Consultation outcome

Consultation on Point of Care manufacturing

Updated 25 January 2023

1. Executive Summary

New types of innovative products are increasingly being manufactured at the point where a patient receives care e.g. personalised medicines made for the patient either within or very close to the healthcare setting. This consultation seeks comments and views on the introduction of a new regulatory framework for these products supplied at the point of care.

We are proposing a regulatory framework that is based on and links into current regulatory systems for medicines approvals, clinical trials, evaluation of regulatory compliance at manufacturing sites and safety monitoring. The aim is to support increased manufacture of point of care products whilst ensuring these products attain the same assurance of safety, quality and efficacy currently in place for more conventional medicinal products.

2. Introduction

Technology is enabling the creation of new types of medicinal product that have features such as very short shelf lives and which may be highly personalised, requiring them to be manufactured and supplied at the point of care (POC).

Current products typically have a shelf life measured in years and are manufactured at large scale in a relatively small number of factory-based sites for global distribution. Medicines regulation is geared for and supports such features, however POC products do not fit this ‘standard model’ of regulation where manufacture is in the hospital and supply to the patient is immediate.

A new regulatory framework is being considered to enable the safe development of POC products for supply to patients through clinical trial studies and then on to licensing, i.e. obtain a Marketing Authorisation underpinned by safety monitoring and minimisation of risks by the Medicines and Healthcare products Regulatory Agency (MHRA). Such a framework requires control measures equivalent to those currently in place for medicinal products to ensure that POC products meet the necessary requirements for quality, safety, and efficacy.

Through engagement with a wide range of stakeholders, MHRA has developed a proposal for such a POC framework in the UK which we believe will enable the growth of an emergent pharmaceutical manufacturing and supply sector. This framework is intended to complement existing manufacturing and supply arrangements which will bring new therapies to patients. During this development work, MHRA has seen a wide range of POC product types including blood products, medical gas products, Advanced Therapy Medicinal Products (ATMPs) and small molecule products.

MHRA is committed to delivering a step-change in the way we engage with patients and the public, putting their views and interests at the heart of our decision-making and culture. The development of the POC framework is no different and engagement with patient groups is scheduled to complement this public consultation.

This proposal for a new POC regulatory framework seeks to balance regulatory requirements for the control of these products to ensure levels of safety equivalent to current products while avoiding unnecessary regulatory barriers by adapting regulatory requirements. In developing this framework, it has become apparent that POC manufacturing is part of a wider spectrum of manufacturing options. Through this consultation we will seek to clarify whether and, if so, to what extent, the POC framework will apply to other types of manufacturing situations beyond the current ‘standard model’ of factory—based manufacture. The new framework is not intended to replace the current model of centralised manufacture and distribution or to be used in preference to it, but to supplement existing regulation in cases where the current model is not feasible.

We are proposing to use powers under the Medicines and Medical Devices Act 2021 to amend the regulatory framework for manufacture of medicinal products. This framework will apply across the UK and the Northern Ireland, Scotland and Wales Devolved Administrations will be involved in any changes.

By taking part in this consultation you will help us to identify regulatory changes that are required to provide a new range of therapies to patients.

Background to the issue

The work to create the new POC regulatory framework is contained within the Second Sector Deal of the UK’s Life Sciences Industrial Strategy as one of the ‘innovative regulation’ projects committed to by MHRA. The emergence of products manufactured and supplied at the POC were identified through a range of sources including enquiries submitted to MHRA’s Innovation Office, enquiries for scientific advice, engagement with a range of organisations in healthcare including the Engineering and Physical Sciences Research Council (EPSRC) funded project to evaluate manufacture through the Redistributed Manufacturing in Healthcare (RiHN) network. From these sources and a number of stakeholder meetings, a wide range of regulatory challenges have been identified with POC products that that we aim to consider and may address in a new regulatory framework. These challenges include:

Short shelf life

Conventional products typically have a shelf life of 2 to 3 years, which allows for a relatively long period at the end of manufacture for Quality Control testing and Qualified Person certification of each batch followed by national or global distribution. POC products have a shelf life in the order of hours, minutes or less, which has two major implications:

• There is only time for local supply of the finished product, which therefore forces manufacture to be in very close proximity to the patient and also means that they will need to be manufactured at a large number of sites, i.e. scale out rather than scale up.
• There is likely be no time at the end of manufacture for Quality Control testing and Qualified Person certification prior to supply. This means that control measures at the time of manufacture are required in order to provide assurance of the quality of products followed by a rapid decision to either supply and administer or to reject the product.

