One of the most frequently voiced complaints about the EU Traditional Herbal Medicinal Products Directive (THMPD) is that it effectively removes traditional Chinese and Indian herbal medicines from the European market. The international press in Europe and Asia writes dozens of articles on the controversial situation each month, and a lawsuit against the legislation is being planned. The Alliance of Natural Health (ANH) in Europe, the natural health nonprofit behind the legal challenge,¹ has called the THMPD a “protectionist tool” for “favor[ing] certain products of the European phytopharmaceutical system and discriminat[ing] against those of non-European traditional systems of medicine.”² About 14 organizations have expressed support for ANH’s THMPD legal challenge,³ and some have also filed their own petitions noting the effects on India and China as a serious problem.

The THMPD, fully implemented in April of 2011, was adopted by the European Union in 2004 as a simplified registration process for traditionally used herbal medicines that do not meet the stringent efficacy standards for obtaining marketing authorization as medicines.⁴ In order to obtain a traditional herbal registration (THR), the herbal medicine must meet the safety and quality standards required for all fully licensed medicines. But, instead of being required to prove efficacy, manufacturers of these products can provide evidence of a minimum of 30 years of traditional use—at least 15 years of which must have taken place within the European Union.

The majority of complaints against the THMPD focus on the requirement for demonstrating at least 15 years of a product’s use within the European Union, as well as the high cost incurred from documenting necessary information required for a license application (which ANH estimates as more than $131,000 per product; other sources say it is less, especially for products that are already well supported by documented research).⁵ Many say that both stipulations will be very difficult—if not impossible—for Ayurvedic and Traditional Chinese Medicine (TCM) products to meet.

However, in a guest editorial in the December 2010 issue of HerbalEGram, natural products industry consultant Thomas Brendler commented that these assumptions are incorrect. “The market remains open,” he wrote, “except for products with unapproved claims. Every manufacturer can carry on selling their herbal tea, Traditional Chinese Medicine, or Ayurvedic product without THMP registration or [European Food Safety Administration] approval, as long as these products are recognized foods and do not make health claims.”⁶

In a recent interview with the American Botanical Council, Brendler went on to note that the main issue with TCM and Ayurvedic products is that they commonly contain multiple compounds, making it more difficult to properly document the quality of these products’ ingredients (validating identification methods, stability testing, etc.) as is required in the THMPD guidelines. “It is not the proof of 15 years of use but the forbidding complexity of the quality documentation which is the true hurdle,” said Brendler.

Ayurveda

Pukka Herbs, a UK company specializing in the production of organic Ayurvedic herbal products, took the only practical route available and relabeled its Ayurvedic herbal capsules as food supplements.⁷ According to Pukka’s statement on the THMPD, the company did this in order to be confident in their products’ legality, and the relabeled products had already been registered as food supplements in a number of EU member states. Additionally, many of the products’ ingredients were also being sold as foods in other member states.

Ranjit Puranik, CEO of Ayurvedic formulations manufacturer Shree Dhootapapeshwar Ltd., in India, said the option of removing health claims and relabeling products as food supplements is a left-handed consolation based on a minimal nuisance consideration by the EU regulatory body.

“It’s all fitting a square peg (traditional medicine) in an available round hole (EU regulatory model),” he said. “It will never satisfy anybody involved nor attract any serious players.”

If Ayurveda were accepted as being a body of knowledge and a lifestyle, Puranik continued, it would not be appropriate to regulate the traditional medicine system according to a product approval mechanism. The 7 Ayurvedic herbal monographs in the EU Pharmacopoeia, which he said would ideally be a factor of a THR application, “is not really any solace at all. In Ayurveda—even at a diminished level of activity—we use over 1,000 medicinal plants. So tapping into THMPD EU opportunity is a very tall order and not very motivating to take on.”

But, he said, “We neither can demand a foreign country or group of countries to accept our aggressive appeal for an opportunity for our traditional medicine to prosper.”

