# European cells and Tissue Directive - can Ruth advise????



## earthe kitt (May 7, 2005)

I came across this on the donor eggs and sperm thread "what clinics are doing to recruit new donors" - it is from Olivia who posted on here some months ago although she is not writing in a personal capacity, just advising on forthcoming changes in the law across the EU

Anyway it appears that eggs and sperm from paid donors will no longer be allowed from April 2007 anywhere in the EU - which could have implications for some Spanish clinics - hopefully Ruth will be able to advise how this may affect some of the Spanish clinics which currently use paid donors

Sorry - I can't do quotes or links...perhaps someone else can so we can see the posting in the context of the thread


"Just to clarify, sperm being imported from the States and Denmark at the moment is from donors who have been paid.  From 1st April, only sperm from donors who have not been paid will be allowed to be used in this country (and rest of the EU).  What is not yet clear is whether sperm from paid donors imported before 1st April, but not used before then, can still be used post April 1st.  The HFEA have yet to rule on this.  I think it is likely that they will say it can still be used...but we just don't know yet.
Hope this helps.
Olivia"


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## aweeze (Nov 8, 2005)

Here is the link to the thread that you are referring to. Reply #10 is as you have posted.

http://www.fertilityfriends.co.uk/forum/index.php?topic=71450.0


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## earthe kitt (May 7, 2005)

Bonnie/B123 - just saw your post on the other thread - well done - you must have spent hour on this

Jo


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## earthe kitt (May 7, 2005)

I meant hours   not an hour


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## three_stars (Jan 19, 2006)

Hi Earthekitt, Hope you are doing well.
Yes I just saw the same comments and ( alarmed) started a reply on the other thread.. I will quote it and finish it here. My first reaction was that if this is true my hopes of still having double donor succesful BFP in Europe just went down the drain. ANd that I should start stockpiling frozen sperm or frozen embryos!!!! 
b123

copied here:
Olivia... you really must back up such comments with solid research or official reports. 
Obviously reading what you stated greatly alarmed me. This would be disastrous to a majority of us women using donor sperm and/ or eggs in Europe if it followed in the footsteps of the HFEA ruling in UK. So I passed the last hour or two researching this and reading the actual Directive, most of which is to ensure quality and tracking of cells and tissues that are donated. 
The parts that related to sperm and eggs as best as I can find do not seem to greatly change things from where they are today. That is each member state decides their rules for compensation to donors. The European directive is asking for it to be voluntary, for advertsing not to be based on donors monetary gain, for traceability for 30 years, but for anonymity to donors and recipients ( as you see the UK has chosen to do the exact opposite here!). Well I am too tired to decipher it more. (I will copy this to the new thread someone just started on this as it goes slightly off the track here. And I will post the printed relevant parts of the directive if anyone wants to read for yourself. Any comments from Moderators or persons in the know of something different then what I found please post. Thank you.)

Here is the link: 
http://www.hfea.gov.uk/cps/rde/xbcr/SID-3F57D79B-18CB5873/hfea/EU_Tissues_and_Cells_Directive.pdf

Excepts from European Union Tissues and Cells Directive:

(1 As a matter of principle, tissue and cell application

programmes should be founded on the philosophy of

voluntary and unpaid donation, anonymity of both

donor and recipient, altruism of the donor and solidarity

between donor and recipient. Member States are urged

to take steps to encourage a strong public and nonprofit

sector involvement in the provision of tissue and

cell application services and the related research and

development.

(19) Voluntary and unpaid tissue and cell donations are a

factor which may contribute to high safety standards for

tissues and cells and therefore to the protection of

human health.

(29) As a general principle, the identity of the recipient(s)

should not be disclosed to the donor or his/her family

and vice versa, without prejudice to legislation in force

in Member States on the conditions of disclosure, which

could authorise in exceptional cases, notably in the case

of gametes donation, the lifting of donor anonymity.

CHAPTER III

DONOR SELECTION AND EVALUATION

Article 12

Principles governing tissue and cell donation

1. Member States shall endeavour to ensure voluntary and

unpaid donations of tissues and cells.

Donors may receive compensation, which is strictly limited to

making good the expenses and inconveniences related to the

donation. In that case, Member States define the conditions

under which compensation may be granted.

Member States shall report to the Commission on these

measures before 7 April 2006 and thereafter every three years.

On the basis of these reports the Commission shall inform the

European Parliament and the Council of any necessary further

measures it intends to take at Community level.

2. Member States shall take all necessary measures to ensure

that any promotion and publicity activities in support of the

donation of human tissues and cells comply with guidelines or

legislative provisions laid down by the Member States. Such

guidelines or legislative provisions shall include appropriate

restrictions or prohibitions on advertising the need for, or availability

of, human tissues and cells with a view to offering or

seeking financial gain or comparable advantage.

