Parts of the general body of text of the Matrix report related to herbal, homeopathic and anthroposophic medicinal products

4.2 Number of Medicinal Products Authorised by Type

Herbal products

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.

Unavailability problem:
Products not authorised/delayed authorisation

Possible Driver:
Divergence in national procedures and approach to herbal medicinal products and HAMPs

Impact:
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.

Geographic Spread:
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

Conclusions

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.

Summary of comments to study on availability of medicines for human use

Agenda item 2d

PHARMACEUTICAL COMMITTEE – 22 October 2014

The Pharmaceutical Committee was asked1 to provide feedback on the study report, in terms of appreciation of the correctness of the analysis and applicability of the findings to national situations. Responses from 20 Member States and Norway, as well as a letter from the HMA (Heads of Medicines Agencies) Management Group were received by the Commission services.

This document serves as a summary of the comments which were issued by the Pharmaceutical Committee on the external study report on the availability of medicinal products for human use prepared by Matrix Insight to the European Commission. The individual comments received are published separately.

Some comments include specific requests to reword or remove some specific paragraphs of the report. It is hereby reminded that whilst the report is being published as it has been provided by the contractor, the information and views set out in this external study report are those of the author(s) and do not necessarily reflect the official opinion of the European Commission. Responsibility for the information and views expressed in the study report lies entirely with the author(s).

On the general approach

In the majority of the responses received there are no comments or no major comments within the defined scope of the study. However, four Member States expressed critical comments, notably on the scope of the study and the methodology used by the contractor. These comments point out for instance that even though the study explicitly excludes the subject of affordability and prices from its scope, considerations on affordability may have an impact on availability in some cases. Other comments point out, on the contrary, that aspects of pharmaceutical pricing and reimbursement should not be included in the report, as responsibilities of the Member States include the management of health services and medical care and the allocation of the resources assigned to them (Art. 168 (7) TFEU is quoted in that respect).

Some comments tend to qualify the approach to availability adopted by the study as insufficiently refined, pointing for instance to the possibility to include in the analysis alternative products or to focus the analysis on predefined ‘essential products’, while criticising the emphasis of one of the conclusions on products such as herbals or homeopathics. Other possible definitions of ‘availability’ are also discussed.

Another critical remark states that it is not possible to ascertain whether the conclusions reached have been sufficiently examined and calls for critical scrutiny of the recommendations of the study and reasonable discussion with the Member States.

On the substance

There is seemingly no agreement on the conclusion regarding the ‘sunset clause’ owing to the fact that different Member States apply that clause in different contexts. One of the comments seems to establish a link between exemptions granted from that clause and the possibility to fill in gaps of availability through parallel imports. Another comment underlines on the contrary that the ‘sunset clause’ is very useful on their market, while recognising that the appreciation may vary depending on the situation on each particular market.

There is seemingly no agreement on the conclusion regarding the ‘sunset clause’ owing to the fact that different Member States apply that clause in different contexts. One of the comments seems to establish a link between exemptions granted from that clause and the possibility to fill in gaps of availability through parallel imports. Another comment underlines on the contrary that the ‘sunset clause’ is very useful on their market, while recognising that the appreciation may vary depending on the situation on each particular market.

Opinions on the application and the effect of Article 126a (‘Cyprus clause’) vary from indifferent to positive, with some critical remarks regarding the conclusion on the need to clarify individual responsibilities, expressed by a Member State who does not seem to experience such difficulties in the application of that clause. It is underlined at the same time that the MRP/DCP procedure is the preferred option and efforts should be made by all stakeholders towards a more systematic use of that procedure versus the 'Cyprus clause' procedure.

Conclusions regarding the application of Article 81 (‘public service obligation’) tend to receive general support. One remark points to possible negative effects of a very stringent interpretation in the specific context of small markets.

Other critical comments relate to the fundamental principle in the EU legislation that there is no obligation for a product that has been authorised to be actually placed on the market. Three Member States discuss directly or indirectly possible new obligations for marketing authorisation holders aimed at improving availability, in the context of possible new incentives. Another comment, however, suggests that the current legislation may be close to achieving the best possible balance between a variety of objectives.

Finally, several replies underline the importance of a good collaboration between marketing authorisation holders and national competent authorities in terms of transparency on foreseeable availability issues, mutual information and information of the public, including through collaboration between Member States and coordination at EU level.

1 Meetings on 23 October 2013 and 26 March 2014

Action to be taken:
For information

Study on the Availability of Medicinal Products for Human Use

Specific Request EAHC/2011/Health/14 for the Implementation of Framework Contract EAHC/2010/Health/01 Lot 1
21 December 2012

Final Report

This study investigates the availability of medicinal products for human use in the EU and EEA, focussing on the authorisation procedures for medicinal products, a principal area of EU competence1

For the purposes of this study, availability of medicinal products is understood to mean the availability to patients of medicinal products in a pharmacy setting. Following the Terms of Reference and due to the fact that the majority of existing information refers to availability of individual products, the study uses medicinal products for human use as the unit of analysis. However, in most cases it is the limited availability of active substances rather than limited availability of individual products that constitutes a public health risk. Therefore, where possible, the study also aims to explore the public health implications associated with non-availability of active substances.

In addition to collecting and analysing the data on availability, the study also investigates the problem drivers and examines the effectiveness of existing European legislative provisions in addressing these problems, making recommendations where relevant.

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