Consultation outcome

The future strategy for batch testing of medicinal products in Great Britain: government response

Updated 15 December 2022

Executive summary

Batch testing is the process of confirming every batch of medicine has the correct composition through laboratory tests by the manufacturer. It helps to ensure that patients get medicines that are of appropriate quality and have the desired therapeutic effect.

The Department of Health and Social Care (DHSC) ran a public consultation seeking views on 4 policy options for a future batch testing policy for Great Britain where medicines are imported from a country with which the UK does not have a mutual recognition agreement (MRA) on batch testing.

A range of stakeholders across the UK and internationally expressed comments and views. The majority of the responses were in favour of option A: no import testing or UK Qualified Person (QP) certification for medicines imported from countries on the list of approved countries for import.

Responses to the consultation highlighted the benefits of this option for the safety and availability of medicines, as well as avoiding adding additional cost and complexity that could disrupt medicine supply chains, making the UK a less attractive market.

After careful consideration of all the responses to the consultation, alongside other relevant information and evidence, the government has decided to make permanent the approach of maintaining a list of approved countries for import which require no import testing or UK QP certification. This policy protects patient safety, supports the aims set out by this government in the Life Sciences Vision to stimulate a thriving UK life sciences sector and avoids adding unnecessary regulation to an already highly regulated sector.

As this policy is currently in operation and in legislation, there is no need for a 2-year period to allow industry to prepare for implementation.

Introduction

The UK’s independence from the European Union (EU) means the UK can set its own regulatory policy in Great Britain on how, when and if to accept batch testing results from third countries we do not have an existing MRA with.

At the end of the transition period, the government implemented a range of standstill measures to support sectors trading with third countries. Currently a ‘listing’ system removes the requirement to batch test on import medicines from certain non-MRA countries and, therefore, allows UK wholesalers to continue importing medicines from the third countries that meet our standards, in order to maintain UK supply. Countries are assessed against an objective standard that tests their equivalence to the UK’s own regulatory standards before they can be ‘listed’. The EU/EEA are the only non-MRA countries listed.

In March 2021, the government announced a full review into Great Britain’s future batch testing policy, to report no later than December 2022. Following the conclusion of this review, the intention was for a 2-year notice period before any changes to the current policy are implemented.

DHSC hosted a public consultation on how, when and if to accept batch testing results from third countries with which the UK does not have an MRA. The consultation ran from 31 May 2022 to 26 July 2022 and sought views on 4 potential options for a future policy. This is the formal government response to that consultation and the conclusion of the government review announced in March 2021.

The objective of the final policy on batch testing of medicines is to protect patient safety and access to medicines, to build the right domestic system for the UK life sciences sector, and to drive international collaboration. This approach would mean patients continue to have access to safe, effective, and high-quality medicines; support the aims of the Life Sciences Vision; and maintain globally harmonised standards.

The consultation proposed 4 options for consideration:

• option A: no import testing or UK Qualified Person (QP) certification for medicines imported from countries on the approved list. The list would be open to all third countries provided they could demonstrate equivalent regulatory standards and membership would be reviewed at least every 3 years. This option would require that a Responsible Person (import) (RPi) in the UK verifies that the batch has been batch tested and certified by a QP in the EU
• option B: implementing UK QP certification and release for countries on the approved list. This would remove the role of the RPi and mean that medicines imported from listed countries would need to be imported by a Manufacture and Importing Authorisation (MIA) holder into a GB importation site and certified and released by a UK QP. The list would be open to all third countries provided they could demonstrate equivalent regulatory standards and membership would be reviewed at least every 3 years
• option C: full quality control batch testing in the UK. It removes the listed approach and would require medicines imported by all non-MRA countries to be imported by an MIA holder into a GB importation site. A UK QP would be responsible for certifying and releasing the batch
• option D: reduced number of import tests and implementing UK QP certification and release for all listed countries. This would require only a limited number of critical tests, such as identification or assay tests, on products from countries on the list. The list would be open to all third countries provided they could demonstrate equivalent regulatory standards and membership would be reviewed at least every 3 years

This consultation response provides a summary of the feedback received from stakeholders and the government’s response.

