This paper analyses the promotion of medicines for human use that have already received marketing authorization, when the advertising is made before the resolution on pricing and inclusion in the Spanish National Health Service. This is an issue addressed by the recent Judgment of the High Court of Justice of the Basque Country (Administrative Chamber) no. 246/2021, of June 30, 2021. In this article, as in the Judgment, it is concluded that in our country there is no prohibition of this type of advertising. Such prohibition does not derive either from the prohibition to promote unauthorized medicinal products or from the obligation to indicate certain information in advertising messages.
1. INTRODUCTION
Recent Judgment 246/2021, of 30 June, by the High Court of Justice of the Basque Country dealt with the controversial matter of advertising medicinal products, and, in particular, whether medicines that have been granted marketing authorisation may be advertised while the decision on pricing and coverage by the Spanish National Health Service is still pending. The Judgment, which is now final, allows medicinal products to be advertised during that period. To understand its meaning and significance, it is necessary to examine the regulatory context in which it was issued, including interpretations by administrative bodies.
2. THE REGULATORY FRAMEWORK
2.1. European Union Law
One of the principles laid down in Directive 2001/83/EC is that medicinal products for human use may not be advertised until they have been granted marketing authorisation. This is a general prohibition on advertising (insofar as it relates to the advertising of medicinal products targeting both healthcare professionals and the general public) set forth in Article 87, which provides that “Member States shall prohibit any advertising of a medicinal product in respect of which a marketing authorisation has not been granted in accordance with Community law“.
Accordingly, when marketing authorisation has been granted, the condition for prohibiting advertising is no longer met, and the prohibition in Article 87 of Directive 2001/83/EC ceases to apply. European Union law contains no prohibition against advertising when marketing authorisation has been granted but the decision on pricing and the terms of public funding has not yet been issued. Upon transposing Directive 2001/83/EC, the Member States included the prohibition set out in Article 87 of that Directive, as was required, but they did not extend it to the point of prohibiting advertising medicinal products that had been granted marketing authorisation but were awaiting a decision on pricing and public funding. The cases of Germany, France, Portugal, Poland, Belgium, Holland, Estonia, Ireland, and Slovenia, among others, may be mentioned by way of example.
2.2. Spanish laws and regulations
The prohibition against advertising medicinal products that have not been granted marketing authorisation in Spain is laid down in paragraph 16 of section 111(2)(c) of Spanish Royal Legislative Decree 1/2015, of 24 July, approving the consolidated text of the Spanish Medicinal Product and Healthcare Device Safeguards and Rational Use Act (“RLD 1/2015”), which classifies “promoting, releasing information on, or advertising unauthorised medicinal products or advertising not in compliance with the provisions of this Act or the general laws on advertising” as a very serious administrative offence. In addition, Section 2(1) of Spanish Royal Decree 1416/1994, of 25 June, on the advertising of medicinal products for human use (“Royal Decree 1416/1994”) provides that “advertising a medicinal product that does not have the corresponding marketing authorisation is prohibited“. Neither RLD 1/2015 nor Royal Decree 1416/1994 contains any provision prohibiting advertising medicinal products with marketing authorisation for which no decision on pricing and NHS coverage has yet been issued.
Circular 6/1995 by the Spanish Ministry of Health’s General-Directorate on Pharmaceutical and Medical Devices, subsequently amended by Circular 7/1999, of 27 May, elucidating Royal Decree 1416/1994, likewise does not contain any such provision. To the contrary, it is to be concluded from that Circular that advertising of medicinal products is allowable when marketing authorisation has been granted. Item I(3) in that Circular explains that the prohibition set out in section 2(1) of Royal Decree 1416/1994 also applies when a marketing authorisation granted in another country does not have effect in Spain, and also when the marketing authorisation procedure has been initiated but has not yet concluded and, therefore, the medicinal product is not authorised in Spain. A contrario sensu, this means that the prohibition does not apply to advertising carried out after marketing authorisation has been secured and that whether or not the decision on pricing and coverage of the product by the NHS has issued is immaterial.
