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Top 10 Guidelines for Life Sciences Companies in 2013
Members of Sidley Austin’s Global Life Sciences Industry Team recently reviewed litigation, policy, regulatory and enforcement trends in their respective fields. Our Team recommends that law and policy departments in the life sciences industry manage risks and take advantage of business opportunities by taking the following steps in 2013:
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Engage in US budget and deficit reduction process. As governments, including the US and China, search for the means to fund priorities or reduce health care costs, prepare to defend the biomedical industry profitability profile and to push for enhanced government support for innovation. Anticipate proposals for additional drug/device rebates, taxes or price controls to be resurrected. Educate policymakers about the role the biomedical industry plays in achieving important national goals such as developing innovative therapies and creating jobs.
dates, and how to leverage the competition between governments to attract biomedical innovators.
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Prepare for ACA implementation. Engage at every phase of the process to implement the Affordable Care Act (ACA). Establish systems and processes to track and report payments and other transfers of value pursuant to the Sunshine Act; modify Medicaid price reporting practices in response to the forthcoming final rule; consider negotiation strategies regarding coverage through the Exchanges and Medicaid expansions; and prepare to advance your goals in the coming ACA legislative and regulatory fix phase. Consider creative new approaches to R&D investment. As supply of venture capital funding for early and mid-stage companies has diminished, a funding problem for many small innovators has continued to grow. This presents opportunities for small innovators, investors and governments to re-develop the system of investing in promising pipelines. Reconsider strategies to expand private and public sector funding for R&D, including terms such as the form of investment (equity or debt), the role of license or collaboration agreements, and the level of access to product candi-
Prepare for clinical trial regulatory and policy changes in the US, EU and China. Given the global nature of clinical trial design and conduct, understand and prepare to implement regional policy changes that impact development and approval processes. In both the US and EU, industry should be prepared for clinical trial data transparency requirements. Enhanced informed consent for research biospecimens, even those stripped of identifiers, also is under consideration. Recent guidances have outlined the extent to which pharmacogenomics may be used in clinical trials. In China, foreign data acceptance issues may hinder local approval. Also, leverage advances in health technology, particularly pharmacogenomics, to increase efficiency and reduce cost.
the “value” of their products relative to alternatives, particularly where there are significant price differences. Mitigate risks through careful review of all current comparative communications, pressure-test internal review processes to assure appropriate management of risks prospectively and support ongoing industry efforts to improve the regulatory environment over the longer term.
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Manage risks arising out of comparative effectiveness research (CER). Biopharmaceutical manufacturers remain keenly interested in generating and communicating CER results to address the demands of payors and prescri ?????????????????????????????????????????????????????????e????????????????????????????????????????????????????????????????????????????????
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