In its Judgment of 2 June 2016 in Falk Pharma, C-410/14, EU:C:2016:399, the European Court of Justice (ECJ) had to revisit the very concepts of procurement and of public contract for the purposes of the interpretation and application of EU public procurement law. The ECJ decided to approach the issue from a 'first principles' perspective and to work deductively on the basis of the general principles and main aims of EU public procurement in order to delineate the contours of what a public contract is. In my opinion, the result of this process is faulty and needs to be criticised because the ECJ only looked at part of the general principles and aims of EU public procurement law and, more importantly, by avoiding a systematic analysis and ignoring the regulation of dynamic purchasing systems, reached a solution that creates internal inconsistency within the system of EU public procurement regulation.
The dispute in the Falk Pharma case
In the case at hand, the ECJ was requested to interpret whether a so-called 'authorisation system' implemented by German authorities in relation with the acquisition of pharmaceutical products was covered by the EU public procurement rules or not. In simple terms, under the relevant part of German social security law concerned with statutory health insurance, 'in the case of the supply of a medicinal product which has been prescribed by indicating its active ingredient and whose replacement by a medicinal product with an equivalent active ingredient is not excluded by the prescribing doctor, pharmacists must replace the medicinal product prescribed with another medicinal product with an equivalent active ingredient in respect of which a rebate contract has been concluded' (C-410/14, para 11). Or, in other words, when operating under the statutory health insurance scheme, German pharmacists are under an obligation to dispense generics for which a rebate scheme is in place unless the prescribing doctor has insisted on a specific branded product.
In order to establish such a rebate system for a given anti-inflammatory drug used to treat inflammatory bowel disease (mesalazine), in the Falk Pharma case, the relevant authorities 'published in the supplement to the Official Journal of the European Union a notice concerning an "authorisation procedure" for the conclusion of rebate contracts ... concerning medicinal products whose active ingredient is mesalazine. The rebate rate was fixed at 15% of the ‘ex-factory’ price and the period covered ran from 1 October 2013 to 30 September 2015' (para 13). It should be noted that the 'procedure provided for the authorisation of all interested undertakings meeting the authorisation criteria and for the conclusion with each of those undertakings of identical contracts whose terms were fixed and non-negotiable. Furthermore, any other undertaking fulfilling those criteria also had the opportunity of acceding on the same terms to the rebate contract scheme during the contract period' (para 14). The German authorities considered that this scheme was not covered by the EU public procurement rules (para 15).
As a result of the procedure, the German authorities entered into only one rebate contract with Kohlpharma. A competing interested undertaking challenged the setting up of the rebate scheme on the basis that the so-called 'authorisation procedure' was actually a public contract and, consequently, should have been advertised and awarded in compliance with the applicable EU rules (at the time, Directive 2004/18). The referring court explained how German courts were divided on this issue. 'For certain courts a public contract is a contract which gives the chosen operator exclusivity, so that a contract which is concluded with all the operators who wish to conclude such a contract does not constitute a public contract. Other courts take the view that all contracts concluded by a contracting authority are public contracts and that the choice of one of the tenderers, and therefore the grant of exclusivity, is an obligation of a contracting authority' (para 22).
After an elaborate discussion on the arguments both for and against the consideration of these schemes as public contracts (paras 23-30), the basic question posed to the ECJ is to determine 'whether Art 1(2)(a) Dir 2004/18 must be interpreted as meaning that a contract scheme ... through which a public entity intends to acquire goods on the market by contracting throughout the period of validity of that scheme with any economic operator who undertakes to provide the goods concerned on fixed terms, without choosing between the interested operators, and allows those operators to accede to that scheme throughout its period of validity, must be classified as a public contract within the meaning of that directive' (para 32).
The ECJ's position in the Falk Pharma case
The ECJ's first reaction is to stress that '[a]dmittedly, ... such a scheme leads to the conclusion of contracts for a pecuniary interest between a public entity, which could be a contracting authority within the meaning of Directive 2004/18, and economic operators whose objective is to supply goods, which corresponds to the definition of "public contracts" laid down in Article 1(2)(a) of that directive' (para 33). In my view, the analysis should have ended here and the ECJ should have limited itself to declare the authorisation scheme covered by EU public procurement rules (more details on the reasons why, below).
