If not novel, does it come with a
health claim?
If a preparation is not considered “novel” according to the simple
yes/no-decision related to the deadline (which by itself is not logical: a
product which came to the market on May 14th 1997 is
perfectly acceptable, a product started on May 16th is not), or
novel food status is granted, the most important question is the way how the
product is to be marketed. As soon as there is a Health Claim or a Risk
Reduction Claim, the corresponding EU Directive (1924/2006/EC) is applicable.
Health
Claims cannot be freely chosen, they must be authorized by the European Food
Safety Authority (EFSA) through a rather complex application procedure. For a
health claim application data on safety, efficacy and quality must be presented
– data distinctly exceeding the requirements for traditional herbal medicinal
product registration. E.g., for the latter no clinical data is required,
whereas a Health Claim would only be acceptable based on sound clinical
double-blind trials – performed in healthy subjects, where it is highly
unlikely that a significant and clinically relevant effect may be observed.
Consequently, >90 percent of all health claim applications for “botanicals”
will most likely be turned down by the EFSA, which may well sweep the EU market
clean of almost all herbal supplements.
Herbal
food could still be marketed under these conditions, provided they do not carry
a health claim. Ayurvedic preparations would, however, almost always come with
a health claim of some sort. In practically no case could the conditions for
the acceptance of Ayurvedic health claims be met: either the association
between claimed effect and scientific data would be too weak, or (in cases of
well-researched herbs) the claim would be considered medicinal and thus not
acceptable for a food item.
If it is not food, could it be a
drug?
Ayurvedic
preparations may in some cases be considered food in India, but the regulatory
bodies in the EU would mostly rather decide for the classification as a drug.
The EU has implemented the Traditional Herbal Medicinal Products Directive
(2001/83/EC as amended) with the intention of simplifying drug registration for
traditional herbal products.
Generally,
the political aim is to shift the unregulated food supplements into the market
of regulated drugs with defined quality. On first sight, registration appears
relatively straightforward, with no clinical data required and only a minimum
of toxicological data asked for. However, the problems with the THMP Directive
quickly become apparent when the details are inspected:
·
The time frame of at least 30 years of documented use, 15 of which
within the EU, is in many cases not easy to demonstrate, and is also subject to
interpretation by the different regulatory bodies. It is not clearly defined
what kind of material may be presented to demonstrate tradition, and how a
continuous use for 30 years should be demonstrated. Thus, the acceptability of
a given preparation may come down to the personal attitude of the public
servant towards the preparations to be registered.
·
The THMP Directive only allows the additional use of vitamins and
minerals when these additions may be regarded as having ancillary functions.
Typical Ayurvedic components such as ghee butter or bee products do not fall
under the scope of the Directive, and would have to be registered in other
categories. There is currently a debate within the EU commission how this
problem should be addressed.
·
Traditional Herbal Medicinal Product Registration requires the
submission of a full quality module, which is not debatable according to the EU
Commission. However, the current rules of compilation of the quality module of
drug registration (mainly the rules of stability testing with quantification of
every single active constituent of a combination) will necessarily make the
registration of multi-herb combinations an almost impossible task –
economically and scientifically -, even if the product would otherwise be
eligible as a THMP.
·
Certain minerals might be declared as excipients, but then quality
according to the standards defined by the European Pharmacopeia is expected.
E.g., cowry might well be considered as a novel excipient as it is not defined
in the European pharmacopoeia, and it does not necessarily meet the standards
for Calcium carbonate Ph. Eur. It can, however, not simply be exchanged against
Calcium carbonate Ph. Eur., as in this case there is no tradition for the use
of such material.
·
Registrations as THMPs can only be made for indications of
self-medication which do not require medical intervention. Correspondingly, the
claims are very “soft” and elusive, and in addition a disclaimer must be given
that even this weak indication has never been proven true.
·
The rules for acceptability of traditional preparations are
interpreted rather narrowly. It is not sufficient that a given plant
combination is used, but also the exact preparation must be similar. E.g., the
proof of tradition for an extract prepared with 50 % ethanol would not be
applicable to an extract manufactured with 60 % ethanol.
