Turbulent Times for Natural Healthcare in Europe: Will the USA Follow?
19th October 2011 | By Dr. Robert Verkerk
The history of natural healthcare in the modern Western world is a troubled one, marked by constant struggles with orthodox medicine for its identity and survival. Ever since the pharmaceutical-led, allopathic model was granted a virtual monopoly in the US and Europe, natural healthcare has been a fringe concern in mainstream medicine.
In recent years, however, something important has changed. Increasing numbers of people have taken a look around and decided they do not like where orthodox medicine is headed. Natural medicine, in all its forms, has been the winner: in 2007, around 38% of US citizens were using some form of natural healthcare, according to the National Center for Complementary and Alternative Medicine (NCCAM). All things being equal, this percentage only looks set to rise in the coming years.
Apart from modern medicine's reliance on technology and its perceived lack of humanity, and a severe case of time starvation on the part of physicians, perhaps the most visible reason for widespread disillusionment with orthodox medicine is its over-reliance on new-to-nature, synthetic pharmaceutical drugs. With prescription medicines causing nearly 64,000 US deaths in 2009, it is hardly surprising that people are looking elsewhere – especially since no deaths at all were caused in the same year by vitamins, herbal medicine, dietary mineral supplements or homeopathic medicines!
Natural healthcare reaches a crossroads
With such an upsurge in interest in natural healthcare, the regulators were boundto take an interest, and so it has proved. Faced with widespread demand for healthcare modalities that are mostly poorly understood by the current model of 'evidence-based medicine', those charged with regulating those modalities effectively have two choices. They can either bow to public demand by nurturing the fledgling sectors, using a light touch to protect the public from charlatans and to shield the industry from unfriendly competition. Or they can take the side of that unfriendly competition, and steamroller natural healthcare out of existence in the face of the public's wishes.
In the European Union (EU), the regulators have chosen the second option – and the US could be next.
The THMPD: Taking aim at herbal medicines
On 1st May 2011, an EU law known as the Traditional Herbal Medicinal Products Directive (THMPD) came into full force across the EU's 27 Member States. The THMPD creates a licensing scheme for herbal medicinal products, under which manufacturers will only be able to sell their products if they have a Traditional Herbal Registration (THR).
Therapeutic herbal products that cannot gain a THR and which cannot be repackaged or reformulated as botanical food supplements become unlicensed medicines, and are effectively banned. As such, it is a form of Napoleonic law, which is common throughout Europe: it means guilty until proven innocent, or in the case of products, illegal unless specifically allowed.
Of course, this would not be a problem if gaining a license were a reasonable and straightforward process, leading to plenty of THRs! However, products must satisfy certain criteria in order to gain access to the THMPD scheme, and many manufacturers have already found that the barriers are too difficult and numerous for them to qualify.
For example, herbal products used by non-European traditional systems of medicine, such as Ayurveda or Traditional Chinese Medicine, are effectively barred from the scheme because they are too new to the EU market, because they contain non-herbal ingredients, or because they are too complex to negotiate the pharmaceutical standards set. Even if compliance is achieved for simpler products, the cost of undertaking the necessary tests and developing the dossier is typically in the region of US$130,000 to US$250,000 per product. Many smaller players simply cannot afford this kind of money, and their business often depends on selling a large number of different products.
The THMPD regime provides a particular obstacle course for polyherbal products, which again hits Ayurveda and Traditional Chinese Medicine hard because of their long history of using complex, multi-herb formulae. Ayurvedic orTraditional Chinese Medicine formulae containing more than 10 herbs are common, but the THMPD scheme locks them out entirely, starkly demonstrating the effectiveness of the anti-Asian roadblock set up by the THMPD.
The fruits of the THMPD
It's easy to pick holes, but what are the results of such a narrow, exclusive regime? Looking at the UK – which is the EU Member State with the most THRs – we see that around 110 products have been granted a license, with around the same number still being considered. As mentioned above, not a single one of these registered products is for a product associated with a non-European medical tradition!
In fact, no THRs have been granted for such products anywhere in the EU. Ayurveda and Traditional Chinese Medicine are two of the oldest, most established and most revered medical systems on the planet, used by millions of people worldwide and with a rapidly expanding user base in Europe – and they are threatened with virtual extinction under the THMPD.
