Consultation responses

HFEA response to draft proposals from the CEN/ISSS Workshop on Coding of and Traceability of Human Tissues and Cells.

14 January 2008

Dear Dr Warwick

Thank you for the opportunity to provide comment on the draft proposals from the CEN/ISSS Workshop on Coding of Information and Traceability of Human Tissues and Cells.

The proposals presented in the consultation document raise a number of issues for the United Kingdom´s assisted reproduction sector.

The Human Fertilisation and Embryology Authority (HFEA) would firstly like the Workshop to make it clear that coding requirements will not apply to partner donated reproductive cells in In-Vitro Fertilisation and Intra-Uterine Insemination. This is consistent with Article 10 of Commission Directive 2006/86/EC. Partner donation of reproductive cells makes up the majority of assisted reproductive treatments in the UK and a requirement to code associated samples, over and above Commission requirements, would be highly burdensome on establishments.

The presumption that assisted conception establishments widely use computers and could therefore easily adopt a bar-coding system is also of concern. A coding system that necessitates the use of computers and additional hardware will be a significant resource issue for establishments. For the United Kingdom´s assisted reproduction sector it is paramount that the implementation of the coding system is low cost.

Following from this, the HFEA considers that a cost-benefit analysis of the possible coding systems in the assisted reproduction sector is required. This would provide an assessment of the relative value of each system and enable the sector to make informed comment on the options.

While the consultation document details the technical aspects of the various coding systems, the practicalities of these systems cannot be ignored. Requirements such as labelling and tracing need to be further explored so that the impact of this on establishments can be assessed. In particular, the HFEA opposes any requirement to retrospectively label samples. This could seriously compromise the viability of samples in storage as well as be a significant burden on establishments.

The HFEA´s detailed response to the consultation document is attached. I urge the Workshop to ensure that the future proposal for the coding system for human tissues and cells reflects the requirements of the assisted reproduction sector.

Yours Sincerely

Walter Merricks
Interim Chair

Response to EC Consultation (82 Kb)