The presentation “Implementation of IDMP is coming: Strategies for making the Business Case” was given by Dr. Andrew Marr, Managing Director of Marr Consultancy Ltd, at LORENZ userBridge.14 in Milan, Italy.
Dr. Andrew Marr is a well-known as a compelling speaker at userBridge conferences. Sharing more than 30 years of experience in regulatory affairs and regulatory operations, he acts as a leading consultant on xEVMPD and IDMP (Identification of Medicinal Product), and is also closely involved in the development of the ISO IDMP standard and guidance and was heavily involved in the current eCTD specifications.
Thanks to his work at the forefront of standards and process development, he has held prominent roles in numerous industry/regulator collaborative projects, including the EFPIA and ICH Expert Working Groups and the PIM programme. He is also currently the topic leader for IDMP in the IRISS Forum.
His presentation at userBridge.14 in Milan gave an overview of the latest developments in the implementation of IDMP, how the pharmaceutical industry should prepare for it, and based on real experiences in industry so far, how a business case can best be made for it.
Although no legislative deadline for IDMP implementation has yet been set in the US, the EU has set 1 July 2016 at its official implementation date.
The EMA and the EU regulatory network are currently defining the exact cases for which IDMP data will be required. In addition to covering fields that were previously subject to the xEVMPD, such as initial applications, variations of pharmacovigilance, the new IDMP requirements could also apply to a host of new areas. These could include information on products used during clinical trials, as well as the types of information required during scientific consultation, in paediatrics, and during inspections and quality control.
Switzerland will probably be a fast follower of the EU, and Canada definitely intends to implement IDMP, although the when and the how are not yet clear as some legislation will need to be implemented to be able to mandate industry to supply such data. Japan is working within Regulator’s group and the ISO technical committee. Nominations to be involved in the first IDMP initiatives have also been received from non-ICH countries such as Australia, Russia and Iran although their direct involvement has been limited to date.
Andrew Marr noted that the actual requirements to be defined prior to implementation include not only common (ISO) guidance on the data elements, but also regional guidance to reflect pharmacovigilance and other regulatory activities, the means of communication and data exchange between industry, regulators and the public, and finally a clear concept for the maintenance organizations, particularly the creation and issuing of identifiers and vocabularies.
The definition of mandatory and optional elements is critical, since regional guidance could well make some of the optional ISO elements mandatory at the regional level. In order to achieve the deadlines in the EU regional guidance will need to be created based on a pre-final ISO draft. So any final changes to the ISO guidance will also need to be reflected in final, revised regional guidance.
All of the specific definitions are still in progress and are unlikely to be completed before the end of 2015. The EMA was expected to share an IDMP roadmap in October 2014, but this was recently delayed until early 2015.
Given this shifting and evolving situation, one thing is clear: the pharmaceutical industry must start its preparations long before the final IDMP definitions are actually available. Yet a recent IRISS survey and interviews with Marr Consultancy clients show that less than 50% of companies have started projects to prepare for IDMP. Even this estimate may be on the high side, since survey respondents and interviewees already share a certain awareness of the topic.
More interesting than the actual numbers is the long list of potential issues and threats. These include the aggressive timelines coupled with the very late availability of specification, the sheer breadth of the impact of IDMP, the sourcing and collection of the newly required data, and the overall level of costs to be incurred vs. the potential benefits.
Beyond this, IDMP also brings a host of data issues into the spotlight. On the one hand, there are the effort and resources required to maintain all of the data and its confidentiality, and on the other, there are massive opportunities for data standardisation and harmonisation, both internally and across agencies, as well as the chance for improved interoperability of systems and processes.
Marr has looked at the variety of IDMP-related projects already under way in companies. It is clear that the business cases vary widely in terms of sponsorship, leadership and funding, in managing the uncertainty of requirements, and in the splitting into sub-projects. A critical element observed: the key driver has a major impact on the design. Is the company really viewing the IDMP as an opportunity to raise its internal benefits? Or is the goal simply to comply with the least amount of effort?
In closing his presentation, Andrew Marr noted that despite all of the delays in its definition, IDMP will be here in less than two years. The effort that will be required for data sourcing, data collation and system connectivity should not be underestimated. His recommendation: act quickly and use IDMP as an opportunity to gain internal benefits right now. The lesser alternative would be to respond late and expend considerable resources for basic compliance.