The laws of the Autonomous Region likewise do not prohibit advertising medicinal products that have been authorised where the decision concerning pricing and public financing is still pending. This has also not been prohibited by any circulars with regulations for implementing Royal Decree 1416/1994 issued by the Autonomous Regions, e.g., Circular 1/2000 by the General-Directorate of Health of the Autonomous Region of Madrid. The content of that Circular 1/2000 confirms that authorised medicinal products may be advertised without having to wait for the decision on pricing and Spanish National Health Service coverage. The section in the Circular that assesses the provision in Royal Decree 1416/1994 and provides that “all elements of advertising for a medicinal product will be in conformity with the information included on the product data sheet” [section 2(2)] contemplates advertising for a new indication for a medicinal product and states that all the information contained in the advertising must be “consistent with the information included on the latest product data sheet (PDS) authorised for that medicinal product. Product characteristics must be expressly recorded on the product’s PDS before they can be advertised”. It is, therefore, clear that there is no need to wait for the outcome of the pricing and Spanish National Health Service coverage procedure for the new indication. It is only necessary that the information be included on the product data sheet, which takes place when the marketing authorisation for the new indication is granted.
2.3. Guidelines and information documents on the advertising of medicinal products
Various Government Authorities have drawn up and published documents, referred to as “guidelines”, with information for citizens on the legal texts that deal with advertising the medicinal products concerned. For instance, the “Guidelines on advertising medicinal products for human use” [“Guía para la publicidad de medicamentos de uso humano”] drawn up by the Department of Health of the Government of the Government of Catalonia (the “Catalonian Guidelines” or the “Guidelines”). The current fourth edition of these Guidelines dates from 2016.
The Guidelines set out an in-depth interpretation of the prohibition on advertising medicinal products that lack marketing authorisation. Not only do they hold marketing authorisation to be necessary (as required by Directive 2001/83/EC and Royal Decree 1416/1994), but they also set additional requirements: 1) a decision on the subsidised or notified price is to have been issued and 2) “the corresponding notice of marketing is to have been submitted“, i.e., notice that sales have actually commenced.
As explained in the following section, we consider this interpretation to be contrary to Directive 2001/83/EC and Royal Decree 1416/1994. However, it also needs to be borne in mind that the Guidelines are devoid of normative force, and, therefore, refuting this interpretation does not even require resorting to the argument that a lower norm may not contradict a higher norm under the principle of the hierarchy of norms.
The Guidelines are simply an information document. They are not even a circular, decree, or service order within the meaning of section 7 of Law 26/2010, of 3 August, on the Legal Framework and Procedure of the Government of Catalonia {also referred to in section 6(1) of the Law 40/2015, of 1 October, on the Legal Framework for the Public Sector} used by government agencies to direct the activities of their subordinate bodies. This is because they are aimed at the pharmaceutical industry and are put forward as a “useful tool for the pharmaceutical industry and medical publishers located in Catalonia“.
Conclusive proof that the Guidelines are devoid of normative authority is that page 2 displays a creative commons licence, i.e., the Guidelines are copyright protected, since otherwise a licence of that kind would serve no purpose. The reason they are protected as a work under copyright law is that they are neither a normative provision nor a decision or binding opinion of any sort. If they were, the exclusion set forth in section 13 of the Intellectual Property Act [Ley de Propiedad Intelectual] would apply: “Provisions of law, regulations, and the corresponding bills or drafts; rulings by the courts; opinions, deliberations, decisions, and acts by government bodies; and official translations of all the above are not copyrightable”.
