Testimony of Tim Sweeney, Director of Public Policy, Greater Boston Chamber of Commerce to the Department of Public Health
January 9, 2009
Good morning. I would like to thank the Department of Public Health and Commissioner Auerbach for the opportunity to submit comments on this important proposed regulation 105 CMR 970.000, Pharmaceutical and Medical Device Manufacturer Conduct.
The life sciences industry is driven by a range of activities: from research, development and manufacturing, to education and training, and finally to marketing and sales. Each of these functions is essential to promoting growth and investment in this world-renowned cluster and to developing cutting-edge therapies, treatments, and vaccines that improve our health and quality of life.
However, since this industry code of conduct was proposed – first in legislation and then in draft regulation – the Chamber has remained steadfast in its assertion that 1) there is a critical distinction between R&D-related & educational activities and sales & marketing activities; and, 2) such a distinction must be reflected in the treatment of those activities in the final regulation. While concerns remain as to the impact that a “first in the nation” code of conduct could have on this critical industry, we applaud the DPH for making this distinction in the draft regulation by precluding research agreements from disclosure requirements. Collaboration and information-sharing between academic researchers and pharmaceutical, medical device, and health care industry professionals – such as occurs in clinical trials – must preserved in the final regulation.
CLINCAL TRIALS
Clinical trials are essential to testing the safety and efficacy of new drugs and medical devices. We all know that Massachusetts contributes mightily to the world’s drug development pipeline, but recent studies have shown the state to also be a national leader in these human studies. Maintaining this concentration of clinical and early-stage trials and fostering continued collaborative medical research in Massachusetts is vital – not only for the tens of thousands of jobs they
continue to support during this severe recession, but also for the accelerated drug development and patient benefits they can bring. A robust clinical trial market ensures greater opportunities for local patients to try groundbreaking therapies and treatments that are being developed here for cancer, Alzheimer’s, cystic fibrosis, and juvenile diabetes. The Chamber joined with the New England Chapter of the Juvenile Diabetes Research Foundation on an op-ed in today’s Boston Herald emphasizing
the importance of preserving our research and clinical trial market.
CONTINUING MEDICAL EDUCATION
Similarly, continuing medical education remains an essential component of quality health care delivery and outcomes for Massachusetts patients. The ability of industry and medical professionals to engage in such training activities must be codified in the final regulation in order to ensure proper utilization of innovative drugs and devices. Specific revisions to the draft regulation could allow widely-used industry training and business practices to continue. For example, an expanded definition of
“hospital setting” would enable technical training to continue to be conducted at a broader spectrum of facilities. Also, a provision which permits compensation for technical training on a device only as part of a purchase contract between the device vendor and health care practitioner could be amended, given that practitioners often choose to test a device before deciding whether purchase.
PRICE CONCESSIONS
Lastly, the draft regulation allows for the provision of price concessions, such as rebates or discounts, in the normal course of business. We hope this important provision will not only be codified in the final regulation, but will be further revised to ensure that such proprietary information is not subject to disclosure. Such a revision would dramatically improve this provision by providing the certainty and protection the industry needs to continue such price concession activities.
CONCLUSION
Through the Life Sciences Initiative, Massachusetts state officials have demonstrated their willingness and resolve to strengthen our internationally recognized leadership in the life sciences. They have established the Massachusetts Life Sciences Center to reinforce ties between sectors of the state’s life sciences community. And they have enacted landmark health care coverage and cost containment policies in an effort to provide all Massachusetts residents with access to the best
health care in the world. Imposing overly burdensome regulations on medical research, clinical trials, and continuing medical education could undermine each of these goals, driving such activities to other states and driving job loss at a time of economic turmoil.
We thank the DPH for their work on this issue, and look forward to continuing to work collaboratively with public officials, industry and health care leaders, and patient communities toward a final regulation that reflect our shared goals of driving research, innovation, and improved health care outcomes.
