1.3.25 Acceptance of rewards and gifts

Goal and purpose

Employees of the HOSPITAL may only accept rewards or gifts in connection with their office or official duties - including for the period after termination of the employment relationship - if the employer consents. The unauthorised acceptance of such benefits constitutes a breach of the employment contract, which may have consequences under labour law or criminal law. This means that

• The company has demonstrated proper and transparent behaviour towards the donors and the public;
• Protect employees from unfounded suspicion of impropriety
• established a procedure for authorisation pursuant to Section 331 (3) StGB to accept benefits
• Responsible handling of donations is achieved

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Area of application

This prohibition covers all material benefits granted to employees in connection with their duties, e.g. money, goods, invitations, car journeys, services of any kind, even if they are performed by others on behalf of the donor, and other benefits and favours such as loans, referrals, etc. to which the employee is not entitled. Rewards, gifts and other benefits may also not be accepted by or for family members or through intermediaries. Employees may not purchase goods for personal purposes from companies or suppliers with whom they have business dealings if they are granted favours in terms of price, payment and delivery conditions or other benefits. Invitations from companies to visits and demonstrations, even outside the company's headquarters, which involve the assumption of travel or accommodation costs, must be declined as a matter of principle.

Connection with the official activity

The gift or reward is deemed to have been granted in connection with the employee's official duties if the giver can assume that the employee has performed or refrained from performing or will perform or refrain from performing actions within his/her area of responsibility. This also includes any secondary employment carried out at the request, suggestion or instigation of the employee's superior or in connection with the employee's official duties.

Personal and social relationships

Benefits that are granted exclusively with regard to personal or social relationships are not granted "in connection with the employee's work". However, if it is to be feared under the circumstances that the personal or social relations are also linked to expectations with regard to the employee's work, further benefits may not be accepted. The employee must then exercise the utmost restraint in personal dealings and, if necessary, break off the relationship.

Realisation

Principle

Irrespective of the following special provisions, low-value benefits of any kind may only be accepted if the donor neither intends nor is concerned that the employee will be influenced by the donor and if there is no external appearance of such influence. In cases of doubt, the approval of the responsible office must always be obtained.

Gifts from colleagues and employees For gifts from colleagues and employees of employees on the occasion of anniversaries, birthdays, retirement or similar occasions, consent is deemed to have been granted.

Light refreshments, fulfilment of representational duties Consent is deemed to have been granted for the acceptance of light refreshments (coffee, tea, juices), biscuits, rolls, individual cigars or cigarettes and for the acceptance of customary hospitality at general events attended by employees in the context of their office or activity, on official business or with regard to the social obligations imposed on them by their office - representational duties - such as, for example Induction into and departure from office, official receptions, social events that serve to maintain university relations or other official interests, anniversaries, inaugurations, opening of exhibitions, company tours and meetings of bodies of commercial enterprises in which the public sector is involved.

Promotional items The acceptance of promotional items, i.e. low-value items labelled with company imprints (e.g. calendars, notebooks, pens), is generally deemed to be approved if they are presented at Christmas, at the turn of the year, on the occasion of a company anniversary or for other promotional reasons. Employees must also exercise restraint when accepting these items. Items where the advertising character is less important than the commercial or other value of the item (e.g. office utensils) may only be accepted with written authorisation. The greatest restraint must be exercised in this regard.

Patient gifts Cash and non-cash benefits granted by members of the public to nursing staff who have regular contact with patients and their relatives as a result of their work may be accepted in recognition of their work under difficult conditions if refusing the benefit would be perceived as discourtesy. Acceptance must be reported immediately to the nursing service management through official channels. However, employees must refrain from doing anything that could give citizens the impression that such a gift is expected.

Invitations to meals Invitations to meals in connection with official duties may only be accepted in exceptional cases if the official business on a given day extends over a longer period of time or takes place at a remote location and refusal would be perceived as discourtesy if a strict standard were applied.

Invitations to events, conferences The free participation of employees in events, in particular lecture events, conferences, including outside working hours, which include hospitality (e.g. a cold buffet) or the granting of other benefits, requires prior written authorisation. Care must be taken to ensure that the number of participants is appropriately limited. Invitations to social events (such as product launch trips) from persons with whom business contacts exist or may exist in the future may not be accepted. If such an invitation is made with regard to existing close personal relationships (e.g. relatives), to which the prohibition on participation set out here does not apply, participation must be notified in advance.

