8 8 http://www.oecd.org/gov/regulatory-policy/asean-oecd-good-regulatory-practice-conference-2015.htm A fundamental role of government is to protect and promote public health. This objective is enabled by a system of laws, regulations and guidelines. The degree to which the regulatory framework fulfils policy objectives depends on the quality of regulatory development and implementation. If done right, then governments can enable higher quality regulation, improved regulatory decision-making, increased efficiency of regulatory systems, and better public health outcomes – without unintended effects of restricting or distorting trade. Regulatory and other non-tariff barriers are the hurdles that medical technology companies increasingly face. For exam- ple, regulatory changes implemented without adequate prior notification can severely restrict market access for companies and their products in a given country. Poorly developed regu- lations also create unnecessary trade barriers (“red tape”), as well as increasing costs for health systems and the public. Increasingly, governments around the world recognize that the highest cost-benefit regulations are those that maximize protection of public health, safety and the environment while simultaneously maximizing the impact of limited government resources. Implementation of the least economically restric- tive public policies from a set of alternatives of the same efficacy minimizes costs to society by economizing the time and resources of every level of the healthcare supply chain, including those of governments, healthcare providers, hospitals, physicians, manufacturers, and patients. AdvaMed welcomes partnering with governments and other stakeholders in Latin America to provide private sector resources and expertise to build capacity in “Regulatory Coherence” and “Regulatory Convergence” – policy tools that support the high quality, cost-effective, predicable, science-based and least economically restrictive regulations that are essential to fostering innovation and ensuring people have timely access to safe and effective medical technologies. Regulatory Coherence and Good Regulatory Practices Good Regulatory Practices (GRPs) are global best practices for making regulations. Per the Organization for Economic Co-operation and Development (OECD), “GRPs are interna- tionally recognized processes, systems, tools and methods for improving the quality of regulations. GRP systematically implements public consultation and stakeholder engagement as well as impact analysis of government proposals, before they are implemented to make sure they are fit for purpose and will deliver what they are set out to achieve.”8 GRPs are “a la carte” policies and may be adopted “vertically” by sector specific regulators and/or “horizontally” by governments for use across multiple agencies. “Regulatory Coherence”, also known as “Good Regulatory Design” or “Regulatory Reform”, is a horizontal, whole-of- government policy, managed at the top executive level of government, implementing the binding rules by which regulatory agencies generate regulations. Regulatory Coher- ence is the minimum package or set of GRPs that governments adopt horizontally across all of its agencies to ensure that the entire public administration of a country implements GRP in a consistent manner. Regulatory Coherence refers to the imple- mentation and use of a comprehensive, consistent, transpar- ent, and predictable set of GRPs in the process of planning, designing, issuing, implementing and reviewing regulatory measures in order to facilitate achievement of domestic policy objectives, and in efforts across governments to enhance regulatory cooperation in order to further those objectives and promote international trade and investment, economic growth and employment. PROMOTING REGULATORY COHERENCE & CONVERGENCE