Healthcare Compliance Policy

Okuvision GmbH is a leading company in the field of treating retinitis pigmentosa (“RP”). The therapy developed by Okuvision GmbH aims to slow the degenerative process of photoreceptors, which typically 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 maintains a wide range of relationships with scientists, physicians, and medical institutions.
A fundamental principle of Okuvision GmbH in its cooperation with physicians, 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 a large number of specific and complex laws and other legal requirements, so it is not always easy for individual employees to distinguish permissible from impermissible conduct. In addition, companies operating in the healthcare sector are under close scrutiny by the media, competitors, and supervisory authorities in their cooperation with members of the professional community. The purpose of this policy is therefore to establish clear and binding principles for this cooperation.

This policy governs cooperation with medical institutions and with physicians in private practice, their employees, and all other members of the healthcare professions and allied health professions; this includes in particular physicians, pharmacists, nurses, and medical-technical assistants, as well as patients and patient associations (hereinafter collectively referred to as “Healthcare Professionals”).
This policy applies to all employees and corporate bodies of Okuvision GmbH when cooperating with Healthcare Professionals.

All employees of Okuvision GmbH and the respective specialist departments are required to comply with this policy when cooperating with Healthcare Professionals. If this policy does not provide any, or any clear, procedural instruction, Okuvision GmbH employees are obliged to coordinate the further course of action with the head of their specialist department. The head of the specialist department must then obtain approval from the management. This procedure also applies in the event of a deviation from this policy in an individual case.
When cooperating with Healthcare Professionals, the individual requirements on healthcare compliance of external employers and medical institutions must also be taken into account insofar as these are known or obvious. In particular, the specialist departments must ensure that any such requirements of external companies that go beyond the standards defined by Okuvision GmbH are complied with.
If you have any questions regarding this policy, 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 “Medical Devices Code” that are based on the relevant laws, case law, and professional regulations. The Code implements the MedTech Europe “Code of Ethical Business Practice” for Germany. The medical device market in the solidarity-funded healthcare system is based on statutory framework conditions. On the basis of these framework conditions, the parties use the Medical Devices Code to establish practical rules of conduct that meet ethical principles as well as the needs of medical research and that help to increase transparency and avoid irritation and undesirable developments. They are a prerequisite for positive competition within a solidarity-funded healthcare system.

(Source: https://www.bvmed.de/download/kodex-medizinprodukte.pdf)

When Okuvision GmbH cooperates with Healthcare Professionals, the following four principles in particular must be observed in order to avoid potential legal violations. These are

• the principle of separating benefits and sales transactions (separation principle),
• the transparency/approval principle,
• the principle of appropriateness of performance and consideration (equivalence principle), and
• the documentation principle.

The separation principle requires a clear separation between benefits and sales transactions. This means that benefits to Healthcare Professionals must not be granted depending on sales transactions with the medical institution.
They must also not be misused to improperly influence Healthcare Professionals in favor of products and/or services of Okuvision GmbH. This applies in particular to therapy, prescribing, and procurement decisions as well as recommendations and referrals.

The transparency/approval principle stipulates that benefits to Healthcare Professionals and service relationships with Healthcare Professionals must be disclosed to the respective employer (transparency principle) and must be approved in writing by the employer (approval principle).

According to the equivalence principle, in service exchange relationships, performance and consideration must be in an appropriate relationship to each other. This is determined in particular by the scope of the service, the time required, and the qualification of the contractual partner necessary to provide the service. The remuneration must be within what is customary in the market for comparable contractual relationships (fair market value).

Agreements with Healthcare Professionals must be set out in writing. The proper provision of the contractually agreed service must also be documented by suitable documents (in particular invoices, lists of services provided, written reports, manuscripts, etc.). Payments are made exclusively by bank transfer to a bank account specified by the contractual partner in the contract. This must be the contractual partner’s bank details and not the bank account of third parties. All documents must be retained for a period of at least ten years so that any later impression of irregularities can be avoided from the outset on the basis of the available documentation.

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

This also applies to:

• the design of service relationships with Healthcare Professionals abroad. In addition, the legal provisions applicable in the respective country must be observed.
• the granting of benefits to third parties close to Healthcare Professionals, such as spouses or children.
• cases where third parties are interposed between our company on the one hand and Healthcare Professionals on the other. In that case, the external service provider must contractually undertake vis-à-vis Okuvision GmbH to comply with the principles of this policy 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 sales partners.

The forms of cooperation presented in the policy can be divided into service exchange relationships and unilateral benefits. Service exchange relationships are characterised by the existence of a service and consideration (e.g., in a consulting or speaker agreement). This is not the case with unilateral services or benefits (e.g., a gift or an invitation to a scientific continuing education event).

Individual examples of service exchange relationships are described below.

Research must not be misused for marketing and sales purposes. The respective project must therefore aim to achieve results in which there is a legitimate medical and scientific interest (e.g., scientific data or patient adherence). A positive assessment of the research project by the management of Okuvision GmbH is mandatory. The Clinical Studies department is also responsible for initiating, conducting, and evaluating the respective research projects. This applies regardless of whether Okuvision GmbH conducts a research project or supports an external research project.

At external events organised by Healthcare Professionals, Okuvision GmbH is generally asked for financial support. This is permissible in the form of sponsorship, through which Okuvision GmbH provides financial support for the medical-scientific continuing education event and, in return, receives the opportunity for image- and/or sales-promoting advertising. Such effective presentation opportunities include, for example, an exhibition stand, distribution of information brochures, or appearing as a sponsor on the invitation with name and logo. Other advertising measures can also be covered by a sponsorship agreement.