Member States shall endeavour to ensure that the procurement

of tissues and cells as such is carried out on a non-profit basis.

Article 13

Consent

1. The procurement of human tissues or cells shall be

authorised only after all mandatory consent or authorisation

requirements in force in the Member State concerned have

been met.

2. Member States shall, in keeping with their national legislation,

take all necessary measures to ensure that donors, their

relatives or any persons granting authorisation on behalf of the

donors are provided with all appropriate information as

referred to in the Annex.

Article 14

Data protection and confidentiality

1. Member States shall take all necessary measures to ensure

that all data, including genetic information, collated within the

scope of this Directive and to which third parties have access,

have been rendered anonymous so that neither donors nor recipients

remain identifiable.

2. For that purpose, they shall ensure that:

(a) data security measures are in place, as well as safeguards

against any unauthorised data additions, deletions or modifications

to donor files or deferral records, and transfer of

information;

(b) procedures are in place to resolve data discrepancies; and

(c) no unauthorised disclosure of information occurs, whilst

guaranteeing the traceability of donations.

3. Member States shall take all necessary measures to ensure

that the identity of the recipient(s) is not disclosed to the donor

or his family and vice versa, without prejudice to legislation in

force in Member States on the conditions for disclosure,

notably in the case of gametes donation.

This post contains an unconfirmed link/information and readers are reminded that FertilityFriends.co.UK or its owners are not responsible for the content of external internet sites


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## three_stars (Jan 19, 2006)

HI Earthe Kitt
I was just getting started


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## aweeze (Nov 8, 2005)

Hi - I posted the first part of this on the other thread but as b123 has followed it up on here as well, I thought I should put it here as well

I think it is important to point out here that Olivia's comments were specifically in relation to the import of donor gametes to the UK from banks where donors have been paid and not in relation to treatment abroad.

b123 - I don't know much about tx abroad and I might be totally wrong but in my limited research (as my brain is also too tired to decipher too much tonight), I think you have answered the question:



b123 said:


> The parts that related to sperm and eggs as best as I can find do not seem to greatly change things from where they are today. That is each member state decides their rules for compensation to donors. The European directive is asking for it to be voluntary, for advertsing not to be based on donors monetary gain, for traceability for 30 years, but for anonymity to donors and recipients ( as you see the UK has chosen to do the exact opposite here!).


Our government and the HFEA have decided our rules for compensation i.e. a few quid in expenses, and imported donors must meet the same criteria. As long as the arrangement that clinics abroad have regarding appropriate compensation for their donors is in line with the new directive then as you say, nothing need change.

I think the best thing is if anyone is worried, they should contact their clinic and ask the question.

Lou
X


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## Ruth (Aug 6, 2004)

Will try to do a longer reply later but in essence, HFEA have decided ruling for their country, each country has to follow the directive and back up why they have decided "X,Y and Z".
Spain follows in that we do not say "payment" but "compensation" and Dr B is always very clear on that. Account is strongly taken as to an egg donor´s motives for donating and if all they say it´s "Money" then that is not the type of donor we want. Honesty is the donor that says it is the compensation and the helping others. We give a compensation of 1000 euros to a donor and that is based on the fact they are normally in the clinic every day during their donation cycle which takes chunks out of their working day (though we do try to keep this to a minimum to make things easier for them) plus a surgical procedure for egg removal whihc invaribly means they do not work that day or the next. It´s not a great deal of money for what they go through as I am sure we would all agree.
The Spanish Fertility Society is very gemmed up on protocols and directives and there has been no rubbles to change the way sperm and egg donation is carried out here other than to ensure that donor´s motives are very clear from the outset.

Hope this helps!!

Ruth


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## safarigirl (Feb 23, 2005)

Thanks for that Ruth

and to Bonnie. Lou and Jo for all your research ......


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## three_stars (Jan 19, 2006)

Thanks for that Ruth... I think that is what any clinics on these boards are doing as well.
Lou... as I stated on the other thread.. Olivia mostly was talking about the Uk but stated "the rest of europe" as well and that is what caused concern. 
We already know that the UK has made a big mistake on this. I was reading on the other thread about what clinics are doing about finding more sperm donors.... it is shocking that many clinics have none or just 1 or 2 donors!! 
Not to mention the problems associated to the new anonymity rules. Maybe the HFEA should look at the recent survey of general public ( posted on abroadies thread recently) and the percentage of people in the general public that feel that anonymity, or lack of, should be by choice. (63%)
b123

PS here is the link http://www.yougov.com/archives/pdf/AssistedReproductionResearch.pdf

This post contains an unconfirmed link/information and readers are reminded that FertilityFriends.co.UK or its owners are not responsible for the content of external internet sites


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