Retina Implant AG - Healthcare Compliance Principles

1. INTRODUCTION

Retina Implant AG is a leading company in the treatment of retinitis pigmentosa ("RP"). It deals with a broad range of medical facilities, registered physicians, their staff and other medical and healthcare professionals (henceforth jointly referred to as the "Healthcare Profession"). Ethical conduct and strict compliance with relevant legislation are fundamental principles governing the work of Retina Implant AG with the Healthcare Profession. The following information is intended to provide employees of Retina Implant AG and its co-operation partners with a summary of the key compliance principles. More detailed requirements can be found in the Retina Implant AG Healthcare Compliance Guideline ("Healthcare Compliance Guideline").

 

2. KEY PRINCIPLES UNDERLYING THE WORK WITH THE HEALTHCARE PROFESSION

With a view to avoiding potential legal infringements, the following four principles in particular should be complied with in Retina Implant AG’s dealings with the Healthcare Profession:

  • principle of separating benefits and sales transactions (principle of separation)
  • principle of transparency/approval
  • principle of proportionality between service and consideration (principle of equivalence)
  • principle of documentation.

1.1. Principle of separation

The principle of separation requires a clear separation between benefits and sales transactions, i.e. benefits to the Healthcare Profession must not be dependent on sales. Furthermore, benefits must not be misused to improperly influence the Healthcare Profession’s conduct, prescription and purchase decisions or its recommendations/referrals in favour of Retina Implant AG’s products and/or services.

1.2. Principle of transparency/approval

The principle of transparency/approval requires unilateral benefits and relationships involving the exchange of services with healthcare professionals to be disclosed to the respective employer (principle of transparency) and approved in writing by this employer (principle of approval).

1.3. Principle of equivalence

According to the principle of equivalence, in the case of relationships involving the exchange of services, the consideration (on the part of Retina Implant AG) must be proportional to the service (on the part of the Healthcare Profession) at fair market value. This is based in particular on the scope of the service, the time spent and the qualifications the contractual partner requires to provide the service.

1.4. Principle of documentation

Agreements with healthcare professionals must always be set down in writing. The proper provision of the agreed service is to be documented by means of appropriate documents (e.g. invoices, schedules of services provided, written reports, manuscripts, etc.). All payments must be made by transfer to the stipulated bank account of the contractual partner. All documentation must be kept for at least ten years.

3. TYPES OF CO-OPERATION WITH HEALTHCARE PROFESSIONALS

1.1. Typical relationships involving the exchange of services

1.1.1. Research agreements and research funding

Research must not be misused for sales and marketing purposes. The relevant project must therefore endeavour to achieve results that are of legitimate medical and scientific interest. This applies regardless of whether Retina Implant AG initiated the research project or is supporting a third-party project.

1.1.2. Sponsorship agreements

Financial support of external events organised by the Healthcare Profession is permitted as long as Retina Implant AG is offered an image and/or sales promotion opportunity in return. Such presentation possibilities with an advertising impact may include an exhibition stand, the distribution of information brochures or the company’s name and logo appearing as a sponsor on the invitation.

1.1.3. Consulting and other service agreements

A consulting agreement or other service agreements will only be considered if an actual need exists for the specific consultancy/service. The healthcare professional must also have the relevant specialist skills. The agreed remuneration must be appropriate for the services to be provided and payment must only be made following proper provision of the service and submission of an invoice. Necessary travel and accommodation expenses can be paid in addition to a fee under consulting and service agreements.

1.2. Unilateral service relationships/benefits

Unilateral services/benefits must not be misused to influence purchase or prescription decisions. Unilateral service relationships normally take the form of

  • providing (samples of) products
  • issuing free samples
  • supporting participation in internal and external training events
  • paying for business meals of healthcare professionals
  • making donations to medical facilities.

The above-mentioned (unilateral) services are only permitted under very strict legal conditions, which are defined in more detail in the Healthcare Compliance Guideline.

4. COMPLIANCE WITH THESE PRINCIPLES / MONITORING / TRAINING

Compliance with the above-mentioned principles and the Healthcare Compliance Guideline is essential for Retina Implant AG in dealings with the Healthcare Profession. Retina Implant AG employees are obliged to adhere to these compliance principles in their day-to-day work and in dealings with doctors, medical facilities and their staff. Compliance with the guideline is an official obligation. Employees are also obliged to promptly notify their head of department or Retina Implant AG’s Executive Board if they become aware of other employees breaching these guidelines. Knowledge of and compliance with these principles will be ensured by means of regular in-house training.