Product range

MHRA has seen POC products that span much of the pharmaceutical spectrum and includes some types of Advanced Therapy Medicinal Products (ATMPs – cell therapy, gene therapy and tissue engineered products), 3D printed products, blood products and medical gasses. The POC framework needs to provide for these and further product types which are expected in the future as technology continues to advance in medicines manufacture and supply.

Number of manufacturing sites

The number of manufacturing sites typically seen for an individual product is often in the range of 3-5, this is due to the ability to scale up manufacture for supply standardised products to very large numbers of patients. The current regulatory requirements are that all manufacturing sites are inspected and authorised, and all are named on the product’s marketing authorisation, this not an issue where there are few manufacturing sites.

Since most POC products have very short shelf lives they cannot be manufactured in advance or supplied to distant locations, some POC products may be manufactured for an individual patient. These mean that supply has to be by scale-out (i.e. by adding more manufacturing sites) and not scale up (i.e. by adding more capacity to a few existing sites). Experience with POC products in clinical development indicate that some will be manufactured at several hundred UK sites. It follows that inspecting and authorising each manufacturing site and naming all on each product’s marketing authorisation becomes a major and possibly insurmountable issue.

Timing / urgency

The fact that some products are currently in clinical trials means that the need for regulatory change in this area is current and needs to be in place to support those products as they approach application for UK marketing authorisations. This proposed framework will ensure that the UK is a favourable location to develop and trial novel medicines by supporting advancing technologies and manufacturing. manufacture advanced technology products and conduct clinical trials.

Classification

Many POC products involve the use of device technologies to generate or isolate their constituent elements and/or to manufacture the medicinal product. Examples include medical gasses (e.g. nitrous oxide, oxygen), 3D print (additive manufacture) of chemical compounds or ATMP manufacture, isolating tissues and cells (e.g. stem cells) or blood components (e.g. platelets, plasma). Since the intended purpose of these POC products is achieved by pharmacological, metabolic or immunological action, they fulfil the definition of a medicinal product rather than a medical device so will be classified as medicinal products.

Type and range of manufacturing location

Manufacture of medicinal products generally occurs within fixed factory sites which may be entirely dedicated to a single product or manufactured on lines within those factories either on a full-time basis or for a period, often termed a campaign. POC manufacture differs from this in that it occurs in close proximity to the patient. This means that there will be a wide range of manufacturing locations which are primarily healthcare facilities such as pharmacies, operating theatres, ambulances, clinics and military field hospitals.

Scientific development is creating new manufacturing technologies which allow and, in many cases, require new delivery mechanisms. POC manufacture is such one such delivery option and it is part of broader spectrum of manufacturing options becoming available for medicinal products. This spectrum extends from the current ‘standard model’ of factory-based manufacture to manufacture that is distributed across multiple locations include modular manufacture, mobile manufacture, POC manufacture and potentially home based manufacture. As with most spectrums, the boundaries between these main categories will most likely overlap as the science and technology continue to advance.

MHRA’s view is that the scope of the new POC regulatory framework are those in close proximity to the patient which includes mobile manufacture that brings manufacture to the patient or where the patient travels to the site of manufacture.

Policy objectives

The aim of this proposed legislative change is to establish a proportionate regulatory framework that supports the safe development of medicines which need to be manufactured and supplied in close proximity to patients or new supply chains that enhance patient access.

We are proposing that the safety of medicines manufactured at POC will be based on established medicines development process such as non-clinical studies and clinical trials, but will be adapted to suit the requirements of multiple sites of manufacture. These adaptions will support the development of new POC products, for example by avoiding the need for each POC site to be named on the marketing authorisation and to be individually inspected by MHRA.

Our objective is for these adaptions together with regulatory clarity and certainty will enable industry to develop a new group of products and manufacturing approaches.

