September 16, 2022
Regulations for Pharmaceutical Advertising in Europe

In the European Union (EU), the promotion of medicinal products is governed by advertising laws and regulations. Particularly, the Directive 2001/83/EC of ‘the European Parliament and of the Council of 6 November 2001, on the Community code relating to medicinal products for human use,’ establishes the European Regulatory framework, which contains articles dedicated to promotional activities and advertising of medicinal products.

As multinational pharma and biotech companies prepare to introduce new drugs in Europe after the marketing authorizations have been granted, promotional activities are undoubtedly an important component of manufacturers’ business strategies. However, such promotions must adhere to the laws governing pharmaceutical advertising enforced by European and/or national authorities.

What is the European Regulatory Environment for Pharmaceutical Advertising?

Effective and adequate monitoring must be provided for all medicinal products’ advertising per Directive 2001/83/EC (article 97). According to the Directive's article 98, the Marketing Authorization Holder (MAH) must set up a scientific service to handle the information about medicinal products and make sure that the authorities or bodies in charge of monitoring the advertising of pharmaceuticals are following their decisions. However, the Directive gives some freedom to the Member States (MS) in the monitoring as it does not exactly elaborate on the rules for the control of pharmaceutical advertising.

Therefore, all MS have enacted additional special regulations relating to the advertising of pharmaceutical products because of each nation's transposition of the European Directive into its own domestic laws and Regulatory guidelines, with some local adjustments. This method is known as “self-regulation” and depending on the MS it can be supervised and controlled either by the government or by a national competent authority. In the context of self-regulation, monitoring, and controlling the activities in the absence of recognized, national competent authorities, the authority may be delegated, for instance, to the national associations of the pharmaceutical industries, multi-stakeholder groups, or the company in charge of the advertising itself. These groups and associations create their own codes and have the authority to evaluate and approve advertisements.

We can rely on several guidelines and standards to adhere to the fundamentals of excellent promotion practices, particularly when the organization is self-regulating. The "Ethical Criteria for Medicinal Drug Promotion," published by the World Health Organization (WHO) in 1988, provides a framework for creating rules and policies to assure ethical promotional actions.

The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) regularly publishes a Code of Practice that defines international guidelines for pharmaceutical promotion.  According to Section 12.3 of the IFPMA Code of Practice 2019, any promotional communications (adequately qualified by scientific personnel) must be approved by a designated company employee who has the necessary expertise and credentials.

Additionally, the European Federation of Pharmaceutical Industries and Associations (EFPIA) releases a Code of Practice on a regular basis. It contains a set of moral guidelines for promoting pharmaceuticals to Healthcare Professionals (HCPs) in the EU. Each member company must create a scientific service in charge of medicinal products information according to Section 20.01 of the EFPIA Code of Practice 2019. It must contain a physician or a pharmacist who will oversee the approval of any promotional material before its release.

What Types of Medicinal Products are Covered in these Regulations?

All sorts of pharmaceuticals, including prescription and over-the-counter medications, vaccines, blood and blood components, gene therapy products, and advanced therapies, are covered under the European Directive 2001/83 on the Community code relating to medicinal products for human use. The Directive does not specify a specific criterion for choosing between the different types of medicinal products based on their therapeutic or financial worth. As a result, all the traditional pharmaceuticals, innovative medicines, and high-value biologicals fall under its purview.

What are the Specific Advertising Laws and Requirements for Different Countries?

Each country in Europe has different laws and regulations for advertising medicinal products in Europe. The below table enlists some key laws and regulations that the pharma manufacturers must abide by.

 

England and Wales

Germany

Italy

Switzerland

Laws and codes for advertising pharmaceuticals

European Federation of Pharmaceutical Industry Associations (EFPIA) Code of Practice

Law on Advertising in the Field of Healthcare

Article 113 of Legislative Decree 219/2006

Federal Act on Medicinal Products and Medical Devices

Laws for internet advertising

Same as the above for advertising

Same as the above for advertising

Governed MoH guidelines of  February 17, 2010

Same as the above for advertising

Laws for advertising on social media

Same as the above for advertising

Same as the above for advertising

Governed MoH guidelines of  February 06, 2017

Same as the above for advertising

Prior arrangements that companies must do

A final form is to be certified by a person on behalf of the company

Appoint an information officer

The MAH must have a scientific office that oversees the information released in the market

The MAH must designate a person who is responsible for advertising medicinal products

Penalties for failing to comply with advertising rules

Unlimited fine or two (02) years of imprisonment

  • Intentional breach: One (01)-year imprisonment or fine
  • Negligent breach: EUR 20,000
  • Negligent or intentional breach of explicitly listed regulations: EUR 50,000

Ranging from €2,600-€15,600 and €10,000-€60,000, when in the press or in radio-television programs

CHF 50,000

Need for SOPs for governing advertising activities

No legal requirement for SOPs

Provision of SOPs is advisable

No legal requirement for SOPs

No legal requirement for SOPs

 

Despite having a common framework in the EU Directive 2001/83/EC, promotional regulations are governed by various texts and frameworks in each of the EU MS and the UK. Each country has local specifics for validating advertising material. Before beginning local promotional operations in the EU nations and the UK, pharmaceutical companies must satisfy several local requirements to comply with local laws. It is worth verifying with individual regulators before continuing too far down any certain path.

Freyr has expertise in preparing promotional and advertising material that complies with the regulations of the EU MS and the UK. Through our ad promo services, Freyr experts and our local affiliates in more than hundred and twenty (120) countries will assist you by developing and coordinating your products’ Regulatory advertising and promotional plan and ensure that all the local standards are met. Reach out to us for compliance best practices.

Author:

Nirupama Parate , Senior Associate, MPR Presales