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Let’s start with the obvious. Brexit is bad for your health. As the representative organisation of all doctors and medical students in the UK, we have said that already and will continue to highlight the implications Brexit will have on the health service at home. What does Brexit have to do with the falsified medicines directive (FMD)? Actually, not much, but now that I have your attention, let me fill you in on where it came from and what it actually means for general practice.
The FMD (Directive 2011/62/EU) was published on 1 July 2011 in the Official Journal of the European Union and the legislation will become effective on 8th February 2019. It introduces tougher rules to ensure medicines are safe and that the trade in medicines is rigorously controlled. This is being introduced to tackle the counterfeiting high-price medicines that are a threat to public health worldwide. So, the principle of it is a good one.
But, and it is a big but, the legislation will require all prescription medicines for sale to carry a unique and randomised serial number encoded in a 2D-barcode and a visible anti-tampering device. At each stage of the supply chain, the product will be inspected to ensure it has not been tampered with, has not previously been dispensed and that the packaging remains intact. On supplying the medicine to the patient, the unique identifier must be ‘decommissioned’ via a scan from the FMD system, to prevent any duplication of a legitimate identifier for use on a falsified medicine. That’s just a brief overview of the process. All practices (dispensing and non-dispensing) will need to have the infrastructure and processes in place to decommission medicines including for prescription and administration of vaccines.
So, practices will need a lot of hardware and software to comply with the new legislation coming in. GPs will also need more time to incorporate this into their consultations – every time one injects a joint or vaccinates a patient and so on will take that little bit longer. The bigger impact will be for dispensing practices who will see their workload increase much more significantly. And it will cost more in time and resource!
So, what’s Brexit got to do with it? Well, if we crash out of Europe (officially referred to as the no-deal Brexit), it is unlikely that the Directive would come into effect in its current form. Before someone paints that on the side of a bus and starts prophesising how wonderful it would ‘save us from FMD’, it is important to note that the government has been clear that it wants to retain a close working partnership with the EU to ensure patients have access to a safe medicine supply.
Whilst we, the BMA team, has met regularly with the Department of Health and Social Care and others involved in the implementation of the Directive to discuss any adverse implications of its introduction on practices are mitigated, this is something I would urge colleagues to start thinking about. We will continue to argue strongly that the NHS must fund the equipment required and make the necessary IT equipment available to facilitate the Directive so that the impact on the workload of GPs and their employees is kept to a minimum.
The government wants to retain a close working partnership with the EU.
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So, what is happening? As a dispensing doctor I am not aware that NHS England has provided us with any training, equipment or software to deal with this. Am I meant to fund it out of my own pocket? I would require buying a new dispensing IT system.
So there is Brexit and other bad stuff.