Use of motor vehicles The offer to give employees a lift in a car to carry out official business may only be accepted if the journey is over short distances, in particular city journeys, and is associated with an official advantage, in particular a gain in time. If an employee's motor vehicle is to be made available for use in connection with the performance of official business (even if only for a short time), this requires the prior authorisation of the superior. If authorisation cannot be obtained in good time, the employee shall decide on the use of the vehicle himself, whereby use of this kind should only take place in the case of compelling business needs. In this case, the employee must inform the line manager immediately afterwards.

Acceptance of gratuitous benefits in connection with business trips Approval for the acceptance of meals, accommodation, use of sleeping cars or ship cabins as part of a business trip must be applied for together with the business trip.

Support for events The acceptance of support for company celebrations or company outings of any kind in the form of money, goods, services or other non-cash benefits is not permitted. The same applies to events organised by individual employees in the office (e.g. promotion celebrations, anniversaries) or family celebrations of individual employees (e.g. weddings, anniversaries, confirmations, birthdays).

Obtaining consent to accept rewards or gifts-The following are responsible for authorising the acceptance of rewards or gifts: The managing director - the department authorised by him/her, for members of the care sector the head of the care service

• Consent may be granted on condition that the gift is passed on to a social organisation, employer or other public corporation, institution or foundation. As a rule, the donor should be informed of the transfer of the reward or gift.
• Consent must be obtained, granted and refused in writing.

General rules for dealing with benefits The acceptance of benefits of any kind may not be in connection with sales transactions. Procurements are made exclusively by the purchasing department.

Direct orders from companies or their employees are not permitted. This rule also applies to procurements from third-party funds. Deliveries are made exclusively via the central goods receiving department, unless deviating procedural instructions exist in individual cases. Company discounts (including discounts in kind) may not be agreed by employees outside the procurement departments and may not be accepted either directly or via third-party accounts. Strict care must be taken to ensure that suggestions/recommendations made by the doctor in procurement are not connected with donations from the donor. Even the impression of corruptibility must be avoided. To avoid conflicts of interest, it is recommended that not only one product, but several equivalent products be proposed for procurement. If a required product is only manufactured by the sponsor, the requester must provide special written justification for the need to procure the product from the sponsor. The bias of a grant recipient could also be neutralised by the fact that an internal hospital/departmental "suggestion panel" suggests a product in which the recipient of a personal grant does not participate. Participation in scientific projects for the testing, research and development of medicinal products, medical devices and equipment excludes membership of the Medicinal Products and/or Medical Devices Commission. Project participants should exercise restraint in proposing the product they are testing for procurement. The individual employee may not request benefits for him/herself or another person from a company (e.g. payment of travelling expenses). Authorisation of the acceptance of benefits is excluded if the benefit is requested. Notwithstanding the permissible and approvable company sponsorship for the promotion of science, the regulations on the acceptance of rewards and gifts (

Advertising If a clinic intends to solicit sponsors for purchases or facilities (embellishment work, structural measures, cafeteria furnishings, etc.), the project must be notified for approval by the Board of Directors, stating the purpose.

Further education and training The following must be observed when companies support the participation of employees of the Clinical Centre in scientific conferences, congresses and symposia: In the case of active participation (paper, moderation, presentation, exercise management, etc.), the following costs can be reimbursed by the company or from the third-party funds raised (insofar as their purpose does not exclude funding): Reasonable outward and return travel costs to/from the event location (no class tickets with the exception of train journeys); reasonable accommodation costs for the duration of the event plus the days of arrival and departure; hospitality, provided this remains within reasonable limits and of minor importance; costs for entertainment, provided this remains within reasonable limits and of minor importance. An appropriate fee for the lecture within the scope of the notified or authorised secondary activity. In the case of passive participation, the costs may be reimbursed if the participation has a clear qualification purpose and the knowledge and experience to be imparted are in the interest of the respective department/institute. This must be certified by the director of the department/institute by signing the business trip application form. The same considerations apply to training events organised and hosted by companies. Any additional costs (theatre visits, sightseeing flights, etc.) must be borne by the participant. Only the costs for a single room may be covered. Differences to double rooms are to be borne by the participant. The costs of a private connecting journey or an additional stopover may not be covered.

Audit and consultancy contracts Testing and consultancy agreements with manufacturers or distributors of medical devices are permitted, provided that a written contract exists; the intended consultants are professionally qualified for the tasks; performance and consideration are appropriate and balanced; appropriate equipment is available to carry out the research or development project; the services provided are documented; no obligation to take over the tested product is assumed with the product testing; the same applies to the provision of loaned equipment. no procurement decisions are associated with or prejudiced by the takeover or implementation; reference is made to the requirement of any ancillary activity authorisation to be applied for.

