Are there any anti-bribery rules apply to communications between pharmaceutical companies and healthcare professionals or healthcare organizations?
As mentioned above, 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.
Furthermore, healthcare professionals may not demand or accept any premium, financial or material advantage as mentioned above.
The Belgian Criminal Code provides for the anti-bribery rules concerning the bribery of private legal entities and private individuals (article 504bis and 504ter) and the bribery of public legal entities and individuals holding a public function (article 246 to 252).
There are many such requirements. General requirements are listed in Code of Pharmaceutical Ethics, the Law on Prevention of Corruption, and the Law on Pharmacy. If a healthcare professional works in a public (budget) medical institution, the requirements of declaring public and private interests are additionally applied to him/her.
There are several anti-bribery rules contained in The Mexican Federal Constitution, The Federal Anticorruption Law for Government Procurement, the Federal Criminal Code, and the International anti-corruption conventions ratified by Mexico. Additionally, the industry codes state a variety of anticorruption, transparency, and data privacy provisions to prevent corruption practices.
General anti-bribery rules apply, such as those under the Criminal Justice (Corruption Offences) Act 2018 which applies to promotional communications between pharmaceutical companies and healthcare professionals or healthcare organisations that are found to be corrupt.
The 2007 Regulations do not allow the supply, offer or promise of a gift, pecuniary advantage or benefit in kind, including by communication, unless it is inexpensive and relevant to the practice of medicine or pharmacy. A healthcare professional shall not accept such a prohibited gift, pecuniary advantage, benefit in kind, hospitality, sponsorship, or any other inducement.
The Medical Council Guide states that doctors should not allow their decisions in work to be influenced by benefits provided by pharmaceutical companies. It highlights that that even low-value promotional materials can influence prescribing and treatment decisions.
There are no such specific rules applying to such communications.
In 2012, the German Federal Court of Justice ("Bundesgerichtshof – BGH") ruled that doctors working under contracts with statutory health insurance organisations are not subject to the general anti-bribery provisions in the German Criminal Code (Strafgesetzbuch - StGB) and yet not punishable even in cases of obvious corruption. As a result, the German legislator introduced specific anti-bribery rules for healthcare in sections 299a to 299c StGB. The provisions prohibit "benefits" for health care professionals as an unlawful reward for
- the prescription of pharmaceuticals, aids and medical devices or
- ordering pharmaceuticals, aids and medical devices if they are intended to be used immediately by health care professionals
- the allocation of patients or examination material.
In many cases, it is difficult to determine whether a specific conduct falls under these provisions. In that respect, courts and public authorities work with the concept of social adequacy. Indications for social adequacy are, for example, a contractual exchange relationship with customary terms and conditions or compliance with statutory fee rates. Self-regulatory codes (see no. 2) can also be taken into consideration when it necessary to assess whether a certain behaviour is social adequate.
Against the background of the new regulation, special prosecutor's groups have been formed.
Philippine anti-bribery and corruption laws apply only to communications between pharmaceutical companies and public HCPs / HCOs. The Anti-Graft and Corrupt Practices Act prohibit communications in which:
- The company offers any employment to a public HCP, if the company has pending official business with the public HCP or had official business with the public HCP within the past year; and
- The company urges the divulging or untimely release by the public HCP of confidential information.
In addition, the Philippine Government Procurement Reform Act provides that:
- Companies participating in a public tender are prohibited from communicating with any member of the relevant bids and awards committee ("BAC"), its staff and personnel, secretariat and technical working group regarding the evaluation of their bids until a Notice of Award is issued; and
- The officers of the company that exert undue influence or pressure on members of the BAC or any officer or employee to favour a particular bidder, or employ schemes to suppress competition, may be held criminally liable.
Yes, the anti-bribery provisions in the Swedish Penal Code (1962:700) applies to any and all interaction between pharmaceutical companies on the one hand, and HCPs and HCOs on the other. The provisions mainly provide as follows:
- an employee or contractor may not receive, accept a promise of or request an improper benefit for carrying out an employment or assignment (passive bribery);
- it is not permitted to provide, promise or offer an improper benefit to an employee or contractor for carrying out an employment or assignment (active bribery);
- it is not permitted to receive, accept a promise of or request an improper benefit in order to influence a person who exercises public authority or decides on public procurements, or to provide, promise or offer an improper benefit in order for the recipient to influence the decision maker when exercising public authority or deciding on a public procurement (trading in influence); and
- a businessman must act with caution when providing cash or other assets to its representatives, agents, cooperation partners and other representatives to ensure that the funds are not used for bribes (negligent financing of bribery).
Further, LER holds a number of rules on all interaction between pharmaceutical companies on the one hand, and HCPs and HCOs on the other, including inducements as mentioned under questions 13-17 above. The rules on bribery are interpreted against the content of the industry code.
