Фармацевтические компании Канады внедряют самоконтроль ИИ из-за отставания законодательства

Pharma turns to AI self-regulation in Canada amid governance lag Compliance experts say innovation outpaces regulation, prompting companies to create internal guardrails for responsible AI deployment in operations. At a Glance - Data privacy tops concerns as 74% of pharma compliance professionals use AI tools daily - Organizations integrate AI governance into existing frameworks rather than creating new structures - Citizen development approach enables employees to innovate with AI while managing compliance risks While artificial intelligent (AI) tools are already embedded in daily operation across the sector, governance is struggling to keep up, according to compliance experts from Boehringer Ingelheim, Amgen, and AstraZeneca. During a session focused on the role and ethical considerations of AI at the PCC Canada Pharma & MedTech Compliance conference in Toronto, panelists discussed the need for self-governance frameworks in the absence of AI regulation in Canada. Lina Combariza, compliance associate director at Amgen, opened the session with a quote from Spider-Man: “With great power comes great responsibility.” She continued, “Basically AI adoption is —and the way innovation is— accelerating, we’re facing a challenge that basically innovation is moving faster than regulation.” Widespread adoption, growing investment Combariza conducted a live polling that revealed that 74% of delegates use AI tools daily, with more than 80% saying their organizations are planning to increase AI investment in compliance activities. According to Combariza, most of those investments are focused on training, risk, assessment, monitoring, transparency and disclosure, and data analytics. Organizations also are deploying AI across a spectrum of applications, from document drafting and policy summarization to sophisticated compliance chatbots and automated monitoring agents. “Those tasks regularly require manual effort. So that’s a great way of compliance using AI capabilities to optimize something that is very operational. For us, compliance professionals, AI is not replacing us. It’s giving us an additional tool, and it’s changing the way we bring value to the organization,” she said. “Technology is a core capability for compliance,” she added. “The challenge is not whether we are using it or not—we see everybody’s using it daily—but how to use it responsibly, transparently, and effectively,” adding that guidance needs to come from a place of knowledge. Privacy tops the list for risk Data privacy and security emerged as the dominant concern, with nine out of 10 professionals expressing worry, when polled about their primary concerns. However, the risk landscape extends beyond data protection. Delegates identified multiple areas of concern: misinformation and AI hallucinations, governance and oversight challenges, data validity questions, over-reliance on AI in decision-making, and confidentiality issues. Notably, job displacement ranked low among concerns. The fear of AI replacing compliance professionals has given way to recognition that the real challenge lies in developing skills to understand and manage AI’s capabilities and limitations. “The biggest risk is not malicious use or malicious intent,” Combariza noted. “It’s companies or employees acting on inaccurate, biased, or incomplete outputs.” Canada’s regulatory environment Liam Campbell, legal counsel, data protection & AI officer, at Boehringer Ingelheim, outlined Canada’s fragmented regulatory environment. Despite being among the first countries to develop a national AI strategy in 2017, he stated Canada currently lacks comprehensive AI-specific legislation following the death of Bill C-27 during parliamentary prorogation in 2025. This has left organizations navigating a patchwork of existing regulations: privacy frameworks under PIPEDA (Personal Information Protection and Electronic Documents Act) and provincial laws, Competition Bureau guidance on AI-related marketing claims, and Health Canada regulations covering AI applications in medical devices, he noted. “Now we’re seeing this percolate back up again in 2026. I understand there’s a new draft national AI strategy that’s going to come about, looking to increase literacy among Canadians and talking about artificial intelligence and how to use it in the workplace, which is excellent,” Campbell said. Combariza added, “Self-regulation is the best way organizations have found to put their own guardrails in place.” Building governance frameworks Campbell shared his four key principles in regard to AI governance: - Hands-on review: Organizations need shared frameworks that enable productive dialogue between business and compliance. - Integrate with existing processes: Rather than creating parallel governance structures, successful organizations are enhancing existing frameworks like privacy impact assessments and vendor due diligence with AI-specific considerations. - Adopt principles-based approaches: With AI evolving rapidly, principles around transparency, accountability, and human oversight provide adaptable guidance across diverse use cases. - Enable citizen development: The most valuable AI applications often emerge from employees closest to operational challenges. Governance must support innovation while managing risk. “AI is new and so it feels like you’re painting it with a paintbrush, and everything around it is new. I think it’s a lot smoother if we take a step back and see, for example, what is the data behind what we’re trying to do with AI? What governance or policies do we already have for that? AI is one more piece to this broader puzzle of governance,” said Denisse Irrgang, AI senior product manager, AstraZeneca. Additionally, Irrgang emphasized the importance of partnership. “That solution mindset from your compliance partners—it really feels like a partnership. Any governance policy, when you have that partnership of everyone coming to the table, is far more effective from the business point of view.” Learning while leading The panelists’ overall message is that AI is no longer optional, and organizations must develop both literacy and experience to provide effective guidance. “We need to learn, we need to play with it, we need to explore. We don’t need to be afraid,” Combariza urged. Pharmaceutical Compliance Congress West (PCC West) Sep 17, 2026 TO Sep 18, 2026 |San Diego, CA Unite with top-tier industry leaders from established and emerging pharmaceutical manufacturers to address complex regulatory changes impacting daily operations: FDA updates on SIUU, DOJ Enforcement Priorities and Patient and HCP Interaction Guidelines. Read more about: Artificial Intelligence (AI)