The public health call for social distancing to help curb the COVID-19 pandemic has no doubt already affected how companies will be sharing information about pharmaceuticals and other licensed health products with healthcare professionals (HCPs), patients, and the public. As industry plays its part in keeping sales representatives and medical science liaisons (MSLs) home to help “flatten the curve”, many interactions between HCPs and companies are moving to the virtual world. At the same time, HCPs will look to the industry to provide timely and accurate information through their medical teams or patient support programs (PSPs) about how to manage medications for patients who have COVID-19 or who are self-isolating at home and cannot come to the clinic. Here are things to keep in mind when sharing information about licensed health products.
- Consider preparing a COVID-19 focused FAQ. Many HCPs will be concerned about how to manage medications for patients who present with COVID-19 and look to industry to respond in a timely fashion. A prepared set of answers of anticipated questions helps ensure your medical team is ready to field these questions while ensuring compliance in the dissemination of the information. Staff should be informed when it is appropriate to provide on-label and off-label information, including changes in dosing or how to safely initiate or discontinue therapy. According to Health Canada’s The Distinction Between Advertising and Other Activities, responses to requests for information that are reactive or as part of person-to-person dialogue are considered non-promotional so long as they focus on the exchange of scientific and clinical information.
- Consider corporate messages instead of discussing pre-market products. There is a lot of interest among the public about what the pharmaceutical industry is doing to help respond to the COVID-19 crisis, whether through antivirals in the pipeline or the creation of a vaccine. Permitted communications about a product prior to receiving market authorization are limited to specific circumstances, and should be careful not to be promotional in nature or discuss the safety or efficacy of a product in the pipeline. To remain engaged, consider the use of corporate messages that do not promote a specific product or product portfolio. These may discuss a company’s commitment to responding to the COVID-19 crisis more generally without mention of any product in the pipeline, and may be permitted to both HCPs and the general public without being characterized as direct-to-consumer advertising. Messaging for non-prescription drugs or natural health products should avoid making any claims, express or implied, that their products can treat COVID-19 unless it is explicitly stated on their product licence.
- Consider digitizing existing materials. Materials that will be disseminated by sales reps or MSLs to all HCPs will likely occur through email or through the company’s HCP-gated portal. Existing print aids can be disseminated as a PDF without being resubmitted to PAAB, so long as the content and layout appear as they would have in print. This can be done by way of a simple “FYI” notice to the Pharmaceutical Advertising Advisory Board (PAAB) office for PAAB-approved materials. Emails that will be used to disseminate these materials may need to be submitted for PAAB preclearance review. PAAB recently issued a notice stating it is working to expedite such requests.
- Monitor social media activity. With many more patients staying at home, online forums and social media will no doubt be one of the primary ways of sharing experiences and disease management strategies while under self-isolation. A manufacturer is responsible for any social media channels, forums, or hashtags that it owns, creates, or promotes, even if they were created before the COVID-19 pandemic. Ensure teams are especially vigilant in ensuring that these discussions remain on-label and monitor for reports of adverse events. For hashtags or forums that have not been created by the manufacturer, company staff should refrain from engaging directly with patient-generated content, including “liking” or “retweeting” a post, and continue ensuring that adverse events reports are quickly acted upon.
- Consider the requirements of your risk management plan (RMP). Many RMPs require manufacturers to have a robust post-marketing surveillance and pharmacovigilance program. Ensure accurate and timely reporting of any adverse events related to patients who are experiencing COVID-19 symptoms or have tested positive for COVID-19, and ensuring that COVID-19 status is included in any adverse event reporting. This will help ensure the company is meeting its requirements while monitoring the longer-term associations of COVID-19 with your products.
- Remind PSP providers and other vendors of patient privacy requirements. Patient support programs have become an indispensable method of delivering healthcare to patients. However, many programs are designed with the understanding that care will take place in an infusion clinic or physician’s office, where maintaining patient confidentiality is the norm. However, some PSPs may need to shift to being delivered in the home, where the usual protections are not in place. Alternatively, caregivers may be calling PSP staff on patients’ behalf to help coordinate or gather information. Ensure your PSP vendor and other service providers have the proper consent before delivering the PSP services. This includes the delivery of medications to a patient home instead of a clinic, or the use of emergency couriers. Note also that some couriers are no longer obtaining signatures, even if requested to do so, to help limit the number of close contacts between individuals.
*The purpose of this communication is to provide general information of a legal nature. It does not contain a full analysis of the law nor does it constitute an opinion of any Norton Rose Fulbright entity on the points of law discussed. You must take specific legal advice on any particular matter which concerns you. If you require any advice or further information, please speak to your usual contact at Norton Rose Fulbright.