3. The proposals

Several of the proposed measures presented here are adapted from precedents in current use in the regulation of medicinal product manufacture and also from the regulation of other areas such as the processing of blood components for use in transfusion and the processing of tissue and cells components for use in transplants. These measures have proven to be effective in ensuring product safety and quality and include adaption of concepts and guidelines which include but are not limited to:

• Good Manufacturing Practice - those guidelines used in the manufacture of short shelf life products such as radiopharmaceuticals, real time release testing and parametric release.
• Master file systems – a collection of records and scientific information that is common to all applications or users that refer to it. These are currently used in support of Marketing Authorisation Applications including for Active Substances, for plasma when used as a starting material for manufacture of fractionated blood products such as albumin and immunoglobulins and for vaccines.
• The ‘hub and spoke’ model used in the regulation of blood for transfusion and the tissue and cells transplant where there is a central licensed site (the hub) and multiple supply sites (the spokes) that connect to the hub.

The Control Site concept

The regulatory system is proposed to be based on a Control Site, this will be the primary focus of regulatory controls by MHRA. The Control Site will be a physical site that will be named on the clinical trial or marketing authorisation application. The Control Site would be responsible for overseeing all aspects of the POC manufacturing system including the addition of new manufacturing sites and control of each manufacturing location and their activities.

The Control Site will be responsible for a range of activities including but not limited to:

• the assessment and addition of new sites through an ‘onboarding’ process and for site no longer required their decommissioning and removal .
• the control strategy to ensure process performance and product quality,
• training of central and local staff,
• oversight of the pharmaceutical quality system,
• provision, control and maintenance of manufacturing equipment,
• supply of raw and starting materials and consumables used in manufacture,
• systems to capture and supply information from local sites to the Control Sites on production activities,
• provision of Qualified Person (QP) oversight,
• traceability information,
• provision of a system or systems to capture and report incidents, issues, out of specification or compliance events, serious breaches of a clinical study protocol or Good Clinical Practice, serious and adverse event reporting, change control and periodic audit of systems and sites.

The oversight duties provided by QPs will need to be adapted to suit manufacture at many POC sites under the Control Site, this includes how products will be approved for use at POC given that there will normally be a very short time to make such decisions. For factory-based manufacture this is usually by end product testing which typically takes several days or weeks after the product has been manufactured. At POC we are considering a system of local verification based on compliance of equipment against qualification criteria, the process against validation criteria, materials against pre defined attributes and the manufacturing process against key process criteria. These decision making criteria could be assessed as part of the clinical trial or marketing authorisation application.

In conjunction with Clinical Trial Application and Marketing Authorisation Application processes, ‘criteria for release’ may be required which would be linked to the product specification ‘product specification’. Other considerations may be the requirement to provide assurance that each batch complies with its specification such as surrogate, testing. Where it is possible to test each product or batch after administration this could be an alternative to confirm that the dose was acceptable. In all cases, actions would need to be taken if the products or batch was out of specification. Again, these would be assessed as part of the clinical trial or marketing authorisation.

This reporting system and its degree of sophistication in exchanging information between the Control Site and each POC manufacturing site, plus other sites such as any used for testing, will need to be related to factors such as the number of sites and the need for immediacy of reporting and action. Reporting systems from POC sites to the Control Site could allow assessment of data in or near real time.

We are proposing that the Control Site will also be required to compile, maintain, and supply to MHRA:

• A POC Master File, POC MF, this will be the key source of information on the state of control over the POC system. It will need to be kept up to date as changes occur and to be supplied on a routine basis to MHRA for review and assessment of the degree of compliance with the different areas of good practice such as Good Manufacturing Practice, Good Clinical Practice and Good Pharmacovigilance Practice. We are proposing that the frequency of reporting is to be on an annual basis and will be linked to the routine re inspection of the POC manufacturing system. In Good Manufacturing Practice (GMP), the POC Master File can cover requirements that would normally be included in separate systems such as the Site Master File.
• Notices of significant events and issues on an as needed basis when significant individual events or emerging trends are apparent through the current interim compliance report system. The POC MF is aimed at streamlining the tasks of all parties in the manufacture, applications for authorisations and regulation. In the initial stages of development, the POC MF will only support one clinical trial application (CTA) and one marketing authorisation application (MAA), however by analogy with the Plasma and Vaccine Antigen Master File systems, the POC MF could support more than one CTA and more than one MAA. Details of the contents of a POC Master File are to be fully determined through feedback from this consultation but, based on other master file precedents referred to above, it will:
• Capture and maintain information that will be used to inform any MHRA Good Practice inspection:
  • GMP inspections - the Control Site would be subject to regular inspection along with selected manufacturing sites. The frequency of inspections of the control and POC sites has not been determined but as for MHRA’s current GMP inspection programme it would be based on risk. This could be an annual GMP inspection for the Control Site and sufficient exemplar POC sites to provide assurance that a satisfactory level of control is exercised by the Control Site over the manufacturing and any testing sites. Each POC site would have nominated individual who would be accountable for complying with the established POC procedures.
  • Good Clinical Practice (GCP) inspections – the POC MF could be part of GCP planning and risk-based inspections with the Control site forming part of an investigator site inspection and be reviewed for GCP aspects, together with sponsor oversight of the process. The inspection planning would determine where GCP and GMP aspect start and stop, or where GCP can review some of the POC GMP aspects (as agreed) at the investigator site which would help inform/support the GMP manufacturing site knowledge and intelligence
  • Good Pharmacovigilance Practice (GPvP) inspections – the Vigilance and Risk Management of Medicines (VRMM) Division would agree a risk management plan (RMP) with the Marketing Authorisation Holder (MAH) and it is likely that Health Care Professionals would need to be given educational materials on the administration of the product, as well as around the reporting of adverse events experienced by the patient at the POC. In addition to adverse events, other special situations such as medication errors, overdose, occupational exposure, etc., represent important information for pharmacovigilance purposes. There may be other risk minimisation activities required and these would be detailed in the RMP. As for any authorised product, the MAH would need to establish a pharmacovigilance system which would need to be described in the pharmacovigilance system master file (PSMF); this system could be subject to a GPvP inspection.
  • Be a stand-alone document which will be separate from the dossier for clinical trial or marketing authorisation and it will provide relevant information for these purposes.
  • Require regular re-certification to demonstrate that requirements of both MA and GMP continue to be met.

Other considerations for the new regulatory framework:

• CTA/MAA - the requirements for the supporting documentation for a CTA or MAA will need to be adapted: Details of the control site will need to be included but there will be no need to specify each individual manufacturing site.
• The process by which new POC sites would be included in the manufacturing network (‘onboarded’) will need to be described, with particular focus on how comparability would be established between product manufactured at different sites.
• Process development, process validation and control sections of the dossier could be captured as a POC Master File component (or as an appendix to the IMPD) and submitted for scientific and technical evaluation as part of the MAA or a CTA.
• Data requirements for finished product testing, batch analyses, stability testing and labelling will be dependent on the nature of the product and the shelf life; these could differ significantly from conventional pharmaceuticals and may need to be agreed on a case-by-case basis.

• The manufacturing equipment may also be directly involved in administering the medicinal product and this may also involve compliance with medical device regulations.

• The Risk Management Plan (RMP) would need to be agreed on a case-by case basis depending on the nature of the product and its clinical use. A key element would be traceability and it may be beneficial to use patient registries to support ongoing evaluation of the benefit-risk balance.

Range and types of manufacturing locations.

The current regulatory framework is primarily geared to the ‘standard model’ of fixed factory based manufacturing sites, which for any individual product has a relatively small number of sites. The new and broadening spectrum of manufacturing options, sometime referred to as ‘distributed manufacture’, has a range of manufacturing categories including:

• modular manufacture – these can be prefabricated manufacturing units which may be totally self-contained or require connection to various services at the new site. They may be moved at intervals measuring months or years, sequentially to different factory or clinical sites.
• mobile manufacture – mobile micro-factories that can be deployed at clinical centres or military field when required.
• POC manufacture – as described in the sections above.
• home based manufacture – some technologies currently permits activities classified as medicinal product manufacture to occur at home, with technological advances this is set to increase. This is being enabled by increasingly sophisticated manufacturing devices and the ability to control these remotely when the device and supplied starting materials are used by a patient.