2.4. Advertising self-regulation
Advertising self-regulation codes also contain the prohibition against advertising medicinal products that do not have marketing authorisation. For instance, rule 5(1) of the “Code of ethics for marketing, promoting, and advertising health self-care medicines (not subject to prescription and not funded by the Spanish National Health Service” and, in particular, the “Farmaindustria Code of best practices for the pharmaceutical industry” (the “Code”). Provision 1(1) of the 2021 version of the latter code currently in effect provides that “Medicinal products may not be advertised before they are granted the corresponding marketing authorisation. This prohibition extends to medicinal products that have been authorised in other countries but have not been granted marketing authorisation in Spain. However, this provision does not limit the right of the scientific community to be fully informed of medical and scientific advances, nor is it intended to restrict full and proper exchange of scientific information regarding medicines and medicinal products, including proper and objective dissemination of research findings in scientific publications and at scientific meetings”..
Therefore, at no time does provision 1(1) of the Code extend this prohibition against advertising medicinal products without marketing authorisation to medicinal products with marketing authorisation for which the decision on pricing and Spanish National Health Service coverage has not yet been issued. Nevertheless, some decisions taken by the Self-Regulation Jury who enforce the Farmaindustria Code have held that authorised medicinal products that are still pending the pricing decision may not be advertised. This was the case of the Decision of 9 September 2009 by the Second Section of the Jury, ratified by the Decision of 8 October 2020 by the Plenary Session in the matter of Cephalon Pharma, S.L.U. vs Prostrakan Farmacéutica, S.L.U.; and the Decision of 22 May 2020 by the First Section, ratified by the Decision of 25 January 2020 by the Plenary Session in the matter of Gilead Sciences, S.L.U. vs Laboratorios ViiV Healthcare, S.L.
2.5. Summary of the current situation
Based on the above, it can be concluded that in Spain, as in other States of the European Union, no provision of law prohibits advertising medicinal products for human use that have been granted the corresponding marketing authorisation but are still awaiting the decision on pricing and possible Spanish National Health Service coverage. The Farmaindustria Code also does not contain any such prohibition.
Nevertheless, the “Guidelines on advertising medicinal products for human use” of the Department of Health of the Government Catalonia and the Self-Regulation Jury have made extensive interpretations holding that prohibition to apply. In so doing, they have relied both on the prohibition against advertising medicinal products that do not have marketing authorisation and the provisions that require the advertising to state the price and whether the product enjoys Spanish National Health Service coverage. That same interpretation has also been accepted by some legal scholars without thinking the matter through and simply repeating the decisions by the Jury and the position taken in the Catalonian Guidelines.
Nevertheless, there are a number of reasons for questioning whether that interpretation is legally valid, and it is our opinion that those reasons demonstrate that neither the prohibition on advertising medicinal products that do not have marketing authorisation nor the requirement to include certain information in advertising texts provides any basis for extending the prohibition to advertising medicinal products that have been authorised but are still awaiting the decision on pricing and public funding. The recent Judgment 246/2021, of 30 June, by the High Court of Justice of the Basque Country has concurred with this view.
3. THE PROHIBITION ON ADVERTISING MEDICINAL PRODUCTS CANNOT BE EXTENDED TO PROHIBIT THE ADVERTISING OF MEDICINAL PRODUCTS FOR WHICH PRICING AND NHS COVERAGE IS PENDING
Directive 2001/83/EC provides that “Member States shall prohibit any advertising of a medicinal product in respect of which a marketing authorization has not been granted in accordance with Community law.“; Royal Decree 1416/1994 states that “Advertising of a medicinal product that has not obtained the corresponding marketing authorisation is prohibited“; and the Farmaindustria Code says that “Medicinal products may not be advertised before they are granted the corresponding marketing authorisation“. Therefore, based on a literal reading, the prohibition ceases to have effect once there is a marketing authorisation.
Setting the price and the decision on public funding of the medicinal product are not part of the marketing authorisation procedure. They are a separate, additional procedure. Marketing authorisation is granted by the Spanish Medicines and Medical Devices Agency or the European Medicines Agency, as the case may be. In contrast, public funding of medicinal products requires an express decision by the Ministry of Health department in charge of the drug formulary setting the terms of coverage and the price in the framework of the Spanish National Health Service [section 92(1) of RLD 1/2015].
