Okuvision GmbH - Healthcare Compliance Guideline

Okuvision GmbH is a leading company in the treatment of retinitis pigmentosa (“RP”).

The therapy developed by Okuvision GmbH aims to slow down the degeneration process of photoreceptors, which usually leads to blindness, as a result of the eye disease retinitis pigmentosa. The products are CE-marked and are currently used in the European market. The company has many relationships with scientists, physicians, and medical institutions.

A fundamental principle of Okuvision GmbH in its cooperation with doctors, medical institutions and all business partners is both ethically impeccable conduct and strict compliance with applicable law. Companies operating in the healthcare sector are subject to many special and complex laws and other legal requirements, so that it is not always easy for individual employees to distinguish permissible from impermissible behaviour. In addition, healthcare companies are closely monitored by the media, competitors and regulatory authorities when working with members of healthcare professions. The aim of this guideline is therefore to establish understandable and binding principles for this cooperation.

This guideline applies to the collaboration with a broad range of medical institutions, registered physicians, their staff, and other medical and healthcare professionals; in particular this encompasses physicians, pharmacists, nurses and medical-technical-assistants as well as patients and patient organisations (henceforth jointly referred to as the “Healthcare Profession”).

The guideline applies to employees and members of the organization of Okuvision GmbH in their collaboration with the Healthcare Profession.

All employees of Okuvision GmbH and the respective specialist departments are required to observe this guideline when working with the Healthcare Profession. Where this guideline results in no or unclear procedural instructions, the Okuvision GmbH employees are obliged to coordinate further actions with the head of their specialist department. The head of the specialist department must then obtain the approval of the management. This procedure also applies in the event of deviations from this guideline in individual cases.

When working with the Healthcare Profession, the individual Healthcare Compliance guidelines of external employers and medical institutions must also be taken into account, in so far as they are known or obvious. In particular, the specialist departments must ensure that any such specifications of external companies that go beyond the requirements set by Okuvision GmbH are adhered to.

If you have any questions regarding these guidelines, please contact the head of your specialist department and/or the management of Okuvision GmbH.

The German Medical Technology Association (BVMed) sets out rules of conduct in its “Code of Conduct for Medical Devices”, which are based on the relevant laws, case law and professional regulations. The Code implements the regulations of the Med-Tech Europe “Code of Ethical Business Practice” for Germany. The market for medical devices in the solidarity-financed healthcare system is based on a legal framework. With the Medical Devices Code, the parties involved provide themselves with practicable rules of conduct on the basis of these framework conditions, which satisfy ethical principles and the needs of medical research and which help to increase transparency and avoid irritations and undesirable developments. They are a prerequisite for positive competition within a healthcare system financed on the basis of solidarity.
(Source: https://www.bvmed.de/download/kodex-medizinprodukte.pdf)

With a view to avoiding potential legal infringements, the following four principles in particular should be complied with in Okuvision GmbH’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.

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 Okuvision GmbH’s products and/or services.

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).

According to the principle of equivalence, in the case of relationships involving the exchange of services, the consideration (on the part of Okuvision GmbH) 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.

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.

These principles must be implemented and observed in all forms of cooperation between Okuvision GmbH and the Healthcare Profession.

This applies as well to:

• the structuring of service relationships with the Healthcare Profession abroad. In addition, the legal regulations applicable in the respective country must be observed.
• the granting of benefits to third parties close to the professional circles, such as spouses or children.
• if third parties are interposed between our company on the one hand and specialist circles on the other. Then the external service provider must contractually commit to Okuvision GmbH to observe the principles of this Directive accordingly. This may be necessary, for example, when commissioning advertising agencies, congress and event agencies, market research companies, clinical/contract research organisations or when involving distribution partners.

The forms of cooperation described in the guidelines can be divided into service exchange relationships and unilateral grants. Service exchange relationships are characterized by the fact that there is a service and consideration (e.g. in the case of a consultancy or referee contract). This is not the case with unilateral services or grants (e.g. a gift or invitation to a scientific advanced training event).

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 (e.g. scientific data or patient adherence). A positive evaluation of the research project by the management of Okuvision GmbH is mandatory. The Clinical Studies Department is also responsible for the initiation, implementation, and evaluation of the respective research projects. This applies regardless of whether Okuvision GmbH initiated the research project or is supporting a third-party pro

Financial support of external events organised by the Healthcare Profession is permitted as long as Okuvision GmbH 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. Other means of promotion can be included in a sponsorship agreement.

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.

The “appropriate remuneration” is to be assessed for each individual case, taking into account the degree of difficulty of the service, the necessary qualifications of the specialist and the time required. The German GOÄ or the EBM can provide indications of this (e.g. GOÄ number 85, complex written expert opinion, 29.14 EUR x up to 3.5, plus writing fees per DIN A4 page [GOÄ number 90/95] = approx. 105 EUR/hour).

“Reasonable travel costs” are train tickets (1st class) as well as car travel costs in the amount of the fiscally approved rate per kilometre for business trips and the reimbursement of other travel costs (public transport, taxi). For air travel, the assumption of costs of economy class for intra-European flights and business class for intercontinental flights is reasonable. Reimbursement of First-Class flights is always unreasonable.

