Aptus.AI’s Compliance Talks, episode 2: interview with Simona Scialpi


The second episode of our Compliance Talks features Simona Scialpi, Head of Legal & Compliance at Daiichi Sankyo Italy. Even turning from the financial sector to the pharmaceutical one, the need of transforming compliance into a proactive function that can generate competitive advantages is significant. Here, then, is another snapshot, from one of the Italian top experts, of the state of the art, critical issues and prospects for technological innovation in the compliance field.

Simona, tell us more about who you are and what you do for your company.

«I have been working in the pharmaceutical sector since 2009, starting in Audit, Risk Management and Financial Compliance roles, moving later on in Ethics & Compliance, where I am currently working at Daiichi Sankyo Italia, a Japanese pharmaceutical company present in the cardiovascular and oncology fields. My job, together with my team, mainly consists of supporting my colleagues in implementing various business projects. We do this both providing a set of internal policies and guidelines for managing processes considered sensitive from a Legal & Compliance point of view, and supporting our colleagues during the several projects steps, to ensure those are implemented in line with business objectives and in compliance with the industry regulations».

What do you enjoy most about your job and what do you find most difficult?

«The part of my job thatI love is thinking that, through it, I can try to improve patients’ life: I am really proud of it, even if my contribution is just a small one. Thinking about my role in the Legal & Compliance area, I strongly believe that compliance should not be seen as a mere approval function: I like to conceive it as a supporting function that, as such, works alongside the business functions since the brainstorming stages because, only in this way, is it possible to achieve common goals in “the right way”. Rather than difficulties, I would talk about complexity, for example in supporting business colleagues in dealing with multi-stakeholder projects requiring to bring different functions (with different objectives) together, always ensuring compliance with the relevant laws and regulations. This is the most complex part, but it also represents a challenge that makes my work continuously motivating».

What are the main skills a Compliance Officer must have in your opinion?

«From a hard skills point of view, a good Compliance Officer must combine a legal and economic background to what is called a “Business Acumen”, which enables an understanding of business objectives in order to provide the most effective support possible. From a soft skills point of view, curiosity and willingness to be constantly updated are both fundamental and necessary at the same time. The interpersonal skills and being an excellent team player are relevant as well since, as already highlighted, the Compliance Officer main responsibility is to support the business starting from the earliest stage of every project, adopting a co-creation approach. In a nutshell, a good Compliance Officer combines a legal-regulatory and economic background with business acumen, excellent interpersonal skills and team spirit». 

What is the main problem or limitation in the area of compliance?

«One of the main risk for the compliance function is being perceived as a hampering function. Therefore, to improve its image, it is very important to create awareness on the role that compliance can play in supporting the business in achieving its objectives by “doing the right thing”, identifying and mitigating risks and preserving the company reputations, shifting then the focus on the enabling role that the compliance function can play, and how it can represent a competitive advantage for the company. To do this, teamwork and cross-functional collaborations are crucial to the achievement of the company's objectives».

Do you think there are sufficient resources dedicated to compliance in Italy?

«I can speak about the pharmaceutical sector, where I have been working for years in large multinationals companies building a strong network: although I am not able to say whether the resources allocated to compliance functions are sufficient or not, I can see that there is a great sensitiveness to compliance topics and, therefore, a clear vision on the value that the function has. My main take-away is that supporting functions growth should always be proportional to business growth, to ensure adequate and effective support».

In which steps of compliance processes would you most need the support of innovative solutions?

«In my opinion, every step of the compliance process is a good one for introducing innovative solutions, since each of them is linked to a specific life cycle phase with its own complexity to be managed. In a highly regulated sector such as pharmaceuticals, great focus is needed from the earliest stages of each project, as the impacts can be different - legal, privacy, reputational -: a careful needs and risks mapping identification exercise is therefore crucial. With regards to potential compliance process automations, every phase is good for capturing insights for improvement. A tool that offers a constant regulatory update could be a valuable asset especially in case of long-lasting projects, where relevant regulation can vary meanwhile. Having a tool that always provides the latest regulatory updates would be useful to promptly update the risk mapping and monitor, adjusting and prioritizing related activities accordingly. This is a crucial need overarching all project management steps, from the design to execution».

Do you currently use technology tools to support your work?

«Today we use (non-automated) alerting tools mainly based on newsletters to stay up-to-date. We then have internal tools for approval flows and internal policy management. However, if we talk about automated regulatory updates, I am not aware of any similar tools in the industry at the moment».

If you had a magic wand, what tool would you create to support your work?

«Being able to automate the aspect of regulatory updates,  the consequent impact on business and the related risks is the fundamental and most critical one, since case law analysis takes time. Reporting systems that bring together different data, for the purpose of carefully and constantly managing risk, would also be value-adding. We often work on different systems, so having dashboards that aggregate sensitive data by providing KPIs would be very useful».

Turning to current issues and focusing on compliance in your industry, how has the Covid-19 pandemic impacted the pharmaceutical regulatory environment?

«In my opinion, in the pharmaceutical field, the pandemic has been an accelerator, especially for interactions related aspects. Several industry activities historically based on physical interaction has not been longer possible with the pandemic. This shifted the focus on digital interaction (like conferences or telemedicine platforms), which led companies and industry associations to reflect on how to apply existing rules and regulations in the light of the new needs. My take home message from this situation is that industry needs and regulation must go hand in hand - and this I believe applies not only to the pharmaceutical sector, but also to the financial sector on which you are focusing at the moment. This alignment is also important with regard to the “regulation-innovation” pairing. I am thinking, for example, about the provisional restriction order issued by the Italian Privacy Authority (Garante della Privacy) for ChatGPT, requiring the implementation of a series of measures and prescriptions to guarantee the protection of personal data. So, innovation should always be welcome, especially when it leads to processes optimization and streamline, ensuring compliance with the applicable regulation at the same time, so that these tools can actually represent an opportunity».