Besides literal interpretation, another hermeneutical approach that can be used (as provided in section 3 of the Civil Code [Código Civil]) is the teleological approach based on the purpose of a norm. From that perspective, prohibiting the advertising of medicinal products that do not have marketing authorisation is intended to prevent products that might be harmful to health and precisely for that reason have not been authorised from being advertised. This point was made by the Court of Justice in its Judgment of 2 April 2009 (Damgaard) on finding that “The public dissemination of information about a medicinal product which is not authorised in a particular Member State may, depending on the context in which that dissemination takes place, influence consumers’ behaviour and encourage them to purchase the medicinal product in question, which could affect public health“.
In contrast, the purpose of the procedure for setting the price and deciding on public funding by the Spanish National Health Service is purely financial in nature and is unrelated to public health concerns. That is why, when a medicinal product has been granted marketing authorisation and has been shown to be safe and not to pose a threat to public health, there is no longer any reason to apply the prohibition laid down in Article 87 of Directive 2001/83/EC, section 2(1) of Royal Decree 1416/1994, and provision 1(1) of the de Farmaindustria Code.
Extending the prohibition against advertising medicinal products to products that have already been authorised but are awaiting completion of the subsequent procedure to decide on pricing and public funding is, therefore, contrary not only to a literal reading of these normative provisions, but also to the intended purpose of the prohibition and the public interest being safeguarded.
Taking all the above into account, requiring marketing authorisation (granted by the Agency or the European Medicines Agency) to be able to advertise a product [as provided by Article 87 of the Directive, section 2(1) of Royal Decree 1416/1994, and provision 1(1) of the Farmaindustria Code] is not to be conflated with the fact that a product may not yet be sold in Spain. As already mentioned, this latter case was the interpretation made by the Self-Regulation Jury in the Decision of 9 September 2009 by the Second Section, ratified by the Decision of 8 October 2020 by the Plenary Session, in holding the advertising objected to in the claim to be in breach of the prohibition laid down in provision 1(1) of the Farmaindustria Code on grounds that what was involved was “a medicinal product that could not yet be sold in Spain”.
It should be emphasised that the law does not require a medicinal product to be eligible to be sold for it to be advertised. All that is required is for it to have been granted marketing authorisation, irrespective of whether other administrative procedures still need to be completed. This is not only because that is how the provision is literal worded, but also because it assures its purpose, which is, namely, to make sure that the medicinal product is safe.
The prohibition considered here cannot be extended to require actual sales and subsequent submission of the notice of marketing to the authority, as the Catalonian Guidelines have done. Even though the medicinal product is not actually being sold, the marketing authorisation remains valid as long as the conditions for applying the sunset clause have not been met. Consequently, as long as a marketing authorisation has been granted and is in force, the prohibition against advertising unauthorised medicinal products does not apply. If sales were a requirement for advertising medicinal products for which sales have been suspended because of supply factors, or are not able to be advertised, for any reason, for as long as the suspension lasts. That prohibition is not envisaged in the law or actually observed in practice.
To conclude, extensive interpretation of the prohibition set forth in paragraph 19 of section 111(2)(c) of the RLD breaches the principle of legality to the extent that, unlike the prohibition on advertising medicinal products that do not have marketing authorisation, there is no statutory provision of law that expressly prohibits advertising authorised medicinal products pending the decision on pricing.
