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.
ECHAMP warmly welcomes the publication of the ‘External Study Report on the Availability of Medicinal Products for Human Use,’ which gives significant prominence, for the first time, to the situation concerning the availability of homeopathic and anthroposophic medicinal products in the EU. Although the report contains some statements that are not fully correct from ECHAMP's point of view, the overall positive aspects clearly outweigh the deficits.
The long-awaited study investigates the availability of medicinal products for human use in the EU and EEA, focusing on the authorisation procedures for medicinal products. It investigates different reasons for lack of availability and the effectiveness of existing European legislative provisions in addressing these problems, exploring six case studies, including the use of Article 126a of Directive 2001/83/EC (Cyprus Clause) and the availability of herbal, homeopathic and anthroposophic medicinal products.
The study quotes ECHAMP’s own report ‘The Availability of Homeopathic and Anthroposophic Medicinal Products in the EU’ as its main source of information on this topic. ECHAMP is now working hard to analyse the new report and we will share our conclusions with Members before Christmas. For now, we welcome the fact that the report acknowledges the need to improve the national implementation of simplified procedures for homeopathic and anthroposophic medicinal products as one example of a specific area for improvement.
This study report is presented as a working document of the Pharmaceutical committee, an advisory Committee to the Commission that consists of senior experts in public health matters from the Member States' administrations; it is an independently written document, which means it does not necessarily reflect the official opinion of the European Commission. Nevertheless, it is hoped it will add significant weight to ECHAMP’s goal of suitable regulation for our products.
Press Release: CAM — an important role to play in combating Antimicrobial Resistance (AMR)
October 22th 2014, Brussels – The NGO signatories of this statement wholeheartedly welcome the announcement of the reversal of the decision by President-elect Jean-Claude Juncker to move the competence for pharmaceutical and medical devices to the enterprise directorate.
Following negotiations within the European Parliament and concerns expressed by a number of member states, President-elect Juncker stated today that the "responsibility for medicines and pharmaceutical products will stay with the Directorate-General for Health because I agree with you that medicines are not goods like any other. The relevant policy will be developed jointly by Vytenis Andriukaitis and by Elżbieta Bieńkowska, who showed her incredible talents in her hearing." This signals that these policies are seen by President-elect Juncker as an essential part of European health policy. It also indicates that the safety and security of Europeans are prioritized in the new Commission. We would like to warmly thank President-elect Juncker for his commitment to the promise that he made in response to an open letter sent to him by 35 public health organizations where he stated that “As President of the Commission, I will make sure that public health will be at least as important in our policies as internal market considerations.”
With this new perspective, Mr Juncker has demonstrated that medicines are not an ordinary internal market good and that pharmaceutical policy is crucial to the sustainability of health systems; not solely an instrument for promoting economic growth. This can be seen also as a clear victory for public health, patients and European citizens. Commissioner-Designate for Health and Food Safety, Dr Vytenis Andriukaitis** will now have the tools to fulfill his mandate to harmonize pharmaceutical governance within the EU and facilitate emergency preparedness; the very reasons that in 2009 led the European Commission to move responsibility for medicines and medical devices into the hands of the health Commissioner.
** (10 September 2014, Brussels – Today Mr Vytenis Andriukaitis, former Health Minister of Lithuania, was designated as new European Commissioner for the Health Policy and Food Safety portfolio)
A delegation headed by Shri Nilanjan Sanyal, Secretary, Deptt. of AYUSH, Ministry of Health and Family Welfare visited Hungary on 21-24th September 2014. Accompanied by Shri Bala Prasad, Joint Secretary, Deptt. of AYUSH and Dr. Abhimanyu Kumar, Director, All India Institute of Ayurveda and Director Incharge Central Council for Research in Ayurvedic Sciences, New Delhi, the delegation came to visit Hungary with the aim to promote Ayurveda in the country, and to participate in the International Ayurveda conference which was held on 22-23rd September in cooperation with the Traditional Indian Medicine for the Public Health in Hungary Foundation.
On 22nd Sept. the inaugural session of the conference was held at the ASCC auditorium of the Embassy from 1500-18:15 featuring a short film on Ayurveda, welcome addresses by Ambassador Malay Mishra and Dr. Peter Medgyessy, Founder, Traditional Indian Medicine for the Public Health in Hungary Foundation and several presentations.