Updated: July 4, 2011 (Initial publication: Jan. 7, 2010)
Releases : I. Isolated Articles
I-1.2 : Protection of public health, control of healthcare expenditure, general competition law and the sector’s regulatory framework
http://www.thejournalofregulation.com/spip.php?article59
This article will be printed soon in a book ouvrage of collection "Droit et Economie" de LGDJ (Lextenso édition), CONCURRENCE, SANTE PUBLIQUE, INNOVATION ET MEDICAMENT
1. Whilst this is a very general study, its timing and context are also very specific, since the European Commission published its report on the pharmaceuticals market on July 8th 2009[1]. The Commission plays two roles in this field. Unlike ordinary markets for goods and services, it is the EU regulator for the sector, in particular via the authorities that issue marketing authorisations for the EU market. However, in this report, it is reasoning as a competition authority seeking to open up the market is if through a liberalisation process, whereas for reasons that will be explained below, the pharmaceuticals sector is a wholly regulated one. In its report, the Commission, as both the sector’s administrator and competition authority, fails to strike a balance between regulatory and competitive issues.
2. The report focuses on the relationship between originator and generic medicines from this standpoint, using a market model deemed to be effective if cheaper products for those requiring the medicines can reach the market freely and without transaction costs and compete with goods already present there. The latter, if more expensive, must either disappear or be offered at a lower price, thereby increasing overall wellbeing.
3. Thus, the main idea and assumption behind the quantifications put forward is that more generics on the pharmaceuticals market is a good thing per se because they are cheaper, and all other considerations, such as the incentive to discover new medicines, are secondary. With this approach, the European Commission is behaving like a competition authority, assuming, in accordance with underlying economic theory, that competition between technically substitutable products - the very definition of generics versus originator medicines - is sufficient to meet the general interest. It believes that it should “force” the market into reaching full competition.
4. Consequently, those pharmaceutical companies that produce originator medicines and fight to prevent generics reaching the market are preventing things from running smoothly. For this alone, the European Commission’s report of July 8th 2009 holds them responsible for a regrettable situation (high prices, little generic entry, too few new medicines discovered), thereby meriting a presumption of fault that the originator companies can only rebut by demonstrating their innocence, i.e. that what they are doing is not only legitimate but also beneficial for wellbeing.
5. This brings to mind one fundamental question: what is a “sector inquiry”? It is supposed to be a sort of snapshot of a sector that the competition authority is seeking to understand better. First of all, this turns it into a supervisory authority acting more as an ex ante regulatory authority than an ex post body. Secondly, because it is acting ex ante, the idea is to prepare possible ex post action by means of prosecution for uncompetitive behaviour. Far from being a snapshot, this resembles more a preliminary inquiry prior to sanctions.
6. Most of the European Commission’s other sector inquiries have resulted in this. The comparison with other inquiries is particularly useful here as a way of foreseeing the direct and indirect repercussions of the Commission’s report.
7. The objective of the banking sector inquiry published on January 31st 2007 was to demonstrate uncompetitive practices in this sector. Here too we have an inquiry into a regulated sector[2], as with the one discussed here, rapidly followed by legal action against the banks at EU and national level and the implementation of the highly complex trans-European interbank payment system in which regulatory law loses ground against competition law.
8. Likewise, the sector inquiry report on energy markets published on January 10th 2007 points to what it calls serious shortcomings in terms of competition on these markets. From a political standpoint, a parallel can be drawn between this report and the third packet of EU energy directives. Not that they are the same in substance (what claims to be a mere snapshot of a sector is quite different from the political construction designed to reorganise a sector), but the sector inquiry points to foreseeable legal action and sanctions, which alone constitutes solid political grounds for negotiating liberalisation directives with national governments.
9. Above all, sector inquiries are weapons used not so much to defend competition as to force it. On July 27th 1999 the Commission launched a sector inquiry into leased lines in the telecommunications sector. Then, on December 11th 2002, noting that prices had since dropped by 40% and deeming that this was thanks to the inquiry itself, which had detected an unjustifiable gap between costs and prices, the Commission decided to close the inquiry without a conclusion. Thus, sector inquiries are weapons in their own right that can be aimed at obtaining satisfactory prices, which is precisely what a regulatory body would do by setting prices correlated to costs. Here however, the Commission gives the appearance of basing its actions on competition law. This is a huge source of confusion[3].
