Is it possible to pay for services provided by healthcare professionals and if so, which restrictions apply?
The Pharmig Code of Conduct contains various restrictions regarding the cooperation between pharmaceutical companies and healthcare professionals.
Services provided by professionals for pharmaceutical companies (e.g. for lectures, consulting, clinical trials, non-interventional studies) may only be used for education/further training, research or support of the health care system or provided within the framework of scientific or professional activities. A written contract must be concluded, clearly stating the service, remuneration, type, scope and purpose of the service.
The provision of services by professionals must not be subject to a condition relating to the recommendation, prescription or supply of a medicinal product.
Furthermore, doctors working in public hospitals might be considered as ‘public officials’ within the meaning of the Austrian Criminal Code. A person/company commits a criminal offence if someone offers, promises or grants an advantage to a public official or a third party for the conduct or omission of an official act in breach of duty.
Yes, on the condition that the services provided by healthcare professionals are of a scientific nature and have a legitimate character. Examples of such services are speaker engagements, participation in advisory boards, consultancy, clinical trial services, etc.
Specific Mdeon guidelines set forth that the healthcare professional’s compensation should be (i) reasonable, (ii) proportionate, (iii) consistent, (iv) a reflection of the “fair market value” of the services, and (v) be in line with the scope and duration of the services (in function of the complexity, level of experience of the healthcare professional, degree of urgency, …). The prescription behavior of the healthcare professional ought not to be a factor for determining the applicable compensation. It is not allowed to use the provision of services by a healthcare professional as a loophole to provide (prohibited) advantages to healthcare professionals.
Yes, it is possible. In the case of services provided by a healthcare professional or pharmacist to a pharmaceutical company, a service contract must be concluded and the scope of the services clearly defined. Typically, such services include the collection and systematisation of clinical practice, the preparation of slides and reading reports, the preparation of advice and recommendations on the use of the product should there be a need to adapt the available material, to summarize clinical trial results, etc.
Accredited healthcare professionals can be hired as consultants to provide health services and medical knowledge, such as help in medical development, participate in clinical research or any kind of investigations, to be speaker at presentations aimed to sales staff. Payment of such services shall follow local market criteria, be consistent with the time spent, the work done and the assumed responsibilities.
Under no circumstance healthcare professionals will be hired for an incentive to use, prescribe, buy or recommend any product.
Healthcare professionals can be paid for services (e.g. chairing or speaking at meetings, being involved in medical/scientific studies or in clinical trials) provided they meet the following restrictions:
- A legitimate need must be identified before the request for such services;
- Contract signed in advance of the commencement of the services;
- Criteria directly related to a need of a company must drive the selection and evaluation of a healthcare professional to provide services;
- Only the number of healthcare professionals reasonably necessary to fulfill the need of the company can be maintained;
- Records concerning the services must be kept;
- The hiring of a healthcare professional must not be an inducement to prescribe, supply, sell or consume a particular medicinal product; and
- Compensation must be fair market value of the services and reasonable.
This does not apply to of one-off phone interviews or mail/email/internet questionnaires.
Yes. Services may be contract and paid to healthcare professionals for their active participation, namely through the presentation of scientific communications in scientific events or training sessions or promotional events of medicines, once, in any case, the payment in question is not dependable or constitutes a compensation for the prescription or dispense of medicines.
In accordance with Apifarma´s Code of Ethics for Promotion Practices of the Pharmaceutical Industry and Interaction with Healthcare Professionals and Institutions, Organisations or Associations Comprising Healthcare Professionals, the payment to healthcare professionals must be reasonable and reflect the market value of the services to be provided by the same.
Yes, as long as the remuneration for such services does not constitute a hidden benefit within the meaning of Sec. 7 HWG. This means that service rendered by the healthcare professional and the agreed-upon remuneration should be proportionate to each other. In addition, any cooperation with healthcare professionals should be made transparent and only on basis of a written agreement.
