Q: Can we start with some insights as to why the Local Affiliate Services solution was established and what its overarching objectives are?
A: There is rising demand from our clients for services at the local level to manage mandatory activities that are normally handled by their affiliates. The need was initially greatest at large organisations, which were looking to streamline the business and focus on their strategic development projects. To achieve that, they needed support to ensure they met their local compliance obligations, especially for their mature products.
There is now a growing trend amongst mid-sized companies wishing to expand into new geographic regions, but without having to invest in the setup of the required local roles. As an example, a Japanese client that was launching products in Europe needed local affiliate support to meet their obligations in various EU markets but decided not to invest in hiring their own people in each country because they would not have enough work for a full-time role.
We have also found that many clients who have been working with a diverse set of local service providers welcome that PharmaLex is in a position to offer them consolidation and all the support they need.
Q: A lot is said about the challenges companies have with managing compliance requirements at the affiliate level. Why is a more all-encompassing approach to managing the local affiliate important?
A: Compliance requirements often relate to more than one country, for example, the update and controlled implementation of a new side effect in a leaflet, an update to packaging material, or the reporting of cases. If such activities are handled by several service providers, the sponsor company would have to oversee the status of each activity for every concerned country.
Having an all-encompassing approach with a program leader and function-related workstream leads at one service provider minimises oversight and control for the client company, while giving them confidence and ensuring compliance.
Another important consideration is the growth in mergers and acquisitions or portfolio acquisitions, which can result in short-term joint ventures. These require a quick setup of local mandatory and operational roles.
Sometimes, contracts preclude having these joint venture activities handled by either company involved in the joint venture, so a third party needs to take over local tasks. These might include changes in packaging materials and ensuring the right information is included to facilitate the transfer of the product/s or venture.