10. Furthermore, the economic theory underlying the report on the pharmaceuticals sector holds that originator companies whose patents are about to expire, foreseeing that they will be unable to compete with the price of the new generic equivalent, will mobilise their strength to come up with patentable innovations, launching new products that will enrich the market or even create new ones, thereby indirectly contributing to public health, which after all is not their primary goal[4].
11. However, the very concept of approaching the economics of medicines through competition law alone is problematic. This is not to say that the sector is entirely exempt from it. Uncompetitive behaviour that does not result from the sector’s regulatory framework must be sanctioned. In this respect, competition law is not “taboo”[5]. Contrary to the frequent affirmation that economic law is a “concrete” form of law on the pretext that it addresses reality without looking at legal forms or qualifications, competition law is an abstract form of law whenever it concerns markets, because markets make all things interchangeable for money. As such, the technical or political substance of the goods in question is no longer taken into account. The goods become abstract.
12. Competition law has rendered the legal concept of goods more abstract and erased the characteristics of “things”, for example, of medicines. Thus, since competition is deemed good for all markets, any obstacle is either prohibited or must at the very least be justified. Regulation must bring demonstrable benefits, and any behaviour on the part of stakeholders that deviates from the principle of free competition between suppliers must also be justified. Thus, the European Commission’s report of July 8th 2009 makes numerous recommendations to States for improving public healthcare systems in order to curb healthcare spending, encourage fair competition and incite research into new medicines, all with a view to the general interest which, unlike the simple law of the market, is no longer just the sum of all the different special interests competing on the market and which can be placed in the State’s hands.
13. However, if we are no longer dealing with a simple market, how can the European Commission as a competition authority legitimately address these questions, presume that the behaviour of some players is questionable and instruct States to adopt certain behaviours? The European Commission is at times the regulatory authority for medicines, in particular because by rights it is the author of many texts on healthcare and on marketing authorisations. Here however, the sector inquiry relies on ordinary competition law whilst referring to such regulatory concerns as public health or balancing the public accounts, things to which market law should be blind. The question of the speed at which generic medicines enter the market is a concern for a regulator, not for a competition authority. The law on medicines takes both viewpoints and the Commission is at times a regulatory authority and at others a competition authority. However, the fact that in the same analysis, it is concerned with regulatory issues under the guise of a competition authority is open to criticism.
14. Because the Commission has chosen to invoke competition law and not regulatory law, anything that complies with market organisation is “normal” in the evidentiary sense of the word, and observing, naming and demonstrating it is enough to prove it. Conversely, an “abnormal” situation i.e. one that differs from the ordinary competitive situation where any item on a market is accessible to anyone with the financial means to acquire it, must be justified. This is an exception, bringing with it a burden of proof, irrespective of the place the party invoking this situation holds in the proceedings. This question of burden of proof is key: anyone invoking the competitive mechanism is not required to prove its merit and, among other things, this results in a natural right to enter the market; anyone invoking a mechanism that blocks this competitive confrontation between suppliers, for example as a result of a patent or national regulation, can only make it acceptable by proving that the exception is good for the general interest.
15. We can see that taking competition law as a starting point as the Commission does here, results in an entire mode of reasoning where all that remains is to discuss how to measure, quantify and detect various behaviours. But the original premise, to give priority to competition, is not questioned. And yet, pharmaceuticals are quite plainly a sector that does not come first and foremost under competition law but under regulatory law, because certain balances must be struck, political balances for which the States are responsible (Section I). Competition is only welcome when it fits into regulatory law and when it can be proved to be beneficial for overall wellbeing. The burden of proof is reversed. The pharmaceuticals sector comes under regulatory law in the name of the right to health, requiring that the burden of proof be the opposite of that under competition law. (Section II).
16. Moreover, there is a fundamental contradiction in the European Commission’s approach, as it claims that it is legitimately entitled to make use of its powers as a competition authority whilst at the same time behaving as a regulatory authority, a role it occupies only in other circumstances, notably via Commission departments other than the one responsible for competition. This latter department is adopting a strictly political approach, whereas a political Europe has not yet been built.
