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Compliance and enforcement


What measures are in place to enforce the laws governing medicinal products?

The Drug Act BE 2510 (1967) specifies criminal penalties (ie, imprisonment and fine) for business operators that fail to comply with the relevant requirements.

Moreover, the Food and Drug Administration (FDA) is also empowered under the Drug Act to enforce the provisions of the Drug Act through various mechanisms, including checking products in the market.

However, personnel restrictions means that the FDA must limit its enforcement to cases where spot checks reveal that products are not up to standard, or when it receives a complaint about a specific drug. The FDA may ask some follow-up questions, and request proof from the complainant to determine the legitimacy of the complaint. The FDA will then start gathering preliminary information on the product and the responsible person. The product at issue will be analysed, and the results compared with the product licence and registrations, and any relevant legislation to determine infractions. The investigation and inspection procedures applied by the FDA vary from case to case. If necessary, the FDA may enlist the Police for assistance. The penalties for the infractions are provided in the relevant legislation.

Dishonest practices

What mechanisms are in place to combat bribery, fraud, collusion, counterfeiting and other dishonest practices in the pharmaceutical sector?

There is no specific mechanism to combat bribery, fraud, collusion, counterfeiting and other dishonest practices in the pharmaceutical sector. Therefore, the general laws and regulations apply. They have been recently amended to be more stringent in order to combat bribery. For example, the Act Supplementing the Constitution Relating to Prevention and Suppression of Corruption BE 2542 (1999) (the Anti-Corruption Act) specifies a presumption of criminal liability on legal persons whose employees offer or receive bribes. The entity will be deemed to be committing the offence, unless it can prove that it has put in place appropriate internal controls.

Section 123/5(2) of the Anti-Corruption Act specifies that if a person who has committed bribery is related to a legal person (eg, an employee or agent) or performing for or on behalf of that legal person, and the offence is committed for the benefit of the legal person and that legal person has not put in place appropriate internal controls to prevent the commission of such an offence, that legal person will be subject to a penalty of a fine up to twice the assets received from the commission of the offence.

On December 16 2017 the Office of the National Anti-Corruption Commission issued a separate notification under the Anti Corruption Act that specifically requires companies to have appropriate internal control measures for the prevention of acts of bribery which may be undertaken by a company's connected persons for the company's benefit. Under the notification, the company's internal control measures must at least include the following eight fundamental elements:

  • strong, visible policies and support from top-level management to prevent bribery;
  • risk assessment to identify and evaluate effectively exposure to bribery;
  • enhanced and detailed measures for high-risk and vulnerable areas;
  • application of anti-bribery measures to business partners;
  • accurate books and accounting records;
  • human resource management policies complementary to anti-bribery measures;
  • communication mechanisms that encourage the reporting of suspicion of bribery; and
  • periodic review and evaluation of anti-bribery prevention measures and their effectiveness.

These key elements are considered as minimum legal requirements. However, an anti-corruption policy is only one part of what may be considered appropriate internal control measures. The notification issued by the Office of the National Anti-Corruption Commission makes it clear that the existence of such minimum internal control measures does not guarantee the company's exemption from liability. Consideration must also be given to how the measures are implemented and used by the company. It may therefore be more important to consider whether such legal person actually implements and uses all the measures required under both the notification and the Official Guidelines (in addition to merely having an anti-corruption policy).

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