Annex III - Practical guidance for communication and relations with the media concerning prescription-only medicines
01. INTRODUCTION
The role of pharmaceutical industry is to research, develop, produce and market medicines, whether they are over-the-counter (also known as OTC products or non-prescription medicines) or prescription-only medicines. The activity of a pharmaceutical company therefore includes numerous drug-related processes that are subject to be communicated, from the discovery of a molecule to the final approval of a drug.
In Spain, the pharmaceutical industry is a highly regulated sector, and all its activity is therefore subject to a series of very specific legal conditions, in particular those connected with prescription-only medicines.
There are in fact regulations in force both at the European level, and also national and regional legislation. This regulatory framework to which the sector is subject determines how and when promotional or advertising activities may be conducted for a prescription-only medicine.
Meanwhile, the vast majority of companies based in Spain which market original prescription-only medicines belong to the National Trade Association of the Spanish-based Pharmaceutical Industry, FARMAINDUSTRIA. In 1991, FARMAINDUSTRIA introduced its Code of Good Practice of the Pharmaceutical Industry in Spain (hereinafter, the Code), a set of standards which are periodically updated and adopted in order to ensure that the promotion of medicines for human use and the interactions with healthcare professionals and healthcare and patient organizations is conducted in accordance with the strictest ethical principles of professionalism and responsibility.
There is, then, a very specific regulatory and self-regulatory framework for the promotion of prescription-only medicines. This does not extend to information tasks, which in many cases are not only advisable, but also, as will be seen later in this document, necessary. The aim of this guide is to define a practical framework and offer a series of practical guidelines and criteria in the task of providing information about prescription-only medicines, and how to conduct the relationship with the media. In short, the idea is to provide companies with a useful tool that will help them to guarantee, reinforce and distinguish the informative rather than promotional nature of communication activities connected with prescription-only medicines.
What do we understand by communication?
The main challenge faced by Communication departments at the companies belonging to FARMAINDUSTRIA is the lack of definition as to what the concept of communication covers within this field, and the ways in which this should be conducted. This lack of definition to an extent demands constant justification of the activities conducted, both internally and externally, and this need for justification, alongside the lack of specific references, often hampers or even prevents numerous communication activities.
The study of theories in this field and their practical application has facilitated an international consensus in compiling all forms of communication in the form of a field known as Communication Science. There are various disciplines attached to this science, which include in particular journalism and advertising.
Each has its own area of action, and they are therefore studied separately.
These disciplines make use of their own tools in order to conduct the task of communication for which they are conceived, namely information in the case of journalism, and promotion in the case of advertising.
These two quite different disciplines have perfectly defined purposes: to inform on the one hand and to promote on the other.
When the two are combined, since they are complementary, the presence of a promotional interest may compromise the purely informative interest. Hence the importance of properly identifying each of them.
02. LEGISLATION AND SELF-REGULATION REGARDING PROMOTION
As has been seen so far, information and promotion are two different communication activities. The distinction between them is essential, bearing in mind that in the field of prescription-only medicines both the current regulations (international, national and regional) and Self-Regulation affect advertising and promotion.
General regulations
The European Council Directive 84/450/EEC of 10 September 1984 concerning misleading advertising, defines advertising in article 2.1 as:
“'advertising' means the making of a representation in any form in connection with a trade, business, craft or profession in order to promote the supply of goods or services, including immovable property, rights and obligations”.
Spain's General Advertising Act 34/1988, of 11 November 1988, defines advertising in article 2 as:
“Any form of communication conducted in connection with a trade, business, craft or profession in order to promote the supply of goods or services, including immovable property, rights and obligations”.
Royal Decree 1416/1994, of 25 June 1994, on Advertising and Promotion of Medicines, defines the concept of "advertising of medicines" in article 1, Scope of application, subsection 2:
“Any form of information offering, prospecting or incitement intended to promote the prescription, dispensation, sale or consumption of medicines”.
By way of clarification, the aforementioned article details in subsection 3 what this concept comprises, establishing that the advertising of medicines comprises:
a) Advertising of medicines addressing the public.
b) Advertising of medicines addressing persons entitled to prescribe or dispense them.
c) Medical visits conducted by medical visitors or information agents of pharmaceutical manufacturers to persons entitled to prescribe or dispense medicines.
d) The distribution of free samples.
e) The sponsorship of promotional meetings attended by persons entitled to prescribe or dispense medicines.
f) The sponsorship of scientific congresses involving persons entitled to prescribe or dispense medicines, and in particular the covering of travel and accommodation costs as a result of such congresses.
g) Incitement to prescribe or dispense medicines through the granting, offering or promise of monetary or in-kind benefits, unless their intrinsic value is minimal.
