The legislation and the National Organization for Medicines (EOF) explicitly prohibit any advertising of medicinal products for purposes not included in their marketing authorisation.

Off-label advertising, as it is known, is quite a serious violation that has come to the attention of authorities of other countries many times and hefty fines have been imposed.

Banning of off-label advertising also includes the promotion of medicinal products at scientific conferences.

However, because the health professionals need to be updated on new developments, the presentation of the latest scientific findings at scientific conferences is permitted, provided that it is stated that the specific active ingredient has not been approved and provided that the trade name is not mentioned.

With its vast experience in pharmaceutical law, commercial law and compliance, the Stefanos Economou & Associates Law Firm is able to meet all the needs of pharmaceutical companies, pharmaceutical warehouses and medical equipment companies for legal services, either as an advisor or before the courts and authorities.

Teasers or teaser ads pertain to the promotion of an advertising message without mentioning the name of the product, in anticipation of the launch of a new major and significant medicinal product in the coming period.

In Greece, teasers are prohibited, given that advertising a medicinal product that has not received a marketing authorisation in not permitted and teasers are essentially indirect advertising, even though they do not include the name of the product.

With its vast experience in pharmaceutical law, commercial law and compliance, the Stefanos Economou & Associates Law Firm is able to meet all the needs of pharmaceutical companies, pharmaceutical warehouses and medical equipment companies for legal services, either as an advisor or before the courts and authorities.

According to Ministerial Decision 32221/2013, the concept of advertising/promotion of medicinal products is quite broad, so as to include any activity a pharmaceutical company carries out to promote the prescribing, supply, sale or consumption of medicinal products.

However, the compliance officers and legal advisors of pharmaceutical companies are used to arguing with the marketing departments as to whether an action is an advertisement or ordinary information, and the arguments put forward by both parties are quite sound most times.

Typical cases that create doubts are press releases, media articles and interviews given by doctors and company executives.

The limits between providing ordinary information and advertising are not always clearly distinguished, and one must take many criteria into account.

If a company issues a statement to the general public about a prescribed drug and this statement is deemed to be advertising and not just ordinary information, then it is at risk of being fined or even have legal actions brought against it by its competitors.

The European Court of Justice, but also the Greek courts have dealt with such issues on many occasions. Our firm’s lawyers who specialise in pharmaceutical law can offer you advice, either as a precaution or before the National Organization for Medicines (EOF) and the courts if an action of yours is beyond the strict limits of information and constitutes an advertising action.

The following key criteria must be taken into account:

1. the purpose of the statement, i.e. whether its aim was to boost sales or not
2. the capacity of the person making the statement

iii. the potential result of the statement in terms of the decision to buy the medicinal product

1. the type of information
2. the recipients of the statement and the medium it appeared in

With its vast experience in pharmaceutical law, commercial law and compliance, the Stefanos Economou & Associates Law Firm is able to meet all the needs of pharmaceutical companies, pharmaceutical warehouses and medical equipment companies for legal services, either as an advisor or before the courts and authorities.

The pharmaceutical industry has adopted codes of ethics, which are self-binding even in countries where the legislation has not set restrictions or has set inadequate restrictions and audits in medicinal product advertising.

These texts are usually called Code of Conduct or Code of Practice.

Our law firm has profound knowledge of the legislation governing the advertising and promotion of medicinal products in general, as well as the compliance of said promotion to the various codes of ethics. Managing partner Stefanos Economou has written the only book in Greek literature on the marketing of medicinal products. The book is entitled Compliance with Legislation and the Code of Ethics in Promoting Medicinal Products.

1. GREEK ETHICS CODES
2. The SFEE Code of Ethics for prescribed medicinal products

The Hellenic Association of Pharmaceutical Companies (SFEE) has been a member of the European Federation of Pharmaceutical Industries and Associations (EFPIA) since 1983.

The Code of Ethics currently in effect for the promotion of prescribed medicinal products was amended and approved by the SFEE General Meeting in March 2017 and came into force on 1 June 2017. Since then, the National Organization for Medicines (EOF) has changed the landscape and, consequently, the SFEE Code needs to be updated so as to correspond to the current state of affairs.

