The role of the affiliate has been under the microscope for many years, with discussion going back and forth about the relative merits of managing regulatory and pharmacovigilance functions at the affiliate office versus from the centre.
Questions about the merits of having on-the-ground regulatory and pharmacovigilance personnel in each market have been raised, but little progress was made in answering those questions. It had been thought that harmonisation and standardisation of the submission process—first through the common technical document (CTD) and next through the electronic CTD—would simplify the affiliate’s role in handling dossiers. In fact the opposite was true. Then the expectation became that regulatory information management (RIM) solutions would improve information sharing both across the enterprise and with external partners.
Despite those developments, the affiliate situation with regard to managing dossiers has changed very little.
A Shifting Climate
Until recently, affiliates played a significant ambassadorial role through their liaisons with health authorities. But now the role of an affiliate has shifted to being an almost exclusively sales role. An affiliate company’s purpose is to produce revenue for the pharmaceutical company. And in that environment, those operational regulatory and pharmacovigilance activities have become unwanted burdens.
The question therefore becomes, does it make sense for every pharmaceutical company to have a regulatory team in every country? Maintaining global regulatory and safety teams is complex and time-consuming; it involves recruitment, training, and staff retention programmes; it requires ensuring continuous cover in markets with one or two staff; and it requires maintaining compliance and training levels across the wide spectrum of affiliates.
The next big question is, how can this be achieved? In this context, can the centre find a way to apply the technology and tools needed to support efficient and compliant delivery of regulatory and pharmacovigilance services while still retaining the effectiveness of local presence without requiring the affiliates to be that presence? One option companies are considering is the use of a centrally managed yet geographically dispersed third-party service.
The idea is that rather than the affiliate’s handling those functions along with its many other roles, the activities would be managed by a third party that takes on equivalent functions for other pharma companies. What the pharma company gets is skilled resources that are dedicated to delivery of the required function, which leads to more-effective and more-efficient outcomes. Past data management concerns, too, are mitigated by RIM technology improvements that enable the centre to control the data while the outsource partner carries out activities under headquarters supervision.
Technology advancements also put an end to data safety and confidentiality concerns. Advanced RIM and other corporate-level data systems let tasks be outsourced without the need to transfer confidential data. That hugely reduces risk for the industry based on the fact that there’s no chance anyone could take a complete copy of a dossier, simply because users can access only the sections that are appropriate to the specific tasks they have been assigned.
Further, the broad policing that comes with having multiple companies use the same outsourcing partner adds another layer of security, because each of those companies will make sure the provider has the wherewithal to maintain the confidentiality of client data.
The Age of Networks
Even though the reasons to outsource have multiplied, whether any service provider could take on the extensive global needs of a pharmaceutical company has long been questioned. The model of a large organisation’s transferring aspects of work to a low-cost destination is not practical when it involves regulatory and pharmacovigilance work at the affiliate level, where in-country capabilities are generally absolute requirements.
The solution potentially lies less in one outsourcing company’s having in-country resources in every market and more in the development of networks managed by service providers with the ability and foresight to do so.
Low cost in a network model is achieved by removing duplication—but at the same time ensuring the work is done where it is most effective, including where necessary in-country. In other words, some tasks can be managed centrally in close correspondence with the client organisation’s central functions’ others may be located in the traditional low-cost environments; still others are accomplished in regional or linguistically organised hubs; and yet others, when required, are carried out by in-country resources.
Furthermore, outsourcing facilitates a clearer focus on compliance at the local level—something that can be hard for affiliates to achieve. But any outsourcing activity must take into account the company’s organisational structure: for example, is regulatory affairs centralised or decentralised? The goal is to provide headquarters with greater control, but how that gets achieved usually hinges on the processes and infrastructure set up at each organisation.
Less-rigid outsourcing models give a client company the dual benefit of realising both efficiencies and consistency in how the company’s regulatory and safety capabilities get managed, but more important for the business as a whole, such models free affiliates to focus on their now central task: to drive sales in each market.
About the Author
Kimty Bui-Van is Head of Function, Regulatory Affairs at ProductLife Group.
Last updated on: 07/04/2015 16:44:42
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