May pharmaceutical companies offer gifts to healthcare professionals and are there any monetary limits?
In the context of the promotion of medicinal products, it is prohibited to grant, offer or promise any premium, financial or material advantage to any person entitled to prescribe or supply a medicinal product, except where such advantage is of negligible value and relevant to medical or pharmaceutical practice.
The payment of reasonable travel and subsistence expenses and the participation fees for exclusively occupation-related scientific events to any person entitled to prescribe or supply a medicinal product is not forbidden. However, only reasonable travel and subsistence expense may be covered.
In any case, the granting of advantages to other persons (e.g. spouse) is inadmissible.
Under Belgian law, gifts to healthcare professionals are prohibited, with the exception of gifts with a limited value and being directly related to the medical profession (article 10 AMP). As a standard for limited value, it is generally accepted that gifts for a maximum value of EUR 125 per healthcare professional per year would be acceptable.
Gifts from pharmaceutical companies to healthcare professionals are prohibited. This is considered as advertising for medicines that is prohibited.
According to statement 4.6.9 of GPP, in any case gifts of significant commercial value may not be offered to healthcare professionals, either any incentives of any kind as inducement to recommend a specific product.
The monetary limit is 40 dollars, set forth in the Federal Law of Public Officers Responsibilities (Ley Federal de Responsabilidades de los Administradores Públicos). This limit only applies for health professionals working at government health entities, however as there is not specific limit in the industry codes, this can be used as a reference for private practice.
The 2007 Regulations do not allow the supply, offer or promise of a gift, pecuniary advantage or benefit in kind, unless it is inexpensive and relevant to the practice of medicine or pharmacy. A healthcare professional shall not accept a prohibited gift.
The Pharmacy Industry Code does not allow gifts, pecuniary advantages or benefits in kind to be supplied, offered or promised to persons qualified to prescribe or supply by a company in relation to the promotion/marketing of prescription medicines.
The Medical Council Guide to Professional Conduct and Ethics for Registered Medical Practitioners (‘Medical Council Guide’) states that registered medical practitioners should not accept gifts (including hospitality) from pharmaceutical, medical devices or other commercial enterprises.
The provision of informational or educational materials is permitted provided the materials are: (i) inexpensive; (ii) directly relevant to the practice of medicine or pharmacy; and (iii) directly beneficial to patient care. Companies may provide pens or paper exclusively during company organised meetings, as long as they are inexpensive and not product branded.
Pharmaceutical companies cannot offer gifts to healthcare professionals nor any pecuniary or in-kind benefit, except if the same are of insignificant pecuniary value (less than 60 Euros) and cumulatively relevant for the medicine or pharmaceutical practice.
Sec. 7 HWG provides that it is generally not permitted to offer, announce or grant benefits or other advertising gifts (goods or services) while providing certain exemptions. Under these exemptions, granting benefits to healthcare professionals can be admissible in the following instances:
- the benefit is of low value (not above one Euro)
- the benefit is a small-value item (no notable economic value)
- rebates in kind or in cash only for over the counter medicines
- discounts in kind or cash for other medicines as long as they are not granted contrary to the price regulations applicable under the AMG
- customary accessories to the product or customary ancillary services
- providing information and advice
- customer magazines
If granted to healthcare professionals, in addition to the above, the benefit needs to be for use in the medical, veterinary or pharmaceutical practice.
When offering gifts, the Criminal Code also must be taken into consideration as this can result in criminal liability under Sec. 299a of the Criminal Code. This provision penalizes bribery of healthcare professionals.
No. Gifts or personal services and benefits unrelated to the work of the HCP shall not be provided by any PPPMD company representative to an HCP or members of their families. However, PPPMD companies may provide promotional aids or items of medical utility 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.
In addition, Philippine anti-bribery and corruption laws, such as the Revised Penal Code and Presidential Decree No. 46, generally prohibit the giving of gifts to an HCP in the public sector ("public HCPs") simply by reason of the public HCP's official position, regardless of the underlying purpose. A public HCP covers doctors, nurses and other healthcare professionals / workers employed by or working in government-owned hospitals. As an exception, certain laws which also apply to public sector HCPs, such as the Anti-Graft and Corrupt Practices Act and the Code of Conduct and Ethical Standards for Public Officers and Employees, allow the giving of unsolicited gifts of nominal value to public HCPs.
