3 Tips To Navigate The Increasingly Complex PVA Landscape

By Jennifer Whittaker, senior pharmacovigilance process director, Roche

Intended to lay out the exchange of safety data and responsibilities, pharmacovigilance agreements (PVAs) are essential for pharmaceutical companies to maintain their commitments to health authorities as well as to their partners. These agreements between two or more companies outline the procedures for reporting adverse events and other safety data, as well as adhering to health authority requirements.

Common Challenges In PVAs

However, there are numerous challenges to finalizing these agreements and keeping up with regulatory requirements in the industry. These regulatory requirements are broadly stated and leave a great deal of room for misunderstandings that can delay the finalization of PVAs. The shifting landscape of industry innovation and unconventional partnerships has created a need for an increased 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 business development, may not be heavily immersed in the PV process and may therefore lack a deep understanding of the PVA life cycle. This lack of understanding of the role of PVAs or the need for PV involvement in these PV agreements can result in additional hurdles for PVA development. There is also complexity in the business relationships; the types of partnerships are changing as the industry develops new technologies. The complex nature of these partnerships and resulting agreements calls for a more streamlined and efficient process.
• Ambiguous PVA language. These agreements often include ambiguous terms and phrases that can create confusion and stall the agreement process. Without common understanding of key terms from all sides of the negotiating parties, the process can easily veer off the path and warrant numerous revisions.
• Painful negotiation process. PVA negotiation is often a slow, complex process, and longer negotiation periods can delay agreements. Depending on the topics being discussed in the negotiation process, it may be necessary to include internal stakeholders who are not heavily immersed in the PVA process. While a necessary step, involving stakeholders without knowledge of the PVA process can cause delays as parties try to agree on all topics defined in the PVA.

The PVAs Of The Future

As companies come together to develop new, and potentially more complex, therapies and to support patient access, the collaborative relationships will extend beyond traditional pharmaceutical companies. Indeed, today, we are already seeing a changing landscape and witnessing synergies in nontraditional partnerships. As a result, PVAs will need to be tailored to address variations in specific relationships. More comprehensive PVA information that is adaptable to the needs of each agreement is imperative. Therefore, tools and solutions designed to support the PVA process must be flexible and able to accommodate a range of priorities.

In addition, incorporating medical devices as part of the therapeutic regimen and more complicated treatments such as cell and gene therapies, for instance, contributes to the increasing complexity of PVAs. The increasing adoption of these cutting-edge technologies in patient treatment regimens creates a need for PVAs that not only account for the drug safety requirements but for those of medical devices and more complex therapies as well.

Having a streamlined PVA process in place can save immediate time and effort as well as help prepare partners for future innovation in the industry. While it may seem daunting to establish a process for agreements that require such intense individualization, there are solutions available that allow flexibility to account for the complexity of the process and address the concerns of all stakeholders, while still maintaining consistency.

How To Improve PVAs

Here are three ways to streamline the PVA process:

1. Build a strong PVA foundation. Having well-established procedures in the process, even before a PVA is needed, can greatly help companies build a foundation for the PVA process and mitigate any pitfalls that may arise in later phases of the PVA life cycle. Some important steps to establishing a strong foundation include knowing key internal stakeholders, assessing whether a PVA is actually needed, providing input to the main agreement, and performing due diligence on a partner company’s PV system. TransCelerate’s PVAO initiative includes a variety of end-to-end tools such as a Process Map to aid stakeholders in understanding and developing PVAs. The Process Map, along with TransCelerates’ other offerings, supports Marketing Authorization Holders in developing a clear understanding of the PVA process, which allows them to move forward more meaningfully.
2. Engage with internal stakeholders early and often. Throughout the entire PVA life cycle, engagement with internal functions and the key stakeholders will be essential to successful implementation of PVA provisions. Increasing awareness of the PVA process with internal stakeholders, such as those managing business collaborations, leads to a greater understanding and proper allocation of resources to drive the PVA process. As part of its PVAO Initiative, TransCelerate 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 may allow partners to curtail potential definitional misunderstandings that may derail the negotiation process.
3. Take a systematic approach to PVA negotiations. PVA negotiations can have long durations, often resulting from repeated steps due to the lack of structure and shared understanding. To ensure compliance with regulations and meet business objectives, PVAs are usually required to be agreed upon within a certain timeframe. Efficiencies in PVA negotiations can be found through incorporation of project management techniques. Certain project management techniques, such as agreeing on milestones and finalization timelines during a kickoff meeting or incorporating a Gantt chart, can help manage negotiation timelines between multiple PVA partners.

Developing replicable yet flexible framework for developing PVAs is only going to become more essential as pharmaceutical partnerships continue to increase in complexity and volume. The PVA processes of the future must be able to adapt to the various needs of different stakeholders. Approaching these agreements with a shared vocabulary and expectation of ongoing communications between stakeholders can aid in creating greater efficiency through the negotiation process, benefitting all stakeholders.  

About The Author:

Jennifer Whittaker is a senior pharmacovigilance process director at Roche. She has extensive experience within the global pharmaceutical industry, spanning partnership management, negotiations, contract management and outsourcing, and pharmacovigilance agreements.