Government decision

We welcome the many useful comments and thank respondents for taking the time to carefully consider our proposals. The review sought to find a policy that balanced our 3 objectives.

After careful review, consideration against our objectives and based on the clear view from respondents, we have decided to adopt option A, no import testing or UK QP certification for listed countries, as the future policy on batch testing of medicines for Great Britain.

Having considered consultation responses and wider analysis as part of the review all options were considered comparable in terms of patient safety. Therefore, the decision was based on the benefits of this option in terms of:

• protecting patient access to medicines
• maintaining a regulatory system that is right for the UK life sciences sector
• enabling innovation and driving growth through efficient and effective regulation without being a barrier to trade

Maintaining the listing system provides regulatory certainty to industry and preserves access by keeping supply chains unaffected and not adding barriers to marketing medicines in GB. The listing approach maintains regulatory flexibility to require full testing on import from non-listed and non-MRA countries where they do not meet the UK’s high standards.

The consultation was carried out in accordance with the Medicines and Medical Devices Act 2021. In considering this policy we have given due regard to:

• the safety of medicines
• the availability of medicines
• whether the UK is likely to be seen as a favourable place in which to research, develop, manufacture or supply medicines

We have assessed the final policy against these factors and the evidence submitted in the consultation and are satisfied it will not have a negative effect on these factors.

We asked a number of questions in the consultation relating to assess the potential impact of the policies and published an impact assessment (IA) alongside the consultation providing analysis of the relevant costs and benefits of the policy options. Responses broadly agreed with the analysis of the costs and benefits contained in the IA. While a final stage IA is not required, a summary of refinements to the original analysis based on the greater understanding generated through the public consultation is contained in Annex A.

Preferred policy option

The following 5 figures give the proportion of respondents choosing from the following 4 options:

• option A: no import testing of UK QP certification or release for listed countries
• option B: implementing UK QP certification and release for listed countries
• option C: full quality control batch testing and implementing UK QP certification or release for all non-MRA countries
• option D: reduced number of import tests and implementing UK QP certification or release for all listed countries

Figure 1: policy preference of all respondents (146 respondents)

Options	Percentage
Option A: no import testing or UK QP certification or release for listed countries	72%
Option B: implementing UK QP certification and release for listed countries	3%
Option C: full quality control batch testing and implementing UK QP certification and release for all non-MRA countries	15%
Option D: reduced number of import tests and implementing UK QP certification and release for all listed countries	10%

The majority of respondents favoured option A (105 respondents, 72%), followed by option C (22 respondents accounting for 15%), option D (14 respondents, 10%) and option B receiving minimal support (5 respondents, 3%).

Figure 2: policy preference on behalf of manufacturing or importing organisations (80 responses)

Options	Percentage
Option A: no import testing or UK QP certification or release for listed countries	85%
Option B: implementing UK QP certification and release for listed countries	4%
Option C: full quality control batch testing and implementing UK QP certification and release for all non-MRA countries	5%
Option D: reduced number of import tests and implementing UK QP certification and release for all listed countries	6%

Manufacturers and importers of medicines overwhelming preferred option A, with 85% (68 respondents) selecting this option; 4% (3 respondents) of them selected option B; 5% (4 respondents) selected option C; and 6% (5 respondents) selected option D.

Figure 3: individual responses (27 respondents)

Options	Percentage
Option A: no import testing or UK QP certification or release for listed countries	22%
Option B: implementing UK QP certification and release for listed countries	7%
Option C: full quality control batch testing and implementing UK QP certification and release for all non-MRA countries	41%
Option D: reduced number of import tests and implementing UK QP certification and release for all listed countries	30%

Individuals were more split in their preferred option: 41% (11 respondents) supported option C; 30% (8 respondents) supported option D; 22% (6 respondents) supported option A; and 7% (2 respondents) supported option B.

Figure 4: outsourced UK contract testing facilities respondents (10 responses)

Options	Percentage
Option A: no import testing or UK QP certification or release for listed countries	30%
Option B: implementing UK QP certification and release for listed countries	0%
Option C: full quality control batch testing and implementing UK QP certification and release for all non-MRA countries	60%
Option D: reduced number of import tests and implementing UK QP certification and release for all listed countries	10%

Organisations providing outsourced contract testing facilities were also slightly split in their preferences: 60% (6 respondents) supported option C; 30% (3 respondents) supported option A; 10% (1 respondent) supported option D; and none selected option B.

