Workshop on Regulatory Cooperation

STRENGTHENING INTERNATIONAL

COOPERATION TO IMPROVE REGULATION IN BRAZIL:

PRO-REG AND REGULATORY GUIDANCE

Alfredo Lobo and Rodrigo RodriguesWorld Trade Organization

Geneva – Switzerland, November 8th, 2011

Federal Brazilian Government

Programme for the Strengthening of the Institutional Capacity for

Regulatory Management - PRO-REG -

Rodrigo RodriguesDeputy-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 8.514.876 km²

Population190.732.694 (2010)

Source: IBGE

GDP US$ 2,3 trillion (2010)

Source: Banco Central do Brasil

7th World EconomySource: 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 10.871, 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 LoboDirector 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 InstitutionsCouncil of Ministers & other Institutions

CBNStandardization

CBMMetrology

CBACConformity Assessment

CCABCodex Alimentarius

CBRRegulation

ResponsibleFor the Guide of Good Regulatory

Practices on TR

CBTCTechnical 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: www.inmetro.gov.br.

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 5th 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) 32161013 or +55(21) 32161015

E-mail: dqual@inmetro.gov.br

• Additional contact points

Call center - Consumer Service: Toll Free 0800 285 1818

E-mail services for Society:

Ask Inmetro: pergunte@inmetro.gov.br

Ombudsman: ouvidoria@inmetro.gov.br

• Websites: www.inmetro.gov.br and www.portaldoconsumidor.gov.br

Inmetro Contact Information