Globalization has created new opportunities for the pharmaceutical industry, but it has also brought both regulatory and logistical challenges. To ensure compliance and safeguard the quality of their products, companies must ensure they remain agile and understand the evolving regulatory environment in each country in which they operate.
Certainly, there have been efforts to harmonize regulatory processes and standards, but different approaches remain in various regions, and these differences can span safety, quality or even administration, technology, or infrastructure.
Even within the EU, country-specific requirements remain. As an example, France requires that if a company wants to register a product in the country, they must have a specific pharmaceutical establishment located in France, the so called “exploitant”, even for early developmental activities[1].
Navigating myriad requirements
While companies must ensure they meet local health authority requirements, many organizations at the global level do not have the capacity to navigate the myriad procedures and requirements across regions. The problem for the local affiliates is that they must try to align with corporate product strategy while ensuring they stay on top of day-to-day requirements, such as monitoring quality, carrying out safety assessments, and overseeing the quality management system. They must also ensure any new local requirements are fed back to headquarters for inclusion in the overall global strategy and plan.
The primary role of local staff, however, is to manage the mandatory national regulatory or legal tasks. That means having people in-country who are familiar with the local obligations, culture, the language and, crucially, are in contact with regulators to exchange on scientific and regulatory approaches.
Given dwindling pipelines, it’s imperative that companies properly manage their mature product portfolios to safeguard those products on the market. Managing these routine tasks can make it hard for affiliates to provide the strategic input they are expected to give or it would require them to bring in additional resources.
Consider efficiencies
These challenges mean companies must start to consider more efficient processes, which can best be achieved by outsourcing to a partner.
The benefits of partnership are many-fold. Local support to meet compliance obligations, particularly for mature products, allows companies to streamline the business and focus on their strategic development projects.
For smaller or mid-size companies that are looking to expand into new markets, partnership allows them to do so without having to invest in the setup of the required local roles. Consider that for these companies, it may be very cost intensive to install a full affiliate model with all the locally required functions and tasks, for example, a designated person for health authority communication, the screening of local literature, the handling of complaints or a 24/7 contact, sometimes even before the launch of their product and having actual revenue.
Hiring challenges
Another consideration is whether there is a need for a full-time employee to manage certain activities, such as pharmacovigilance obligations. Hiring someone with the required education and background for just 20 hours a month can be extremely difficult, if not impossible, especially in markets where there is competition for a limited number of professionals.
In many countries, for example, there is a critical shortage of STEM professionals, which can severely impact companies’ regulatory, quality and safety obligations. One estimate projects a 20% increase in demand for STEM (science, technology, engineering, and mathematics) related roles in the life sciences industry, whereas the current pool of talent is at least 14% lower than demand[2].
However, a service provider that has the expertise to handle those tasks is not only a more sustainable option for many companies, but also delivers greater efficiency and cost effectiveness because those local staff members manage compliance activities for several clients.
Removing complexity
Given the cost and complexities involved, companies need to find ways to streamline their processes and their operational frameworks to avoid missteps, delays, and other issues that could jeopardize their marketing authorization strategy, or that could add undue stress and cost to the local affiliate model.
Bringing in an external perspective can help to remove these barriers and lead to more efficient ways of working. Download the paper, Reshaping Affiliate Models to Stay Competitive and Remain Compliant.
About the author:
Dr. Stefanie Lietsch-Dallwig is Senior Director Global Program Management – Service Solution Lead Local Affiliate Services, at PharmaLex
[1] Public health code, Section 1: Scope and definitions (Articles R5124-1 to R5124-15), Legifrance. https://www.legifrance.gouv.fr/codes/article_lc/LEGIARTI000043761806
[2] Emerging from disruption: The future of pharma operations strategy, McKinsey and Co., Oct 2022. https://www.mckinsey.com/capabilities/operations/our-insights/emerging-from-disruption-the-future-of-pharma-operations-strategy
