Workshop on Regulatory Cooperation STRENGTHENING INTERNATIONAL COOPERATION TO IMPROVE REGULATION IN BRAZIL: PRO-REG AND REGULATORY GUIDANCE Alfredo Lobo and Rodrigo Rodrigues World Trade Organization Geneva – Switzerland, November 8 th, 2011 Federal Brazilian Government

Programme for the Strengthening of the Institutional Capacity for Regulatory Management - PRO-REG - Rodrigo Rodrigues Deputy-Head of the Department of Analysis and Attendance of Governmental Policies (SAG – Casa Civil) Presidence of the Federative Republic of Brazil

Federative Republic of Brazil Territorial Extension km² Population (2010) Source: IBGE GDP US$ 2,3 trillion (2010) Source: Banco Central do Brasil 7 th World Economy Source: World Bank

Improve quality regulation; Reduction of regulatory risks; Increase transparency and accountability; Wider social participation in the improvement of regulatory framework with a stronger consumer engagement; Reinforce regulatory performance; Improve regulatory governance. Brazilian Regulatory Main Directives

Main proposals for regulatory reform in Brazil Consolidation of regulatory agencies role and improve their institutional capacity to regulate markets; Regulatory technical staff – Law , from 2004, that provide the regulatory agencies careers; Law Bill on the administration, organization and accountability of the federal regulatory agencies (Law Bill 3337/2004) - A Government priority, included in the Programme for the Acceleration of Growth (PAC); Programme for the Strengthening of the Institutional Capacity for Regulatory Management – PRO-REG to improve the regulatory management system of the country.

PEER REVIEW OCDE (2008) The OECD Peer Review of Regulatory Framework in Brazil represents a unique opportunity to discuss current regulatory practices in Brazil, in order to: improve the performance of the system; achieve policy objectives; demystify the ideological debate over regulatory structure involving ministries and agencies; and learn from the international experience. The report emphasizes that is necessary to adopt Regulatory Impact Analysis in Brazil. Moreover, it call attention to the importance of an Oversight Body.

Strengthening International Cooperation Following the OECD recommendations, PRO-REG envisages the conception and set-up of a Unit of Co-ordination, Monitoring, and Evaluation of Regulatory Issues in the Executive branch and is engaged with to introduce Regulatory Impact Analysis – RIA. For this proposal try to learn with international best practices. PRO-REG is sponsored by Inter-American Development Bank – IDB (US$ 3.85 million from 2007 to 2012 with US$ 2.85 million from Brazilian Government counterpart): Capacity building up to 1,800 people:1,200 public civil servants from regulatory agencies and 600 from ministries, state agencies and consumers organizations. The Institute of Brazilian Issues – George Washington University tailored a Short Course on Regulation to Brazilian public civil servants from regulatory agencies: 7 courses, 182 participants. Office of Information and Regulatory Affairs (OIRA) – OMB/USA: work visits, workshops, videoconferences RIA. RIA pilot projects with 6 Brazilian regulatory agencies: power (ANEEL); oil, gas and biofuels (ANP); health insurance (ANS); food and drugs (ANVISA); port and maritime transport (ANTAQ) and motion picture (ANCINE). Cooperation Agreement between the Brazilian Federal Government and the Embassy of the United Kingdom in Brazil, with technical assessment from Better Regulation Executive – BRE (£ 159,000 from 2010 to 2013): Work visits, workshops, short courses to Brazilian public civil servants (staff from BRE and London School of Economics and Political Science). Cooperation with Comisión Federal de Mejora Regulatória – COFEMER – Mexico.

Guide on Good Regulatory Practices on Technical Regulations Alfredo Lobo Director of Quality Brazilian National Institute of Metrology, Quality and Technology - INMETRO

Inmetro - National Institute of Metrology, Quality and Technology

Agency under the Ministry of the Development, Industry and Foreign Trade (MDIC) Inmetro - National Institute of Metrology, Quality and Technology MAIN ACTIVITIES Scientific and Industrial Metrology Legal Metrology Conformity Assessment Accreditation of Certification & Inspection Bodies and Testing & Calibration Laboratories Enquiry Point for the Agreement on Technical Barriers to Trade (WTO) Innovation & Knowledge Diffusion

Council of Ministers & other Institutions CBN Standardization CBM Metrology CBAC Conformity Assessment CCAB Codex Alimentarius CBR Regulation Responsible For the Guide of Good Regulatory Practices on TR CBTC Technical Barriers SINMETRO, CONMETRO and its TCs Brazilian System on Conformity Assessment The approach is systemic, strategic and structuring

Regulatory Authorities in Brazil Inmetro may act in any area/product since there is no Brazilian Regulatory Authority legally established. Inmetro may also regulate by delegation. Agencies number: 32 Main Agencies: ANVISA (Health), DENATRAN (Traffic Safety), IBAMA (Environment) etc. Examples of products regulated by Inmetro: Toys, Tires, Household Appliances, Auto Parts and Electric Wires and Cables. Examples of products or services regulated by Inmetro by delegation: Condoms, Feeding-Bottles, Pacifiers and Vehicle Safety.

Development of the Guide on Good Regulatory Practices on Technical Regulations Published by CONMETRO on 18/dec/2007 Sector panels were conducted to ensure the effective participation of stakeholders in the GBP development; Deployment Plan established, involving several dissemination and training actions in various government institution, including the National Congress; Development and implementation of training program for managers and professionals from 32 Regulatory Authorities; Guide Edition in Portuguese, English and Spanish available at Inmetro´s website: Strengthening Activities regarding Regulatory Practices in Brazil - 1

Development and implementation of a methodology for Impact Assessment and Technical Feasibility of Technical Regulations and Conformity Assessment Procedures Applicable to all Technical Regulations and Conformity Assessment Programs, new or revised ones within the Sinmetro; 32 % appear to be unfeasible; Feasible examples: tires (labelling), domestic cookers, light bulbs; Unviable examples: fireworks, notebook batteries. Strengthening Activities regarding Regulatory Practices in Brazil - 2

Assisted Deployment of Technical Regulations and Conformity Assessment Procedures Identify factors that may facilitate or hinder its implementation, as well as to develop actions to mitigate impacts and promote the understanding, acceptance and compliance to Technical Regulations and Conformity Assessment Procedures to all stakeholders. Strengthening Activities regarding Regulatory Practices in Brazil - 3

Key Implementation Actions performed for each Assisted Program of Conformity Assessment Stakeholders mapping; Identification of factors which facilitate or hinder the deployment; Preparation of Assisted Deployment Plan. a)Dissemination to stakeholder and assistance to the information interpretation; b)Capacity building actions toward affected parties, focusing SMEs; c)Technical advisory toward affected parts related to compliance with the CAP requirements; d)Promote Foment Actions.

Brazil is the 5 th country in notifications on WTO; Brazilian technical regulations comply with international standards; Few complaints and Specific Trade Concerns - less than 1 % of the Brazilian notifications. Important Outcomes Regarding the Implementation of Good Regulatory Practices Programs like PRO-REG and The guide on GRP

Brazil (INMETRO) – USA (CPSC) cooperation; Brazil (INMETRO) – China (AQSIQ) cooperation; Brazil (INMETRO) – Mozambique (INNOQ) cooperation. Some Regulatory Cooperations regarding the Implementation of the Guide on Good Regulatory Practices on Technical Regulations

Quality Directorate Phones: +55(21) or +55(21) Additional contact points Call center - Consumer Service: Toll Free services for Society: Ask Inmetro: Ombudsman: Websites: and Inmetro Contact Information