Section I
Medicines are not a matter for specialised competition law
but for regulatory law and laws designed to instate balance
§1. The concept of medicines is rendered neutral
by giving priority to competition law
17. The European Commission, apparently producing its report as a competition authority and not as a regulatory authority, approaches medicines as if they were abstract goods exchangeable on a market (§1), but in reality it is behaving like the sector’s regulatory authority by stating from the outset in its Pharmaceutical Sector Inquiry Report of July 8th 2009 that its concern is the health of European citizens and its goal is to provide them with safe, effective and affordable medicines whilst creating a favourable environment for research. However, it is also taking over the Member States’ role by making political choices that it does not have the legitimacy to make. It is overstepping its technical regulatory jurisdiction and claiming to build the sector in the name of competition. In fact, medicines are specific economic objects because there is political agreement that, for reasons of distributive justice, they are public goods to which everyone must have access by dissociating the person who needs them from the entity that pays for them. This political dimension extracts medicines from competition law and places them under regulatory law, making the national normative level legitimate. Although this does not mean that competition law entirely disappears, it does become secondary (§2). Competition law is based on the premise that goods are exchanged
§1. The concept of medicine is rendered neutral
by giving priority to competition law
18. on markets between buyers and sellers, and that these transactions must occur massively and without impediment from monopolies or market entry barriers for example, in order to produce a fair price. This assumes that buyers have enough power, information and mobility to place multiple suppliers in competition against each other. Whether the market itself transforms the object into a good is another matter. For example, the labour market exists because the workforce is something that can be bought. However, since such economic value is inseperable from the individual, the labour market is highly regulated and specialists in this field of law are generally highly critical of any intrusion of competition law into employment law. This criticism is not expressed in detail but rather by massively and pre-emptively condemning a failure to grasp the human dimension.
19. This opens the way to what has been called the “imperialism” of competition law, i.e. the fact that it places itself first. What makes this possible is its abstraction, because everything and anything becomes a good whenever it is desired by an economic player, thereby creating a price[6]. In this approach, a “sector”, like the pharmaceutical sector, is nothing more than a group of markets. It may be specific, because all pharmaceuticals markets allow the circulation of this type of goods, but it is no different from the general market model. Thus, a sector inquiry performed by a competition authority, which is what the European Commission is, amounts to nothing more than taking the pulse of a set of markets at a given point in time, which is not the same as supervising it, which is what a regulatory authority would do.
20. Competition law’s abstract approach makes it quite the opposite of regulatory law. The latter is not restricted to administrative regulations[7], but is composed of a coherent set of rules, principles, decisions and specialised institutions, all justified by the fact that a specific object is at stake. Regulatory law can be said to emanate from its object[8]. This is why regulatory law is concrete and governs a sector for substantive reasons, because sectors cannot build and maintain a balance purely through competition.
21. Here, it is the object that comes first and determines which branch of law applies[9]. For example: certain key infrastructures require ex ante organisation that only regulatory law can perform[10]; certain imbalances of information must be avoided or corrected; and competition can increase rather than prevent certain systemic risks. In all of this, competition law is too abstract to be either legitimate or effective. Consequently, whilst its repulsion for monopolies and restrictive practices is legitimate in its own field, here it can no longer take priority. The burden of proof is reversed.
22. What about medicines? Firstly, medicines are inseparable from the healthcare sector as a whole, which is subject to State regulatory control. This results in ex ante technical regulatory mechanisms, in particular administrative marketing authorisation processes and monopolies for the professionals who prescribe or handle medicines.
23. This then is a purely technical regulatory framework, as is the case in other sectors whose regulatory mechanisms stem from the technical characteristics of the objects involved, making a regulatory approach quite natural, as for example with transport networks, which from an economic standpoint are natural monopolies. In that case, it could be argued that the pharmaceuticals market is freely competitive and produces a fair price, as long as there is no uncompetitive behaviour, which would be sanctioned ex post by the competition authority. The sector inquiry has provided it with ample information to make this possible[11].
24. However, once we concede this, it is technically possible to argue that only the law of the market should apply. Indeed, the first law of the market is not a positive one where the buyer chooses the seller that can offer him the best product at the best price, but a negative one, i.e. those buyers without sufficient financial means to pay said faire price and acquire the good are excluded. The law of the market is one of selection, destroying weak sellers and excluding impecunious buyers. Competition law protects market exchanges and fights against artificial and organised entry barriers, not as barriers but because they are the sign of uncompetitive behaviour, for example predatory pricing policies designed to eliminate competitors. Competition law is a safeguard. It does not organise market entry, to which it is indifferent. It does not have the power to impose liberalisation, and it tolerates monopolies and only sanctions them when they are abused.
