The pharmaceutical market in Poland has significantly developed during the last decades making it attractive for investors. This article aims to briefly summarize current issues with regard to rules of comparative advertising of pharmaceutical products in Poland.
Legal context
The statutory definition of advertising of pharmaceutical products in Poland comprises any activity consisting of provision of information on or encouragement to use a medicinal product with the purpose of increasing: the number of prescriptions, delivery/sale or consumption of medicinal products. The Polish Pharmaceutical Law (PPL) prohibits advertising of some kinds of medicinal products (prescription drugs, drugs reimbursed by the state) but it does not introduce specific conditions for pharmaceutical comparative advertising. However, it is acknowledged that such comparative advertising is permissible and it is governed by general rules of Polish Unfair Competition Law and Polish Industrial Property Law, in accordance with Directive 2006/114.
The Polish law does not set the obligation to notify a competitor of the content of pharmaceutical comparative advertising involving its product. In accordance with general rules comparative advertising is permissible if it is not misleading, it fairly and objectively compares drugs with similar properties or indications, refers to the price or one or more of essential and verifiable features, in particular those described in the summary of product characteristics, there is no confusion in distinguishing drugs, advertising does not unfairly exploit reputation of the trademark of the compared drug, company name or other distinctive indications of a competitor, advertising does not present a drug as an imitation or copy, advertising does not discredit goods, business, trademarks, company or other distinctive signs, circumstances surrounding a competitor or does not discredit the reputation of the competitor, the competitor itself or its product.
Case law
Polish jurisprudence does not provide an exhaustive set of rules for pharmaceutical comparative advertising. The following guidelines may be extracted from the body of case law.
Polish courts confirmed that advertising simply presenting a list of pharmaceutical products with lowered price and price described as 'typical', 'old' offered in another, concrete pharmacy, or in any other way suggesting that the given pharmacy sells pharmaceutical product at discount price constitutes comparative advertising.
Moreover, under Polish case law advertising referring to 'the cheapest' pharmacy, constitutes an illegal advertising of pharmacies, which is banned as from amendment to the PPL introduced in 2012 prohibiting advertising of pharmacies.
Recently, jurisprudence has also confirmed that comparing dietary supplements to pharmaceutical products constitutes illegal comparative advertising infringing honest trade practices. Consumers cannot be convinced that consumption of dietary supplement has any medical effect equal to administration of drugs with proven clinical tests. Similarly, one cannot compare in advertising price of dietary supplement to price of a medicinal product.
Regulatory authorities in a number of decisions confirmed legality of comparative advertising between innovative and generic drugs. However, such comparative advertising cannot denigrate generic pharmaceutical products, i.e. indicate poorer quality or inferior effectiveness of generic product. It is not allowed to use in advertising general terms that discredit a competitor and undermine the effect of administration of a generic product or its registration process. For instance, the regulatory authority has held that advertising slogans: 'Choose the proven effectiveness' and 'Reflection is not always accurate' go beyond limits of lawful comparative advertising.
Open questions
There are many important problems that remain unsolved. First, there are no specific guidelines, what pharmaceutical products can be compared. In particular, whether one can compare products of different chemical categories with same therapeutic effects. Second, it is not clear, what is the scope of the permissible comparison, in particular, whether one can compare efficacy or security of application, including healing effect and side-effects, posology, the length of the treatment, bioavailability of pharmaceutical products. Third, it is not clear, what rules should be followed when comparing innovative and generic drugs. In particular if one can only compare price of innovative and generic drugs, or is it permitted to compare also their characteristics. Fourth, it remains doubtful, if it is legal to compare the cost of the treatment. Another problem is that, until now, Polish courts have not provided clear guidance on conditions of use of results of clinical tests specified in market authorization in comparative advertising.
Conclusion
Due to lack of specific statutory regulation and limited case-law, the comparative advertising of pharmaceutical products in Poland causes many pitfalls. However, since Poland is not a case-law country and Polish courts are not bound by existing court decisions, the limited regulation leaves the Polish market open to different scenarios.
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.
