By Jennifer Whittaker, Senior Pharmacovigilance Process Director, Roche
Pharmacovigilance Agreements (PVAs) are intended to regulate the sharing of safety data and responsibilities and are essential for pharmaceutical companies to meet their obligations to health authorities and their partners. These agreements between two or more companies detail the procedures for reporting adverse events and other safety data, and compliance with health authority requirements.
Common challenges in PVAs
However, there are numerous challenges in completing these agreements and keeping up with regulatory requirements in the industry. These regulatory requirements are formulated in general terms and leave a lot of room for misunderstanding that can delay the completion of PVAs. The changing landscape of industry innovations and unconventional partnerships has created a need for a larger number of PVAs with higher levels of complexity. As a result, many stakeholders face new challenges in drafting, negotiating, and finalizing PVAs.
- PVA and partnership complexity. Many functions outside of pharmacovigilance (PV), such as B. Business development may not be deeply immersed in the PV process and therefore may not have a deep understanding of the PVA life cycle. This lack of understanding of the role of PVAs or the need for PV participation in these PV arrangements can create additional hurdles for PVA development. There is also complexity in business relationships; The types of partnerships are changing as the industry develops new technologies. The complexity of these partnerships and the resulting agreements requires a more streamlined and efficient process.
- Ambiguous PVA language. These agreements often contain ambiguous terms and phrases that can create confusion and block the agreement process. Without a common understanding of the key terms on all sides of the negotiating parties, the process can easily go astray and require numerous revisions.
- Painful negotiation process. PVA negotiations are often a slow, complex process, and longer negotiation periods can delay agreements. Depending on the issues discussed in the negotiation process, it may be necessary to involve internal stakeholders who are not heavily immersed in the PVA process. While engaging stakeholders without knowledge of the PVA process is a necessary step, it can cause delays as the parties try to agree on all the issues defined in the PVA.
The PVAs of the future
As companies come together to develop new and potentially more complex therapies and support patient access, collaborative relationships will extend beyond traditional pharmaceutical companies. In fact, today we are already seeing a changing landscape and witnessing synergies in non-traditional partnerships. As a result, PVAs must be adjusted to account for variations in specific relationships. More comprehensive PVA information, which can be customized to meet the needs of each agreement, is mandatory. As such, tools and solutions to support the PVA process must be flexible and able to address a range of priorities.
In addition, the incorporation of medical devices as part of the therapeutic regimen and more complicated treatments such as cell and gene therapies contribute to the increasing complexity of PVAs. The increasing adoption of these cutting-edge technologies in patient treatment regimens creates a need for PVAs that address not only drug safety requirements, but also those of medical devices and more complex therapies.
A streamlined PVA process can immediately save time and effort and prepare partners for future industry innovations. While it may seem daunting to set up a process for agreements that require such intense individualization, there are solutions that allow flexibility to accommodate the complexity of the process and address the concerns of everyone involved, while maintaining consistency.
How to improve PVAs
Here are three ways to streamline the PVA process:
- Build a strong PVA foundation. Well-established procedures in the process, even before a PVA is needed, can greatly help companies to establish a foundation for the PVA process and mitigate any pitfalls that may arise in later stages of the PVA lifecycle. Some key steps to creating a strong foundation include knowing key internal stakeholders, assessing whether a PVA is actually required, providing input to the main contract, and conducting due diligence on a partner company’s PV system. TransCelerate’s PVAO initiative includes a variety of end-to-end tools such as: B. A process map to help stakeholders understand and develop PVAs. Along with TransCelerates’ other offerings, the process card assists Marketing Authorization Holders in developing a clear understanding of the PVA process that enables them to move forward more meaningfully.
- Engage early and often with internal stakeholders. Throughout the PVA lifecycle, collaboration with internal functions and key stakeholders is essential for successful implementation of PVA regulations. Raising awareness of the PVA process among internal stakeholders, such as B. those managing business collaborations, leads to a better understanding and proper allocation of resources to drive the PVA process forward. As part of its PVAO initiative, TransCelerate has developed a PVA Glossary and Table of Contents (TOC) for stakeholders to reference. The glossary provides definitions and synonyms for the terms commonly used in PVAs, which can enable partners to mitigate potential misunderstandings of definitions that could derail the negotiation process.
- Be systematic in PVA negotiations. PVA negotiations can take a long time and often result in repeated steps due to the lack of structure and common understanding. To ensure regulatory compliance and achieve business goals, PVAs typically need to be agreed within a specific time frame. Efficiency gains in PVA negotiations can be found by incorporating project management techniques. Certain project management techniques, such as agreeing on milestones and completion timelines during a kickoff meeting or including a Gantt chart, can help manage negotiation timelines between multiple PVA partners.
Developing a replicable yet flexible framework for developing PVAs is becoming increasingly important as pharmaceutical partnerships grow in complexity and scale. The PVA processes of the future must be able to adapt to the different needs of different stakeholders. Approaching these agreements with a shared vocabulary and the expectation of ongoing communication between parties can help make the negotiation process more efficient, which benefits everyone involved.
About the author:
Jennifer Whittaker is Senior Pharmacovigilance Process Director at Roche. She has extensive experience in the global pharmaceutical industry, which includes partnership management, negotiations, contract management and outsourcing, and pharmacovigilance agreements.