4. THE PROHIBITION AGAINST ADVERTISING MEDICINAL PRODUCTS AWAITING PRICING AND SPANISH NATIONAL HEALTH SERVICE COVERAGE DOES NOT ENSUE FROM THE REGULATIONS CONCERNING THE REQUIRED CONTENT OF MEDICAL ADVERTISING: Judgment 246/2021, of 30 June, by the High Court of Justice of the Basque Country (Judicial Review Chamber)
It should be noted that, in contrast to the interpretation contained in the Catalonian Guidelines and in the Decision of 22 May 2020 by the First Section of the Self-Regulation Jury, ratified by the Decision of 25 January 2020 by the Plenary Session, Circular 1/2000 by the General-Directorate of Health of the Autonomous Region of Madrid made no reference to the alleged prohibition against advertising authorised medicinal products until the decision on pricing and Spanish National Health Service coverage had been issued when elaborating on the repercussions stemming from the reporting requirement set forth in section 10 of Royal Decree 1416/1994. Circular 1/2002, of 25 November, on sales calls on physicians and other pharmaceutical promotional activities in the single public healthcare network in the Autonomous Region of Madrid also contains no such reference.
It is wrong to base a purported prohibition on advertising authorised medicinal products awaiting the decision on pricing and Spanish National Health Service coverage on the above requirement to include certain information about those products. This was made clear recently by Judgment 246/2021, of 30 June, handed down by the High Court of Justice of the Basque Country (Judicial Review Chamber) ruling on a challenge to the Decree of 10 February 2020 issued by the Department of Health of the Autonomous Government of the Basque Country, as amended by the Decree of 30 March 2020 “on sales calls by pharmaceutical industry and manufacturers’ representatives, dealers, or health product and technology representatives on physicians at Basque Health Service healthcare service organisations” [Orden de 30 de marzo de 2020].
One of the grounds for the challenge to that Decree was that, in the appellant’s view, the Decree would require promotions by pharmaceutical representatives to explain how payment by the competent Social Security authorities was to take place and that this was in breach of the prevailing law, in which advertising was entirely feasible as soon as a medicinal product is granted marketing authorisation.
The challenge was brought against section 2(2) of the Decree, which provided:
“Advertising of medicinal products that targets persons authorised to prescribe medicines and other healthcare professionals will furnish the technical and scientific information necessary to enable recipients to judge the therapeutic value of the medicines for themselves. Furthermore, it is to be based on the data listed on the authorised product data sheet and is to provide information on the approved terms for funding and the other aspects specified in section 4 of this Decree…”
The above section 4 provides, inter alia:
“On each call pharmaceutical representatives will provide, or will have at the healthcare professional’s disposal, the authorised product data sheet for each of the medicinal products being presented, together with data on clinical trials (basically, pivotal trials), the different pharmaceutical forms and doses, indications, prescribing and dispensing rules, therapeutic positioning reports, safety and risk management plan, information on pricing, and the terms of inclusion on the Spanish National Health Service’s formulary, where applicable, and, whenever possible, the estimated cost of treatment”.
The High Court of Justice of the Basque Country held that such Decree “does not lay down any unavoidable requirement to provide information on the terms of funding coverage in all cases“, as “section 4 specifies that the data for the medicinal product concerned is to be brought on calls and that those data include ‘information on pricing and the terms of inclusion on the Spanish National Health Service’s formulary, where applicable…”. This last distinction, “where applicable”, unmistakeably in reference to information on the terms of inclusion on the Spanish National Health Service’s formulary leaves no doubt that, on a call, information is to be provided on coverage by the Social Security system only where that coverage has been approved and does not make calls conditional on any need for prior approval“.
In support of that interpretation the High Court of Justice of the Basque Country has also relied on the rules set forth in Royal Decree 1416/1994 and expressly held that “the text of the Royal Decree is otherwise basically similar to that of the contested Decree“. And, on considering Royal Decree 1416/1994, the Court concluded that calls on healthcare personnel (a means of promoting medicinal products) are to be allowed
“for all medicinal products that have been granted the relevant marketing authorisation (section 2 of the Royal Decree expressly prohibits advertising medicinal products that have not been authorised) even where they have not yet been granted or are not going to be granted coverage under the Spanish National Health Service. This is a reasonable interpretation, in view of the tenor of the provision, as regards the purpose of advertising and is borne out by the fact that when setting out the content of the information on the terms of Spanish National Health Service coverage to be furnished by pharmaceutical representatives, sections 10(2) and 10(3) do not stipulate that if that information is not available the call may not be made. Rather, the information is to be provided “where applicable”, that is, if it is already available”.
