Urgent: 'no eForms, no fun' -- getting serious about building a procurement data architecture in the EU

EU Member States only have about one year to make crucial decisions that will affect the procurement data architecture of the EU and the likelihood of successful adoption of digital technologies for procurement governance for years or decades to come’. Put like that, the relevance of the approaching deadline for the national implementation of new procurement eForms may grab more attention than the alternative statement that ‘in just about a year, new eForms will be mandatory for publication of procurement notices in TED’.

This latter more technical (obscure, and uninspiring?) understanding of the new eForms seems to have been dominating the approach to eForms implementation, which does not seem to have generally gained a high profile in domestic policy-making at EU Member State level despite the Publications Office’s efforts.

In this post, I reflect about the strategic importance of the eForms implementation for the digitalisation of procurement, the limited incentives for an ambitious implementation that stem from the voluntary approach of the most innovative aspects of the new eForms, and the opportunity that would be lost with a minimalistic approach to compliance with the new rules. I argue that it is urgent for EU Member States to get serious about building a procurement data architecture that facilitates the uptake of digital technologies for procurement governance across the EU, which requires an ambitious implementation of eForms beyond their minimum mandatory requirements.

eForms: some background

The EU is in the process of reforming the exchange of information about procurement procedures. This information exchange is mandated by the EU procurement rules, which regulate a variety of procurement notices with the two-fold objective of (i) fostering cross-border competition for public contracts and (ii) facilitating the oversight of procurement practices by the Member States, both in relation to the specific procedure (eg to enable access to remedies) and from a broad policy perspective (eg through the Single Market Scoreboard). In other words, this information exchange underpins the EU’s approach to procurement transparency, which mainly translates into publication of notices in the Tenders Electronic Daily (TED).

A 2019 Implementing Regulation established new standard forms for the publication of notices in the field of public procurement (eForms). The Implementing Regulation is accompanied by a detailed Implementation Handbook. The transition to eForms is about to hit a crucial milestone with the authorisation for their voluntary use from 14 November 2022, in parallel with the continued use of current forms. Following that, eForms will be mandatory and the only accepted format for publication of TED notices from 25 October 2023. There will thus have been a very long implementation period (of over four years), including an also lengthy (11-month) experimentation period about to start. This contrasts with previous revisions of the TED templates, which had given under six months’ notice (eg in 2015) or even just a 20-day implementation period (eg in 2011). This extended implementation period is reflective of the fact that the transition of eForms is not merely a matter of replacing a set of forms with another.

Indeed, eForms are not solely the new templates for the collection of information to be published in TED. eForms represent the EU’s open standard for publishing public procurement data — or, in other words, the ‘EU OCDS’ (which goes much beyond the OCDS mapping of the current TED forms). The importance of the implementation of a new data standard has been highlighted at strategic level, as this is the cornerstone of the EU’s efforts to improve the availability and quality of procurement data, which remain suboptimal (to say the least) despite continued efforts to improve the quality and (re)usability of TED data.

In that regard, the 2020 European strategy for data, emphasised that ‘Public procurement data are essential to improve transparency and accountability of public spending, fighting corruption and improving spending quality. Public procurement data is spread over several systems in the Member States, made available in different formats and is not easily possible to use for policy purposes in real-time. In many cases, the data quality needs to be improved.’ The European Commission now stresses how ‘eForms are at the core of the digital transformation of public procurement in the EU. Through the use of a common standard and terminology, they can significantly improve the quality and analysis of data’ (emphasis added).

It should thus be clear that the eForms implementation is not only about low level form-filling, but also (or primarily) about building a procurement data architecture that facilitates the uptake of digital technologies for procurement governance across the EU. Therefore, the implementation of eForms and the related data standard seeks to achieve two goals: first, to ensure the data quality (eg standardisation, machine-readability) required to facilitate its automated treatment for the purposes of publication of procurement notices mandated by EU law (ie their primary use); and, second, to build a data architecture that can facilitate the accumulation of big data so that advanced data analytics can be deployed by re-users of procurement data. This second(ary) goal is particularly relevant to our discussion. This requires some unpacking.