Figure 5: those responding on behalf of other categories (29 responses)

Options	Percentage
Option A: no import testing or UK QP certification or release for listed countries	97%
Option B: implementing UK QP certification and release for listed countries	0%
Option C: full quality control batch testing and implementing UK QP certification and release for all non-MRA countries	3%
Option D: reduced number of import tests and implementing UK QP certification and release for all listed countries	0%

Other respondents, for example industry associations or marketing authorisation (MA) holders, overwhelmingly supported option A (97%, 28 respondents), with 3% (1 respondent) supporting option C, and none selected options B and D.

The predominant reasons given by those selecting this option related to maintaining existing supply chains without adding cost, complexity, or disruption; beneficial for the availability of medicines; and, good for patient safety.

Those who favour option B cited greater control over testing and certification; safety and attracting investment and innovation.

Those favouring option C and D, which involved introducing some form of testing, cited: greater control over testing; that it supports UK pharma resilience and positive for patient safety.

We note several respondents expressed a preference for an MRA with the EU. This consultation considered operational solutions for the future batch testing policy and was clear that an MRA with the EU was outside the scope of the consultation.

Summary of responses

The consultation asked what effect each of the options would have on a range of factors which included:

• patient safety and access to medicines, including impacts on health disparities and protected characteristics
• making the UK an attractive place for the research, manufacture and marketing of medicines
• supply chain resilience
• environmental impacts

Option A: no import testing or UK QP certification or release for listed countries (72%)

Respondents highlighted this option would be positive for access, availability, and overall for the supply of medicines. While 26 respondents mentioned option A being good for access and supply, there were 6 who said it could have a negative effect on access and availability.

There were 23 respondents who stated this option would be positive for patient safety, recognising the high standards required to be added to the list of approved countries for import, compared to 12 whose responses mentioned negative effects to patient safety.

Respondents noted supply chains would not be affected by this option and it would therefore avoid delays to medicines being available in the UK. Respondents felt the option would avoid adding cost or regulatory burden to businesses, which could then be passed onto patients and the NHS. When asked about environmental impacts, this option was seen as positive for avoiding increased use of solvents, chemicals, single-use plastics and reducing the sector’s carbon footprint.

Responses were balanced around the effect this option would have on the attractiveness of the UK market: 24 responses highlighted the positive effect it could have while 24 responses highlighted concerns that this option could disincentivise investment in the UK. Other negative themes in responses related to concerns around reduced oversight and control over supply chains, which could be negative for patient safety.

Option B: no import testing but implementing UK QP certification and release for listed countries (3%)

On this option, respondents were broadly more negative than positive about the factors asked about in the consultation. Sixty-four respondents stated this option would be negative for access, availability, and supply of medicines due to adding the additional step of requiring UK QP certification and release before medicines could be sold.

The option was also seen by 35 respondents as adding cost, complexity, and additional barriers to supplying medicines to Great Britain, which 34 respondents stated would make the UK less attractive for marketing medicines. There were also concerns raised by 37 respondents about having sufficient skills and capacity, particularly around additional QPs, which would make implementation challenging.

Of the positive responses to this option, 16 viewed it as potentially increasing investment in the UK as more sites would need MIAs and QPs, which could then lead to greater investment in research and manufacturing. The increase in QPs required by this option and the minimal importation requirements were seen by some as making the UK a more attractive market.

Option C: full quality control batch testing and implementing UK QP certification and release for all non-MRA countries (15%)

Responses to this policy option were mixed. The majority of respondents were strongly opposed to this option, with a minority, predominantly made up of individual responses (41%) and those providing outsourced contract testing facilities (60%), being strongly in favour and stating it as their preferred policy option. Several in favour of this option viewed it posing challenges in the short to medium term but felt it would be the best option longer-term for the UK.

Concerns were raised by 63 respondents about this option having a negative impact on access and availability of medicines, as the extra time required for testing and release could lead to stock shortages, availability issues and presented a particular problem for medicines with short lifespans. The risk of some medicines being discontinued under this option was mentioned in 32 responses. For example, the increased costs of testing could make some product lines financially untenable and therefore stop supply of these medicines to the UK which would be bad for patient access.

