Insights from the Asia-Pacific Pharmaceutical and Medical Device Compliance Congress

By Lisa van de Kamp

The Sixth Annual Asia-Pacific Pharmaceutical and Medical Device Compliance Congress was held September 21-23 in Singapore. Senior Partner, Marc Eigner, Consultant, Dana Liu and I attended as representatives of Polaris.

Having recently opened an office in Hong Kong to serve clients in AsiaPac, we were eager to meet industry professionals in the region and share Polaris’ global insights and compliance solutions.

The Congress addressed many of the main areas life science companies are focused on in the region, with topics ranging from continuous developments in compliance codes, and moving from a cost to value proposition in the organization, to optimizing relationships with third parties.

Speakers repeatedly emphasized the importance of building a culture of compliance, and positioned the discipline as a key business partner, with the ultimate goal of creating a sustainable process that makes a significant impact.

Based on the debates at the Congress, it seemed unanimous that another top priority for the region is to build a solid foundation in data analytics. This is consistent with the trend we see in other regions due to the push for transparency. For Asia-Pacific, the data, with a focus on qualitative data, can be a driver to enable the maturing of the compliance function. Unlike in Europe and the US, transparency reporting is not a main concern in the region.

Most companies have a lot of data from several different sources. Bundling and tapping into their data repository enables them to identify and address specific areas of risk within the company. A poll taken at the Congress revealed that in the Asia-Pacific region, 70% of the issues are Anti-Bribery and Anti-Corruption related. Using data for non-transparency reporting purposes, such as auditing and monitoring of spends, validating whether compliance guidelines are followed, and identifying specific areas of risk, can be beneficial in addressing these issues, and ultimately incorporating compliance elements into business processes in the form of business intelligence.

Currently, transparency requirements are only applicable to a few countries (eg. Japan and Australia) in the region. With the expectation that more countries will follow suit, having good qualitative data will prepare companies to address their transparency needs.

Another topic generated a lot of discussion during one of the panels. Building a sustainable program where compliance is a valued business partner requires a balance in the function between being and acting as the controller versus understanding the business and being able to discuss the associated risks with the rest of the business whilst bringing solutions to the table.

The takeaway was that there is no single approach that works for all. There are numerous variables to take into account that can differ per organization. Some of those discussed were business ownership of compliance, available technologies and how they can contribute, third party/government officials’ relations, culture and size of business and/or country. These variables impact an organization’s risk areas, the ability to identify them and the ability to move away from an extreme controller type function.

Marc participated in a panel discussion entitled “Innovation in Compliance,” in which a group of five industry professionals focused on three specific areas. First, the group discussed why innovation is required in compliance. They concluded that as more and more regulations come into effect, it will be harder to get employees to comply, and therefore innovative methods are required. Second, they addressed the challenges of increasing innovation within compliance teams. The solution was to hire different types of employees, not just traditional compliance staff, but maybe even individuals from outside the pharmaceutical field for a fresh perspective. Lastly, they examined the role technology plays in improving innovation. It was agreed that by automating compliance processes, business processes can be improved, and compliance can then be a ‘happy side effect’ rather than a ‘roadblock.’ The other members of the panel were Dr. Milind Antani, Partner in charge, Pharma and Healthcare Practice, Nishith Desai Associates, Sarah Kochling, Managing Principal, Blossom Consultancy Ltd., Maria “Maru” Quindimil, APAC Ethics and Compliance Lead and Karen Eryou, Senior Director, Corporate Compliance APAC, both of UCB Pharma.

In summary, the conference served as a useful platform to discuss various approaches, processes and tools needed to mature the compliance function in the Asia-Pacific region. It also highlighted many of the challenges the life sciences industry is addressing and innovative ways to solve them.

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