Gifts are generally prohibited and shall not be provided, offered or promised to HCPs. However, LER stipulates a few exemptions from the prohibition, namely:
- Informational and educational materials can be provided if the total value does not exceed SEK 450 (incl. VAT) and under the conditions that the material is directly relevant to the practice of the recipient and directly beneficial to the care of patients.
- Items of medical utility can be provided for purposes of educating employees and for the care of patients if the total value does not exceed SEK 450 (incl. VAT) and the item is not such which is routinely used in the recipient's business.
Gifts allowed according to the above may never be supplied, offered or promised as an incentive to recommend, prescribe, purchase, supply, sell or administer specific medicinal products
Persons prescribing, delivering, using or purchasing prescription medicines and organisations employing such persons may not solicit, be promised or accepted, for themselves or for a third party, an unlawful benefit (new Art. 55 TPA).
Therefore, gifts are not allowed. However, gifts 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 them) are allowed (new Art. 3 OITTP). Year-end gifts are not considered as connected to the professional activities. For contest gifts, it is additionally required that the gift shall not be connected with the purchase of prescription medicines (new Art. 3 par. 3 OITTP).
The gifts may be given on a traditional, customary or cultural occasion, or on an occasion on which it is general social practice to give gifts. In any case, no government official may receive any gifts with a value in excess of Baht 3,000 (approximately USD 100) on a single occasion from a person that are not relatives.
Furthermore, under the current Medical Council Regulations on the Preservation of Medical Ethics, B.E. 2549 (2006), all HCPs (whether deemed government officials or not) shall not accept any gifts worth more than Baht 3,000 from the operators of businesses related to healthcare products.
Article 300(1) of the Regulations provides that no gift, pecuniary advantage or other benefit may be provided to healthcare professionals in connection with the promotion of medicinal products unless it is (i) inexpensive and (ii) relevant to the practice of medicine or pharmacy.
Paragraph 6.15 of the Blue Guide sets out guidance on the interpretation of “inexpensive” and “relevant” and confirms that “both conditions must be satisfied.”
- Inexpensive: “those which do not cost a company more than GBP6 (excluding VAT) and represent a similar value to the recipient”;
- Relevance: “only met by items which have a clear business use and may include such items as pens, notepads, calculators, computer accessories, diaries, calendars, surgical gloves, tissues and coffee mugs”.
The Blue Guide contains an explicit warning that breach of Article 300(1) of the Regulations is a criminal offence. It is also an offence for any person qualified to prescribe or supply medicinal products to solicit or accept any gift, pecuniary advantage or any benefit in kind in breach of this provision.
For POMs, the ABPI Code is more restrictive than the Regulations: any gift to health professional or other relevant decision-makers is prohibited as a rule, save in exceptional circumstances. The ABPI Code carves out three main exceptions to this rule and allows for:
- Inexpensive promotional materials provided at events to the attendees (Clause 18.3), i.e. a set of notebook and pen or pencil each, for a total costs not exceeding £6 (excluding VAT) per individual and the perceived value by the recipient must be similar;
- the provision of information support DVDs or memory sticks for educational or promotional material if the support cannot be used to store other data, respectively, is commensurate with the amount of data to be stored (Clause 18.1 Supplementary Information);
- information material to be passed on to patients, which will not be consider promotional if it is limited to “leaflets, booklets and textbooks about medicines and their uses” (Clause 18.1 Supplementary information; see also “patient support items” (Clause 18.2 Supplementary information).
Apart from these exceptions, according to the ABPI, any items (also referred to as "promotional aid", i.e. a “non-monetary gift made for a promotional purpose”) provided must “directly benefit patient care”, and “be passed on to patients” as “part of a formal patient support programme” with appropriate documentation and certification. The ABPI also considerably restrict the modes through which, and the purposes for which, the items may be given out (Paragraphs 18.2 and 18.3). Thus, items must not be provided from exhibition stands or to administrative staff. The ABPI (Clause 18.1, supplementary information) states that no item may be provided for the personal benefit of health professionals or other relevant decision makers, and also excludes items that would be used within the course of their business: “coffee mugs, stationery, computer accessories, diaries, calendars and the like are not acceptable”, or even as part of their clinical practice: “Gifts of items for use with patients in the clinic, surgery or treatment room etc., such as surgical gloves, nail brushes, tongue depressors, tissues and the like, are also not acceptable”.
