What are the rules (whether statutory or self-regulatory) which govern the offering of benefits or inducements to healthcare professionals?
In the context of the promotion of medicinal products the offering of benefits or inducements to healthcare professionals is governed by the AMG (see inter alia point 20).
Furthermore, under the Pharmig Code of Conduct, financial or material donations as well as grants to institutions consisting of professionals may only be made for certain purposes (see point 21).
It is prohibited to offer, supply or promise (in)direct benefits to healthcare professionals and healthcare organisations (For exceptions, see question 12).
The Law on Pharmacy of the Republic of Lithuania (approved by the Seimas), Regulations on Medicinal Products Advertising (approved by the Order of the Minister of Health), Procedure for Qualification Improvement of Healthcare and Pharmaceutical Specialists (approved by the Order of the Minister of Health), Code of Pharmaceutical Ethics (a self-regulatory document).
(i) Federal Law of Public Officers Responsibilities.
(ii) The industry Codes:
i) The Code of Ethics and Transparency of the Pharmaceutical Industry;
ii) The Code of Good Practices of Promotion.
The 2007 Regulations state that offering a benefit or inducement to healthcare professionals is not allowed unless it is inexpensive and relevant to the practice of medicine or pharmacy. The offering of benefits or inducements to healthcare professionals must also be in accordance with the Pharmaceutical Industry Code. Some of the restrictions governing same can be found at 13 and 14 above.
The Medical Council Guide states that medical practitioners should not accept gifts (including hospitality) from pharmaceutical, medical devices or other commercial enterprises. This does not prevent medical practitioners attending educational meetings or receiving payment of reasonable fees for professional services to commercial enterprises. The Medical Council Guide states that practitioners should be aware that even low-value promotional materials can influence prescribing and treatment decisions.
Article 158 of Decree Law 176/2006 of August 30 and article 21 of 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.
In general, there are three groups of rules that govern the offering of benefits or inducements to healthcare professionals:
Most importantly, the offering of benefits or inducements for health care professionals is governed by German criminal law (see no. 20).
Further statutory provisions can be found in sec. 7 HWG, in several provisions of the AMG and in sec. 128 of the German Social Code (SGB V), which is, however, only applicable for aids.
Self-regulatory codes (see no. 2) do contain extensive regulations on the offering of benefits or inducements.
Under the PPPMD Guidelines, any item which does not have any direct patient benefit or is not related to the work of the HCP shall not be permitted. Gifts or personal services and benefits unrelated to the work of the HCP shall not be provided by any PPPMD company representative to a health care professional or members of their families. PPPMD companies may provide promotional aids to HCPs, provided these (a) are of modest value; and (b) are relevant to the practice of the health care professions or education of the patients. PPPMD companies may occasionally provide items of medical utility to HCOs and HCPs such as textbooks, subscriptions to medical journals or anatomical models which benefit patients or serve a genuine educational function for the HCO or HCP. Items of medical utility should be modest.
Under the PHAP Code, financial benefit or benefit in-kind (including grants, scholarships, subsidies, support, consulting contracts, or educational practice-related items) may not be provided or offered to HCPs in exchange for prescribing, recommending, purchasing, supplying or administering products or for a commitment to continue to do so. Gifts of any kind for the personal benefit of HCP are also not allowed, irrespective of value, kind or occasion.
In addition, Philippine procurement, anti-bribery and corruption laws, such as the Revised Penal Code and the Anti-Graft and Corrupt Practices Act, apply to the offering of benefits or inducements to public HCPs. Among others, the following acts are prohibited:
- The giving of gifts to public sector HCPs and communications that may constitute inducements such as employment offers are generally prohibited, subject to limited exceptions (such as unsolicited gifts of nominal value that are not given by reason of the public HCP's office);
- The exertion of undue influence or pressure on members of the BAC or any officer or employee of a procuring government entity to take a particular action that favours or tends to favour a particular bidder; and
- The employment of schemes, in connivance with a public HCP, that tend to restrain or stifle competition in the bidding.
The statutory rules applying to the offering of benefits or inducements to HCPs are the anti-bribery provisions in the Swedish Penal Code (1962:700), please see question 20 above.
On top of the anti-bribery provision, detailed rules on the offering of benefits or inducements to HCPs can be found in LER, please see questions 12-18 and 20 above. Additional self-regulation can be found in the IMM Code, please see question 20 above.
Offering of benefits or inducements to healthcare professionals rules were part of the amendments agreed to the TPA and the adoption of the new OITTP. According to the new Art. 55 TPA, persons prescribing, delivering, using or purchasing prescription medicines and organizations employing such persons, may not solicit, be promised or accepted an unlawful benefit. It is also prohibited to offer, promise or to grant these persons or organisations an unlawful benefit.
Are not considered unlawful benefits and are therefore allowed, the following benefits (new Art. 55 par. 2 TPA):
- Benefits of a modest value (not more than CHF 300 per year per professional) and related to the practice of medicine or pharmacy (directly connected to the professional activity or when patients directly benefit from it) (new Art. 3 OITTP) (see Answer 12 above).