As with most spectrums, there will be a range of manufacturing options within each of the main categories and also the boundaries between these categories will most likely overlap as the science and technology continue to advance.

Modular manufacture, given that this involves relatively infrequent changes of site and location primarily in factory settings, could be considered to be controlled adequately by the current regulatory framework and may only require the addition of new GMP guidance documents.

Further work to implement the POC scheme.

On the basis that a new POC regulatory framework will be brought into UK law, supplementary guidelines will be required to provide more detailed operational guidance on topics such as the application process, how to present information in the applications and interpretive guidance documents such as GMP expectations.

4. Questions

Question 1

Do you agree that point of care manufacturing is sufficiently different to the current ‘standard model’ of factory-based manufacture of medicinal products that a new framework is required?

If no, please provide further information on alternative regulatory arrangements to cover POC products.

If yes, please provide further information on changes or additional arrangements that you consider to be required in order to support development of POC products.

Question 2

Do you agree with the proposals for the new regulatory regime for POC products?

If no, please provide further information on alternative proposals to cover POC products.

If yes, please provide further information on changes or additional arrangements that you consider to be required. For the POC master file system, please include details on contents you consider appropriate.

Question 3

We are seeking to clarify the scope of the new POC regulatory framework in relation to the above manufacturing categories.

3a. Do you consider that the new POC regulatory framework should be further adapted to also cover modular manufacturing?

3b. Do you consider that the new POC regulatory framework should extend to cover home based manufacturing?

3c. Do you consider that there are other areas of POC manufacture that should be covered?

3d. If you consider that this new framework should not be adapted to cover one or more of these above manufacturing categories, what regulatory controls do you consider are required?

Question 4

Are there other aspects of the POC framework that you believe have not been considered? This could include any additional positive and negative impact that the framework may have on the delivery of healthcare in the UK.

Please provide further information.

Annex A – Legal basis and assessment of the matters set out in section 2 of the Medicines and Medical Devices Act 2021

The Medicines and Medical Devices Act 2021 (the Act) received Royal Assent on 11 February 2021. We propose to make the legislative changes under consultation in this document using powers in Part 2 of the Act, which provides powers to make regulations about human medicines.

This consultation is conducted in line with the consultation requirement in section 45(1) of the Act.

Section 2 of the Act states that patient safety must be the overarching objective of the appropriate authority when making regulations. Section 2 requires that when assessing whether regulations would contribute to the objective of safeguarding public health, the appropriate authority must have regard to three factors:

(a) The safety of human medicines and that the benefits of doing so outweigh any risks

(b) The availability of human medicines

(c) The likelihood of the relevant part of the United Kingdom being seen as a favourable place which to –

(i) Carry out research relating to human medicines

(ii) Conduct clinical trials, or

(iii) Manufacture or supply human medicines

As set out in section 2(3) of the Act, where regulations under subsection (1) may have an impact on the safety of human medicines, the appropriate authority may make the regulations only if the authority considers that the benefits of doing so outweigh the risks.

Below we have assessed the proposals against each of the factors set out in the Act.

Safety

The proposals for the new regulatory framework are designed to ensure that products manufactured at the point of care meet the high standards of safety expected for medicinal products, this will ensure the upmost protection for patients who will receive these treatments.

Manufacture of medicines under the proposed new POC framework is built on existing and internationally accepted pharmaceutical principles to maintain equivalent standards of product quality, safety and efficacy with those currently in place. These include high-quality science during the discovery phase, at pre clinical studies, thorough regulatory evaluation at clinical trials and at marketing authorisation application stages followed by post-market safety monitoring through pharmacovigilance. We are proposing that the quality of products is also assured by compliance with good practice though inspections against the requirements of Good Laboratory Practice, Good Manufacturing Practice, Good Clinical Practice and Good Pharmacovigilance Practice. This proposal will therefore provide the necessary regulatory oversight to give assurance of the safety of point of care medicines and ensure patients receive high quality, safe and effective products.

