The European Herbal Directive: Friend or Foe? (Article)

The word “traditional” is critical so it is important to demonstrate that the herbal medicine or 'corresponding' (i.e. comparable) product(s) has been in traditional medicinaluse for 30 years preceding the date of the application for the required medicinal indication. 15 years of this usage must have been within the European Union (EU). If the 15 years of usage in the EU cannot be satisfied but the product(s) meets all the other requirements of the Directive, the Health Authority can refer the product(s) to the Committee on Herbal Medicinal Products (HMPC) who have the discretion to lower the requirement for 15 years' use (but there is no guarantee of this).

So why regulate herbal remedies?
The words “natural”, “herbal” and “plant derived” can be misleading and it is important for the public to be reminded that herbal remedies are medicines in their own right. Health Authorities have been concerned about the safety profile and quality of such medicines for a number of years. The laws applicable to herbal preparations varied across the EU and therefore, the EU Directive 2004/24/EC was implemented in order toharmonisethe regulations, enable the free movement of herbal products within Europe and protect the consumer.

Feedback from Industry
A couple of informal polls were carried out by GRS: one at a Pharmaceutical Conference and the other at a Natural Products Conference. In the main, the pharmaceutical responders saw the Herbal Directive as an opportunity, citing:

It reinforces the perception of ‘healthy’ which is a useful marketing tool.
There will be an increased pool of recorded information.
Conventional clinicians may now be encouraged to offer patients traditional herbal medicines because they will have information on their safety profile.
Increase in choice i.e. use in Primary and Secondary Care to complement or perhaps even replace existing treatments.
Improvement in Quality and Safety.
Regulation improves Public confidence.
More robust products.

Compare this to responders at the Natural Products Conference who see the Directive as a threat for the following reasons:

Lack of choice for the consumer: it is predicted that out of 3000 herbal remedies available on the UK market, only 300 will be registered by April 2011.
Monopolies.
Loss of tradition: companies are finding that registration of their herbal products is cost prohibitive and so the remedy (and therefore, tradition) will be lost.
Increased costs in order to achieve compliance (GMP, GACP, PV, licence fees etc).
Amendment to Article 2.2 i.e. ‘in cases of doubt’ and where the definition of a medicine applies even if the product is already covered under other aspects of EU legislation (e.g. foods), medicinal classification has supremacy.

Overall the herbal industry believes that choice and therefore tradition will be lost forever after April 2011. Many have said they will stop supplying herbal remedies and some are even going as far as winding up their businesses.

April 2011 - how will the Directive be enforced?
The MHRA has confirmed that they are identifying companies and products on the UK market which might be subject to the Directive and are corresponding with them so that they are fully aware of what’s happening. After 30 April 2011, enforcement will be a mixture of checking and responding to complaints. After the deadline no further stock of unlicensed product can be sold. Stock already on retail shelves (i.e. not with wholesalers or manufacturers) will be able to remain on the market until sold. Products with applications in hand at 30 April 2011 (but registration not granted), technically, will have to be removed until the licence is granted. The MHRA are in dialogue with companies going through the procedure.

The European Herbal Directive: Friend or Foe?
It is clear from the above that the answer to this question is dependent on whether or not a company has a pharmaceutical or natural product background. If the former, the Directive is a ‘friend’, if the latter, it is a ‘foe’.

Acknowledgements
Deirdre McIntosh of McIntosh Scientific Advice Services Limited
MHRA, UK
Clinical Contract Research Association (CCRA) - www.ccra.org.uk

Author: Greer Deal, Director of Global Regulatory Services