Factsheet“2015 marks the 50th anniversary of the adoption of the first law on the authorisation of pharmaceuticals at EU level, which set the basis for some of the key principles that are still valid today.

Much of the impetus behind the adoption of the first law on pharmaceuticals at EU level stemmed from the determination to prevent a recurrence of the thalidomide disaster of the late 1950s early 1960s, when thousands of babies were born with limb deformities as a result of their mothers taking thalidomide as a sedative during pregnancy. This experience, which shook public health authorities and the general public, made it clear that to safeguard public health, no medicinal product must ever again be marketed without prior authorisation. Over the past 50 years a large body of legislation has been developed around this principle, with the progressive harmonisation of requirements for the granting of marketing authorisations and post-marketing monitoring implemented across the entire EU.

To mark the 50th anniversary of the adoption of the first EU pharmaceutical law the European Commission is organising a one-day conference that will take place in Brussels on 28 September 2015. The conference will review past achievements while focusing on the present and future role of EU pharmaceutical legislation in protecting the health of citizens in the EU and in the world, and in promoting advances in science, innovation and public health. Despite the many achievements there are still many challenges ahead. Different stakeholders see these challenges but each from different perspectives. The conference wants to bring to surface these different perspectives in an open and stimulating exchange with representatives from national governments, European institutions, national competent authorities, industry, healthcare professionals, academia and patient groups, with the objective of working towards a shared vision for the future.”

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by the PHARMACEUTICAL COMMITTEE of the EU-Commission (Health systems and products- Medicinal products – authorizations, European Medicines Agency) in relation to the Matrix-Report of 2012, referring to the Herbal aspect.

By Nora Laubstein (inspired by Dr. Mathias Schmidt and Dr. Hubert Schwabl)

The summary of comments about the Matrix report gives a fairly good overview about the regulatory difficulties of herbal medicinal products. But in the report a rather neutral position prevails.

An example - Looking back in German Herbal Medicines history:

Practically all of the registrations mentioned in the report for Germany are NOT new products or switches from food supplement to drug status; they are generally products that existed for many years as authorized herbal medicinal products.

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

TradeReg-Symposium 2013

kraeuter

by Dr. Mathias Schmidt (ANME+EUAA)

From 30 September to 2 October the symposium “TradeReg 2013: Regulation of Herbal and Traditional Medicinal Products – European and global strategies” took place in Bonn (Germany). During this three-day-symposium the regulatory approaches were presented for Europe and beyond the EU borders: there were, for example, presentations on the regulatory situation of herbal medicinal products in Brazil, Japan, Canada or the United States of America.

Of course, a major emphasis went to the collected experience with the registration of traditional herbal medicinal products in Europe.In view of the current European situation many participants had hoped for answers to pressing questions, especially with respect to the transfer of unregulated food supplements to the market segment of regulated traditional medicinal products. This hope was, however, deceived: ultimately the messages gave more information on what is not possible than aids to the question how manufacturers of food supplements could make practical use the so-called facilitated registration.

European Herbal and Traditional Medicine Practitioners Association

Herbs to combat the threat of microbial resistance to antibiotics

A paper from the European Herbal and Traditional Medicine Practitioners Association (EHTPA) for the House of Commons Select Committee on Science and Technology’s antimicrobial resistance (AMR) inquiry.

Executive Summary:

In light of growing concerns relating to microbial resistance to antibiotics increasing attention is being given to the role that herbal medicines may play as autonomous anti-bacterial agents or as adjuvant treatments used to potentiate conventional drugs. This paper selectively reviews the evidence for herbal medicine as a valuable resource to combat bacterial resistance to antibiotics and suggests that further research is warranted.

  1. Synergy is an important characteristic determining the medicinal action of many herbal medicines occurring at pharmacodynamic and pharmacokinetic level1 2 and a number of papers have been published investigating potential benefits conferred by the synergism of phytoconstituents3 4 5 6. In particular, researchers have demonstrated that combining antibiotics with plant medicines can enhance the action of antibiotics thereby overcoming antibiotic resistance7.
  2. This is achieved in three main ways: firstly by means of a combined phytochemical and antibiotic attack on the bacterial cell wall - epigallocatechin gallate (EGCG) as found in green tea and carob powder is effective in this regard. Secondly, antibiotic resistance can be overcome by inhibition of enzymes that are generated by bacteria for the deactivation of antibiotics (again EGCG is active here) or by thirdly by disabling an efflux pumping system developed by several bacteria in order to prevent potentially destructive compounds such as antibiotics from penetrating into the bacteria, or to expel the antibiotics out of the bacteria cell once they have invaded it8.

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