It takes a lot of prescriptions to add up to $5.6 billion (yes -- with a “b”), but that's how much money was paid out by pharmaceutical companies to settle federal lawsuits in the US in 2009. With numbers like these, compliance with industry-governing regulations could be one of the most important business decisions a pharmaceutical company makes.
Crawford Wright welcomes the OPMA members
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The Code of Conduct: a young and evolving document
Although Wright notes that the Rx&D has been around in some form since 1914, the now-ubiquitous Code of Conduct has only existed for the past 20 years. This is in contrast with countries such as the UK, where similar codes have been in existence for much longer, but Canada is quickly catching up.
Another contrast with other countries is the narrow focus of the Rx&D Code of Conduct on the industry's dealings with healthcare professionals, but here, too, Canada's Code is expected to grow to become more comprehensive, encompassing diverse areas such as government and pricing, although these changes will take time to be vetted.
Monitoring the industry to keep the Code current
The industry is always changing, and the Code needs to change to keep pace. That is Wright's role with Rx&D. As part of the Industry Practices Committee (IPC), Wright and his colleagues monitor industry trends both within Canada and elsewhere in the world to make sure Canada doesn't fall behind. The IPC also consults with stakeholders including the CMA, the Royal College of Physicians and Surgeons, and PAAB, to ensure a comprehensive view.
Crawford Wright explaining the consequences of an RxD infraction
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Complaints and corrections
The complaints process is designed to be transparent, and complaints and resolutions are posted on the Rx&D website . Complaints must be issued in writing, and must refer to an infraction alleged to have occurred within the past 120 days.
When companies are found to have indeed violated the Code, fines are issued, and they increase with repeat infractions. The fines are relatively small, though, topping out at $50,000 at the third infraction. But Wright says the deterrent is not the cost of the fines, but the “naming and shaming” of the company that comes with them. At the second infraction ($25,000), the offending company is required to appear before the Rx&D Board with an action plan to rectify the situation. This, says Wright, is the real motivation to comply with the Code.
Live by the spirit, not the letter, of the Code
We may be tempted to find “loopholes” in the Code to gain what we see as a competitive advantage. This human temptation inspired the “11 Guiding Principles,” put into practice in 2006. These Guiding Principles (which can be found within the Code of Conduct here) establish the spirit of the Code, and offer guidance when specific language is absent or unclear.
The value of trust
The real value, says Wright, of compliance is that it builds trust: a priceless asset in a trust-dependent industry like healthcare. Not only do healthcare professionals feel more comfortable dealing with companies they see as ethical, but so too do government agencies, whose approval times for marketing, pricing, and access can improve when they know the submitting company can be trusted, which in turn improves healthcare for patients.
And last but not least, company employees feel greater pride and passion about an ethical employer, and can thus represent the company in a more positive light.
It's here to stay: learn to work with it
All too often, says Wright, industry regulations are seen as a hindrance to doing business. But he disagrees, pointing to his employer, AstraZeneca Canada Inc., as an example: “Every year, we make our numbers,” he says, despite his strict oversight of regulatory compliance. Wright urges Rx&D members and non-members alike to see the code as a tool to building trust as a key business advantage.
And if that's not enough motivation, Wright foresees a future where compliance will only become more central to the daily operations of a pharmaceutical company. He cites trends such as pressure from global head offices to adhere to global corporate standards; greater transparency in monitoring & reporting compliance findings; and the extension of expectations of compliance to third-party vendors supporting the industry, such as meeting planners.
So, which comes first, compliance or business?
Discussing the presentation with OPMA members
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About the Author
Rachel McCready is Creative Director at CPC Healthcare Communications. She can be reached at rmccready@cpchealthcare.com