Why a Data Health Check May Be the Best Medicine for Pharmaceutical Regulatory Compliance

Darren Cooper

The way medicines are discovered and developed is changing, and regulatory organizations around the world, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), are working on alignment schemes to create Identification of Medicinal Products (IDMP) standards. IDMP, which covers data elements, formats, and terminologies, is a set of five International Organization for Standardization (ISO) norms which were developed in response to worldwide demand for internationally harmonized specifications for medicinal products. IDMP provides the basis for the unique identification of these products and facilitates the activities of medicines and regulatory agencies worldwide for a variety of activities, including development, registration, and lifecycle management of medicinal products; pharmacovigilance; and risk management. IDMP is quickly gaining worldwide momentum, and in July 2016 legislation around the IDMP came into force within the European Union.   Faced with these compliance challenges, pharma companies need to recognize that with these regulatory changes comes added benefits, because the overall effect of this new legislation will make the exchange of data easier. In turn, this will lead to long-term cost savings for the industry, enabling them to become more agile in adding value to existing business processes, and in making it easier to trade internationally.  

Prescription for better data health: data governance

But how should companies make the most of these new opportunities? A first step in preparing for the future is for businesses to gain tighter control of data and undertake a “data health check”. For example, business-critical data is typically dispersed so that companies hold huge amounts of information – on products, prices, customers, clinical information, etc. – within different silos. Often this data is formatted differently for and by different systems; it’s overseen by stakeholders with different priorities; and data held in one part of the company may even contradict information held elsewhere. In contrast, what pharma companies really need is data that’s consistent, trustworthy, and readily accessible across the business. It also needs to clearly identify who has responsibility for maintaining the data and ensuring its quality.   To undertake such a data health check, companies need to focus on the discipline of data governance, which is defined as having people, processes and information technology working together to ensure the seamless management of data and enhance its value to the business. Successful implementation of a data governance strategy means companies can be confident they hold reliable and consistent data that can be exchanged between departments, and with different parties in and around the supply chain, such as healthcare providers and regulators. In practical terms, for example, the information feeding into the Enterprise Resource Planning (ERP) system will be aligned with that being used in other enterprise software modules, and vice versa.   Achieving data governance may involve utilizing a master data management (MDM) solution, which enables the exchange of vital data, while reducing operational costs and streamlining other business processes. But as we’ve already suggested, it’s also about refining business processes and about building an organization that becomes accountable for the accuracy, accessibility, consistency, and completeness of a company’s data. The data governance team forms part of this organization and is responsible for both defining and implementing information policy – the standards by which data is defined, measured, curated and shared.  Setting such policy is key to successful support of both regulatory compliance and the implementation of new business models under the guise of digital transformation strategies.   It is important to emphasize that data governance is an ongoing initiative rather than something that is dealt with once a year.  As such, it requires points of measurement and evaluation to improve its performance.   This move towards standardization and transparency within the supply chain puts a responsibility on companies to ensure high standards of data governance so that they can provide and maintain this information in a timely, cost-effective, and reliable fashion.  

The global reach of data harmonization

There’s also a global perspective to consider, as regulators harmonize their approaches. For example, in the U.S., the 2010 Physician Payments Sunshine Act requires pharmaceutical companies to track their financial relationships with doctors and teaching hospitals, with the overall aim of uncovering any potential conflicts of interest. The Drug Supply Chain Security Act signed into law in 2013, and in the words of the FDA, “…outlines critical steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States”.   According to the European Medicines Agency, the rollout of ISO IDMP standards is broadly consistent with what’s happening in the U.S., and practices are aligned with one another. At a macro level, the Transatlantic Trade and Investment Partnership promises greater harmonization between the European Union and North America.   A move towards harmonization, however imperfect and slow, affords companies an opportunity to focus in on data as a business asset. Gaining better control of data and making sure it’s consistent not only makes it easier for the business to share and work with this data across different departments, but also to use this information across multiple jurisdictions and territories, and for different purposes. Those with good control of data are better able to tailor business processes to make the most of the opportunities and to communicate across the supply chain.  

Better data health leads to better business efficiencies

The pharmaceutical industry is undergoing huge change, driven both by legislators and, longer term, by the adoption of digital technologies that will transform business and healthcare practices. Companies’ success in navigating this evolving business landscape will, in great part, rest on using the data it holds efficiently. However, the reality is that many companies within the pharmaceutical sector still hold information in silos, with different departments holding data, sometimes on the same products, in separate files and in a variety of formats.   Strong data governance, supported by a master data management solution, enables companies to consolidate and centralize data to create a trusted source of information. This information can then be easily shared across the business, and with suppliers, customers and regulatory bodies. Attention to data governance means companies can reliably share information on a medicine’s ingredients, effects, and potential side effects with healthcare providers and others involved in the healthcare continuum. More importantly, better and measurable “data health” infuses businesses with a trusted resource of information that can be used both to drive business efficiencies today and to make the company more agile for the future.  

Darren Cooper is Director of Industry Solutions for Stibo Systems (www.stibosystems.com).