Pukka Herbs maintains its stance that the THMPD is “a disproportionate regulation, especially for herbs from non-European traditional medicinal systems such as Ayurveda, and an infringement on human rights by limiting an individual’s access to natural plant medicines.” Pukka is a supporter of the safe production of herbal products as well as the ANH’s campaign for judicial review of the THMPD.

Pukka’s Co-Managing and Herbal Director Sebastian Pole noted that the company has been working on THMPD applications for 3 of its products for the last 2 years. “Because of the less researched nature of the species that we are proposing for registration, the more complex nature of the analytical work, and the reduced volume of available data, it has taken us longer than anticipated,” said Pole. “But we will get there.”

Pole estimated that the cost per application will end up being about $114,000 (about £70,000) and noted that this figure is probably higher than the costs for products containing well-known species documented by quality research, but lower than the cost for highly complex, multi-botanical formulae. “And many traditional medicines are in any event excluded from the registration scheme on eligibility grounds (e.g., they contain mineral active ingredients or they cannot demonstrate more than 15 years usage within the EU).” Additionally, Pole pointed out that many Ayurvedic herbs and products cannot be recognized as foods supplements—such as Astragalus spp. (Fabaceae), the herbal blend Triphala, and Coriolus versicolor (Polyporaceae)—making this route around the THMPD impossible for them.

Because the United Kingdom’s Medicines and Healthcare products Regulatory Agency has allowed for the sale of compliant products purchased by retailers before April 30, 2011 (until the product stocks run out or expire), the biggest impact on herbal companies is yet to be felt. Still, Pole noted that sales of Pukka’s Ayurvedic product lines have decreased by about 15% since May of 2011, despite the rest of the business growing at a rate double this.

“We relate this loss to consumer and retailer confusion, fear and doubt, created by wide-scale publicity about the effects of the EU Herbal Directive, as well as associated, generally unfounded, negative publicity about safety concerns over herbal products,” said Pole. “We have been inundated with calls from concerned customers who have benefited from our products and are worried that they will not be available in the future. Some people have been stockpiling, but rather like our approach to health and ecology, this has resulted in short-term security for a few, but long-term vulnerability for the many.”

According to the Times of India, in January of 2011, a delegation of Indian officials visited the European Union and asked lawmakers to revise the THMPD’s traditional use requirement so that products used for at least 30 years inside or outside the European Union could be eligible for a registration.9 The officials also asked that the European Union accept non-herbal ingredients commonly used in Ayurvedic medicinal products, such as honey and ghee, within the THMPD framework. The European Union, however, has not made any changes to the legislation, and in July of 2011, the International Ayurveda Foundation urged the Indian government to fight the THMPD and began planning to pursue legal action.¹⁰

Traditional Chinese Medicine

Prior to the THMPD’s full implementation date of April 2011, several departments of the Chinese government began recommending certain medicinal products that should attempt to obtain THMPD registration.¹¹ One company, Lanzhou Foci Pharmaceutical Company, Ltd., in the Gansu Province of China, applied for a THMPD license for its Concentrated Pill of Angelica (containing Chinese angelica, Angelica sinensis, Apiaceae) in March of 2011. Most news articles refer to Foci as the only or one of the only international companies to seek THMP registration.

As reported by the magazine China Today, Foci sent its application to the Swedish Drug Institute and was told that a response would be issued within 200 days. According to the article, Foci sent its application after analyzing the THMPD requirements and conducting internal research, both of which led them to conclude that it could prove its product’s safety and at least 30 years of use, including 15 within the European Union.¹¹ [Editor’s Note: Several interview requests sent to Foci were not answered as of press time.]

Simon Mills, a UK herbal expert and renowned author, noted a strangeness in Foci’s application for this product, considering that Angelica species (containing furanocoumarins) have long been listed in Europe as unsuitable for general sale.* He attributed this to a lack of cross-cultural communication on both sides and said he hoped that better chosen TCM applications would be forthcoming soon.

