4.2 Number of Medicinal Products Authorised by Type
Issues regarding authorisation have also been raised with regard to herbal products. Herbal products are defined by Directive 2004/24/EC on Traditional Herbal Medicinal Products (THMPD) as products “exclusively containing as active ingredients one or more herbal substances or one or more herbal preparations, or one or more such herbal substances in combination with one or more such herbal preparations”a. The Directive defines traditional herbal medicinal products as products fulfilling the following criteria:
- they have indications exclusively appropriate to traditional herbal medicinal products which, by virtue of their composition and purpose, are intended and designed for use without the supervision of a medical practitioner for diagnostic purposes or for prescription or monitoring of treatment;
- they are exclusively for administration in accordance with a specified strength and posology;
- they are an oral, external and/or inhalation preparation;
- the data on the traditional use of the medicinal product are sufficient; in particular the product proves not to be harmful in the specified conditions of use and the pharmacological
effects or efficacy of the medicinal product are plausible on the basis of long-standing use and experienceb.
Under the revised Directive 2001/83/EC, a simplified authorisation registration procedure is established for these products. Although the NCAs have not noted such products to be problematic with regard to availability, consulted industry stakeholders pointed out that the process of authorising products can take a long time (up to five years) and the approach to authorising such products can differ substantially between Member States. This makes it difficult for producers to bring such products to the market as medicinal products, potentially resulting in unavailability. Since the coming to force of Directive 2004/24/EC on Traditional Herbal Medicinal Products (THMPD), 572 products have been registered, with significant discrepancies across Member States (only seven Member States saw more than 20 products registered, and over 150 of all registrations were in Poland)c. It is however not clear how these figures relate to products on the market prior to that time or to the demand for such products. It is important to note that some products 17 Article 1 of Directive 2004/24/EC on Traditional Herbal Medicinal Products 18 Article 1 of Directive 2004/24/EC on Traditional Herbal Medicinal Products 19 AESGP (2012) might already be available on the market as food substitutes, with any delay in authorisation procedures only relating to the products becoming available as medicinal products in a pharmacy setting. The availability of herbal medicinal products is explored in more detail in a case study in Appendix I.
Homeopathic and anthroposophic products
Homeopathic and anthroposophic products (HAMPs) are another type of product where there are potential availability problems. Homeopathic products consist of diluted doses of substances which in larger quantities would create the symptoms in a healthy person, while
anthroposophic medicines are products that use natural substances and require “heat, rhythmic preparation and potentising methods”d.
According to industry stakeholders, such products tend not to be registered, or the registration process is incomplete or outstanding. A study commissioned by the European Coalition on Homeopathic and Anthroposophic Medicinal Products (ECHAMP) found gaps in direct availability of HAMPs in five Member States investigated (Bulgaria, France, Germany, Romania and Spain) and identified availability issues even if a product were to be ordered. Like in the case of herbal productse, unauthorised HAMPs, which have been introduced prior to the Council Directive 92/73/EEC could still be on the market under transition rules. According to an industry representative, certain products are available in selected Member States, but have no clear status. This also means that there are substantial variations in how individual Member States approach such products. These products are explored in a case study in Appendix I along with herbal products.
5.1 Marketing Authorisation
There are also specific issues related to particular types of products. Stakeholders in the self- medication industry note that differences in attitudes to OTC products in individual Member States may result in the application to switch a product’s status from prescription to OTC as being difficult and time consuming, if not ultimately rejected. Similarly, these stakeholders also identify similar national differences with regard to authorising herbal medicinal products. In both cases this can result in limited availability of such products as medicinal products in pharmacy settings. In the field of HAMPs, lack of a coherent legal framework across the EU that would allow for products to be authorised (both new products and those already on the market) is also seen as an important driver of availability problems.
5.5 Summary of Problem Drivers
Purely regulatory problem drivers can mainly be linked to unavailability of specific product types. This includes for example herbal medicinal products and HAMPs, where simplified registration procedures are viewed as broadly appropriate but their incomplete and ineffective implementation in Member States seems to result in relatively few products becoming registered as medicinal products.
Products not authorised/delayed authorisation
Divergence in national procedures and approach to herbal medicinal products and HAMPs
Depends on the demand for herbal products and HAMPs. Potentially moderate if MS with general lower use of such products are the ones where most delays/authorisation issues occur. In addition, Herbal products can be available on the market as, for example, food supplements.
2015-01-11Selected EU27 Member States (i.e. Italy) Relevant Product Types: Herbal products and HAMPs
Relevant Product Types:
Herbal products and HAMPs
Competence (EU/National) and available instruments:
Legal framework set out in Article 13 0 Article 16 of Directive 2001/83/EC and in Directive 2004/24/EC on Traditional Herbal Medicinal Products
Relatively few products are authorised centrally, and whilst the procedure is likely to become a more prevalent form of authorisation over time, efforts should still be made to support a broad range of authorisation procedures and to assess how the interaction between authorisation and availability can be most effectively addressed. As such there is evident scope for improvement in the European pharmaceutical acquis. In terms of recommendations there is a need to better understand issues relating to availability as it impacts on public health and most particularly the impact of different policy measures on the availability of a broad range of products and active substances. This in turn will help to focus efforts at future policy amendment or change. Specific recommendations include:
- Remove or revise the Sunset Clausef provision to avoid reducing the number of authorisations in place in individual EU Member States
- Further clarify the responsibilities of individual actors when using a Cyprus Clauseg procedure to make it a viable solution to availability problems for more Member States facing such problems
- Work to improve the national implementation of simplified procedures for herbal medicinal products and HAMPs
- Ensure more effective transposition and implementation of Article 81
a Article 1 of Directive 2004/24/EC on Traditional Herbal Medicinal Products
b Article 1 of Directive 2004/24/EC on Traditional Herbal Medicinal Products
c AESGP (2012)
d See http://www.echamp.eu
e PwC 2012
f Sunset Clause: Article 24 of Directive 2001/83/EC, setting out that an authorisation is to be invalidated if a product has not been placed on the market within three years of authorisation.
gCyprus Clause: Article 126a of Directive 2001/83/EC which has been used in Malta and Cyprus to bring unauthorised products onto the market and whilst not being seen to be ideal is considered an important method of ensuring patient access to essential medicinal products in these countries.