Four Reasons Why Ethics and Compliance Are Important for Patient Support Programs

PSPs can have various forms and structures. There are different kinds of interactions that need to be clearly understood before implementing a program. As a start, all relevant functions must be involved in the discussion as it is important to have different perspectives and different angles covered in analyzing the risks, market access, medical, legal, data privacy, and other key processes. It must be clearly outlined how everyone is going to interact and how the program is structured.

Focusing on the why, the how, and looking into the context of what the business purpose of the program is becomes key. Questions to ask include: what are we trying to achieve here as an organization? How will the program be deployed and implemented? Who would the different stakeholders be? And finally, what are the interaction points with each of them?

Interactions with patients are also becoming a critical area. As regulations are still rather loose around this area, patients’ voices are growing louder and pressuring healthcare providers to take this matter more seriously. We are seeing more regulations being introduced with the intent of protecting patients’ independence and ensuring that providers establish the proper interactions with patients.

PSPs generate a lot of sensitive information that is managed or discussed within this type of program. This is sensitive personal data that needs to be protected and used correctly to avoid unwanted consequences to pharmaceutical companies.

To protect patients’ privacy, we are seeing a clear surge in government enforcement when it comes to patient data with several well-known cases having been investigated and sanctioned. For example, the Azure Algerian case in 2017 and the United Therapeutics case in 2018 in which companies were accused of paying kickbacks to patients through independent charitable foundations. Healthcare companies and those adopting PSPs need to be mindful of this when deploying these programs in their respective markets.

As PSPs are a relatively new concept in Asia, providers need to raise the ethical bar in these programs and apply the general compliance principles and ethical standards to all activities within a PSP. And while the general principles remain the same, as we go through the details and understand how providers interact with patients, those interactions can be outlined in certain specific aspects.

Compliance professionals need to tailor PSPs with seasonal guidelines or standard operating procedures that meet the needs of the business. These include to outline and flag touchpoints, flag incidents, and highlight key parts of a PSP’s procedures, including business operations that were not taken into consideration before this.

When an infringement occurs related to ethics and compliance, the company’s reputation is at risk, especially when news is released out to the public. Following that, any formal investigation by regulatory bodies may reveal private company’s data, historical incidences, and penalties incurred. These reports will affect business operations, ongoing projects, tenders, future mergers, and potential acquisitions.

While the loss of business is the visible consequence, what this means for the team is that the integrity of the procedure and the process of the PSP has failed. A PSP’s objective is to assist patients to get the right treatment, and when we compromise ethics and compliance to gain an unfair business advantage, the provider has let the patient down by delivering them inadequate treatment.

We must also bear in mind that the compromise here or the consequences can apply both ways, not only on the company or the patient but also on the physician. When the integrity of the treatment is harmed or damaged, it is a risk that the physician will need to take, and most likely they will not want to take that risk because of the severe consequences.