Reuters Events | Pharma

Thought leadership and innovation for the Pharmaceutical Industry

Making compliance processes fit for the digital age quickly moved from being merely an important problem to a mission critical one this year. In the massive and almost overnight shift to digital engagement since pandemic lockdowns began, the demand for digital content has soared.

 

The marketeers’ challenge of supplying content in the quantities and formats HCPs require just when they want it, is matched by the challenge of passing it all through the medical legal review (MLR) process that pharma was only beginning to reconfigure for the new digital realities before the pandemic struck.

 

“MLR as a process has been viewed in isolation more than it should have been,” says Chetak Buaria, Global Head of Customer Engagement & Channel Evolution, Biopharma Global, Merck. “It has been treated like a box to be checked, as a tunnel you have to go through somehow from creation to execution. It worked before, it was manageable but there is a strong sense of urgency now to look at things differently.”

 

The use of new platforms for distributing content, the variety of new formats, consumed in different contexts all challenge a process set up for a slower-paced review process more suited to printed collateral and slowly evolving website content. 

 

The reuse of content in particular is another pressing issue, adds Buaria. “It has become critical that we optimise content reuse. For us that is a super big challenge.”

 

These are not the only problems either. The sudden surge in demand for digital content has created a comparable surge in demand for, and a consequent shortage of, medico legal reviewers. 

 

The differing content rules and needs of different markets in different regions pose a further challenge to the smooth approval of these new types and higher volumes of content.

 

As if all that were not enough to contend with, the often adversarial nature of the process as currently configured in most pharma organisations is a further barrier against a more optimal way of approving content.

 

The solutions to all this may be placed in three broad categories: people, processes and technology. New approaches and ways of working in all these areas can help optimize approval processes for the digital age.

 

People

Getting colleagues from the various functions to understand the challenges and requirements they all face is important in helping build new and more co-operative ways of working, says Susan Garfield, Principal, Commercial Lead, Health Sciences and Wellness Sector, EY. “MLR is a team sport, so make sure you are getting everybody involved.

 

“The best solutions are where medical, compliance and commercial can align around a set of processes, people, engagement capabilities and technologies that improve the overall system for everyone.”

 

This includes trying to reimagine the review process to reduce the burden and improve the experience of reviewers, says Garfield. “It’s about making the process more enjoyable, making the system more pleasant to be a part of so the professionals want to stay and do this job.”

 

It is a high turnover role because it can be a boring, high-friction process, says Garfield. “Making sure they are valued as important team members on the MLR side and the commercial side entails bringing together those sometimes opposing points of view and recognising they are on the same team with a shared vision, and a shared purpose.”

 

Part of the process of creating this shared vision will entail encouraging marketeers to experience the process from the compliance point of view so that they more fully understand the constraints compliance colleagues operate under, says Jennifer Klein, Head, Strategic Scaling, Measurement & MLR Planing, AstraZeneca.

 

Some decisions they make are straightforward but others lie in grey areas that require a nuanced understanding that is not always understood outside of the MLR process, says Klein. “How do you orient people in that process in marketing for instance into the regulations as to whether something is black and white or not? Marketeers need to know what is black and white and engage with medical colleagues in what is grey to set them up for success.”

 

Creating a shared vision also involves cultivating a wider, more holistic view of what the ultimate goal is, adds Klein. This could be, for example, as simple as sharing the positive results of a patient activation programme that MLR colleagues may have been involved in.

 

“That is what creates the camaraderie. We are solving a business problem based on having patients treat their disease and interface with their medicines better. It changes the way you collaborate. Everyone has skin in the game. Everyone has a role to play in achieving a common goal.”

 

Training, upskilling teams and knowledge transfer processes are also important components of an effective approach to content and compliance, as are the right incentives. New approaches to measuring success here include different KPIs too.

 

The new KPIs might include, says Buaria, "the volume of material coming into the content ‘funnel’, how it is passing through different gates, how much time it takes and how many cycles it takes to pass through, the time from approval to distribution, and how you measure content reuse; that is a critical factor.”

 

Processes

Stepping back and defining the challenge is essential to improving processes, says Garfield. “You need to really look at the teams and the SOPs around MLRs. How are the different people involved working together? Many companies are using a combination of full time and contract employees. How is that process working? Define the problems and challenges first and then look into the technology.

 

“In many cases companies are trying to solve for throughput and speed of approving content, in other cases there is the challenge in finding good medico legal reviews and how to leverage these scarce resources effectively and efficiently. That is a different thing to solve for, making the system more pleasant to be a part of so these professionals want to stay and do this job.”

 

Secondment is another potentially useful best practice process that can help build the right shared culture and attitudes to compliance, adds Garfield.  “Having people come into compliance from other parts either marketing or internal audit or logistics is one thing I have seen companies do with lots of success, the prosecutor becoming the defence attorney, so to speak. It helps you develop that empathy, and you can educate your group.

 

The right governance structures will also help create the processes necessary to ensuring global and local teams work well together to ensure content is compliant in the face of the quirks of local markets, adds Buaria.

 

“Governance is critical to the platform and the process to strike the right balance between local needs and standardisation. Global governance processes will help create the structured dialogue necessary to achieve that balance.”

 

Technology

Once there is alignment on processes and a more harmonious dynamic and governance process between stakeholders, the potential for technology to help move content through the approval bottlenecks can then be considered.

 

The technology applied should offer full integration from end to end, says Buaria. “You need a platform and technology that supports you. You need to see the content supply chain in a fully integrated manner with MLR being linked to a digital asset management platform and linking that to your distribution channel. That allows you to have full visibility of what is in it at any given time and it becomes your brand portal, offering an Amazon-like experience for affiliates to pull out content that is relevant to them.”

 

Painful experience has demonstrated that approaches to procuring such platform technology should favour the off-the-shelf over the heavily customised approach, says Klein. “We have the scars from using highly customised approaches in the past where you find you can’t adopt innovation from the vendor fast enough. Then we went ‘off the shelf’. That does not mean you are not configuring but we are able to leverage the tool better because we have not over customised it.”

 

AI is emerging as a powerful new tool that many are experimenting with as a tool for outright automation of repetitive leg work, such as for auto tagging content, claims and references linkages to reduce time and effort.

 

It is an exciting emerging area that is starting to demonstrate great potential, says Garfield. “There are different levels of engagement and we are seeing companies getting comfortable doing pilots right now.

 

“[Technology is] doing time consuming but simple tasks, like checking spelling mistakes, making sure the language is not subjective versus objective, looking for alignment on a label change. These are the types of activities that are extremely ripe for an AI intervention. You can programme the system to look for these and fix it without high human involvement.”

 

Other applications are more nuanced, such as analysing subjective language, says Garfield. “We have taught our platform the rules for each country but the application of those rules especially in the grey zone becomes challenging.”

 

Even where AI cannot resolve issues that are in this grey area, it can still help, she adds. “You can use AI to highlight potentially problematic language and tag it for review, as opposed to actually adjudicating the outcome."