Medicines and Medical Devices Bill

Debate between Baroness Wheeler and Baroness Jolly

Report stage & Report stage (Hansard): House of Lords & Report: 1st sitting & Report: 1st sitting: House of Lords
Tuesday 12th January 2021 Lords Chamber

[Baroness Jolly (LD) [V]]

My Lords, the purpose of this amendment, tabled by my noble friend Lady Sheehan, with cross-party support, is to ensure that fair and affordable access to medicines for all must be a consideration when regulations are made with respect to human medicines. This is key for two reasons. The first is to ensure that medicines, including on the NHS, are available at a fair price. We know that the NHS buys medicines at an industrial scale and is very able to be tough in its bargaining to get a good deal for the taxpayer. The second is that the British Government used to play a pivotal role, through DfID, in helping many across the world in the eradication of polio and other life-changing or life-threatening diseases. Will the Minister outline what criteria are used now that DfID has been subsumed by FCDO?

On Covid-19, collaboration on the production of vaccines is critical. What is being done by the Government to collaborate in this life-saving mission? Time is of the essence. Can the Minister tell us where we are now and outline what support is going to those who have neither the contacts nor the money to fund these vaccinations? Our economy has taken a serious hit, but we have a moral duty to support those with no industry, and so no income. I endorse all the comments from the noble Lord, Lord Crisp, who has many years’ experience of these issues—many more than I have. I would be grateful if the Minister could answer my questions.

[Baroness Wheeler (Lab)]

My Lords, I too congratulate the noble Baroness, Lady Sheehan, on another important speech on this key issue and the dogged way she has pursued her arguments and key questions to the Minister. I thank her for sharing her response letter of 7 January to the Minister, which clearly sets out the issues she is still pressing the Minister to address, and I am looking forward to the response from the noble Baroness, Lady Penn, on these matters. I also welcome the very expert and thoughtful contributions from other noble Lords both today and in Committee on this issue, drawing on their extensive professional and international experience and knowledge.

As my noble friend Lady Thornton made clear in Committee, we support this amendment. The reassurance from the Minister during Committee about the Government’s commitment to collaborating with public and private partners in the UK and globally to promote affordable access to vaccines and medicines for all is welcome. Also, we are grateful for their continued commitment to the UK’s obligations on the WHO TRIPS agreement and the DOHA declaration, which provide important flexibilities that support access to medicines and are especially vital during public health emergencies such as the Covid-19 pandemic that is so engulfing us today.

Noble Lords are right to underline the deep concerns of patient groups on the issue of fair and free access to medicines. I remind the House that the Royal College of Physicians, the Faculty of Pharmaceutical Medicine, the British Association of Dermatologists and other key stakeholders have called for a review of the processes for issuing sole manufacturing licences and consideration of the use of price control mechanisms in relation to costs of production to increase access to medicines at fair prices. The Government’s assertion that non-exclusive voluntary licensing provides incentives for developing new medicines and health technologies is not borne out by recent evidence on newly patented drugs, as the noble Baroness, Lady Sheehan, has pointed out.

On vaccines, and our participation as a country in the global sharing and effort, access to the Covid-19 tools accelerator COVAX advance market commitment needs continuing support from the UK and wealthier nations. The promise was for matched funding if the £1 billion target was reached by the end of last year. Can the Minister update the House on this, and what will be the UK’s contribution? Is there any further information on the role the UK will play in the WHO’s proposed Technology Access Pool, C-TAP?

Finally, on funding of research and development, a number of noble Lords raised the issue of the absence of analysis of, and data on, how much public and private money goes into the development of new vaccines and medicines. The Minister referred to the VPAS voluntary pricing scheme negotiated with the industry, which runs alongside the statutory pricing scheme, the NICE appraisal process and the commercial NHSI arrangements. The scheme is designed to support patient access to innovative medicines and expires next year, so these coming months will provide a crucial opportunity to commence a detailed review on how the research and development of medicines are actually funded. This would not only strengthen the Government’s negotiating position but lead to greater transparency in the UK’s future relationship with the pharmaceutical industry, which we all want to see.

Coronavirus Vaccine

Debate between Baroness Wheeler and Baroness Jolly

Thursday 3rd December 2020 Lords Chamber

[Baroness Wheeler (Lab)]

My Lords, I thank the Minister for the Statement. Yesterday’s great news about the Pfizer/BioNTech vaccine and the MHRA’s clinical authorisation was the breakthrough that we all hoped for. We on these Benches join in with the heartfelt thanks to the dedicated scientists and those who have taken part in the trials, testing and validation process. Coming with the absolute assurance from the MHRA that no corners have been cut by it in the speeding-up of the vaccine, and that safety of the public has rightly remained paramount, the news is especially welcome.