However, in order to answer more fully this seemingly simple question, the ECJ decided to go back to the very basics and interrogate Dir 2004/18 for its general aims and goals. In that regard, and after repeating some standard arguments on the EU procurement rules' goal to avoid favouritism in the award of public contracts (paras 34-36), the ECJ establishes the most controversial part of the Falk Pharma Judgment by finding that:
37 ... where a public entity seeks to conclude supply contracts with all the economic operators wishing to supply the goods concerned in accordance with the conditions specified by that entity, the fact that the contracting authority does not designate an economic operator to whom contractual exclusivity is to be awarded means that there is no need to control, through the detailed rules of Directive 2004/18, the action of that contracting authority so as to prevent it from awarding a contract in favour of national operators.
38 It is therefore apparent that the choice of a tender and, thus, of a successful tenderer, is intrinsically linked to the regulation of public contracts by that directive and, consequently, to the concept of ‘public contract’ within the meaning of Article 1(2) of that directive (C-410/14, paras 37 & 38, emphasis added).
I find both points faulty for the reasons explored below. Moreover, I find this position very worrying because of the sweeping implications it has for the definition of public contract and because this understanding of public procurement as an activity necessarily requiring the choice of a successful tenderer will carry over to the interpretation and enforcement of Directive 2014/24 because, according to the ECJ:
40 ... that principle is expressly set out in the definition of the concept of ‘procurement’, now set out in Article 1(2) of Directive 2014/24, in respect of which one aspect is the choice by the contracting authority of the economic operator from whom it will acquire by means of a public contract the works, supplies or services which are the subject matter of that contract (C-410/14, para 40, emphasis added).
What the ECJ got wrong
The absence of risk of protectionism or competitive restriction
Regarding the finding of the ECJ in para 37 of Falk Pharma that there is no need to control the conclusion of this type of contractual mechanisms under the specific rules of the EU public procurement directives because there is no risk of award those contracts in favour of national operators, I submit that the ECJ failed to understand the mechanics of the supply chain involved in the so-called 'authorisation scheme' or 'rebate contracts' and that this led to an improper assessment of the risk of favouritism or protectionism of certain economic operators. Moreover, I also submit that, in any case, this is not the correct logic to follow and that a competition-based assessment should lead to a different conclusion.
These rebate contracts only make sense for entities active in Germany and with working distribution mechanisms whereby their medicine is made available to German pharmacies. The mechanics of the rebate are quite obvious in requiring two pre-conditions for the actual delivery of the medicine by a specific provider. One, it is necessary for the provider to conclude the required rebate contract with the authorities managing the statutory health insurance system. Two, it is necessary for the provider to have its products available in German pharmacies. Even then, there is no guarantee to end up selling the product if a competing supplier has a rebate scheme in place, has its products available at the pharmacy and has a lower selling price because, despite being obliged to grant the same rebate (in the case, 15%) it has a lower ex-factory price (for details on this, see the recent report on pharmaceutical product pricing).
Therefore, in my view and to the extent to which it is possible to grasp the economic reality behind the case on the basis of the pyrrhic information available in the Falk Pharma Judgment, the creation of this rebate scheme still clearly has potential 'protectionistic' effects in that it favours pharmaceutical companies already established and active in Germany over potential suppliers that would need to enter the pharmacy distribution channels in order to take part in the 'authorisation scheme'. Thus, in my view, even from the perpective of limiting EU public procurement rules to an anti-protectionism goal, the ECJ would have gotten the assessment wrong by remaining at a level of generality that masks the fact that the scheme formally open to any willing supplier is actually skewed in favour of pharmaceutical companies already active in Germany--which, in terms of the ECJ's analysis, are more likely to be domestic companies.
