Commercial Practice Standards

1. About BIOTECanada

BIOTECanada is the Canadian national industry‐funded association representing the broad spectrum of biotechnology constituents including emerging, established and related service companies in the health, agricultural, and industrial sectors.

Mission Statement: BIOTECanada is dedicated to the sustainable commercial development of biotechnology in Canada.

BIOTECanada’s Goal: Inspire our domestic and international community to recognize the value of biotechnology in Canada and provide solutions to the challenges our constituents face.

BIOTECanada, together with its signatory members, has developed a number of important principles that have been further adopted by BIOTECanada members including Biotechnology Industry Statement of Ethical Principles.

2. Purpose of the Commercial Practice Standards

The Commercial Practice Standards (the “CPS”) sets forth standards to guide biopharmaceutical company members of BIOTECanada (“Members”) in their interactions with healthcare professionals, the scientific research community, government officials, public office holders, and the general public.

3. Application

The CPS applies to all activities undertaken by Members in Canada.

4. Principles

4.1 Interactions in general

All interactions with healthcare professionals, government officials, public office holders, the scientific research and health communities and the general public shall be in accordance with all applicable laws and regulations.

Members shall act ethically in all interactions.

All interactions shall be consistent with the advancement of innovation, the health of Canadians, and the Canadian economy.

The independence of opinion of all persons with whom interactions take place will be valued and protected.

Information provided by Members during interactions will be truthful and scientifically sound.

4.2 Interactions with the health sector

All interactions with health‐related groups, including payers, patients and patient advocacy groups, and other related associations should serve to advance the health of patients and Canadians in general.

Members may promote and or support clinical research and other studies as well as meetings, programs and various activities that take place in conjunction with the activities of groups or individuals within the health sector.

4.2.1 Activities, studies, conferences and events: Members may support and or promote activities such as conferences, demonstrations, studies and meetings, including through the provision of funds, grants and scientific data, to a reasonable extent. To the extent that activity support has a promotional objective, the Member shall require such objective to be clearly stated in materials related to the activity, to the extent reasonably possible.

Members shall take reasonable steps to ensure that all studies supported by Members will be subject to the highest possible ethical standards and scientific rigours.

Members may contribute to costs related to any such activity, provided such costs are directly related to the activity and any person who shall benefit from the support provided must have a legitimate professional interest in such activity. No support shall be given to guests, including spouses or family members, of the persons receiving support. All hospitality expenses (including meals and lodging) shall be reasonable in value and related directly to the timeframe of the activity.

4.2.2 Gifts and Financial Incentives: Members shall not use the offer of gifts or financial incentives to influence decisions by healthcare professionals regarding the purchase, sale, use or recommendation of Member products or services or in any other way that might be seen reasonably to compromise the independence of opinion of the recipient party. Any other gifts from a Member shall be restricted to those that are modest and reasonable in nature. Gifts shall not take the form of cash or cash equivalents.

4.2.3 Education tools: Members may provide educational items, whose primary purpose is to enhance education and treatment, such as scientific publications, textbooks, or research tools to healthcare professionals.

4.2.4 Samples: In accordance with applicable laws and regulations Members shall be entitled to provide appropriate samples or products for evaluation in order to support optimizing patient care.

4.2.5 Consultants: Contracting services performed by experts and professionals, including scientists and healthcare professionals such as physicians, when required for legitimate business needs, will be chosen based on expertise and knowledge. Fees and honoraria provided for contracting services shall not exceed the fair market value for such services.

4.2.6 Product Promotion: Members shall encourage appropriate use of their products by presenting them objectively, without exaggeration of their properties, in accordance with all applicable laws and regulations.

No product shall be marketed for use until the required approval for marketing of such product has been obtained.