The importance of data for the deployment of digital technologies

It is generally accepted that quality (big) data is the primary requirement for the deployment of digital technologies to extract data-driven insights, as well as to automate menial back-office tasks. In a detailed analysis of these technologies, I stress the relevance of procurement data across technological solutions that could be deployed to improve procurement governance. In short, the outcome of robotic process automation (RPA) can only be as good as its sources of information, and adequate machine learning (ML) solutions can only be trained on high-quality big data—which thus conditions the possibility of developing recommender systems, chatbots, or algorithmic screens for procurement monitoring and oversight. Distributed Ledger Technology (DLT) systems (aka blockchain) can manage data, but cannot verify its content, accuracy, or reliability. Internet of Things (IoT) applications and software oracles can automatically capture data, which can alleviate some of the difficulties in generating an adequate data infrastructure. But this is only in relation with the observation of the ‘real world’ or in relation to digitally available information, which quality raises the same issues as other sources of data. In short, all digital technologies are data-centric or, more clearly, data-dependent.

Given the crucial relevance of data across digital technologies, it is hard to emphasise how any shortcomings in the enabling data architecture curtail the likelihood of successful adoption of digital technologies for procurement governance. With inadequate data, it may simply be impossible to develop digital solutions at all. And the development and adoption of digital solutions developed on poor or inadequate data can generate further problems—eg skewing decision-making on the basis of inadequately derived ‘data insights’. Ultimately, then, ensuring that adequate data is available to develop digital governance solutions is a challenging but unavoidable requirement in the process of procurement digitalisation. Success, or lack of it, in the creation of an enabling data architecture will determine the viability of the deployment of digital technologies more generally. From this perspective, the implementation of eForms gains clear strategic importance.

eForms Implementation: a flexible model

Implementing eForms is not an easy task. The migration towards eForms requires a complete redesign of information exchange mechanisms. eForms are designed around universal business language and involve the use of a much more structured information schema, compatible with the EU’s eProcurement Ontology, than the current TED forms. eForms are also meant to collect a larger amount of information than current TED forms, especially in relation to sub-units within a tender, such as lots, or in relation to framework agreements. eForms are meant to be flexible and regularly revised, in particular to add new fields to facilitate data capture in relation to specific EU-mandated requirements in procurement, such as in relation with the clean vehicles rules (with some changes already coming up, likely in November 2022).

From an informational point of view, the main constraint that remains despite the adoption of eForms is that their mandatory content is determined by existing obligations to report and publish tender-specific information under the current EU procurement rules, as well as to meet broader reporting requirements under international and EU law (eg the WTO GPA). This mandatory content is thus rather limited. Ultimately, eForms’ main concentration is on disseminating details of contract opportunities and capturing different aspects of decision-making by the contracting authorities. Given the process-orientedness and transactional focus of the procurement rules, most of the information to be mandatorily captured by the eForms concerns the scope and design of the tender procedure, some aspects concerning the award and formal implementation of the contract, as well as some minimal data points concerning its material outcome—primarily limited to the winning tender. As the Director-General of the Publications Office put it an eForms workshop yesterday, the new eForms will provide information on ‘who buys what, from whom and for what price’. While some of that information (especially in relation to the winning tender) will be reflective of broader market conditions, and while the accumulation of information across procurement procedures can progressively generate a broader view of (some of) the relevant markets, it is worth stressing that eForms are not designed as a tool of market intelligence.

Indeed, eForms do not capture the entirety of information generated by a procurement process and, as mentioned, their mandatory content is rather limited. eForms do include several voluntary or optional fields, and they could be adapted for some voluntary uses, such as in relation to detection of collusion in procurement, or in relation to the beneficial ownership of tenderers and subcontractors. Extensive use of voluntary fields and the development of additional fields and uses could contribute to generating data that enabled the deployment of digital technologies for the purposes of eg market intelligence, integrity checks, or other sorts of (policy-related) analysis. For example, there are voluntary fields in relation to green, social or innovation procurement, which could serve as the basis for data-driven insights into how to maximise the effects of such policy interventions. There are also voluntary fields concerning procurement challenges and disputes, which could facilitate a monitoring of eg areas requiring guidance or training. However, while the eForms are flexible, include voluntary fields, and the schema facilitates the development of additional fields, is it unclear that adequate incentives exist for adoption beyond their mandatory minimum content.

Implementation in two tiers

The fact that eForms are in part mandatory and in part voluntary will most likely result in two separate tiers of eForms implementation across the EU. Tier 1 will solely concern the collection and exchange of information mandated by EU law, that is the minimum mandatory eForm content. Tier 2 will concern the optional collection and exchange of a much larger volume of information concerning eg the entirety of tenders received, as well as qualitative information on eg specific policy goals embedded in a tender process. Of course, in the absence of coordination, a (large) degree of variation within Tier 2 can be expected. Tier 2 is potentially very important for (digital) procurement governance, but there is no guarantee that Member States will decide to implement eForms covering it.