There were concerns raised in 43 responses that this option would be costly to implement – requiring the cost of establishing testing methods within the UK and the routine cost of testing each imported batch, which would reduce profit margins for businesses and costs could be passed on to the NHS and to patients. A negative impact on overall supply chain resilience was mentioned by 67 respondents, which they reported would be due to the additional step of testing increasing the risk of something going wrong and further stress placed on the medicines. The additional time required for testing would have knock-on effects to the wider supply chain. Concerns also mentioned the risk of creating an unattractive regulatory environment because of the additional costs and burden of import testing, which several respondents saw as being unnecessary for no additional benefit.

The positive themes that emerged from respondents’ answers were around the potential for this option to increase long-term investment in the UK, which was mentioned in 27 responses as it could encourage more innovation and attract smaller pharmaceutical companies to establish themselves in the UK market. The additional highly skilled staff to support this option was also seen as creating a favourable skills base that would be attractive to companies. Greater control over testing and certification was mentioned in 11 responses, as was the potential for this option to support overall resilience of the UK pharmaceutical industry. Nine respondents viewed this option as positive for patient safety as the UK would have direct oversight of testing and release processes providing increased confidence that medicines met the UK’s high standards.

Option D: reduced number of import tests and implementing UK QP certification and release for all listed countries (10%)

Only 10% of respondents selected option D as their preferred policy. Respondents were asked how they thought option D would differ from option C in terms of impact. The most common themes in responses were around option D adding less time to the supply of medicines; having lower costs for businesses; having less impact on supply chains in terms of delays and a reduced risk of shortages of medicines; and reduced environmental waste.

Some viewed this option as more balanced or pragmatic compared to the full testing required under option C: fewer tests would mean a reduced impact on manufacturing duration, less likelihood of causing supply delays and was more appropriate than full testing of all imported batches. Others reported the effects and impacts would be broadly the same: the additional testing and QP certification and release would have much the same impact because the testing facilities would still require the same lab testing methods and administrative costs of managing the testing requirements.

Overview of consultation activity

The government launched the consultation ‘The future strategy for batch testing of medicinal products in Great Britain’ on 31 May 2022 which ran until 26 July 2022. In total, 147 responses were received directly by email and via the online survey platform, accessible via GOV.UK.

Figure 6: capacity of respondents to the survey (134 respondents)

Capacity of respondents	Percentage
On behalf of a manufacturing or importing organisation	60%
Individual	20%
Other – please specify	13%
On behalf of an organisation that provides outsource UK contract testing facilities	7%

Of the total 134 responses, 60% (80 respondents) were from organisations that manufacture or import medicines, 20% (27 respondents) were from individuals, 7% (10 respondents) from organisations that provide outsourced contract testing facilities and 13% (17 respondents) that fell outside these categories, for example a non-governmental organisation or industry group.

Figure 7: respondents by main activities of the organisation (134 respondents)

Main activities of organisation	Percentage
Branded and/or over the counter	41%
Generics	37%
Biologicals	8%
Contract lab organisation	8%
Veterinary medicines	4%
Other – please specify	2%
Charity	1%
Academia or non-commercial	0%

The main activities of organisations represented in the consultation were broadly split between branded and/or over the counter medicines (41%, 38 respondents) and generics (37%, 34 respondents), with the remaining responses spread between biologicals (8%, 7 respondents), contract lab organisations (8%, 7 respondents), veterinary medicines (4%, 4 respondents), other (2%, 2 respondents) and 1% (1 respondent) from charity.

There was an even split between large organisations (47% having more than 250 employees), small and medium sized enterprises (45%) and less than 10% from micro-organisations. 75% of respondents said they imported medicines within scope of this policy.

The variety of interests of the respondents provides a good diversity of views and is considered to be representative of interested stakeholders. The responses received were often comprehensive and rich in detail which has enabled government to understand both the broader issues and the more nuanced comments underpinning consultation feedback.