Subsection 4 below sets out examples of certain activities that would not be subject to said RD 1416/94, as they are not considered to be "advertising of medicines". These are:
a) The labelling of medicinal products and accompanying package leaflets.
b) Correspondence, accompanied where applicable by any non-advertising document required in order to respond to a specific question about a given medicine.
c) Specific information and reference material relating, for example, to pack changes, warnings on adverse reactions in the context of pharmacovigilance, trade catalogues and price lists, provided they include no information on the medicine.
d) Information on human health or diseases, provided there is no reference, even indirect, to a specific medicine
Regional sectoral regulations
Particular mention should be made in this regard of the initiatives by the Health Department of the Autonomous Government of Catalonia (Guide for the advertising of medicines for human use; last update, April 2016), and the Directorate-General for Health of the Autonomous Government of Madrid (Circular 1/2000), the purpose of which is to facilitate the application of legislation on the advertising of medicines for human use, so as to contribute to and obtain quality advertising, for the benefit of public health interests.
In their interpretation of the provisions of article 1 of RD 1416/94, both regulations specifically include a practice that must not be interpreted as advertising/promotional activity: information.
The Catalan Guide for the advertising of medicines for human use asserts, in its interpretation of RD 1416/94, that the difference between information and advertising lies in the purpose behind the attempt to reach out to the recipient. In this regard it adopts the following approach:
ADVERTISING
when the content offered has the purpose of prescription, dispensation, sale or consumption of a medicine.
INFORMATION
the dissemination of new information about a medicine or any material of scientific interest communicated in a manner unconnected with promotional or advertising aspects, through the distribution of original published documentation, without including any type of advertising.
It then goes on explicitly to acknowledge that the following is an example of “information”:
Journalistic information of communication professionals in the course of their professional work.
Meanwhile, Circular 1/2000 of the Directorate-General for Health of the Autonomous Region of Madrid acknowledges as "non-advertising information":
Texts written and produced by journalists in their professional work in regular editions, supplements, extraordinary numbers or editions, etc., of newspapers, magazines, television or radio programmes, etc., in which information about drug therapies, specific treatments or “new” medicines, scientific studies or papers or references to a specific medicine, lines of research or product launchings, press conferences, publications, etc. is presented as a news item, an interview, a debate, an editorial or another similar format, provided that a contractual relationship does not exist between the research pharmaceutical company, or owner of the trade mark or of the medicines and the firm responsible for editing or the author of the information. All the foregoing without prejudice to the legislation in force. See also paragraph 19-22 of this Circular, corresponding to “Advertorial Content”.
Self-Regulation
As set out in the Code, its scope of application corresponds to all forms of: "(i) promotion of prescription-only medicines, (ii) interactions between pharmaceutical companies and Healthcare Professionals and Healthcare Organisations, and (iii) relationship between pharmaceutical companies and Patient Organisations”.
It continues: “In the field of promotion of medicines for human use, this covers all methods of promotion, including press and direct advertising, activities of pharmaceutical company ' employees, the Internet, use of audiovisual material such as films, videos, data storage systems and any others that might arise in the future”.
And the Code specifies that it does not consider promotion of prescription-only medicines:
“Texts written or prepared by journalists as part of their professional work in regular editions, supplements, special issues or editions, etc. of newspapers, magazines, television or radio programmes, etc., in which information about drug therapies, specific treatments or "new’ medicines, scientific studies or papers or references to a specific medicine, lines of research or products launches, press conferences, publications, etc. is presented as a "news item”, "interview”, "debate”, "editorial” or in another similar format, provided that a contractual relationship does not exist between the research pharmaceutical company or owner of the trade mark or medicinal products and the company responsible for publication or the author of the information.”.
As in the case of national and regional regulations, then, the Code self-regulates communication activity of a promotional nature with reference to a prescription-only medicine, rather than informative communication. As a result, and as already stated, this guide aims to define a practical framework and offer a series of criteria in the task of providing information as to prescription-only medicines and how to conduct the relationship with the media.
03. RIGHT TO INFORM
As with all other legal entities, the law protects the right of pharmaceutical companies to provide all manner of information, including any directly connected with their medicines that are subject to medical prescription.
