Press-release shall not be an advertisement
Pharmaceutical companies incorporated and/or have their businesses in Cyprus issue on a regular basis press releases in regard to their medicinal products. The position under Cypriot law as regards the 'press releases of medicinal products' is essentially based on (A) 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 as has been amended (hereinafter the "Directive") and (B) the Regulation (EC) No 726/2004. It is noted that, the main provisions of the Directive and Regulation have been adopted by the the Medicinal products for human use (Control of Quality, Supply and Prices) Law L.70(I)/2001 (as it is amended).
It should be noted that pursuant to express provisions of the L.70(I)/2001, the advertisement of any medicinal product (A) is strictly prohibited in Cyprus, if that medicinal product has not received marketing authorization in Cyprus issued by the Committee; and (B) must comply with the particulars listed in the summary of the product as per the authorization issued by the Committee.
The question which may arise is whether a press release may constitute an advertisement of a medicinal product. The L.70(I)/2001 and the Directive provide that, advertising of medicinal products may include any form of door-to-door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products.
Evidently, if a pharmaceutical company through its press release promotes the prescription, supply, sale or consumption of medicinal products, this will usually be regarded as an advertising of a medicinal product which is prohibited by law.
Advertisement or mere information
In a judgment of the European Court of Justice was held that the fundamental criterion for separating advertising from mere information lies in the objective pursued: if the intention is to promote 'the prescription, supply, sale or consumption' of medicinal products, there will be advertising for the purposes of the Directive; if, on the other hand, 'purely' informative material is being disseminated without promotional intent, it will not come within the Community rules on advertising of medicinal products.
The crucial element is thus the deliberate and direct intention of the party who issues the message and usually, the 'promotion' of a medicinal product is ensured by someone who, owing to his direct or indirect relationship with the manufacturers or distributors, benefits from an increase in sales.
Off-label information
It is noted that a proactive provision of information by a pharmaceutical company about an unauthorized medicine (or off-label information) is very likely to be seen as a promotion. As a result, a press release referring to an off-label information usually will constitute a breach of the provisions of the L.70(I)/2001 and Directive.
Nevertheless, it is possible to issue press releases about unauthorized medicinal products and off-label use to the general public, provided that the said press releases are not promotional in tone. For the avoidance of any doubt, a press release may contain information with regards to off-label use (including discussions at international meetings and/or congresses), provided that:
- the tone and content of the said press release is accurate, factual and balanced; and
- the trade name of the pharmaceutical company is used in moderation.
Position under Cyprus law
For the purposes of any press release as regards the medicinal products, the following principles will be recognized and applied by the Cypriot authorities:
- A press release with regards to a medicinal product would be regarded as an advertisement of the said product, if the purpose of the message and the objective pursued is to promote the prescription, supply, sale or consumption of that medicinal product;
- If the intention of the press release is as described above, then the medicinal product which the press release is referred to shall be authorized.
- The content of the press release shall comply with the particulars listed in the summary of product characteristics.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