Hospital trust staff will receive the vaccine first. This is a massive logistical challenge given the size of the workforce, the temperatures that this vaccine must be stored at and the two doses needed. We understand that 50 hospitals are already set up and waiting to receive the vaccine. How many NHS staff are expected to be vaccinated by January? When will mass-vaccination centres start opening in our communities?

On care homes, today we have the reality of the difficulty of ensuring that the vaccine can be delivered safely and quickly to them, in the light of its low temperature requirements and because of the fragmented social care system, involving thousands of predominantly small providers employing permanent and often frequently changing temporary staff. The Joint Committee on Vaccination and Immunisation’s Covid-19 priority lists advises that care homes residents and the staff who treat them should be first in line to be inoculated. We now understand that only care home staff will be among the first to be vaccinated, travelling to an NHS centre. While this and readiness in parts of the NHS to administer the vaccine are welcome, can the Minister update the House on how the Government will ensure that in the rollout of this essential vaccine, that hopefully will help to protect thousands of care home residents, they do not find themselves at the back of the queue once again? Care home managers are demanding clarity over this issue and have warned of confusion and raised expectations among vulnerable people.

Overall, we have historic strengths with vaccination, but in recent years we have lost our measles-free status, and we know that vaccination rates can often be lower in poorer and more vulnerable communities. While Covid-19 has affected everyone, the burden of the pandemic has disproportionately impacted the poorest, who are more likely to die than the richest. Can the Minister ensure that there is a health equality strategy, so that black and ethnic-minority groups, and the poorest and most vulnerable, do not miss out on this vaccine?

I also make a special plea for unpaid carers. Carers UK is deeply disappointed that carers are not on the priority list for the vaccine in England. Can the Minister explain the thinking behind this by the JCVI or the Government? They were prioritised for the flu vaccine, as it was recognised that if they get flu, the loved ones they care for are at risk and cannot be properly cared for. As a carer myself, I am in touch with many local carers, who play a vital role in keeping older, disabled and seriously ill people safe during the pandemic.

On the supply of vaccines, the UK has promised 40 million doses by spring, which is estimated as enough to give the required two jabs to health and care workers and everyone over 65. Nevertheless, in the first few weeks of winter, our ability to vaccinate could easily outstrip supply. Current figures are that there will be 800,000 doses in the country within days, with several million more to follow in weeks. I understand that the jabs are being manufactured in Belgium. What assessment have the Government made of the impact of Brexit on importation? Can the Minister reassure the House that supplies will not be disrupted, deal or no deal? We all understand that the restrictions will remain in place for some time but in the meantime, if someone is vaccinated, will they still have to isolate if contacted by test and trace, or are they now released from that obligation?

The Government’s document, Community Testing: A Guide for Local Delivery, suggests that local areas can use mass testing as a freedom pass. What does this mean in practice? How will local areas enforce rules if some people are able to follow different rules based on their testing status? In the Commons yesterday, the Prime Minister suggested that people may want to take advantage of mass testing ahead of visiting their families this Christmas, but what does this mean for people in areas that do not have access to lateral flow testing? Needless to say, despite the approval of a vaccine the restrictions will need to remain in place for some time, and test and trace will be key. Can the Minister confirm that mass testing will therefore be rolled out in all areas in time for Christmas? What are the consequences of the Christmas exemption period if not?

We must not forget that the Minister’s Statement also announced the welcome news that family visits can now take place in care homes, subject to visitors testing negative for Covid-19. However, the increase in staff and resident testing, alongside the introduction of visitor testing, must be backed up by additional resources to make this possible. What extra funding is being made available to care homes to meet the costs of additional testing, cleaning, PPE and visitor administrations that they will incur?

Today’s focus is on the vaccine and how it will be distributed. However, for the record, in response to the Secretary of State, Matt Hancock, claiming that the process of vaccine approval has been one of the early benefits of leaving the EU, the MHRA has today made it clear that the process for developing and authorising the vaccine has been undertaken under the terms of European law, which remain in force until the completion of the Brexit transition period at the end of the year. In other words, Matt Hancock’s assertion is simply not true.

[Baroness Jolly (LD) [V]]

No one can deny that the news about the Pfizer-BioNTech vaccine is just what we need as the days get shorter and Christmas still seems some way off. The technical achievement is enormous, and I am happy to congratulate all those involved in the creation of the vaccine, in the lightning regulation process and in its manufacture. The logistical challenge is next, and I feel sure that, again, the armed services will figure highly here.

Some time ago, I asked the Minister who might carry out the vaccinations. There are not enough NHS staff free to do it. Is there a plan to train others? The training is very short and needs no clinical background whatever. I seem to remember that student friends, when training to be doctors, would practise their technique by injecting oranges. I understand that it will be at least Easter before all the population has received the first round of the Pfizer vaccine and midsummer before we have all had the two jabs.

