What will be the benefits of the THMRS?
The THMRS will ensure the quality and safety of herbal medicines available for self selection by patients. Under the THMRS, patients will have confidence that the medicine will contain the right ingredient which will be present in the stated quantity.
As well as an assurance of quality, products will have a defined and recognised safety profile. By May 2011, all manufactured herbal medicines will be required to have either a traditional herbal registration or a product licence.
A further requirement of licensing under the THMRS is that product manufacturers must provide information on their product to a patient in the form of a patient information leaflet.
How does the THMRS address efficacy?
Any new herbal medicines wishing to obtain a marketing authorisation (product licence) will have to demonstrate the quality, safety and efficacy of the product, with efficacy demonstrated through data obtained from clinical trials.
For products registered under the THMRS, randomised controlled trials are not required to demonstrate efficacy. Permitted indications for these medicines are based on traditional use, provided the pharmacological effects are plausible on the basis of long-standing use and experience.
An application under the THMRS will be refused if the data on traditional use are insufficient, or if the pharmacological effects are not plausible.
Within the THMRS, the traditional use of the herbal medicine means that it has been in medicinal use throughout a period of 30 years, including at least 15 years within the European community.
What types of conditions with can be treated under the THMRS?
Herbal medicines registered under the THMRS are suitable for use without medical intervention. They are used to treat minor conditions that are suitable for self medication such as the common cold, cough, sleep problems, migraine or low mood. Indications for serious conditions are not permitted within the context of the THMRS.
Under the THMRS, products administered via the oral, external and inhalation routes may be licensed, but injectable preparations cannot be registered through this scheme.
How will I be able to tell if a product is a Traditional Herbal Medicine?
All herbal medicines registered under the THMRS will include a number starting with the letters THR on the product container or packaging.
The Traditional Herbal Registration (THR) certification mark (see above) is a type of trade mark that indicates that a herbal medicine has been registered under the THMRS. This certification mark was designed as an additional visible symbol to help patients easily distinguish products registered through the THMRS.
While the MHRA is recommending that manufacturers include the certification mark on their registered products, the use of the certification mark is not compulsory.
Will all herbal products be authorised as Traditional Herbal Medicines?
In March 2011, there were several hundred herbal medicines that held a marketing authorisation (product licence). The vast majority of these products had obtained a product licence of right (PLR) when the Medicines Act was introduced in 1968, and were subsequently given a product licence (PL) in the early 1990’s; for these products, claims for efficacy were essentially based on their traditional use. However, it is recognised that clinical trials have been undertaken for some herbal products.
Herbal medicines with a PL are currently being reviewed by the MHRA to assess whether they would be more appropriately covered by the THMRS, and some herbal medicines with a PL have already been transferred to the THMRS.
Sativex spray, a herbal cannabinoid product, has recently been granted a product licence and some single herbal laxative medicines, such as those based on senna or ispaghula, will also retain their full marketing authorisations. However, due to the costs involved, it is unlikely that many manufacturers of herbal medicines will pursue full marketing authorisations.
In addition, some herbal products that are considered to be non-medicinal may be regulated under food legislation; the Borderline Unit at the MHRA will make decisions on whether a herbal product is classed as a medicine or a food.
Will the new legislation affect product availability?
Any unlicensed herbal medicines previously made available through the Section 12(2) Medicines Act exemption can no longer be placed on the market after April 2011 unless they have been registered through the THMRS or obtained a marketing authorisation.
New herbal medicines with less than 30 years use or less than 15 years use in the EU, or those not currently used, may not be granted a registration. Herbal medicines imported from outside of the EU are unlikely to comply with the new licensing requirements i.e. are not registered through the THMRS so cannot be made available for sale.
Furthermore, some manufacturers of herbal products that could potentially be registered, may decide that it is not commercially viable to put their products through the registration scheme as the registration process is too expensive compared with potential sales.
Will unlicensed herbal medicines continue to be available from 1 May 2011?
Unlicensed medicines that comply with the requirements of Section 12(2) of the Medicines Act 1968 can be put on market up until April 2011, and can legally be sold by retailers until their expiry date or until the stock has been sold. However, an offence would be committed if a company (manufacturer, wholesaler or importer) placed further stocks of unlicensed medicine on the market after April 2011.
Also, unlicensed preparations can still be supplied under the Section 12(1) exemption i.e. can be supplied following a consultation with a patient.
When a patient requests advice about a herbal product, pharmacists should explain the difference between a registered and an unlicensed herbal preparation to enable a patient to make an informed choice. If asked by a patient to recommend a suitable manufactured herbal product, only registered preparations bearing a THR or PL number should be recommended.
This is in line with MHRA advice that, where there is a licensed pharmaceutical product available on the market and available for use, then an unlicensed product should only be used if the licensed product is not suitable for the patient.
What messages should pharmacists give to patients about herbal medicines?
- Pharmacists should advise patients that the quality and safety of authorised herbal medicines bearing either a PL or THR number on the packaging will have been assessed by the MHRA. For herbal medicines with a THR number, efficacy will be based on their traditional use, although the proposed indications must be pharmacologically plausible. Efficacy does not have to be supported by randomised controlled trials, although clinical trials have been performed on some herbal products.
- Pharmacists should be aware that there will be herbal medicines on the market bearing a PL number whose efficacy has also been accepted on the basis of traditional use. These products currently have the wording ‘traditional herbal remedy’ on their packaging and they will undergo review to determine if they should be moved to the THR category. There will continue to be unlicensed herbal medicines available for retail sale after 30 April 2011, and up until the expiry date of these unlicensed medicines, although the amount of unlicensed medicines on the market will decrease over time as stock will not be replaced.
- Patients should be made aware that there is the risk of adverse effects with herbal medicines and the potential for interactions with conventional medicines. Most herbal medicines should be avoided in pregnancy and during lactation, and may not be suitable for young or old patients. Patients should also be reminded that although herbal medicines may be described as natural, herbal or derived from plants, this does not necessarily mean that they are all completely safe. In addition, it may be helpful to explain to patients the differences between herbal and homeopathic preparations as there is public confusion around the differences between these types of therapy.
- Patients should be advised that they should consult a doctor or qualified healthcare practitioner if their symptoms persist or if adverse effects other than those specified for the herbal medicine occur. If any unusual adverse effects do occur, reporting these to the Commission on Human Medicine (via the Yellow Card Scheme) either by the patient or via a qualified healthcare professional should be encouraged. If a patient has a reaction to a herbal medicine they should stop taking the medicine and inform a healthcare professional such as a pharmacist or a doctor.
- Patients should be encouraged to inform all healthcare professionals that they deal with that they are taking a herbal medicine. Patients should also be advised to continue taking their prescribed medicines in the way recommended by their healthcare professional while they are taking a herbal medicine. Any changes to a prescribed medication should only be done following a consultation with the patient’s prescriber.
- Patients should be encouraged to read the Patient Information Leaflet that will be included with a herbal medicinal product. Patients should also be reminded that as herbal medicines are medicines they should be kept out of the sight and reach of children.