There are differences between current factory based manufacture and supply and POC products, largely the relatively short duration of manufacture and time before administration. These differences place limitations on the ability to conduct tests on the products during manufacture and prior to use. In order to maintain the safety and quality of POC products, greater reliance will be placed on assurance measures during manufacture such as in-process monitoring and controls. These will be built on a comprehensive understanding by the developer of the product’s critical quality attributes through enhanced product and process development. Such requirements are well established in internationally harmonised regulatory guidance through the Quality Guidelines of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), in particular ICH Q8 to Q12.

This proposal and the measures contained within it for POC products will ensure that they are as safe to patients as current medicinal products.

We have also considered environmental safety and impact of the proposals on the wider environment. The proposals are intended to increase the availability of safe, effective and high quality products that are manufactured at the site where the patient receives the product. Manufacture and immediate usage of medicinal products at the point of usage has many environmental advantages, principally the absence of the need for long-term storage and national or international transportation. The immediate usage also means that there are minimal requirements for packaging materials beyond the temporary protection and containment of the product between the time of production and administration. This will also reduce the quantity of manufacturing waste and equipment wash down materials to be disposed of. In addition, based on the bespoke manufacture and immediate administration of the product there will be minimal waste medicinal product for disposal.

Availability

The POC framework is specifically designed to create and regulate a step change in the range of manufacturing options to enable the supply and increase the availability of innovative new medicinal products. Under the current regulatory framework, POC products would either be manufactured and authorised with substantial bureaucratic and financial limitations or could not be manufactured and authorised at all. This is a consequence of scientific advances creating new products and processes that could not have been foreseen at the time current regulatory framework was devised. The proposal to introduce specific control measures means there will be a regulatory framework tailored for the manufacture and licensing of these innovative products. This will make it easier for POC products to be manufactured on a commercial scale and reach a wider range of patients.

This new manufacturing and supply market in the NHS and wider UK healthcare system will benefit patients that currently have no or few treatment options by improving the availability of innovative medicines.

Favourability

The POC framework is specifically intended to have a positive effect on the UK pharmaceutical manufacturing and supply industry by creating a new sector to support and deliver innovative new products to patients. The framework is not intended to replace the existing factory based model but to enable appropriate and effective of products that do not fit into current regulatory requirements.

The POC regulatory framework delivers on ambitions in the Life Sciences Industrial Strategy, meeting several of the challenges and themes identified in that Strategy such as science, growth and the NHS. A new framework for point of care manufacture is specifically identified in the Life Sciences Sector Deal 2, and as described in that document An effective regulator, working within well-functioning regulatory frameworks, is an essential part of a strong business environment for the life sciences sector.” The proposed POC framework is designed to ensure the regulatory regime reflects novel and innovative manufacturing, to encourage increased manufacture and supply of these products.

MHRA, in moving to an enabling regulator, understands that taking innovative products and processes through the development process to supply patients requires regulatory support and guidance and also linkages to other parts of the UK healthcare network. There are two MHRA mechanisms for this:

• The Innovation Office - established in 2013 and a year later jointly formed a cross UK regulatory forum for regenerative medicines, The Regulatory Advice Service for Regenerative Medicines with other UK regulators. These are the fora which most POC innovators will come to the MHRA at a very early stage of development. This early engagement is aimed to start an ongoing series of interactions which will provide the innovators with free advice to clarify regulatory requirements so accelerating product development and facilitate financial investment. As the products progress through their development, the regulatory interaction options available to innovators continue with scientific advice meetings, potentially jointly with MHRA and NICE.
• The Innovative Licensing and Access Pathway - launched in January 2021 which provides access to the permanents partners MHRA, NICE and SMC plus the supporting partners NHS England and NHS Improvement, the Health Research Authority and the National Institute for Health Research. It is anticipated that due to the innovative nature of POC products, they are likely to meet the ILAP eligibility criteria. One early stage POC product has applied and been accepted into the ILAP scheme. These measures provide concrete evidence of MHRA’s intent to move away from a common perception of regulators as a progress blocker to a progress enabler.

The POC framework is a world first in the regulation of this emerging area of innovation, in this respect it is a unique approach. However, although first identified in the UK, these innovations are not solely present in the UK and equivalent regulatory approaches will be needed in other territories. MHRA has initiated discussions with international regulatory partners on this approach to help make these new products available to a wide number of patients.

