MHRA enforcement chief paints picture of UK counterfeit trade

High-profile cases of counterfeit medicines entering the UK’s legitimate supply chain have shown that the weak link is generally insufficient ‘due diligence’ conducted by the purchaser, according to a senior UK regulatory official.

Mick Deats, head of the enforcement group at the UK Medicines and Healthcare products Regulatory Agency (MHRA), said at a meeting in Brussels, Belgium, last month that an analysis of UK incidents show some common features.

The counterfeit product is usually manufactured in the Far East, and shipped to a port in the European Union where customs clearance is obtained. UK freight carriers collect the product and deliver it to the customer in the UK, or store it in a freight warehouse. The transactions are often negotiated by unlicensed brokers or traders operating outside the UK.

All these elements are tough for national enforcement organisations to tackle, particularly if the product is destined for Internet sale, Deats told The Organisation for Professionals in Regulatory Affairs (TOPRA) meeting.

However, if the counterfeiters want to get the product into the legitimate supply chain they will need to make use of someone with a wholesaler dealer license.

For this reason, towards the end of last year the MHRA asked for greater powers to vet people applying for wholesaler licenses in a bid to strengthen the medicines supply chain.

The proposals are the upshot of a review of the medicines supply chain by the agency - along with HM Revenue & Customs - over the latter half of 2008.

Deats told SecuringPharma.com in a recent interview that the agency has been spurred into action by a dramatic increase in the number of counterfeits being uncovered in the legitimate supply chain in recent years.

"There were no seizures at all between 1994 and 2003, but the rate has been steadily picking up since then," said Deats, with nine incidents in which counterfeits reached pharmacies or patients, and another four cases in which counterfeit medicines were discovered at wholesalers.

"The UK is something of a target for counterfeiters because medicines there carry relatively high prices, and it has a complex supply chain with a number of possible entry points," he said.

With wholesalers now identified as one of the weak links in the chain, the MHRA wants to be able to determine the suitability of applicants for wholesale dealers' licences - for example by checking for criminal records - and also limit the number of licences held per business.

"There are around 1,700 dealer's licenses in the UK, but just 11 wholesalers account for around 85 per cent of the activity," said Deats.

Licenses have simply been too easy to acquire, he continued, and there is a pressing need to make the whole process more rigorous.

Furthermore, once acquired a license holder should have increased responsibility - and culpability - for the wholesale activities.

For example, the MHRA wants to raise the professional status of the Responsible Person identified in the wholesale license, as well as any deputies, and introduce a Code of Practice. The RP would also need to be present at all times when the business is operating.

Other measures under consideration include a strengthening of controls over medicines in transit, such as requiring logistics providers to comply with appropriate standards of record keeping and due diligence, and giving the MHRA authority to inspect their records.

The proposals also include measures to: ensure that pharmacists engaging in wholesaling activity are licensed as wholesale dealers; increase controls over disposal of packaging; and introduce a specific new offense for the manufacture, possession of or intent to supply counterfeit medicines which will carry stiffer penalties.

The consultation on these proposals closed on March 13, and finalising an agreed text taking into account the EU pharma package proposals is likely to take at least 18 months.
 
Consultation on UK plans to implement any EU legislation is unlikely to take place until 2010 at the earliest.