Donations Donations from companies, institutions (e.g. also support associations) or private individuals to medical institutions must be used for charitable purposes, such as support for research and teaching, procurement of equipment and furnishings, training and further education, support for the organisation of scientific events, business trips for these purposes. When using donations, the same principles must be observed as for project-related third-party funds. The acceptance of donations must not be connected with the favouritism of the donor. Donations to private accounts are just as inadmissible as "social donations" (e.g. support for anniversaries, company outings, Christmas and birthday parties).

Application procedure according to § 331 para. 3 StGB All of the forms of benefit undertaken must be notified to the department for approval in accordance with Section 331 (3) StGB, irrespective of whether they are carried out on official business or as authorised secondary employment. Reference is made to the application forms in Annexes 1 and 2. The notification must be submitted in good time, if possible 14 days before the start of the funding project. As an individual review is not possible in every case, the application is deemed to be generally approved if, according to the information provided by the applicant, there is no indication of a conflict of interest and the applicant has also given an assurance that he/she will not do anything to act directly or indirectly in the interests of the funding organisation to promote sales. This procedure does not replace the researcher's own examination of whether an unauthorised benefit can or must be inferred from the actual circumstances. The application does not replace any necessary authorisation for secondary employment. However, it should be expressly pointed out that a granted authorisation to accept an advantage can nevertheless not rule out investigations by the public prosecutor's office in individual cases where there is initial suspicion.

Control and review of the authorisation process The benefits reported to the administration are summarised by the respective reporting recipients (V5; V75...) on a flat-rate basis and submitted to Internal Audit on a quarterly basis. At the same time, Internal Audit can request summaries of the departments' order volumes from individual suppliers from the relevant competence centres (purchasing departments). Internal Audit also carries out spot checks. This enables findings and experience to be gained as to whether and to what extent the receipt of grants and order volume/behaviour can be correlated at all and whether this gives rise to a more in-depth review or a change in approval practice in general or in individual cases. Any questions that arise can be clarified promptly through feedback to the grant recipient or the respective competence centre. Obvious entanglements between the receipt of funding and official actions should thus be recognised and eliminated to protect affected employees and funding providers.

Documentation

Contract documents for grants with management approval note

Responsibility

Notes and comments

Reason for this regulation

In view of the new version of Section 331 of the German Criminal Code (acceptance of benefits; see legal text in the appendix) and the court decisions that have become known on the issue of punishable acceptance of benefits, there is a need to subject research funding by industry, which is in itself politically desirable and indispensable for medical science, to binding rules on the handling of these funds. This involves clarifying and supplementing existing regulations and instructions. All grants from private commercial enterprises in connection with medical research activities are to be included in the review and regulation, irrespective of whether they are granted on a full-time or part-time basis. In addition to the support of scientific conferences, congresses and symposia, this includes the realisation of clinical drug and product observation studies as well as the promotion of basic research, but also the provision of medical equipment of all kinds, and finally donations and gifts.

Criminal law issues In addition to the standards and rules of conduct that already result from employment law and the law governing the medical profession, some information should be provided on criminal law issues. According to § Section 331 (1) StGB (acceptance of benefits) employees in a hospital are liable to prosecution if they demand a benefit for themselves or a third party in return, allow themselves to be promised or assume that they have provided a service or will do so in the future. According to § Section 331 (3) StGB, the offence is not punishableif the unclaimed benefit is authorised in advance by the responsible department or is subsequently authorised following immediate notification. This acceptance of an advantage is a criminal offence if it is accompanied by a so-called unlawful agreement. This is the case if the grantor and the employee agree that, for example, orders could be placed with the company in return for the benefit granted or, in view of the existing contacts, corresponding order proposals could be made to the procurement office. The protective purpose of Section 331 (1) StGB is the integrity of the public service. The very impression of venality should be prevented. Accepting an advantage can therefore also be considered to have taken place if there is no breach of duty in the performance of duties - neither present nor future. Even if an advantage is not granted for a specific official act, benefits for so-called "climate care" or in order to obtain the "goodwill" or "favour" of the doctor should also be covered by Section 331 para. 1 StGB according to the widely held view. Since, according to the very broad interpretation by case law, the factual requirements of Section 331 para. 1 StGB can be fulfilled in many cases, the justification ground of Section 331 para. 3 StGB (authorisation by the employer) is therefore of considerable practical importance. This authorisation to accept an advantage, which is possible under Section 331 (3) StGB, does not offer any protection against the offence of bribery (Section 332 StGB). Employees who are involved in the selection, testing and assessment of drugs or medical devices - primarily department directors and senior physicians, but possibly also subordinate physicians - and who therefore have an influence on ordering decisions, can be accused of bribery. The offence of corruptibility (Section 332 para. 3 no. 2 StGB) is essentially characterised by the fact that it involves an official act contrary to duty or discretionary decisions in which the recipient of the benefit expressly or tacitly shows a willingness to be influenced by the benefit, i.e. not to allow exclusively objective considerations to prevail in his future decision. In this case, the impression that the employee will place the advantage on the "scales" of the decision is sufficient. The employee's inner attitude of actually placing orders solely on the basis of objective criteria and not being guided by the advantage granted does not protect the employee.