Entering into a consulting agreement or other service agreements is only considered if there is an actual need for a consulting or service activity, which must be carefully reviewed and documented in each individual case. In addition, the decision to conclude the agreement with a specific member of the Healthcare Professionals must be justified by that person’s professional expertise.
The agreed remuneration must be appropriate in view of the services to be provided, and payment should only be made after proper performance of the service and invoicing. Within the scope of consulting and service agreements, travel and accommodation costs that are necessarily incurred in fulfilling the agreement may be reimbursed to an appropriate extent in addition to a fee.
“Appropriate remuneration” must be assessed on a case-by-case basis, taking into account the degree of difficulty of the service, the necessary qualifications of the Healthcare Professional, and the required time expenditure. The GOÄ or the EBM may provide guidance for this (e.g., GOÄ code 85, extensive written expert opinion, EUR 29.14 x up to 3.5, plus writing fees per DIN A4 page [GOÄ code 90/95] = approx. EUR 105/hour).
“Appropriate travel expenses” include train tickets (1st class) as well as car travel costs at the flat-rate kilometre allowance permitted for business travel per kilometre travelled, and reimbursement of other travel expenses (public transport, taxi). For air travel, covering the costs of economy class for intra-European flights and business class for intercontinental flights is appropriate. Reimbursement of first-class flights is always inappropriate.

In the case of unilateral benefits to Healthcare Professionals for which there is no, or no adequate, consideration, increased caution is required in view of the criminal-law risks existing in Germany, as there is a particular risk that such benefits may be regarded as improper influence.

Unilateral services or benefits must not be misused to influence procurement or prescribing decisions. Nor may statutory provisions be circumvented in this way. Price reductions and discounts, etc. must therefore be granted transparently, either as a cash discount (a monetary amount calculated in a specific way) or as a quantity discount (additional units of the same goods), and must not be granted indirectly via support services (e.g., donations). In addition, the existing documentation and approval requirements must also be observed here.

Individual unilateral services are described below.

The free provision of devices is only possible in the following cases:

• Provision of devices within the scope and for the duration of a study agreement/clinical trial/research funding agreement. After expiry of the agreement/study, the device must be returned or may be purchased at an appropriate value; agreeing an appropriate rental fee after expiry of the agreement/study is also possible.
• Devices may be purchased on a trial basis or, for a limited period, provided as a trial order. In the case of a purchase on a trial basis, the buyer may return the goods within a specified period. This must be set out in a contract. The trial order serves the purpose of providing a prospective buyer with the product for testing so that they can form an impression of it. A trial order agreement/receipt confirmation for the trial order is required. The term of trial orders should only cover the period the prospective buyer needs for comprehensive testing of the device; for complex medical devices with fewer use cases, a period of 3 to 6 months may be justified.

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

• the samples are provided on the basis of a prior written request by the Healthcare Professional;
• the samples are provided exclusively for training purposes;
• only the smallest available pack size is provided; and
• no more than 2 units per year are provided.

The provision of samples differs from provision or trial orders (legally classified as a loan) in that the sample in question is not returned to Okuvision GmbH after use on the patient or after expiry of the training period, e.g., because it is an implant or consumable materials.

Hospitality is only permissible in the context of business meals and company-run training and continuing education events.

Hospitality costs must not exceed an appropriate and socially acceptable amount of approximately EUR 60 net per person in Germany; in high-price countries abroad, exceeding this threshold by approx. 10% is justified. Only those benefits that correspond to the general rules of courtesy are considered socially acceptable. Hospitality for accompanying persons is not permitted. There must be an objective justification for a business meal.

Okuvision GmbH may invite Healthcare Professionals to job-related (i.e., scientific and/or professional) training and continuing education events. This applies both to company-run and external events.

The following generally applies to training and continuing education events:

• there must be a direct connection to Okuvision GmbH or to the product area, as well as an objective connection to the participant’s field of activity;
• scientific information and the dissemination of job-related knowledge clearly take precedence;
• the choice of conference location and venue must be based exclusively on objective and logistical considerations (such as good accessibility, suitable conference rooms, programme content, etc.); a leisure and luxury character must be avoided;
• the invitation may be addressed directly to Healthcare Professionals, but it is also possible to invite a medical institution or a practice; the institution/practice may designate the employees who are to participate in the event;
• costs for accompanying persons must not be covered;
• approval from the employer must be obtained for employed Healthcare Professionals;
• the leisure and entertainment aspect must be clearly subordinate; the professional component must predominate.

Gifts to Healthcare Professionals are subject to strict limits under criminal, civil service, advertising, and professional law. Permissible gifts are low-value benefits, so-called promotional items such as pencils, low-value ballpoint pens, notepads, etc. These must bear a product logo or the Okuvision GmbH company logo and be intended exclusively for use in the medical practice/clinic.

Donations (monetary and in-kind donations) may only be granted to non-profit medical institutions or organisations, provided they can issue a donation receipt within the meaning of the German Fiscal Code. Donations to individuals, physicians, and other employees are therefore not possible. Donations to support associations of hospitals or university hospitals are granted only exceptionally and with the involvement of the respective medical institution (administration).

Donations are always granted for the benefit of the general public and for a specific purpose, i.e., for the purposes of research and teaching, improving healthcare or patient care, training and continuing education purposes, or charitable purposes. Monetary donations may only be transferred to special donation or third-party funds accounts of the medical institution or other organisations. Accordingly, for in-kind donations it must also be ensured that they pass into the control of the medical institution. In return, the medical institution or organisation must issue a donation receipt within the meaning of tax law.