Importance of Regulations for Advertising Medicines and Medical Devices

Healthcare regulations safeguard public health by ensuring accurate information and ethical marketing. They prevent misleading claims, promote responsible advertising, and require scientific evidence for product claims. This empowers patients with reliable information and protects them from misuse of medications. Regulations also ensure fair competition within the industry.

1. Which laws apply when it comes to promoting medicines and medical devices?

Medicines

Royal Decree 1416/1994: Governs advertising of medicines for human use.
Circular 6/95: Issued by the Spanish Agency of Medicines and Medical Devices (AEMPS), further developing Royal Decree 1416/1994.
Guidance dated June 2019: Issued by the Ministry of Health on advertising to the general public, further developing Royal Decree 1416/1994.

Medical Devices

Health competencies in Spain are attributed to the Autonomous Communities, therefore advertising of medicines and medical devices is also subject to local regulations.

2. Are there any additional legislative frameworks or self-regulatory codes of conduct?

Medicines

Farmaindustria – Code of Farmaindustria
Association for Health Self-Care (ANEFP):
- Code of Ethical Standards (2021)
- Code of Ethical Standards for Self-Care Products (2020)
Spanish Association of Generic Medicines (AESEG): Code of Conduct

Medical Devices

Spanish Federation of Healthcare Technology Companies (FENIN): Code of Ethics

3. What licenses, approvals, or fees are required?

OTC Medicines: No licenses, approvals, or fees required at national level. The Community of Madrid requires communication of any advertising activity at the time of broadcasting.
Medicines: Prior communication is required.
Medical Devices: Prior authorization is required.
Medical Devices: No licenses, approvals, or fees required.

4. Does Spanish law govern prescription and over-the-counter medicines differently?

Advertising of prescription-only medicines to the general public is prohibited.

5. What are the primary limits on promoting drugs and medical devices to the public?

5.1 Medicines

Advertising of medicines to the general public is prohibited in the following cases:

Prescription-only medicines
Medicines reimbursed by the Spanish National Health System (SNS)
Medicines containing narcotics or psychotropic substances

When allowed, advertising shall not include any element which:

Implies that medical consultation or surgical intervention is unnecessary
Suggests guaranteed effects, absence of side effects, or superiority over other treatments
Implies health improvement only through use or deterioration if not used, except certain vaccination campaigns
Suggests enhancement of sporting performance
Targets exclusively or predominantly children
Refers to endorsements by scientists, healthcare professionals, or notable figures
Equates the medicine with food products, cosmetics, or consumer goods
Suggests safety or efficacy due to natural origin
Leads to false self-diagnosis
Makes abusive, alarming, or misleading claims of cure
Uses misleading visual representations of bodily changes
Mentions that the medicine has obtained health or other authorizations
Includes testimonials, endorsements, or claims based on health or sanitary authorizations in any country

The following therapeutic indications cannot be mentioned:

Tuberculosis
Sexually transmitted infections
Other serious infectious diseases
Cancer and other tumor diseases
Chronic insomnia
Diabetes and other metabolic diseases

5.2 Medical Devices

Medical devices reimbursed by the SNS
Medical devices intended exclusively for use by healthcare professionals

References to health authorities or endorsements by scientists, healthcare professionals, or influential figures are prohibited, except for advertising initiated by public administrations.

6. What are the primary limits on promoting drugs and medical devices to healthcare professionals?

Offering incentives, bonuses, discounts, or gifts (except items of insignificant value) to healthcare professionals, their relatives, or cohabitants is prohibited.

7. Required information for advertisements directed only at healthcare professionals

Medicines

Essential product information
Prescription and dispensation regime
Presentations, dosage, and pharmaceutical form
Retail price and reimbursement conditions
Date of the last revision

Medical Devices

Technical data
Conformity with legislation
Contraindications and possible side effects

8. Information required in public-facing advertisements

Medicines

Name of the medicine
Essential use information
Warning to read instructions
Recommendation to consult a pharmacist
Identifying data and safety recommendations

Medical Devices

Technical data for objective assessment
Conformity with legislation
Contraindications and possible side effects

9. Constraints on data supporting promotional claims

Data must be accurate, verifiable, complete, and up-to-date. Quotations and illustrations from medical journals or scientific works must be accurately sourced.

10. Rules governing comparative advertising

Comparative advertising is prohibited unless based on essential and similar characteristics that can be objectively proven. Comparative claims to the general public suggesting superiority are not allowed.

11. Internet and social media advertising

Advertising is subject to the same controls, prohibitions, and requirements as other advertising media.

12. Oversight bodies and legal consequences

The AEMPS and local health authorities oversee compliance. Advertising disputes often go to self-regulatory bodies such as Farmaindustria, Autocontrol, and FENIN.

Medical device violations may result in fines from EUR 30,001 to EUR 90,000. Medicines-related breaches may incur fines from EUR 90,001 to EUR 1,000,000, potentially increasing up to five times the value involved.

Non-compliance may also result in civil and/or criminal liability.

13. Future developments in Spain

The approval of Royal Decree 192/2023 has initiated discussions on updated advertising regulations for medical devices. Existing rules under Royal Decree 1591/2009 remain in effect pending new legislation.

The Ministry of Health is also processing a draft royal decree aimed at modernizing advertising regulations in response to digital and audiovisual media trends.

How can OMC help?

Professional review of marketing and advertising materials with reports
Services to obtain authority approvals where required
Translation of marketing materials by a professional translation agency certified with ISO 17100