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Compliance and enforcement
What measures are in place to enforce the laws governing medicinal products?
With regard to medicines authorised under the centralised procedure, enforcement action can be taken by the European Commission under the Penalties Regulation (Regulation (EC) 658/2007). In the United Kingdom, the Medicines and Healthcare products Regulatory Agency (MHRA) exercises its enforcement powers based on:
- the Human Medicines Regulations 2012;
- the Consumer Protection Act 1987;
- the Medical Devices Regulations 2002; and
- the General Product Safety Regulations 2005.
The MHRA’s enforcement powers include the launch of criminal proceedings in appropriate circumstances. However, in practice, prosecutions are rare. The agency prefers to use alternative enforcement powers, including issuance of warning letters, notices and formal cautions.
Following an investigation, the MHRA has a range of penalties. It can issue warning letters or formal cautions, suspend, revoke or vary licences or seek injunctions from the civil courts (eg, to prevent the supply of medicines that have not been properly authorised). There are also powers relating to specific areas of law (eg, infringement notices for breach of pharmacovigilance requirements and notices regarding advertising duties).
The MHRA may also bring criminal prosecutions, punishable by an unlimited fine (on summary conviction) or by an unlimited fine or up to two years’ imprisonment or both (on indictment).
What mechanisms are in place to combat bribery, fraud, collusion, counterfeiting and other dishonest practices in the pharmaceutical sector?
In addition to the prohibited acts under the Bribery Act 2010, Regulation 300(1) of the Human Medicines Regulations prohibits the supply, offer or promise of any gift, pecuniary advantage or benefit to healthcare service providers in connection with the promotion of medicinal products, unless it is inexpensive and relevant to medical practice.
Healthcare professionals must similarly refrain from accepting or soliciting such benefits (Regulation 300(4)). Examples of practices that fall within the scope of Regulation 300(1) include:
- price promotions;
- bonus schemes; and
- merchandising offers.
The provision of hospitality to healthcare professionals, which includes sponsorship and travel expense payments, is restricted under Regulation 300(2). Guidance on how the provisions will be applied is set out in Section 6.14 of the MHRA’s Blue Guide. All financial relationships between healthcare professionals and their suppliers must also comply with the Bribery Act.
In addition to the legislative framework, the Prescription Medicines Code of Practice Authority may impose penalties where a breach of the Association of the British Pharmaceutical Industry Code is found to have occurred. If so, the relevant company must give an undertaking that the practice in question has ceased immediately and that all possible steps have been taken to avoid a similar breach in future. An undertaking must be accompanied by details of the action taken to implement the ruling. Detailed case reports are published once the case has been concluded.
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