I. Introduction
In 2015, Bavarian media uncovered an outbreak of salmonella at the agricultural company Bayern-Ei. Footnote 1 As a result of the outbreak, hundreds of consumers fell ill and at least one died. The structural problem was quickly found: the food control system seemed to be ill-suited. Therefore, the establishment of a new food control system was proposed. Discussions turned to whether and how to reform regulatory oversight of food business operations. Footnote 2 Four years later, a similar event took place: in 2019, three deaths arose in the State of Hessen due to the consumption of Listeria-contaminated pizza salami from the Wilke company. Footnote 3 The subsequent investigations revealed significant deficiencies in hygiene as well as further violations of law in the production and sales of the company. Again, food control exercised by public authorities was quickly named as the culprit and reforms were suggested. It seems that whenever problems occur in the food chain, food control authorities are singled out as the wrongdoers. Almost reflexively, they are restructured and given more or fewer tasks. It is seldom evident whether a lack of public control is a cause of the respective undesirable situations and whether a reform of public control is the right reaction to remedy future violations of food law.
It is perhaps more pertinent to ask which type of enforcement can effectively punish violations of food law or prevent them from occurring in the first place. Like any decision-makers, addressees of food law react to stimuli from the external and internal environments at the time of their decisions. Food business operators only comply with food law requirements if they are effectively urged to do so by external or internal stimuli. Law enforcement belongs to external stimuli. Jurisprudential literature differentiates four parameters of law enforcement: Footnote 4
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(1) The allocation of law enforcement powers to several institutions;
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(2) The type of sanction (injunction, fee, penalty);
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(3) The timing of enforcement (ex ante supervision or ex post enforcement);
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(4) Centralised or decentralised enforcement.
Empirical and theoretical research illustrates that these parameters are equally important to ensuring the enforcement’s effectiveness. Footnote 5 This article concerns the first parameter. The question is whether it is more effective to entrust private actors (food business operators or consumers) with food law enforcement or to vest such powers in public actors. Past research has not treated the two as mutually exclusive alternatives. Rather, in other areas of law, such as competition law Footnote 6 or consumer protection law, Footnote 7 research has been predominantly concerned with the question of how to design the most efficient mix of private and public enforcement (ie to combine the best of all worlds). Footnote 8 Admittedly, searching for an effective enforcement approach is a normative task. The determination of what is understood as “effective” depends on whether and how the enforcement costs are evaluated and how effectively private versus public enforcement deters food business operators from violations of the law. Footnote 9 Furthermore, this article does not assume the existence of one “Idealtyp” mix of effective enforcement. Rather, what is “ideal” depends on several factors, such as the type of breach, its severity, the type of victim, etc.
Public enforcement is understood as the ex ante supervision and ex post enforcement by a public authority that is empowered by law to do so. Footnote 10 Private enforcement is the enforcement of substantive law by subjects of private law. Footnote 11 For this purpose, they can be endowed with special rights, such as a privileged standing or a right to information. Footnote 12 This article first takes stock of the situation. What is the mix of private and public enforcement in European Union (EU) food law? The article then presents research that has dealt with the optimal composition of such a mix in other areas of law and in economic research. In the final step, the article applies these findings to the current regulation of enforcement in EU food law. Based on this, the article presents a conclusion.
II. Private and public enforcement in EU food law
Regulation (EC) No 178/2002 Footnote 13 (“General Food Law”) lays down the basic system-building principles and rules of EU food law, including its enforcement. Footnote 14 EU food law enforcement entail elements of public and private kind: Article 17 of the General Food Law establishes a dual system of compliance control by food business operators and enforcement by Member States. First, according to Article 17(1) of the General Food Law, food business operators are primarily tasked with the control of compliance with food law. Second, Article 17(2) of the General Food Law provides that Member States have the duty to enforce and monitor compliance with food law as they “shall maintain a system of official controls”. Article 17(2) of the General Food Law thus places the onus on Member States to ensure effective public enforcement. Moreover, Member States also have discretion to introduce “other activities as appropriate to the circumstances”, such as measures facilitating private enforcement.