Can the Minister clarify what sort of immunity someone would have if they failed to get the second jab? What is the timescale of the availability of the other vaccines that we know are in the pipeline? When do we expect all the population of the UK who are willing to be vaccinated to have received their vaccine, and does he have an indication of how many will refuse it?

Vaccine is not a magic bullet—yet. Those of us who will not get it for some time will have to be careful and adhere to the rules outlined by the Government. We might be surprised that not everyone is aware of the symptoms of the virus—the cough and the loss of taste and smell, along with flu-like symptoms. They have not been part of the messaging but, on prevention, we all know “hands, face, space”. Was there a reason that the messaging did not include symptoms? I appreciate that if you are an avid follower of the PM’s No. 10 virus briefings, all that information is at your fingertips, but for many these are not required viewing. How much is the department using Instagram, Facebook and Twitter to get these messages out? If it is not using them, why not? For months to come, people will be testing positive, and anyone who does will still be required to quarantine.

I would like to spend the rest of my time addressing some issues relating to self-isolation that have come from research by King’s College London, based on surveys carried out by the Department of Health and Social Care. Many of us who have been in this situation isolate, as that is doing our bit to prevent the spread of the virus. King’s found that intentions to isolate were high but, when it came to sticking to it, the numbers were low. It found that there were both practical and psychological barriers to an effective isolation system. Practically, there is the issue of finance. The evidence suggests that those of a lower socioeconomic status with dependent children or older relatives struggle financially or lose their pay if they self-isolate, and they choose to ignore the advice.

The £500 grant has not been available since the onset of the lockdowns, and £250 does not cover all the costs for a family for a week if you lose your wage. If a child has to go into quarantine, there is no eligibility for support, yet in all probability a parent will have to take time off work to care for the child. Not all employers continue paying a salary to those isolating or caring for someone who is isolating.

The data that I referred to came from a series of surveys carried out by the department. Is that data in the public domain? It would be really interesting to see the breakdown by geography and demography.

Covid-19 Update

Debate between Baroness Wheeler and Baroness Jolly

Thursday 12th November 2020 Lords Chamber

[Baroness Wheeler (Lab)]

My Lords, this Statement was made in the Commons on Tuesday and, as we know, events move quickly where the coronavirus pandemic is concerned. Since Tuesday, further details about the welcome breakthrough in the development of a vaccine have been emerging and there is much scope for optimism. Also welcome is that the Government have, at last, agreed to a six-day travel window for students in England next month, after the end of lockdown, so that they can go home before Christmas and undertake periods of isolation, if needed, and be with their families. This requires mass testing on university campuses before students can leave, so can the Minister update the House on the plans and arrangements for this, please?

However, yesterday we also reached the grim milestone of Britain’s Covid-19 death toll passing 50,000—a sobering reminder of the severity of the crisis, as we struggle through the second wave. As Labour’s leader, Keir Starmer, said:

“Behind these numbers is a devastated family, one for every death, and they have to be uppermost in our mind.”


The announcement in Tuesday’s Statement of twice-weekly routine testing for front-line NHS staff is a very important development. It is vital not just for protecting staff, but for infection control in healthcare settings. We have been pressing for a systematic programme for this for months. Can the Minister please update the House on the progress and roll-out timescales to which the Government are now working?

On testing more broadly, the Government have announced plans for the mass distribution of lateral flow tests. I understand that local directors of public health have been asked to develop local strategies, but does the Minister agree that families with a loved one in a care home should be given priority access to these tests, so that they can see, and hold the hand of, that loved one? Will public health teams be put in charge of contract tracing from day one? At a Commons Select Committee this week, the noble Baroness, Lady Harding, who is in charge of test and trace, finally admitted what we have been saying all along: that people are not self-isolating

“because they find it very difficult … the need to keep earning and … feed your family is … fundamental”.

Does the Minister therefore accept that a better package of financial support is needed to ensure isolation is adhered to? Can the Minister also tell the House if it is the Government’s intention to reduce the isolation period? What assessment has been made of evidence that a negative PCR swab, seven days after exposure, could release someone from quarantine?

The vaccine is a moment of great hope and optimism, in a bleak, dismal year that has shattered so many lives and families. The Government need to continue to be optimistic, but must be cautious to resist the urge to talk up and overpromise, and adopt their usual best-in-the-world rhetoric. As further details about the vaccine emerge, there will be many questions, and I am sure noble Lords will follow these up. We strongly support the priority list drawn up by the Joint Committee on Vaccination and Immunisation, under which care home residents and staff get the vaccine first, followed by the over-80s and other NHS and care staff. There will need to be widespread consultation with key stakeholders on the arrangements, timings, resources and logistics. Given past experience, can the Minister specifically reassure the House that the adult social care sector, and care homes in particular, will be fully involved in planning delivery of and administering the vaccine?

