Contribution
I am grateful to the noble Lord for both his contribution and his welcome. He can tell that I am still shuffling papers around.
I suppose that there are always unintended consequences to any piece of legislation; we have all been around long enough to know that. Part of the answer here is that the new hub-and-spoke method creates a degree of flexibility while not compromising health and safety standards, which means that, if there are problems in the supply chain, it would be pragmatic to put in measures that would compensate for those. If you simply have a big factory churning out tons of drugs and treatments and that factory has a problem, it is much more difficult to alleviate that problem. Also, the factories, inspection plants and other points along the hub-and-spoke model will be subject to inspections in order to ensure health and safety and quality. That is principally the MHRA but there are also—this is off the top of my head—nine other third-party agencies that are used, for want of a better phrase, by the MHRA to conduct inspections.
I want to make a few comments in closing that will partly touch on the points raised by the noble Lord. I shall summarise the key aims of the new framework and how the MHRA is already preparing to deliver these changes. Having met MHRA officials, I can say with some confidence that they have been planning for this for a long time. It is vital that the regulatory framework supports the development of new medicines while protecting patient safety, which is in essence what the noble Lord was talking about.
The safety of patients remains the paramount interest in the new framework. The regulations are not about relaxing patient safety requirements; they are about making sensible changes to reflect the circumstances in which medicines are being manufactured. The new regulatory framework is based on and links into the current regulatory processes but, obviously, the existing regulatory processes address a very different method of manufacture and distribution. The new system will ensure that point-of-care and modular manufacture products meet the necessary standards of safety, effectiveness and quality.
The new framework will also bring a wide range of benefits to patients. By opening up a new sector of medicines manufacturing, patients will benefit from access to new and more personalised medicines in a timely and convenient manner. There is potential for patients to be treated with medicines outside hospital settings, even in their own homes, thus reducing travel time; in some cases, there will be no travel time because they will be manufactured by a small device in the patient’s home. The framework supports the concept of moving care from hospitals to communities, relieving pressures on the NHS. This may also reduce the overall treatment and social care cost.
The MHRA is ensuring that the health and care sector is ready to adapt to this new framework so that the benefits can be realised. Engagement is happening now, has been happening for a while and will continue to take place with a wide range of key health partners in industry, academia and other UK regulators, including the Care Quality Commission, the Human Tissue Authority and the Health Research Authority; obviously, the GMC and the NHS are also part of the extensive stakeholder engagement network to ensure institutional readiness. The MHRA’s engagement with stakeholders through the development of the regulations, including a formal public consultation, has shown widespread support; I am talking about cross-industry support for the new framework. Industry continues to be supportive of the framework. The Government and the MHRA will continue to engage with industry and manufactures, as noble Lords might expect.
As far as international collaboration is concerned, the MHRA is working internationally to ensure maximum alignment of regulatory approaches across international regulators. That is not global, but it is as far as can be reasonably practicable. This will enable the benefits of point-of-care and modular manufacture products to reach patients across the world. This international work is particularly important as the UK is the first country to introduce a framework to enable innovative ways of manufacturing medicine, so, in effect, the UK leads the way in this field—and this is UK-wide.
In short, these changes will support wider access to life-saving, innovative medicines. I hope that noble Lords will agree with them and, on this basis, join me in supporting these important regulatory changes.