New legislation in the US state of Massachusetts covering relations between pharmaceutical manufacturers and health care professionals has the potential to go well beyond the industry’s code of practice and will “scare away” investments in the life sciences, Eli Lilly’s president and chief executive – and soon to be board chairman – John Lechleiter, has warned.
The new rules could potentially stifle clinical research in Massachusetts and complicate the ability to share information, Dr Lechleiter told the executive forum of the Associated Industries of Massachusetts (AIM) last Friday (September 19).
“For biotech and pharma, our innovation only becomes meaningful when the people who can apply that innovation – doctors – learn that it exists. Doctors prefer to learn from other doctors, for obvious reasons, so it’s vital that companies such as Lilly be able to compensate doctors for their valuable time, such as when they speak to scientific and educations conferences about new discoveries and products,” he said.
The ultimate implications of the state law – which Governor Deval Patrick signed into law last August – remain unclear, but it has the potential to go well beyond the Pharmaceutical Research and Manufacturers of America (PhRMA) Code of Interaction with Healthcare Providers, he said, and cautioned: “this could put doctors in Massachusetts in a class by themselves, where compensation for legitimate speaking activities is concerned.”
Dr Lechleiter also warned of the potential effects of the new law’s “complex financial disclosure requirements” about payments to doctors, hospitals and academic institutions for clinical trial research.
“Right now, there are more than 5,600 clinical trials in progress in Massachusetts. Such work is the backbone of R&D in biotech and pharmaceuticals, and it’s about to get a whole lot more difficult in this state, which almost certainly means that less of this important work will take place here in the future,” he told the AIM, and warned: “life sciences investment will be scared away.”
Dr Lechleiter went on to point out that the law works at cross-purposes with the $1 billion Massachusetts Life Science Strategy, a package of tax incentives, grants and capital projects which Gov Patrick unveiled last year with the aim of making Massachusetts the world leader in life sciences within 10 years.
A few days before Gov Patrick signed the controversial new legislation – Senate Bill 2863, An Act to Promote Cost Containment, Transparency and Efficiency in the Delivery of Quality Health Care – a full-page ad published in the Boston Globe signed by PhRMA, the Biotechnology Industry Organization (BIO) and local industry groups warned of the dangers it posed to the success of the Strategy.
Moreover, SB 2863’s requirement that companies developing new treatments should disclose to their competitors which products and areas of research they are involved in would significantly curtail, if not end altogether, the availability of “last-hope” clinical trials in Massachusetts, the signatories added.
However, Gov Patrick said he was “confident” that the state Department of Public Health (DPH) 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.”
– In May, Christopher Viehbacher, president of US pharmaceuticals at GlaxoSmithKline (GSK), warned state political leaders that the bill would make Massachusetts ‘“the most hostile state in the nation when it comes to biopharmaceutical sales.”