1. Private and public enforcement in the General Food Law
The first part of the dual system of enforcement under Article 17 of the General Food Law consists of an obligation of a food business operator to inform, withdraw or recall a product.Footnote 15 The obligation arises when a food business operator “considers or has a reason to believe” that a foodstuff under its control is “not in compliance with the food safety requirements”. Footnote 16 While Article 19 of the General Food Law does not provide for private enforcement itself, it requires food business operators to have measures of private enforcement in place. This places private enforcement at a prominent position in the General Food Law since food business operators must also address the identified infringements (or reasonable suspicions thereof). Under certain conditions, food business operators must also inform competent authorities of the identified infringements, who must then adopt necessary measures. One could say that the enforcement regime of EU food law is based on private enforcement by food business operators flanked by public enforcement. This relationship is confirmed, for example, by Article 14 a) of Regulation (EU) 2017/625 Footnote 17 (“Control Regulation”), which provides that official controls must include “an examination of the controls that operators have put in place and of the results obtained”. In the core area of EU food law (ie the General Food Law), private enforcement plays a considerable role. It is therefore surprising that in the case of food safety crises political reform efforts regularly target public control. Why is the improvement of food control primarily sought in the reform of public enforcement, even though the General Food Law seems to assume more effective enforcement by private entities?
2. Private and public enforcement in specific areas of EU food law
In more specific areas of EU food law, public enforcement is a dominating type of enforcement. Examples include authorisation procedures, such as those concerning genetically modified organisms (GMOs), Footnote 18 novel foods Footnote 19 and food additives, Footnote 20 as well as nutrition and health claims on food. Footnote 21 Another distinct area of EU food law (Directive (EU) 2019/633 on Unfair Trading Practices in Business-to-Business Relationships in the Agricultural and Food Supply Chain (“UTP Directive”)) is based on a competition law enforcement regime that combines elements of both private and public enforcement. Footnote 22 The third specific EU food law area encompasses private enforcement embodied in self-regulation regimes, such as standardisation and certification.
a. Authorisations and enforcement
GMO food law represents the most comprehensive public enforcement mechanism. Any placing on the market of a food intended to be used as a GMO is subject to authorisation according to Article 4(2) of Regulation (EC) No 1829/2003 and must fulfil the authorisation requirements. This allows the European Food Safety Authority/European Commission to sanction a breach of substantive law by not granting an authorisation before the market entry, arguably one of the most effective forms of public enforcement. Here, the asymmetry of information between the authority and the applicant – a serious problem of public enforcement – is weak. However, other problems arise: depending on their design, authorisation procedures may take years, Footnote 23 and businesses and society may thus incur high costs. Footnote 24 In particular, innovative small and medium-sized enterprises often cannot afford application costs Footnote 25 and so cannot compete with larger enterprises. Consequently, society does not benefit from urgently needed innovations in the food sector. Moreover, if an authorisation procedure contains extra-legal, political elements, then the outcome of the process becomes unpredictable: even if an applicant has fulfilled the authorisation requirements, authorisation may not be granted. This generates an additional deterrent effect – a phenomenon well-known from GMO laws in Europe. The coronavirus pandemic illustrates that this de facto market foreclosure through effective enforcement is not just a mind game, but has developed into a tangible problem that requires an urgent fix. The fix quickly came six months into the pandemic when the approval requirements for certain GMO vaccines were partially suspended on the grounds that they prolong the authorisation process and stand in the way of innovations needed to combat the virus. Footnote 26
b. Unfair competition law and enforcement
Unfair competition law has traditionally been an area of private enforcement Footnote 27 as regards consumer-to-business (C2B) relationships. In EU food law, however, the UTP Directive concerning unfair commercial practices in business-to-business (B2B) relationships has changed this approach and put in place a public enforcement structure. Footnote 28 According to the UTP Directive, each Member State must designate one or two authorities to enforce the prohibitions of unfair trading practices. Such authorities are competent to receive complaints submitted by suppliers, producers or their organisations. They may require buyers and suppliers to provide all necessary information to conduct investigations of prohibited trading practices. They may carry out unannounced on-site inspections. Finally, they may impose a fine, publish their decisions or not take any decision at all. It remains to be seen whether this will become the norm for other regulations governing supply chains beyond the UTP Directive. Footnote 29
c. Labelling, standardisation and certification and enforcement
