The legal environment surrounding the healthcare products industry is constantly evolving. Product safety requirements, budgetary constraints due to increases in social spending, increased pressure from EU and international entities, public authorities’ growing tendency to replace clearly defined policies with measures that are difficult to predict, the heightened demands of patients and patient organisations: all are factors that contribute to the changing legal landscape.
These developments have subsequently triggered substantial changes in the relationships between manufacturers, healthcare providers, distributors and patients as well as between industry and government. In this setting, companies in this sector are consequently required to monitor or, better yet, foresee such developments that raise new and increasingly complex questions.
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