Select Committee on European Scrutiny Twenty-Third Report


COM(02) 1

Draft Directive amending directive 2001/83/EC as regards traditional herbal medicinal products.

Legal base:Article 95 EC; co-decision; qualified majority voting
Document originated:17 January 2002
Forwarded to the Council: 17 January 2002
Deposited in Parliament: 28 February 2002
Basis of consideration: EM of 7 March 2002
Previous Committee Report: None
To be discussed in Council: No date set
Committee's assessment:Politically important
Committee's decision:For debate in European Standing Committee C (together with the documents already recommended for debate on the authorisation of human and veterinary medicines)


  4.1  Under Community legislation governing pharmaceuticals, no medicinal product may be placed on the market without having obtained a marketing authorisation granted either by the Commission under the centralised procedure laid down in Regulation 2093/93[13] or, in the case of human medicines, by a Member State under the decentralised (mutual recognition) procedure in Directive 2001/83[14]. Among other things, the latter specifies the information which must be supplied in support of an application for authorisation, including the results of pharmaceutical and clinical trials carried out to establish quality, safety and efficacy. However, the Directive makes an exception to the need to present particulars relating to safety and efficacy in the case of products where it can be demonstrated by detailed references to published scientific literature that there is a well-established medicinal use. The purpose of the present document is to propose changes in the way in which these provisions are applied to traditional herbal medicinal products.

The current proposal

  4.2  According to the Commission, the legal framework in Directive 2001/83[15] is suitable for certain such products. However, it says that, for many which have been used for a long period, sufficient published literature to demonstrate a well-established use is not available. It also points out that, whilst new tests and trials are in theory possible, this can lead to significant financial burdens for the companies concerned, which are often small or medium-sized, and it suggests that it would be difficult to justify this where the traditional use of the product allows sound conclusions to be drawn on its safety and efficacy.

  4.3  Against this background, and the fragmentation of the single market arising from the different ways in which Member States currently treat these products, this proposal provides for a special procedure to apply to certain traditional herbal medicinal products. This would permit their registration, and hence marketing, without requiring particulars and documents on tests and trials on safety and efficacy (though other requirements, such as those relating to their manufacturing and quality, would still be subject to the same conditions as other products).

  4.4  Those products to which the proposal applies would be identified in a positive list, subject to their meeting certain conditions, including:

  • the need for safety to be demonstrated through bibliographic data and an expert report;

  • the normal requirement for proof of efficacy being replaced by a requirement to demonstrate a history of 30 years use in the Community (though evidence for up to 15 of the 30 years can relate to use outside the Community);

  • the use of agreed medical indications, but limited to those adapted for traditional herbal products for use without the advice or intervention of a doctor;

  • the need for labelling to include a clear statement that product efficacy is not proven, as well as other information for the safe use of the product.

  4.5  There would be a subsequent review of the operation of the Directive, with a view to a possible extension of traditional use registrations to other categories of traditional medicinal products, for example those containing non-herbal ingredients, such as minerals.

The Government's view

  4.6  In his Explanatory Memorandum of 7 March 2002, the Parliamentary Under-Secretary of State at the Department of Health (Lord Hunt of Kings Heath) says that the Government considers that this proposal will rectify a number of the widely acknowledged weaknesses in the current regulatory arrangements for herbal medicines in the UK. He points out that a company can currently place such a medicine on the market by obtaining a marketing authorisation obtained on the basis of efficacy requirements, but that the majority of those medicines may also be placed on the market as unlicensed herbal remedies without meeting specific safety or quality requirements. He says that the Government regards these two options as being either too onerous in certain respects or not suitable, and that it has advocated European legislation to regulate traditional herbal medicines.

  4.7  The Minister therefore believes that the Commission's proposals are overall consistent with what the Government would wish to see. However, he adds that the UK will wish to seek clarification on, and to pursue, a number of points, such as:

  • the proposed positive list of herbal substances, where it appears unclear how the arrangement would work in a number of likely situations (for example, if several ingredients contained separately on the positive list were to be combined within one product);

  • the need to retain a provision allowing evidence for at least some of the period of traditional use to be drawn from outside the Community, so as to accommodate medicines from non-western herbal traditions.

The UK welcomes the proposal for a subsequent review of the extension of the Directive's scope, since it considers there are a number of genuinely traditional medicines which may contain non-herbal active ingredients.

  4.8  The Minister has enclosed with his Explanatory Memorandum a partial Regulatory Impact Assessment. This identifies the potential benefits as being improved public health protection, greater consumer confidence, a secure legal home for the products in question, and a more level playing field as between the companies involved, though it says these are all difficult to quantify at this stage. Similarly, although the Assessment suggests that 55 companies in the UK, with sizes varying from less than 10 to over 250 employees, would be affected, it points out that the impact of the compliance costs (arising from the need to prepare applications for registration, and to adjust products in order to meet the terms of the Directive) are likely to vary widely according to specific circumstances. One cost in particular will be the registration fee charged by the Medicines Control Agency, which will need to recover the "substantial" compliance costs it will face, but here too the Assessment says that it is too early to estimate the likely fee levels.


  4.9  We note the Government's general support for this proposal, subject to the need to clarify a number of points, and, were we considering it in isolation, we would be minded to clear it without further comment. However, since the proposal relates to the more general Commission proposals on the authorisation of human (and veterinary) medicines which we recommended on 20 March 2002 for debate in European Standing Committee C[16], we are recommending that it be debated at the same time.

13   OJ No. L.214, 24.8.93, p.1. Back

14   OJ No. L.311, 28.11.01, p.67. Back

15   OJ No. L.214, 24.8.93, p.1. Back

16  (22867) 13361/01 and (23022) 14591/01; see HC 152-xxii (2001-02), paragraph 3 (20 March 2002). Back

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