25. In order to take the opposite approach, i.e. to require that market entry be as broadly accessible as possible, or even to organise it as in a liberalisation process, the competition authority would have to use its status as a pretext and transform itself into a regulator, which can be criticised as a breach of the separation of powers. Thus, the Commission is claiming that the initiative first launched on January 15th 2008 and that led to the sector inquiry report stems from competition law, as if regulating a sector were nothing more than a part of general competition law, a sort of special, secondary part of the whole, thereby giving the competition authority special jurisdiction because it has overall jurisdiction.
26. The report asserts that it is essential for generic medicines to enter the market as quickly as possible in order for competition to function, leading to a drop in prices and relieving state budgets. Who could possibly disagree with the substance of such an assertion? But there is a major legal problem regarding the source of law. The European Commission, following Article 17, § 1 of Council Regulation 1/2003, justifies the sector inquiry itself by pointing to indications suggesting that the ban on uncompetitive behaviour has somehow been breached. It therefore refers exclusively to competition law. If regulatory law is nothing more than a special form of competition law sanctioning uncompetitive behaviour in a given sector, then what applies to the whole also applies to part of it, and what gives authority for the whole also gives authority for part of it.
27. But regulatory law refers to something other than competition law. The goal may be to forcibly introduce competition law once the end of a monopoly has been declared, or to organise zones of competition within more or less integrated economic chains, or else to balance competition with another principle. The entire unstable art of regulatory law lies in this balance. Consequently, it is inaccurate to say that regulatory law is part of competition law.
28. This is a fundamental mistake because, in a report based on Article 17, § 1 of Council Regulation 1/2003, the Commission is entirely legitimate in the field of competition law but not at all in that of regulatory law, since these two fields of law are different or even opposite in nature. Competition law has at times thwarted unwarranted behaviour by companies and there have been sanctions for concerted practices or abuse of dominant position, because the sector is not exempt. However in some of these aspects, medicines come under regulatory law and not competition law because politicians refuse to allow the law of the market to effect exclusion, which is what abstract competition law is designed to preserve. With social security, society has chosen to dissociate the person who needs medicines from the entity that pays for them, and, since a political Europe still does not exist, the States remain free to use their public finances as they wish, even if this means managing scarcity or increasing the collective burden according to national choices in the field of public health.
29. In fact, “mistake” is the wrong word. To speak more severely, this inquiry could be described as a “strategic” manoeuvre, because the report expressly states that whilst “the inquiry’s main focus is company behaviour”, to the extent that the entire sector is regulated, it is also appropriate to assess, for example, the entire patent system, marketing authorisations and pricing and reimbursement, in short, the sector’s entire regulatory framework.
30. Moreover, the report states that the objective of competition law is the “promotion of innovation and driving economic growth” which, according to the Commission, aligns it with industrial property law, thereby justifying its entire approach. There are approving statements about intellectual property’s link to innovation. This brings us back to the fundamental question raised above: what is a sector inquiry?[12] It is an exercise designed to describe the situation of a given sector, but in fact, like a regulator, the Commission is at the least declaring a competition policy, and at the most declaring a policy for the optimum, fair economic organisation of the pharmaceuticals market. A sector inquiry is meant to be scientific, describing a state of affairs, and not political, i.e. laying down what the future state of affairs should be. The Commission does not appear to be respecting this definition.
31. In addition, and the two are linked, “driving economic growth”, which could be put more plainly as “economic policy” but such a term would be too transparent, is a matter for the State and not for European institutions, of which there may be several but which do not yet add up to one.
32. We can note with equal severity that, when arguments unrelated to the organisation of market exchanges are raised, such as the issue of the scientific challenges involved in discovering new molecules, the Commission recalls that “the legal basis for launching a sector inquiry is EC competition law” and therefore the argument was not analysed, because the companies raising said argument have not provided any direct evidence. This kind of two-faced behaviour is open to criticism, as the Commission is behaving at times as a regulator, at others as a competition authority, to serve its own ends, i.e. to open up markets to generics. This is not its legitimate role, because it deliberately refrains from analysing the overall issue of medicines in its totality, something that can only be legitimately done by politicians, who alone have the legitimacy to make choices within that totality.
