Call for compliance upgrade in the pharmaceutical industry is the result of frequent changes in the pharmaceutical industry. Machine learning and inclination to digital technologies such as automation can further support compliance and maintain its position of a strategic partner to the business of pharmaceuticals, however this task will become increasingly difficult if compliance operations at pharma companies are not modernized.
The changing trends in pharma companies have shown growth in regulatory requirements, in addition to increase in regulators’ capabilities to identify risks and bad behaviors. Furthermore, there is also growth in sophistication and speed, along with other internal pressures to minimize costs. Experts also suggest that digital technologies have increasingly become a source of risk, as businesses have tried to implement new tools and other ways to engage customers.
The Deloitte Center for Health Solutions’ carried out an interview with some of the industry executives belonging to 10 pharma companies. The results of the interviews were as follows:
Technology deployment was determined to be variable. One organization for instance implemented a sophisticated digital tool for policy inquires while other struggled with real-time monitoring in addition to continuous control of financial transactions.
It was also observed that several compliance activities required manual effort, and although the adoption of digital technologies was still nascent, they implemented use cases in order to support reactive activities was a prominent occurrence. These included identifying and reporting past events.
Furthermore, although digital technologies were on the radar for compliance executives, several traditional approaches for compliance operating models, current workflow systems resulted into constraints.
Lastly, experts allege the possibility that compliance departments could be overlooked, cannot be denied. This mainly happens because other functions are often more targeted for digital investments.
According to sources, compliance in pharma companies covers several facets, which include foreign corruption, bribery, human resources, communications with patients and healthcare professionals, patient assistance programs and reporting to regulatory bodies. Owning to the need for specialized expertise for each of these domains, along with dependence on other parts of the organization, it can be inferred that compliance operations have depended traditionally upon manual processes. Furthermore, study also alleges that compliance program can be powerful with the number of people assigned to it.
With the help of digital technologies, rote tasks can be kept at a distance, it becomes easy to maintain pace with increasing number of data and the transformation of compliance into value-creating organization becomes possible. In addition it also helps to anticipate adversaries and find solutions for it to keep it from happening.
A survey led by Deloitte however provides insight into the question, do pharma companies make most of the opportunities provided by digital technologies in order to modernize compliance operations? The question was answered with reference to existing levels of future opportunities and technology adoption for compliance modernization. Furthermore, the study reviews 16 executives from medical affairs, compliance and commercial functions belonging to 10 pharma companies. One of the key highlights of the results suggested that although digital technologies were still in the nascent stage, opportunities and interest were on the rise.
One of the foremost findings suggests that the resource-intensive nature of the operational activities were responsible for imposing time restrictions on compliance executives to carry out strategic tasks. Although this trait is not uncommon across the pharma industry, it suggests that companies may not be getting the expected value from their compliance operations.
It was further also observed that considerable resources were required to manage compliance policies. These included generating reports, ad-hoc activities, customizing training needs, etc. It was also observed that executives from the business side found the compliance-related activities to be resource-intensive, such as evaluating promotional materials, customer relationship management (CRM), managing product samples and performing administrative tasks needed for the policy.
Using digital technology is compliance regarded as an exception rather than a rule
The research confirmed that adoption of digital technologies in compliance across pharma companies is still nascent, although it enhances quality and efficiency. Furthermore, even when digital technologies are implemented, their levels of adoption and types of technologies vary according to the companies.
While some companies use complex algorithms like natural language processing (NLP), a majority also builds reports and dashboards. Furthermore, compliance professionals also depend upon generic software such as Microsoft suite for several other tasks.
In addition, the implemented use cases found through this study supported reactive activities which include reporting and identifying past events. Some of the examples of implemented solutions are monitoring, reporting and policy.
Monitoring: Study alleges that compliance functions require considerable time on the retrospective review of emails which forms a part of risk monitoring. The NLP tool was deployed by a large pharma company for initial email screening in order to evaluate potential risks. Figures suggest that this exercise minimized the number of emails for review by compliance officers from 2500 to 20.