One of the major obstacles to the broad adoption of a procurement data model so far, at least in the European Union, relates to the slow uptake of e-procurement (as discussed eg here). Without an underlying highly automated e-procurement system, the generation and capture of procurement data is a main challenge, as it is a labour-intensive process prone to input error. The entry into force of the eForms rules could serve as a further push for the completion of the transition to e-procurement—at least in relation to procurement covered by EU law (as below thresholds procurement is a voluntary potential use of eForms). However, it is also possible that low e-procurement uptake and generalised unsophisticated approaches to e-procurement (eg reduced automation) will limit the future functionality of eForms, with Member States that have so far lagged behind restricting the use of eForms to tier 1. Non life-cycle (automated) e-procurement systems may require manual inputs into the new eForms (or the databases from which they can draw information) and this implies that there is a direct cost to the implementation of each additional (voluntary) data field. Contracting authorities may not perceive the (potential) advantages of incurring those costs, or may more simply be constrained by their available budget. A collective action problem arises here, as the cost of adding more data to the eForms is to be shouldered by each public buyer, while the ensuing big data would potentially benefit everyone (especially as it will be published—although there are also possibilities to capture but not publish information that should be explored, at least to prevent excessive market transparency; but let’s park that issue for now) and perhaps in particular data re-users offering for pay added-value services.

In direct relation to this, and compounding the (dis)incentives problem, the possibility (or likelihood) of minimal implementation is compounded by the fact that, in many Member States, the operational adaptation to eForms does not directly concern public sector entities, but rather their service providers. e-procurement services providers compete for the provision of large volume, entirely standardised platform services, which are markets characterised by small operational margins. This creates incentives for a minimal adaptation of current e-sending systems and disincentives for the inclusion of added-value (data) services potentially unlikely to be used by public buyers. Some (or most) optional aspects of the eForm implementation will thus remain unused due to these market structure and dynamics, which does not clearly incentivise a race to the top (unless there is clear demand pull for it).

With some more nuance, it should be stressed that it is also possible that the adoption of eForms is uneven within a given jurisdiction where the voluntary character of parts of the eForm is kept (rather than made mandatory across the board through domestic legislation), with advanced procurement entities (eg central purchasing bodies, or large buyers) adopting tier 2 eForms, and (most) other public buyers limiting themselves to tier 1.

Ensuing data fragmentation

While this variety of approaches across the EU and within a Member State would not pose legal challenges, it would have a major effect on the utility of the eForms-generated data for the purposes of eg developing ML solutions, as the data would be fragmented, hardly representative of important aspects of procurement (markets), and could hardly be generalisable. The only consistent data would be that covered by tier 1 (ie mandatory and standardised implementation) and this would limit the potential use cases for the deployment of digital technologies—with some possibly limited to the procurement remit of the specific institutions with tier 2 implementations.

Relatedly, it should be stressed that, despite the effort to harmonise the underlying data architecture and link it to the Procurement Ontology, the Implementation Handbook makes clear that ‘eForms are not an “off the shelf” product that can be implemented only by IT developers. Instead, before developers start working, procurement policy decision-makers have to make a wide range of policy decisions on how eForms should be implemented’ in the different Member States.

This poses an additional challenge from the perspective of data quality (and consistency), as there are many fields to be tailored in the eForms implementation process that can result in significant discrepancies in the underlying understanding or methodology to determine them, in addition to the risk of potential further divergence stemming from the domestic interpretation of very similar requirements. This simply extends to the digital data world the current situation, eg in relation to diverging understandings of what is ‘recyclable’ or what is ‘social value’ and how to measure them. Whenever open-ended concepts are used, the data may be a poor source for comparative and aggregate analysis. Where there are other sources of standardisation or methodology, this issue may be minimised—eg in relation to the green public procurement criteria developed in the EU, if they are properly used. However, where there are no outside or additional sources of harmonisation, it seems that there is scope for quite a few difficult issues in trying to develop digital solutions on top of eForms data, except in relation to quantitative issues or in relation to information structured in clearly defined categories—which will mainly link back to the design of the procurement.

An opportunity about to be lost?

Overall, while the implementation of eForms could in theory build a big data architecture and facilitate the development of ML solutions, there are many challenges ahead and the generalised adoption of tier 2 eForms implementations seems unlikely, unless Member States make a positive decision in the process of national adoption. The importance of an ambitious tier 2 implementation of eForms should be assessed in light of its downstream importance for the potential deployment of digital technologies to extract data-driven insights and to automate parts of the procurement process. A minimalistic implementation of eForms would significantly constrain future possibilities of procurement digitalisation. Primarily in the specific jurisdiction, but also with spillover effects across the EU.

