MHRA unveils feedback on anti-counterfeit measures

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published the findings of its public consultation into measures designed to reduce the risk of counterfeit medicines entering the supply chain.

The MHRA launched its consultation last December as part of an effort to get feedback on various proposals intended to improve the security of the UK supply chain. All the documents are available for review on the MHRA website here, but the following provides an overview of the key points raised.

Wholesalers

At the heart of the raft of proposals are a series of measures designed to improve the MHRA’s ability to regulate the medicinal wholesaler industry, which at the moment is sprawling and fragmented.

There are around 1,700 people holding dealer’s licenses in the UK, but 11 of them account for 85 per cent of the market, and the fear is that the rest of the horde could contain unscrupulous individuals whose dealerships act as entry points for fake medicines.

In its proposals the MHRA has asked for greater powers over the registration medicinal wholesalers. Measures include background checks on applicants for licenses, revised fees for registration and inspection and greater powers to decline a license, for example in the event of a relevant criminal conviction.

In particular the agency wants to introduce an obligation for license holders to carry out ‘due diligence’ such as informing the MHRA about any suspicious activity.

Overall the proposals received broad support, although there were some concerns voiced. These included the removal of a lower threshold for turnover (currently £35,000 a year) under which fees are not charged. Some respondents argued this would damage small businesses and they would prefer a sliding scale based on turnover.

Responsible person

In the UK each wholesaler should have a nominated ‘responsible person’ (RP) who is deemed responsible for safeguarding product users from hazards arising from poor distribution practices.

The MHRA would like to increase the minimum qualifications for this role – some respondents said it should be a qualified pharmacist in keeping with a number of other EU countries – and also require membership of a professional body and establish a nationwide register of RPs. It also plans to set up a code of practice against which an RP’s performance could be judged, and require them to be in attendance at a wholesaler at all times.

The latter element raised some comments, with some respondents suggesting that an RP should be responsible for ensuring that appropriate quality management systems are in place, rather than being constantly in attendance at a wholesaler.

Transit and storage

Theft of pharmaceuticals is a growing problem in the UK (see our report here), and in order to tackling the storage and transit medicines, the MHRA is seeking an ‘audit trail’ for logistics companies, as well as the right to inspect providers and make them responsible to “ensure the probity of those with whom they contract.”

While welcomed in principle, there were concerns raised about how these measures could apply across the wide range of transport suppliers currently serving the market, with suggestions that some may decline to transport medicines if such measures were introduced.

Another element of the proposals, the placing of additional controls on medicines imported for export to third countries, met with general agreement and would be discussed further with the UK customs authorities, said the agency.

Pharmacies

The bulk of responses received by the MHRA concerned its proposals for pharmacies, which include a major project to collect and analyse data on wholesale activity, with the aim of understanding the possible impact of any legislation.

Depending on the outcome of that assessment, the agency would consider restricting use of the so-called Section 10(7) exemption, which permits pharmacists to obtain medicines from other pharmacies to ensure that their patients receive the medicines they require in a timely manner.

The MHRA has suggested this might only be applicable to emergency situations, but respondents pointed out that clear guidance would be required to define what constitutes an emergency.

Another section of the proposal deals with the drawing up of protocols for the disposal of unused and discarded pharmaceutical packaging. Once again this was agreed with in principle, although some respondents said that it was important that pharmacy staff should not be involved in lengthy disposal techniques.

Criminal sanctions

The final element in the MHRA’s blueprint – stiffer penalties for those involved in the trade in counterfeit medicines – received widespread support. In particular there was general agreement that a specific counterfeiting offence be added to the statute book.

However, comments were made that anyone who could demonstrate that they had applied “due diligence” shouldn't be held liable if counterfeits failed to be identified.

The agency said it will revisit the proposals and release a second draft for further consultation later this year.