There are likewise specific rules, such as Royal Legislative Decree 4/2015, approving the recast text of the Securities Market Act applicable to listed companies, which cover the publication of price-sensitive information.
04. PRACTICAL CRITERIA
Having determined the differences between promotion and information, and clarified the right and duty of pharmaceutical companies to inform, this document sets out a series of recommendations, guidelines and practical criteria as to how and when to provide information connected with prescription-only medicines and the relationship between pharmaceutical companies and the media (and media professionals).
Fulfilment of these criteria should help to ensure that communication actions and activities conducted with regard to prescription-only medicines would be considered as informative and not promotional, which should avoid any conflict with the regulation and self-regulation of the promotion of medicines.
When to inform
The purpose of information is to disclose a relevant or newsworthy fact. The life-cycle of a prescription-only medicine is subject to numerous events that are significant or subject to be communicated.
The principle of newsworthiness establishes that the criteria in order to consider an event newsworthy would include: "novelty; originality, unexpected and previously undisclosed nature; future evolution of events; importance and seriousness; geographical proximity between the event and society; magnitude given the number of people or locations involved; hierarchical status of the figures involved… 1". (1 Periodismo, noticia y noticiabilidad (2000). Martini, Stella)
According to the regulations in Catalonia and Madrid, the following may be considered newsworthy events:
“information about pharmacotherapy, specific treatments, particular medicines presented as new developments, studies or scientific works or references regarding any medicine, line of research or product launches, press conferences, publications, etc.”.
There are, then, numerous milestones over the course of the process of research, development and marketing of a prescription-only medicine that are subject to be presented as information.
These would include:
- Discovery of an innovative molecule.
- Development of a new treatment.
- National and international approvals of a medicine (FDA approval, positive opinion from the EMA, authorisation from the European Commission, etc.).
- Price setting and inclusion within the public funding system.
- New scientific evidence (positive or negative), such as the outcome of a study, that needs to be communicated as a relevant event in accordance with the regulations.
- New indication.
- Loss of patent.
- Adverse effects.
- Product recall…
Any communication actions concerning a prescription-only medicine that does not correspond to a newsworthy event may be interpreted as an activity with promotional or advertising components.
How to inform
The conveyance of information may be performed in two ways: by means of a written or audiovisual platform (informative materials) or verbally (spokespeople).
INFORMATIVE MATERIALS
Informative materials are tools devised with the aim of disseminating a newsworthy fact. There are various platforms used to develop such informative materials, and technological progress will provide ever more means of providing information.
This document therefore does not aim to list the existing types of informative materials (press releases, announcements, photographic news features, videos, infographics, posts, tweets, etc.), nor the formats or platforms that may be used for this purpose, but rather to offer a series of recommendations and practical guidelines to ensure that the contents are purely informative.
1. First, they must as a prerequisite correspond to one or more newsworthy facts (in this case connected with prescription-only medicines), based on proven scientific data rather than opinions, and at all times including references to the original information on which they are based (if any), in order to allow the journalist to ascertain their veracity.
2. It must be quite clear which entity, organisation or enterprise is disseminating the information, irrespective of whether this is done directly or through third parties. It would therefore be essential to indicate the contact details of those responsible for the communication, or in default thereof, designated individuals with responsibility, in order to allow journalists to confirm the information.
3. The trade mark of a medicine has informative value, and so may be cited in any materials produced. In any event, in order to safeguard the informative nature of the material, the recommendation is that pharmaceutical companies should take into account the following measures:
a) The trade mark should only be cited if the medicine has a positive opinion from the EMA. Never before, even if the pharmaceutical company has already made a firm proposal to said agency.
b) For information prior to the positive opinion from the EMA, only the active ingredient should be used, with the Official Spanish Designation taking priority. If this does not yet exist, then the International Non-proprietary Name (INN) could be used. Lastly, only in those cases where the WHO has not yet granted the compound an INN, use could be made of the pharmaceutical company's own designation or, if preferred, the IUPAC nomenclature2. (2 The IUPAC Nomenclature is a nomenclature system for chemical compounds and for scientific and chemical description in general).
c) If a newsworthy and relevant fact is announced about a medicine in countries outside the European Union that has not yet been authorized in any country of the EU itself, references may be made to the trade name, while specifying that the designation in question has been awarded in the specific country involved.
d) To avoid possible misinterpretations as to the purpose of informative material that might be susceptible to be considered promotional, the trade name or active ingredient must be cited in moderation, preferably once or at the most twice, aiming to replace this with generic terms such as medicine, drug, innovation, molecule, etc. and normally avoiding any mention in the headlines. The name of the medicine is not the main news item, except in certain cases, such as a recall, for example.