·
Even though the THMP Directive states that safety is considered
given through the 30 years of continuous use, additional toxicological data is
in fact required. Thus, the preparation must be shown not to have genotoxic
properties, and if the applicant cannot provide data that the product is safe
in pregnant or lactating women (which is practically impossible) there will be
disclaimers warning against the use in women of child-bearing age in general –
not merely for pregnant women, as the authorities point out that a woman in the
early phases of pregnancy may not even be aware of her condition. In the logic
of the EU consumer protection she must therefore be protected against the
potential dangers of plant products – tobacco excluded as this would not be
considered a medication.
If it is not a traditional herbal
medicinal product, could it be well-established?
The
most likely alternative to traditional herbal medicinal products is the
registration as a “well-established” herbal medicinal product. This procedure
requires, however, the demonstration of a substantial use in the claimed
indication for at least 10 years, and bibliographic data demonstrating efficacy
through clinical double-blind trials. There is no difference regarding the
quality standards, but toxicological data must be provided, although
bibliographic data may be acceptable.
In
reality few Ayurvedic products would be considered as potential candidates for
the registration as well-established herbal medicinal products, as they would
mostly not meet the criterion of being scientifically well-established – by
Western standards.
If it is not well-established,
could a full registration be made?
The regular procedure of full registration, even of bibliographic
registrations combined with product-specific data does not appear feasible for
the vast majority of herbal preparations. The major obstacle is the costs and
the lack of proprietary protection. This procedure is mostly used by companies
producing “special extracts”, which are by definition not comparable to other
preparations or application forms on the market.
Could it be a Medical Device?
Medical Devices are regulated by EU Directive 93/42/EEC. They are
usually products which do not act as a drug on pharmacological targets within
the organism, but rather on body surfaces. E.g., laxatives which are not
absorbed but act solely by binding water within the gastrointestinal tract can
be considered a Medical Device (e.g. Ispaghula husk, Plantagopsyllium, could
be a Medical Device, but senna leaves could not). The classification
as a Medical Device would therefore in most cases not be an option of
Ayurvedic preparations.
Conclusion and Actions to be Taken
The
current realities are:
·
Marketing of Ayurvedic products as food supplements will possibly
come to an end with the full implementation of the Health Claim Directive and
the THMPD. With the current practice of handling health claims on an extremely high
level of clinical standards, successful applications of Ayurvedic preparations
do not appear highly likely.
·
The market segment of Traditional Herbal Medicinal Products
appears to be the more straightforward way, and has the advantage of being
politically supported in the process of harmonization of the EU markets.
However, this procedure would currently exclude a relatively high number of
preparations from the markets.
As
this situation will effectively close the door on many Indian Ayurvedic
preparations, political activity is required:
·
The EU commissions Trade, Sanco and Enterprise must be informed on
the consequences of the currently conflicting legislatory situation in the EU.
Solutions must be sought to establish rules which deserve the name of “facilitated
registration”, while at the same time keeping up a high level of product
safety.
·
Since the consequence of the current legislation is a de
facto ban of many Indian products, the current situation might have to
be analyzed in the light of WTO regulations.
A
viable start could be an active participation in the development of EU
pharmacopoeial standards for Ayurvedic plants and excipients. The quality
definitions of the Ayurvedic Pharmacopoeia of India (API) for defined herbal
drug substances and/or excipients could be updated to Ph. Eur. standards,
thus paving the way for a commitment of the EU to accept Indian
pharmacopoeial standards as equivalent to Ph. Eur. standards.
On
the political level the EUAA is struggling for better conditions of
traditional herbal medicinal product registration at affordable costs. The EUAA
is also developing and presenting alternative strategies to challenge the
currently conflicting and – to our opinion –disproportionate obstacles for
ancient non-EU-traditions such as Ayurveda to enter the European markets.
These
goals can, however, only be reached with the support of the
stake-holders and – most importantly – the consumers who want the free
access to natural therapies such as Ayurveda.