5. Closing remarks
1) We think that this judgment is to be viewed in an extremely positive light, because it confirms that advertising medicinal products is possible from the time when they are granted marketing authorisation without having to wait for the decision in the proceedings concerning pricing and public funding.
2) Considering this type of advertising to be prohibited could infringe the principle of legality and could unfairly limit the constitutional principles of free enterprise and freedom of speech.
3) Similarly, in our opinion, there would be no justification for approving a normative provision introducing such a prohibition. Statutory prohibition of advertising medicinal products that have been granted marketing authorisation but are still pending the decision on pricing would violate the principles of necessity and proportionality required when establishing a limitation on the exercise of (or entry to) an economic activity according to the Treaty on the Functioning of the European Union and Law 17/2009, of 23 November.
Advertising of authorised medicinal products before the price and the terms of Spanish National Health Service coverage have been set cannot be based on reasons of public health (because the products have already been granted marketing authorisation) or on the public interest in preserving the financial health of the Social Security system, because, given that the products are not covered by the Spanish National Health Service, and, therefore, do not give rise to any cost to the system, there are in principle no losses to public funds.
To the contrary, the public interest requires advertising of medicinal products to be allowed as soon as products have been authorised, because this fosters knowledge of the products by healthcare personnel. Otherwise products may take time to become known to healthcare professionals after the decision on Spanish National Health Service coverage, keeping them from being prescribed and benefitting patients. This is particularly true when considering that proceedings regarding public funding and Spanish National Health Service coverage of medicinal products are lengthy and tend to experience delays.
Also, we see no reason why the advertising of medicinal products before the decision on pricing and public funding should be prohibited on grounds of protecting the interests of patients and healthcare professionals. Both the European and Spanish law currently in force already set out requirements to ensure that medicinal products are advertised in a manner consistent with safeguarding those interests. More specifically, the obligation to conform to the product data sheet and the obligation to present products objectively and scientifically both contribute effectively to protecting the interests of consumers without unwarranted limitations. Whether or not the price of a medicinal product is included in the information furnished to healthcare professionals would not seem to restrict the professionals’ right to full scientific information regarding medicines and medical advances, especially where the advertising material expressly states that the price of the product still has to be set.
4) Besides this proper safeguarding of interests, there is another reason why the prohibition on advertising medicinal products that are pending decision on Spanish National Health Service coverage should not be introduced into Spanish law, one we regard as conclusive, namely, that that prohibition would in our opinion be contrary to Directive 2001/83/EC.
That Directive sets forth maximum standards, therefore, “where the option of laying down different rules is not given to Member States expressly, the only conditions which they can place on advertising for medicinal products are those laid down by Directive 2001/83” (Judgment of the Court of Justice of 8 November 2007, Gintec). The Judgment by the High Court of Justice of the Basque Country considered here has already held that the prohibition against advertising authorised medicinal products for which the decision on pricing and Spanish National Health Service coverage is still pending cannot emanate from the authority granted to the Member States to require “such advertising to include the selling price or indicative price of the various presentations and the conditions for reimbursement by social security bodies” under Article 91(1) of Directive 2001/83/EC. An express normative provision prohibiting the type of advertising considered here would, therefore, be contrary to Directive 2001/83/EC.
[Commentary on Judgment 246/2021, of 30 June 2021, by the High Court of Justice of the Basque Country (Judicial Review Chamber)]
Ángel García Vidal
Professor of Commercial Law at the University of Santiago de Compostela. Academic Adviser to Gómez-Acebo & Pombo
Irene Fernández Puyol
Partner Coordinator, Life Sciences Practice Area, Gómez-Acebo & Pombo
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