Foley & Lardner, LLP, Boston, MA 02199, USA.
J Vasc Surg. 2011 Sep;54(3 Suppl):22S-5S. doi: 10.1016/j.jvs.2011.05.106.
Long subject to legal scrutiny under the federal Anti-Kickback Statute, financial ties between physicians and drug manufacturers have recently come under additional pressure as a result of recently enacted state and federal disclosure laws and state gift restrictions, the latest coming in connection with the Federal Health Reform Law. These "sunshine" laws have been motivated by the concern that gifts and payments by manufacturers to physicians may lead to conflicts of interest and improperly influence physicians in their drug- or device-prescribing decisions. As a backdrop to these new laws, it is helpful to review prior guidance regarding manufacturer-physician financial relationships, both from the federal government and the industry itself. These laws do not prohibit physician involvement with industry in research and education, but they impose various new compliance requirements on these relationships, and also in many cases, require public disclosure of arrangements that previously were treated as confidential. It is still too early to tell if these laws will stifle innovation, but they do require a heightened degree of diligence to avoid, at a minimum, adverse publicity and embarrassment and, at worst, criminal and civil liability.
长期以来，医生与制药商之间的财务关系一直受到联邦反回扣法规的法律审查，最近由于新颁布的州和联邦披露法以及州礼品限制，这种关系最近又与《联邦医疗改革法》有关，受到了额外的压力。这些“阳光”法的动机是担心制造商向医生提供的礼物和付款可能导致利益冲突，并不当影响医生在开药物或设备处方方面的决策。作为这些新法律的背景，回顾一下联邦政府和行业本身之前关于制造商-医生财务关系的指导意见是有帮助的。这些法律并不禁止医生参与与行业相关的研究和教育，但它们对这些关系施加了各种新的合规要求，并且在许多情况下，还要求公开以前被视为机密的安排。这些法律是否会扼杀创新还为时过早，但它们确实需要更高程度的谨慎，以避免至少是负面宣传和尴尬，最坏的情况下还会导致刑事和民事责任。