But the final proof of the THMPD's flaws lies in the composition of the licensed products themselves. Hardly any of them contain any whole plant material. Many registered products have been manufactured using a process that extracts certain chemicals from the herbs, using either alcohol or acetone – AKA nail-polish remover! A range of chemicals is added to many of these extracts, including benzoate preservatives, sweeteners like sodium cyclamate (banned in the US) and aspartame, detergents like sodium lauryl sulphate, and polymers like polyvinyl alcohol, which may even be carcinogenic.
And the winner is...
The losers under the THMPD are many: consumers who maintain their health with manufactured herbal medicines; practitioners who prescribe ready-made remedies; manufacturers of products that cannot be licensed; and retailers who used to sell those products. But whenever there is a loser, there must be a winner – so who gains from the situation?
One group who is very pleased with the THMPD is the socalled phytopharmaceutical industry. Originating in Germany, phytopharmaceuticals are exactly those products that are being registered under the THMPD: extracts of mostly single herbs, stabilised in a pharmaceutical base. Phytopharmaceutical methods only recently entered the field of herbal medicine, having developed only in the 20th century.
Compare this to Ayurveda and Traditional Chinese Medicine both of which have histories stretching back over 4,000 years! So it seems that, in 2011, the phytopharmaceutical industry may be celebrating its relatively few birthdays all at once: muchof its competition is suddenly excluded from the EU market, by a regulatory regime that appears uniquely suitable for its products!
The other big winners will be the pharmaceutical companies and orthodox medicine itself. Not only will pharmaceutical companies benefit from reduced competition from pesky herbal manufacturers, but they can easily find the resources to develop new herbal products and get them registered under the THMPD. Compared with the costs of pharmaceutical research and development and marketing authorization, the THMPD's costs are mere sofa change. In effect, a whole new market has been opened up to them, and their existing markets will inevitably expand once the people who can no longer obtain their trusted herbal products wind up in the care of orthodox physicians.
When all else fails: take 'em to court!
We at the Alliance for Natural Health International (ANHIntl) – a small but passionately committed non-governmental organisation, based in the UK but active internationally – believe that the THMPD is fundamentally flawed. It does not do what it set out to do, that is, create a streamlined registration scheme for herbal products associated with all forms of traditional medicine. Although European Parliamentarians voted for an inclusive system nothing like today’s THMPD, the unelected European Commission bureaucrats have refused all opportunities to try to fix it.
This is why we feel we have no choice other than to mount a legal challenge to the THMPD, and we are currently finalizing our case ready for filing at the Royal Courts of Justice in London. From there, we hope to get to the European Court of Justice. Rather than overturning the Directive, we see the legal challenge as a catalyst that will repair the deficiencies of the THMPD, since only a handful of European Directives have ever been completely withdrawn. Although this sounds like an uphill task, we have an amazing legal team who think we have every chance of success. Wish us luck!
Handing high-dose vitamins to Big Pharma
Unfortunately, the THMPD's attack on herbal medicine is far from the only threat to natural healthcare in the EU. The Food Supplements Directive (FSD) has been law since 2002, and it is every bit as problematic for dietary supplements as the THMPD is for herbal products.
First of all, the FSD brought in a 'positive list' of vitamins and minerals that were approved for use in food supplements: another example of the creeping imposition of Napoleonic law across Europe. After a legal challenge from ANH-Intl, the FSD's rules were relaxed to allow vitamins and mineralsnormally found in the diet to be sold as food supplements without being on the positive list. This important ruling has become known as the 'natural source exception', and has proven vitally important: without it, natural mixed carotenoids and the natural forms of vitamin E, selenium and folic acid would have been lost.
Secondly, the FSD promises to bring in maximum permitted levels (MPLs) of vitamins and minerals in food supplements. Two peer-reviewed papers that I published in the international journal Toxicology showed that the risk assessment methods being used by the EU to develop these MPLs are flawed.
The EU's models look at risk without taking potential benefits into account, so the MPLs may well prove so low that vitamin and mineral supplements with beneficial effects will be impossible – opening the way for pharmaceutical companies to introduce their own, high-dose, presciption-only versions.Europeans will be waving goodbye to their beloved high-dose vitamins, and of course to a thriving industry. That’s unless we kick up a storm, and use legal and scientific means to force the regulators to take a more rational approach.
