Reviewer's report
Title:Italian law on medically assisted reproduction: do women's autonomy and
health matter?
Version:3Date:17 August 2015
Reviewer: Wybo J Dondorp
Reviewer's report:
The paper has improved from better structuring and more extensive explanation
of some of the relevant issues. Although my earlier general assessment that the
paper is more journalistic than academic still applies, I can see that readers may
be interested in this update of the legislative situation in Italy.
Major revisions. There are still some important points that in my view would need
addressing:
1) The reasoning behind the 2004 Act is still not properly explained. Obviously
the Act meant to protect ‘the conceived child’ (line 65). But this an ambiguous
formulation: is this the child to be or also the embryo as such? The authors
mention specific issues relevant for the future child’s welfare that the legislator
wanted to address such as ‘paternal disownment, posthumous insemination and
surrogacy’ (line 66-67). Part of the 2004 Act aims at protecting the traditional
family as the environment believed by the legislator to be most conducive to the
welfare of the future child (see also second comment below). But some of the
more contentious parts of the Act have nothing to do with the interests of the
future child. These elements (eg. the obligation to transfer all embryos created
through IVF to the womb line 76ff, or the restricted scope for withdrawal of
consent, line 217ff) are only understandable as reflecting the view of the
legislator that an embryo of a few days is already a human person deserving
legal protection. If embryos are ‘unborn children’ IVF is indeed only acceptable in
the way specified by the criticized Act. The Italian judiciary obviously did not
share this view. If embryos are not unborn children but mere clusters of cells that
may perhaps grow into a child, or potential persons at most, the normative
landscape is entirely different. It would then indeed appear that requirements
such as the duty to transfer all embryos violate the interests of fertility patients for
no good reason. So my point remains that the paper fails to explain the
normative background of the Act, which is crucial for understanding the clash
between the Italian legislator and judiciary. At issue is whether a minority world
view (Roman-Catholic doctrine regarding the status of the embryo) can be a
basis for legislation of a morally contentious issue in a modern pluralist society.
2) In lines 187ff the authors righty point out that beyond the rulings of the
Constitutional Court, criticism is also possible of the still restricted access to IVF
in Italy under its present legislation. Although the door may now be opened for
PGD for fertile couples at genetic risk, same sex couples are still excluded from
medically assisted reproduction. Good point, but whereas the authors elsewhere
in the paper speak of a ‘blatant violation of personal liberty….’ (line 134) they are
far less critical here, when speaking of a ‘challenging and unresolved topic’ (189).
They even seem to condone the practice of discriminatory exclusion when
suggesting that there are ‘studies which highlight the negative repercussions on
the wellbeing of the child …. who has grown up outside the traditional family’. I
do not know of any studies showing this, neither does the paper by Peterson
referred to here. See the recent position statement of ESHRE’s Task Force
Ethics & Law (Hum Reprod 2014 29:1859-65).
3) Discussion of reimburement issues. Line 274 ‘severely limits equal access’. Is
that true? These limits (age, number of cycles) apply to everyone, so how are
they discriminatory? What is the problem with society limiting reimbursement
using criteria of efficiency, as long as this is not done in a discriminatory way? As
indicated earlier, the authors fail to acknowledge the opportunity costs of
reimbursing all requests for MAR without limits. This has little to do with the 2004
Act and its implications, so I would propose skipping the reimbursement issue.
Further minor points:
-69 ‘the mother’s anonymity’ Will readers understand that this refers to
surrogacy?
-84 PGS is not the same as PGD. Either explain or delete reference to PGS.
Better leave PGS out, as according to ESHRE guidelines this is a still unproven
technology that although widely marketed for commercial reasons, should not be
offered outside a research context.
-115 ‘reproductive tourism’: ESHRE guidelines have rejected the use of this term
as it is depreciatory; instead official documents refer to ‘cross border reproductive
care’.
-134 ‘blatant’. Is violation not enough?
-142 ‘sterile’ . Why not: couples with fertility problems? (many of which will not be
technically sterile)
-172 ‘pre-implant diagnosis’. Should be pre-implantation. Or better: PGD (the
abbreviation is introduced earlier in the paper).
-189 Italia> Italy
-203 ‘ideology’ is not a neutral term.
-256 ‘ trend toward open identity’ The authors seem to suggest that sticking to
anonymity would be wrong if there is such a trend? Why would that be so? Line
262 ‘ At the same time….’ This suggests that this EC ruling has definite
implications for the open identity vs anonymity issue. It is not clear at all whether
that would be the case.
Discretionary revisions:
Further to the above comments, I propose skipping lines 240-289. It seems
enough to list the key points for further debates as presented in lines 234ff.
Level of interest: An article of limited interest
Quality of written English: Acceptable
Statistical review: No, the manuscript does not need to be seen by a statistician.
Declaration of competing interests:
'I declare that I have no competing interests'