- Donations for research, postgraduate education or continuous education, as long as they are offered to the organisation and under certain conditions (new Art. 4 and 5 OITTP). There are specific rules for donations for the participation to events related to postgraduate or continuous education (new Art. 6 OITTP) (see Answers 14, 15 and 17 above).
- Compensation granted in return for equivalent services, in particular those granted for orders and deliveries of therapeutic products under certain conditions (new Art. 7 OITTP) (see Answer 16 above).
- Discounts (difference between the standard price or the factory price for listed medicines and the paid price) or rebates granted on the purchase of therapeutic products as long as they do not influence the choice of treatment (new Art. 8 par 1 OITTP). Delivery of a greater quantity than the one ordered and invoiced is prohibited (new Art. 8 par. 2 OITTP) (see Answer 18 above).
All agreements with healthcare professionals or organisations concerning the abovementioned benefits shall be kept for ten years. A list of all the healthcare professionals and the organisation having benefited from advantages shall be established (new Art. 11 OITTP).
Moreover, any benefit shall be mentioned in the invoice and the direct or indirect benefits he/she receives shall be passed on to the final debtor of the medicine (patient/insurance) (Art. 56 HIA and new 76a OHI). However, from 1 January 2020, insurers and service providers will be allowed to provide, in an agreement, that a minor part of the benefits are not to be passed on but to be used in a verifiable way to improve the quality of treatment (new Art. 56 par. 3bis HIA).
The Pharma Code also provide rules on offering benefits or inducement that are similar to the abovementioned rules (and more detailed), which may be slightly amended following the adoption of the new rules of the TPA and the OITTP.
The Penal Code and the Act Supplementing the Constitution Relating to the Prevention and Suppression of Corruption, B.E. 2561 (2018) (the "Anti-Corruption Act") are the main laws that govern the offering of benefits or inducements to the HCPs, especially if the HCPs are deemed to be government officials.
A person may be guilty of bribery if he or she gives, offers, or agrees to give property or any other benefit to an official in order to induce the official to do or refrain from doing any act, or to delay the performance of any act, in a manner contrary to the official's functions or duties. To prove bribery, there must be dishonest intent, and benefits being given to make the official perform or not perform his or her duty on a quid pro quo basis.
Part 14 of the Regulations (in particular Article 300) regulates the advertising to persons “authorised to prescribe or supply medicinal products”, including any benefits (e.g. free samples, gifts or other advantages) offered to such persons.
According to Article 7, the term "advertisement", in relation to a medicinal product, "includes anything designed to promote the prescription, supply, sale or use of that product" (Article 7(1), and specifically Article 7(2)), including:
a) “the provision of inducements to prescribe or supply medicinal products by the gift, offer or promise of any benefit or bonus, whether in money or in kind, except where the intrinsic value of such inducements is minimal;
b) the sponsorship of promotional meetings attended by persons qualified to prescribe or supply medicinal products; and
c) the sponsorship of scientific congresses attended by persons qualified to prescribe or supply medicinal products, including the payment of their travelling and accommodation expenses in that connection.”
Paragraph 6.14 of the Blue Guide provides some guidance on the interpretation of the types of promotion which are prohibited because of their potential to adversely impact public health. It states that any "promotional activity which encourages the purchase, supply or sale of a medicinal product by PQPS" will be caught by Article 300(1) of the Regulations if it offers a collateral benefit which does not satisfy the tests of being “inexpensive” and “relevant to the practice of medicine or pharmacy” (see section 9.1), unless it is exempt under Article 300(6). It clarifies further that any “person” promoting medicines to PQPS will be subject to Article 300(1), where the term "person" covers both corporate and unincorporated bodies as well as individuals and includes manufacturers and distributors of medicines, including wholesale dealers. Breach of Article 300(1) is a criminal offence, as is the soliciting or accepting of any gift, benefit in kind, hospitality or sponsorship prohibited by the regulations, by a PQPS.
Transfers of value to healthcare professionals in the UK are also subject to the ABPI Code. If such a transfer is made to a PQPS, to any relevant decision maker, or any company located in the UK (irrespective of where in Europe the recipients are), then such transfer is within the scope of the ABPI Code.
If the transfer of value is either hospitality or a gift which are in some way inappropriate, they may fall foul of the ABPI Code and attract sanctions. Examples include hospitality that is inappropriate and disproportional to the occasion, or a gift, pecuniary advantage, or benefit being supplied, offered, or promised in connection with the promotion or prescription of a medicine.
Possible sanctions of breaching the ABPI Code include: a company being ordered to give an undertaking that the practice in question has ceased and all possible steps have been taken to prevent a similar breach in the future; an audit of company procedures; and the issue of a corrective statement or a public reprimand.