Food information law and the law governing private standards are enforced via private and public means, with an emphasis placed on private enforcement mechanisms. Footnote 30 The system of private enforcement in food information law in the C2B sector is linked to the regime of unfair competition law by virtue of the wording of Article 7 of Regulation (EU) No 1169/2011 Footnote 31 (“FIC”). Any breach of Article 7 FIC can be enforced by the imposition of an injunctive relief by qualified institutions of Member States according to Article 2 Directive 2009/22/EC. Footnote 32 Other means of enforcement are subject to Member State legislation, which may provide for the employment of private enforcement mechanisms by providing business operators or consumers with a right to impose injunctive relief or claim compensation for a breach of unfair competition law before a court. Footnote 33
Private standardisation consists of standard-setting, certification and accreditation – the so-called Tripartite Standards Regime. Footnote 34 The regime is a hybrid public–private one, as private parties regularly conduct certification, while accreditation bodies represent a public control element. Footnote 35 In the EU, such public control is exercised by virtue of Regulation (EC) No 765/2008 Footnote 36 (“Accreditation Regulation”). The Accreditation Regulation contains several provisions to ensure the impartiality, functioning, objectivity and competence of accreditation bodies. Footnote 37 For voluntary certification schemes for agricultural products and foodstuffs, the Commission issued non-binding best practice guidelines. Footnote 38 According to recommendation 8 of the guidelines, certification bodies should be independent. The scheme’s requirements are enforced by private bodies carrying out inspections, which should follow certain minimum standards as stipulated under recommendation 6.2 of the guidelines.
According to the Commission’s guidelines, voluntary certification schemes must also be in compliance with EU law, such as that concerning fundamental freedoms, competition and public procurement. Footnote 39 However, the application of these EU law areas to voluntary certification schemes is problematic, as many of these schemes escape their scope of application. Footnote 40 For example, despite the Court of Justice of the European Union (CJEU) having offered some hints, it is still unclear as to how to reconcile the private nature of voluntary certification schemes with the fact that most of the abovementioned EU law areas concern public measures. Footnote 41 In the food sector, most of these schemes are displayed as additional labelling on the food packaging. They qualify as voluntary food information subject to Article 36 FIC in connection with Article 7 FIC and the corresponding enforcement provisions. Taken together with the provisions from Directive 2005/29/EC, Footnote 42 these provisions “impose a positive obligation on food business operators to provide information about the nature of the control that a given scheme is subject to in a way that is clear, i.e. intelligible, unambiguous, not confusing, and easy to understand”. Footnote 43
d. Enforcement by technology
Looking into the future, the potential of private enforcement may increase if it is fuelled by new technologies. These possibilities are mainly discussed under the concept of “technological management”, Footnote 44 according to which new technologies and big data may replace law as a regulating force in society. Footnote 45 Properly applied, however, technological management can also be used for law enforcement. Consider the following example: a patient’s digital health record notes that a patient has an allergy to nuts. This information is linked to a bonus card with which the patient-customer collects points in a supermarket. If a food business operator forgets to label nuts separately in the list of ingredients, even the trained allergy-suffering eye of the customer may overlook that a product contains ingredients that could cause an allergic reaction in them. If there were not only labelling obligations but also reporting obligations of the producer of a product containing allergenic ingredients, information about the allergenic properties of the product could be transferred to a state-operated digital platform. The customer could then be warned at the checkout, right after they scanned the bonus card and before paying, that they are about to buy a product to which they are allergic. They could also be informed of this separately on a printed copy of a bill. Of course, this would no longer meet the food information requirements, as this information would be provided after the purchase. Nevertheless, if one accepts the potential offered by technological management, many new ways of combining private and public enforcement are conceivable in the future.
III. What is an optimal mix of private and public enforcement? Insights from other areas of law and the economic analysis of law
The basis of the academic discussion of an optimal design of enforcement is the doctrine that substantive rights are meaningless unless they are associated, as it were, with an effective enforcement mechanism. Footnote 46 In the economic analysis of law, to which this paper subscribes, enforcement does not only have a compensatory role. Rather, it is understood to have an effective deterrent effect that offers an incentive to comply with legal rules. Footnote 47 Efficient enforcement follows the maxim of minimising the costs of a legal violation for society as a whole, including the costs of enforcement. Footnote 48 Article 17(2) subparagraph 3 of the General Food Law, which prescribes the measures and penalties needed to be “effective, proportionate and dissuasive”, reflects this understanding of efficient enforcement. Article 139(1) sentence 2 of the Control Regulation and Article 6(1) subparagraph 2 of the UTP Directive prescribe similar requirements. The Control Regulation specifies what is meant by “dissuasive” within its scope of application: financial penalties must “reflect, in accordance with national law, at least either the economic advantage for the operator or, as appropriate, a percentage of the operator’s turnover”. Footnote 49 This provision underscores that the economic analysis of law is an appropriate method for examining the effectiveness of the enforcement of EU food law. It also raises the question of how people are motivated to enforce law.
