The legal situation in Europe regarding advertisement of PSPs is highly fragmented with different jurisdictions taking varying approaches to address upcoming problems.
Patient Support Programmes (PSPs) are increasingly popular across Europe, offering services to a patient on behalf of a pharmaceutical company to accompany the medication of – mostly chronically – ill patients (for example, compliance and adherence programmes, nurse educator programmes and homecare).
However, PSPs raise a range of issues around advertising law, with European jurisdictions taking different approaches. Some European countries, such as Italy and France, have already reacted to this increase in PSPs with specific advertising legislation; other have started legislative initiatives but these are yet to be realised in law. Belgium's initiatives, for example, were put on hold in 2017 and have not yet been resumed. In Germany, there is neither specific legislation nor supreme court case law on the interpretation of general advertising laws for PSPs. Pharmaceutical companies, therefore, must rely on lower court jurisprudence and industry codes of practice.
The aim of legal restrictions on advertising for PSP is to maintain objectivity and neutrality in medical treatment. Therefore, pharmaceutical companies are prohibited from creating incentives for recommending, prescribing, purchasing, selling, supplying or administering a concrete medication. The design of the communication of PSP programmes plays an essential role for the admissibility of such programmes under advertising law:
Channels for communication
Communication channels can be decisive for admissibility under advertising law. In Spain, Italy and the UK, only health care professionals (HCPs) or patient organisations are allowed to communicate PSPs to patients. That means, pharmaceutical companies must not promote any PSP openly and to the general public. In the UK, a further restriction on the advertisement of PSPs by pharmaceutical companies to HCPs is that this communication must include essential information compatible with the summary of the product characteristics.
In Belgium, it is even required that the pharmaceutical company hires a qualified third party for the organisation of the PSP, which acts as an intermediary between the pharmaceutical company and the HCPs. In Germany, it is highly controversial whether PSPs can be communicated at all via HCPs. Single courts consider the strengthening of the doctor-patient relationship through the offer of a PSP or the saving of capacities in the HCP’s offices to be an advantage and an inadmissible influence on HCP’s prescribing decisions.
Also the design of materials can be relevant for admissibility of PSP programmes. According to general principles of advertising law in almost all European countries, the communication materials in the context of PSP must be factual, educational and neutral in nature, clear of promotional content and not lurid.
This means that, for example, in Italy and Belgium, the registration documents handed over from the HCP to the patient must not contain any reference to the medicinal product but address only the service rendered to the patient within the framework of the PSP. Furthermore, the materials submitted by the pharmaceutical companies to HCPs should not contain any reference to the medicinal product, the trade name or that of the active substance, or any reference to studies and claims related to the medicinal product used in the PSP.
Role of HCPs
In addition to the fact that in several countries, only HCPs are allowed to communicate PSP to patients, there are often further requirements regarding the exact role of HCPs in this communication.
Italian law specifies that HCPs must have an objective decision-making and reviewing function and must not promote PSPs as their own service. Furthermore, HCPs must communicate PSPs only to patients who are already being treated with the particular medicinal product that the service is for. Belgium law specifies that PSPs must be offered without discrimination to all patients who meet the eligibility criteria.
In Germany, there is a strong opinion in legal literature that only measures ensuring the correct application and use of the pharmaceutical product – not the original tasks of a HCP that require special expertise (for example, initiation of treatment, monitoring and decisions on eligibility) – can be performed by pharmaceutical companies
General involvement of pharmaceuticals
Beyond these issues of communication, single countries even restrict the general participation of pharmaceutical companies in PSPs.
In Europe, French law seems to be one of the strictest with regard to the involvement of pharmaceutical companies in PSP. The French Law on Patients Therapeutic Education provides that pharmaceutical companies can contribute to PSPs only with financial support. This financial support is then granted to HCPs organisations or patients communities that initiate PSPs. The French law, therefore, prohibits pharmaceutical companies from being active in the initiation and in the performance of PSPs. That means, companies in France cannot draft, organise, communicate or conduct PSPs or select the HCPs who will handle the related sessions with patients.
Purpose of the PSP
Some countries have specific requirements for the purpose of the PSP. In Germany, for example, the communication of a PSP via HCPs to patients might not be seen as unfair marketing, if the PSP follows a medical rationale, that is, if a cost-benefit assessment, which considers, for example, the risks of side effects, is positive from a medical point of view.
According to Catalonian guidelines on PSP, the programmes must serve to help the patients understand the development of the disease, improve their quality of life or contribute to the adequate compliance with the treatment.
Disease awareness campaigns
As in several European countries, it is not permissible to promote PSP directly to patients, disease awareness campaigns (DACs) were set up and, for example, in UK are officially recognised as permissible under certain circumstances. The aim of DACs is to provide high-quality information to patients and to the public about health, diseases and their management. In this context, pharmaceutical companies can share information on pathologies and their medical environment and make reference to the availability of treatment options. This way, pharmaceutical companies can educate about the existence of PSP. These campaigns must, however, not promote the use of a particular medicinal product and must not include direct or indirect references to medicinal products.
The legal situation in Europe with regard to the advertisement of PSPs is highly fragmented. While in France PSPs in general have been very strongly and strictly restricted, other countries such as Belgium, Italy and Spain have only restricted certain aspects, above all the communication channels and communication content. In Germany, the picture is still very blurred with regard to the legal requirements, as both a specific law and higher court rulings are lacking so far.
It remains to be seen how the legal situation will develop and whether there will even be regulatory efforts at the European level. The purpose of this article is to outline the critical aspects that PSP face with regard to advertising law and to give an overview about several European jurisdictions and the approaches to deal with the upcoming problems.