Therefore, a minimalistic eForms implementation approach would perpetuate (most of the) data deficit that prevents effective procurement digitalisation. It would be a short-sighted saving. Moreover, the effects of a ‘middle of the road’ approach should also be considered. A minimalistic implementation with a view to a more ambitious extension down the line could have short-term gains, but would delay the possibility of deploying digital technologies because the gains resulting from the data architecture are not immediate. In most cases, it will be necessary to wait for the accumulation of sufficiently big data. In some cases of infrequent procurement, missing data points will generate further time lags in the extraction of valuable insights. It is no exaggeration that every data point not captured carries an opportunity cost.

If Member States are serious about the digitalisation of public procurement, they will make the most of the coming year to develop tier 2 eForms implementations in their jurisdiction. They should also keep an eye on cross-border coordination. And the European Commission, both DG GROW and the Publications Office, would do well to put as much pressure on Member States as possible.

Interesting Procurement Paper (Li & Xu, 2016): A Blueprint for Variable Remuneration of Public Procurement Officers? A Warning against some types of Centralised Procurement?

I have just read the paper by D Z Li and M Xu, 'Competition in Procurement Auctions with Corruption' (February 2, 2016), which assesses an interesting scenario of competition in public procurement tenders where the person in charge of running the procedure (the procurement officer, or 'bureaucrat', in their terminology) can require bribes from winning bidders, and where those bribes can be proportionate to the final value of the contract awarded.

Their paper is interesting because it fleshes out the incentives that a bureaucrat that expects to obtain a rent at the end of the procedure has, both in terms of affecting the number of bidders (to reduce it), and the level of disclosure of information (to conceal information in order to cover the corrupt practice). My personal intuition is that their insights should be useful to consider non-corrupt scenarios involving buyer rents other than bribes and, in particular, the introduction of bonuses or other variable retribution mechanisms for public buyers, which could well create the same incentives (as discussed below). Moreover, I find the paper thought-provoking because (legitimate) kick-backs are used to finance the activities of central purchasing bodies, which raises issues of their impact on social welfare if they behave like individual bureaucrats would (as also discussed below).

The paper and its model

As they explain in their abstract:

We study the effects of corruption on equilibrium competition and social welfare in a public procurement auction. A bureaucrat runs the auction on behalf of the government. He invites firms into the auction at positive costs, and may request a bribe from the winning firm afterward[s]. We first show that, in the absence of corruption, the bureaucrat invites more firms than social optimum under quite standard assumptions. Secondly, the effects of corruption on competition and social welfare vary across different forms of bribery. In the case of fixed bribe, corruption has no effect on equilibrium competition, yet [it does] induce social welfare loss due to the distortion cost of increased public spending. In the case of proportional bribe, the corrupt bureaucrat will invite less firms into the auction, which may result in Pareto-improving allocation in equilibrium. Finally, we also show that information disclosure may consistently induce more firms to be invited, if compared with the case of no information disclosure, no matter [whether] there is corruption or not.

I find some of the assumptions and insights of their paper particularly thought-provoking. They (implicitly) base their model on the existence of an agency relationship between the bureaucrat and the government, as well as between the government and society at large [for discussion, see here and here and, in Spanish, here]. This makes the model interesting from the perspective of the social externalities that improperly designed public procurement models can create, particularly if they allow public buyers to pursue (self-serving) goals that do not align with promotion of social welfare.

In their paper, Li & Xu explain that 'the government is modelled as a government division ... who cares about its own procurement pay-off rather than the overall social welfare' (p. 2). This can lead to designing the procurement process in a manner that invites too many interested bidders because 'the optimal number of firms that maximizes the government's pay-off is larger than the efficient number of firms that maximizes social welfare' (ibid), and due to the fact that 'the government prefers [a] higher level of competition in the procurement process' than would be socially efficient (p. 3). The undesirability of the excessive number of bidders is mainly derived from the costs they incur in order to participate in the tender, which are wasted for all those that did not stand a real chance of winning the contract (or, indeed, for all except the winning bidder).

The main insight of their paper is that, while the existence of a fixed bribe hurts both the government and society at large due to the higher cost of procurement, the existence of a proportionate bribe may 'increase social welfare [by inducing an efficient number of firms, or just one firm, to be invited], yet it hurts the government, as the government prefers higher level of competition in the procurement process' because that reduces its (private) procurement cost and imposes the externality derived from excessive tendering costs assumed by the disappointed private bidders [for discussion on the absence of consideration of these costs in economic surveys supporting recent public procurement law reforms in the EU, see here].

