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14 March 2012
New EU herbal remedy laws need urgent review, warns
Global Regulatory Services
A regulatory consultancy for the herbal industry is urging EU health officials to review new laws which came into force in April last year, warning that it is being flouted by a number of companies to avoid its costly licensing process, and that its future in Europe is at risk.
The Traditional Herbal Medicinal Products Directive (THMPD) is aimed at protecting consumers from potentially damaging traditional medicines, but some companies are finding the new rigorous process a considerable burden and ignoring the new guidelines in order to survive, says Greer Deal, Director of Global Regulatory Services (GRS).
Greer urges EU health officials to reduce bureaucracy by prioritising consumer safety to ensure that non-registered and potentially unsafe products are not allowed on the market, while at the same time implementing changes to the regulations that will protect the centuries-old industry and not favour the larger more established companies.
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 (MHRA), 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.”
Greer says that spiralling costs and the considerable time needed to provide vast amounts of data, without guarantee of being granted a licence to market the herbal product, is making companies want to quit, resulting in less consumer choice, and inevitably providing larger companies with a bigger share of the market.
“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,” warns Greer.
“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 be suggesting that the following steps are taken to ensure Europe’s survival of the traditional herbal medicine industry and wider consumer choice:
GRS welcomes the opportunity to provide feedback to the Government via the Red Tape Challenge and urge others to give their views too. This is your chance to contribute and make a difference.
Notes to Editors:
1. Global Regulatory Services is a one-stop shop for all regulatory requirements. They advise on the regulations which may affect the life science industry, ranging from food supplements to stem cell therapy and regenerative medicine.
With their global reach and extensive network of highly skilled consultants, they are able to help companies located anywhere in the world to enter any new market.
3. A photo of Greer Deal is available on request. Please contact Press Consultant Ellee Seymour on +44(0)1353 648107, +44(0)7939 811961, email: email@example.com
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