Promotional aids must not bear the name or any information about any medicine, but may bear the name of the company providing them. If such items are included in conference bags provided at third party organised conferences, the gifts should not include the company name or the name of any medicine or any information about medicines
Paragraph 6.15 of the Blue Guide adds that the restrictions of the Regulations also apply to membership schemes and cumulative points schemes which have the effect of conferring benefits in the form of free or reduced price goods or services.
Finally, the National Health Service (NHS) has also published general Guidelines on Commercial Sponsorship, setting out ethical standards that all healthcare professionals must observe. For example, NHS staff and contractors must refuse to accept gifts, benefits, hospitality or sponsorship of any kind that might reasonably be seen to compromise their personal judgment or integrity. In addition, gifts, benefits and sponsorships must be declared in a register.
The promotion and advertising of medicines can never occur in form of financial or material benefit in favor of the health professionals, or of any other physician or legal person in charge of prescribing and administrating medicines. Consequently, any support to health professionals from the pharmaceutical industry for participating in scientific, educational or international events can never be conditioned to the obligation of promoting or announcing any kind of medicines.
The entertainments or any other gesture of hospitality of the health professionals by a pharmaceutical company in educative scientific events must occupy a secondary place in respect to the primary target of the meeting and have to stay in a modest level.
The federal Physician Payments Sunshine Act (the “Sunshine Act”) requires each “applicable manufacturer” of a covered device, drug, biologic, or medical supply that is operating in the United States to report information on payments made in the preceding year to both physicians and teaching hospitals. The Sunshine Act does not prohibit pharmaceutical companies from giving gifts to health care professionals. Rather, it requires such companies to publicly report its gifts. Instead of outright prohibiting the giving of gifts to health care professionals, the intention of the federal statute is to shine a light on potential conflicts of interest that may result from substantial gift giving. Some states have enacted laws that go so far as to prohibit pharmaceutical companies from giving gifts and incentives to health care professionals. Additionally, some state statutes require pharmaceutical companies to report gifts, and other states have put a monetary limit on such gifts.
In addition to the federal and state statutes, there are a number of guidelines available that advise with respect to gifts. The OIG Compliance Program Guidance for Pharmaceutical Manufacturers (April 2003) (https://oig.hhs.gov/fraud/docs/complianceguidance/042803pharmacymfgnonfr.pdf) advises that “[a]ny time a pharmaceutical manufacturer provides anything of value to a physician who might prescribe the manufacturer’s product, the manufacturer should examine whether it is providing a valuable tangible benefit to the physician with the intent to induce or reward referrals.” 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) advises that “[p]ayments in cash or cash equivalents (such as gift certificates) should not be offered to health care professionals either directly or indirectly, except as compensation for bona fide services,” as “[c]ash or equivalent payments of any kind create a potential appearance of impropriety or conflict of interest.” Finally, the American Medical Association (“AMA”) Code of Medical Ethics’ Opinions on Physicians’ Relationships with Drug Companies and Duty to Assist in Containing Drug Costs, Opinion 8.061 (https://journalofethics.ama-assn.org/article/ama-code-medical-ethics-opinions-physicians-relationships-drug-companies-and-duty-assist-containing/2014-04) advises that to avoid the acceptance of inappropriate gifts, physicians should ensure that any gifts accepted by physicians individually primarily benefit patients and are not of substantial value. The ABA advises that cash payments are inappropriate, but textbooks, modest meals, pens and notepads are appropriate. The AMA ethics opinion goes on to state that “[n]o gifts should be accepted if there are strings attached.”
Gifts to healthcare professionals are not permitted under any circumstances, except for company branded stationary, educational materials, sponsorship to attend educational events and appropriate hospitality at those events.
 - Medicines Australia, Medicines Australia Code of Conduct, 18th ed. June 2015, s 9.12.