The Medicines and Healthcare products Regulatory Agency (MHRA) is planning to make dealing in counterfeit medicines a specific criminal offence, with the most serious offences carrying terms of imprisonment of up to 12 years.

The Agency puts this proposal forward in a new consultation, to run until March 12, on measures to strengthen the UK medicines supply chain, following an initial consultation held last year. “Once we have received and analysed the responses to this consultation, we aim to have most of the revised provisions agreed by April 2010,” it says.

The 2009 consultation revealed widespread support for the Agency’s plans to tighten controls on who can obtain a wholesale dealer’s license. To this end, it says it intends to take forward a number of proposals, which include requiring: - that applicants for such a license should demonstrate that they are a “fit and proper person” to undertake such a role, with minimum requirements relating to competence, integrity/honesty, relevant experience and regulatory history; - disclosure by applicants of relevant criminal records and empowering the Agency to decline a license if an application discloses a relevant criminal conviction.

However, the MHRA’s proposal to remove the fee concession for businesses whose turnover is less than £35,000 proved more controversial. A number of respondents expressed concerns that this could have a significant impact on not only small and medium-sized enterprises (SMEs) but also new businesses and the National Health Service (NHS). The MHRA response is that while it understands these misgivings, medicines are not ordinary items of commerce, and because of their importance to the public health and the need to ensure they are properly stored, they should be traded by trained professionals only.

“We therefore believe that concessions that encourage short-term engagement in trading of medicines by persons without the necessary experience or business premises should be discouraged,” says the Agency, adding that, therefore, removal of this concession represents an important element of its overall strategy of improving supply chain security.

On its proposals to introduce a specific offence for dealing with/trading in/brokering sales of counterfeit medicines, the Agency says it has not yet determined exactly what language the offence will be couched in, but both “supplying” and “offering to supply” will be included, as will manufacture, assembly and possession/storage with intent to supply.

As regards intent, it is expected that there will be two ways in which the offence may be committed – “intentional” commission of the offence, which will be the most serious matter, and “reckless” commission, which will have a lower starting scale of penalty. “Due diligence” will be a defence.

The maximum penalty available will be 10-12 years’ imprisonment for the most serious offences, says the Agency, pointing out that a maximum penalty of 10 years’ imprisonment already exists under the Trade Mark Act, the legislation under which most prosecutions involving counterfeit medicines are currently brought.

The MHRA says it expects to phase in the new requirements for businesses which do not meet the proposed new standards, although steps will be taken to ensure that their introduction will not disrupt medicines supplies, either to the public or the NHS. It also believes it is “likely that as a result of this initiative, there will be a reduction in numbers of businesses operating within the sector.”