Conclusions from the criminal law problem The often difficult demarcation line to § 332 StGB (see legal text in the appendix) requires the physician who has received a benefit to completely refrain from business relationships with the sponsor outside of his scientific funding interests, or at least to exercise extreme caution. This obligation (also) under employment law applies to those doctors and university lecturers who, as part of their freedom of therapy, are obliged to ensure that the patients entrusted to them are provided with medicines and medical devices that meet the necessary suitability and quality in accordance with the medical indication. The conflict, which nevertheless cannot be ruled out in individual cases, can be largely neutralised by clearly separating the product description (doctor) from the procurement process (procurement office). In addition, the doctor may not participate in consultations and decisions of the Drug Commission and Medical Devices Commission in which bias could exist due to contacts with the manufacturer (consultancy contract, product studies). An inappropriately high benefit (excessive fee, participation in "luxury" conferences, etc.) may nevertheless give rise to the suspicion that the doctor might be inclined to increase sales for the company generously sponsoring him. It is therefore the doctor's duty to ensure that the benefits granted to him do not exceed a reasonable limit. In view of the broad definition of the term "benefit" ("training gain") and the fact that every company sponsorship also has an advertising character ("landscape management"), any proximity to a company, however scientifically orientated, can give the impression of "venality". Therefore, before accepting an advantage, the doctor must, in his own interest alone, submit an application for authorisation in accordance with Section 331 (3) of the German Criminal Code to the department.

Different types of benefits The benefits granted by commercial enterprises are either benefits with consideration or benefits without consideration. Grants from third parties in return for services in kind include the participation of clinics or institutes in medical studies (e.g. observational studies), sponsored conferences with the active participation of employees (lectures, moderations, presentations, instructions for use), the assumption of general, remunerated consulting, lecture, licensing or know-how activities. Benefits without consideration may include donations, non-active participation in sponsored training conferences, the "loan" of auxiliary staff, the provision of items for use or consumption or the granting of discounts. In the case of donations with a quid pro quo, these should be unobjectionable if they are appropriate and the recipient also assures that they will not influence any sales transactions with the donor. Critical scrutiny is required, however, in cases involving donations without consideration. In these cases, it must be clear from the contract with the donor that there is no connection with sales transactions. If it is obvious or there is a suspicion that the donor intends to gain advantages for himself or for third parties with the benefit or that he recognisably wants to influence the official actions of the hospital employees, the benefit must be refused. The provision of an assistant free of charge in return for the obligation to only purchase the products manufactured or distributed by the donor would be inadmissible and could already fulfil the offence of corruptibility. In the case of non-active participation in a training event, the department's authorisation must meet stricter requirements.

Applicable regulations

Provisions

Declaration of Helsinki Medicinal Products Act (in particular §§ 40 ff. AMG) Medical Devices Act (in particular §§ 17 ff. MPG) Professional Code of Conduct for Physicians Legal text §§ 331 and 332 StGB

Terms

In the broadest sense, an "advantage" is any material or immaterial gain with or without consideration (payment of travel and hotel costs, discount, lecture fee, etc.). Passive participation in a conference is also seen as an advantage (training gain with improved career opportunities). Furthermore, the realisation of industry-funded research projects such as study contracts, test series, etc. can also be considered an advantage, as can the temporary or permanent provision of loaned equipment. Case law includes not only material advantages such as an economic improvement but also immaterial advantages such as "satisfaction of ambition, vanity, the need for recognition or career opportunities in the concept of an advantage.

Attachments