UK MHRA proposes safeguard for medicines supplies to patients
ABPI expects move will positively affect availability of medicines
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has proposed the repeal of the part of the Medicines Act that permits trading between pharmacies without the need for a wholesalers licence.
The Medicines Act 1968 contains an exemption that allows pharmacies in the UK to trade pharmaceutical products without holding a wholesalers’ licence.
As this contravenes current European Union legislation, the proposal is expected to be approved, and then implemented in June 2012.
The change will mean that pharmacies will only be permitted to trade where this is necessary to meet a public health need, is in small quantities, is infrequent and is not for profit.
The Association of the British Pharmaceutical Industry (ABPI) welcomes this proposition, and expects the implementation of the policy to positively affect the availability of medicines to patients in the UK.
Stephen Whitehead, chief executive of the ABPI, explains: ‘As the UK now has amongst the lowest prices in Europe, medicines intended for UK patients have been flowing out of the UK. Allowing pharmacies to sell medicines abroad, where they may make an increased profit has had a direct effect on UK medicine supplies – causing considerable anxiety and putting patients at risk. The practice of selling on medicines intended for UK patients is therefore not acceptable.
‘The ABPI welcomes the MHRA proposal to end the trading of medicines by pharmacies that do not have a wholesale dealers licence, except in exceptional circumstances to meet a public health need. However, it is essential that the new exemptions put in place to cover trading where such a public health need exists, do not merely replicate the problems this change in the law seeks to overcome. ’
He concluded: ‘If the proposition is implemented it will have a positive effect on the UK healthcare system. Whilst there are still significant issues to resolve in order to prevent medicines intended for UK patients being sold abroad, the repeal of this legislation is a good first step to protect UK patients and the NHS. To fully address this challenge it is now essential that pharmacies who serve NHS patients directly need to separate wholesaling activities from pharmacy dispensing activities.
‘The next step is for all of those involved in the chain between a medicine’s production and its dispensing in the UK to co-operate to ensure that UK patients are the priority. The ABPI looks forward to taking an active role in solving the on-going challenges.’