Conclusion and next steps

The consultation provided extremely valuable feedback on our policy proposals which has helped us adopt a policy that is right for patients and the life sciences sector. After considering the responses to the consultation, in addition to evidence gathered for the IA, stakeholder engagement and views of the Medicines and Healthcare products Regulatory Agency (MHRA), we have adopted the option favoured by 72% of respondents (option A, no import testing or UK QP certification for listed countries), which we have judged to best fit with the objectives guiding the review.

As this policy is currently in operation and in existing legislation (UK Human Medicines Regulations (as amended), Regulation 18A (UK SI 2019/775)), there is no need for a 2-year period to allow industry to prepare for implementation of the policy. We will work with stakeholders to ensure the sector is aware of the conclusion of the government review into batch testing and will monitor the implementation and impacts of this policy. We will also issue guidance to the sector on the long-term operation of the list, including how the membership would be reviewed.

We will not be publishing an updated IA as the policy will continue to be in operation. However, we have published alongside this response our assessment of where the consultation responses would change our assessments of the options presented in the IA, which can be found in Annex A, below.

We wish to thank everyone who submitted a response to this consultation and engaged with us during this review into batch testing policy.

Annex A: summary of responses to the consultation stage impact assessment

As part of the consultation, we invited feedback on the consultation stage IA for this policy. The IA presents our analysis of the policy options using the best available evidence we were aware of. We used the consultation to test the assumptions we had made, identify further sources of relevant evidence and gather suggestions about any costs, benefits or risks of the options that we had not considered.

Below is a summary of responses relating to the IA. The information provided has not materially changed our previous assessment of the alternative options but has strengthened areas of the evidence base used to inform policy making. We will not be updating the IA as the batch testing policy is not changing but the consultation evidence provided will inform our ongoing evaluation of the policy.

Where respondents have been able to provide estimates of the resource requirements of different options, these reflect a broad range in line with the IA but does not narrow the range of values used in the IA. Understanding the effectiveness of repeat testing is a key area where evidence is limited. The IA outlines the reasons why we do not expect import testing of batches from the EU to identify issues. A small number of consultation respondents expressed views, suggesting that the patient safety risk in the IA may be either too high or too low but none provided robust information to enable us to increase the evidence base or refine the assumptions in this area.

Feedback on the analysis of option A

We received 83 responses with feedback on the IA content for option A. Of those, 66 agreed with the assessment of costs and benefits. The majority of those stating that they disagreed raised points that are out of scope of the analysis (9 responses) or reflected a misreading or misunderstanding of the analysis (2 responses). The remaining 6 responses covered 2 themes that have further informed our views of option A. The remaining 6 responses included feedback on the themes of market stability and patient safety:

Three respondents indicated that there is a key benefit of option A for industry that is not referenced in the IA. This benefit is market stability, which will help to maintain consistent supply and provide increased business confidence for longer-term decision-making.

There were contradicting views on the scale of patient safety risk associated with accepting batch testing results from EU QPs, with 2 responses suggesting that the analysis presents the risk as too low and one response suggesting that the risk is too high because it would be no different under this option compared to the alternatives.

Responses to “Do you agree or disagree with the types of costs and benefits associated with option A as set out in the impact assessment?”

Of the responses to this question:

• 66 (80%) agreed with the types of costs and benefits
• 17 (20%) disagreed with the types of costs and benefits

Of which comments reflected:

• patient safety (3 responses)
• industry or business impacts (3 responses)
• issues were not directly applicable to the IA (11 responses)

In addition, 4 respondents indicated that the analysis of option A was missing costs in terms of the likelihood of RPi salaries increasing over time and increasing costs to the regulator in the event of longer-term divergence of UK and EU policies. These are useful considerations that are being factored into policy development but are not captured in the IA because, as costs of continuing with this status quo, they are implicit in the baseline costs of option A that the other options are compared against.

Feedback on the analysis of option B

We sought specific feedback on option B to understand the likely scale of increase in UK-based personnel for testing (and related activities) compared to the current system (see table 1, below). Of 65 respondents reporting that this option would require extra QPs, 57 suggested that they would have difficulty recruiting the additional staff required due to a combination of:

• a perceived shortage of QPs in the UK to meet an increase in demand, including in specific locations or for specific product types
• the cost of recruiting, training and employing QPs and firms

Table 1: responses to “Will you require additional UK-based QPs to implement option B?