4. Informative materials may contain direct or indirect quotations from individuals or organisations, whether internal or external:
a) Internal quotations are left up to the company's judgment. If they are used, they must be from duly identified and accredited sources at the pharmaceutical company. Assertions about the medicine must be avoided unless there is scientific basis in support of them, including references to potential benefits for patients, of whatever nature, unless they are proven. The expression of opinions about any aspect of the medicine must be avoided.
b) If external sources are drawn on to provide quotations about a prescription-only medicine, these may be scientific or medical bodies (Healthcare Organizations, international or national organisations, universities, hospitals, etc.) or individuals, such as accredited Healthcare Professionals or those from the field of research. The quotation should be based on scientific aspects and be supported by demonstrable clinical or medical data. If the source has any type of contractual relationship with the company, this must be specified and a declaration of interests must be issued and included in the informative material.
If quotations are used from other external sources comprising other types of body (Patient Organisations, consumer organisations, etc.) or individuals (patients, relatives, carers, etc.), reference must never be made to the medicine covered by the information, and they should instead recount their experience with the disease and how it or its consequences affect them in their daily life. In the case of patients, it should be done through Patient Organisations, while in exceptional and justified cases, individual patients may be used.
5. Informative material may contain images (photographs, illustrations, graphics, etc.), provided that they would not distort the purely informative objective.
SPOKESPEOPLE
Spokespeople convey verbal information provided by a company (either directly or through third parties) to a media outlet. This type of activity may be active (through an informative action) or reactive (at the request of the media outlet itself).
1. When an informative action is conducted about a medicine (press conference, involvement at a medical congress, etc.), the company may invite the media to convey information verbally. In such cases, any information that might be provided about a prescription-only medicine may be given by an internal agent at the company (managing director, medical director, etc.) or by an external spokesperson (accredited Healthcare Professional, researcher, etc.). In both cases, the recommendation is to follow the recommendations set out in the subsection on quotations included in the point concerning informative materials in this document:
a) In the case of an internal spokesperson, assertions about the medicine must be avoided unless there is scientific basis in support of them, including references to potential benefits for patients, of whatever nature, unless they are proven.
b) For external spokespeople, their references must be based on scientific aspects, and ideally supported by demonstrable clinical or medical data. If the source has any type of contractual relationship with the company, this must be specified during the action, and a declaration of interests issued and included in the informative material. As in the aforementioned subsection on quotations, if an external spokesperson from some other type of body is used (Patient Organisations, consumer organisations, etc.) or an individual (patient, relative, carer, etc.), reference must never be made to the medicine involved in the information, and they should instead recount their experience with the disease and how it or its consequences affect them in their daily life. Likewise, in the case of patients it should be done through Patient Organizations, although in exceptional and justified cases, individual patients may be used.
2. Reactive informative actions are those in which the company provides information in response to a request from a media outlet. The offering of information about a prescription-only medicine may be carried out through a very wide range of formulae (interviews, statements, data requests, etc.). In all cases, and even if the offering of information does not go beyond the scope of the article produced by the journalist, the recommendation is to follow the terms set out above: provide proven scientific data without expressing opinions, supported by the informative materials referring to them.
In both cases the data provided by the spokespeople must be supported by the informative materials referring to them, in order to allow the media to corroborate them.
On occasion, the media outlet may also request recommendations from the company as to external statements referring to some aspects connected with the medicine (Healthcare Professionals, patients, etc.). If so, the company may facilitate such contact, by informing the media outlet in question of any relationship that might exist between the pharmaceutical company and those experts.
Which media to provide information to
Fulfilment of the recommendations, guidelines and practical criteria set out above means that to a large extent there is no relevant distinction to be made between general and specialized media outlets, since they could all bel susceptible to receive information (whether through informative materials or verbally) concerning a prescription-only medicine. As a result, the media that are to be provided with information would be left to the discretion of the company, in accordance with its individual judgment.
Communication actions combining information and promotion will need to comply with the national and regional regulations in force with reference to the promotion of medicines, as well as the Code of Practice, as the promotional interest will always prevail over the informative interest. As a result, in such cases any communication initiative may only address specialist media outlets for Healthcare Professionals.
