Please note: In October and November 2010, the MHRA moved from its Market Towers address to a new location on Buckingham Palace Road. Please go to the contact us section of the website for updated contact details.
The UK medicines’ regulator, the MHRA, has published a consultation document on proposals to strengthen the medicines supply chain in the UK in the light of increasing threat from counterfeit medicines.
Medicines counterfeiting is a growing threat worldwide. Since 2004 the MHRA has investigated 9 incidents in which batches of counterfeit medicines reached pharmacies and patients. In a further 4 cases counterfeit medicines were found at wholesale dealer level. In the light of these incidents we believe there is a strong case for strengthening the medicines supply chain to reduce the threat from counterfeit medicines and to protect public health.
The MHRA is seeking views from everyone who is likely to be affected by the proposals – 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.
In summary, the proposals on which we are consulting would:
- Increase our powers to determine the suitability of applicants for Wholesale Dealers’ licences and limit the number of Wholesale Dealers’ licences held per 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 Responsible Person with a requirement to notify suspicious events
- Strengthen controls over medicines in transit, requiring logistics provides to comply with appropriate standards, to be audited by contractors and records inspected by regulators
- Strengthen controls over businesses that import medicines for export to non-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 increase controls over disposal of packaging
- Introduce a new specific offence for manufacture, possession or intent to supply counterfeit medicines which takes account of the potential harm to patients
The European Commission has also proposed changes to EU legislation to tackle the increasing threat from counterfeit medicines which will:
- Extend rules governing wholesale dealers to everyone who trades in medicines
- Provide the Commission with powers to require features that allow identity, authenticity and traceability of certain prescription medicines to be established, such as a serialisation number and seal, but 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 the Commission to clarify (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 import to the EU of Active Pharmaceutical Ingredients (APIs), providing public health protection at least equivalent to that applying within the EU, and auditing of API manufacturers
- Strengthen rules governing inspection of manufacturers, wholesale distributors of medicines and APIs
These proposals will be the subject of negotiation between Member States and the European Parliament. In order to inform the UK position in these negotiations we are seeking views on them in this consultation exercise.
The consultation will close on 13 March 2009. The consultation and links to the other relevant documents including the EU proposals are available below:
