Manufacture, marketing and supply

Part of Medicines and Medical Devices Bill – in a Public Bill Committee am 12:15 pm ar 8 Mehefin 2020.

Danfonwch hysbysiad imi am ddadleuon fel hyn

Photo of Jo Churchill Jo Churchill The Parliamentary Under-Secretary for Health and Social Care 12:15, 8 Mehefin 2020

I thank the hon. Member for St Helens South and Whiston for raising this issue and the pack that she so diligently sent to us all over the weekend, which I read with great interest. I know she holds this issue dear to her heart and she is passionate about it. I fully understand the intention behind the amendment. It is absolutely right that medicines that enter the UK supply must not have been manufactured or developed to using organs or human tissues that do not come from authorised sources.

I can assure the hon. Lady that safeguards are in place to provide surety on these issues. The requirements around the donation, procurement, testing, processing, storage and distribution of organs, tissues and cells intended for human application are set out in the Human Tissue (Quality and Safety for Human Application) Regulations 2007 and the Human Tissue Act 2004, which are separate from measures on medicines manufacture.

Medicines legislation already ensures that human tissues and cells used in the manufacture of medicinal products must meet those requirements. Safeguards are in place in those Acts to ensure that the appropriate quality, safety and origin of human tissue is known—for example, consent and traceability requirements apply to any human tissue or cell component imported into the United Kingdom and used as a material in the manufacture of a medicinal product. Importantly, a researcher is not able to conduct research on human tissue in the UK if they cannot provide evidence that it has been obtained ethically and in accordance with legal requirements. The Government will ensure that, under the new deemed consent arrangements for organ donations, donations of cells for advanced therapy and medicinal products cannot happen without expressed consent.

The Bill is designed to ensure that we can update legislation to maintain an effective regulatory regime for medicines, clinical trials and devices. I want to assure hon. Members that the Bill as drafted includes a power in relation to the requirement that must be met in the manufacture of medicines under clause 2(1)(b), and in relation to clinical trials for the development of human medicines under clause 4. Such powers will enable us to update, as needed, the regulatory requirements in these areas to protect patient safety and to ensure the UK complies with international good clinical practice standards, including ethical considerations as set out in clause 4(1)(b). However, I am happy to commit to write to the hon. Member for St Helens South and Whiston on the reviewing of the FCO position, to which she alluded during her speech.

I trust that hon. Members agree that the amendment is not appropriate for the Bill— however well meaning—and that it is unnecessary, given the way in which medicines and medical devices are regulated. To that end, I respectfully ask the hon. Member for St Helens South and Whiston to withdraw the amendment.