Against the background of the criminal law risks existing in Germany, increased caution is called for in the case of unilateral donations to specialist circles which are not matched by any or no adequate consideration, as there is a particular danger that such donations could be regarded as unfair influence.

Unilateral benefits or grants must not be misused to influence procurement or regulatory decisions. Nor may legal provisions be circumvented in this way. Price reductions and rebates etc. must therefore be made openly, must be in a certain amount of money (cash rebate) or quantity of the same goods (natural rebate) and may not be granted by way of support services (e.g. donations). In addition, the existing documentation and approval requirements must also be observed here.

Individual one-sided services are described below.

The free provision of equipment resp. device trials are only possible in the following cases:

• Provision of equipment within the scope and for the duration of a study contract/clinical examination/research funding contract. At the end of the contract/study, the equipment must be returned or can be acquired at an adequate value; the agreement of an adequate rent after the end of the contract/study is also possible.
• Equipment can be purchased by Heatlhcare Professionals on a trial basis or can be provided for a limited time as a trial sample to Healthcare Professionals. In the context of a purchase on trial, the buyer can return the goods within a fixed period. This must be reflected in a contract. The purpose of the trial order is to allow a prospective buyer to try out the product so that he or she can get an idea of the product. A sample order contract/confirmation of receipt of sample order is required. The duration of the trial order should only cover the time required by the potential purchaser for a comprehensive trial of the device; for complex medical devices with fewer applications, a period of 3 to 6 months may be justified.

The provision of (free) samples to the Healthcare Profession is only legally permissible under strict conditions:

• the samples are submitted based on a prior written request from the Healthcare Professional;
• the provision of samples is exclusively for training purposes;
• only the smallest available packaging unit is supplied; and
• no more than 2 units per year will be delivered.

The delivery of samples differs from the provision or ordering of samples (legally as a loan) in that the sample in question cannot be returned to Okuvision GmbH after it has been used on the patient or after the training period has expired, for example, because it is an implant or consumables.

Hospitality is only permitted within the framework of working lunches and company-internal further education and training events.

The entertainment costs may not exceed a reasonable and socially adequate amount of about 60 € net per person in Germany; in high-priced foreign countries, exceeding this limit by about 10% is justified. Only those services which comply with the general rules of politeness are considered socially adequate. Hospitality for accompanying persons is not permitted. There must be an objective justification for a business lunch.

Okuvision GmbH may invite specialists to job-related (i.e. scientific and/or professional) further education and training events. This applies to both internal and external events.

The following applies in general to further and advanced training events:

• there must be a direct reference to Okuvision GmbH or to the product area as well as a factual reference to the field of activity of the participating person;
• the scientific information or transfer of job-related knowledge is clearly in the foreground;
• the selection of the conference location and the conference venue must be made exclusively on the basis of factual and logistical aspects (e.g. good accessibility, suitable conference rooms, content, etc.); a leisure and luxury character is to be avoided;
• the invitation may be addressed directly to the Healthcare Profession, but it is also possible to invite a medical facility or practice; the latter may nominate the employees who are to attend the event;
• costs for accompanying persons are not to be covered;
• an employer’s approval for employed specialists must be provided;
• the leisure and entertainment aspect must be clearly subordinate, the professional part must predominate.

Gifts to professionals are subject to narrow limits under criminal, service, advertising and professional law. These are permitted in the form of low-value gifts, so-called giveaways such as pencils, low-value ballpoint pens, notepads, etc. These must be provided with a product logo or company logo of Okuvision GmbH and must be intended exclusively for use in the medical practice / clinic.

Donations (cash and material donations) may only be made to non-profit medical institutions or organisations, provided that they can issue a donation receipt in accordance with the German Fiscal Code. Donations to individual persons, doctors and other employees are therefore not possible. Donations are only granted to sponsoring associations of hospitals or university clinics in exceptional cases and with the involvement of the respective medical institution (administration).

Donations are always made for the benefit of the general public and for a specific purpose, i.e. for the purpose of research and teaching, for the improvement of health or patient care, for training and further education or for charitable purposes. Monetary donations may only be transferred to special donation or third-party funds accounts of the medical institution or other organisations. Accordingly, it must be ensured that donations in kind are also transferred to the medical institution. In return, the medical institution or organisation must issue a donation receipt in accordance with tax law.

Employees of Okuvision GmbH are obliged to observe this guideline in their daily work and in their cooperation with doctors, medical institutions and their employees. Observance of the guideline is an official obligation.

In cases of doubt in the application of this guideline, the employee is obliged to obtain the necessary information from the head of his department or the management of Okuvision Ltd. and to follow these instructions and decisions.

Furthermore, the employee is obliged to immediately inform the head of his or her department or the management of Okuvision Ltd. of any breaches of these guidelines by other employees that come to his or her attention. A violation of the guidelines can result in consequences under labour law, up to and including extraordinary termination of the employment relationship.

In addition, violations can also have criminal consequences and be punished in the form of fines and imprisonment.