TGA's role in improving international blood safety and quality standards

The TGA's contribution to improving the safety and quality of blood transfusions in Australia is closely linked to its efforts in the international blood safety environment.

In 2000, the TGA chose the Council of Europe's Guide for blood components as the Australian standard for these products. This occurred as a key element in the TGA's regulatory framework for fresh blood components introduced on 1 July 2000.

In 2002 the TGA was granted membership of the Council of Europe Committee of Experts in Quality Assurance of Blood Components. This eminent body of transfusionists from Europe is tasked with maintaining and enhancing the quality of the Guide, through yearly meetings and extensive industry engagement.

Regulators outside Europe, such as the TGA, the US FDA and Health Canada, are allowed observer status in the Guide and contribute strongly to its development. Although widely considered to be reflective of best practice in the area, the Guide has not been a mandatory document in the Council of Europe. However, with the promulgation of a European Commission Directive on Blood Safety and Quality, the key technical requirements of the Guide are set to become mandatory in the European Union over the next year.

In some ways the TGA and Australia may well be perceived as being ahead of Europe in this aspect as the TGA mandated the Guide in 2000. This is recognised in the Council of Europe Committee where Australia's experience with the Guide gives rise to considerable interest and discussion.

After three years of experience with the Guide, the TGA and the Australian blood system have developed new strategies to address several problems of blood safety and quality in areas covered by the Guide. The TGA's experience was reported to the Council of Europe Committee at its meeting in Dublin in February 2004 by Dr Albert Farrugia, head of the Blood and Tissues Unit, Office of Devices, Blood and Tissues, TGA, and Australia's representative on the Committee. Dr Farrugia presented papers to the Committee on two important issues which link blood component safety and supply.

The level of haemoglobin in blood donors prior to donation is a crucial parameter which affects donor health and product quality. Since 2000, the TGA has worked with the blood service in establishing donor haemoglobin levels which are commensurate with adequate donor health and product quality while maintaining Australia's blood supply to the required levels. Under the TGA's guidance, the blood service has performed studies assessing which haemoglobin levels strike the best balance between blood safety and supply.

In his paper to the Committee, Dr Farrugia proposed that the Australian experience indicated that a review of the donor haemoglobin levels required by the Guide was appropriate and timely. This was accepted by the Committee and Dr Farrugia was directed to chair a task force of select experts which would develop concrete proposals for the Committee's consideration and eventual endorsement by the Council of Europe and the industry.

Blood donors who visit or who have lived in areas where malaria is endemic are deferred from donating blood for a considerable time period after they return. This is to ensure that any malaria infection picked up while overseas is not transmitted to patients. While adherence to this policy contributes greatly to the safety of blood, it is known to be not foolproof. Furthermore, the majority of donors who visit malarial areas are known to be not infected with the malarial parasite. This leads to the loss of considerable numbers of blood donations which are perfectly safe.

The TGA has been working with the blood service in recent years to develop alternative strategies to minimising the risk of malaria from blood transfusion. In particular, the option of testing, rather than deferring, donors is attractive as it will allow the blood components from most of the donors who visit malarious areas to be fully utilised. The experience of the blood service and overseas developments indicates that this is possible.

Dr Farrugia proposed to the Council of Europe that an intensive review of this area be conducted with the intention of developing appropriate policies which would minimise malarial risk but not lead to the loss of safe blood. In this context he is charged with chairing another working party which will work on this issue over the coming year and make recommendations to the Council of Europe Committee at its next meeting. Dr Farrugia anticipates that, in addition to Council of Europe Experts already enrolled within the working party, he will be seeking to recruit Australian experts into the exercise. Much hinges on the success of this approach, as it is estimated that 35,000 blood units are lost yearly as a result of the current policy.

The TGA's high profile in blood matters internationally serves Australia and the region well. It continues to contribute to the success of the TGA's oversight of the blood system, which international consensus indicates to be one of the best in the world.

2nd round of consultation on tissues and cellular therapies regulatory framework

The TGA is undertaking another round of consultations with stakeholders. Letters of invitation, the workshop schedule and Summary of Proposed Framework for the Regulation of Cell and Tissue Therapies were sent to stakeholders on 23 January 2004.