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The legitimate need of promotion in the pharmaceutical industry (Guest blog)

The pharmaceutical industry's raison d'être is the research and development of new medicines. These innovations are key in combatting disease, extending life expectancy, and improving quality of life. This mission is inextricably linked to the commitment to help ensure that all people who need them can access them. It would make no sense to develop breakthrough treatments if they never reach patients.

For this reason, it is essential to ensure that the latest scientific discoveries are effectively communicated to qualified professionals. Building strong, transparent relationships with key stakeholders – especially healthcare professionals – is a critical part of this effort. Healthcare professionals are ultimately responsible, under applicable regulations, for diagnosing patients, prescribing treatments, and dispensing medicines. Their access to accurate, up-to-date information is therefore crucial.

In the relationship between the pharmaceutical industry and healthcare stakeholders, different types of communication coexist: some are purely informative, others promotional, and some provide educational value. Distinguishing between these can be challenging – yet it is essential. This is particularly important given that, in most countries (with the exception of the USA and New Zealand), it is prohibited to promote prescription-only medicines directly to the general public.

The challenge lies in the fact that promotion constitutes a form of information – but with a specific goal: “the sale of a good or service”. In the context of the pharmaceutical industry, any promotional activity must carefully reflect both the unique nature of medicines and the professional qualifications of the intended audience.

The Directive 2001/83/EC[1], when defining medicines promotion, refers to advertising as: “any form of door-to-door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products”. Given the sensitive nature of prescription-only medicines, strict regulations have been put in place to ensure that promotional activities are directed solely toward qualified healthcare professionals. These restrictions are essential to safeguard the appropriate communication of complex medical information and to maintain the integrity of the prescribing process.

In any case, it should be clarified that promotion is a legally protected right inherent to all business activities. For this reason, the pharmaceutical industry is fully entitled to promote and sell its core product – medicines.

In the field of prescription-only medicines promotion, there are different forms of activity that are considered promotion, such as: medicinal product promotion aimed at persons authorised to prescribe or dispense medicinal products, medical representatives visits by medical representatives or information agents from laboratories to persons authorised to prescribe or dispense medicinal products, the provision of free samples, sponsorship of promotional meetings and scientific conferences attended by persons authorised to prescribe or dispense medicinal products. Such promotion is subject to compliance with a series of very rigorous requirements.

Through the implementation of self-regulation systems, the pharmaceutical industry has demonstrated its firm commitment to ensuring that both the promotion of medicinal products and the interaction with healthcare professionals, healthcare organisations and patient organisations is carried out under the strictest ethical principles of professionalism and responsibility. These systems defend and justify the legitimacy of the promotion of medicinal products and the interrelation with their main stakeholders and impose a series of commitments and obligations on pharmaceutical companies to guarantee the adequacy of these activities.

  • In relation to the promotion of medicinal products aimed at people authorised to prescribe or dispense them, they establish, among other requirements, that the promotion must be accurate, balanced, honest, objective and sufficiently complete so that the health professionals can judge for themselves the therapeutic value of the medicinal product. It must be based on an adequate scientific evaluation and clearly reflect it, and it must not lead to confusion through distortion, unjustified insistence, omission, or any other form.

  •  When it comes to sponsoring promotional meetings and scientific congresses, clear standards are in place to ensure ethical conduct. One key requirement is that the scientific and professional quality of the program must be the central focus of the event. Accordingly, the venue must be appropriate for the event’s educational purpose, and any hospitality provided should remain modest and clearly secondary to the meeting’s scientific objectives.

  • Regarding medical representatives’ visits, the established measures include the requirement for the representatives to carry out their work responsibly, without using any incentives or subterfuge to secure meetings. They must ensure that the frequency, timing, and duration of their visits – along with the way they are conducted – do not cause inconvenience. Additionally, they are obliged to report to the company's scientific service any information they receive related to the use of medicinal products, especially any adverse reactions communicated by the healthcare professionals they visit.

Promotional activities by pharmaceutical companies provide a clear benefit to both patients and society. They ensure that healthcare professionals – who are responsible for prescribing medicines – have access to accurate, up-to-date scientific information to support effective disease management.

For all these reasons, the promotion of medicinal products is not only a legitimate right of the pharmaceutical industry, but also a profound responsibility. Doing it well it is our commitment and obligation.

References:

[1] The Directive 2001/83/EC sets the legal foundation for how and when medicinal products can be promoted. It is accessible here https://eur-lex.europa.eu/eli/dir/2001/83/oj/eng

Santiago Páramo

Santiago Páramo is the Deputy Director of the Code of Practice Surveillance Unit (USD), one of the control bodies...
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José Fco. Zamarriego

José Fco. Zamarriego has a Phd in Economics and Business Sciences from the Complutense University of Madrid, an...
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