Can IDMP Teams Relax Now?
Regulatory Affairs departments in Europe may be feeling more relaxed about the implementation of IDMP now than a few months ago. Not only because of holiday season, but buoyed by the intent to delay the official IDMP compliance deadline of July 1st 2016. Although the EU Commission has not formally accepted a delay, there are positive signs the phased implementation proposal will be accepted. Should the proposal be accepted, compliance to IDMP will become mandatory towards end of 2017, roughly 18 months after the initial plan.
But does that mean the industry can relax? This question was put to Illaria del Sapia of the EMA in June at the EMA’s IDMP information day. Her response was a statement that the timelines are feasible, but we [regulators and industry] should not relax too much. I would agree with her. A key reason for the request for the delay was that July 2016 was looking increasingly unfeasible for most pharmaceutical companies. Slow publication of final guidance contributed to the pressure of a 2016 deadline. However, an industry-wide underestimation of the difficulty of identifying, collecting, cleansing and managing the broad set of data required for IDMP compliance played a major role. This led to a lack of investment in IDMP compliance until it was effectively too late to achieve compliance by July 2016.
General interest in IDMP only really picked up towards the end of 2014, with the majority trying to learn from the few leaders who had begun their efforts. My observation in early 2015 was that those who had started generally thought compliance would be more challenging than those who had not yet started. From this it was clear that 18 months was not enough time to define a strategy for IDMP compliance, and deliver on that strategy. During Q2 2015 the inevitable slip of defining a strategy to deploying tactics for ‘just getting over the line’ had begun. The proposed new timeline allows the industry to take a breath and return to defining an IDMP compliance strategy vs. implementing a tactical solution.
Note that the complexity of IDMP compliance has not been removed, but now there is an opportunity to define and build something of real value. That is, to develop and maintain an ability to manage and govern a complete set of product data for the benefit of pharmaceutical companies, regulators and most importantly – the patient.
This implies there is no time to relax.
In many pharmaceutical companies, the challenges associated with IDMP compliance are now understood. Initial discovery phases have frequently highlighted poor product data management capabilities. IDMP momentum has been building in 2015. Internal awareness of compliance and it’s data management challenges has increased, and most companies have established IDMP compliance teams. To relax now would be to lose momentum, and possibly internal knowledge and awareness. It could also mean delaying until the only remaining option is a rushed solution that delivers no value beyond the act of compliance.
Now is a good time to return to the efforts of delivering a strategic (and beneficial) approach to IDMP compliance. This is reflected in the conversations I have been having recently which include elements of data governance, and the creation of multi-purpose product data store. An increasingly common topic is how to deliver business value beyond compliance, leveraging the effort it will require to collect and cleanse the data required for IDMP.
Developing data governance capabilities has been proven to deliver value. Analysts such as Aberdeen associate improved product data management with reduced operational cost. Informatica customers cite benefits across supply chain and manufacturing from improved availability of high quality product data. However, data governance capabilities take time to develop and take hold, especially in large complex organisations. Informatica’s experience shows that a phased approach to master data management and data governance is best. Using a phased approach, an organisation can mature its data governance practice as it increases the amount of master data under management. Well-designed phases will deliver business value, so as to increase support for and maintain momentum of data governance initiatives.
The phased approach to IDMP provides an excellent timeline and incentive to either begin or continue your journey towards delivering business value through better data governance. The phases are structured much like we would structure a MDM or data governance project: start with the data that is the easiest to collect, and has the most potential to deliver value. I would argue that the proposed phases for IDMP compliance in Europe have delivered a framework to enable pharmaceutical companies to develop excellence in MDM and data governance for product data.
So I see little time to relax. However, with such a large opportunity to reform data management, and deliver business value from regulatory requirements, why would you want to?