view he’d voiced just two months earlier from senior figures in the Parliament’s ENVI committee. He went on to say it was worth being boxed on the nose on that one because the Commission would have serious ‘egg on face’ if it tried to pass the legislation more surreptitiously when the European Parliament was off guard, for whatever reason.
Ms Marian Harkin (MEP, Ireland) greets Ms Sirpa Pietikainen (MEP, Finland) [photo: European Parliament]
During questions, Mr Mathioudakis conceded that the European Commission was still in favour of not issuing maximum levels for vitamins and minerals for which there was no evidence of any safety concerns, even at very high doses. However, he also gave a word of caution, saying “The member states might not be so happy with this approach.” He was clearly speaking particularly about vitamins B1, B2, B12, pantothenic acid (B5) and biotin. One wonders why member states — and we imagine tangential reference was being made to the ‘low dose terrorists’ of Germany and Denmark — should be unhappy if the science shows these and, actually numerous other vitamins and minerals, are perfectly safe even at very high doses. Unless of course there is an unspoken ulterior motive…..
The most revealing aspect of the inflexibility of the approach taken by European regulators came when Mr Mathioudakis responded to a question by the host of the lunchtime seminar, Marian Harkin. Ms Harkin asked if there might be any leeway in the approach to the substantiation requirements for health claims. She raised the recent victory against the FDA with which ANH-USA acted as one of the plaintiffs, which ruled that credible, rather than conclusive, evidence was sufficient to justify a health claim, in this particular case relating to selenium and the reduction of cancer risk. Answering Ms Harkin, Mr Mathioudakis simply said, “There will be no leeway on the level of substantiation for claims in the Regulation”. He justified his position by saying that he was constrained by the text of the legislation that had already been agreed by the Commission, member states and Parliament. Apart from the Commission and EFSA, we think it would be true to say, most officials in member states, as well as MEPs would not have known about the detail of the proposal. That’s because the detail wasn’t available to them. As Ms Harkin herself added; “The devil, with these things, is so often in the detail.”
A concluding note: a pearl
While it was clear that the audience present, without any obvious exceptions, was in sympathy with Dr Verkerk’s concerns, one of the few pearls to emerge from either of the two regulators present, came just moments before the close of the seminar.
Before we offer you, the reader, the pearl, let’s explain the context. The pearl emerged shortly after Dr Verkerk had explained that the European law definition of a medicinal product didn’t make any sense given its extreme breadth of scope which effectively classifies all foods as drugs. It is only the seventh sentence of the seventh recital of the 2004 amendment (amending Directive 2004/27/EC) to the main European law on pharmaceutical drugs (Directive 2001/83/EC) that allows most foods and food supplements to escape the clutches of European drug laws. And then only on the basis that such products are “clearly” foods or food supplements. This tortuous regulatory system means that any product used therapeutically, however closely it might resemble food, can be classified as a drug. It gives the regulator a loaded gun — that can be used arbitrarily. There are already many thousands of natural products that are both safe and beneficial that can’t be sold in Europe for fear of them being classified as drugs. Others are regularly impounded by the authorities for being unlicensed medicines. But they are really just foods, valuable, healthy and beneficial foods. Their only sin is that they compete, head to head, with pharmaceutical drugs.
The overarching power of the European definition of a drug, which actually has supremacy over any other European law (see ‘rule of doubt’, Article 2.2, Directive 2004/27/EC) flies in the face of an increasing amount of nutritional and botanical science which shows that natural products can correct, modify and restore physiological functions in the body, while exerting a metabolic or immunological action (these are among the key tenets of the European definition of a medicine). The fact is, foods, food constituents and products derived from plants, can indeed heal. This is an incontestable fact. Such products most certainly can also have drug-like properties (i.e. they can treat or prevent diseases), but, used properly, they have no, or extremely limited, side effects.
Nutrigenomics and epigenetics would suggest that biocompatible approaches to healthcare that involve nutrition, botanical products and lifestyle changes, are the future of healthcare. Eminent scientist Prof Bruce Ames makes this abundantly clear. Yet these very modalities are now massively threatened by a regulatory regime that is supposed to protect us — from ourselves. All this when food supplements and herbs used traditionally for medicinal purposes are the safest things we put into our mouths. Yes, as shown by Ron Law using New Zealand government statistics, natural health products are probably, on average, around 1000 times safer than conventional foods, and around 100,000 times safer than drugs. What’s going on, you may ask? You may also ask, is there any desire from regulatory authorities to see any change in a regulatory system that is, ultimately, inconsistent with the laws of natural science?
Then came the pearl, almost out of the blue. Mr Mathioudakis said, “The laws are as they are now but in 15 or 20 years time, the next generation may have a different legal framework.”
If you hadn’t already understood one of the main underlying objectives of ANH’s work in Europe, hopefully you will now. Coming back to the proposition posed by the lunchtime debate in the European Parliament, an entirely new scientific and legal framework is required if humans want to deal more effectively with the chronic, and even infectious, disease burden. This is something we at ANH are working on around the clock, in different parts of the world, not just in Europe. This burden can only be managed and reduced if regulatory authorities are encouraged — or forced — to change track. While the European regulatory model has massive global influence, and is already framing what is happening internationally at Codex and what is happening in the USA and Canada, European citizens hold some very important cards here.
Our message to European citizens, is that it is essential that if you have issues over the current and proposed regulatory system affecting natural health, you have got to speak up. While some remnants of the democratic system remain, keeping silent on these issues makes you complicit with the regulatory madness that is in the process of being implemented in Europe.
Call to action
Calling all European citizens: have you corresponded with or spoken to your MEP recently about these issues? Find out what you can do on our Get Involved page.
By contrast with a recent meeting on health claims convened by EFSA in its home base in Parma, northern Italy, where some of the food was less than wholesome and healthy, Ms Harkin’s menu selection was admirable. The food was highly nutritious — and delicious! In our experience, an MEP who ‘walks the talk’ is worth both talking to and listening to.
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