Annex B – Consultation questions and how to respond

How to respond

The Government invites responses on the specific questions raised. The questions can be found through the document and are also listed in full below This consultation will close on 23rd September. Please respond through our online consultation survey.

When responding please say if you are a business, individual or representative body. In the case of representative bodies, please provide information on the number and nature of individuals or firms you represent.

Summary of questions

Consultation Questions

Do you agree that point of care manufacturing is sufficiently different to the current ‘standard model’ of factory-based manufacture of medicinal products that a new framework is required?

If no, please provide further information on alternative regulatory arrangements to cover POC products.

If yes, please provide further information on changes or additional arrangements that you consider to be required in order to support development of POC products.

Do you agree with the proposals for a new regulatory regime for POC products?

If no, please provide further information on alternative proposals to cover POC products.

If yes, please provide further information on changes or additional arrangements that you consider to be required.

We are seeking to clarify the scope of the new POC regulatory framework in relation to the above manufacturing categories.

a. Do you consider that the new POC regulatory framework should be adapted to cover modular manufacturing?

b. Do you consider that the new POC regulatory framework should extend to cover home based manufacturing?

If you consider that this new framework should not be adapted to cover one or both of these above manufacturing categories, what regulatory controls do you consider are required?

Are there other aspects of the POC framework that you believe have not been considered? This could include any additional positive and negative impact that the framework may have on the delivery of healthcare in the UK.

Please provide further information.

Background questions

Which best applies to you:

• I am responding as an individual
• I am responding on behalf of an organisation

Where do you live?

• England
• Northern Ireland
• Scotland
• Wales
• Other – please specify

Please tell us the geographical area your organisation covers?

• United Kingdom
• Great Britain
• England
• Northern Ireland
• Scotland
• Wales
• Other – please specify

Name of organisation

Main activities of your organisation

Have you had a personal experience with POC?

• Yes
• No

If you ticked Yes above, do you think you might benefit from POC?

If you ticked No above, please share any thoughts or comments on how you think POC may impact patients?

Are you a healthcare professional?

• Yes
• No

If you ticked Yes above, do you have professional experience prescribing or supplying POC medicines?

Are you responding from an organisation that manufactures or will manufacture POC medicines when the legislation comes into effect?

• Yes
• No

If you ticked Yes above, please provide a brief summary of the POC medicines

Equality and Rural Screening

In Northern Ireland new policies must be screened under Section 75 of the Northern Ireland Act 1998, https://www.legislation.gov.uk/ukpga/1998/47/section/75 which places a statutory duty on public authorities, to mainstream equality in all its functions – so that equality of opportunity and good relations are central to policy making and service delivery. In addition new or revised policies must be rural proofed in line with the Rural Needs Act (NI) 2016 https://www.legislation.gov.uk/nia/2016/19/contents which requires public authorities to have due regard to rural needs.

We do not consider that our proposals risk impacting different people differently with reference to their protected characteristics or where they live in NI. We welcome views on this point.

Do you think the proposals risk impacting people differently with reference to their [or could impact adversely on any of the] protected characteristics covered by the Public Sector Equality Duty set out in section 149 of the Equality Act 2010 or by section 75 of the Northern Ireland Act 1998? If so, please provide details.

Confidentiality of Information

Information published in response to this consultation, including personal information may be published or disclosed in accordance with the access to information regimes. These are primarily the Freedom of Information Act 2000 (FOIA), the Data Protection Act 2018 (DPA), UK General Data Protection Regulation (UK GDPR) and the Environmental Information Regulations 2004.

If you want the information that you provide to be treated as confidential it would be helpful if you could explain to us why you regard the information you have provided as confidential. Any information not published, including personal information, may still be subject to disclosure in accordance with the Freedom of Information Act. If we receive a request for disclosure of such unpublished information, we will take full account of your explanation, but we cannot give an assurance that confidentiality can be maintained in all circumstances. We will not take a standard confidentiality statement included in an email message as a specific request for non-disclosure.

The MHRA will process your personal data in accordance with the DPA and UK GDPR and in the majority of circumstances this will mean that your personal data will not be disclosed to third parties. However, the information you send us may need to be published in a summary of responses to this consultation.