Counterfeit drugs - meeting of international regulatory authorities

A meeting of the International Laboratory Forum on Counterfeit Medicines was held in Phoenix, Arizona, on 12-15 December 2000. The meeting was attended by Dr Larry Kelly, from the Chemistry area of the TGA Laboratories Branch, and by counterparts from various national regulatory agencies. The work of the group was recognised earlier in the year with the awarding of the Al Gore Hammer award (see last issue). The Phoenix meeting continued the informal sharing of information relating to the detection of counterfeit and sub-standard medicines with particular emphasis on analytical methodology. Included in the meeting were discussions on the approaches taken by the various laboratories to the detection of aristolochic acid in herbal medicines.

Official Medicines Control Laboratories meeting

The 5th annual meeting of the European Network of Official Medicines Control Laboratories (OMCL) was held in Lisbon in October 2000. TGA Laboratories Director, Dr Joe Smith, participated in meeting. The TGA has been an active participant in this Council of Europe forum because of the importance of European standards and protocols to the Australian regulatory framework for medicines and devices and the need to have input to, and remain aware of developments in Europe. The TGA also benefits from collaboration with other OMCLs in areas such as developing and solving problems associated with testing methodology, sharing in market surveillance activities, and participating in quality assurance activities.

Issues discussed at the meeting were invariably directly relevant to the TGA's operations, and to which the TGA could make useful contributions. While Australia's participation in OMCL activities has always been considered important because of the close links between the European and Australian regulatory systems, the participation of countries like Canada and Australia in these meetings is now even more relevant given the development of Mutual Recognition Agreements on Conformity Assessment with Europe.

Some of the key outcomes of the OMCL meeting included:

• A resolution for a position paper to be prepared and presented to laboratory accrediting agencies on a number of issues related to the application of the new ISO Guide 17025 to medicine testing laboratories. ISO Guide 17025 forms the basis of accreditation of laboratories by NATA and its international counterparts. There are substantial issues with the application of this standard, particularly in areas such as reporting of measurement uncertainty.
• A review of the outcomes of OMCL Market Surveillance Studies completed to date, identification of changes necessary to the program to improve its effectiveness, and planning for future studies.
• Discussion on various testing activities generated considerable interest in future collaboration. Of particular interest was work being done in Australia, the Netherlands and France testing somatropin products, and international efforts on the analysis of Chinese herbals for aristolochic acid.
• Agreement on the need for collaboration within the OMCL network on laboratory activities for the control of gene therapy products.
• Discussion of annual reports from all of the OMCLs. Australia's report generated considerable interest, particularly the laboratory accreditation experiences and product testing activities. International collaborative efforts on counterfeit medicines were also discussed.
• Continued debate on the need for OMCLs to meet the full requirements of the EP in relation to sterility testing. The issue has been referred for further consideration by a working group of the OMCLs.

TGA involvement in international blood safety initiatives

Dr Albert Farrugia, Manager of Blood and Tissues Services in the TGA Laboratories, has recently been appointed as a Specialist Advisor to the World Federation of Hemophilia (WFH) in the field of blood safety. The WFH is an international non-profit organisation which caters for the needs of people with hemophilia, a group of inherited disorders of the blood clooting system that makes sufferers dependant, for their survival and a normal life, on concentrates of plasma proteins or genetically engineered equivalents. The WFH is served by a panel of international experts and holds regular conferences that are key events in the medical scientific calendar. As such, it is regarded internationally as a peer professional organisation in the field of blood and blood products. Dr Farrugia's appointment as one of eight specialist advisors to the WFH is a singular honour recognising his expertise in blood safety and TGA's role in this important area of health care.

Dr Farrugia has also recently returned from the World Health Organization's first meeting of the Global Collaboration for Blood Safety, where he was appointed by WHO as rapporteur for the meeting. The meeting brought together experts from all over the world to develop strategies and make recommendations to WHO on blood safety issues, including issues related to policy development, plasma fractionation, development of blood services and the implementation of quality systems. The meeting appointed a number of expert working groups to develop these issues further and implement the recommendations of the meeting.