Seven years ago, a registration scheme for traditional herbal medicines was introduced, imposing conditions that must be satisfied before such medicines can be placed on the European market. Under the Traditional Herbal Medicinal Products Directive 2004/24/EC (THMPD) – published on 30 April 2004 – manufacturers of such medicines have to demonstrate the safety and efficacy of their products through traditional use for at least 30 years within the EU, or 15 years within the EU and 30 years outside the EU.
The THMPD was transposed into the UK by the Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005 (THMPD) on 30 October 2005. These regulations included a seven-year transitional period (starting in April 2004 and ending on 30 April 2011) giving manufacturers of herbal medicines products time to prepare for the changes implemented by the new regime.
However, a very recent statement by the health secretary, Andrew Lansley, casts considerable doubt on quite how this new regime will work in practice. On 16 February, Mr Lansley announced in parliament that subject to parliamentary procedures, herbal medicine practitioners will be regulated from April 2012. The UK health authorities have agreed that the Health Professions Council should hold a statutory register of practitioners who supply unlicensed herbal medicines.
This proposed new system will “ensure that practitioners have met specified registration standards”. It will be “underpinned by medicines legislation that will provide further safeguards to protect public health”. Not surprisingly, Mr Lansley’s statement has been warmly welcomed by herbalists but heavily criticised by medics, who say that the new plan confers legitimacy on suppliers of products that have not been properly tested.
The UK health authorities will consult on the draft legislation and give practitioners and the public the opportunity to comment.
The new regime
During the transitional period, unlicensed herbal medicinal products can be legally marketed in the UK either with a marketing authorisation or, if they qualify, as exempt herbal remedies under section 12 of the Medicines Act.
However, from 1 May 2011, any herbal product that is deemed to be a medicine can no longer be legally distributed or sold in Europe without being properly licensed and tested as a conventional medicine. In the UK, this will be subject to any further legal developments flowing from Mr Lansley’s 16 February statement.
As a general plan, it would still be sensible for companies in the supply chain of herbal products to make sure that their products are accurately classified. This is especially the case if their products might be sold elsewhere in the EU. If the products are medicines, they must meet the new rules in order to remain legally on sale. If they are not, companies will need to ensure that they comply with other relevant legislation (for example, national statutory provisions covering food or cosmetics).
The MHRA
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) offers advice on the status of borderline products in cases where it is not clear whether something is a medicine or not. In making a decision, the MHRA will consider each individual product on its merits, together with any information which may have a bearing on the product's status. Relevant criteria will include, for example:
- The pharmacological properties of the ingredient
- The presentation of the product including labelling, packaging and its target customer base
- Any representations made about the product
- Whether there are any similar licensed products on the market
Criminal penalties
It is important to note that in the interim period stocks of herbal medicines that were already legally on the market before 30 April 2011 will not have to be recalled. However, if a manufacturer, retailer or distributor puts a herbal medicine on the EU market without complying with the new rules, they will be committing a criminal offence and could face criminal charges. It is not clear, though, how far such liability in the UK will survive Mr Lansley’s reported intention “to use a derogation in the European legislation to set up a UK scheme” so as to regulate the supply of unlicensed herbal medicines “to meet individual patient needs”.
Insurers risk
Insurers that cover manufacturers and suppliers of herbal products should take note of their regulation in the EU and the likelihood that potential liabilities will increase as a consequence.