§2. Healthcare, a political object remote
from competition law
33. Indeed, only politicians can legitimately make fundamental choices regarding life in society and the future of their populations. Politicians can decide that healthcare is a political object, unlike bread for example, because contrary to bread, they deem the former to be a common good that is not easy to access[13]. The object in question does have economic value and also a cost, but it does not enter the market solely at the discretion of an economic player. Chairman Jean Marimbert, for example, firmly stated that "the role of a health agency like Afssaps is resolutely non economic”[14]. This is a matter of political and technical choices that depend not just on the country but on each country’s history, since the social or economic dimension through which the State reasons in this field varies[15].
34. Thus, politicians have deemed that people must have access to medicines according to their needs and not their ability to pay, which law translates through the concept of public service, often referring healthcare law to public law by means of a technical translation.
35. Furthermore, in order to give everyone access to medicines as a way of guaranteeing health, the community pays on behalf of the individual. Thus, the model of health and social protection (the two are inseparable) is completely different from the competitive one, since the person requiring the medicine is dissociated from the entity paying for it. The intermediary between the two, the prescriber, is usually deemed to be the holder of blank cheques.
36. These are political choices which the community could decide to give up by abandoning social security. This is out of the question in France, a country that accords particular importance to distributive justice[16], something that is foreign to the market, which is based on commutative justice. As long as taxpayers accept this redistribution by electing those who implement it, this is legitimate and must hold competition law at bay.
37. Furthermore, Europe is the right level at which to exert normative legal power when it comes to markets for abstract goods or for technical regulatory mechanism, as applicable to the telecoms sector or to financial markets for example. But, as long as there is no federal Europe, or, in the words of the German constitutional court in a recent ruling of June 30th 2009[17], because a “European people” does not yet exist, EU institutions do not have the legitimacy to make political choices in the Member States’ place.
38. Thus the State, because it pays in consideration for the political choice of redistributive justice, is entitled to keep European law at bay, since it has made global financial choices in which competition law has no place (the following examples are political choices: health for all rather than education for all; or the opposite, the reimbursement of all medicines or a graduated system depending on how necessary the medicine is). Thus, pharmaceutical law only comes under
39. general competition law in a secondary way as applied to a restricted sector, and comes mainly under regulatory law, which is specific here for political reasons, because this is a choice for the community as a whole to redistribute wealth in accordance with collective preferences.
Section II
Laws concerning medicines come under
regulatory law
40. The organisation of the market circulation of medicines is a matter of political choice. As long as no “European people” exists for which the European Commission could legitimately make choices, medicines are subject to regulatory law, i.e. national law. Competition law applies within the scope of regulatory law only when market mechanisms are beneficial. This prevalence of regulatory law over competition law imposes a system of burden of proof that the Commission does not respect, laying it open to criticism (§1). This political and administrative regulatory approach is justified by the fact that legal systems can be rendered subjective, in this case in the name of the right to health that is at the foundation of public policy (§2).
§1. The burden of proof arising from the prevalence of
regulatory law over competition
41. Over and above the fact that the European Commission is acting as a regulator by seeking to organise the forcible entry of medicines onto the market, something that it does not have the normative means to do as the mere competition authority that it should remain until there is a federal Europe, the Commission is making competition the rule. Even if it should only be the guardian and not the organiser of competition, it refers to this as a principle, resulting in a system of burden of proof based on the idea that this principle is the norm.
42. Indeed, the Commission is attempting to remain within its only legitimate role which is that of a competition authority, without claiming to forcibly organise competition by means of a kind of liberalisation, which is a regulatory prerogative, and to do so it is using the burden of proof as a technique. Thus, competitive situations that comply with the (“normative”) principle and are therefore the “norm” need no justification. Conversely, non-competitive or uncompetitive situations, e.g. monopolies created either by statute or by the administrative decision to issue a patent, are allegedly “abnormal” because they do not comply with the principle. Here, the Commission avoids venturing into the field of substance by claiming that they are illegal per se, but uses the burden of proof, suggesting that those who organise and/or benefit from these situations must prove that they are legitimate, and explain the goal that justifies deviating from the principle of competition and the proportionality of the means versus the ends.
