The UK will be the first country to introduce a framework for the regulation of innovative products, known as Point of Care (POC) products, that are manufactured at the point where a patient receives care. The Medicines and Healthcare products Regulatory Agency (MHRA) announced this new framework, which will enable new medicines with short shelf lives and highly personalised medicines to be made in or near a hospital setting and ambulances, and get to patients who need them more quickly.
Benefits of the innovation
The new framework will ensure that there are no regulatory barriers to innovative manufacturing and that products made through these routes have the same safety, quality, and effectiveness assurances as conventional medicinal products. This follows a public consultation conducted by the MHRA, which received feedback from individuals and organisations across the UK and internationally. Responders to the consultation emphasised the need to establish a regulatory framework for these vital and varied products.
The establishment of a regulatory framework for POC manufacturing would bring benefits to patients, healthcare professionals, and innovators. Patients and carers will have access to new and more personalised treatments in a timely and more convenient manner, with less travel and time spent in hospitals. Healthcare professionals will have access to a greater range of treatment options and improved patients’ adherence to those treatments. Innovators will have clear regulatory expectations and easier product development. Once implemented, this framework will apply to all POC products manufactured in the UK, including a range of Advanced Therapy Medicinal Products such as cell therapy, gene therapy and tissue engineered products; 3D printed products, blood products, and medicinal gases
Patients, carers and healthcare staff across the country will benefit from this landmark initiative which will give them quicker access to innovative and personalised treatments closer to home
Will Quince, Minister of Sate for Health and Secondary Care
Plan of implementation
To implement this framework, new legislation is being developed to amend the UK’s Human Medicines and Clinical Trials legislation and will be brought to Parliament later this year. The MHRA will also begin developing guidance in conjunction with stakeholders to accompany the new framework, which will be issued in due course. Work has already begun on a joined-up approach with other regulators within the UK and internationally to facilitate the development of equivalent regulatory processes and will continue throughout this process.
This new framework has received support from stakeholders, including Ian Rees, MHRA Point of Care manufacturing lead, who stated that the regulator is delighted that stakeholders are overwhelmingly supportive of introducing a fit-for-purpose UK legislative framework for Point of Care manufacturing. Health Minister Will Quince also stated that patients, carers, and healthcare staff across the country will benefit from this initiative, as it will give them quicker access to innovative and personalised treatments closer to home. The UK is a world leader in medicines, and this initiative will break down unnecessary regulatory barriers, free up hospital beds and ease pressure on the health service.
As a regulator that champions innovation, we are delighted that our stakeholders are overwhelmingly supportive of introducing a fit-for-purpose UK legislative framework for Point of Care manufacturing.When implemented, these changes will drive tangible benefits for patients, with visible differences at the product innovation stage right up to the point of care, which will allow easier access to a greater and more personalised range of treatments for those in need
Ian Rees, Manufacturing Lead at MHRA Point of Care
Final thought
Such innovation in the UK seems extremely timely, given the extreme patient pressures faced by the NHS and the corresponding shocks and stalls to the supply chain of medical care. This policy would help bring a wide range of benefits not only to patients, in terms of immediate assistance and relief, but would also help healthcare professionals significantly, by making available a range of options for treatment. Policies of this kind, if implemented correctly, help all relevant stakeholders to work together, faster, and more efficiently to improve health indicators in the medium run.
Personalised medicine is a field that has promised much over and this change in regulation may give it the space required to deliver on itโs promises.
Itโs unclear how an NHS so bogged down by current concerns will have capacity for innovation but in certain areas, at certain times, progress will still be made and while not all innovation can help alleviate current problems, some certainly can.