Rhonda Croxton, PhD, Judy Fallon, PharmD, Jeffrey Keller, ICON plc (formerly The CHC Group), North Wales, PA
One of the most essential responsibilities that medical communications agencies possess is the promise to maintain the confidentiality of their pharmaceutical/biotech client partners’ information. From the clinical trial data to the strategic and tactical communication plans emerging from those data, everything must be carefully safeguarded such that only those agency team members who need to know the information have access to the information. The ramifications of sharing confidential client information, whether intentionally or inadvertently, include tangible financial losses for the client that are legally actionable and could be costly for the agency—eroding the integrity of the agency-client partnership and tarnishing the agency’s reputation. This article aims to provide pragmatic suggestions for agency partners to implement that will reinforce the commitment to preserving client confidentiality and enhance client confidence in the agency’s ability to successfully maintain client confidentiality, even when engaging in other business within a similar therapeutic area.
Agency–Client Master Services Agreement
During the negotiation of the agency-client Master Services Agreement (MSA), it is important for agency management to review the terminology in the MSA with regard to client expectations about providing service contemporaneously for competitor products within similar therapeutic areas. Before final signatures on the MSA, a deeper discussion may be necessary to ensure that both parties are in agreement with how the agency partner will manage potential conflicts of interest to protect clients’ confidential information. Larger agencies often own several satellite offices to allow for the preservation of client confidentiality in a manner that enables the agency to engage in other business within a similar or overlapping therapeutic area. Smaller agencies may have other effective measures in place to appropriately manage conflicts of interest/client confidentiality. As long as stringent standard operating procedures (SOPs) are enforced across the entire agency, and agencies are thoroughly transparent with regard to existing safeguards to protect each client’s proprietary information, clients should feel comfortable with these arrangements.
Agency–Employee Confidentiality Agreement
New relationships between agency and client should begin with the signing of a nondisclosure agreement, thereby initiating the implementation of the agency’s internal policies and SOPs around maintaining confidentiality. Certainly, agency employees are driven by personal ethics to maintain client confidentiality. As an added measure of security, agencies can require that employees sign a statement that outlines individual responsibilities and best practices for maintaining client confidentiality throughout and beyond the lifetime of the agency/client partnership. This is a wise SOP for agencies to implement, and it provides documentation for clients to reassure them that their agency partners are committed to preserving their proprietary information.
Organization of Physical Space and Files
Medical communications agencies should be organized in a manner that prevents conflicts of interest. Optimally, this is achieved by implementing measures to ensure thorough separation of teams that may be engaged in providing services in a similar therapeutic area or whose audience(s) would be responsible for making treatment decisions for the same patient population, disease state, or indication. Physical separation of working space is imperative for teams engaged in medical communications activities within a competing therapeutic area. This separation should include restricted access to files containing client information. Storing information in a secure manner on separate servers creates firewalls, and limiting access to client information using a filing system that requires permissions-based access ensures that only agency team members who are actively working on the account can view or retrieve information. In addition, a heightened level of security can be achieved with smart printer technology. This approach provides secure retrieval of printed materials, can prevent inadvertent perusal by passers-by, and has the added benefit of reducing clutter around office printers in the form of forgotten printouts.
Dedicated Teams and Staffing Oversight
A dedicated agency team approach for each client is an effective strategy to reduce the risk of inadvertent information sharing within the agency. In this model, the same agency personnel should provide ongoing service to the same client throughout the agency/client relationship. Although a dedicated team approach can introduce resourcing challenges to an agency because of the seasonal ebb and flow of project delivery timing, situations involving therapeutic area–related conflicts of interest require this level of separation. Creating groupings of teams supporting unrelated therapeutic areas and cross-training staff can alleviate these resourcing challenges to a certain degree.
Agencies structured differently that share a common pool of medical writers and/or content reviewers (eg, medical directors, scientific directors, account managers) across multiple clients and/or accounts will require heightened and continual managerial oversight to ensure that individual contributors only provide support to a single client’s deliverables in areas of potential conflicts of interest. Likewise, agencies using freelance medical writers must ensure that freelancers are aware of the agency’s policies around maintaining confidentiality, and freelancers should sign an agreement indicating that they will not engage in project work for other agencies/clients within a prespecified period of time that could pose a conflict of interest to their current commitments.
