A definition of PSPs

A general and the most popular understanding is that PSPs are a variety of actions that aim to provide solutions to patients beyond the medication itself. Overall, the main goal of a PSP is to increase the quality of the patient’s life by enhancing treatment adherence, improving clinical outcomes and facilitating the patient’s experience during their treatment.[1]

The European Medicines Agency (EMA) describes PSPs in a narrower way. According to the EMA, a PSP ‘is an organised system where a marketing authorisation holder receives and collects information relating to the use of its medicinal products’. Examples of such programmes include post-authorisation patient support and disease management programmes, surveys of patients and healthcare professionals (HCPs), information gathering on patient compliance and compensation and reimbursement schemes.[2]

Regardless of the theoretical definition, most PSPs share a common goal related to the need to increase the quality of the patient’s life and can be attributed to the one of the following categories:[3]

  • adherence PSP, which help patients to take their medications as prescribed and provide them with the necessary support;
  • education PSPs, which help patients to learn about and understand their condition and provide general advice on how to manage their disease more effectively; and
  • patient access programmes, which provide financial assistance or reimbursement in regard to the medicines required by patients.

Key principles of the regulatory framework and current practices

PSPs are relatively new; therefore, there are no general laws and regulations uniformly governing PSPs.[4] In the majority of countries, PSPs fall into the so-called grey zone and are neither directly permitted nor prohibited. In such cases, PSPs are regulated in a fragmented way by other regulatory authorities, in regard to areas of law such as advertising, data protection, pharmacovigilance and anti-bribery.

Nevertheless, some specific principles of the regulatory framework for PSPs can be indicated that reflect current practices. At the outset, PSPs must be of a non-commercial nature. To achieve this, PSPs must be organised through HCPs/healthcare organisations (HCOs) and have obtained their approval. Naturally, no advertising is allowed to take place in regard to PSPs. It is also important that the entire PSP implementation process is transparent and the activities carried out by PSPs are well-documented and they are included in the company’s pharmacovigilance plan. The transparency principle also mandates that patients are provided with sufficient information, which is needed for the patient to decide whether to participate in the programme and, in the case of a positive decision, explicit consent must be obtained from the patient.[5] In addition to the material requirements, PSPs are also subject to certain administrative rules that are important to be followed while implementing these programmes. For example, in regard to a PSP being carried out not by a pharmaceutical company, but by a third-party service provider, it must be ensured that a proper agreement is in place between these two entities. In such cases, special attention must be paid to employment laws to ensure that illegal staff leasing is avoided.[6]

Even though the abovementioned principles represent a general regulatory framework for PSPs and reflect current market practices, some local industry initiatives foresee additional requirements for PSPs. In Canada, for instance, a local code of conduct states that PSPs must have clear objectives, timelines and scope, whereas in Australia, PSP providers must ensure that the clinical rationale for these programmes is documented.[7] In conclusion, even though there are some general rules for the implementation of PSPs, currently the market lacks a clear legal framework governing PSPs.

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