Response type	Number of responses	Share of total
Yes	65	77%
No	15	18%
Don’t know	4	5%
Total	84	100%

In response to our request for additional evidence about the costs of implementing option B, 2 reasons were given to suggest that our personnel cost estimates may be undervalued. Firstly, due to undervaluing staff overheads, with more consideration needed for costs of recruitment and hiring processes of the required staff in a tight labour market. Secondly, 2 respondents disagreed with our assumption that QP services could be shared across organisations, suggesting that each importing business would need to hire QPs for certification and release activities.

We sought feedback on the risks of implementing option B. Three respondents stated that UK-based QPs may not receive sufficient access to, or oversight of manufacturing and supply chain activities to fulfil their obligations. We perceive the risk to be low as manufacturers are aware that QPs require this information in order to release batches and option B reflects the existing processes we have in place for countries with which the UK has an MRA. Four respondents indicated that 2 of the risks that were identified in the IA for option C would also apply to option B in terms of:

• the risk of QP and manufacturing flight due to testing activity taking place in the EU (3 responses)
• risks to the ability to maintain parallel imports (1 response)

Feedback on the analysis of option C

For option C, we sought feedback on the expected costs of implementing the proposal. Almost one-third of consultation responses (40 of 147) included information about the possible costs of this option and this information, along with the other consultation responses has informed our decision-making.

Respondents told us that setup costs could range from an implied value of £5,000 per product line to almost £1 million with annual running costs from less than £100,000 to over £10 million per year. This range reflects the variation in the size of organisations affected by the policy as well as the types of products they import and availability of existing infrastructure and capacity for testing.

There were 34 responses indicating that option C would be challenging to implement due to the need to secure new or extra capacity with contract lab or research organisations to carry out additional testing. Of 13 respondents reporting that they have current UK based testing capacity, 5 indicated that their capacity is fully utilised with others suggesting some capacity for extra testing, for between 100 and 5,000 batches.

Consistent with the assumptions made in the IA, consultation responses show that some products will be at higher risk of supply disruption than others due to the extra time required for import testing. As shown in table 2, there were 31 respondents who indicated that none of their products would be at risk due to time delays, however several mentioned that this would be contingent on allowing sufficient time for implementation and a transitory period to increase stock holdings. In contrast, 61 respondents indicated that time delays would create supply risks for at least some product lines. While some respondents noted a general risk of delay, particular examples of products most impacted included vaccines, radioactive medicinal products, advanced therapy medicinal products (ATMPs) due to short shelf lives, as well as products requiring more extensive and complex tests.

There were 54 respondents indicating that the increased costs of option C would lead to products at risk of discontinuation (see table 2). Key products identified include low margin products, orphan drugs, low volume products (including parallel imports) and products already identified as ‘at risk’ due to other factors.

Table 2: responses relating to whether products will be at risk of supply disruption due to the extra time required for import testing or the extra costs associated with import testing

Response	Extra time required: number of responses (proportion)	Extra costs: number of responses (proportion)
Yes	61 (66%)	71 (57%)
No	31 (34%)	54 (43%)
Total (where assessment made)	92 (100%)	125 (100%)

We received feedback to suggest that the IA did not give sufficient weight to the benefit of option C in maintaining and increasing UK based employment opportunities, particularly science sector jobs (3 responses).

In terms of implementing option C, respondents highlighted that repeat testing would not be viable for some product types, particularly ATMPs. Three respondents also highlighted challenges with repeat testing in terms of QPs having access to the right information to complete testing and queried how any discrepancies or contradictions in testing results would be handled.

Feedback on the analysis of option D

We asked for feedback to understand the scale of difference in costs between options C and D. Respondents indicated that the primary or setup costs for the 2 options are likely to be similar. While there may be reduced testing costs, based on the information provided about option D, respondents were not able to estimate how much lower ongoing testing costs might be.

We received feedback on the likely effectiveness of option D compared to C. Five respondents felt that option D could have higher patient safety risks than option C on the basis that poor quality medication could get through limited testing. Two respondents also felt that option C was more likely to be cost effective than option D in terms of the likelihood of identifying faulty or ineffective batches.