The spectrum of possible behaviours is wide; there are those who refrain from law enforcement even though the law was violated. This is the case when it is not “worthwhile” to enforce the law because only a small damage occurred and the enforcement costs are high. Footnote 50 This is called “rational apathy”. Footnote 51 For example, if we buy an apple and later realise that it is no longer edible, then we will probably dispose of the apple, even though we might have the right to exchange it in the shop. Such rational apathy is especially problematic when the damage to an individual is small but society sustains significant damage. Footnote 52 If the reason for the apple being inedible is a structural problem in the supply chain that could affect all apples, more effective enforcement on behalf of the community is warranted. The extent to which the right of private enforcement is used also depends on cultural conditions. For example, research has shown that post-communist EU Member States traditionally rely more on public enforcement as compared to private enforcement. Footnote 53
Moreover, private entities may refrain from taking legal action if they do not have sufficient information to determine whether the action will be successful. Such an information deficit is an important aspect of law enforcement because private entities cannot avail of the same possibilities to obtain enforcement-relevant information as public authorities. Footnote 54 The far-reaching control powers of public authorities, such as those contained in Article 14 of the Control Regulation, are not available to private entities. By means of a request under national right of information laws, private entities may be able to obtain relevant information, but only if it has been previously collected by a public authority.
Finally, fear has been identified as a factor (the so-called “fear factor”) in business decision-making concerning private enforcement in the supply chain. The UTP Directive explains the shift from private to public enforcement of B2B unfair trading practices by stating that “[w]here reliance on contract law or self-regulatory initiatives is possible, fear of commercial retaliation against a complainant, as well as financial risks involved in challenging such practices, limit the practical value of those forms of redress”. Footnote 55 In other words, smaller businesses in a supply chain structure fear exclusion from the chain should they use private enforcement to defend themselves against their more powerful trading partners.
This perspective seems to favour public enforcement; however, even public enforcement faces several obstacles. First, the resources (financial, human, knowledge) available to a public authority for enforcement purposes may significantly influence its effectiveness. Footnote 56 Even if resources are optimal, public officials may still decide not to enforce, often for understandable reasons, with the most cited reason being so-called “regulatory capture”. Footnote 57 According to its broad definition, regulatory capture describes “the process through which special interests affect state intervention in any of its forms, which can include areas as diverse as the setting of taxes, the choice of foreign or monetary policy, or the legislation affecting R&D”.Footnote 58 Employees of public authorities also pursue vested interests, such as climbing the internal career ladder, salary increases or finding a job outside of public administration. Footnote 59 For this reason, as some authors argue, public officials are motivated to extensively cooperate with private entities, such as food business operators. Footnote 60 For EU food law, however, such closeness to industry may not automatically mean an illegitimate vested interest, as Recital 39 of the Control Regulation clarifies that competent Member State authorities act both “in the interest of operators and of the general public”. Additionally, problems of capture and vested interests can often be resolved by not allowing individual authorities to become too powerful. Footnote 61 If competences are distributed between several authorities, the possible effects of capture and vested interests may be reduced. Footnote 62 A similar effect can be achieved via regulator audits inside public authorities.
