P103: Evaluation of the Economic Impact of Reliance Review: A SAHPRA Case Study
Poster Presenter
Stuart Russel Walker
Professor and Consultant
Centre for Innovation In Regulatory Science (CIRS) United Kingdom
Objectives
To evaluate the economic impact of reliance on a national regulatory authority (NRA) by analyzing the cost involved with abridged versus full review of new applications, review the financial impact on an NRA to attain ML3 and assess Industry’s views on the economic value of reliance pathways.
Method
The costs associated with reliance versus full review of quality/bioequivalence (BE) data of registration dossiers within the South African regulator and the cost of maintaining WHO ML3 were collected. A review of NRA fee structures was also carried out, as well as a Pharma industry questionnaire.
Results
The South African regulator (SAHPRA) cleared a backlog of 16,000 medicine applications (2019-2022). Evaluation of the backlog project revealed that the implementation of reliance review expedited patients’ access to medicines, with abridged reviews demonstrating a reduction in assessment time of registration applications.
This study investigated the assessor costs associated with both full and abridged review of quality data for innovator products and there was a 61% reduction in assessment hours when utilizing reliance, with commensurate decreased costs (median of $734,47 vs $2614,55). Similarly, for generic products, the assessment time for both quality and BE, was decreased by 71% with the costs associated with abridged and full review $883,85 and $4730,98, respectively.
As a further study aim was to determine the direct and indirect costs influencing the operational capacity of an African NRA, especially when striving for World Health Organization (WHO) ML3 status, the agency costs (operational and capital expenditure), inclusive of human resource management, rental costs and digitalization of operations, were considered. Expenses for activities prescribed by the WHO, such as post-marketing surveillance, vigilance and implementation of a robust quality management system, were also considered, especially since these do not directly attract fees from pharmaceutical companies.
A survey, completed by the Heads of Regulatory Affairs of pharmaceutical companies, identified that the private sector is willing to pay increased fees for expedited reviews, but also highlighted the benefits as well as the disadvantages of reliance implementation within specifically African NRAs.
A review of NRAs’ fee structures indicated that there is little differentiation between the fees charged by agencies for full and reliance reviews. However, many fee structures are outdated and not in line with the financial requirements of NRAs, especially those aiming to achieve WHO ML3.
Conclusion
Reliance review implementation saves time as well as human and financial resources. Agencies incur significant costs to remain operational and to enhance their maturity levels. In many instances there is an imbalance between the treasury grants and the non-fee generating activities, which are expensive to perform. In this regard, NRAs should consider differentiated fees for different review pathways and activities. Fast-track services are generally more expensive, with some WHO-listed authorities, such as the Singaporean agency, charging higher fees for reliance review. This aligns with the opinion of pharmaceutical companies, with these willing to contribute more to enable mature NRAs with validated service charter outcomes.
A mature NRA brings great benefits to all stakeholders, including the country and region, as well as pharmaceutical companies, in terms of safe, efficacious medicines of good quality, with an increase in local production and a proportionate boost to the economy. However, the financial and human resource impact of striving towards WHO ML3 is considerable. Therefore, if less financial resources could be utilized for marketing authorization by the implementation of reliance, more funds would be available to an NRA for regulatory and information systems strengthening.
Recommendations:
To ensure financial sustainability, NRAs should:
1. Put in place a differentiated fee structure for full and reliance review pathways for applications.
2. Develop and present a strategic plan to governments to ensure surplus funds are retained.
3. Institute a development fund for additional income, thereby improving sustainability independent of outside funders’ contributions.
4. Introduce an annual fee for pharmaceutical companies to cover the wide range of activities not explicitly funded through application fees, with many of these required for maintaining ML3 status.
