Legal regime governing medicines for human use – rules governing access by medical sales representatives (DIMs) to National Health Service (SNS) establishments, departments and services
National Health Service;
Restrictions on fundamental rights;
Executive Law developing general bases;
Patients’ right to life;
Patients’ right to healthcare;
Right to medical information;
Marketing and promoting medicines;
RULING No. 538/15
20 of October of 2015
The Constitutional Court found no unconstitutionality in either: 1) A norm in the 2006 Executive Law that established the legal regime governing medicines for human use, under which the regime governing access by medical sales representatives (DIMs) to establishments, departments and services that form part of the National Health Service (SNS) is defined by Order of the Minister of Health. Given both the place a Basic Law occupies in the distribution of legislative competences enshrined in the Constitution, and the type and nature of the matter at hand, the Court said that this norm does not fall within the scope of the “Bases of the National Health Service”; or 2) Certain norms included in the Order of the Minister of Health issued under the terms of the Executive Law.
The government issued the Executive Law under the legislative competence derived from the legal regime established by the Law governing the Bases of the Health System (aka the “Basic Law on Health”). The Executive Law represented a development of the general Bases, and its purpose was to create a real “Medicine Statute” that would, among other things, address matters linked to the marketing and sale of medicines for human use.
Visiting SNS facilities is an important part of a DIM’s work, and its purpose includes both providing health professionals with information and clarifications and promoting the DIM’s products. The Court said that even if one were to accept that the marketing and sales process can be included in the strict definition of the ‘pharmaceutical business activity’, and that when the government concretely regulates that activity, its role is to provide a parametric content (set out in the Law governing the Bases of the Health System) and it must employ a certain format (the type of Executive Law that develops more general Laws), the distribution of tasks imposed by a Basic Law does not neutralise the government’s regulatory power. The Court therefore concluded that the norms did not suffer from any organic unconstitutionality.
The petitioner alleged that various points in the Health Minister’s Order were materially unconstitutional, in that they made it possible to revoke a DIM’s access to SNS facilities as a consequence of his/her failure to comply with certain norms in the same Order. It argued that this meant that the Order created the power to undertake ablative administrative acts involving the imposition of sanctions, and that in doing so it employed concepts which did not ensure compliance with the principle that the Administration can only act in accordance with the law, inasmuch as this trespassed on the Assembly of the Republic’s exclusive legislative competence with regard to rights, freedoms and guarantees. The Court took the view that the law does not qualify that access as a right, but instead conveys the idea that access is an exception to the rule, which is one of non-access or that access is normally prohibited. The access in question is to SNS establishments – particularly hospitals. These are not public spaces, but places whose legal status must be functionally appropriate to the treatment of illness and injury. The main factors conditioning the access of persons other than hospital staff are the situation of the patients and the conditions needed for doctors and other members of staff to do their work proficiently.
The permission for DIMs to access these spaces is configured in the shape of the removal of an obstacle to access – a removal that entails an administrative act of admission and the issue of credentials. That act must be subject to the requirement that the access be opportune and convenient, and must envisage the possibility of temporarily suspending the access on the sole grounds that the manner in which it was exercised disturbed the operation of a department or service by not complying with the conditions imposed when it was granted.
The intensity of the protection the law affords to the act of permitting access is firmly linked to the public interests which can be threatened by the exercise of that access and which SNS establishments are bound to defend. This is a unilateral act undertaken by the Administration and does not create or consolidate rights within the legal sphere of its beneficiaries; it merely underpins a legal situation whose protection is less intense than that afforded to rights. Suspending it does not undermine the principle of the protection of trust (legal certainty), because that principle can be countered by the need to respect other constitutionally important principles, such as the requirement to pursue the public interest, which applies in this situation.
The petitioner alleged that the Order contained primary regulations affecting constitutional rights, freedoms and guarantees, inasmuch as both a “refusal to issue credentials” and above all a “prohibition on access” affected both the fundamental right of DIMs to exercise their occupation and the freedom of pharmaceutical companies to exercise economic initiative As such, in issuing an Order on this matter the government exceeded its competence. In this respect the Court said that the principle that certain matters are reserved to the parliamentary legislator does indeed both preclude the Administration from trespassing on reserved matters without express permission from Parliament (the Assembly of the Republic), and prohibit the Parliament from delegating regulatory powers with regard to any aspect of primary normative rulemaking to the Administration. The Administration’s normative activities are limited to secondary aspects, and must take the form of executive regulations. Where constitutional rights, freedoms and guarantees are concerned, this exclusion of any regulatory intervention by the Administration does not only refer to restrictions on rights, freedoms and guarantees themselves, but also covers their regulation in its entirety, regardless of whether the Administration is seeking to create a regime that is more restrictive, or on the contrary more permissive, than the one that already exists.
