MODULE ONE: UNDERTAKING A STATUS ASSESSMENT FACILITATORS: CHRISOULA (CANADA) & REINER (THE PHILIPPINES)

Overview Undertake a status assessment of where each of us stand on advancing Code of Ethics implementation; Discuss the need for designing and an appropriate training program; Develop effective techniques for evolving Code of Ethics implementation.

Objective This workshop is intended to assist economies, who are at later stages of developing and implementing a Code of Practice, to assess the progress made in the implementation of their Code of Ethics The outcomes of this first module will help inform the next modules: discuss the development of appropriate training programs to further the evolution and sustainability of Code implementation You may all be at different stages of implementation but always wanting to improve

Process We have developed a series of questions that we hope will help you assess and evaluate your current state of code implementation. We can break out into small groups of 6-8 people and discuss the state of our code implantation.

The Importance of a Code A Code adds value as both an internal guideline and external statement Internally, a code serves to: Clarify an organization's mission, values and principles, linking them with standards of professional conduct As a central guide and reference for employees to support day-to-day decision making. Externally, a code serves several important purposes: Compliance: Legislation and other forms of guidance. Marketing: A code serves as a public statement of what the organizations stands for and its commitment to high standards and appropriate conduct. Risk Mitigation: can reduce the financial risks associated with government fines for ethical misconduct by demonstrating they have made a "good faith effort" to prevent illegal acts. Lets remind everyone of the importance of having a Code A code of conduct clarifies an organization's mission, values and principles, linking them with standards of professional conduct. The code articulates the values the organization wishes to foster in leaders and employees and, in doing so, defines desired behavior. As a result, written codes of conduct or ethics can become benchmarks against which individual and organizational performance can be measured. . A code encourages discussions of ethics and compliance, empowering employees to handle ethical dilemmas they encounter in everyday work. It can also serve as a valuable reference, helping employees locate relevant documents, services and other resources related to ethics within the organization.

The Importance of a Compliance Program Compliance programs are designed to ensure that: Company and Association policies are being followed and that controls are in place to prevent and detect misconduct, identify problems and address policy concerns Periodically assessing the effectiveness of the compliance program helps make certain that standards and expectations are being met

The Importance of Regular Status Assessment Situations and needs will change. Each of us need to know what is working, what is not working, what new vulnerabilities have emerged, what progress have been made, and where there is work that needs to be done. Status Assessments: Demonstrate that the organization is conducting due diligence and devoting attention to its code and compliance program. Promote an organizational culture that encourages ethical conduct. Demonstrate that the organization is committed to the Code and a compliance program. As an added bonus, regular assessments will demonstrate internally (and, if ever needed, externally) that the resources you've invested in ethics and compliance have made a difference.

Codes are Not Self-Implementing Printing a code of conduct and placing it on a wall, is not implementation. There must be an institutional fabric for developing the code, communicating it, interpreting it, training or education on the code, enforcing it and assessing it …together they form a whole cloth of prevention and make the code operational as part of the organizational culture. The challenge of implementation is to utilize the dynamics which have emerged from the formulation of the code. This will support a continuous process of reflection on the central values and standards contained in the code.

Questions we want to ask ourselves Code Where is your Code today? Where do you want to take it? Who is your audience? What are your peers doing? How can we learn from others? If you could do anything to your Code, what would you do? What is holding you back? What tasks need to be undertaken to ensure organisational compliance with the Code?

MODULE TWO: DESIGNING A TRAINING PROGRAM FACILITATORS: SABRINA (HONG KONG, CHINA), MINNIE (THE PHILIPPINES), & LAURA (THE UNITED STATES)

Overview This 45-minute session is centered on the critical role that training programs have when advancing implementation of code of ethics. We will review a referential flow of training and then each group/table will be then asked to brainstorm (5 mins): 2 characteristics of a successful training and write them on green-colored cards, 2 possible limitations and write them on red-colored cards A representative from each table/group will present the 4 cards, commenting as needed, and place them in a basket (5-7 mins) Room will be split in 2/3 teams; each team will be randomly assigned several cards each of each color and asked to come up with a game/module to complement a training session, that address the characteristics and limitations noted in the cards the each team received (15 mins) Teams present their game and as a room discussed the challenges encountered, best practices (10+ 10 mins)

Reference Flow for Training Objective Setting Introduction of Principles Case Studies Be specific Limit scope of training with clear target audiences Use of slogans/mnemonics Scope setting Knowledge impartation Clear and well-defined cases Simulated ethical breaches should be close to reality Reinforcement Application Group Discussions/ Interactive Games Trainer to review and positively reinforce behaviours learned by participants through consistent messaging Referring to own code or international guidelines if necessary Open discussions (if time and space allow) Interaction enhances memory

BIOPHARMACEUTICAL SECTOR CODE IMPLEMENTATION WORKSHOP (7 SEPTEMBER) BIOPHARMACEUTICAL SECTOR LUNCH BREAK LOCATION: OVEN D’OR RESTAURANT (12:30 – 13:30)

EVOLVING CODE IMPLEMENTATION KAREN (CANADA) & MARCO (MEXICO) MODULE THREE: EVOLVING CODE IMPLEMENTATION FACILITATORS: KAREN (CANADA) & MARCO (MEXICO)

Setting the Scene Our ultimate stakeholder: Patients Increased presence of ethics in discussions. Coming up in the workshop: Case study on interactions between industry associations and enterprises with health care professional groups, patient organizations and/or governments to collectively strengthen ethical business practices Case study on strengthening ethical business practices for third party sales and marketing intermediaries, such as distributors.

Module Overview Managing risk and evolving codes. Advancing the Code What does success look like? Strategy for next steps   Select a topic below and find group members: Discuss in your group for 20 mins: Share with larger group (20 mins) How do we assess risk today and in the future? Challenges on how to implement or address transparency & disclosure complaint system direct sponsorships other topic as selected by group members How can we do a better job with evolving our codes in order to be proactive with codes vs reactive? How do we deal with a non-member dilemma? How do we engage with non-industry actors (i.e. Medical Associations) Good practices from associations and examples on how codes have been implemented. What does success look like: give past example or future idea. Suggestion on strategy and actions incorporating both evolving issues and code changes.

Wrap Up Session Five Minutes Extra Time Permitting: Mentor Sessions