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Brexit uncertainties: Contractors need to carefully choose FMD system, NPA urges


By Beth Kennedy

02 Aug 2018

Due to Brexit uncertainties, community pharmacies need to ‘carefully consider which Falsified Medicines Directive (FMD) systems they choose’, the National Pharmacy Association (NPA) has said.

 

FMD is a series of European anti-counterfeiting measures that will see pharmacists scan medicine products to verify their authenticity before decommissioning and handing them to patients from 9 February 2019.

 

The NPA said that community pharmacies should be able to connect to the UK FMD system – provided by systems provider Arvato and which will connect to the central European Union (EU) FMD hub – in September.

 

UK FMD Working Group for Community Pharmacy chair and NPA Board member Raj Patel said: ‘Given continued Brexit uncertainties, pharmacy should ensure that – whatever system they choose – termination of the contract without penalties is possible, in the remote possibility there is no workable UK FMD repository.’

 

‘Regulatory inspections’

 

Earlier this month, the Medicines and Healthcare products Regulatory Agency (MHRA) published an FMD impact assessment consultation for what are known as Article 23 providers. These include those authorised or entitled to supply medicinal products to the public who do not operate within a healthcare institution or pharmacy.

 

The consultation said that there will be ‘regulatory inspections for each sector’ to ensure the FMD-concerned sectors comply with the directive.

 

The document added: ‘In line with other regulatory provisions on medicines, there are also proposed legislative changes to provide sanctions to enforce compliance.’

 

The MHRA confirmed that by ‘each sector’ it refers to all FMD-concerned sectors, including community pharmacy.

 

Cost uncertainties

 

According to the working group, pharmacists will have to bear the costs of the barcode scanners.

 

The Pharmaceutical Services Negotiating Committee (PSNC) said that the four national pharmacy negotiators are working on ensuring FMD-related costs – including initial set-up, IT, software and hardware and ongoing operational costs – are recognised in future NHS funding settlements.

 

Mr Patel said: ‘With a lack of certainty as to just how long the FMD system will be needed for, combined with the financial squeeze on community pharmacy, and the lack of any announcement on government funding for this regulation, it is hard to justify the investment.’

 

Impact assessment

 

An MHRA spokesperson confirmed The Pharmacist on 18 July it ‘has not published a UK-specific full impact assessment, and does not intend to publish one at this point in time’

 

They added: ‘We are doing a focused impact assessment [on Article 23 providers] as we are only consulting on those areas where the UK has legal flexibility to make policy decisions.

 

‘Under the delegated regulation, pharmacies are required to decommission medicines and there is no legal flexibility available to the UK to make changes.’

 

For more information on FMD, click here.


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