Japan, the third largest pharmaceutical market, is updating its code of conduct, with far-reaching compliance implications for pharmaceutical companies. The Product Information Offering Activities of Ethical Drugs Act brings Japan in line with other standards set for pharma in North America. The new code goes into force October 1, 2019. Now is the time for global companies to act quickly and adhere with these updated standards, for a market valued to reach $126 billion in the next 5 years.
Understanding the new regulations
The regulations are designed to ensure safe and effective use of products. Specifically, the new code:
- Mandates companies create a new department and committee to approve all marketing messaging
- Applies to all employees and third parties, across all sales & marketing channels
- Sets new conditions for product marketing
- Mandates record-keeping of all interactions for compliance
That means pharma must maintain compliance across all branded social accounts, third-party communications, field team interactions with HCPs, field team open text entry, and internal communications.
For example, a field rep might connect with an HCP via WhatsApp, then record the details of their conversation in Veeva CRM via a free text call notes field. All of those interactions would need to be captured, evaluated for compliance, and archived. These cloud and digital channels make a field force more agile, but the speed and scale of communications also poses a compliance challenge.
Consider a conservatively sized team of 1,000 sellers that each have, on average, 20 interactions per day, across a variety of channels. That equates to 20,000 conversations in one day, or 7M+ conversations in one year. The human resources cost to manually review these interactions is prohibitively high and inefficient, assuming the company has captured all the information. Analyzing only a sample of the data is also not a sufficient alternative under these regulatory objectives.
In order to do that successfully, compliance teams need to protect all interactions across sellers’ digital, social, and mobile channels. While pharma codes of conduct in other global markets may already adhere to these standards, it is now a requirement to do business in Japan.
How to take advantage of the business opportunity
Automation is key to ensuring real-time compliance and maintaining records across channels. Our NextGen Compliance platform empowers enterprise compliance teams to create their own rule sets and capture data that matters, while remaining compliant and reducing overall workloads. With an extensive policy library and AI/ML, teams automatically:
- Archive all insider communications on protected channels
- Remediate inappropriate posting of documents, attachments, and links
- Enable data analytics with our cloud-scale archive to harvest valuable business insights
- Supervise messages & attachments for compliance violations with our customizable policy engine
If you are already a SafeGuard Cyber customer, you can get your team up and running in no time. Reach out to your rep to start protecting your business in Japan.
Contact us to see how our NextGen compliance platform unlocks new market opportunity.