Landscape of Legal Issues
Industry acknowledges the value and importance of integrating patient perspectives into research and development from an early stage. Patients can help drug sponsors better understand the burden of a particular disease, identify unmet medical needs that are most important to the patient, and develop patient-centered outcomes and endpoints. Obtaining these perspectives requires new considerations of the legal and ethical issues that may arise when interacting with, and collecting data from, patients and patient organizations.
At FasterCures, we want to help patient groups and industry better navigate the legal landscape and equip both entities to engage in meaningful collaborations where each party:
- feels protected and secure in the interaction,
- understands the objectives of each side,
- exchanges time, money, and expertise in a way that is fair and equitable, and
- is compliant with existing laws and regulations
The Clinical Trials Transformation Initiative (“CTTI”) in its recommendations for “Effective Engagement with Patient Groups Around Clinical Trials” identified common examples of ways in which patient groups might engage with industry, including:
- patient groups as non-compensated collaborators,
- patient groups as service providers to a company on a contractual basis
In any arrangement with either individual patients, patient foundations, or advocacy groups, it is critical for the parties to outline expectations to avoid misunderstandings, address any real or perceived conflicts of interest, and mitigate risk. Below we identify some of the challenges that can be encountered when engaging with patients and propose five action items to address these challenges.
- Lack of a standard operating procedure (SOP) – Pharmaceutical and biotech companies, both large and small, typically establish SOPs to help ensure consistency and predictability across departments. Without an SOP to govern these relationships and interactions, internal compliance teams are left trying to “fit a square peg into a round hole,” often resorting to molding pre-existing contracts and procedures to fit the engagement effort they want to undertake. Without a clear precedent for how these meetings should be structured or conducted, companies may be more hesitant to engage. While companies may want or need the opportunity to experiment before committing to an SOP, documenting the steps required to enter into a meaningful –and compliant – engagement will help to address and remove some of the delay and uncertainty.
- Level of compensation – It is not always clear what level of compensation is appropriate for a patient representative who contributes time, ideas, or other data to an industry-sponsored initiative. When is an honorarium appropriate? If the patient must travel to participate, can travel and accommodation expenses be reimbursed and at what level? Many patient representatives are employed by patient organizations and will be participating in a meeting in their professional capacity. With this in mind, representatives might prefer that the payment goes directly to their non-profit patient organization.
- Addressing real or perceived conflicts of interest – It is critical for patient groups to maintain their independence. Even perceived impropriety can present risks to their reputation or jeopardize some sources of non-profit funding. Many biopharmaceutical companies acknowledge this need and adhere to conflict of interest policies that provide clear guidelines about how to fund patient groups and patient group projects in a manner that ensures the independence of the patient group.
- Concerns regarding pre-approval promotion – Sponsors may be reluctant to engage with patient groups out of concern that the interaction will be viewed as violating pre-approval promotion regulations. Direct communications between sponsors and patients are not prohibited, but if the communication violates existing regulations governing off-label promotion, there can be serious consequences. Sponsors can take steps to ensure that a sponsor-patient interaction stays within wholly legal and appropriate contexts and does not become promotional in nature. SOPs and guidelines for conducting meetings and interactions can give sponsors more certainty and comfort that the meeting will be legally compliant. The National Heath Council and Genetic Alliance are currently partnering to draft guidance for consideration by the Food and Drug Administration that is intended to help clarify the bounds of permissible interactions.
- Intellectual Property and ownership issues – Intellectual property clauses that may be needed when engaging with scientists or third-party consultants, may not be necessary, or even appropriate, when engaging with patients or non-profit patient organizations. For example, when a sponsor convenes a meeting with patients and patient representatives to discuss unmet needs, new ideas about how to move forward are likely to be generated. Patients may not be willing to participate if they forfeit their right to share ideas generated in that discussion with other companies or patient groups. Moreover, where patient groups are involved in contributing data through a patient preference study or patient registry, sponsors may need to treat the ownership and use of this data differently than research conducted in-house. Patients may not be willing to give exclusive use to sponsors and indeed, many sponsors have recognized that it is appropriate for the patient group to retain ownership.
This is new territory. That itself is a barrier for many companies, especially those who are risk-averse. Below are five proposed action items that we at FasterCures believe can help interested stakeholders move forward with more certainty and efficiency.
- Develop model SOPs for interacting with patients as service providers to the company and for interacting with patient groups as non-compensated collaborators.
- Draft best practices or principles of engagement for meetings where patient perspectives will be solicited and shared.
- Develop model provisions for use in contractual agreements between patients and sponsors.
- Create guidelines for setting appropriate compensation.
- Share case studies of different types of engagement that can be replicated by other entities (e.g. focus groups, research panel, advisory board, or one-on-one interviews).