New guidelines on patient support programs have been adopted by the Italian pharmaceutical industry association (Farmindustria) on January 19, 2022. The new guidelines have been incorporated in a new release of the industry ethical code, where also several provisions regarding educational activities, market access and scientific data exchange have been updated.

Patient support programs are not expressly regulated under Italian law and, for such reason, the guidelines issued by Farmindustria are particularly helpful in identifying the best market practices. The new guidelines define patient support programs as initiatives implemented by pharmaceutical companies aimed at making available additional services for the direct benefit of patients. Such services are not intended to replace the services of hospitals and other healthcare organizations.

Patient support programs can only be implemented in connection with medicinals that have received a marketing authorization, for the sole purpose of providing information on the correct use of the medicinal product and to foster patients’ compliance with its administration. They can never have a promotional purpose.

The new Farmindustria guidelines expressly acknowledge that patient support programs may be implemented by pharmaceutical companies through a third party service provider, which may carry out services in favour of patients by means of adequately qualified professionals. The pharmaceutical companies, however, continue to have overall responsibility for the program.

A noteworthy innovation has been adopted with regard to the processing of patients’ personal data. In fact, the new guidelines provide that pharmaceutical companies must not directly process the data of patients enrolled in a patient support program, and should rather only access aggregated data for statistical purposes on the use of the services. 

This latter provision is particularly troublesome from a data protection standpoint, as it may be interpreted as preventing pharmaceutical companies from acting as data controllers in connection with the deployment of patient support programs, even if they remain responsible for the programs themselves. Therefore, new mechanisms shall be implemented to segregate identifiable data and prevent their processing by pharmaceutical companies unless they are previously de-identified.