Their insight is based, among other elements, on the 'standard assumption for procurement auctions that firms' cost distribution is of decreasing reversed hazard rate (DRHR)' (p. 1, for an explanation of the reversed hazard rate and how it operates, see here). As Li & Xu explain, 'The intuition behind this ... is that increasing competition will gradually squeeze out the expected rent of the winning firm. Furthermore, the expected rent converges to zero when the number of firms approaches to infinity'. Or, in very simple words, that the lower the number of bidders, the higher the expected rent by those that participate. That is what would allow bidders to tender less competitive prices when competitive pressure is reduced (ie less bidders are invited), which would also be in the interest of the bureaucrat expecting to receive a proportional bribe (a higher rent for the winning bidder carries a higher rent for the bureaucrat as well).

They also stress in clear terms that 'information disclosure will increase both the efficiency and the optimal number of firms in the procurement auction. The intuition is that, under information disclosure, firms' cost estimates become more heterogen[e]ous, and therefore, for [a] given number of firms, the auction becomes less competitive than before' (p. 13). Furthermore, 'under information disclosure, firms become more heterogen[e]ous in their cost estimates, and the winning rent, which [in their model] is the difference between the lowest and second lowest costs, may also get larger as well'. However, t'when a corrupt bureaucrat can control information release, it would be more difficult to detect corruption. As we know, information disclosure implies more firms to be invited into the auction, and corruption under the proportion[ate] bribe implies less firms to be invited. The combined effects of these two are mixed'. Overall, then, the implications of their findings seems to be that a corrupt bureaucrat will have mixed incentives on whether to reduce the volume of information disclosed in the tender process because more information may increase its own proportionate rent, but it will also trigger both more interest in the tender and more risk of detection of the corruption.

a blueprint for variable remuneration of procurement officers?

As mentioned, my intuition is that these insights can be useful to consider non-corrupt scenarios involving 'bureaucrat' rents other than bribes and, in particular, the introduction of bonuses or other variable retribution mechanisms for public buyers, which could well create the same incentives. My intuition is that, should the bureaucrat have a legal financial incentive to obtain a rent a the end of the tender, and should the existence of this rent not need to be hidden, it would have an incentive to pursue strategies that maximize social value (even if not necessarily government pay-offs) by disclosing information that reduces the number of potentially interested bidders for which the tender is not actually competitive. Moreover, the financial incentive could include an element of reverse proportionality, so that the bonus would be larger when the government pay-off is increased (ie when the total cost of the procurement is reduced as much as possible within the framework of the competition between the efficient number of bidders). If this is true, then, one of the main aspects that Member States should consider going forward would not only be linked to decisions on how to transpose and develop the rules for restricted procedures and for procurement procedures involving negotiations, but also linked to the establishment of appropriate systems of incentives for procurement officers (bureaucrats) to make the right choice of procedure and to conduct the tender in a way that is aligned with social welfare and with (intra)governmental pay-offs.

what implications for kick-back based central purchasing financing?

Central purchasing bodies (CPBs) can be financed in many ways, but a popular model is for them to receive kick-backs (in the form of rappels of fees) from suppliers included in the framework agreements and other contracts that CPBs manage. Those kick-backs are generally proportionate the value of the call-offs that end-user contracting authorities place with each supplier. In that case, the CPB is not in a different economic position than a procurement officer (bureaucrat) expecting to receive a proportionate rent (or bribe) at the end of the procurement process it runs. Therefore, it seems to me that one of the transferable insights of Li & Xu's paper is that CPBs will be structurally in a situation where they might as well aim to achieve the highest rent, which would require for them to reduce the number of bidders and (possibly, but not necessarily) the information disclosed at the outset of the procedure, so as to reduce the number of competitors and increase their expected rents--thus triggering higher kick-backs for the CPB. This would match well with the intuition that CPBs can become self-interested organisations in the way they run their framework agreements, and not pay excessive attention to the real interest of their principal (end-user contracting authorities) or society at large, particularly if the use of their services is mandatory (ie if they do not need to justify net advantages, at least for the end-user contracting authorities, in order to attract volume of orders).