43. This provides a comfortable basis for the report, because the Commission refers to “concerns”[18] that generic entry is not occurring quickly enough and that innovation is slowed, without demonstrating blame for these phenomena. This is contrary to the rules of enforcing law, of which competition law is a part, because a person or category of persons (in this instance the originator companies) cannot be held responsible for the mere observation of a regrettable phenomenon such as the lack of innovation, without proving a causal connection.
44. But in fact, the relevant legal grounds for organising the entry and circulation of medicines on a market do not lie in competition law but in regulatory law, for the technical and political reasons explained above. Consequently, the system of burden of proof is reversed, because the benefits of competition will be welcome as long as they do not contradict the public good for which the State is responsible and for which it has powers it can enforce against the competition authority.
45. Thus, it is up to the competition authority to demonstrate that, despite the fact that it is regulatory law that is involved, competition is beneficial because it also contributes to the State’s objective of the common good. For example, if the patents office issues a patent to a pharmaceutical company, thereby giving it a monopoly to encourage it to pursue more research without the need for state financial support, the competition authority is not entitled to see this as an exception.
46. Indeed, it is important to remember that competition law exists at the very instant of market exchanges, and it is this instantaneousness, this lack of actual duration, that allows the emergence of a fair, mobile price. Contrary to this, regulatory law is long term. We can even put this the other way around and say that regulatory law exists when there is a need for long term economic action, in particular investment.
47. Competition law is blind to that. This again is part of its abstract view described above: it sees neither the objects themselves being exchanged on markets, nor time because the moment, the instant the exchange occurs, is not part of the notion of time.
48. Regulatory law, in particular as applied by means of patents and ex ante administrative organisation, takes a long term view of the creation and circulation of medicines. The competition authority must demonstrate that, in a specific case, this is abnormal because of the existence of restrictive practices or abuse of dominant position. However in itself, this is “the norm”, in particular because patents - a weapon that the State has normative power to use to create objects of ownership - encourage research i.e. risky investment over time. For this reason, the authority cannot find fault with it without providing more proof, whereas those who act within regulatory processes e.g. within public health or patent policies, do not have to justify this because it is the norm.
§2. The sector is subject to regulatory mechanisms in consideration
for the right to health
49. Dean Carbonnier reproachfully described the way in which, under the 5th Republic, law had “pulverised” the legal system that in the past was built around objective rules laid down by law, transforming it into one built around subjective rights invoked by the individual[19], rights that become human rights whenever natural subjective law is involved. Law, which is objective, has become a tool at the service of subjective rights, whose concretisation is supervised by judges[20].
50. Today, healthcare law exists to serve the right to health. It is difficult to define this “right to health” and the role of medicines in it. Thus, the distinction between originator and generic medicines has no place because the holder of the right to health is the person looking for the products on the market (including the potential or already sick patient), and because replacing an originator product with a generic benefits the payer i.e. the public social security organisations, and ultimately the taxpayers.
51. Thus, because we are functioning on the basis of distributive justice and this is a political choice made by the national community, the right to health is guaranteed by the system’s administrative regulatory framework. This national regulatory system, concerned with controlling public healthcare expenditure, has created regulatory mechanisms such as the pharmacists’ power to substitute products.
52. Furthermore, the right to health includes access to the healthcare mechanisms where medicines are found, in particular
access to hospitals.
This access will be more or less free depending on how necessary the medicine is, which is again determined by complex rules of public law that organise the degree of reimbursement according to different illnesses. In this instance, there the way in which hospitals are organised and the power of doctors to prescribe medicines are subject to regulatory mechanisms.
53. The principle of the individual’s right to health can be contested on the grounds that market mechanisms are more relevant or that public finances cannot support the wieldy protection system required to render this right concrete (this is a political choice). We can also say that this right does not only concern available treatment, but also those still to come. In fact, competition law manages the present because it is in the present, and regulatory law manages the future, because it is long term.
54. If we adopt an extensive understanding of the right to health, the individual is entitled to the medicines available on the market but also to medicines that could cure him or her but that are not yet available because they have not been discovered. This brings us back to the importance of research as more than just public policy, whether it is internalised within State laboratories funded by the taxpayer, or externalised via patents that encourage private companies to pursue a profitable line of research. We could thus consider that the individual has a kind of right to innovation.