Transparent staffing models allow clients to readily understand how their information will be handled and by whom. This level of transparency should be universally employed for all agency teams and team members, but is particularly important when agencies are engaged in firewalled accounts supporting separate clients in therapeutic areas with potential conflicts of interest. Agency SOPs in alignment with good publication practices (eg, GPP31) that require detailed acknowledgement statements thoroughly describing the physical location and identity of the agency team members who contributed significantly to the work are another source of reassurance for clients.
Staff Washout Period
Agencies face staffing dilemmas when new business opportunities arrive and new teams must be created to support the new opportunity. Certainly, the hiring of new team members is vital to support growth, but frequently the new opportunity arrives before new talent can be identified and hired. When creating new teams from existing personnel, agency staff who have experience working in the therapeutic area of interest via providing services to a different client’s product should undergo an appropriate “washout” period, the duration of which should be agreed on by all parties. In the absence of guidance from one or both client partners, agencies should have a standing policy that defines an acceptable minimal washout period. The purpose is to allow sufficient time to elapse, whereby strategic and/or tactical plans would have likely evolved to such an extent that the employee’s knowledge of the specific proprietary information of one client would likely be obsolete by the time the employee engages in learning about the specifics of another client’s product in the therapeutic area. For example, given that most active communication plans undergo sufficient transformation in priorities and/or data availability each quarter, a 90-day washout period is likely appropriate and sufficient, but this should be discussed with and mutually agreed on by all affected parties. Staff should also be required to maintain confidentiality following the washout period pursuant to the terms and conditions established in client contracts.
Samples of Work Product
When prospective clients are selecting an agency partner, the client may request samples of agency work product as a component of their decision-making process. Agencies are eager to put forth their best examples in these circumstances; nonetheless, it is imperative that only materials that are readily available in the public domain be considered for this purpose. Materials used in a public forum but not readily available as enduring materials may be acceptable to share, but written consent from the compliance/legal representatives of the client owner of those materials should be obtained before sharing.
It is important to note that samples of deliverables not available or used in the public domain should not be shared. However, representative concepts of deliverable types may be acceptable to share as long as appropriate measures are taken to anonymize the work product, such that the contextual rationale remains without any specific details that could identify the sponsor or product for which the work was performed. In these situations, it is imperative to maintain transparency and ensure that the client owner of the original deliverable is aware of the plan to anonymize and share, and clients should be given the option to review the modified sample for their approval before sharing the anonymized deliverable externally.
Agencies have an important (and legal) responsibility to preserve the confidentiality of their clients’ information at all costs, and stringent SOPs and safeguards must be in place to ensure achievement of this requirement. Strategies to facilitate preservation of confidentiality include the following:
- Ensuring agency employee awareness of the importance of maintaining client confidentiality at all times
- Executing confidentiality agreements with individual staff and external partners
- Establishing secure firewalls, both physically and electronically, for teams that may be engaged in providing services within similar therapeutic areas
- Employing a dedicated team–based approach for each client
- Requiring sufficient washout periods for agency team members before they can engage in work within a similar therapeutic area again
- Obtaining client permission and anonymizing work samples to eliminate all identifying aspects of product or client before distribution to satisfy an external request or pursue a new business opportunity
Perhaps the most important aspect of ensuring client confidence in the agency’s ability to preserve the confidentiality of the client’s information is frequent communication and complete transparency so that clients have a thorough understanding of their agency partner’s best practices for all matters relating to the management of potential conflicts of interest. Trust between clients and their agency partners is the foundation of a successful business relationship, and maintaining client confidentiality is one of the cornerstones on which that level of trust can be built.
- Battisti WP, Wager E, Baltzer L, et al. Good publication practice for communicating company-sponsored medical research: GPP3. Ann Intern Med. 2015;163(6):461-464.