Medicines and Healthcare Products Regulatory Agency

Wednesday 19th July 2017 Written Statements

[The Secretary of State for Health (Mr Jeremy Hunt)]

On Wednesday 12 July, Ministers at the Department of Health were informed by the Medicines and Healthcare products Regulatory Agency (MHRA) about an issue identified during a routine inspection of Bio Products Laboratory (BPL). The MHRA provided confirmation on Monday of this week that, in light of all of the information currently available, their assessment is that no patients have been harmed and none put at additional risk of harm due to the issue.

BPL is responsible for the supply of a range of plasma products to the NHS and a range of other major health systems around the world. The company, in line with best practice, operates a three stage process to ensure the safety of its products:

1. Selection of healthy donors, with all donations tested and traceable to the donor.

2. Further safety tests of plasma in advance of the manufacturing process.

3. During the manufacturing process, all products are specially treated to inactivate viruses.

The MHRA informed Ministers that their inspection identified a problem with the computer software, which controls the stage one process set out above. Following the identification of the issue by the MHRA, a manual review was undertaken by the company to ensure that no inappropriate donations made it through this stage of the process due to the problems with the computer system. This manual review confirmed that no inappropriate samples had made it through to the next stage of the process, and a range of other risk mitigation steps were also implemented.

The MHRA have continued to provide progress updates to Ministers regularly since notification on 12 July.

On Monday of this week the MHRA confirmed to Ministers their assessment that the problem had been addressed through interim measures to provide the necessary assurance while long-term solutions are being implemented. In the opinion of the MHRA, due to the three stage process outlined above, and in light of all of the information currently available, no patients have been harmed and none put at additional risk of harm due to the issue.

The MHRA is continuing to undertake all necessary regulatory activities in order to ensure patient safety, and will continue to keep Ministers informed of this work.

Although there is no evidence of risk to patients in this case, in the interest of transparency, I wanted to update the House to this situation as quickly as possible with the relevant information. In the unlikely event of any changes, I will update the House accordingly.

[HCWS70]