But, beyond this, I think that the ECJ's assessment was also affected by tunnel vision and failed to evaluate the situation from the perspective of the pro-competitive orientation of the EU public procurement rules, despite the referring court's stress on the fact that 'EU law on public contracts has always been characterised by an element of competition' (para 25). From this functional perspective, it is criticisable that the ECJ decided to exclude the 'authorisation scheme' from the scope of application of the EU public procurement directives on the basis that it does not constitute a public contract, while at the same time going back to the obscure requirement that its award is based on a procedure that 'in so far as its subject matter is of certain cross-border interest, is subject to the fundamental rules of the [TFEU], in particular the principles of equal treatment and of non-discrimination between economic operators and the consequent obligation of transparency, that obligation requiring that there be adequate publicity. In that regard, Member States have some latitude in a situation such as that at issue in the main proceedings for the purpose of adopting measures intended to ensure observance of the principles of equal treatment and the obligation of transparency' (para 44).
This only creates legal uncertainty and potentially limits competition for the contract. It would have been preferable for the ECJ to actually look at the entirety of the goals of the EU public procurement rules and, it being clear that the 'authorisation scheme' 'leads to the conclusion of contracts for a pecuniary interest between a public entity ... and economic operators whose objective is to supply goods' (para 33), subject it to compliance with the specific rules of the EU public procurement directives (concerning dynamic purchasing systems, as elaborated below), if nothing else for the purpose of ensuring competition for these contracts.
The need to make a final choice as an essential element of procurement procedures
Furthermore, the ECJ's finding in para 38 of the Falk Pharma Judgment, that 'one aspect [of the concept of procurement] is the choice by the contracting authority of the economic operator from whom it will acquire by means of a public contract the works, supplies or services', should also be criticised. First, because too strict an interpretation of this element of choice of the specific contractor, supplier or service provider (ab initio or from the start of the contractual relationship) by the contracting authority can result in ridiculous results, e.g. where end users are given choice between alternative suppliers, be it within framework agreements or dynamic purchasing systems, or where the contracting authority draws from contractual systems set up by third parties (such as central purchasing bodies, or through other types of collaborative procurement). In many a case, the contracting authority that sets up the general contractual scheme does not necessarily end up choosing the provider itself or in a direct manner. But this should not exclude the applicability of the EU public procurement rules.
Secondly, reliance on the specific wording of Art 1(2) Dir 2014/24 should also be criticised because the ECJ seems to read too much into the definition of procurement created ex novo in this instrument. Remarkably, when the European Commission proposed the text of the new Directive in 2011, it defined procurement in a broader and functional manner by indicating that: 'Procurement within the meaning of this Directive is the purchase or other forms of acquisition of works, supplies or services by one or more contracting authorities from economic operators chosen by those contracting authorities, whether or not the works, supplies or services are intended for a public purpose'. The justification given by the Commission for this introduction was that '[t]he basic concept of "procurement" ... has been newly introduced in order to better determine the scope and purpose of procurement law and to facilitate the application of the thresholds'. However, there is no further explanation of the purpose of this definition.
The final text of Art 1(2) of Dir 2014/24 deviates from the proposal by establishing that 'Procurement within the meaning of this Directive is the acquisition by means of a public contract of works, supplies or services by one or more contracting authorities from economic operators chosen by those contracting authorities, whether or not the works, supplies or services are intended for a public purpose' (the emphasis indicates the differences). This change of drafting originates from the second compromise text of the Council (see here), and the debate seems to only have revolved around the need for a public contract to exist in order to trigger the application of the Directive. To the best to my knowledge, the element of choice of economic operator was not controversial and did not attract any relevant attention in the legislative process--as evidenced, for instance, by the fact that the provision is not dealt with in any detail in relevant scholarship: Constant De Koninck, Thierry Ronse and William Timmermans, European Public Procurement Law. The Public Sector Procurement Directive 2014/24/EU Explained through 30 Years of Case Law by the Court of Justice of the European Union, 2nd edn (Wolters Kluwer Law & Business, 2015).
As clearly criticised by Caranta, 'the new definition provided in Article 1(2) of Directive 2014/24 still [leaves] wide margins of ambiguity' and, further, '[t]he legislative drafting technique here leaves much to be desired. The two provisions might easily have been merged, and the distinction between “procurement” and “public contract” is simply lost in most of the other language versions. Moreover, “public contract” is clearly the genus, with “procurement” being the species. The genus should have been defined first, with the specification elements (in writing, acquisition, pecuniary interest, and so on) added at a later stage' [see R Caranta, 'The changes to the public contract directives and the story they tell about how EU law works' (2015) 52(2) Common Market Law Review 391-459, emphasis added]. As Caranta points out, the definition seems to only bring about a change in terms of stressing the requirement for an 'acquisition' to take place (for the reasons he explains), which in the Falk Pharma case is uncontroversial.
