LIFESCIENCES PULSE

Regulatory Compliance Challenges In Life Sciences: Is Blockchain The Answer?

 
November 18, 2019

Today, emerging technologies such as blockchain, Artificial Intelligence (AI), and Robotic Process Automation (RPA) are bringing about a paradigm shift in the life sciences sector. In addition to redefining operations, these technologies have great potential to revolutionize the way we address the issues of regulatory compliance within the industry.

While technologies like AI and RPA have long since made significant inroads, the pace of realizing the benefits of blockchain is slow.

Why blockchain for Life Sciences compliance?

Healthcare regulations vary across geographies, so multinational enterprises need to adhere to global and local requirements for receiving regulatory approval. An approach to mastering compliance via a hybrid blockchain implementation can be incredibly useful in this context.

Blockchain technology offers a way to store and transfer information over a secure peer-to-peer network. All information transfers on blockchain are verified by multiple users on the network. This makes it easier for regulatory authorities to assess the authenticity of the records.

Let’s understand how Blockchain can address some of the most alarming regulatory and compliance issues in the life sciences industry today.

1. Pharmaceutical supply chain

Counterfeit drugs pose one of the biggest challenges faced by the regulatory agencies and pharmaceutical companies. Key issues with drug safety in the pharmaceutical supply chain pertain to the way drugs are manufactured and the traceability of the active pharmaceutical ingredients. Data and systems used across the pharma value chain are often inconsistent, leading to little or no visibility into end-customer sale data for manufacturers. Research from the World Health Organization indicates that at least 10% of drugs worldwide are counterfeit, leading to 1 million deaths annually.

A blockchain-based solution can bring transparency and visibility into the pharma industry’s supply chain, thus making pharmaceutical products less expensive to track for regulatory bodies. Information systems based on blockchain can hold details like expiration dates and certificates of origin that can be made visible to all regulatory parties at each stage of the drug’s journey.

2. Subject identification for successful clinical trials

A key factor in successful drug discovery is the ability to find the right subjects for clinical trials. Each patient or subject is unique and therefore possessing a single source of truth for each person within the network is critical. Wrong choice of the subject due to the unavailability of correct patient information may lead to failure of clinical trials, and ultimately, delays in drug release and huge monetary losses indirectly impacting cost-to-cure.

Blockchain can help patients maintain their own medical data and reach out to clinical trial recruiters themselves, while investigators and doctors can save their observations on the same chain. In this way, patient data will be secured, un-tampered with, and accessible to the right stakeholders through role-based access.

3. Communication between regulatory agencies and pharma sponsors

Another challenge is enabling transparency between the regulatory agency and pharmaceutical sponsors during the drug approval process and other interactions. In the absence of a common platform, many regulatory agencies develop their own portals to receive information from pharmaceutical companies and continue to use traditional methods (e-mails, letters or calls) to communicate with sponsors. At times, it can take up to a year to complete an interaction with an agency.

With blockchain, life sciences organizations can set up a framework to manage submissions and allow collaboration with functional contributors, such as regulatory agencies and pharmaceutical sponsors. Once the sponsor receives regulatory approval relevant information can be released on a public blockchain node and made accessible to stakeholders involved in developing safety measures, clinical trials, or cross-border compatibility.

4. Leveraging smart contracts for content standardization

Appropriate and timely communication with Health Authorities (HAs) is crucial for speedy approval and uninterrupted commercialization of a medicinal product. To increase efficiency and ensure all team members are providing the same response globally, companies create and use medical information letters to standardize their responses to inquiries. The current systems and processes for Health Authority Queries, however, are lengthy, tedious, only semi-automated, and rely on e-mail-based processes.

Smart contracts promise stakeholders trustworthy execution of the contracts at a much faster pace than the current process and help establish a single source of truth for all life science data. With the help of smart contracts, blockchain offers improved communication protocols, while the data can be stored anonymously and shared without any challenges.

Summary

Blockchain, if implemented correctly, can streamline processes like clinical trials, supply chain, regulatory queries, etc., and reduce product-processing time. Since a blockchain network allows participants to manage and exchange information in a secure and robust way, it reduces the time and resources needed to provide un-altered data to the key stakeholders – pharmaceutical companies, regulators, investigators, sales networks, patients and consumers.

Although it is still in early stages of adoption, blockchain holds great potential. It is simply a matter of time before we see regulatory bodies and pharmaceutical companies coming together and driving projects that leverage innovative blockchain solutions.

 

Mohit Gupta has a life sciences industry experience of 12+ years and is a part of the Life Sciences Platform team for past 5 years with expertise in regulatory platforms. He has an IT experience of 21 years  and  a Bachelor’s degree in Engineering from NIT Silchar.