The objectives of this working group were: 1) to share recent observations related to herbal medicines' safety concerns, 2) to identify better ways to apply the WHO guidelines and other technical documents to enhance safety of herbal medicines, 3) to identify means of creating trust among health professionals, providers of herbal medicines and patients for the prevention of potentially serious risks from misuse of herbal medicines, 4) to propose tools for assessment of the effectiveness of national pharmacovigilance systems for monitoring of herbal medicines, and 5) to make recommendations to WHO about specific technical assistance to national centres. 

Discussions for the objectives from 1 to 5 include the following:  

The group agreed to distinguish the differences between "herbal medicines" (referring to herbal products regulated as medicines under national regulatory framework) and "herbal remedies" (referring to herbal products not regulated as medicines under the national regulatory framework and herbal preparation directly given by the practitioners, e.g. traditional medicine practitioners, and herbalists). 

1) Proliferation on the market of developing countries of herbal remedies and the so-called food supplements adulterated with undeclared pharmaceutical substances (orthodox medicines) pose a serious threat to patient safety. Patient safety continues to

be compromised by the misconception that every natural product is safe. In the absence of a regulatory framework for herbal medicines in most of these countries, it is almost impossible to implement any effective regulatory intervention including adverse drug reaction monitoring of herbal medicines. It was also pointed out that the traditional medicine practitioners or herbalists in these countries provide their own herbal formularies directly to their patients as part of their practice and that these herbal formularies are usually not the subject under the national regulation. It is difficult to regulate such products particularly in these developing countries. It was suggested that the establishment of a national regulatory framework for registration of traditional medicine practitioners or herbalists may be one

2) The group acknowledged the availability of WHO guidelines and other documents which could be applied not only to guide regulation of herbal medicines and the monitoring of their safety, but also to provide training. However, there-appear to be cases where these resource materials are kept in offices without being utilized in those countries where herbal remedies are on the market.  

3) The low numbers of spontaneous adverse drug reaction reports associated with herbal medicines were attributed to the general lack of "pharmacovigilance culture" among stakeholders. For trust, transparency is necessary and there must be the willingness by both producers of herbal medicines and providers of herbal medicines, especially traditional practitioners to learn proven ways of doing things better and to observe regulatory requirements and best practices. A herbal remedy that has been subjected to the necessary scientific assessment and is duly registered induces confidence for its use and for its safety profile to be better monitored. 

4) In principle, it was recognized that there is the need for the assessment of the effectiveness of a pharmacovigilance system for monitoring the safety of patients who use herbal medicines. It was, however, observed that until the necessary legislative and regulatory framework and the accompanying infrastructure are put in place, it is practically impossible to define the required assessment tools.  

5) Since countries are at various levels of regulatory "maturity" in respect of the regulation of herbal medicines, it was the opinion of the group that national centres and national regulatory authorities should identify their specific needs to be presented to their respective governments and WHO.  

It was recommended that governments should exercise the political will to put in place the necessary legislative framework for the effective regulation of herbal medicines. National regulatory authorities and pharmacovigilance centres should make use of available resources including the WHO guidelines and other published texts to enhance their regulatory processes and safety monitoring efforts. WHO, in collaboration with national centres, should take the lead in the creation of training opportunities for providers of herbal medicines to improve their knowledge base in quality issues in general and to introduce them to the culture of pharmacovigilance in particular to enhance spontaneous reporting by providers of herbal medicines. Countries should strengthen the capacity of their quality control infrastructures to analyse herbal medicines and the so-called food supplements, and to share such information.  

Discussion:
For effective therapeutic and ADR monitoring of herbal medicines, the labels of products should indicate the place of origin in order to identify the drug properly.