To the extent that additional regulatory requirements are deemed necessary in Europe, Member State must be advised to consult with industry in advance and to ensure that such requirements are consistent with the objectives of global harmonization. AdvaMed and its member companies look forward to working with both sides on implementing the agreement in such a way that supports transatlantic business and economic activities and, in particular, supports industry's efforts to research, develop, and bring to market medical technologies that offer great promise for patients on both sides of the Atlantic. New Technologies A primary goal of all economies is to provide high quality, cost effective healthcare products and services to all citizens. The mission, and sovereign right, of a government's regulatory agency is to oversee the efforts of medical technology manufacturers to ensure that their products are safe and effective. Establish meaningful appeals processes.
Many countries maintain significant tariff and nontariff barriers to trade for medical technology.
Such barriers represent a self-imposed and unnecessary tax that substantially increases both the cost of health care to their own citizens. Such barriers also delay the introduction of new cost-effective, medically beneficial treatments. As a result, regional forums are striving to enhance market access for a number of important sectors. USTR should take strides to ensure ATL and non-tariff barrier reduction initiatives developed under APEC reach fruition via the appropriate trade forum. Moreover, a new WTO round should be seen as an opportunity to improve access to new medical technology on a global basis.