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Legislative proposals around FMD could compromise data safety, says MP

Lord Clement Jones: The bill “considerably broadens" the original FMD data collection
Lord Clement Jones: The bill “considerably broadens" the original FMD data collection

Proposed legislation to ensure falsified medicines do not enter the UK supply chain risks broadening the use of sensitive data, a Liberal Democrat peer has warned.

The EU’s anti-counterfeit legislation, the Falsified Medicines Directive (FMD) – which requires all pharmacies to scan barcodes on medicines packaging at the point of dispensing – came into force on February 9, 2019.

On February 13 this year, the Medicines and Medical Devices Bill was presented to parliament to fill the “regulatory gap” left by the EU directives that would previously have provided the legal framework for medicines in the UK.

Clause 3 of the bill – which relates to creating a successor UK system – refers to “the use, retention and disclosure, for any purpose to do with human medicines, of information collected for the purpose of preventing the supply of falsified human medicines”.

During the second reading of the bill in the House of Lords last week (September 2), Liberal Democrat Lords spokesperson (digital) Lord Clement-Jones raised concerns that the clause as it stands “considerably broadens the original data-collection provisions of the FMD”.

Lord Clement-Jones argued that the government already has access to a “very wide range” of data on medicines sales and use in the UK.

“Given both this access and the known sensitivities around falsified medicines data, it is unclear why the department wants to extend the purposes for which data is collected under a future UK system and why this has not been discussed with stakeholders in the existing FMD scheme,” he said.

“Pharmacists have concerns not just that the department might accidentally release commercially sensitive data but that it might use such data to gain an unfair advantage, given its monopoly position as the main purchaser of medicines in the UK,” Lord Clement-Jones added.

In response, parliamentary under-secretary for health and social care Lord Bethell, who also sponsors the bill, said the government will “fully consult with industry, patient groups, pharmacists and all interested parties on any regulatory changes before they are implemented”.

Liberal Democrat Lords spokesperson (health) Baroness Jolly said the bill “enables community pharmacy contractors to use innovative new systems to support dispensing and is welcomed by members of the profession”.

CCA: “Grave concerns”

The Company Chemists’ Association (CCA), which said it had briefed Lord Clement-Jones ahead of the second reading of the bill in the House of Lords, has also expressed concerns about the bill.

Chief executive Malcolm Harrison told C+D earlier this week (September 8) that the CCA has “grave concerns” about the wording of clause 3.

“To avoid unintended consequences of data being used for purposes other than to ensure that medicines are safe, we are asking ‘for any purpose’ to be amended to ‘in an agreed framework’,” Mr Harrison said.

“We are pleased that the government intends to consult on any regulatory changes before they are made, but believe that changing the wording of the bill itself is needed to ensure this data is only used to ensure that medicines are safe,” he added.

RPS: “We have not seen the necessary progress”

Royal Pharmaceutical Society (RPS) president Sandra Gidley told C+D earlier this week (September 8) that the RPS is “concerned that we have not seen the necessary progress on identifying an approach to the verification of authenticity of medicines, following Brexit across Great Britain”. 

“The safety of medicines for patients’ use is paramount. There is now urgency in ensuring a robust system is put in place to protect the UK against counterfeit medicine and we would like to see a commitment to a timeline for this work,” she said.

Any system that is implemented needs to be “interoperable with the systems that have already been invested so heavily in by pharmacy and pharmaceutical industry,” she added.

AIMp: “Monitoring the impact of Brexit on FMD”

Association of Independent Multiple Pharmacies (AIMp) chief executive Leyla Hannbeck told C+D that “AIMp, as members of the UK FMD Working Group [for Community Pharmacy], is monitoring the impact of Brexit on FMD”.

“AIMp will seek to maintain the security that FMD brings to the medicines supply chain but resist any unnecessary administration or unpaid extra work,” Ms Hannbeck added.

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