Du Xiangdong, general manager of the European and American Division for Department of Natural Medical Product at China MEHECO Corporation—a botanical medicine and pharmaceutical company—recently told China Daily in a televised interview that the THMPD has “markedly affected” its export trade of patented herbal medications.¹² Huang Jianyin, deputy secretary of World Federation of Chinese Medicine Societies (WFCMS), echoed this situation, noting that very few TCM products are currently attempting to obtain a license due to the high cost.

“The main impact will be that there are no Chinese patent drugs for sale. As the ban takes effect, many TCM pharmacies will have to be closed, which may cause some unemployment” (e-mail, September 23, 2011).

Jianyin emphasized, however, that TCM exports to Europe account for a small percentage of China’s overall TCM sales.

“The biggest portion of China’s TCM sales is in Asia,” said Jianyin. “The key issue is that TCM culture has not become popular yet in Europe and the rest of the world. This leads to the limited scale of our TCM export trade. Many manufactures are interested in domestic market share instead of European market, as there is a little market share for their TCM products.”

The Association for Traditional Chinese Medicine (ATCM) in the United Kingdom welcomed the THMPD as a regulation to promote public healthcare and consumer safety (H. Shen, email, September 11, 2011). But the organization of TCM practitioners points out that no TCM products have been registered, and attributes this to the requirement for quality control of every ingredient of the product. According to ATCM President Huijun Shen, this “makes it very difficult, costly, and even impossible for TCM products with multiple ingredients to register [for] THR.”

ATCM is encouraging an amendment to and simplification of the THMPD that would give multiple-ingredient products a chance at registration while maintaining quality standards. Shen said these goals could be achieved by adopting the quality control methods for multiple-ingredient herbal products used in the Chinese pharmacopeia. These establish a small number of main ingredients (usually 1 to 3) from a complex product, have been used for several decades, and have proven to be safe and cost effective, he said.

Until such amendments are considered, however, ATCM is supporting the United Kingdom’s decision to give TCM practitioners statutory regulation, which Shen said is currently “the only way to maintain the public access to TCM products.”

Conclusion

What may make proof of 15 years EU usage somewhat easier for Ayurvedic and TCM companies is the fact that the THMPD legislation allows for the inclusion of overseas EU territories under this requirement, said Brendler. Also, he continued, different EU countries have different interpretations of the THMPD. “Some accept traditional use evidence for an herbal preparation from which the THR is derived,” he said. “Others stringently require evidence for reference products equal or similar to the product in question. The guideline leaves room for interpretation in this matter.”

Because the THMPD is intended for products sold over-the-counter for self-medication purposes where no healthcare professional is in attendance, some say that most Ayurvedic and TCM products—which are usually developed for prescription by a practitioner of the traditional medicine system—are not appropriate for this regulatory category.

“There needs to be further translation of Ayurvedic and Chinese health concepts into labeled claims suitable for the open market,” said Mills, who is also the secretary of the European Scientific Cooperative on Phytotherapy, the lead European body working to ensure quality, safety, and efficacy for herbal medicinal products with the European Medicines Agency. Mills noted that the effort from these traditional medicine sectors should be focused on creating statutory regulation of practitioners (as is currently taking place in the United Kingdom).

“If Ayurvedic and TCM practitioners were to achieve licensed status,” he continued, “they could prescribe most of their materia medica to their patients without hindrance.”

But Pole of Pukka Herbs brought up the possibility that if the Ayurvedic or TCM product is in “any way processed,” which helps the patient be more compliant with usage, its ability to be simply prescribed by a practitioner is more questionable.

“This is the question,” said Pole. “What category are [Ayurvedic and TCM products] appropriate for?”

—Lindsay Stafford

*European Medicines Agency. Post-authorisation Evaluation of Medicines for Human Use. Committee on herbal medicinal products (HMPC). Reflection paper on the risks associated with furocoumarins contained in preparations of Angelica archangelica l. London, October 31, 2007. Doc. Ref. EMEA/HMPC/317913/2006.

References

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