Similarly, the EFPIA HCP Code 2013 and the EFPIA Disclosure Code 2014 provide for its member associations to establish national procedures to receive and process complaints, determine sanctions and publish appropriate details regarding the same. If complaints are received, they should be adjudicated by the national associations of EFPIA, which should have procedures and structures for this purpose, including an appeals process. Any final decision taken will be published – and should include the company name in the case of serious/repeated breaches.
The promotion or advertising of medicinal products will be only allowed free or below their real value, if related to the health professional or hospitals and offer a benefit for the patient. Otherwise, the discount could be considered as a financial benefit against the provisions of the Board.
Under United States law, gifts, payments and other benefits or inducements made to health care professionals to induce them to prescribe a manufacturer’s products are strictly prohibited, pursuant to the Federal Health Care Program Anti-Kickback Statute (the “AKS”), 42 U.S.C. § 1320-a-7b(b). Subject to certain safe harbors, the AKS makes it a criminal felony to knowingly and willfully offer any type of remuneration (including a kickback, bribe, or rebate) to any person or entity in a position to purchase, lease, order or prescribe (or influence the purchase, lease, order or supply) a service or item reimbursed by a state or federal health care program. The statute extends equally to the solicitation or acceptance of remuneration for referrals. Additionally, some states have enacted laws that prohibit and/or cap gifts and payments to health care providers. Relevant state laws should be consulted prior to making any such payments or gifts.
The Foreign Corrupt Practices Act (“FCPA), 15 U.S.C. §78dd-1, et seq., is a federal anti-bribery statute that governs financial relationships with foreign government officials to combat corruption. The FCPA prohibits corrupt payments to foreign officials for the purpose of obtaining or keeping business. The law also applies to foreign firms and persons who cause, directly, or through agents, an act in furtherance of such a corrupt payment to take place within the United States. The law applies equally to money, gifts, or anything of value. The law also requires companies whose securities are listed in the United States to meet certain accounting provisions, which were designed to operate in tandem with the anti-bribery provisions of the FCPA and require corporations covered by the provisions to (a) make and keep books and records that accurately and failure reflect the transactions of the corporation and (b) devise and maintain an adequate system of internal accounting controls. 15 U.S.C. §78m.
The Office of the Inspector General (“OIG”) has repeatedly expressed concern about free goods and services being offered to health care providers as an inducement to prescribe or purchase a certain drug or device. Guidance has been issued in the United States to aid pharmaceutical manufacturers and others in a position to make or influence referrals. For instance, the Department of Health and Human Services OIG issued a Compliance Program Guidance for Pharmaceutical Manufacturers in May 2003 (https://oig.hhs.gov/authorities/docs/03/050503FRCPGPharmac.pdf).
Voluntary codes have also been issued to aid companies in complying with the law. Specifically, the PhRMA Code on Interactions with Health Care Professionals (https://www.phrma.org/-/media/Project/PhRMA/PhRMA-Org/PhRMA-Org/PDF/Code-of-Interaction_FINAL21.pdf) (“PhRMA Code”), is a code that member companies of PhRMA have voluntarily undertaken to comply with. The OIG has stated that compliance with the PhRMA Code would substantially reduce a manufacturer’s risk under the AKS, and although the PhRMA Code is a voluntary code, certain state laws require pharmaceutical manufactures to adopt compliance programs consistent with the PhRMA Code.
Furthermore, the Advanced Medical Technology Association (“AdvaMed”), a trade association for medical device manufacturers, has adopted the Code of Ethics on Interactions with Health Care Professionals (https://www.advamed.org/sites/default/files/resource/advamed-code-ethics-2020.pdf) (the “AdvaMed Code”). Although the AdvaMed Code is voluntary, certain states require device manufacturers to adopt compliance programs consistent with the AdvaMed Code. The revised AdvaMEd Code goes into effect on January 1, 2020.
Finally, the American Medical Association (“AMA”) has also issued the Code of Medical Ethics Opinion 9.6.2 (https://www.ama-assn.org/delivering-care/ethics/gifts-physicians-industry) regarding gifts to physicians from the industry.
While these Codes are voluntary, United States authorities have encouraged manufacturers to comply with them, and as stated above, some states even require compliance.
Inducements of any kind made to healthcare professionals to prescribe, recommend, dispense or administer a company's products are prohibited by the Medicines Australia Code. Additionally, interactions between companies and healthcare professions must not discredit the industry. Inducements or benefits, other than legitimate consulting activities, conference attendance etc. as permitted under the Code are likely to discredit the industry.
It is an offence under the Health Practitioner Regulation National Law section 136 to direct or incite any health practitioner to do anything which amounts to unprofessional conduct. Unprofessional conduct includes accepting a benefit for referring a patient, recommending a product or providing a service (including prescribing medicines) when not reasonably necessary. As a result, offering inducements to recommend or prescribe a product is likely to be an offence.
 - Medicines Australia, Medicines Australia Code of Conduct, 18th ed. June 2015, s 9.12.
 - Medicines Australia, Medicines Australia Code of Conduct, 18th ed. June 2015, s 9.13.
 - Health Practitioner Regulation National Law (NSW), s139B.