Reporting: The need for a mileage-calculation solution as reporting. This process was automated with the help of an algorithm which captures employees’ inputs, in addition to calculating the distance between two locations, by means of external data used by the algorithm from Google maps.
Policy: Chatbot-based apps were used by two of the companies interviewed for the survey. These further helped field-based professionals to look for answers based on policy-related questions. With the app, the application of this becomes easy and possible in real time. In addition, the app also provides specific language preferences for policy documents.
In spite of this the experts believe there is still more opportunity available for adopting digital technologies. In addition, compliance organizations at pharma companies do not have a well-developed strategy for making the most of opportunities.
Digital maturity model to leverage digital capabilities in compliance
The fundamental stage of the model includes preparatory work which means to make systems and processes analytics ready and to put them in place by streamlining basic analytic capabilities. The next stage involves insight generation, more time preference to compliance professionals than on data management. The model suggests that as more compliance and analytic work is automated, the compliance function can move from swift from backward-looking analysis and report towards generating foresights, thus anticipating and preventing future risks.
Opportunities for digitizing compliance
The survey respondents offered several ideas for adopting digital technologies in order to enhance business and compliance processes. The results can help to draw the following use cases which are applicable for most of the pharma companies’ compliance operations. These include, monitoring, policy, training, operational tasks and contracting.
An automated risk assessment process with regards to product portfolio built especially on the current risk management platform can help to capture data from stakeholders such as product owner, brand team, etc. via a standardized survey. The survey covers risks domains with regards to company’s requirements along with an automated schedule which would further ensure the desired frequency of data collection.
Experts allege with automated data collection, the compliance activities can move from gathering to analyzing data, in addition to providing meaningful insights. Moreover, the solution can guide compliance teams to become more targeted by dedicating more attention to higher risk areas through in-person visits.
The survey also draws attention to the several HCP engagement requests undertaken by pharma companies. The process is known to be labor-intensive. The algorithms can also be a combination of ML with NLP and NLG which can further help to enhance the efficiency of the process. For instance, when a business submits a request via a CRM portal or through a similar system, an algorithm performs the first level of review and the results can be routed to compliance. The dashboard which shows all HCP requests also include confidence score and other reasons for either approving or rejecting a request. The compliance professional can further either accept the algorithm or also perform a secondary review.
Furthermore, the results from the secondary level of review feed back into ML algorithms also continue to learn as the system is been used.
Continuous monitoring of third parties
NLP is used in a risk-sensing solution in order to mine unstructured text from hundreds of thousands of external data sources from multiple countries and languages in order to provide early warnings of potential third-party risks. Some of the examples of the risk domains the solution and can further track for any specific party are: compliance, financial and reputational risks and operational risks and strategic risks.
The study further also provides insights into how compliance executives regard merit technological solutions, considering their limitations on budget. The study recommends that the companies should approach such compliance executives thoughtfully, in addition to considering the context of the organization’s structure and business needs. Value, impact on internal compliance operations vs business line processes, resource use, feasibility and speed along with ease of implementation are some of the crucial points to be considered.
The study also speaks about the strategic role played by the compliance departments in all the ten companies interviewed for the research. In addition, most of the respondents also agreed that it took a great deal of effort to relationship-building to develop compliance departments.
Furthermore, it can also be concluded that the demands on the compliance departments were anticipated to grow in the future. Experts also allege that the capabilities of regulators to recognize possible bad behaviors and risks are evolving. In addition, the internal pressure to minimize costs and do more with less has become more significant. Finally digital technologies can themselves also be a significant source of risk.
Experts further also suggest that compliance functions can continue to modernize their processes or they may think it difficult to retain hard-earned positions as crucial partners for businesses. Furthermore with challenging work, they may also find it difficult to be effective with tackling and blocking.
Experts suggest this time is the most recommended for investing in digital transformation. Every company can work towards modernizing its compliance operations no matter where it is on digital maturity continuum. The steps for this include, understanding and aligning, defining success, going fast and scaling up.
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