Yes, the PPPMD Guidelines allows speaker and consultant arrangements between PPPMD companies and HCPs. In particular, the engagement of HCPs in medical conferences or scientific studies may be allowed, provided there is a written contract which specifies the nature of services rendered and payment for such services, including the following:
- Criteria for consultant selection is based on identified need and expertise;
- Contracting company keeps a record of all transactions;
- Compensation for said services is reasonable and reflect the fair market value for said services;
- Disclosure of any potential or actual conflict of interest by the consultant or speaker must be made; and
- Information is to be made public, if and when requested for legitimate purposes.
If the consultant is a public HCP, the consultant should be duly authorized by the head of his / her agency to engage in private practice of profession.
All manufacturers of drugs, medical devices, biological and medical supplies registered by the FDA shall collect and track all financial relationships with health care professionals and health care providers and report these to the DOH, which shall then make this list publicly available in accordance with existing laws. There are currently no clear timelines or deadlines imposed on such report.
Yes, it is possible to pay for consultations and assignments provided by HCPs, e.g., participation in advisory boards and market research. However, such payments risk being considered improper inducements and are strictly regulated in LER. The primary rule is that consultations and assignments may never constitute an incentive to recommend, prescribe, purchase, supply, sell or administer specific medicinal products. Further, all interaction with HCPs must comply with the general rules for cooperation (please see question 14 above). Transfers of value must also be recorded (please see question 18 below).
The remuneration paid to HCPs for their services in consultations and assignments shall be reasonable in relation to the content of the work and the time spent. Where applicable, reimbursement of expenses shall be paid in accordance with the employer's rules for travel and expenses. No other benefits, remuneration or gifts may occur. Compensation for work carried out as a part of normal work duties shall be paid to the employer.
It is possible to pay compensation in return for equivalent services, in particular those granted for orders and deliveries of therapeutic products. This means they shall be connected to the purchase of prescription medicines, teaching, expert/advisory activities, clinical studies, experience report in scientific journals and participation to consultative committees or market studies (Art. 7 par. 4 OITTP).
The compensation shall be agreed by written agreement, be proportionate and not for a service that the professional (or the organisation) does for himself (or itself), be part of a legal duty or already paid by other means (new Art. 7 OITTP).
It is possible for a pharmaceutical company to pay for services provided by HCPs, as long as there is a legitimate reason to hire them. Fees for services should be the reasonable and represent fair-market rate. There are also no laws or regulations that require HCPs to obtain pre-approval from their employer before signing a service contract with a pharmaceutical company. However, the pharmaceutical company should inform the HCP's employer of its intent to enter the service contract, especially if the HCPs are deemed to be government officials.
The Blue Guide implicitly accepts that health professionals may be remunerated for providing services to pharmaceutical companies (the Blue Guide names advisory boards, market research as illustrations), but insists that “particular care should be taken […] to ensure that there is no element of promotion”. The services should be “clearly designed to answer legitimate business questions and the number of participants should be kept to the minimum needed for this purpose”.
Clause 23 of the ABPI Code provides that it is possible to pay healthcare professionals to provide genuine consultancy or other services such as "speaking at and chairing meetings, involvement in medical/scientific studies, clinical trials or training services, participation at advisory board meetings, and participation in market research where such participation involves remuneration and/or travel" (ABPI Code, Paragraph 23.1). However, the following conditions apply:
- The consultancy or other services must be genuine;
- Written contract agreed in advance specifying the nature of the services and the basis for the payment;
- Clear identification of a legitimate need in advance of the request;
- Criteria for selection must be directly related to the needs, and selection must be conducted by persons qualified to verify these criteria;
- Number of consultants limited to what is strictly necessary;
- Maintain records and make appropriate use of the services;
- the hiring of the consultant must not be an inducement to prescribe, supply, administer, recommend, buy or sell any medicine
- Compensation must be reasonable, reflect the fair market value;
- Contracts must include obligation for the consultant to declare the consultancy whenever writes or speaks on a relevant topics to the public;
ABPI (Supplementary Information ABPI Code Paragraph 18.1) provides that donations to charities “in return for health professionals’ attendance at company stands at meetings are not unacceptable” provided that certain conditions are fulfilled and the payment would not be otherwise unacceptable under the ABPI Code (e.g. the donation may not amount to an impermissible ‘inducement’).
