New rules hamper life sciences effort
AMID MUCH fanfare this summer, Governor Deval Patrick signed into law a bill that invests $1 billion over 10 years in the Bay State's life sciences community. Surrounded by legislators, industry representatives, doctors, and patients, the governor proclaimed that this initiative would secure the state's "rightful place as a global leader in the life sciences."
Not two months later, excitement in the life science community has turned to disappointment, with the passage of separate legislation that would interfere with the collaborations that have been essential to expansion of this sector in Massachusetts. If signed into law, these provisions would repel investment in the Bay State. Many of the partnerships crucial to bringing new healthcare products to market would be prohibited. Governor Patrick has been a leader in promoting innovation in the Commonwealth and should veto these provisions.
This year started with a laudable goal of reducing the price of healthcare services. But with only a few hours left on the last day of the legislative session July 31, House and Senate leaders unveiled a different cost-control plan that included language governing interactions between life science company representatives and healthcare practitioners.
We believe that elements of this language stray from the goal of the legislation - and are unlikely to result in savings.
As approved by the House and Senate, the plan will require companies to file an annual report to the state listing fees or payments in excess of $50 to doctors, nurses, and technicians. Companies would have to provide the name of the recipient, the amount paid, and the purpose of the action in these reports, which would be made public through the Massachusetts Department of Public Health's website.
In addition to adding costs for company compliance, this provision would allow competing companies to gain access to information on product development collaborations taking place at Massachusetts hospitals and research institutions. In a highly competitive market, this information is extraordinary and would encourage life sciences companies to consult with out-of-state doctors to avoid Massachusetts law.
This provision would impede efforts to bring more clinical trials to the Bay State's 16 teaching hospitals, as both in-state and out-of-state companies will not be interested in having their clinical initiatives publicized in this fashion. This change will absolutely affect whether companies continue to choose our world-class hospitals for this important clinical work.
The bill would also prohibit payment for meals "offered, consumed, or provided outside of the healthcare practitioners' office or hospital setting." This rule would hem in the many Massachusetts medical device companies that have invested millions of dollars on training facilities. Surgeons and technicians from around the world come to be trained on state-of-the-art equipment, but companies would not be able to feed these visitors.
The meals restrictions would also prohibit the standard practice of product development focus groups, where healthcare practitioners and research teams discuss a range of products. These collaborations are vital to innovation and must occur at off-hours, when healthcare providers have free time. As presented, this proposal would criminalize the act of providing meals before, during, or after these sessions.
There are legitimate business practice reporting requirements now, but this new language goes too far. Unlike existing FDA disclosure rules, for instance, the new state law would provide the public, including competing companies, with details on industry-provider collaborations in their earliest stages, exposing proprietary plans for new drug and device development.
There can be no doubt that the advantage Massachusetts currently enjoys in the life science sector, and which politicians are rightfully proud of, is at risk if this legislation is enacted. In fact, we know of one company which has put its training facility expansion on hold and another which is considering shipping that aspect of its business to Ohio.
The governor and the Legislature have shown their commitment to this industry by enacting the Life Sciences Initiative. But the language before the governor now is hastily drafted and destructive to the state's interests. We urge the governor to veto the portions of this bill that will discourage medical innovation and life science growth here.
Douglas W. Lawrence, vice president and general manager of BD Ophthalmic, is chairman of the Massachusetts Medical Device Industry Council. Mark Leuchtenberger, president and CEO of Targanta Therapeutics, is chairman of the Massachusetts Biotechnology Council. 
