The Medicines and Healthcare products Regulatory Agency (MHRA) says it wants to hear from “everyone” who is likely to be affected by its newly-announced proposals to strengthen the UK medicines supply chain in light of the growing threat of counterfeit medicines.

Announcing a new public consultation, the agency is calling for comment from large manufacturers and wholesale dealers to community pharmacies and patients. “We want to hear about how these proposals may affect you, what additional benefits they may bring, as well as any additional costs they may incur. We will assess the responses to the consultation before putting forward concrete proposals for change. We are committed to ensuring that any changes we introduce are proportionate to the risk that counterfeit medicines represent and that they are effective in protecting patients in the UK from harm,” says the agency.

Since 2004, the MHRA has investigated nine incidents in which batches of counterfeit drugs reached pharmacies and patients, and a further four cases in which fake drugs were found to have reached wholesale dealer level. “In light of these incidents, we believe there is a strong case for strengthening the medicines supply chain,” it says.

Specifically, the agency is seeking to: - increase its powers to determine the suitability of applicants for Wholesale Dealer licenses and limit the number of such licences held by each business; - raise the professional status of the Responsible Person, and their deputies, introduce a Code of Practice and require their continuous presence when a business is operating; - introduce a “due diligence” obligation for Wholesale Dealer licence holders and the Responsible Person with a requirement to notify suspicious events; - strengthen controls over medicines in transit, requiring logistics providers to comply with appropriate standards, be audited by contractors and have their records inspected by regulators; - strengthen controls over businesses that import medicines for export to non-European Union (EU) countries; - ensure that pharmacists engaging in inter-pharmacy trade “that is not explicitly to meet local emergencies” are licensed as wholesale dealers and subject to regulation, and also increase controls over disposal of packaging; and – introduce a new specific offense for the manufacture, possession of intent to supply counterfeit medicines which takes account of the potential harm to patients.

The consultation is also seeking views on the proposed new measures put forward by the European Commission last week to tackle the increasing threat from counterfeiting to the EU drugs supply.

The Commission is proposing to: - extend the rules governing wholesale dealers to everyone who trades in medicines; - assume powers to require features that allow identity, authenticity and traceability of certain prescription medicines to be established, such as a serialization number and seal, but also allow parallel traders to open packs to insert leaflets in the national language and replace the security features in a way that maintains security of the product; - commit to clarifying, in future legislation, the status of and rules applying to products held in free zones and free ports within the EU; - introduce new rules governing imports of active pharmaceutical ingredients (APIs) into the EU, providing public health protection at least equivalent to that applying within the EU, and auditing of API manufacturers; and – strengthen rules governing inspection of manufacturers and wholesale distributors of medicines and APIs.

The consultation closes on March 13, 2009. The total process involved in finalising an agreed text on the EU proposals is likely to take at least 18 months, and consultation on UK plans to implement any EU legislation is unlikely to take place until 2010 at the earliest, says the agency.