As a compliance professional, it’s exciting to witness new Codes of Ethics take root worldwide. Voluntary industry Codes of Ethics serve several important functions. A credible Code demonstrates industry’s ability to self-regulate, in turn fostering consumer and governmental trust and confidence. A Code centers stakeholders on the most meaningful business principles that the entire industry can stand behind– in our industry’s case, addressing interactions to advance medical innovation and patient health. Effective, living Codes nurture a compliance community and guide business leaders and professionals through the complexities of dynamic marketplaces.
While all new Codes are essential to instill confidence in medical decision making and preserve innovation, perhaps among the most meaningful industry ethics work is in China.
– Market magnitude: The Chinese medical device marketplace ranks as the world’s third largest. Almost three years ago, there were about 16,000 medical device manufacturers and over 160,000 medical device distributors in China. And yet, despite these staggering numbers, recent reports show that the Chinese device marketplace is underdeveloped when compared to other countries. Demographic and other trends also contribute to growing healthcare needs: the population is aging, people are living longer and healthier lives; the middle class is rapidly growing; and public and private health care spending are increasing in response to patient demands for better and more modern medical care.
– Enforcement trends and complexity: Increased scrutiny and far-reaching enforcement are accompanying rapid health sector growth. Chinese anti-corruption efforts made headlines now familiar to compliance professionals in the US and EU. Multiple ministries and national and regional authorities exercise health sector oversight. Recent pronouncements such as the New Donation Rules and The Nine Prohibitions both provide clarity and raise new questions, and it can be difficult to discern precedent in general.
Based on these and other trends, an industry Code is particularly valuable in this vital country— but it was also challenging to develop.
When AdvaMed first opened is China office in Shanghai, the AdvaMed China Board formed a working group to address business practices in China and to develop a China-specific Code of Ethics. Recognizing that not all markets operate the same way, AdvaMed set out to design a Code tailored for the Chinese market to advance key principles for our industry: instill confidence and integrity in medical decision making, promote patient access to safe and effective medical technologies, establish industry credibility, promote medical innovation and guide business leaders within this exciting, yet imprecise market.
After nearly two years of hard work, the AdvaMed China Code of Ethics is now a reality. I’m awed by our industry leaders, whose vision and principled determination launched this work: from the outset, they steered hard for the higher road. I’m humbled and impressed by the gifted, hardworking compliance professionals in China, whose passionate discussions and balanced analyses brought clarity to the most challenging of topics (cultural gifts, direct sponsorship, and third party distributors, among others) and forged a vibrant community of compliance colleagues. And, I look forward to further collaborating with Chinese industry stakeholders, with whom AdvaMed developed valuble longstanding cooperative exchanges, to advance broad industry wide ethics work. Most of all, I’m proud to say I’m part of this remarkable industry.
The AdvaMed China Code of Ethics is effective as of January 1, 2016, and available to members here. Stay tuned for more information as we formally launch this work in the year ahead.
This May, at the Global Medical Technology Compliance Conference, I look forward to connecting with the many global compliance leaders who undertook similar work in their countries to launch new Codes and advance ethical interactions among medical device companies and health care professionals.