Introduction
The Spanish pharmaceutical industry is committed to promoting patient well-being and high-quality healthcare by conducting its activities according to ethical criteria of professionalism and responsibility. As an integral part of the healthcare system, pharmaceutical companies can and must collaborate in creating and maintaining confidence that decisions made in relation to prescribing medicines are based on the best quality of patient care.
FARMAINDUSTRIA, the National Trade Association of the Spanish-based Pharmaceutical Industry, it gathers most of the R&D based pharmaceutical companies established in our country, representing nearly 100% of prescription medicines sales in Spain. They are largely responsible for the value medicines provide to social progress and quality of life in the country. The commitment of the Spanish pharmaceutical industry in providing medicines of the highest quality and efficacy provides a very important benefit to the country, both from a health perspective as well as an economic perspective.
In order to ensure that the conduct of companies is ethical, professional and responsible, respecting the legitimate right of companies to promote their products, it is necessary to identify and establish the balance between the needs of patients, Healthcare Professionals and the general public. In view of the political and social environment in which the pharmaceutical industry operates, with the administrative control that exists for medicines, the availability of complete, accurate and objective information on medicines is essential to ensure their rational use.
As a proof of this commitment, FARMAINDUSTRIA adopted the European Code of Practice on the Promotion of Medicines of the European Federation of Pharmaceutical Industries and Associations (EFPIA) as the Spanish Code in 1991. Since this first version, the Code has been revised on a regular basis in order to adapt to and anticipate the new requirements of a constantly evolving society. This process of evolution and continuous improvement is motivated, among other factors, by the obligation to adapt its terms and conditions to regulatory changes and new initiatives on self-regulation, and by the need to provide coverage to all of the activities conducted by pharmaceutical companies with those stakeholders with which they interrelate and interact, as well as the desire to strengthen their compliance and provide the Code with greater credibility and transparency. Our system must guarantee to Healthcare Professionals that the information, medical education and promotion of medicines embody as central elements scientific rigor, transparency and ethics.
This has led to this new version of the Code of Practice for the Pharmaceutical Industry, whose latest modification has been ratified by FARMAINDUSTRIA General Assembly in June 2025. The Code is based on:
- Directive 2001/83/EC of the European Parliament and of the Council, dated 6 November 2001, on the Community code relating to medicinal products for human use.
- Royal Decree 1416/1994, of 25 June, regulating the advertising of medicinal products for human use.
- Royal Legislative Decree 1/2015, of 24 July, approving consolidated Law on Guarantees and Rational Use of Medicinal Products and Medical Devices.
- Law 3/1991, of 10 January, on Unfair Competition.
- European Federation of Pharmaceutical Industries and Associations (EFPIA) Code.1
- International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Code of Practices.2
- Spanish Data Protection Agency (SDPA) Legal Department report Nº 2016-0172 (REF143318/2016), of April 22nd reproduced in Annex I of the Code.
The Self-Regulation System is based on the following principles and values that must guide the actions of the pharmaceutical industry as a whole, and will serve as a reference and guidance for all matters not specifically covered by the Code:
TRUST: This is the fundamental value on which the reputation and image of the pharmaceutical industry are founded, and which must form the basis of all its actions. Trust which is achieved only by acting with integrity and honesty in improving patient care and quality of life, and respecting the independence of the different stakeholders with whom we interact.
INTEGRITY: Promoting legitimate, honest, balanced and transparent relationships with those we have interacting, avoiding undue influence and properly handling conflicts of interests.
RESPECT: Maintain the independence of Healthcare Professionals and Organisations, with a commitment not to influence the relationship between them and their patients. We are committed to ensuring that the relationship with our stakeholders takes place in an open, responsible and constructive manner with continuous improvement, based on mutual respect. This maintains the independence of the stakeholders in the decision-making process, based on scientific evidence, and while taking account of patients and healthcare system interests.
LEGALITY: The rules of the Code not only respect and are fully aligned with the national and international legislation in force fostering fair competition among pharmaceutical companies, but also providing guidelines and practical recommendations for aspects subject to interpretation.
TRANSPARENCY: Promotes public knowledge of our interactions, in particular with those with whom conflicts of interests could exist.
PREVENTION: The Self-Regulation System must actively monitor compliance and enforcement of the Code, so as to strengthen, reinforce and protect reputation and trust in the pharmaceutical industry.
The Code essentially addresses three areas:
(i) Promotion of Prescription-Only Medicines. Respecting the right of the scientific community to be completely informed about medical and scientific progress, on one hand, and the legitimate interest of pharmaceutical companies to inform and promote their products, on the other hand. This section of the Code provides for a series of regulations designed to guarantee that the information provided in the context of the promotion of prescription-only medicines is appropriate, honest, precise, objective, complete, accurate, and truthful.
(ii) Relationships with Healthcare Professionals and Healthcare Organisations. The interactions between Healthcare Professionals and the pharmaceutical industry have a fundamental influence on patient care and research development; for this reason, it is necessary to establish criteria and guidelines to guarantee that these activities are conducted in a professional and responsible manner.
(iii) Relationships with Patient Organisations. Patient Organisations and the pharmaceutical industry share common interests, such as improving the quality of life of patients and attention to their interests. The rules included in this section guarantee that the manner in which companies interact with patients and with the organisations that represent them is appropriate and in compliance with, among others, the principles of independence, mutual respect and transparency.
The continuous commitment of pharmaceutical companies to the development, efficacy and rigor of the Self-Regulation system is the result of the responsible attitude of Farmaindustria members and those companies that have decided to adhere to the Code voluntarily. This Self-Regulation initiative, aligned with the compliance objectives of the pharmaceutical industry is proved by the implementation by the companies of robust internal procedures designed to guarantee compliance with the Code, with the aim of ensuring appropriate training of their employees.
These internal procedures are themselves an integral part of the regulatory compliance programs of the pharmaceutical companies and reinforce the surveillance and control measures of these organisational and management models, resulting in a firm commitment by the companies and their senior management teams to generate and maintain a global culture of corporate compliance.
The transparency of the Self-Regulation system is offered as an essential tool for promoting and strengthening confidence in the pharmaceutical industry, facilitating public access to their actions. Proof of this commitment is the publication of the Resolutions of the Jury of the Association for Self-Regulation of Commercial Communications in complaint procedures, information related to clinical trials, collaboration provided to Patient Organisations and, more recently, the disclosure of Transfers of Value to Healthcare Professionals and Healthcare Organisations.
The monitoring functions of the Code are conducted by three Control Bodies: the Code of Practice Surveillance Unit, the Code of Practice Committee and the Jury of the Association for Self-Regulation of Commercial Communications. These Bodies are responsible for monitoring compliance with the Code, providing consultation and orientation on the interpretation of the Code to members, mediating in the case of complaints and issuing resolutions for those disputes in which a mediation agreement has not been reached.
1 EFPIA Code.
2 International Federation of Pharmaceutical Manufacturers & Associations Code of Practice.