Next-gen compliance for pharmaceutical and life science companies

Perspectives from Tim Canonico, Principal, Pharmaceutical and Life Sciences, PwC US

Navigating the complex regulatory environment

PwC’s Pharmaceutical and Life Sciences (PLS) risk and regulatory professionals help our clients tackle their compliance and regulatory challenges. Tim Canonico, and his firm colleagues, focus on tech enablement to help reduce compliance costs, make it more efficient — and drive value-creation for PLS companies.

Healthcare professional (HCP)/healthcare organization (HCO) interactions and transparency are hot topics. Historically, interactions and transparency have been manual and disparate processes that few people are fond of — whether they’re internal stakeholders or external healthcare professionals. These processes can be typically slow, expensive and burdensome.

Most companies in this space were already facing tremendous pressure to lower costs, as well as looming patent cliffs and changing drug pricing regulations — on top of new laws and compliance challenges. To make things worse, the pandemic threw a wrench into how pharmaceutical and medical device companies interact with healthcare professionals.

These companies are rethinking how they can flip the script when it comes to HCP engagement and global transparency. In PwC’s Pharmaceutical and Life Sciences practice, that’s what we’re spending most of our time on right now: fundamentally transforming HCP engagement and spending transparency — and the monitoring that comes with it.

"PwC has been on the forefront of helping pharma/life sciences companies deal with these regulatory requirements from a consulting perspective for over 25 years," says Canonico. "Most companies had to build custom, in-house software to address either HCP engagement or spend transparency needs. The business is constantly changing, so these homegrown systems tend to become perpetual projects that can be very expensive to maintain. We recognized a need to introduce technology that can change the game on how this happens."

Because there weren’t any great solutions on the market, many of our clients who knew of our consulting experience in this space asked for our help. We had a long list of requirements they wanted and needed in a true end-to-end HCP engagement solution — and it had to be one that’s:

• Global

• Mobile-enabled

• Flexible

• Secure

• Enterprise-grade

• Integrates with other solutions

We looked for appropriate solutions but couldn’t find anything on the market that met all our clients’ needs — in particular, around HCP engagement, so we built our own software solutions for interactions, transparency and detection/monitoring. PwC’s solutions across three different parts of the value chain can fundamentally change the end-to-end lifecycle process for the industry. We built these tools to work individually and as an integrated set of technology:

•  Interactions Hub, a PwC product, handles all HCP engagement: advisory boards, consulting service agreements, speaker programs, external funding and more. It deeply supports all the end-to-end activities a manufacturer would do in terms of fee-for-service-related activities — from annual plan through needs assessment, fair market value (FMV) through contracting, proof of performance and payment. And it’s designed to work globally for clients of all sizes, has multiple system integrations and is multilingual, mobile and multicurrency.

•  Transparency Hub, a PwC product, handles our clients’ global transparency challenges. It does the heavy lifting and reduces the inefficiency inherent in transparency reporting. It can take data in any format, help find the issues — and correct them. It creates an audit trail and allows you to generate reports anywhere in the world for all the jurisdictions with transparency reporting requirements.

• Risk Detect, a PwC product formerly known as Detection Monitoring Hub, digitizes risk assessment and compliance monitoring, another area where we see significant need for digital enablement to help drive more efficiency.

Most people already know PwC as a multinational professional services firm with a history that spans over 150 years. However, we’ve transformed ourselves into a services and products company. PwC’s products business offers more than 100 products today and has a team of over 1,900 engineers, developers, support maintenance professionals and more.

It’s an exciting way to deliver more value to our clients at lower costs – and that’s what they’re asking for. We’ve brought together our consulting, products and managed services to help our clients in their transformational efforts:

• We help them to design their strategy, build a future state process and help make that change happen.

• We implement our products to tech-enable the vision we set out in our consulting engagements.

• We provide managed services for our clients who need assistance to further lower costs and take away the heavy burden.

The bottom line on this transformation for Canonico — "This is where we believe we can add the most value for our clients, and that’s what we’re excited about for the future: creating more and more of these integrated solutions for our clients."