Wording of UK bill to match FMD is amended on data concerns

Amendments have been proposed to a UK bill intended to maintain parity with the EU Falsified Medicines Directive (FMD) after the end of this year.

The move has been prompted concerns that that the prior wording of the Medicines and Medical Devices Bill went well beyond the data-collection requirements of the FMD.

The MMDB – which attempts to fill the regulatory void for medicines after the UK’s post-Brexit transition period ends on December 31 – moved one step closer to being passed into UK law last week after a second reading in the House of Lords.

Liberal Democrat peer Lord Clement-Jones raised concerns during the debate on the reading that Clause 3 of the bill “broadens the original data-collection provisions of the FMD” so could lead to data being used for purposes other than to ensure that medicines are safe.

His comments appear to have been taken on board. Proposed amendments to the bill published yesterday (September 14) ahead of the committee stages include the insertion of new wording in Clause 3 as follows:

Within 6 months of this Act coming into force, the Secretary of State must:

(a) consult with the pharmaceutical and pharmacy community on an agreed framework outlining the use, retention and disclosure of information collected for the purpose of preventing the supply of falsified human medicines; and

(b) lay a copy of the agreed framework before Parliament.

Pharmacy bodies had expressed concern that the breadth of data proposed in the MMDB could result in the accidental release of commercially-sensitive information by the Department of Health, and could also allow the DH to exploit its position as the primary purchaser of medicines in the UK.

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Another amendment (to Clause 1) reinforces the intention that the bill will maintain close regulatory alignment with the FMD – something that is top of the list of requirements for pharmaceutical companies.

The Company Chemists’ Association (CCA) – which represents large businesses engaged in community pharmacy in the UK – told Chemist & Druggist magazine ahead of the amendment that “changing the wording of the bill itself is needed to ensure this data is only used to ensure that medicines are safe.”

There are also amendments aimed at maintaining the UK’s collaboration with EU countries on clinical trials and new medicines research via the Innovative Medicines Fund.

The MMDB was first introduced into the House of Commons on February 13, before being passed onto the House of Lords in June.

A key date for the FMD came in February last year when the delegated regulation on safety features went live in an attempt to protect patients from counterfeit medicines.

Now, every new pack of medicine put on the EU market has a unique barcode to be scanned before the medicine can be dispensed, to prevent patients receiving falsified, expired, recalled or otherwise unsafe drugs.

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