If this intuition holds true, it would be interesting to look at the impact of the financing of CPBs through kick-backs in more detail, in order to assess whether this system of financial incentives and rewards fosters social welfare overall, or is only beneficial for the CPB (and/or, the government) at the expense of broader social interests. This would be particularly relevant if, as anecdotal evidence indicates, access to centralised procurement is difficult for most firms (and, in particular, SMEs), so that CPBs structurally reduce the number of bidders for their (large) contracts, which the model in the paper would suggest increases the rents for both the CPBs and the included suppliers, but imposes both direct costs on government (through higher procurement costs that could be achievable in alternative settings of increased competition within CPB procurement) and indirect social costs via externalities [for discussion of some of these economic issues, see here].

Don't skip a beat: CJEU intends to strengthen consumer protection of medical devices, but does it? (C-503/13)

In the interesting Judgment in Boston Scientific Medizintechnik, C-503/13, EU:C:2015:148, the Court of Justice of the European Union (CJEU) has clarified the requirements for the application of the EU rules on liability for damage caused by defective products to the manufacturers of potentially defective medical devices which substitution require surgical intervention. 

In the case at hand, the issue was whether the manufacturer of potentially defective pacemakers and implantable cardioverter defibrillators was liable to cover the cost of surgery and related damages to patients that needed those potentially defective products replaced. 

In a clear and rather short Judgment, the CJEU has ruled that such situations are covered by the special liability regime. This is bound to trigger commercial adjustments in this sector, as well as in the insurance sector and I would not be surprised if the Boston Scientific Medizintechnik is strongly criticised. I can think of some reasons why, which I sketch below.

The key controversial legal issues were whether the mere fact that a specific product is potentially defective suffices to classify it as defective for the purposes of EU law and, if so, whether the surgery needed to replace (potentially) defective medical devices was within the scope of the damages imposed on the producer. The CJEU has answered both questions in the affirmative. Some of its reasoning is worth considering in detail.

Firstly, regarding the way in which potentially defective medical devices should be treated, the CJEU determined that
37 ... a product is defective when it does not provide the safety which a person is entitled to expect, taking all the circumstances into account, including the presentation of the product, the use to which it could reasonably be expected that it would be put and the time when the product was put into circulation. Moreover ... that assessment must be carried out having regard to the reasonable expectations of the public at large.
38 The safety which the public at large is entitled to expect ... must therefore be assessed by taking into account, inter alia, the intended purpose, the objective characteristics and properties of the product in question and the specific requirements of the group of users for whom the product is intended.
39 With regard to medical devices such as the pacemakers and implantable cardioverter defibrillators at issue in the main proceedings, it is clear that, in the light of their function and the particularly vulnerable situation of patients using such devices, the safety requirements for those devices which such patients are entitled to expect are particularly high.
40 Moreover, as observed, in essence, by the Advocate General at point 30 of his Opinion, the potential lack of safety which would give rise to liability on the part of the producer ... stems, for products such as those at issue in the main proceedings, from the abnormal potential for damage which those products might cause to the person concerned.
41 Accordingly, where it is found that such products belonging to the same group or forming part of the same production series have a potential defect, it is possible to classify as defective all the products in that group or series, without there being any need to show that the product in question is defective
(C-503/13, paras 37 to 41, emphasis added).
This is a very significant line of reasoning, as it clearly establishes that the potential for damage is an element to take into consideration when assessing the level of safety that users of specific products can expect. In that regard, the higher the potential for damages (in this case, possibly, death), the lower the threshold for the special liability regime to be applicable. This basically comes to create a further objectification of the test for the imposition of objective liability under the EU rules and, in my view, significantly raises the financial risks faced by producers of medical devices. 

A law and economics detailed assessment would be necessary, but this case seems like a good candidate in the list of cases where the good intentions of the CJEU may create unforeseen and undesirable effects, eg by imposing additional costs on producers of medical devices that they pass-on to consumers, ultimately pricing out those with a lower acquisition power [for general discussion, see A Sanchez Graells,  The Importance of Assessing the Economic Impact of the Case Law of the Court of Justice of the European Union: Some Exploratory Thoughts (April 18, 2013)].

