SciGen Marketing Policy

1. AIM OF THE POLICY

The following SciGen Marketing Policy (hereinafter “Policy”) was drawn by SciGen (“SCIGEN”) in order to provide a unified, law-abiding and ethical procedures performed by SCIGEN in the field of their advertising, promotional and marketing related activities.

2. SUBJECT OF THE POLICY

The policy defines conditions for the implementation and rules for proper execution in relevant geographical area where SCIGEN has commercial presence.

Before undertaking any actions covered by the Policy, every SCIGEN-related person is obligated to familiarize themselves with the current Policy and act in compliance to its provisions. The SCIGEN employee responsible for a given task is responsible for informing Distributors about current provisions.

In all matters of application, interpretation and enforcement of any section of this Policy, compliance with the local laws and regulation and its requirements will take precedence.

3. SCOPE OF RESPONSIBILITIES AND OBLIGATIONS

The SCIGEN Board of Directors is responsible for the overall adherence of the Policy.

Every person who executes actions covered by the Policy on behalf of SCIGEN is responsible for maintaining compliance of their actions with the Policy.

4. DEFINITIONS

For the purposes of the Policy, the following terms used in the Policy or attached documents are defined as follows:

  • “SCIGEN Board of Directors” – All members of the SCIGEN Board as lodged with Accounting and Corporate Regulatory Authority (ACRA).
  • “Person holding public function” – a public official, a member of a self-government organization, a person employed in an organizational unit that has public funds, as well as any other  person whose powers and duties related to their public function are defined or qualified by a Singapore law or binding international agreement – unless their activities are purely a service. In the meaning of the following procedures, a person holding public function, in particular: employee of Ministry of Health, Health Science Authority, a member of Agency for Science, Technology and Research, a doctor or a pharmacist to the extent that their actions impact appropriation of public funds.
  • “Distributor of medicinal products”, “Distributor of medical devices” – a person listed in one of the following categories:
      1. Every person distributing, respectively, medicinal products or medical devices to patients in pharmacies and pharmaceutical points (pharmacists, pharmacy managers etc.), as well as in non-pharmacy retail points (salespersons, managers of non-pharmacy points etc.);
      2. All persons hired in pharmaceutical wholesalers in positions directly related to sales of, respectively, medicinal products or medical devices (including pharmaceutical wholesaler manager);
      3. An individual entrepreneur running a pharmaceutical wholesaler, pharmacy or a non-pharmacy retail point;

         

  • “Person authorized to represent SCIGEN” – a person authorized to individual representation of SCIGEN in accordance with current representation, or persons authorized to jointly represent SCIGEN in accordance with current representation provisions (in the case of more members of the Board), or a proxy established by such person/persons.

     

  • “Healthcare Entity” – every entity being a part of healthcare system notwithstanding its legal and organization form, such as a hospital, a clinic, a doctor’s office in the exercise of its powers as healthcare facility.

     

  • “Medical professional” – a doctor, a nurse authorized to issue prescriptions, as well as a distributor of medicinal products (including pharmacists and pharmaceutical technicians distributing medicinal products).

5. REQUIREMENTS FOR PROMOTIONAL ACTIVITIES

Promotional activities covered within the scope of the Policy shall include but are not exclusive to the following:

  • Direct-to-consumer advertising
  • Journal and mail advertising; materials used by SCIGEN representatives including detailing aids and other printed promotional materials
  • Supply of samples and gifts
  • Free-of-charge distribution of injectors for further distribution to patients
  • Promotional meetings concerning medicinal products and medical devices
  • Sponsorship of Healthcare Professional or meetings (either promotional or scientific)
  • Advertisement using light and sound projection using audio-visual materials such as films, slides, overhead presentations, audio/video and other interactive data systems
  • Electronic communications through email and the Internet

It shall be the responsibility of SCIGEN to ensure that all advertised information is correct and truthful and any (health and/or medical) claims relating to a particular

medicinal product must be aligned with the appropriate use of the labelled indication and the category of medicinal product classification.

 

SCIGEN must ensure that all medical advertisements fulfil the following criteria:

  • The nature, quality and medicinal properties of the product is truthful and lack claims exaggeration
  • Claims and/or testimonials made in the advertisement are well-substantiated by data from credible sources
  • Information is presented in a balance, unbiased, current, objective and accurate manner
  • Advertisement shall not contain any comparative claim that will denigrate any other products in the industry
  • The names of competitive products shall not be stated for comparison
  • Advertisement shall not infringe the use of logo, trademark or name of other institution without their written permission, including logos or name of any professional group or the authority

All medical advertisement and sales promotion materials will be evaluated by the compliance and/or regulatory department(s) for appropriateness and ensure that the sales promotion mechanics are alignment to this Policy prior to distribution to the public.

