The New Active Substance Work-Sharing Initiative (NASWSI), or “Access” for simplicity, allows regulatory authorities (RAs) of countries that are part of the Access Consortium (Australia, Canada, Singapore, Switzerland, and the UK) to jointly review applications for the registration of new active substances or new indications. The Access Consortium is a coalition of medium-sized RAs that aims to maximize international co-operation, reduce duplications, and increase RAs’ capacity to ensure timely access to high quality, safe, and effective therapeutic products through collaboration and work-sharing. Each RA maintains the power to make final decisions.
Towards the end of 2022, the pharmaceutical industry trade associations of the Access Consortium countries launched a survey among industry affiliates based in their countries, to explore perceptions around Access. A response rate of 66% (108/164) was achieved (specifically, 41 respondents had already participated in Access while 67 had not).
This project was led by the Association of the British Pharmaceutical Industry (ABPI). Clarivate partnered with members of ABPI and other trade associations to analyze the survey results and co-develop a peer-reviewed manuscript (published on the TIRS (DIA) journal in March 2024).
Grasping the industry perceptions of Access is critical to inform policy discussions on how to enhance the initiative, as a regulatory submission via Access is voluntary for the industry.
Affiliates mostly reported positive experiences with Access
Most affiliates who participated in Access reported good experiences with the various phases of the initiative. Affiliates mainly reported positive interactions with the RAs and receipt of consolidated list of questions at set times. Nevertheless, affiliates also flagged some challenges, including the receipt of rolling questions, which made resource planning more difficult.
It should be noted that variation in reported experiences among affiliates may be due to their participation in different Access reviews (with different contexts), but also to their participation in the pathway at different times. With time, Access appears to be positively evolving, as indicated by affiliates reporting clearer guidance in recent years compared to older phases of the initiative.
Interestingly, according to the majority (80%) of affiliates who participated in Access, an approval via Access had “no impact” on pricing and reimbursement timelines in their country, suggesting that more efforts are needed to ensure that gains from earlier regulatory approvals translate into expedited access at country levels. Exploring collaboration with national HTA bodies was already a strategic objective of the 2021-2024 Access Consortium Strategic Plan, so progress in this area might occur in the future.
Perceived barriers to participation exist
Affiliate’ reasons for not participating in Access (more than one could be provided via multiple-choice questions) included risk of divergent decisions between RAs (39%), process too complicated to manage (37%), and differences in requirements and review practices among countries (36%).
Lack of experience with the process was also added as a reason for not participating. Survey results suggest that the more affiliates participated in Access, the more they became accustomed to the process, as shown by the decreasing need to have a pre-submission logistics meeting after the first submission(s).
Opportunities to continue to improve Access
Recommendations from the survey were categorized into six areas: ensuring predictability (including respecting timelines, avoiding rolling questions, and aiming for shorter review timelines versus national pathways), increasing guidance and transparency, streamlining processes, maintaining flexibility, increasing harmonization (particularly for priority review requests), and advancing cooperation between industry and RAs.
Even though Access does not aim to provide accelerated review timelines, but rather to facilitate efficient use of resources, affiliates might still expect shorter review timelines via Access. RAs may in fact be perceived to have less work in this collaborative review, compared to standard national reviews.
Positively, concrete steps to enhance Access have already been taken, even before the industry survey results were published. For instance, the “Promise Pilot pathway”, announced in December 2023, provides a more harmonized process for priority review requests, including a collaborative evaluation among RAs and common timelines (as opposed to each RA analyzing the eligibility of priority review requests). Moreover, the new joint pipeline meetings between RAs and companies will enable information exchange on new developments and more collaboration.
Access appears to be improving with time, and even though opportunities to enhance the scheme remain, results are promising for the ongoing effectiveness of the initiative. Clarivate’s health policy consulting experts support a vast array of stakeholders, including trade associations and biopharmaceutical companies, to drive health policy change.
If you would like to discuss your plans with any of our Commercial Strategy team, including Health Policy and Market Access experts, please connect with us here.
This post was written by Gaia Geraci a Health Policy Consultant at Clarivate. Gaia supports a wide range of clients, including trade associations and a variety of biopharmaceutical companies, to understand the policy landscape and drive policy change.