An alternative approach could have been explored by focusing on the level of security that medical professionals could expect, as medical devices are clearly not products directly offered to their end users. More alternatives could have been explored in view of the fact that the claimants in the case are mandatory insurance funds and not the ultimate users of the medical devices, which could also have triggered an analysis of the justification for medical insurance itself and the eventual obligation of medical insurers to absorb some of the risks they are perceived to insure. However, none of these issues are addressed by the CJEU in its Boston Scientific Medizintechnik Judgment.

http://candorville.com/2013/08/16/hypocritical-oath/

Secondly, regarding the classification of the surgery costs and related damages as "damage caused by death or by personal injuries" for the purposes of EU law, the CJEU made a distinction based on the recommendations of the manufacturer as to how best to minimise or reduce the risk derived from the potential defect. In that regard, it is worth stressing that
49 Compensation for damage thus relates to all that is necessary to eliminate harmful consequences and to restore the level of safety which a person is entitled to expect...
50 As a consequence, in the case of medical devices, such as pacemakers and implantable cardioverter defibrillators, which are defective ... compensation for damage must cover, inter alia, the costs relating to the replacement of the defective product.
51 In the present case ...
[the manufacturer/importer] recommended to surgeons that they should consider replacing the pacemakers in question.
52 In that case, the Court finds that the costs relating to the replacement of such pacemakers, including the costs of the surgical operations, constitute damage ... for which the producer is liable...
53 That finding may be different in the case of implantable cardioverter defibrillators, as
[the manufacturer/importer] recommended ... that the magnetic switch of those medical devices should simply be deactivated.
54 In that regard, it is for the national court to determine whether, having regard to the particularly vulnerable situation of patients using an implantable cardioverter defibrillator, the deactivation of the magnetic switch is sufficient for the purpose of overcoming the defect in that product, bearing in mind the abnormal risk of damage to which it subjects the patients concerned, or whether it is necessary to replace that product in order to overcome the defect
(C-503/13, paras 49 to 54, emphasis added).
In my view, this nuanced approach of the CJEU that makes the imposition of liability dependent on the recommendation issued by the manufacturer/importer of the potentially defective medical devices is tricky. On the one hand, it shows some space for technical considerations and allows manufacturers to take responsibility in finding the best ways to correct the defect or substitute the defective product. 
 
On the other hand, however, the CJEU is not very clear on this point and hints at the fact that the "particularly vulnerable situation of patients using an implantable cardioverter defibrillator" may tilt the national court's assessment on whether the manufacturer/importer's recommendation was actually fit for purpose. Once more, the focus seems to be in the wrong place, as the technical criteria of the doctors is not being taken into consideration.

If doctors performed an operation to substitute certain medical devices despite the fact that the manufacturer/importer had recommended a less intrusive approach, the medical criterion should be taken into account and, most likely, prevail. A doctor under the Hippocratic Oath is under a duty not to impose (unnecesary) suffering or damage. In this specific context, a doctor would be liable for performing an unnecessary surgery to replace a potentially defective medical device that could be satisfactorily fixed in an alternative way.
 
Hence, determining that the intervention was not necessary (ie releasing the manufacturer/importer from liability) would almost automatically trigger liability for the doctor. This, again, would create undesirable incentives for physicians, who would abstain from replacement surgery where the manufacturer/importer recommendation was different. In that case, there would be no technical check on the manufacturer/importer's views, and users (rectius, patients) could be at a clear disadvantage.

All in all, then, I think that the CJEU's Boston Scientific Medizintechnik Judgment creates significant distortions in the incentives that all parties involved have when medical devices are potentially defective. In my view, this derives from a lack of thought on the implications derived from the fact that medical devices are not acquired freely or willingly by their users, but under a strong prescriptive supervision by the medical profession. And that, in turn, their activities are further overseen (and influenced) by medical insurers. This is something that I would like to see gain more space in future Judgments or, otherwise, the consumerization of healthcare will end up actually under-protecting patients.

A 'private tax-payer test' for State aid? ... or how the Commission is not getting it (about the Apple APA case)

Thanks to @Detig's twitter encouragement, I have finally set out to read the recently released 11 June 2014 Decision of the European Commission SA.38373 in the case of alleged Irish aid to Apple due to the treatment of its advanced pricing arrangements (APAs). Generally, this is a case that pushes the boundaries of State aid law as tax sovereignty is concerned and may force some interesting developments. However, in the particulars, its seems that some of the foundations of the Commission's position are rather shaky.
 
In my view, one of the points where the Commission's logic is particularly flimsy comes when it tries to justify the application of the private operator/investor test in this context, in what should be rebranded as 'private tax-payer' test, by stressing that 'to avoid this type of advantage [ie the allocation of profit to subsidiaries in low tax jurisdictions] it is necessary to ensure that taxable income is determined in line with the taxable income a private operator would declare in a similar situation' (para 9, emphasis added). This just does not make sense and incorrectly focusses on the incentives of the economic operator (tax payer) instead of those of the tax authority (which, in the end, is the one that may have accepted APAs that granted an undue economic advantage to the former).
 
