The Association of the British Pharmaceutical Industry (ABPI) has welcomed news that a Medicines Act exemption which allows pharmacies to trade in small quantities of medicines without a wholesale dealer's licence is to be removed.
The Medicines and Healthcare products Regulatory Authority (MHRA) announced the move in its newly-launched formal public consultation on plans to consolidate UK medicines legislation.
The MHRA says that the exemption, which exists in section 10(7) of the Medicines Act 1968, is being removed because it is not compatible with the European Union (EU) Falsified Medicines Directive, which must be implemented by January 2, 2013.
"Once the consolidated regulations come into force, pharmacists who wish to trade commercially in medicines will be required to hold a wholesale dealer's licence and meet all the regulatory obligations associated with that licence," says the MHRA consultation document.
It adds: "pharmacists will not be required to hold a wholesale dealer's licence if they provide medicines to healthcare professionals and others who need to hold them to pass on to their patients. Pharmacists will also be allowed to supply other pharmacists with small quantities of medicines without holding a wholesale dealer's licence as long as this is on an occasional and not-for-profit basis and to meet the individual needs of patients (for example, if a pharmacy cannot otherwise obtain supplies to dispense a prescription for a patient."
The ABPI welcomed the exemption's removal as "a good first step to protect UK patients and the NHS."
“As the UK now has among the lowest prices in Europe, medicines intended for UK patients have been flowing out of the UK,” said the Association's chief executive, Stephen Whitehead. “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 is therefore not acceptable.”
However, he added that: "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 cooperate to ensure that UK patients are the priority," he went on.
Mr Whitehead also emphasised the need to ensure that the new exemptions to be put in place to cover trading where a public need exists "do not merely replicate the problem this change in the law seeks to overcome."
- The MHRA consolidation exercise aims to replace around 200 Statutory Instruments and much of the Medicines Act with uniform and simplified regulations, entitled The Human Medicines Regulations. MHRA chief executive Sir Kent Woods said this "will amalgamate 40 years of outdated and fragmented legislation, reducing it by around two-thirds, making it clearer and easier to understand as well as ensuring that medicines regulation is supported by a modern and straightforward legal framework."
The deadline for responses to the consultation is January 17 2012, and the finalised consolidated legislation is due to come into force in July 2012.