Asia Pacific Economic Co-operation (APEC) Principles for voluntary codes of business ethics

Chrisoula NikidisExecutive Director, Ethics and Compliance, Rx&D CanadaThe Asia-Pacific Pharmaceutical Compliance Congress and Best Practices ForumAsia- Pacific Anti-Corruption Update RoundtableSeptember 11, 2013 Kuala Lumpur, Malaysia

Overview

•Brief overview of the APEC initiative on biopharmaceutical business ethics for SMEs

•Why focus on business ethics?• The Kuala Lumpur Principles• The Mexico City Principles

•Outcomes to date

3

APEC Member Countries

Overview: “Business Ethics for APEC SMEs” initiative

Small & Medium Enterprises (SMEs) are the engine of economic growth and will continue to serve as a key driver in the APEC region’s economic expansion as long as they are able to operate, trade, and innovate in ethical business environments.

As a result, the Business Ethics for APEC SMEs initiative was launched under the APEC SME Working Group in 2010.

The initiative was led by the United States, co-sponsored by 16 APEC economies (Australia, Brunei Darussalam, Canada, Hong Kong China, Indonesia, Japan, Korea, Malaysia, Mexico, New Zealand, Peru, The Philippines, Singapore, Chinese Taipei, Thailand, and Vietnam), and strongly supported by the APEC Business Advisory Council (ABAC). 4

APECs work in Developing Voluntary Codes of Ethics

Benefits APEC member economiesProvides a platform for effective industry self-regulationSupports government enforcement and anti-corruption efforts

Benefits businesses, especially resource-constrained SMEs• Provides companies with clarity and harmonization in rules and practices• Allows companies to compete across the region at a reduced cost• Facilitates ongoing innovation

Benefits patients Ethical collaborations fuel advances and promote access to life-saving medicinesEthical collaborations ensure that decisions are made in the best interest of patients

APEC Principles for codes of business ethics in three sectors, setting high ethical standards for the region, each developed by experts from government, industry and academia

What has been achieved?

6

Endorsement by APEC Ministers

7

“We applaud the decision of the APEC SME Ministers at Big Sky, Montana in May 2011 to endorse the Kuala Lumpur Principles for Medical Device Sector Codes of Business Ethics. This set of principles for the region’s medical devices industry is the first of its kind, and will improve the quality of patient care, encourage innovation, and promote the growth of SMEs that produce medical devices. We also congratulate the work of the APEC SME Working Group in establishing voluntary sets of ethics principles for the biopharmaceutical sector (the Mexico City Principles) and the construction and engineering sector (the Hanoi Principles). We endorse these three sets of principles and look forward to further APEC efforts to ensure that these principles have a practical impact for small and medium-sized companies.”

-- November 2011, Honolulu, Hawaii

Support by APEC Leaders in the Russia APEC Host Year

8

Corruption is “...a tremendous barrier to economic growth, the safety of citizens, and to the strengthening of economic and investment cooperation among APEC…We will also support the efforts of respective member economies to build capacity to combat corruption…by encouraging the implementation of high standard codes of ethics.”

-- November 2012, Vladivostok

Jan/Feb 2012

Mar/Apr 2012

May/ June2012

July/ Aug2012

Sep/ Oct

2012

Nov/ Dec2012

Jan/ Feb2013

March/ April2013

May/ June 2013

July/ Aug2013

Sept/ Oct

2013

April 22-24, 2012Brunei Darussalam

APEC workshop to assist industry associations to draft codes aligned

with The KL Principles

July 10-11, 2012Taipei, Chinese Taipei

APEC workshop to assist industry associations to draft codes aligned with The Mexico City Principles

April 2012 – todayMonitoring programs and mentor teams in all three sectors are progressing

implementation of codes of ethics in preparation.

August 26 – 30, 2013KL, Malaysia

APEC Train-the-Trainer Workshop hosted by Malaysian

Anti-Corruption Academy

9

Creation of a network of over 100 ethics trainers, spanning all three sectors and 21 economies!

KL Train-the-Trainer Workshop Objectives

A. Build common, region wide: • Awareness of anti corruption trends applicable to the

industry; and• Understanding of biopharmaceutical sector’s top

compliance challenges.

B. Build technical compliance skills necessary to organize, manage and drive effective biopharmaceutical company compliance programs.

Making Tools Available to Facilitate Code Adoption & Best Practices

Making Tools Available to Communicate Best Practices

Making Tools Available to Implement Good Governance

New codes of ethics are being developed by industry associations in many of the APEC economies in both the Medical device sector and the Biopharmaceutical sector

.

Healthcare Stakeholder Awareness High Level Meeting

Nusa Dua -- Sept 3, 2013

•Included representatives from: • Heads of physician groups, medical

associations, hospital associations, boards of medicine, and health insurance companies. Ministries of health and economy, Health regulators, Government medical councils, Industry, and Anti-corruption authorities.

•Endorsed a joint statement

Feedback from SMEs, industry associations, governments and key stakeholders is that:

They APPLAUD APEC and the APEC SME Working Group for taking leadership in this key area

BUT…

SUSTAINED capacity building, ongoing dialogue, and high-level support is crucial.

• A three day forum to facilitate regional cooperation, identify common problems and practical solutions and sustain the momentum that has been created through the Business Ethics for APEC SMEs initiative launched in 2010.

• Concept note was submitted for APEC funding on Sept 4th

Thank you