El Comité para la igualdad de oportunidades entre mujeres y

The NTA was an important part of the official ova provision regime due to its supervisory and regulatory role, however its activity involved more than the provision of gametes. During our interview, Severin expressed his deep contempt for the fact that IVF was added to the

NTA’s responsibilities on top of the organ procurement activities, which had constituted its point of focus throughout the years. Severin was adamant that another, dedicated authority should have taken on the supervision of IVF and release the NTA from this administrative burden.

Severin elaborated:

They [medical professionals] ask us all kinds of things, that we approve all kinds of transfers between clinics, things that have no connection to (…) some asked to use [sperm] from a cadaver, again, it is not in our competence to authorise it, but they ask us because this is what they think they should do, since it is called a competent authority you have to answer for everything, it is a communist idea, it’s not really like that, each has their own field of competence. What we authorise are imports, especially sperm imports (...) But we ensure they respect quality standards (...), and that they enter the country legally, that is our only competence.

(Mircea Severin, legislator, interview)

Although Severin emphasises the NTA’s role as primarily concerned with accrediting cell banks, the role of the institution is practically much broader, since it is the main advisor for both state institutions and medical professionals in relation to more contentious aspects of AR. Assessing requests for sperm imports is a routine activity, but other less mundane issues, usually unregulated, such as surrogacy or sperm retrievals from dead persons, also have to be tackled by the NTA. In this context, the image of the NTA and its representatives as specialists with legitimacy in IVF matters is contested by Severin himself, who points an accusing finger not at the institution but at the authorities which enabled the obfuscation of the NTA’s role. This adds another layer to understanding why ova and organs might have been cast as

equivalent entities as part of the official regime: institutional shortages required a simplification of the material-discursive practices governing provision. It is not clear who should be held accountable for this institutional organisation, as the entangled decision making agencies have made the attribution of responsibility difficult (Beck, 1998). But the

unclear status of the NTA affects its legitimacy in the eyes of medical professionals, who sometimes find the authority’s personnel

inadequately prepared to guide them through what they perceive as an unclear legal framework.

The relationship between medical professionals and the NTA highlights a process of boundary drawing between specialists, triggered not only by hierarchical relationships - the NTA is ultimately responsible for accrediting fertility clinics - but also by what is considered to count as relevant expertise. The main goal of the NTA, as presented by Severin, is to ultimately ensure assisted reproduction remains inside legal

boundaries, preferring a strategy of prevention when such boundaries do not exist (for e.g., surrogacy was not regulated, so the NTA rejected such requests). But ambiguities are not tolerated by the authorities even when they stem from already existing legal provisions. Any complications arising in medical settings due to such legal difficulties are deemed irrelevant by the NTA even when the institution has the power to influence regulations. In these cases, the fault is attributed to infertility specialists’ lack of professionalisation: “they don’t have a clue what medicine is,” Mircea Severin declared during an interview. In his view, a proper infertility specialist should be knowledgeable not only in medical issues, but also legal ones, and legal provisions, like medical

procedures, seem to be endowed with unquestionable scientific

objectivity. Medical professionals are not completely excluded from the decisions made by NTA, as Manea explained below. However, judging by the difficulties they encounter in interpreting NTA’s regulations, their impact is hard to evaluate:

They [the NTA] are the authority that authorises and inspects us regularly, and they do it very seriously. I mean, of course they request specialised opinions from time to time, they asked us to send protocol recommendations when they made some changes, but in principle we are not collaborators. (Doina Manea, clinician, interview)

Manea’s account illustrates a process of continuous performance on the part of both the NTA and infertility specialists meant to negotiate the boundaries of their competence. Their identities as professionals are constantly put to the challenge, contested and reconfirmed as they

define what legal medical procedures entail. The performativity of the law – what it allows to be done and what it forbids – is temporarily settled, one case at a time. Since what is legally acceptable is not necessarily defined once and for all, clarifications are constantly required by medical professionals in relation to less routine procedures:

We requested their help in a variety of issues, about sperm imports, and what we can do with some embryos which were imported and the patients no longer want to use them because they obtained 2 pregnancies and don’t wish to keep them, because they have to pay for the embryos’ preservation. So, we asked if we can use them, without any material advantage, so that, as they were donated to the clinic we would donate them further to couples who need them (...). Their [the NTA’s] answer was negative, although it seems to me a bit...I don’t understand why, if somebody wanted to donate them and somebody could have used them, it was a useless material investment by that couple but which could have helped somebody else. (Sonia Ducu, clinician and embryologist, interview)