55. Competition law is foreign to all of this. Although it has been said that it created a “right to competition”, since competition is nothing more than the ability of a buyer who can afford it to acquire available goods by paying a fair price set moment by moment as transactions occur (which is why financial markets are the purest form of market), it does not necessarily serve the right to health, which is based on everybody having access to the good and a common effort to encourage investment in research whenever there is political agreement to do so and to collectively carry the financial burden that comes with it.
[1]Similarly, the French Competition Authority’s first "competition symposium” on November 16th 2009 was dedicated to the following general topic: The healthcare sector: Is competition taboo?, with particular attention given to the Commission’s report
[2]See, for example, M.-A. Frison-Roche (dir.), Les banques entre droit et économie, coll. "Droit et économie, LGDJ, 2006.
[3]See, in general, M.-A. Frison-Roche, Regulation et régulation en droit européen, Revue Lamy Concurrence, Jan.-March 2008, no 14, p. 154-155.
[4]This complies with Adam Smith’s market theory, according to which it is the confrontation of specific interests and the will of players to achieve their own ends that, by both addition and confrontation, produces the general interest.
[5]To use the same term as the French Competition Authority’s “Competition Symposium” of November 16th 2009, The Healthcare Sector: Is competition law taboo? Putting the questions in these terms not only steers implicitly towards a negative answer, which is self-evident, but also suggests that competition law comes first, which is disputable, because competition should interfere in administratively regulated economies only where it produces beneficial effects.
[6]Thus, although Roman law never asserted that a slave was not a person, they were persons whose bodies were made available on the market. Because their bodies were objects, they became goods.
[7]A misinterpretation caused by the fact that the meaning of the English term regulation is restricted to the idea of rules (“réglementation” in French), i.e. the part that is applicable to the whole (V. M.-A. Frison-Roche, Regulation et régulation en droit communautaire, préc.).
[8]8. V. M.-A. Frison-Roche, Le droit de la régulation, D. 2001, chron., p. 610-616 ; Définition du droit de la régulation économique. D. 2004., chron., p. 126-129
[9]9. M.-A. Frison-Roche, Dialectique entre concurrence et régulation, in Actualité du droit de la régulation, Revue Lamy Concurrence, 2007, p. 168-174.
[10]M.-A. Frison-Roche, Le couple Ex Ante-Ex Post, justification d’un droit spécial et propre de la régulation, in Les engagements, coll. Droit et Économie de la Régulation, vol. 4, Presses de Sciences-Po/Dalloz, 2006,
p. 33-48
[11]This is not in itself criticisable, but would suggest that the competition authority, since it is not a regulator responsible for supervising a technical sector and addressing “dominance”, is in reality launching an inquiry to provide material for possible future legal proceedings. This would mean that, from a legal standpoint, it should not be qualified as a mere sector inquiry but as a preliminary investigation in which the rights of the defendant should be respected, which is not the case here.
[12]V. supra n°5
[13]Because it is a political object it can vary between States and over time. Thus, housing used to be no more of a political object than bread until French politicians decided to create an enforceable right to housing.
[14]Régulateur et sécurité sanitaire des produits de santé, in La régulation de la santé, Annales de la régulation,
Th. Revet and L. Vidal (di.), vo. 2, 2009, p. 285-293, p. 285. Among other things, the Chairman underlines the fact that the Authority acts “within the context of general public health policy and the plans or initiatives that translate it” (p.289).
[15]On this dimension, see the remarkable cognitive sociology study by Daniel Benamouzig, La santé au miroir de l’économie, coll. «Sociologies », PUF, 2005.
[16]On the issue as a whole, referring in particular to the work of John Rawls and Amartya Sen, Cl. Schneider-Bunner, Santé et justice sociale. L’économie des systèmes de santé face à l’équité, Economica, 1997.
[17]F. Chaltier, Le Traité de Lisbonne devant la Cour constitutionnelle allemande : conformité et démocratie européenne, Les Petites Affiches, July 23rd 2009, p.4s
[18]Executive summary of the inquiry report, referring to the position of consumer representatives, the generics industry and the health insurance sector, p. 7
[20]For a more approving presentation, V. H. Motulsky, Principes d’une réalisation méthodique du droit privé. La théorie des éléments générateurs des droits subjectifs, P, Sirey, 1948, reprint Dalloz 2002.
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