There are also regulatees who attempt to enforce the law for motives other than justice and the protection of legal interests. Frivolous enforcement, notably the emergence of the “litigation industry”, has been subject to repeated criticism. Footnote 63 The unrealistic promises of the litigation industry only leave plaintiffs disappointed and public authorities and courts potentially overburdened. Footnote 64 Even in the situation of the overburdening of courts and public authorities, a state must ensure that the institutions responsible for law enforcement are properly functioning and adequately equipped. Footnote 65 Sometimes private litigants are not primarily motivated to enforce rights or obligations, but rather to make “noise” and attract media attention or financing – motives that are ultimately different from the objectives of achieving justice and legal protection. Footnote 66 In some cases, despite the incongruity between private enforcement motives and enforcement policy objectives, rights may receive effective protection and obligations may be effectively fulfilled. The effect, however, may be the opposite, too: the litigation industry, fuelled by the availability of collective redress mechanisms, may impede effective law enforcement and raise its cost. Footnote 67 This includes legal actions that are taken solely to harm a competing food business operator. One way to try to counteract frivolous enforcement is to endow specific organisations or legal professionals with a privileged right to sue. But even then there is no guarantee that frivolous legal enforcement will not occur. Ultimately, the legislature and legal practitioners are also called upon to create an appropriate legal framework and legal culture to effectively prosecute legal actions of the same class that are expected in a modern society. Footnote 68 An efficient mix of private and public enforcement is not easy to achieve. Both types of enforcement have their advantages and disadvantages, and an effective mix can be effectively examined only upon a closer look at different determinants.
Outside the core area of food law, we also find a well-thought-out mix of private and public enforcement; for example, breaches of food information law in the EU can be enforced via class (representative) actions. Footnote 69 An individual consumer would most probably not sue when they notice that a food package is not designed in accordance with food information law. Therefore, representative actions constitute an adequate means of law enforcement. In areas of information asymmetry between food business operators, other market players and public authorities, food law also provides for special information mechanisms. This is the case concerning novel foods and GMO foods where authorisation procedures ensure that food information is effectively communicated to the authorities, who can then decide on special post-marketing monitoring and supervision measures. Footnote 70
The cost of enforcement is the key determinant of whether a food business operator avails of means of private enforcement. Footnote 71 Businesses calculate carefully whether to use private enforcement based on a cost/benefit ratio. Costs include costs for legal representation, court fees, costs associated with the preservation of evidence and time. Benefits include, for example, monetary or reputational gains. Businesses also consider the probabilities of success. In Germany, for example, it is argued that the lack of a legal framework for taking class actions diminishes the success of private enforcement (ie individual actions). Footnote 72 Rather, since small claims cannot be bundled together to make their litigation financially more attractive, legal professionals are disincentivised to represents clients in such cases en masse. Footnote 73 Therefore, if the costs outweigh the benefits (or the probability thereof), claimants behave in rational apathy and individually decide against enforcement. Footnote 74 To prevent this, several options are proposed to strengthen private enforcement. If only individual cases can be brought before a court, rational apathy can be overcome by legal expenses insurance, legal aid or legislating for the possibility to take collective or representative actions.Footnote 75
If a damage is greater, affecting society at large, public enforcement measures are generally preferred. Footnote 76 In such cases, the costs of enforcement and the risks of loss are borne by the public. However, it is difficult to determine how the relevant authorities can receive information of possible infringements. Therefore, notification mechanisms prompting an official action are proposed in the literature. Someone must give the authorities a “hint”, making effective public enforcement contingent upon private initiatives. However, even here, the “rational apathy” problem of private enforcement arises. If both private and public enforcement options are available, a food business operator may decide to avoid private enforcement and “convince” – potentially anonymously – public authorities to act against its competitors. The “tipper” will only do so if the benefits outweigh the costs. For example, an anonymous notification may mitigate the fear factor that could otherwise restrain businesses from taking effective legal action. In addition, special protection of whistle-blowers can incentivise “tippers” to notify. For example, Article 140 of the Control Regulation, considered in the context of the Whistleblower Directive, Footnote 77 provides special protection for whistle-blowers who report infringements to authorities.
Better possibilities for authorities to obtain information can justify the use of public enforcement. Footnote 78 Especially in times of increasing digitalisation, it may be easier for public authorities to obtain the relevant data on supply chains in order to prosecute infringements. Footnote 79 Private individuals often do not have these possibilities. Moreover, as technological management demonstrates, public enforcement can surpass the limits of official administrative procedures, and it can also take place via technical means. A food safety authority may work as a data platform that brings different users together, supports them in their own enforcement and monitors the fair collection, processing and use of data.
The main disadvantages of private enforcement are rational apathy, information asymmetry and the fear factor. These may be resolved by public enforcement, provided capture effects are avoided and sufficient resources and notification mechanisms are ensured. To that effect, EU food law offers a thoroughly modern solution: food business operators must themselves notify the competent authorities in cases listed in Article 19 of the General Food Law.