No promotion of “off‐label” uses shall be made to healthcare professionals. This is not intended to restrict full public disclosure of information to relevant parties, nor is it intended to prevent the right of the scientific community and the public to be fully informed concerning scientific and medical progress. It is expected that a complete exchange of scientific information concerning a product will be made, including through the appropriate dissemination of investigational findings at scientific conferences or through other appropriate diffusion media.

4.2.7 Standards for biopharmaceutical company representatives: Company representatives shall act in an ethical manner in all interactions with health sector professionals. Representatives shall maintain high standards of accuracy and professionalism in their statements and actions, and shall be provided with appropriate training. Representatives shall not pay fees in exchange for access to healthcare professionals.

4.2.8 Professional Codes of Conduct: Members shall encourage all professionals within the heath sector to comply with their respective codes of professional conduct.

4.3 Interactions with public office holders, government officials and other decision‐makers

All interactions shall be motivated by the advancement of the health of Canadians, quality of life, innovation and or the Canadian economy, as applicable.

All interactions shall be in accordance with all applicable laws and regulations, and shall demonstrate the Members commitment to maintaining high ethical standards.

All information, facts, data and related advocacy materials used in interactions will be truthful, non‐misleading and transparent.

4.4 Other Principles

Members shall take reasonable steps to provide to all interested parties immediate, complete, transparent and non‐misleading reporting regarding any information required to be disseminated in accordance with applicable laws and regulations; including but not limited to information related to changes in efficaciousness and safety of specific products.

Members shall comply fully with all applicable laws, regulations and ethical standards with respect to the protection of personal health information.

Advertising and promotion, defined as paid communications with the intent to influence an audience, shall be accurate. The communicated message shall be presented in an ethical, responsible and appropriate manner. Advertising of products shall comply with PAAB and ASC standards.

Phase IV (post‐market) clinical trials of products shall be undertaken for the purpose of furthering the scientific understanding of such products and shall be reviewed and approved by the Member’s board of ethics, internal review process and/or a central/local external ethics review board.

5. Implementation of the CPS

Members shall sign an annual licensing agreement with BIOTECanada, affirming their commitment to, and compliance with, the CPS. Members shall have the right to display the BIOTECanada CPS logo in materials prepared by the Member.

Members shall establish and maintain appropriate procedures to ensure full compliance with the CPS. Members shall communicate their adherence to the CPS to their employees and are recommended to communicate their adherence to the CPS to contractors, service‐providers and other relevant stakeholders and representatives, with the expectation that they will also adhere to the CPS, to every extent reasonably possible.

6. Dispute Resolution Process

All complaints with respect to compliance or adherence by a Member with respect to its obligations under the CPS shall be resolved through the following approach:

Step 1: BIOTECanada has agreed to accept complaints with respect to compliance by Members with the provisions of the CPS. Complaints shall be filed electronically through BIOTECanada’s online submission process.

Step 2: If the complaint is from anyone other than the general public, the complaint shall be referred directly to the Commercial Practice Standards Committee of BIOTECanada (the “Committee”) for consideration and determination, such Committee created by BIOTECanada’s Board of Directors and comprised of industry representatives. If the complaint is from a member of the general public with respect to the conduct of a Member, BIOTECanada shall first inform the concerned Member of the complaint. In that event the Member shall contact the complainant directly in order to discuss the issue or issues raised and to seek to resolve the matter. The Member shall in turn inform BIOTECanada in writing of its actions with respect to the complaint within 30 days of the initial receipt.

Step 3: In the event that the complaint is from a member of the general public and the complaint has not been resolved in the process set out above, or the complaint is from someone other than a member of the general public, the Committee shall assume responsibility for the resolution of the complaint and further communication with the complainant, and such complaint shall be resolved in accordance with procedures established by the Committee.

Step 4: In every instance where the Committee is responsible for the resolution of a complaint, the complainant shall receive a written decision with respect to the complaint that shall include information with respect to actions, if any, taken with respect to the Member.

Step 5: Complaints and decisions will be posted on the BIOTECanada website.