 As the Commission had itself very clearly indicated (para 8 of the same document), the financial incentives that (multinational) private operators have are exactly in line with Apple's behaviour. Hence, the Commission should have stuck to the simple truth that, from an economic perspective, the only rational behaviour that can be expected from economic (corporate) operators is to try to minimise fiscal pressure and to incentivise their tax directors to do so [Armstrong, Blouin & Larcker, 'The incentives for tax planning' (2012) 53(1) Journal of Accounting and Economics 391-411].
 
This may not be the socially desirable behaviour, and precisely that is why tax law is there [as, indeed, 'if we were ideally virtuous, there would be no need to study what people should pay in taxes to finance subsidies to the poor, the employment of a police force, and provision of an urban infrastructure, or to find ways of reducing the environmental damage we do'; J Mirrlees, Welfare, Incentives, and Taxation (Oxford, OUP, 2006) iv]. 
 
If the Commission is of the view that the activity of the (Irish) tax authorities was not in line with rational behaviour, it should not try to find a justification in the behaviour that could be expected from the tax payer, but rather on the rationality of the decision of the tax authorities on the basis of the existing knowledge on optimal taxation--an issue discussed by Mirrlees (131-73) and many others, without having necessarily reached a final conclusion so far [see an interesting discussion of the main insights achieved so far in NG Mankiw, M Weinzierl and D Yagan, 'Optimal Taxation in Theory and Practice', (2009) 23(4) Journal of Economic Perspectives 147-74].
 
Trying to conflate this insight and to word the criterion for the assessment of Apple's APAs as a 'private tax-payer' test does not make sense and risks damaging the consistency and logic behind the principle of private operator/investor test as a general principle for the assessment of State aid [for discussion, see A Sanchez Graells, 'Bringing the ‘Market Economy Agent’ Principle to Full Power' (2012) 33 European Competition Law Review 35-39].
 
In my view, this is plain to see in the oddity of the detailed reasoning in which the Commission engages, when it establishes that
When accepting a calculation method of the taxable basis proposed by the taxpayer, the tax authorities should compare that method to the prudent behaviour of a hypothetical market operator, which would require a market conform remuneration of a subsidiary or a branch, which reflect normal conditions of competition. For example, a market operator would not accept that its revenues are based on a method which achieves the lowest possible outcome if the facts and circumstances of the case could justify the use of other, more appropriate methods (SA.38373, para 56, emphasis added).
Quite honestly, it is very difficult to understand what the Commission exactly means by this--and this is the more worrying because '[i]t is in the light of these general observations that the Commission will examine whether the contested rulings comply with the arm’s length principle' (para 57). If what the Commission indicates is that for the purposes of taxation, a rational/prudent economic operator would not accept a method that results in the lowest possible tax base, this just does not make sense. Differently, if what the Commission means is that for purposes other than taxation (which would those be?) the rational/prudent economic operator would equally oppose that method, then much more detailed explanation of why and how that is the case would be needed.
 
Worse of all, the Commission has a strong cases on the facts. The Irish tax authorities entered into negotiations with Apple and allowed the company to deviate very significantly from the applicable (general) tax rules. Moreover, despite the very significant development of international standards on transfer pricing, a 1991 ruling was used until 2007 with no revision. This sweet deal for Apple was clearly linked to an objective of keeping (regional) employment and ensruring some tax income. These may be rational (?/justifiable?) political decisions, but they do not meet any acceptable standard of objectivity, professionalism and transparency and, consequently run against the basic requirements of good (tax) administration. And, what is more important, clearly point towards a selectivity in the application of the tax system that makes the whole deal fall foul of the prohibition in Art 107(1) TFEU [the important legal point is, indeed, made at para 70 of the Decision].
 
 
In view of all this, one cannot but wonder why would the Commission base its case on such unfocussed and difficult to share (to put it mildly) points of departure. One possible option, of course, is the rebalancing of powers in tax matters derived from the Treaty of Lisbon and the very limited space for action in the front of direct taxation that is not supported unanimously by the 28 Member States (see art 115 TFEU) [for discussion, see TA Kaye, 'Direct taxation in the European Union: from Maastricht to Lisbon' (2012) 35(5) Fordham International Law Journal].
 
Another possible option is that the Commission is trying to deflect the bad publicity from the Member State concerned (Ireland) towards the multinational (Apple), hoping to find less resistance (or to trigger support) at Member State level. There can be a myriad other reasons, of course. But none of them seems to justify risking a case (and a principle of enforcement of State aid law) in an attempt to get the prohibition decision through.