EU medicinal herbal remedy laws need urgent review

The medicinal herbal remedy industry is at risk in Europe following the introduction of new EU laws a year ago, according to Greer Deal, Director of Global Regulatory Services.

She tells me that the Traditional Herbal Medicinal Products Directive is being flouted by some companies to avoid paying exhorbitant fees, a system which favours larger companies, while smaller businesses are struggling to survive faced with demands for submitting vast data without guarantee of being granted a licence. At the end of the day, this will mean reduced choice for consumers.

To register a herbal product under the new guidelines, a company has to prove at least 30 years of traditional use, with 15 years being recorded in Europe, as well as completing a vast dossier of paperwork similar to that which is required to register new pharmaceuticals (albeit largely compiled of bibliographical evidence); registration can cost €50,000 to €80,000 and in some cases more.

Greer says there are now far fewer herbal products on the market because many companies cannot afford the fees.  These companies also feel that even if they do get a licence it is pretty worthless because so many others are still operating illegally without any sign of being reprimanded for doing so.

She is also aware that there are companies which have used the seven year transition period to launch hundreds of new products on to the market.  This transition period was intended to enable UK companies to become compliant before the Directive was fully enforced at end of April 2011.

“Before this new directive, there were thousands of herbal remedies available in the UK, but as of December 2011, only 236 applications have been submitted to the UK’s Medicine’s and Healthcare products Regulatory Agency, and so far 143 out of these 236 applications have been granted licences.  This is a fraction of the original herbal market.  In other European countries, registration numbers are even lower: the Netherlands has about 7 registrations and Italy has 5, and some countries have none! This is a very worrying decline of the herbal medicinal industry within Europe, and we need to find ways to prevent it from getting worse,” she says.

“Some companies are doing their utmost to comply with the Herbal Directive, whilst others appear to be openly flouting it because of what they believe to be over bearing bureaucracy.  Others are seriously considering leaving the industry altogether.”

“I have heard that many companies are ignoring the new law and have also been reliably informed that one membership organisation for herbal companies and individuals in the UK has advised its members to continue trading the same as before the Traditional Herbal Directive came into force in April 2011. They are saying that the directive is unenforceable and restricts a free market system for something that has been working well for centuries.

“Of course, it is vital that public safety should be paramount, and it is also important to remember that customers gain reassurance from seeing the Traditional Herbal Certification mark on a medicinal herbal product to demonstrate that it has reached the high quality and safety standards required, and the industry needs to maintain those standards.”

As part of the UK Government’s Red Tape Challenge for Traditional Herbal Medicines, Greer will recommend that the following steps are taken to ensure Europe’s survival of the traditional herbal medicine industry and wider consumer choice:

  • Reduce bureaucracy

Incentivise companies to produce herbal monographs to include on the EU “pre-approved” list.  Any herbs on this “pre-approved” list are exempt from requirements to demonstrate traditional use or safety thereby reducing the burdensome paperwork of the full traditional herbal registration.

  • 30/15 year rule and safety monitoring

If a company can demonstrate at least 15 years traditional use in Europe, then this could ‘fast track’ their application. If a company cannot demonstrate 15 years traditional use in Europe, but can demonstrate 30 years outside of Europe, this should be acceptable, with the caveat that they have more stringent safety monitoring to adhere to over a defined period of time.

A similar system to the UK’s black triangle scheme could be used for the two years after product registration to indicate it is new to the market.

  • Harmonisation of pre-registration advice

Harmonise the provision of EU pre-registration advice to enable companies to follow a structure to obtain advice about their herbal remedy before committing to the significant financial investment and effort to register their product. The same advice should be available to all Member States so they are all adhering to the same guidelines.