Regulatory and Legislative strategy
Members share intelligence in this dynamic landscape that has the potential to impact the industry, so that we can interpret once and act with confidence.
The biotech/pharma industry faces a range of regulatory challenges across different countries and regions where it operates. Understanding and communicating the scale of regulatory requirements and utilizing industry voice and solutions can be challenging. There is a lack of awareness and understanding of forthcoming regulatory challenges, making prioritizing responses with limited resources difficult.Additionally, organizations struggle with the lack of clarity around ownership and accountability for reporting requirements, compounded by organizational change and the lack of appropriate digital tools and metrics.
The disproportionate burden and targets placed on the biopharma sector can have various impacts. Organizations may focus more on sustainability as reporting and compliance, rather than driving high-impact changes. The lack of proactive participation in the regulatory process can result in missed opportunities and increased costs. Non-compliance with regulations poses legal exposure, while the reputation of companies and the sector, as well as the health of customers, may be negatively affected.
Unified sector voice
- Develop a unified understanding of regulatory requirements and associated responses, enabling resource consolidation across the sector
- Establish a unified sector voice for discussing implications with regulators
Achieving these goals can lead to several benefits for the biotech/pharma sector:
- Setting achievable targets that the sector is well-positioned to meet
- Reducing internal anxiety by providing clarity on how to respond to regulations
- Easing the burden of compliance
- Avoiding unnecessary fines and taxes
- Improving the sector’s reputation and trust with regulators
- Enhancing employee engagement and customer satisfaction
Regulatory and Legislative strategy deliverables
More related workstreams
Our workstreams focus on the areas with the greatest impact across the industry. Led by science, our members are problem-solving today’s sustainability issues. By working with the regulatory governance community, they are also creating future-ready outcomes for the industry.
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