Regulation of assisted reproduction under the European Union tissues and cells directives

Published on August 31, 2015   33 min
0:00
EDGAR MOCANU: I'm Edgar Mocanu, consultant obstetrician and gynecologist at the Rotunda Hospital in Dublin. I'm also the European Society of Human Reproduction and Embryology EU TCD task force coordinator. I'll be talking about the regulation of assisted reproduction under the European tissue and cell directors.
0:25
I will specifically address the objectives of introducing regulation in this field and dissect the three directives, which have been transposed into law in European countries. I would like to describe the specific implications for member states, for tissue establishments, and for competent authorities.
0:49
From the beginning, I would like to acknowledge that ART services have no country or continental borders at present. Both patients and reproductive materials like gametes, embryos, and frozen issues liberally cross borders, as do individuals that can act both as recipients or donors. This makes the regulation and quality assurance of reproductive tourism a significant task.
1:18
From this perspective, the European Commission has introduced the directives in order to set standards of quality and safety for human tissues and cells intended for human medical treatments and to ensure a high level of protection of human health.
1:36
While the directives apply to hermatopoetic peripheral blood, umbilical cord blood, bone marrow stem cells, fetal tissues and cells, embryonic stem cells, I'll specifically focus on reproductive cells in my talk.
1:52
The European tissue and cell directives specifically deal with the donation, procurement, processing, preservation, storage, and distribution of human tissues and cells.
2:06
In a quick snapshot of the three directives, I would like to introduce you to what specifically each directive deals with. The first directive, in 2004, set the standards of quality and safety. The second directive presented the technical requirements specifically for the donation, procurement, and testing of human tissues and cells, while the last directive, directive 86 from 2006, specifies the traceability requirements, the notification of serious adverse reactions and events, and certain technical requirements related to the coding, processing, preservation, storage, and distribution of human tissues and cells.
2:50
The first directive discusses the standards of quality and safety.
2:56
It specifies that member states have an immediate duty to establish a competent authority which has a legal obligation to implement the requirements of the director. It must accredit tissue establishment through regular inspections that should occur no less than every two years. Furthermore, it imposes stringent requirements for the competent authority to ensure that its inspectors are trained and their competence and performance regularly assessed. The directive specifies that all procurement and testing must be undertaken by qualified personnel only in the circumstances of unaccredited environment, for example, the air quality in the laboratory, and also in the presence of a tissue establishment that is overall accredited.
3:49
In regards to traceability, in article 8, member states must ensure traceability of all tissues and cells, including the products and materials that come in contact with such issues and cells. It specifies the need to establish a donor identification system in the form of a code and also the minimum requirement for data storage, which is 30 years after clinical use.
4:15
Article 9 specifies the import export conditions under which this activity should take part. And it clearly states that all export import activity must be undertaken by accredited tissue establishments. There's a duty upon member states to register the accredited issue establishments, to provide a list of centers, and the activities for which each center has been accredited. It also states that a European network of accredited centers should be established.
4:50
In article 11, the first directive introduces a system of reporting serious adverse reactions and serious adverse events. Article 12 describes the requirements for donation, which must be voluntary and unpaid, and prohibits advertising for financial gain. Article 13 introduces the consent procedure and in particular discusses the information that needs to be provided prior to consent. In article 14, patient data protection and confidentiality is safeguarded with third party anonymous information.
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Regulation of assisted reproduction under the European Union tissues and cells directives

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