Furthermore, the SFEE has adopted a Code of Ethics that governs the relations between pharmaceutical companies and patient associations, which is in effect today, as amended after the General Meeting of the SFEE on 20/03/2015.

1. The EFEX Code on OTC drugs

With regard to over-the-counter (OTC) drugs, the Association of the Greek Self-Medication Industry (EFEX), which is a member of the Association of the European Self-Medication Industry (AESGP), has drawn up the Code of Ethics and Advertising of OTC Drugs.

1. The Code of Medical Ethics

The Code of Medical Ethics also includes provisions that are indirectly linked to the promotion of medicinal products and the relationships of doctors with the pharmaceutical industry.

1. EUROPEAN & INTERNATIONAL ETHICS CODES
2. The EFPIA Code of Practice

The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the pharmaceutical industry operating in the European Union. Its members are 36 national associations of EU member states and 34 pharmaceutical companies.

1. The IFPMA Code

The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) represents research-based pharmaceutical companies and associations from around the world.

The IFPMA issued a Code of Ethics for the first time in 1981, which has since been amended on numerous occasions.

As of 01/01/2019, the IFPMA Code has become stricter and bans gifts to health professionals, as had already been done by the EFPIA and the SFEE.

1. The WHO decision

On 13/05/1988, the World Health Organization (WHO) decided to adopt the Ethical Criteria for Medicinal Drug Promotion.

With its vast experience in pharmaceutical law, commercial law and compliance, the Stefanos Economou & Associates Law Firm is able to meet all the needs of pharmaceutical companies, pharmaceutical warehouses and medical equipment companies for legal services, either as an advisor or before the courts and authorities.

Our law firm has profound knowledge of the legislation governing advertising and the promotion of medicinal products in general. Managing partner Stefanos Economou has written the only book in Greek literature on the marketing of medicinal products. The book is entitled Compliance with Legislation and the Code of Ethics in Promoting Medicinal Products.

Consequently, we can offer you advice on any legal issue relating to the promotion of your products, either pharmaceutical products or medical equipment, as well as on any compliance issue.

Regulations on promoting medicinal products appear both in European and national legislation. The main ones are:

1. Legislative Decree 96/73 on trading in pharmaceutical, dietary & cosmetic products, which includes Articles 16-19 on the main obligations and restrictions in the advertising of medicinal products.
2. Directive 2001/83/EC of the European Parliament and the Council of 6 November 2001 on the Community code relating to medicinal products for human use, which includes provisions on advertising and information for medicinal products under Articles 86-100.

It aims to accomplish free and safe marketing of medicinal products for human use and eliminate technical obstacles during the relevant transactions, while promoting the operation of the internal market and ensuring a high level of public health.

29. Ministerial Decision No. ΔΥΓ3α/Γ.Π. 32221 (Government Gazette 1049/B/29.04.2013) on the harmonisation of the Greek legislation to the relevant EU legislation in the area of manufacturing and marketing of medicinal products for human use, in compliance with Directive 2001/83/EC on the Community code relating to medicinal products for human use (Law 311/28.11.2001), as in force and amended by Directive 2011/62/EC as regards the prevention of the entry into the legal supply chain of falsified medicinal products (Law 174/01.07.2011).

This Joint Ministerial Decision (hereinafter JMD 32221/2013) incorporated in the Greek law Directive 2001/83/EC, as amended by Directive 2004/27/EC, and includes all the provisions on medicinal product advertising in Articles 118-132, repeating and enriching the provisions of incorporated Directive 2001/83/EC.

1. Law 4316/2014

Provisions on promoting transparency when marketing medicinal products and on the doctor/manufacturer relations are also included in Article 66(7) of Law 4316/2014, which made it mandatory for pharmaceutical companies to disclose the benefits offered to health professionals.

With its vast experience in pharmaceutical law, commercial law and compliance, the Stefanos Economou & Associates Law Firm is able to meet all the needs of pharmaceutical companies, pharmaceutical warehouses and medical equipment companies for legal services, either as an advisor or before the courts and authorities.