In the present case, the Court considered that the legal norms contained in the Order neither restrict, nor even seek to shape, the fundamental right to exercise an occupation or the freedom to exercise economic initiative. As such, it found no violation of the Parliament’s exclusive power to issue legislation regarding constitutional rights, freedoms and guarantees.
This abstract ex post facto review was requested by the Attorney-General. The petitioner challenged a number of norms concerning access by medical sales representatives (DIMs) to establishments belonging to the National Health Service (SNS), the issue of their credentials by the National Authority of Medicines and Health Products (INFARMED), and the regime governing their visits to SNS facilities, all of which are included in an Executive Law that established the legal regime governing medicines for human use, or in a Ministerial Order issued under the terms of the Executive Law.
The Attorney-General argued that the matter of access by DIMs to the SNS formed part of the “Bases of the National Health Service” – an area in which the Constitution reserves legislative competence to the Assembly of the Republic.
The Court recalled that the Constitution does not define what Basic Laws are, so such a Law is not just one that calls itself by that name, but any Law in which the legislator limits itself to setting out the key outlines of a given legal regime. It questioned whether the matter of marketing and selling medicines, which is directly linked to the work of DIMs (in that, for public health reasons, the promotion and advertising of medicinal products is dependent on actions designed to inform health professionals about them), falls within the scope of the General Bases governing the Pharmaceutical Business, as delimited in the Law governing the Bases of the Health System.
The petitioner’s view was that the terms of the Health Minister’s Order entailed imposing a sanction in the form of the revocation of an earlier administrative act issuing credentials and regulating a DIM’s access to SNS facilities – a sanction designed to respond to a failure by the DIM to fulfil certain behavioural duties provided for by law. The Attorney-General’s position was that under the norms, the act of issuing the credentials that allow DIMs to gain access to SNS facilities could be revoked as a penalty for committing an administrative offence, the normative framework for which was vague.
The Court said that acts which create rights enjoy (some) protection against the Administration’s power to revoke them. However, inasmuch as the act that permits access to SNS establishments does not create rights, it can be the object of valid administrative suspension. Such suspensions are subject to a duty to hear the interested parties before taking a decision to suspend, and to provide the grounds for that decision afterwards, and it must be possible to challenge them jurisdictionally. However, they cannot be opposed on the grounds of the existence of interests that would warrant a more intense protection than that. DIMs do not possess a subjective public right to gain access to and circulate within SNS spaces, and the administrative act by which that access is temporarily denied must be qualified as a suspensive act. It is legitimate to say that the suspension of access is underlain by the impossibility of reconciling continued access with the proper operation of the SNS department or service. The degree of protection afforded to access by DIMs to SNS establishments is linked to the risk which that access poses to the values and assets – maxime patients’ right to life and to healthcare – whose safeguarding is a primary responsibility of SNS establishments. These values and assets are more important than a DIM’s access, so that access must be subject to conditions which render it precarious and which are determined in the light of the superior values and assets. The Court said that regardless of whether one sees the act imposing the prohibition as a revocation or as a sanction, there is no doubt as to the validity of the empowering norm or the legality of the regulatory Order. Even if one were to argue that the nature of the norm is essentially that of one which imposes a sanction and the norm is therefore subject to the principles governing the whole of the law on public sanctions, it fulfils the applicable requirements in terms of typification (whose intensity varies across the different aspects of the law on sanctions). While there can be no doubt that whenever a sanction exists, there must always be a minimum degree of determinability as to both the content of the illicit fact and the type of sanction that can be imposed, that degree is indeed respected in the Order before the Court.
The challenged norms enable the parties that are the object of administration (DIMs and the pharmaceutical companies they represent) to know both exactly what duties they must fulfil if they are not to risk seeing their access to SNS facilities suspended, and what the maximum duration of such a suspension can be. The norms present a content that is operable and precise enough not to conflict with the dimension of the principle that the Administration can only act in accordance with the law under which certain normative provisions can only be determined by certain entities using certain formats.
As such, the Court declined the Attorney-General’s request to declare the norms unconstitutional.
Two Justices concurred with the Ruling, and three partially dissented from it. The dissenting opinions primarily took issue with specific aspects of the majority finding that the norms were not organically unconstitutional.
Rulings nos. 326/86 (25-11-1986); 307/88 (21-12-1988); 329/99; 517/99 (22-09-1999); 602/99 (09-11-1999); 128/00 (23-02-2000); 255/02 (12-06-2002); 368/03 (14-07-2003); 41/04 (14-01-2004); 289/04 (27-04-2004); 666/06 (05-12-2006); 620/07 (20-12-2007); and 398/08 (29-07-2008).
Directive no. 2001/83/EC of the European Parliament and of the Council of 6 November 2001.