I recently spoke with Jon Bigelow, Executive Director for the Coalition for Healthcare Communication (CHC), about the importance of advocating for the First Amendment rights of pharma manufacturers and their agencies, as well as how data privacy regulation is changing the future of healthcare communications. 3D graphics image by Quince Creative
The abbreviated interview was posted on our blog. The full text of our conversation is below.
What is the CHC? What was the impetus behind its foundation?
The Coalition for Healthcare Communication is the industry’s voice at the table when proposals affecting healthcare marketing and communications are discussed. The Coalition’s members—currently 28 organizations with hundreds of agencies—span advertising, marketing, scientific communications, public relations, medical journals, and digital platforms. Our members are united in support of the Coalition’s mission, to protect and promote the free flow and accessibility of accurate and credible health information.
The Coalition was founded in 1991 to advocate for the First Amendment rights of pharma manufacturers and their agencies to educate healthcare providers and patients about their products, in the belief that communications and marketing are just as important as R&D in bringing innovations to patient care. More recently, we expanded our mission to emphasize, in an era when misinformation spreads quickly, the importance of accurate and credible health information.
Have the needs of CHC members been changing, and how is the organization tackling and adapting to those changes?
The environment in which health communications takes place has evolved greatly since 1991– witness the decline of sales forces and the growth in DTC, the rise of Big Data, passage of the Affordable Care Act and the Sunshine Act, the impact of a series of PDUFA bills, the trend away from private clinical practice toward health systems, and the sharply partisan environment in Washington. Meanwhile, the needs of Coalition members have evolved with consolidation of agency networks, diversification into market access and payer strategy, new technology, the growth of social media and digital marketing, drugs with more targeted patient populations, and so on. It’s no surprise that the issues we address have also evolved.
In its earlier years, the Coalition supported the IMS v Sorrell case, where the Supreme Court confirmed that the First Amendment applies to medical marketing, and helped to focus CMS guidelines for Sunshine Act reporting. More recently, a lot of our effort went into averting a threatened removal of tax deductibility for pharma marketing expenses, preserving DTC advertising, and encouraging simpler and clearer FDA promotional guidelines. This year, we are focused on efforts to restrict or compel specific messages in medical marketing, renewed attempts to tax pharma marketing, new FDA initiatives, and considering how best to regulate data privacy and security.
The Coalition monitors issues as they develop in Congress or the administration; keeps members informed about what is happening and what it means; joins the dialogue by presenting the industry’s side of the story to the media, lawmakers, and regulators; and, when necessary, mobilizes members to show support or opposition for various proposals.
What are you currently observing on the development of new data privacy legislation, or amendments to existing? Can you share any insights beyond the facts of these laws?
Collection and interpretation of personal data offers great potential to improve clinical care, clinical research, public health, and marketing, but the risks to privacy and security are increasingly clear. While historically the U.S. government has been reticent to regulate in this area, clearly the patience of the public, and of Congress, has worn thin and regulation is coming. The key questions now concern what form that regulation will take, and how it will affect the healthcare ecosystem.
Some speculate the U.S. will follow the European Union’s Good Data Practices Regulation (GDPR), which expanded the definition of personal data and requires that consumers opt-in, rather than simply being given the opportunity to opt-out. We’re also watching the California Consumer Privacy Act (CCPA), which—pending likely modifications before the January 1, 2020 effective date—grants consumers more visibility into what is being collected and how that data is used, and emphasizes mechanisms to opt out. Various data privacy bills are being introduced in state legislatures around the country.
A concern is that the GDPR and CCPA models still leave the burden on consumers. GDPR, for example, requires consumers to scroll through long and abstruse terms and conditions, often within a time limit and on a mobile phone, to opt-in. A different approach—exemplified by the “Privacy for America” initiative supported by the 4As, Association of National Advertisers, Interactive Advertising Bureau, and other groups—would have the Federal government simplify the consumer burden by setting tighter guardrails on the use of personal data and establishing a Data Protection Bureau.
Over 20 competing data privacy bills have been introduced so far this year in Congress, from legislators of both parties. We are watching carefully as this debate unfolds, especially in how the proposals affect healthcare—for example, the use of algorithms to aid clinical diagnosis, the transparency of data on clinical trial sets, the safety of information in electronic health records, and the ability to target marketing messages.
From the Coalition’s perspective, is there an increased level of awareness of data privacy? Are pharmaceutical manufacturers and other healthcare organizations taking action – and taking action quickly enough?
We certainly see heightened recognition that data regulation is coming, and that it is best done at the Federal level to avoid having to deal with 50 different laws. Many or most organizations in this industry are working to conform to GDPR requirements. But there may not be sufficient understanding yet that data privacy regulation may take a very different form than GDPR, nor of how regulation will affect specific health care applications. This issue is complex, fast moving, and of great importance.
What advice would you give pharma marketers as they look to understand and support data privacy efforts within their roles and companies, while they also are working towards providing quality healthcare information to their audiences?
I would encourage pharma marketers to, first, get their own houses in order: Be certain your current data practices are compliant with HIPAA, GDPR, and other existing standards. Be sure your vendors are also fully compliant. And stay informed by, for example, following the Coalition’s coverage on our website.
What are some challenges in making sure the healthcare communications industry is heard on relevant legislative proposals and ensuring they are informed of any new developments/changes?
A first challenge is that there are so many “players” to monitor—at HHS, CMS, the FDA, and the FTC; in the relevant House and Senate committees; and in various Washington organizations. Then one needs to stay in touch with partners (sometimes different ones on different issues) with common interests, and to get attention at the right moment in the process. For some issues, one can predict when key developments will occur; other proposals can pop up with little warning, and we need to be prepared to respond immediately, with facts and logic to support our positions.
What are some challenges in making sure the healthcare communications industry is heard on relevant legislative proposals and ensuring they are informed of any new developments/changes?
In an MM&M article published earlier this year you mentioned data privacy as one of the areas to watch in Washington this year. Can you briefly explain the importance of being alert for any changes in legislation or trends that will affect your ability to get important information to physicians and patients?
These are exciting times, with so many resources devoted to research and development work leading to innovative therapies that save lives, enhance the quality of life, and bring savings to the healthcare system. But the success of the healthcare system—and excellence in patient care—depends on well-informed providers, payers, and patients who know when and how to use those therapies. Accurate and accessible health information brings high value to our society, yet many policymakers do not fully understand how our ecosystem works and even well-intentioned legislative or regulatory proposals can have unintended effects. As the industry’s voice, the Coalition endeavors to help policymakers make wiser decisions to keep the information flowing.
Jon Bigelow is Executive Director of the Coalition for Healthcare Communication, representing health communicators across advertising, marketing, medical communications, medical publishing, and digital media. He keeps Coalition members informed on evolving regulations and legislation that may aid, or impede, the free flow of accurate and credible medical information.
Jon previously was CEO and President of KnowledgePoint360 Group, a leading provider of multichannel medical communications, digital and strategic consulting, benchmarking services, and workflow solutions with 18 agencies across the U.S., U.K., and Germany. Earlier, he was President of Cliggott Publishing; founding Editor of a series of innovative controlled circulation clinical journals; and President of the Association of Medical Media. He provides strategic support to businesses and serves on boards at two companies and an ocean sciences laboratory.
