The EU herbal products sector has come in with a mixed reaction to the UK MHRA announcement last week that the sell-through period for unregistered herbal medicines would finish on April 30 next year – some welcome the market clarity and clean-up it promises. Others point to its draconian consequences. Others want something else all together...
For the likes of Simon Mills, a practising complementary therapist and former chief of the British Herbal Medicine Association (BHMA), the end of the sell-through period for products already on-market is welcomed as that period was already extended two years from April 2011 and led to some manufacturers, “taking the mickey a little with use-by dates on products.”
“Yes it can be viewed as being draconian but it delivers long-term gains and it is important to have harsh measures against products that are not up to scratch," he said.
He pointed to the hardline 1980s campaign mounted by the Australian Therapeutic Goods Administration (TGA) to implement and enforce herbal Good Manufacturing Processes (GMPs) as an example of thorough regulation that has delivered a botanicals market widely regarded as the cleanest and safest in the world.
If the letter of the EU Traditional Herbal Medicinal Products Directive (THMPD) is followed, all products deemed to be herbal medicines not in possession of a THMPD registration will be wiped from the market at the end of April. The most affected will be Traditional Chinese Medicines (TCMs) and Ayurvedic medicines, where 1000s of products available via natural therapists, herbalists, in stores and online will become contraband.
While most of them have a fine safety record, it is also true that most contamination and safety issues stem from these types of products, along with those manufactured in the US.
In this light, the UK Medicines and Healthcare products Regulatory Agency (MHRA) announcement to finally end the regulatory limbo for said products seems hard to argue with. A herbal market improving no-brainer.
After all the THMPD was written into law in 2004 – it already contained a built-in transition period of 7 years, subsequently extended to 9. Why wait any longer?
What is less concise is the definition of just what a medicinal herbal product is - a definition that varies greatly in the UK and Europe as it does for what constitutes a herbal food supplement or foodstuff.
The Court of Justice of the European Communities (ECJ) defines medicinal products as those designed, “to cover products whose pharmacological properties have been scientifically observed and which are genuinely designed to make a medical diagnosis or to restore, correct or modify physiological functions”.
But it can be argued that all bodily inputs "modify physiological functions". Hmmm…so if a practitioner administers turmeric to a patient is that turmeric considered a medicine or a food? It depends on the format in which the turmeric arrived, its marketing etc…a la case-by-case...
As the MHRA told us yesterday: “It is not always that easy to distinguish a medicine from food supplements. Decisions on whether a product is considered medicinal will depend on a number of factors, including the intended use, form and presentation of that particular product.”
Once those kinds of demarcations have been made the MHRA has every intention to step up its policing activity via its ‘Enforcement Group’ (EG) come May 1 next year.
The EG would, “investigate and take necessary action against reported breaches of medicines legislation.”
“Herbal products are treated in the same way. Any referral involving a non-compliant herbal medicine will be considered and appropriate action taken.”
Outlets included, “major chains of supermarkets, pharmacists, and health food retailers as well as a wide range of independent pharmacists and health food retailers.”
While elements the herbal sector, as represented by the likes of the Alliance of Natural Health (ANH), warn of the TCM-Ayurvedic and herbal supplement threat of the THMPD, herbal practitioners like Simon Mills are looking to other legislation to ease the ambiguity.
Herbal practitioner statutory self regulation
Mills told us statutory self regulation for herbalists, campaigned for in the UK since the turn of the millennium, had won UK Department of Health favour. “They have removed most of the blocks out of the way,” Mills said.
If that status is achieved it changes the game because herbalists suddenly have much greater freedom to administer herbal products and extracts – even those that are not in possession of THMPD registrations – which by the way have not been sought for many products on cost grounds rather than scientific grounds.
Similar principles have already been implemented albeit in somewhat different ways in different EU markets like Spain and Belgium where positive lists for herbal extracts exist that can be used by practitioners.
That principle has been backed by ECJ along with mutual recognition – that means any products on-sale in one EU market should be available for sale in all 28 EU member states. One of these decisions forced Spain to cease its practice of systematically considering products that contain herbs as medicinal, despite these products being lawfully manufactured in other member states as food supplements.
Multiple routes to market
Patrick Coppens at the European Botanical Forum (EBF) said the classification problem was not necessarily one of the THMPD, but the varied interpretation of it, the cost of registrations, and its interaction with other regulations like the EU 2002 Food Supplements Directive (FSD).
“There are multiple legal frameworks for similar products and multiple routes to market but the lack of THMPD registrations across the EU shows there is a problem with it. The cost is prohibitive.”
So real THMPD pain, but will it deliver real gain?