Overall, then, I cannot understand why the ECJ got so hung up on the specific wording of Art 1(2) Dir 2014/24 and why it gave such relevance to the need to choose a supplier for procurement to exist. From a functional perspective, it would seem superior to interpret procurement as any contractual mechanism whereby the contracting authority determines which suppliers can supply and under which conditions, regardless of whether there is any element of exclusivity or whether any potential supplier is excluded from the scheme. This functional approach certainly bodes better with the regulation of undisputed (if not too regularly used) EU public procurement mechanisms such as the dynamic purchasing system, which was simply ignored by the ECJ.
How the ECJ ignored the regulation of dynamic purchasing systems
Indeed, beyond the general criticisms above, the Falk Pharma Judgment must also be criticised because the ECJ enters into a very limited systematic analysis of the EU public procurement architecture that ignores the regulation of dynamic purchasing systems, both in Dir 2004/18 and Dir 2014/24. Indeed, the ECJ simply considered that
41 ... it should be noted that the special feature of a contractual scheme, such as that at issue in the main proceedings, namely its permanent availability for the duration of its validity to interested operators and, therefore, its not being limited to a preliminary period in the course of which undertakings are invited to express their interest to the public entity concerned, suffices to distinguish that scheme from a framework agreement. In accordance with Article 32(2), second paragraph, of Directive 2004/18, contracts based on a framework agreement can only be awarded to economic operators who are originally parties to that framework agreement (C-410/14, para 41, emphasis added).
That is true. But the ECJ's analysis flagrantly failed to assess the compatibility of those general features (ie permanent availability of the possibility to opt in to interested operators, despite not having expressed initial interest) with the regulation of dynamic purchasing systems under Art 33 Dir 2004/18, which are precisely this type of contractual arrangement. Granted, the specific rules on the running of the dynamic purchasing system would have required some further assessment and the fact that pharmacists draw from the electronic catalogue resulting from the rebate agreements could have created some difficulties regarding the specific mechanics of the dynamic purchasing systems envisaged in Dir 2004/18 regarding the need for indicative tenders and the mini-competitions for each award (not so much under the revised rules of Art 34 Dir 2014/24, especially if coupled with the rules on electronic catalogues in Art 36 Dir 2014/24), but that should not have excluded from the scope of application of EU public procurement rules (both under Dir 2004/18 and, more importantly, Dir 2014/24) any type of contractual scheme permanently open to economic operators willing to supply for the entirety of its duration. In my view, this is bound to result in a major systematic incongruence--why call something a dynamic purchasing system and comply with EU public procurement rules if you can call it 'authorisation process' or any other creative name and do away those requirements? Definitely not a desirable outcome from the perspective of regulatory consistency.
For all the reasons explored above, I think that the Falk Pharma Judgment is an undesirable development of EU public procurement law. Moreover, I am puzzled by the absence of an Advocate General Opinion. Given the fundamental relevance of the concept of public contract, and now of procurement itself, for the application of this regulatory system, the worse thing to do is to carry out analyses based on linguistics without exploring the systematic and functional implications of definitional issues. In my view, this is an issue worth resending to the CJEU for clarification at the earliest possible opportunity as soon as any slightly different "authorisation scheme" or "alternative acquisition mechanism" is tendered in any of the Member States, so that the full ECJ and, if possible, on the back of a strong Advocate General Opinion, has the opportunity to fix this--or, on the contrary, continues a dangerous path of recognition (and legitimacy) of "non-procurement acquisition systems" subjected to the basic principles of the EU Treaties and the requirements derived from the internal market fundamental freedoms, but not to the EU public procurement rules, which would extend the difficulties traditionally linked to below-thresholds and not-covered contracts to a whole new dimension of acquisition contractual mechanisms, and which I would certainly find undesirable.