Insights from Pharmaceutical Compliance Congress (PCC) Asia

03.29.18 | By Dana Liu and Michael Arbini

On March 13th and 14th, compliance professionals across Asia attended CBI’s inaugural Pharmaceutical Compliance Conference (PCC) Asia in Shanghai, China.

Major topics of discussion included the trend of increased transparency legislation that is being implemented across the region, the heightened scrutiny surrounding anti-bribery and anti-corruption (ABAC) and cybersecurity and data management.

Before launching into a packed two-day agenda, Polaris’ Managing Partner Asia-Pacific and Europe, Geert van Gansewinkel, serving as the conference Chairperson, welcomed participants.

A key issue on many conference-goers’ minds was China’s cybersecurity law and what companies’ compliance and legal department needs to know about it, with significant concern surrounding cross-border data transfers. The Chinese Cyber Security Law (CSL) was implemented on June 1st, 2017, with the Guidelines for Data Cross-Border Transfer Security Assessment (2nd Draft) published on Aug 30th, 2017.

The CSL targets two specific types of data: Personal data and Critical data. For a network operator to collect personal information, necessity and the individual’s consent is needed. To transfer data outside of China, the company needs to first establish business needs, then request a regulator to conduct a security assessment. Although the process sounds very similar to Europe’s General Data Protection Regulation (GDPR), the common belief is that the government security assessment process in China would be more complicated.

Speakers and panelists also discussed new transparency requirements in the region. Groups assessed South Korea’s “Sunshine Act”, examined new reporting requirements in Japan, Indonesia, and the Philippines, and the disclosure of financial relationships in Australia.

In addition to serving as the conference Chairman, van Gansewinkel spoke about building a healthy vendor and third-party program to lower companies’ exposure to corruption risks.

He highlighted that in China, India, and other Asian markets, third parties are crucial partners because they can provide market access, conduct clinical trials, and manage various of events. Geert discussed approaches to assess third party risks and identify high risk vendors. Additionally, he provided recommendations on how to construct an effective Anti-Bribery and Anti-Corruption (ABAC) Third Party management program. He shared best practices for the authentication, monitoring and auditing of third party entities, while illustrating how technology can help manage the high volume of Third Parties.

Later in the conference, van Gansewinkel also moderated a Transparency Panel Discussion. Following Merck KGaA’s Regional Compliance officer Albert van Maaren and Taiho’s director Hiroyuki Fukumori’s presentations on Transparency related topics, the three examined key regional and global transparency trends and the impacts they are having on the industry and the region in particular. They each shared insights and best practices that attendees could take away and implement immediately. For example, they discussed how companies can overcome challenges of integrating APAC transparency systems with ones used in the US and Europe.

Polaris Asia-Pac’s Managing Director, Joyce Wong, led an insightful discussion about evaluating risks associated with HCP engagements. She spoke about the importance of developing an effective process to review and monitor promotional risks. Subsequently, she shared best practices to evaluate and manage risks related to interactions with HCPs, and methods to determine KOL tiering and Fair Market Value for HCP engagements.

Attendees said that their main takeaways from the conference were that:

  • HCP engagement and third-party related ABAC risks remain hot topics
  • New transparency requirements and regulations in the region demonstrate a growing compliance focus from local governments and associations
  • Following the example set by GDPR, the Chinese government is tightening controls on data privacy, calling for accountability and action from companies.

Since 2001, Polaris, an IQVIA company, has worked with Life Sciences companies around the globe to navigate the ever-shifting compliance landscape. Polaris’ experts have years of knowledge and expertise to help companies adapt to new legislation such as China’s cybersecurity law and focus on shifting priorities such as data management.

Polaris helps firms create, implement and manage efficient, end-to-end compliance programs. Our consulting experts assess and guide compliance teams helping to leverage our innovative technology to streamline processes, reducing costs and risks, while improving efficiencies across the organization. Learn more at www.polarismanagement.com.