IVF doctor urges regulators to defer new human tissue rules pending EU trends

(sz) The Irish Fertility Society, of which Dr John Water­stone is a committee mem­ber, has written to the De­partment of Health and the Irish Medicines Board highlighting its concerns at the interpretation and implementation of the EU human tissue directive.
Ireland and Denmark are the only two countries which have transposed the Directive into law, so Ireland, along with Denmark, are at the forefront of its implementation.
Dr Waterstone, who is Medical Director of the Cork Fertility Centre, told IMN that the regulatory bodies should consider a delay in implementing the regulations, before it finalises its own interpretation, in order to see how other countries go about introducing the legislation.
The Society’s two major issues relate to the air quality requirements for IVF clinics and the timing of screening for Hepatitis B, Hepatitis C and HIV in patients. Dr Waterstone said Denmark has not even spoken about air quality “which again exemplifies our bone of contention”. He said there is “no empirical evidence… there is no evidence whatsoever that…pure air is going to make your success rates better”.
In addition, he said that in Denmark patients are tested for Hep C/Hep B and HIV up to 30 days before egg collection and if there is a negative result the patient does not have to be re­tested for 24 months. more…

From: »The Irish Medical News«

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