A long-awaited consultation on how some elements of the EU Falsified Medicines Directive (FMD) will be implemented in the UK has been further delayed by the unexpected decision by the Prime Minister to hold a general election in June.
The Department of Health and MHRA had initially planned to start the consultation period at the beginning of 2017 but this was delayed by the need to seek further internal approvals. The consultation had been widely expected to be launched by the end of April. The pre-election “purdah” period means that this is no longer possible. The consultation is unlikely to be held until after the election, and after any Ministerial changes that might occur at the Department of Health as a result.
The consultation is expected to be accompanied by an impact assessment that sets out the potential costs and benefits of implementing FMD. The UK FMD Working Group for Community Pharmacy has facilitated visits by DH and MHRA officials to pharmacies so that they can understand the changes that are likely to be needed and the potential costs.
Whenever the consultation is published, the UK Working Group will be encouraging pharmacy contractors to respond to it.
The consultation will only cover selected elements of FMD. The majority of the EU Delegated Regulation (2016/161) that implements FMD is binding on all Member States, but there are a few areas where national governments can make changes to accommodate particular elements of their health systems.
These include the use of national reimbursement numbers, where applicable, in unique identifiers printed on packs of medicines, and Article 23, which allows wholesalers to undertake the decommissioning of medicines for certain groups or organisations that only handle small volumes of medicines as part of their activities. This does not include pharmacies or hospitals.