General Law for Pharmaceutical Advertising in Cyprus

EU legislation

The legislation that governs the advertisement of pharmaceutical products within the EU is the Directive 2001/83/EC. This directive provides a legal framework for the regulation of pharmaceuticals and medicinal products in the EU and should be transposed into the national law of member states.

As of April 2023, the European Commission (EC) published a new proposed Directive and Regulation for centrally authorised medicines. These will replace both the Directive 2001/83/EC and the Regulation 726/2004 and contains some direction on advertisement regulations. This is the largest altering of EU pharmaceutical legislation in 20 years.

Other relevant legislation includes:

• Directive 2005/29/EC which regulates advertising to consumers;
• Directive 2006/114/EC concerning misleading and comparative advertising;
• Regulation (EC) No 1223/2009 which implements safety requirements for sale of cosmetics in the EU;
• Council Directive 2010/13/EU concerning the provision of audio–visual media services; and
• Regulation (EU) 2017/2394 on the co-operation between national authorities responsible for the enforcement of consumer protection laws.

National laws

Cyprus’ regulatory framework for advertising pharmaceutical and cosmetic products encompasses the following laws.

• The Medicines for Human Use (Quality Control, Supply and Prices) Law of 2001 (70(I)/2001) (the “Law”), which transposes Directive 2001/83/EC into national law.
• The Broadcasting Organisations Law of 1998 (7(I)/1998).
• The Cosmetic Product Law of 2017 (57(I)/2017).

The Law governs the regulation of advertising, promotion and sale of pharmaceuticals and medical devices. The Law appoints the Cyprus Medical Council (CMC), which works as part of the Pharmaceutical Services and within the Ministry of Health, as the main regulatory body. The CMC oversees and governs the advertisement of medicinal products, including information presented for the purpose of attracting customers and anticipating or exhorting the purpose of promoting the prescription, supply, sale or consumption of medicinal products and homeopathic medicinal products. The CMC is under obligation to examine on appeal or even on its own motion, whether any advertising of medicinal and pharmaceutical products – published or imminent – is misleading or generally inconsistent with the provisions of the Law, and to grant market authorisation for the advertising of any such products accordingly. The CMC can also prohibit the advertising of certain medicinal products to the public – the costs of which may be reimbursed from any insurance or social security organisation – or may be covered by any social security organisation – or those which are directly promoted for use to the public by the pharmaceutical companies.

The Law outlines the conditions necessary for permitted advertising as described below.

• Any advertising of a pharmaceutical product for which a marketing authorisation has not been issued is prohibited.
• All the elements of the advertisement of a medicinal product must correspond to the information included in the summary description of the characteristics of the product.
• The advertisement of a medicinal product must:
1. promote the rational use of the medicinal product by presenting it objectively and without exaggerating its properties; and
2. not be misleading within the meaning of the Control of Misleading and Comparative Advertising Act 2000 (repealed).

The Pharmacy and Poisons Law, Chapter 254, also regulates the sale of drugs to the public, with Section 4A(1) mentioning that no other persons except registered pharmacists are allowed to provide or sell drugs to anyone. Chapter 254 also provides that no person shall, without the permission of the Minister of Health, publish, or cause to be published, any advertisement referring to any article or articles of any description under conditions which tend to lead to the use of the said article or articles for the purpose of treating humans for any of the following diseases/conditions:

• Bright’s disease;
• cataracts;
• diabetes;
• epilepsy or convulsions;
• glaucoma;
• motor ataxia;
• paralysis;
• cancer; and
• tuberculosis.

Self-Regulation

In the pharmaceutical industry, self-regulatory bodies perform an important function, providing greater detail and guidance than both national and EU legislation.

The Cyprus Association of Research and Development Pharmaceutical Companies (KEFEA) code of conduct aims to go beyond existing legal regulations and provide detailed regulations for the supply of medicinal products. KEFEA is aligned with the regulatory framework of the Code of the European Federation of Pharmaceutical Industries and Associations (EFPIA). For instance, once a marketing authorisation has been granted, the holder of that authorisation must create and manage a “Scientific Service”. The purpose of the Scientific Service, outlined in the KEFEA code of conduct, is to be a source of information on pharmaceutical products that have been marketed to consumers. The services carry out compliance reviews and receive questions on individual products from medical sale representatives, patients and others.

The Cyprus Medicines Verification Organization (CyMVO) is a non-profit legal entity that maintains and supports the Cyprus Drug Verification System and is committed to adhering to the Falsified Medicines Directive (Directive 2011/62/EU) and the Commission Delegated Regulation (EU) 2016/161, both of which aim to ensure the sale of medicines is tightly regulated, and the necessary safety features of products to gain approval.

Advertisement Definition

Advertising is defined by the Law and this definition is maintained in the 2023 proposed Directive. “Advertisement of medicinal products” is defined as any form of solicitation, prediction or solicitation intended to promote the prescribing, supply, sale or consumption of medicinal products and homeopathic medicinal products.

The definition includes:

• the advertising of medicinal products to the general public;
• advertising of medicinal products to persons qualified to prescribe or supply them;
• visits by medical sales representatives to persons qualified to prescribe medicinal products;
• the supply of samples;
• the provision of inducements to prescribe or supply medicinal products by the gift, offer or promise of any benefit or bonus, whether in money or in kind, except when their intrinsic value is minimal;
• sponsorship of promotional meetings attended by persons qualified to prescribe or supply medicinal products; and
• sponsorship of scientific conferences attended by people qualified to prescribe or supply medicinal products and in particular payment of their travelling and accommodation expenses in connection therewith.

The 2023 proposed Directive includes “advertising related to medicinal products, that does not refer to specific medicinal products” as an additional example of advertisements. This inclusion is a reflection of current European case law which has interpreted pharmaceutical advertising broadly, with the incorporation of undefined medicinal products. Notably, this wording can be interpreted to define what amounts to pharmaceutical advertising to encompass numerous other health-related correspondence.

General Restrictions and Penalties

Under Cypriot law, any medicinal or pharmaceutical product which has not acquired market authorisation from the CMC is prohibited from being advertised or promoted publicly in any manner. Companies breaching these regulations will be subject to an administrative fine of up to CYP25,000.

The CMC can similarly impose the following penalties to breaches of the Law in regard to advertisements.

• Submit an order to the pharmaceutical council to discontinue the offence by an established deadline.
• After an administrative fine of CYP25,000, if the breach is continued, a daily administrative fine of up to CYP200 can be ordered.

Changes to EU Pharmaceutical Advertisement Legislation

As indicated previously, the EC introduced a proposed Directive and Regulation in 2023 with reforms to pharmaceutical legislation. However, advertising and marketing was not a specific objective under the proposed Directive and, therefore, changes to the Directive 2001/83/EC are modest.

Although the proposed Directive replaces the existing legislation, the regulations regarding advertisement are generally maintained or supplemented, but not replaced.

General regulations and changes

The proposed Directive contains certain changes to pharmaceutical advertising that should be of note to pharmaceutical companies.

• Advertising to the general public of medicinal products that are available only on medical prescription will be prohibited.
• Distributing samples free of charge to the general public for promotional ends will be prohibited.
• Teleshopping for medicinal products will be prohibited.
• Negatively highlighting another medicinal product or to suggest that the advertised pharmaceutical may be safer or have higher efficacy than another pharmaceutical product is expressly forbidden.
• Pharmaceutical sales representatives should be subject to particular obligations, most importantly the obligation to supply the person visited with a summary of product characteristics (SmPC).

The 2023 proposed Directive provides strict exceptions to the existing rules prohibiting the distribution of free samples of pharmaceutical products. It specifies that free samples may be provided to persons qualified to prescribe or supply them for the purpose of gaining appropriate experience and familiarity with the new products. Additionally, the Directive proposes that in exceptional circumstances, the exceptions may be extended to free samples provided for pharmaceutical products not subject to prescriptions.

The 2023 proposed Directive further broadens the scope of the previous definition of “persons qualified to prescribe or supply” to “persons qualified to prescribe, administer or supply”. However, it is important to note that this legislative change is already reflected in the EFPIA Code of Conduct, which the KEFEA incorporates. In essence, this regulation is already in action and the incorporation of this broader term merely reflects this.

Comparative advertising

In Cyprus, national law permits the use of comparative advertising for pharmaceutical products subject to other legislation regarding advertisements of specific products or services (including the Law). The Consumer Protection Law of 2021 regulates comparative advertising in Cyprus, typically involving a company advertising their product as superior to a competitor company’s product.

The 2023 proposed Directive introduces a new regulation stating that “any form of advertising that aims to highlight negatively another medicinal product shall be prohibited”. Accordingly, the proposed regulation does not provide a complete prohibition of comparative advertisement but implements more stringent regulations. The Directive further provides that advertisements suggesting a pharmaceutical has better safety or higher efficacy are prohibited, “unless demonstrated and supported by the summary of product characteristics”.

Claims that compare products in such a way that the competitor’s product safety or efficacy is negatively compared must be restricted to the reported data contained in the SmPC and may not be supplemented by additional information. Given that the proposed Directive provides that comparing medicinal products is only permitted based on information included in the SmPC, it further restricts comparative analyses and prevents biosimilar comparisons of reduced efficacy and safety without evidence from the SmPC.

Restrictions on Press Releases

Pharmaceutical companies, whether headquartered in Cyprus or seeking to promote and market their products within the country, frequently employ press releases. Yet, a key consideration arises regarding whether a press release qualifies as an advertisement according to Cypriot law, consequently subjecting it to advertising restrictions and regulations. In this respect, the most relevant regulation is the strict prohibition on medicinal products that have not received marketing authorisation from being advertised to the public.

Press release and advertisement distinction

The definition of advertisement under the Law encompasses any press release that in any way promotes the prescription, supply, sale or consumption of the pharmaceutical product. Hence, there is a distinction to be made between press releases which function as advertisements under this definition, and ones which simply provide information.

The European Court of Justice has provided further guidance on this, distinguishing a press release based on the objective of the relevant information. If information within the press release is published to merely provide information with no identifiable promotional character, the press release will not be subject to the 2023 proposed Directive and its Regulations of pharmaceutical advertisement. A conscious and direct intention to produce promotion within the press release can often be demonstrated if either the manufacturers or sellers benefit from an increase in sales subject to the press release.

Off-label information

Providing off-label information on a pharmaceutical product that has marketing authorisation is an area of potential ambiguity. Off-label information is information that is not within the marketing authorisation licence, such as providing information of a medicinal product’s utility for treating a particular condition where it has been authorised for treatment of a different condition.

In Cyprus, off-label information is not expressly regulated in any applicable law. Most likely, it will be treated as a breach of pharmaceutical advertising conditions, as the information will likely lead to an increase in product sales or will be regarded as intending to do so, hence appearing to be promotional in nature.

Nevertheless, the rule is not applicable in all circumstances. If the press release contains information as to off-label use which is accurate, factual and balanced in both tone and content, and the use of the company’s trade name is modest and reasonable, the press release may be deemed as merely informational.