Health claims: destroying freedom of speech
To choose between the many tens of thousands of natural healthcare products on the European market, an individualmust rely to some extent on the claims made by the manufacturer. Imagine if a natural-health 'newbie' went into a healthfood store to see rows and rows of bottles, jars, tubes and flasks with no information on them beyond the name of the product: for example, Devil's Claw, Vitamin K2 or Calendula Cream. They would probably turn around and walk out of the shop! Imagine further that, even if those products did have some limited extra information on them, such as "Vitamin K helps to improve bone health", it would be illegal for the shop assistant to tell you anything about those products' health benefits that wasn't on the label.
That is exactly what is happening in Europe, except that the true situation is actually worse. The Nutrition and Health Claims Regulation (NHCR) further cements Napoleonic law by banning any product-related health claims that are not approved by the European Food Safety Authority (EFSA) on the basis of human studies.
That's 'banned' as in it cannot be spoken, written down, or recorded for audiovisual use – banned really does mean banned in this case! EFSA has set the bar so high for approval of health claims that it has rejected 80% of applications so far, and 90% in the case of botanicals. Even the term 'superfood' will disappear, and the term 'antioxidant' will be disallowed unless the associated product has a pre-approved health claim. How are people meant to get useful information about the potential benefits of healthcare products under such a regime?
Not only will permitted claims be bland, limited and uninformative, but the claims regime also extends beyond supplements into the realm of foods. If the public cannot be told that berries have antioxidant effects, for example, how are they meant to make sensible decisions about healthy eating?
In an environment where claims on products and foods are so tightly regulated that very little can be said about the health benefits of certain foods over others, we can imagine a time where the public will not know why it should choose an antioxidant- and nutrient-rich salad over a Big Mac! The consequences of the NHCR are truly mind-boggling.
Joining the dots
So, the EU natural healthcare sector is in the midst of massive upheaval, but are there any signs that US authorities are preparing to go down the same misguided road?
Disappointingly, the answer is "yes". In terms of dietary (food) supplements, the most obvious parallel came with Senator John McCain's Dietary Supplement Safety Act of 2010 (S 3002), which attempted to 'Europeanize' the US food supplement regime. It would have brought in an approved list like the EU positive list and required registration of manufacturers, along with making the approval of new ingredients far more difficult.
McCain eventually withdrew support for his own bill under pressure particularly from a powerful campaign led by our US arm, Alliance for Natural Health USA (ANHUSA). The Wall Street Reform and Consumer Protection Act of 2009 (HR 4173) would have greatly increased the powers of the Federal Trade Commission, powers that would have been used to target food supplements.
Fortunately, this bill was defeated in the Senate. The FDA Food Safety Modernization Act (S 510) was passed as a House bill, HR 2751, after some very dodgy dealings in Washington. During its history, this bill had attempted to introduce the European food supplements regime by harmonizing with certain sections of the international Codex Alimentarius guidelines. Again, ANH-USA managed to get this particular wording removed from the bill.
All this when food supplements are already perfectly well regulated by the Dietary Supplement Health and Education Act of 1994!
Perhaps we should not be so surprised at these attempts to globally harmonize legislation on natural products. Globalization has been given the thumbs up by the most powerful nations and corporations on the planet, and increasingly the world is being divided up into trading blocs. The EU is one of the biggest, but there are plenty more, such as the Asia-Pacific Economic Cooperation (APEC), the Cairns Group, G20 and, of course, the North American Free Trade Agreement (NAFTA). There was an all-important agreement signed between the US Food & Drug Administration (FDA) and EFSA back in 2007 that is beginning to show fruit, especially on approaches to health claims and new dietary ingredients.
What many perhaps don't realize is that we, the citizens, hold the cards. By choosing what we buy, where we buy it, and how we vote, we can exert considerable control over our destiny – including how we manage our own health and what we put into our mouths.
To this end, we hope that the Alliance for Natural Health, through its European and US regional offices, can help you make the right decisions. Decisions that we hope can help secure your future, as well as that of future generations.