IV. How can these findings be applied to EU food law?
EU food law also serves as a model for other areas of law regarding an effective enforcement mix. First, Article 17(2) of the General Food Law establishes the primacy of public enforcement at the level of Member States, thereby addressing the problem of rational apathy. At the same time, by qualifying enforcement as “effective, proportionate and dissuasive”, it also tasks Member States to address the resource problem of effective enforcement. It is obvious that in practice this creates a variety of enforcement regimes throughout the Union. Footnote 80 Economically stronger Member States, for example, will find it easier to devote the necessary resources to effective public enforcement. In addition, where the costs of litigation are high relative to a country’s GDP per capita, enforcement has a different effect compared to countries where such costs are lower.
However, it is difficult to undertake any practical comparison in this regard. As the Commission noted, the data presented in the annual reports of official control bodies have varied greatly. The Control Regulation, effective since 2019, attempted to remedy this problem by introducing a standard form for the annual reports. However, new data are not yet available, as the latest of the Commission’s reports covering the period of 2017–2018 was only published in May 2021. Footnote 81 Significant delays in the reports’ submission are surely to blame: only six Member States submitted their annual reports within the deadline. Nonetheless, this report from the Commission contains certain important insights. It notes that Member States fail to clearly define strategic objectives in their multi-annual national control plans, thereby making it impossible to decide which indicators to measure. Another problem appears to be a lack of methodological rigour in determining risk-based priorities according to which national authorities should plan their official controls. For example, some Member States use information from private quality assurance schemes to inform their risk assessments. The Commission’s report also notes that several Member States experienced budget cuts that resulted in reduced staffing levels and material resources. This has happened even though the control of some food safety risks (such as the African swine fever epidemic) requires significantly more resources than others (such as microbiological safety). As a result, activities planned in the multi-annual national control plans could not be fulfilled. In some Member States, as a mitigation strategy, data analysis and information technologies were employed to compensate for staffing shortages.
Comparing data from the annual reports, such as the number of instances of non-compliance, can be a problematic exercise. High non-compliance numbers may either indicate a bad food safety situation or may be equally understood as involving the employment of a more effective control mechanism. In other words, any self-reporting on official controls by national authorities must be contextualised, but the precise data for contextualising, and for better understanding the resource problem, are not available. Additional auditing of official control outputs may contribute to better contextualising of the effectiveness of official controls. Nonetheless, the narrative behind the revealed non-compliance points to the same common causes: a lack of understanding of legal requirements on the side of food business operators, high staff turnover and insufficient training and resources to bring food business operations into compliance. In response, Member States provide guidance, lead information and awareness campaigns and organise training. In the experience of official control bodies, enhanced knowledge leads to greater compliance rates. Footnote 82
Regular official and risk-based controls, which are carried out unannounced and according to the rules of the multi-annual national control plans, Footnote 83 create an incentive for food business operators to take their control and reporting obligations seriously. If an infringement is detected during these controls, severe sanctions may be applied, ranging from a mere “classification” Footnote 84 to an imposition of a penalty of an amount at least equal to the economic advantage for the food business operator or, if applicable, set as a percentage of the food business operator’s turnover. Footnote 85 If sanctions are imposed, a food business operator is likely to suffer a reputation or revenue loss. Most businesses affected by sanctions ended in insolvency. Footnote 86 It may therefore be less costly for food business operators to immediately comply with their obligation to notify and withdraw. Measures of public enforcement are therefore not an end in themselves, but rather provide for the effective application of private enforcement as laid down in Article 19 of the General Food Law. Sanctions may motivate food business operators to privately enforce their obligations. The system is designed in such a way that authorities would ideally exercise control at regular risk-based control intervals and react if they receive further notifications of potential infringements.
V. Conclusion
EU food law establishes a modern and forward-looking mix of private and public enforcement. The various EU food law instruments largely ensure a resource-efficient and effectively coordinated mix. However, in trying to achieve a practical implementation of such an effective mix, the realities of the European internal market must be considered. Moreover, new technologies have the potential to stimulate a novel enforcement mix. In this area, public authorities could become data platform operators, while consumers as users of these platforms enforce their rights themselves via their behaviour. To harness the technological potential of a novel enforcement mix, it is important to understand the finely tuned system of private and public law enforcement and to make improvements where needed.
Competing interests
The authors declare none.
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