Redefining Regulatory Information Management With Blockchain

Transcription

1 Redefining Regulatory Information Management With Blockchain The Opportunity With more consumers demanding a greater say in how their health is managed, life sciences and healthcare companies are increasingly adopting a patient-centric business model. In response to this paradigm shift, enterprises will need to reimagine how they receive regulatory approval for new products while meeting local and global regulatory requirements and gain access to information that can be shared rapidly with the patients and care givers. Regulatory affairs (RA) is one of the most critical areas within the life sciences domain and is the gateway for acquiring product approvals. Regulatory process are subject to changes and adoption due to the ever changing updates to regulation as well as the new and emerging regulations. This causes several challenges traceability and global visibility of the process, are the submissions being done as per the current or the earlier regulations, are we current on the latest labelling requirements, and are the products being shipped to that country in conformance with the submission made there in? Equally important is that the entire organization and external consumers (such as clinical research organization (CRO), institutional review board (IRB), patients, and contract manufacturing organization (CMO) in the ecosystem have the most relevant and current data or information sets are the regulatory data like CMC coming from the several stakeholders consistent? This becomes a complicated affair when a globally distributed network of af liates are responsible for managing a signi cant volume of critical product information

2 In this regard, Blockchain could play a vital role. This technology allows companies to gain total ownership of regulatory data while ensuring that it can be securely stored and privately shared with authorized stakeholders. As a decentralized shared ledger that requires cryptographic signatures to access or modify, Blockchain can create a transparent, traceable system of recording transactions across the regulatory data/content aggregation and approval lifecycle. The Value Chain Potential For some time now, the nancial services sector has been championing Blockchain adoption. Taking a leaf out of their playbook, many other sectors such as consumer-packaged goods (CPG) are waking up to its potential. The life sciences and healthcare ecosystem is jumping on to the bandwagon. There are several areas within the healthcare value chain that could see a wide application of Blockchain for collective bene t and mutual value outcomes. Peer Validated Registries - Clinical Investigators, Patient Pool Registries; Clinical Research data sharing and obligations managed Secure Share of Personal Medical Data, Patients Control their medical records and data Disruption of current models like Health Information Exchange, All Payer Claims Databases Key Result Areas Integrated Healthcare Data Fluidity Pa ent Experience Health Outcomes Generation of Patient data in Non Clinical Context ( e.g. wearable, patient generated data from personalized devices) Integrating Prescription, Dispense, Claims Processing and Management, Billing and Adherence Drug and Device Provenance, Adherence and Incentives First Adopters with large scale Blockchain solutions could emerge by 2019, Mainstream adoption by 2022* *Source: January 2017 Hyperledger Healthcare Working Group Survey, N=29 Figure 1 : Blockchain in Healthcare There are four key characteristics of Blockchain that could nd relevance in the life sciences domain.

3 01 Transparency Improved collaborative working as all participants are viewing and working off a common single source of truth, while the chain improves the data integrity 02 Disintermediation 02 Elimination of many middlemen or intermediaries in a more efficient manner (allows connecting to the interested parties without going through the intermediate parties) 03 Trust 03 Distributed validation structure, connected data blocks means that the participant can inherently trust other participants in the system 04 Auditability Data is immutable, versioning is inherent and intrinsically tamper proof, thus providing everlasting record keeping capability Figure 2: Blockchain Features Relevant to Life Sciences Blockchain Application In Pharma Some areas where Blockchain can be deployed to streamline processes are as below. IDMP Management With identi cation of medicinal products (IDMP) emerging as the new global standard for managing healthcare product data, the case for adopting blockchain grows stronger. Information required for meeting IDMP standards ows in from multiple processes including clinical trials, manufacturing, and labeling, among others. As such, process owners have to meaningfully integrate the myriad systems where this information is stored and converge it into a single source of truth for building the IDMP data model. For example, a pharma company and the country s regulatory body can operate their own distinct Blockchains in parallel with a public Blockchain accessible to the general population. Once the pharma company publishes a product s data on their Blockchain, it is replicated at the nodes maintained by regulators. The data from the regulator s node is combined with the pharma company s data block to create a single source of truth. This can be used to submit clinical trial application forms, market authorization requests, patient label summary Information or even summary of product

