Navigating the Legal landscape: Patient Support Programs in Spain

Patient Support Programs (PSPs) play a key role in ensuring enhanced patient outcomes and patient experiences. For pharmaceutical experts, understanding the legal landscape governing these programs is crucial. In this article, we will focus on the Spanish context, trying to explain and ease all complexities of the various perspectives.

Despite the rise of patient support programs (“PSPs”) in recent years, up-to-date regulation on such programs has been quite scarce. With the introduction of the Royal Decree 957/2020 in January 2021, PSPs are defined and addressed for the first time in the Spanish legal system. The aim of this Royal Decree 957/2020 was especially to simplify the process for conducting observational studies in Spain by introducing a common single evaluation procedure for all studies of this type and by reducing the prior requirements.

The Royal Decree makes reference to the PSPs twice, defining them as “an organized system where a marketing authorisation holder receives and collects information on individuals related to their use of medicinal products“ and including, in Article 3.2, the requirement that PSPs “which provide for the recording of information on the use of medicinal products through planned contacts with patients may be carried out in Spain only in the context of a protocol which includes as its objectives one of those described in Article 2.1.a)“.

It is this last reference (in Article 3.2) which has made it a controversial question : should patient support programs meet the requirements provided for non-interventional studies?

In November 2021, an explanatory memorandum of the Royal Decree was published, which incorporates another extremely important reference to PSPs : “only those programmes which meet the criteria to be considered observational studies with medicinal products must be carried out in accordance with the provisions of this Royal Decree”.

With this information we need address the question we raised earlier: Should planned patient support activities/programmes carried out or funded by industry in Spain meet the same requirements as observational studies ?

In order to answer this question it is useful to split the question in two: can the activity be considered as an observational study referring to  art.2.1.a of Royal Decree 957/2020; and, if no, can the activity be considered as a PSP referring to art.2.1.g of Royal Decree 957/2020 ?

• If the answer to the first question is yes, then all the requirements applicable to observational studies will apply to the activity.
• If the answer to the first question is no and the answer to the second question is yes, then in our view only the requirement to have a protocol with specific objectives will apply to the activity.
• Finally, if the answer is negative on both questions, the activity will be completely outside the scope of Royal Decree 957/2020.

A notable outcome of these legal references is the clarity that running Patient Support Programs does not necessarily equate to conducting observational studies.
The Memorandum of November 2021 elucidates this aspect, providing a pathway for pharmaceutical entities to navigate the regulatory landscape without being constrained by the observational study framework.

The mention of PSPs in Royal Decree 957/2020 aims to ensure that they serve to improve the health of patients and to prevent them from being used as covert tools for the promotion of medicines

Indeed, in our view (supported by the advice of  2 independent legal experts in the feld), if the PSP does not involve research with medicinal products for human use (“research” being understood as a systematic, organised and objective process aimed at verifying a scientific hypothesis and modifying or adding new knowledge to existing knowledge ) but  is merely a provision of services aimed at improving adherence to treatment, and if the collection and management of data is carried out for the sole purpose of providing the service, we believe the PSPs fall outside the scope of application of the Royal Decree 957/2020.

We cannot speak of a regulation for PSP’s as such.
However, armed with the knowledge embedded in the Royal Decree 957/2020 and the Memorandum we believe pharmaceutical entities can confidently design and execute Patient Support Programs that align with legal standards.

Disclaimer: This article is for informational purposes only and does not constitute legal advice. It is recommended to consult legal professionals for specific guidance on compliance with regulatory frameworks.