Additionally, the Swedish Anti-Corruption Institute (Sw. Institutet Mot Mutor) issues a national code of practice for business conduct, the Code on Gifts, Rewards and other Benefits in Business (the ‘IMM Code’). The IMM Code is in principle stricter than the anti-bribery provisions in the Penal Code, and the outspoken purpose of the code is that it should provide businesses with guidance so that they are able to determine what constitutes a permitted or an improper benefit. The provisions mainly provide as follows:
- all kinds of gifts, rewards and other benefits, even those without real direct financial value, e.g., memberships in exclusive clubs or prestigious awards, may constitute an improper benefit;
- it is forbidden to provide any benefits to those who exercise public authority or decide on public procurements;
- there are other categories for which particular restrictiveness should be observed such as employees or contractors at public entities, even if they do not participate in the exercise of public authority or in public procurements, or in sectors where integrity is particularly sensitive and in which particular interests must be protected; and
- no matter the recipient, certain forms of benefits are improper and should not be provided, e.g., (i) monetary gifts, (ii) monetary loans on terms more favourable than market terms, (iii) work or services provided free of charge, (iv) benefits conditional on some performance of the recipient, (v) access to vehicles, boats and holiday homes, (vi) holiday trips, and (vii) offers that are perceived as generally unethical, e.g., strip club visits, etc.
Swiss criminal Code (“SCC”) prohibits active and passive bribery in the private sector (Article 322octies and 322novies SCC). In the case of healthcare professionals working in a public hospital (with public function), the prohibition of active and passive bribery of public officials is applicable (Art. 322ter and 322quater SCC), as well as the prohibition of the acceptance and the granting of an advantage (without any relationship of exchange with the undue advantage) (Art. 322quinquies and 322sexies SCC).
As a general rule, the mere “granting of an advantage” is not punishable between private parties in the SCC. However, in the pharmaceutical sector, the TPA provides criminal sanctions in some cases. From 1 January 2020, the acceptance or the granting of unlawful benefits in favour of persons who prescribe, supply, use or purchase prescription medicines or in favour of organisations that employed such persons (new Art. 55), commits a criminal offence (new Art. 86 TPA). Negligence (failure to consider or disregard of the consequences of his conduct due to a culpable lack of care) is also a criminal offence (Art. 86 par 4 TPA).
There are no specific anti-bribery rules that apply to communications between pharmaceutical companies and HCPs or healthcare organizations. However, representatives of pharmaceutical companies should not communicate with HCPs when HCPs are performing their duties or diagnosing patients.
The Bribery Act 2010 provides a legal framework to combat bribery in the public or private sectors. It includes offences covering the offering, promising or giving of an advantage, and requesting, agreeing to receive or accepting of an advantage. It is enforced by the Serious Fraud Office (SFO). The SFO has advised that this does not prevent proportionate promotional expenditure. It will not seek to prosecute unless it considers this is in the public interest, and in reaching such a decision the SFO will take into account relevant action taken by the PMCPA and the MHRA.
The Bribery Act 2010 requires organisations to implement anti-corruption policies or codes of conduct that are fit for purpose and regular anti-corruption training for its staff. A failure to implement such policies, and/or a breach of the Bribery Act 2010, is likely to result in civil and criminal liability for organisations and individuals, including agents anywhere in the world. If corruption is uncovered, and the relevant organisation responds appropriately, for example by disciplining members of staff involved, and reviewing the effectiveness of internal policies and anti-corruption training, this may help mitigate or avoid criminal liability.
No other than common law actions against bribery. Moreover, a physician might be subject to either ethical or criminal sanctions whether it can be supported he failed to provide the best care to a patient due to payments, grants, favours or bribery.
Subject to certain limited exceptions, the Federal Health Care Program Anti-Kickback Statute (“AKS”) prohibits knowingly and willfully offering any type of remuneration (including a kickback, bribe, or rebate), to induce a person or entity in a position to purchase, lease, order or prescribe, or influence the purchase, lease, order or supply, of any service or item reimbursed by a federal health care program if a purpose of the remuneration is to increase the utilization of products or services reimbursed under those schemes. See 42 U.S.C. § 1320a-7b(b). Thus, if the purpose of the communications were to aid in violations of the AKS, then they would be prohibited.
All States and Territories have domestic anti-corruption or anti-bribery provisions. These are generally broadly defined to include any corrupt giving or receiving of an inducement by an agent to influence the affairs or business of their principal. The agent and principal may be private individuals, corporations or government agents. Bribery under these provisions is sufficiently broadly defined to make any attempt to dishonestly induce or influence a healthcare professional or healthcare organisation in order to gain a benefit (e.g. for a pharmaceutical company) an offence.
 - See Crimes Act 1900 (NSW), pt 4A; Crimes Act 1958 (Vic) ss 175-179; Criminal Code 2002 (ACT) pt 3.7; Criminal Law Consolidation Act 1935 (SA) pt 6; Criminal Code 1913 (WA) ch LV; Criminal Code 1924 (Tas) ss 266-266B; Criminal Code 1983 (NT) ss 236-237; Criminal Code 1899 (Qld) ch 42A.