Embryo donation is regulated in the same way as ova provision, so for Ducu the NTA’s negative answer came as a surprise. The fact that she could not explain this refusal even at the time of our interview

illustrates that the same law can lead to different outcomes at different moments in time. Such unforeseeable procedural deliberations affect the NTA’s image as a trustworthy, knowledgeable institution, delegitimising its supervisory role. On the other hand, medical professionals

acknowledge the NTA’s difficulties in having to fill in missing legal

provisions, but on the other, they question the reasons at the basis of the NTA’s decisions, as the above-cited case shows. Clinicians and

embryologists have their own understanding of what appropriate

supervision requires, and are ambivalent, if not outright critical, of the assisted reproduction expertise the NTA personnel has. Under the gaze of infertility specialists, the hard strokes of the official regime become blurred, divorced from the material imperatives of medical practice.

Asked about whether she believed the NTA has the capacity to

appropriately supervise the assisted reproductive industry, Ducu replied:

Not at all, far from what they should do. In my opinion, they are asked for things they cannot deliver. They have no personnel, they have no money, they have no specialists, they can’t do it.

They can’t do it. (Sonia Ducu, clinician, embryologist, interview)

I know they handle everything, transplant... I mean, not only [assisted reproduction] ... and I haven’t identified any person dedicated [to assisted reproduction] ... at one point, we offered to pay a yearly tax, all clinics, so they could hire a dedicated person, who knows what it’s all about, because answers to any problem come very slowly, they are not specialised exactly in this field.

And maybe they don’t necessarily understand that this is not identical with [organ] transplant, that there are some peculiarities.

But, apparently, it can’t be done. (Doina Manea, clinician, interview)

The lack of specialisation that these medical professionals spoke of, which consists primarily in the conflation of assisted reproduction with organ transplant, has had an important impact on shaping the official regime of ova provision, especially its monetary aspect, as I have already discussed. But despite these perceived conundrums, politically, the authority of the NTA, and especially of Severin, could not be

challenged: although medical professionals have been invited to contribute to law proposals, and certain divergences between other legislators and Severin have occurred, the latter retained his position of expertise both due to his institutional position and professional career.

Illustrative of this point is the way in which he was addressed during one Parliamentary debate concerning the latest proposal on assisted

reproduction: the leader of the discussions called him ‘professor’ even though he had no academic qualifications to recommend him as such.

While in Parliament this does not mean he has the last say, his

regulations as part of the NTA are immune to outside intervention from stakeholders. Given the multiple roles Severin has accumulated, he has had the power to frame the take on ova provision in a similar manner across sites (Delazay and Rask Madsen, 2006, cited in Woll and

Jacquot, 2010). This shows that the official regime has emerged through the enactment of a complex apparatus made of institutions, laws,

technologies and practices in a field of unequal power relationships. The regime, then, sets the boundaries to not only what legal ova provision is, but also to who is entitled to effect changes on those boundaries. The intra-action of boundaries and the identities of those enacting them comes to the forefront through this dynamic of mutual determination.

The NTA is part of varying regulating processes, and its expert opinion has often been requested not only by medical professionals, but also by the Parliament. Besides the fact that NTA representatives have attended debates as part of legislation adoption, many law proposals requested the agency to further detail the methodological guidelines of the medical practices they regulated. Along the years, the NTA has issued several such regulations, and it is these that act as guidance for infertility specialists. For Severin, this sometimes accumulated to what he considers an exaggerated burden:

I know some of these NGOs came up with this law 5-6 years ago, it was unimaginable, a stupidity which...at one point I even

suspected them of something else, they were either stupid, or...once every two lines they wrote: the NTA will regulate, the NTA will regulate. So, they were making a law that told me I had to regulate everything afterwards. (Mircea Severin, legislator, interview)

Through Severin’s words the picture of a power struggle is constructed, based on how and to whom scientific legitimacy should be attributed and where politics end, making way for expert contribution and

vice versa (Miller, 2004). His accusations, directed at various

stakeholders of assisted reproduction, focused on their lack of expertise as well as on their failures to be persistent in their legislation efforts. In talking about the regulations issued by the NTA, Severin often assumed authorship and, in so doing, illustrated a type of push and pull

relationship with other actors involved in regulating the field: he

emphasised the effort he and the institution have deployed in assisted reproduction and legitimised his standing as a dedicated policy maker that has to compensate for the lack of involvement of those who should be the primary bearers of the responsibility of regulation. However, although he apparently resents his role, he also expressed his

unwillingness to integrate others’ experiences and takes on the matter:

Morea said at one point that we are the only country which doesn’t have one [a law] and that the EU requests it....so let’s make one, on our knees, so at least we have it. Well, no, here I didn’t agree. If I do it, I do it right. (...) All European countries have a special law for this, Romania is the only one who doesn’t and we’re wasting time now in Parliament, you saw now, I don’t know how many meetings you’ve been to, you saw what circus they make, and you talk to people who have no idea, with all kinds of NGOs who want to be noticed. The law needs to be made by specialists, specialists need to regulate what is most important for the everyday person. (Mircea Severin, regulator, interview)

Severin is critical of the political processes that inform legislation adoption and especially of the plurality of voices that are involved in decision making, eluding the issue of accountability. He favours what he understands as a depoliticised approach to the matter, while totally confiding in the objectivity of science made and regulated by ‘specialists’, without clarifying what being a ‘specialist’ actually means. Public

participation, either through representatives in the Parliament, or through NGOs, is ruled out by Severin as unnecessary and even harming as it distracts attention, thus denying ‘the everyday person’ any claim to expertise. But while rhetorically he drastically delineates the borders

between specialists and non-specialists, in practice he performs an even more narrow allocation of expertise by ignoring the feedback infertility medical specialists give to NTA’s issued legislation, which he claims to have authored:

The [existing] legislation is very good and needs to be applied.

Now, everybody applies it as they understand it, if there are clinics who think it’s been outlawed [ova provision] or that it is very hard to do, that is their problem and their decision, I won’t change it just because they don’t understand how it needs to be applied. I don’t see why. (Mircea Severin, legislator, interview)

In the above quote, Severin refers to those infertility specialists who, after the issue of a set of secondary regulations entitled Norms for establishing a rapid system of alert for human organs, tissues, and cells transplant (2014), stopped doing IVF with provided ova due to what they perceived to be unclear legal provisions. Doina Manea, a clinician and owner of a fertility clinic, explained in an interview that the Norms had brought in questions for which they had no answer, such as the amounts of serum that needed to be stored. Later, she added:

Since this new regulation came up with the alert system, who had the eyes to see it, to read it, it scared us, we said that if we

needed to do that too it would be impossible to be legal, so practically you cannot continue that way and we stopped it

completely [IVF with provided ova]. And now everyone who needs it goes abroad. (Doina Manea, clinician, interview)

The official regime forces infertility specialists to perform ova provision choreographies that avoid the pitfalls of the official regime’s blind spots. What is left unwritten is as important as what is made known, and this line of visibility performs the role of a threshold

differentiating legal ova provision from ova ‘trafficking’. In practice, these regulations have led to a scarcity of ova after several clinics have

stopped performing this procedure. In order to be able to offer patients

IVF with ova, Manea has had to choose between the risk of being accused of illegalities, or bearing the high expenses of storing what she considers to be considerable amounts of biological material from

providers that cannot be charged since following the Sabyc case no medical facility can extract profits from gamete banking (RFI, 2009). At the same time, for Manea, the risk of being accused of ‘trafficking’ is too real, and she tends to believe that “almost everyone is surveilled one way or another”. With this remark, Manea recalls the spectre of the ova commercialisation cases which still affects the field of assisted

reproduction both in terms of legislation and medical practices. The understanding of ova ‘trafficking’ brought by the police regime has performed boundary delineations that leave little room for diverging interpretations of the intermingling of money and ova provision.

For the Romanian authorities in general, and Severin in particular, being accountable means not so much tending to the interests of all stakeholders, but rather escaping the responsibility for unwanted events.

The official ova provision regime regulates the flow of ova in such a strict manner that, if any complaints are made, they cannot contest the

authorities’ dedication to the public good, namely, what Severin calls the prevention of ‘abuse’ and the encouragement of altruism and social solidarity. The police regime, which highlighted the ‘dangers’ of commercialised provision in conjunction with greed and the pursuit of personal interests, has been integrated into a larger field of visibility. Due to its complexity and endurance in time, this field of visibility has the character of a regime. As such, it defines not only how ova provision is best understood and then regulated, but by whom. Neither overflowings, such as the Sabyc case in 2009, nor the shortcomings signalled by medical professionals have led to any major reconsideration of the regime, which begs the question of whether it has been a quick fix in the face of EU apprehensions following the Global ART case. The dynamics of power relationships comes to the fore in Severin’s discourse, where accountability clearly does not manifest in relation to those who have to abide by the regulations of the NTA, and who are thus of ‘lower ranking’.

The construction of their identities as lacking expertise legitimises their

exclusion from decision-making and obfuscates discussions that question the premises of the regime.

5.5 First attempts at altering the official ova provision