It is possible to pay physicians to provide expert services (e.g. participating in focus groups), as long as such payment is not made as a consequence of the promotion or advertising of a medicinal product, and does not compromise the scientific truth or the opinion of the health professional.
While payments made to healthcare professionals to induce them to prescribe a specific product are prohibited under United States law, it is possible to pay healthcare professionals in connection with consulting agreements, so long as the agreement is for bona fide services, at a fair market value, and the arrangement is not intended to influence the health care professional’s prescribing decisions.
The Federal Health Care Program Anti-Kickback Statute (“AKS”) in the United States creates a safe harbor for “personal services.” This safe harbor can be implemented to protect consulting or services agreements between manufacturers and healthcare professionals so long as certain requirements are met. See 42 C.F.R. § 1001.952(d). The safe harbor requirements are as follows: (1) the agreement must be in writing and signed by both parties; (2) the agreement must cover all the services the agent provides to the principal for the term of the agreement and specify the services to be provided by the agent; (3) if the agreement is intended to provide for periodic, sporadic, or part-time services, rather than on a full-time basis, the agreement must specify the schedule of such intervals, the length of such intervals and the exact charge for such intervals; (4) the term of the agreement may not be for less than one (1) year; (5) the aggregate compensation paid to the agent over the term of the agreement must be set in advance, consistent with fair market value in arms-length transactions, and must not take into account the volume or value of any referrals or business generated between the parties for which payment may be made in whole or in part under Medicare, Medicaid or other Federal health care programs; (6) the services must not involve the counselling or promotion of business arrangement or other activity that violates federal or state law; and (7) the aggregate services contracted for must not exceed those which are reasonably necessary to accomplish the commercially reasonable business purpose.
In addition, the PhRMA Code states that it is appropriate for consultants who provide advisory services to be offered reasonable compensation for those services and reimbursement for reasonable travel, lodging, and meal expenses incurred as part of providing those services, and that any compensation or reimbursement made in conjunction with a consulting arrangement should be reasonable and based on fair market value. The PhRMA Code states the following factors support the existence of a bona fide arrangement: (i) a written contract that specifies the nature of the consulting services to be provided and the basis for payment of those services; (ii) a legitimate need for the consulting services has been clearly identified in advance of requesting the services and entering into arrangements with the prospective consultants; (iii) the criteria for selecting consultants is directly related to the identified purpose and the persons responsible for selecting the consultants have the expertise necessary to evaluate whether the particular health care professionals meet those criteria; (iv) the number of health care professionals retained is not greater than the number reasonably necessary to achieve the identified purpose; (v) the retaining company maintains records concerning and makes appropriate use of the services provided by consultants; and (vi) the venue and circumstances of any meeting with consultants are conducive to the consulting services and activities related to the services are the primary focus of the meeting, specifically, resorts re not appropriate venues.
Pharmaceutical companies may pay suitably qualified healthcare professionals for services such as consultancy and advisory board membership. A legitimate need for the services must be clearly identified prior to engaging the health professional and details of the arrangement, including a clear objective, set out in a written contract. The number of healthcare professionals engaged and their remuneration must be reasonable in light of the defined purpose.
When convening advisory boards, a document justifying the need, size and objective of the board must be available for public scrutiny. Advisory boards must generally meet in Australia and records of their activity must be maintained.
 - Medicines Australia, Medicines Australia Code of Conduct, 18th ed. June 2015, ss 9.8-9.9.
 - Medicines Australia, Medicines Australia Code of Conduct, 18th ed. June 2015, ss 9.8.2-9.8.4.
 - Medicines Australia, Medicines Australia Code of Conduct, 18th ed. June 2015, s 9.9.