4 characteristics (SmPC). Part of this information can then be released on the public Blockchain node and made accessible for cross-border product compatibility and identi cation, and other similar scenarios. While each entity operates on their own Blockchain or a common one, the information available can be trusted and used for rapid dissemination. Based on its inherent quality, it can automate and simplify processes such as reconciling product recall data. 1 Pharma Company sends IDMP data 2 Transaction is represented online as a block 3 The block is broadcast to every Regulatory Agency in the network???? 6 Pharma Company receives noti cation of acceptance form Regulatory Agency 5 The block can then be added to the chain which records the entire non-reversible history of transactions in public ledger 4 Those in network approve that the transaction is valid 7 Consumers are able to trust this data and reference it for various scenarios (e.g. product compatibility, safety information etc. Figure 3: Simpli ed Illustrative Scenario for IDMP Data Management Marketing Authorization Another potential Blockchain application in the regulatory space is the marketing authorization process. In the SEA / ASEAN regions, it is most likely that the pharmaceutical company is selling the same drug product with slight differences in labelling. However, change of the drug product would warrant re-submission of the marketing authorization request and fresh approvals. In many cases, the manufacturing location is different from the country of sale, and high number of licenses leads to an increase in the supply chain nodes. Consider an example of a Foreign Medical Device Company seeking to sell in Country X. County X mandates that the Foreign Company cannot sell directly to the Medical Institution or Care Providers. They can do so only through a marketing

5 authorization holder who holds the certi cation and is responsible for distribution of products. But in order to sell the product physically in the country there has to be other Licensed Entities Import License Holders and the Retail License Holder. We consider all the parties to be different in this situation. Hence, each party s application is dependent upon a regulatory approval of the others to realize the business value. Blockchain-based process or application could bring in ef ciencies, timely noti cation, and action thereof for the af liates to manage the regulatory aspects effectively with the ability to cut down the total cycle time. Sends approval request(containing product information, exporting country regulatory certi cation) Foreign Medical Device 01 Manufacturer 02 Receives the request and adds MAH Establishment information and other Licensed Partners Regulatory / Healthcare Authority Country X Marketing Authorization Holder Importer in Country X 03 Shares the Licenses data and other information that authorizes import and storage Receives Application Issues Market Authorization Dealer 04 Can Sell the Product directly to Institutions and is responsible for Field Services and Repair 05 Compiles and submits the Information for Grant of Market Authorization Figure 4: Market Authorization Application- Medical Devices Streamlining The Regulatory Process With Blockchain To sum up, Blockchain deployment can streamline the regulatory affairs by: a) Ensuring an effective chain of custody for the information and data set while providing individualized updates but preserving the data integrity and relevance. b) Ensuring that the product-related data being shared across the ecosystem is consistent, most current over a distributed ledge model.

6 c) Improving collaboration between the data generators, approvers, and consumers for a more real-time, auditable, and traceable content while providing the exibility to operate independently. With respect to managing regulatory activities, a Blockchainbased solution exhibits immense potential and can, in fact, double up as regulatory information management (RIM) platform for the enterprise. It will allow regional af liates to easily update the localized and country-speci c information in real time, making the validation and stakeholder communication process redundant. This will ensure integrity, validity, and complete accessibility to regulatory information for any medical product. Therefore, Blockchain adoption can provide a faster time-toapprove since data sets are available with end-to-end traceability of data travelling across the entire regulatory value chain. The entire ow of information can be easily traced or relied upon for taking regulatory actions such as recalling products or issuing statutory warnings. Blockchain can act as the backbone for a global harmonized regulatory landscape at a much lower Total Cost of Compliance and improved stakeholder centricity.

7 About The Author Yezhuvath Vinesh Balakrishnan Yezhuvath Vinesh Balakrishnan is currently working with the life sciences business unit at TCS, leading some of the key initiatives in the areas of Blockchain and IDMP. He has over 26 years of experience in supply chain management, manufacturing, process excellence, and IT management across pharmaceutical and chemical industries. He combines process orientation and analytical abilities with an in-depth understanding of technology to conceptualize innovative solutions. As part of the Centre of Excellence, he is involved in strategy & consulting, optimization, practice management as well as product/service development. An alumni of Birla Institute of Technology and Science (BITS Pilani), Vinesh holds a graduate degree in Chemical Engineering and a postgraduate degree in Mathematics. Contact Visit the Life Sciences & Healthcare page on lshcip.pmo@tcs.com Subscribe to TCS White Papers TCS.com RSS: Feedburner: About Tata Consultancy Services Ltd (TCS) Tata Consultancy Services is an IT services, consulting and business solutions organization that delivers real results to global business, ensuring a level of certainty no other firm can match. TCS offers a consulting-led, integrated portfolio of IT and IT-enabled, infrastructure, engineering and assurance services. This is TM delivered through its unique Global Network Delivery Model, recognized as the benchmark of excellence in software development. A part of the Tata Group, India s largest industrial conglomerate, TCS has a global footprint and is listed on the National Stock Exchange and Bombay Stock Exchange in India. For more information, visit us at All content / information present here is the exclusive property of Tata Consultancy Services Limited (TCS). The content / information contained here is correct at the time of publishing. No material from here may be copied, modified, reproduced, republished, uploaded, transmitted, posted or distributed in any form without prior written permission from TCS. Unauthorized use of the content / information appearing here may violate copyright, trademark and other applicable laws, and could result in criminal or civil penalties. Copyright 2018 Tata Consultancy Services Limited TCS Design Services I M I 03 I 18