U.K. Herbals: Current & Future Regulatory Status

Whatever one’s opinion on evolving European political matters, the certainty is further implementation of European Union (E.U.) legislation will bring about change. We are now seeing the implementation of many pieces of centralized E.U. legislation, and the United Kingdom (U.K.) natural products industry is beginning to grapple with its new, exacting requirements. But is this for the better?

In the case of herbs, the U.K. position was clearly unsatisfactory in that the existing system did not usually allow adequate communication of product benefits nor did it impose minimum uniform standards of quality for manufacturers, consumers and authorities alike. Change was therefore inevitable and, following years of debate, the Traditional Herbal Medicinal Products Directive (THMPD) has now been created to attempt to redress this situation.

But the new law regarding herbals is complex and, while it has the intention to eventually harmonize the legal position across the E.U., the current position is one where national interpretation of the legislation is the norm.

Status of THMPD

The THMPD was adopted by the E.U. in Spring 2004 and was implemented in the U.K. on Oct. 30, 2005. The immediate implications are minor. No further “medicinal herb” products can be launched without Traditional Herbal Medicinal Products (THMP) registration or marketing authorization (licence), but existing products (sold legally) can remain on the market until the transitional period ends in 2011. The THMPD allows herbal products to be registered as THMP under medicines law. To gain this registration, these products must demonstrate high (pharmaceutical) standards of manufacture and product quality and mild claims can be made for the products.

Herbal products that have been used traditionally in the E.U. for 30 years may be registered with a dossier showing quality data on the product and its ingredients, evidence of its traditional use and a bibliographic review of safety. Approval of such a dossier satisfies the medicinal requirements of safety and quality, with efficacy demonstrated by long term use. In this “simplified” registration it is also possible that the evidence of tradition and safety review is not required if the product is already on a central E.U. list or has a central monograph.

This differs from the previous U.K. system, which included four categories of herbal products on sale in the U.K.: those classed as botanicals or herbal food supplements; those under Section 12.2 of the Medicines Act relating to a specific exemption that allows for the sale of certain medicinal herbs provided that no product claims are made; Section 12.1 herbals, another exemption which allows practitioners to supply certain herbal materials to their clients on a one-to-one basis; and, finally, licensed herbal products converted from ‘licences of right’ granted to products on the market in 1968 and for which limited claims are allowed.

When the THMPD is fully implemented in 2011, there will still be four categories but two major changes will occur. The Section 12.2 exemption will lapse, as it is assumed that most current 12.2 products will have by then obtained THMP status. One benefit of the THMPD is herb/nutrient combinations (which do not technically fit under 12.2 legislation) will be allowed if the nutrient is plausible and at a safe level. A further change is that the Section 12.1 system is undergoing review by the U.K. authorities with a view to establish statutory registration of practitioners.

But other options also exist for manufacturers to market herbs separately from the THMPD, with either a further marketing authorization category called “well-established use” or under the category of botanicals (herbal food supplements).Well-established products are relevant to herbal products deemed capable of meeting THMPD’s more stringent criteria—the rewards are potentially stronger claims and possibly higher dosages; however, no herbal product has yet achieved this status in the U.K. The botanicals category is under separate review as an extension of the Food Supplements Directive but the use of herbs in food supplements is likely to be distinctly limited.

In this way, the law establishes a means for companies to decide to which category to apply the marketing of their products. The decision depends, to some extent, on the level of data available or the level of claim which they wish to make.

Problems with THMPD

There are significant differences between the U.K. herbals market and herbals markets in several other E.U. Member States. Many suppliers in the U.K. are SMEs (Small and Medium-sized Enterprises) compared to some other markets, which are dominated by big players. The U.K. also has a long-established network of herbal practitioners who tend to favor the use of multi-herb combination products; other Member States have single herb products that tend to be prescribed by medical doctors. U.K. consumers tend to use predominately multi-component products compared to single herbal products that have much stronger use elsewhere in the E.U. And the U.K. has vibrant ethnic herbal medicine disciplines, particularly the Ayurvedic and Traditional Chinese Medicine (TCM) systems, both of which are heavily reliant on multi-component products. Indeed, it is the multi-component nature of so many U.K. products that is the root cause of many U.K. problems with the E.U. legislation.

The THMPD involves very major new costs for many suppliers that result from bringing herbal products under pharmaceuticalbased medicines legislation. Requirements include expensive analytical testing, product registrations, GMPs (good manufacturing practices), various licences, pharmacovigilance measures and staff training. Even the U.K. authority, the Medicines & Healthcare Product Regulatory Agency (MHRA), estimates the average cost of preparing a single registration application for a simple single-herb product could be approximately £40,000 before taking into account the cost of any GMP upgrades or additional personnel. This cost would, of course, increase significantly for multi-component products. The MHRA has also concluded, “There may well be some rationalisation within the UK market as regards both businesses and products.”

Industry believes the MHRA cost estimates will probably prove conservative largely because the analytical regime required to demonstrate quality and stability is inappropriately and disproportionately onerous for multi-component products. U.K. industry is surprisingly united in arguing that more practical (and lower-cost) analytical test regimes are more appropriate without in any way imperilling product safety.

As things currently stand, the optimistic outlook of a fastgrowing herbals sector supplying high quality, safe and efficacious products is looking rather less likely than one in which company closures are accompanied by a sharp decrease in consumer choice; product development is stifled by high cost barriers and the supposed gains in consumer safety are undermined by a consumer exodus from U.K. retailers to buying from overseas suppliers selling products unregulated according to E.U. law over the Internet.

Because of this, 14 different bodies, including the Health Food Manufacturers Association (HFMA), have joined together over the last five years into the Herbal Forum to further negotiate with the MHRA on THMPD implementation. The result has been a commitment from the MHRA to maximize the simplicity and flexibility of their approach to implementation within the terms of the legislation. However, they themselves are restricted by pan- E.U. Guidelines being ratified by the Herbals Medicinal Products Committee (HMPC) of the E.U. Medicines Agency (EMEA). Therefore, there is still much lobbying at all levels to achieve a practical and satisfactory outcome.

So, although the valid intention is to achieve the goal of E.U. harmonisation of herbal law, many E.U. countries have yet to even address the issues of implementation of the THMPD into their national systems. Even when this is achieved, it is likely that some elements of national interpretation may prevail for many years thereafter.

Martin Last is a leading marketing consultant with over 25 years experience, specializing in the health products and food supplements industry and representing manufacturers and ingredient suppliers around the world. He is also the vice chairman of the U.K. Health Food Manufacturers Association (HFMA).