6. POST-APPROVAL MARKETING SURVEILLANCE

SCIGEN may conduct or engage its Distributor to conduct post-marketing surveillance studies following registration approval. SCIGEN shall supply the Distributor, as needed, the quantities of product as agreed upon for it to reasonably conduct the study. The study must be conducted in compliance with local laws and regulations.

SCIGEN shall, to its best knowledge, assist to answer any questions pertaining to the product that arise prior to, during or post to the study.

All forms of incentives offered to the subjects of the surveillance study, if any, shall be to compensate for the work involved. No product shall be provided to the subjects at the end of the study.

7. SPONSORSHIP

Sponsoring of a health care programme for both local and overseas meetings must conform to the professional standards of ethics. The following criteria must be fulfilled:

  • Not related to government or political event
  • Sponsorship must be clearly stated in advance at the meeting and in any proceedings
  • No payments are made to compensate Healthcare Professional for time spent in attending the event
  • No payments are made to cover costs of persons accompanying invited members of the medical profession
  • Payments of reasonable honoraria may be provided to healthcare professionals who are providing services as speakers for the event

Sponsorship to any individual is limited to travel, accommodation and registration fees for overseas meeting. Such support to any individual must not be conditional upon any obligation to prescribe or promote SCIGEN products.

Request for sponsorship shall be approved in advance via submission of Sponsorship Request Form (Appendix 1).

8. ENTERTAINMENT

No entertainment shall be offered to any individual to influence them in the prescription, recommendation or promotion of products, nor to gain favour for SCIGEN.

For any meeting or conference, entertainment should be secondary to the main purpose of the meeting or conference. Venue of entertainment shall be conducive to the purpose of the meeting and conforms to professional ethics.

9. GIFTS

No gifts shall be offered to any individual to influence them in the prescription, recommendation or promotion of products, nor to gain favour for SCIGEN. Payments in cash or cash equivalents (such as gift certificate) to is strictly prohibited.

As an exception to the above, as long as they are not forbidden by current legislation, gifts of modest values are allowed when they correspond to signs of courtesy or to local cultural norms.

If the receiver is a Health Professional, we must also adhere to the codes of conduct that are applicable in the country where they carry out their profession.

Request for sponsorship shall be approved in advance via submission of Gift Request Form (Appendix 2).

10. DONATIONS

Donation is strictly for charitable purposes and must be:

  • Unrelated to commercial objectives
  • Made to benefit a non-healthcare organisation
  • Unrelated to the prescription, purchase and registration of any products

Request for donation must be submitted by Country Manager and substantiated by written documentation of aid required and its beneficiaries.

Donation must be jointly approved by Chief Executive Officer and Chief Financial Officer for amounts up to USD10,000. Any amount above USD10,000 must be approved by the Board of Directors.

Request for donation shall be approved in advance via submission of Donation Request Form (Appendix 3).

11. SAMPLES

Provision of “samples” as an inducement to purchase is strictly prohibited.

Reasonable quantities of samples must be clearly identified as “samples”, may be supplied to the prescribing Healthcare Professional to familiarise them with the product and to gain experience regarding efficacy and side-effects of the product.

Samples must not be sold.

Samples must be kept in a conducive environment in compliance with regulations.

Expired samples must not be distributed and must be destroyed according to SCIGEN internal SOP procedure and subject to local regulation.

Where samples of products restricted by law to supply on prescription are distributed by a sales representative, the sample must be handed directly to the doctor or to a person authorised to receive the sample on the doctor’s behalf.

Sales representatives must account for the distribution of samples and return the list of sample inventory to logistic personnel.

12. RESPONSIBILITY FOR POLICY INFRINGEMENT

SCIGEN has a complaints and queries channel which will enable all the staff to send in queries about this Policy in full confidence, as well as to report possible infringements or violations of it.

Infringement of Policy provisions exposes SCIGEN to material and non-material damage. Therefore, disciplinary actions will be taken against any employee, who infringes the Policy provisions.

Policy infringement may also be regarded as severe worker misconduct and may result in employment contract termination without notice due to the employee’ fault.

An employee who becomes aware of other person infringing the Policy provisions, is obliged to report this immediately to their immediate superior, or the Head of Human Resources Department.

The immediate superior and the head of Human Resources Department shall immediately report this infringement information to the Chief Executive Officer, unless in their opinion there is lack of evidence of infringement. In such cases, they shall document receipt of report and their opinion with a memo.

The complaints which can be substantiated by evidence will be escalated to the Board of Directors for review. Remedial actions must be taken as soon as possible after each review.

Database of complaints, review findings and action plans must be archived at the corporate headquarters in Singapore and respective subsidiaries’.

13. ANNEX