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October 07, 2010

Massachusetts Gubernatorial Candidates Unanimously Support Repeal of the Gift Ban

Mass Gov Candidates 
In politics it is rare for politicians running for the same off office to agree on anything.  But this week a unique agreement arose between the three gubernatorial candidates in Massachusetts.

As the negative consequences surfaced in Massachusetts on the Pharmaceutical and Medical Device Manufactures Code of Conduct i.e. “the gift ban” and built up over time, individuals in the commonwealth running for governor realized the significant disapproval of the gift ban and as a result, the State House News Service reported yesterday that whoever the next governor is, the gift ban may be gone.

The gift ban legislation was highlighted this week during a 90-minute gubernatorial forum on the biotechnology industry in Massachusetts, sponsored by MassBIO. During the forum, Democrat Deval Patrick, Republican Charles Baker and Independent Tim Cahill all said “they saw defects with the current gift ban.” According to the News Service, “Baker and Cahill said they would fight to remove the ban outright, while Patrick said he would seek to conform gift rules to those that the pharmaceutical industry uses to police itself.”

In particular, Cahill asserted that he would “work to repeal” the gift ban, while Baker noted that the “national health reform signed in March would make the gift ban unnecessary.” Baker added further that the gift ban is a “terrible drag” on the medical and restaurant industries. He pointed to the terrible damage the legislation has caused to tons of restaurants in Massachusetts.

Cahill, the state treasurer, said the current gift rules “put the onus on the companies and mostly the medical profession and treat them... as if they’re guilty of making a sin because they grabbed a pen or someone’s giving them a meal.”

Background

On August 11, 2008, Massachusetts Governor Deval Patrick signed into law S2660, also known as the “Gift Ban.” Over the past two years, this legislation has required pharmaceutical and medical device manufacturing companies to report to the state Department of Public Health any payment or gift of more than $50 made to a healthcare professional. The state then makes the payments public by displaying them on the state’s website.

The legislation also requires manufacturers and drug makers to adopt a set marketing code of conduct to help ensure that health care providers were making choices about prescription drugs for their patients based on therapeutic benefits and cost-effectiveness. This code had a number of provisions governing the types and nature of interactions industry could have with physicians.

Proponents of the bill such as Governor Patrick asserted that the gift ban would “help contain the skyrocketing costs of health care, while ensuring transparency and continued quality of care for all Massachusetts residents.”  Massachusetts Senate President Therese Murray added that the legislation would help decrease the cost of care by increasing transparency for consumers.

At the time, Governor Patrick also asserted that he was “confident that the Department of Public Health would safeguard the confidentiality of companies’ trade secrets and proprietary information and protect against roadblocks to medical research or the education of health care providers.” Despite his hopes, the gift ban has had significant and unintended consequences, many of which opponents of the bill predicted two years ago.

For example, a recent thesis by Daniel W. Wolf, MBA, a student in the Biomedical Enterprise Program in the Harvard-MIT Division of Health Sciences and Technology, examined the impact of the legislation on innovation in Massachusetts. Based on his survey of a number of stakeholders including industry, academia, and physicians, Mr. Wolf’s thesis found that the enactment of the Pharmaceutical and Medical Device Manufacturer Code of Conduct (PCOC) has “increased the barriers between physicians and medical device companies, impairing physician-industry collaboration on technology development, new device training, and medical education.” He further recognized that PCOC causes “additional concerns from Massachusetts-licensed physicians that industry withdrawal will impair their ability as physicians to innovate and deploy new device therapies, educate the next generation of physicians, and provide optimal patient care.”

Another negative impact from PCOC is that pharmaceutical and device companies have been “curtailing sales, marketing and training activities in Massachusetts” in order to comply with the new rules, and “some outside companies are avoiding Massachusetts altogether.” In fact, an article in the Boston Globe noted how the new laws have resulted in “fewer jobs related to training, medical device sales and clinical trials.” Moreover, one article noted how the gift ban is having a negative effect on primary care physicians in Massachusetts because it is cutting off opportunities for clinicians to gather new scientific information and exchange real-world clinical information. Additionally, the gift ban has resulted in companies withdrawing funding for fellowships, professorships, and other faculty positions and departments in Massachusetts.

The gift ban has also had a negative impact on business in Massachusetts. For example, one major medical group cancelled its annual multimillion-dollar convention in Boston, citing the state’s new law cracking down on free gifts, meals and other goodies handed out to doctors by the pharmaceutical industry as the reason. In fact, the gift ban law sent a chill to the convention and medical meeting community in Boston. The restaurant business also voiced its concerns about the gift ban bill because of declining business and revenue associated with less medical meetings. Moreover, medical device companies noted the significant burden the legislation placed on them considering the fact that many physicians needed to work directly with industry to learn how to use certain medical devices. Even Merck decided to close one of its facilities in response to the legislation. 

This past summer the Massachusetts state house voted to repeal the “gift ban”.  Members of the Association of Clinical Researchers and Educators including Thomas Stossel, MD were instrumental in outlining the pitfalls of the law on medical innovation.

Other Issues

Another issue that was discussed during the forum was proposed legislation in the Massachusetts House that would permit pharmaceutical companies to offer coupons for prescription drugs to consumers.” However, that bill never gained approval before the formal sessions ended in July, something that Cahill pointed to as the governor’s “failure of leadership.”

Opponents of the coupons believe it is merely a “ploy” aimed at luring consumers to purchase expensive brand name drugs. Supporters “reject the assertion, saying doctors are still required to exercise discretion when writing prescriptions and state laws include strict requirements that generic drugs be prescribed over brand names whenever possible.” Patrick predicted that he could get the coupon bill done and fix the gift ban together in the next legislative session. Meanwhile, Baker said he would “move aggressively” to support the coupon proposal, also known as “co-pay assistance.”

In addition, Patrick promoted his success as governor by pointing to the “supercluster” of biotech companies and activity in the industry that has taken place in Massachusetts. Nevertheless, this statement however, did not account for the negative impact on jobs, training, and funding in the biotech industry that has incurred since the bans enactment, as we described above.  Consequently, Baker said to support the industry, he would lower taxes “across the board” to bolster all industries, including biotech.

Ultimately, this forum clearly showed that politicians in Massachusetts have responded to the concerns of patients, physicians, and industry. The efforts of these groups are gaining recognition, and these candidates are beginning to acknowledge what many asserted from the beginning: that the gift ban stifles innovation, chills research, and ultimately will hurt patients. As a result, it seems likely from the long list of negative consequences, and the large number of people this legislation has affected, that the next governor of Massachusetts will repeal this ban.

 

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The gift ban has also had a negative impact on the ability of Massachusetts physicians to influence product development by industry. Last week our organization was asked to introduce a startup medical device company to vascular experts outside of Massachusetts. The company felt it didn't have the resources to navigate the Massachusetts regulatory environment.

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