Contact with the media
The relationship between pharmaceutical companies and the media is based on the transmission of information, whether actively or reactively, which accounts for the vast majority of interactions between the two.
However, there are many other forms of collaboration between the two parties, some of which may be provision of a service, usually by a media outlet to the pharmaceutical company.
As set out in previous subsections, this document does not aim to list all types of agreement that a pharmaceutical company might reach with a media outlet, but instead to offer a series of recommendations and practical guidelines for pharmaceutical companies to foster responsible relationships and accurate and rigorous journalism:
1. Collaboration agreements between a company and a media outlet may be of a very diverse nature: from editorial or informative material to advertising or promotional formats.
a) Advertising or promotional agreements (whether through advertisements, advertorial, branded content or any other of the existing formulas) will need to comply with the national and regional regulations in force with regard to the promotion of medicines, as well as the Code of Practice.
b) Agreements commonly known as editorial agreements must not imply, foster or incite the publication of information in the media outlet in question as to the company's prescription-only medicines.
2. Furthermore there are occasions on which the company invites the media to a press event which includes transport to a venue other than the journalist's place of residence. In such cases the company typically covers the costs of travel, accommodation and meals of the journalists that it invites. To minimise the risk that this could be interpreted as a contractual relationship between the pharmaceutical company responsible for the medicine and the journalist who will potentially be reporting on the event, the recommendation is to adopt the following safeguards:
a) The company's Communication Department should handle the invitation of Spanish journalists to the event, accompanying them during the trip and serving as go-between with the spokespeople.
b) Informative materials should be adapted into Spanish, taking into account the criteria set out in this document. If the journalist has access to information contained in foreign materials, it should be specified that the materials validated by the company for the Spanish media are those produced ad hoc.
c) The invitation should explicitly state to the journalist that the funding of the trip does not mean that the media outlet should publish information about the event.
In any case, the journalist (and the media outlet to which they belong) will, in accordance with the relevance of the information received, decide whether or not to publish.
d) The journalist should be advised that, if they publish information connected with the event, they should clarify that they attended on the invitation of the company and that it financed their trip.
e) The hospitality offered should always be reasonable and moderate, and be consistent with the terms of article 11 of the Code of Practice.
The value of Communication Departments
Irrespective of whether informative materials and informative actions are produced and developed internally or externally (communication agency), it is the pharmaceutical company which is ultimately responsible for their content. As a result, in accordance with the spirit of this document it is advisable for such activities as far as possible to be developed and overseen by information professionals.
The company's Head of Communication may request medical and scientific supervision of materials in those cases where this is deemed necessary, and in accordance with the criteria established by the company itself.
It is advisable for the Heads of Communication appointed by each company to be information professionals who have the appropriate technical knowledge to decide when an action complies with the requirements to be deemed of informative purpose. As a result, one of this figure's overarching tasks is to ensure that all informative actions and activities do indeed have such informative status.
05. DECALOGUE
1. Pharmaceutical companies are entitled to offer all types of information, including information directly connected with the main object of their activity: medicinal products.
2. The informative activity must correspond to criteria of veracity, honesty and transparency, and be clearly distinguished from promotional initiatives. Information and promotion must not be mixed.
3. Any information actions (whatever the chosen format and channel) about a prescription-only medicine must correspond to a newsworthy event.
4. All information must be based on evidence, not all opinions. It must be complete and must clearly reference the sources on which it is based.
5. The trade mark of a medicine, and the active ingredient, has informative value and may be cited in informative materials, but at all times in a prudent and proportionate manner. This is normally not the main reason for the information.
6. An information action about a prescription-only medicine produced in accordance with the criteria set out may be addressed to any media outlet, whether general interest or specialised.
7. If a company invites media representatives to a press event which includes covering the travel, accommodation and meal expenses of the journalists invited, the journalist must be explicitly informed that the funding of the trip does not entail any obligation to publish information.
8. Beyond the transmission of information, there are other forms of equally legitimate collaboration between pharmaceutical company and the media, although no agreement may imply that the media outlet should publish information about prescription-only medicines.
9. Advertising or promotional agreements must comply with the national and regional regulations in force with reference to the promotion of medicines, and the Code of Practice of the Pharmaceutical Industry.
10. The communication actions of a pharmaceutical company must be led by information professionals belonging to the Communication Departments, with the skills required to distinguish between informative and promotional initiatives.