The UK’s pharmaceutical wholesale licensing regime needs addressing urgently, so that supply chain partners can be more confident about security, wholesalers have told the government.

The Medicines and Healthcare products Regulatory Agency (MHRA) must address the total number of Wholesale Dealers’ Licences (WL) issued in the UK, adds the British Association of Pharmaceutical Wholesalers (BAPW), in its response to the MHRA’s consultation on proposals to strengthen the UK medicines supply chain.

84 responses were received during the agency's three-month consultation, during which it sought comments on proposals to improve supply chain security through changes to the rules governing wholesale dealers, the “responsible person,” medicines imported into the UK for expert only, storage and transit of medicines, pharmacies and criminal sanctions for offences related to drug counterfeiting activities.

In its response, the BAPW tells the MHRA that anyone who handles pharmaceuticals should have a WL, including exporters and importers, and that there should be the same standards of practice for medicines handling for any organisation in the supply chain - including pharmacy, dispensing doctors, brokers and traders. Moreover, everyone should pay the same amount of MHRA fees associated with wholesale dealing - there should be no reduced fees for companies with turnover of less than £35,000 per annum, it says.

The BAPW also notes its concern about the level of resources available to the MHRA for its regulatory activities in this area, a point which is taken up by the European Alliance for Access to Safe Medicines (EAASM), which says it is “entirely unacceptable” that the agency should be in the position, as it has stated, that its current powers to determine the suitability of applicant for a WL are limited.

“We (quite rightly) expect our medicines supply chain to be secure and effectively regulated, and yet the agency charged with regulating that supply chain does not have at its disposal instruments that it considers adequate,” says the EAASM. Moreover, it adds: “we think it unacceptable that our own regulator has to deal with an environment that has a ‘long and convoluted’ supply chain and ‘a variety of transport systems.’ This must, inevitably, make regulation difficult.”

The response of the Association of the British Pharmaceutical Industry (ABPI) supports wider powers for the MHRA to inspect the premises and records of businesses that conduct “import for export,” but adds that any further regulatory requirements should not place an unnecessary burden on the “many legitimate businesses within the European Union carrying out this activity.” Any additional requirements must take into account the global nature of pharmaceutical manufacture and the often-complex supply chains that exist within such operations; these movements are already closely monitored to ensure the integrity of these materials and should not be subject to any unnecessary further controls, says the industry group, which also points out that companies are already required to carry out testing when importing products from one of their own factories if based in a country where no medicines regulatory agency exists.

The ABPI also calls for the requirements for this activity to be aligned across Europe “so as not to place the UK at either an advantage or disadvantage versus other member states.”

The Royal Pharmaceutical Society of Great Britain (RPSGB) also stresses that legitimate operators who may be involved in the distribution of life-saving medicines should not be overburdened with new regulatory requirements. Removing the exemption to subject all medicines imported for export to third countries from the full batch testing requirements may be the most effective way at limiting the risk of counterfeits entering the supply chain, but could also have a negative impact on those legitimate operators, and have the effect of moving activity away from EU-based packing operations, the Society warns.

However, it welcomes proposals to widen the MHRA’s powers to inspect premises of operators that conduct “import for export” businesses, and suggests: “could this requirement negate the need to require packing operations that pack medicines for subsequent export to fully test each batch of product?”

Commenting on the responses, the MHRA says it will conduct a further three-month public consultation in the autumn on the detailed proposals which it will now develop following this first consultation. “We will take stock of the responses we receive and expect to implement the new arrangements wherever possible by April 2010,” it says.