Just as important, how will the disproportionate impact of the virus on minority ethnic communities be taken into account, when drawing up the final priority list arrangements? What is the Government’s working assumption of what proportion of the population needs to be vaccinated to establish herd immunity and bring the R rate below one? Can the Minister outline the latest clinical thinking around vaccination of children?

I understand that each person will require two shots of the vaccine, three weeks apart, and that protection develops a month after the first shot. Details of the Government’s plan for what amounts to the biggest vaccine manufacture, campaign and distribution in history are beginning to emerge. We need to learn lessons from the failures of the rollout of test and trace, and the early procurement of PPE. None of us wants to see booking systems overloaded with people told to travel miles, as we have seen with testing, so when will we see the Government develop that plan and their overall strategy?

Are the Government working with international partners to ensure that there are enough raw materials, enzymes and bioreactors to guarantee the mass manufacturing needed? Will there be the cold chain for transport and storage in various parts of the country for the Pfizer vaccine, which needs to be kept at minus 70 degrees centigrade? Have arrangements begun for procurement of the appropriate storage equipment? Will liquid nitrogen and freezers be provided to health centres, doctors’ practices and care homes? How is the vaccine to be distributed and administered to ensure that it is kept at such low temperatures?

On safety, it is comforting that the Deputy CMO, Jonathan Van-Tam, has assured us that he would urge his elderly mother to be vaccinated and that safety will not be compromised, despite the speed of the programme. The regulator, the MRHA, has rightly promised that there is no chance that it will compromise on standards of safety or effectiveness. How do the Government plan to get that message across to the public?

We know that vaccine hesitancy and denial is a growing problem. Labour has offered to work with the Government on a cross-party basis to build public confidence in the vaccine, promote take-up and dispel anti-vax myths, many of which are not just fiction but malicious. I look forward to a positive response from the Minister.

[Baroness Jolly (LD) [V]]

I thank the Minister. I am going to address testing and tracing. He may not have answers but I should be grateful if he could write to me. There have been more than 10 million downloads of the NHS Covid-19 contact tracing app. There have also been many complaints of Bluetooth draining batteries. I second those. Will he confirm whether there is a solution in the pipeline for that issue? If people do as I do and just switch off Bluetooth, the system will not work. How many of these app users are active? If 10 million people are actively telling the world where they are and are checking in and out of where they have been, that is wonderful. But if they do not do so, it is not terribly helpful.

Critically, how many people have been triggered via the app to isolate? Of those, what proportion have had their isolation checked and by whom? Testing is quick and easy but the delay in response time is unhelpful. Swab processing time is not reducing due to the increase in the number of swabs, and labs are taking longer. Is there yet sufficient capacity, and how many staff are being trained weekly to take on the extra capacity? Can the Minister indicate the cost of taking a swab and getting the results back to the individual? Finally, will he confirm when he expects to move to lateral flow tests, which are much quicker and would transform the lives of the staff of care homes, their residents and visiting families?

Medicines and Medical Devices Bill

Debate between Baroness Wheeler and Baroness Jolly

Committee stage & Committee: 5th sitting (Hansard) & Committee: 5th sitting (Hansard): House of Lords
Wednesday 11th November 2020 Grand Committee

[Baroness Wheeler (Lab)]

My Lords, I am pleased to move Amendment 62 in the name of my noble friend Lady Thornton. It amends Clause 9 of the Bill dealing with manufacture, marketing, supply and field trials. This is a probing amendment. It would give the Secretary of State the responsibility to make provisions, in respect of the cascade, risk-based decision-making process, allowing vets to prescribe unauthorised medicines when they are unable to get hold of suitable authorised medicines.

The cascade provision for the medical treatment of animals will be vitally important if there are problems with the supply of veterinary medicines in the event of no deal. The British Veterinary Association has underlined the importance of maintaining the cascade, and of the Veterinary Medicines Directorate reviewing the cascade to consider whether it would be possible to allow greater flexibility on the use of medicinal products licensed elsewhere in the EU and those of other partners within the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicine Products, known as VICH.

I am always struck by how much one learns during the course of working on legislation in the House of Lords, and how much is new that one was previously unaware of but should have been. The cascade system for prescribing unauthorised medicines is a good example for me. It is a vitally important procedure, underpinned by 2019 guidance from the Veterinary Medicines Directorate, whereby vets are permitted to use their clinical judgment where there is no suitable veterinary medicine authorised in the UK for the specific condition in the animal being treated. Cascade gives vets access to a wider range of medicines to treat animals within their care and to prevent unavoidable suffering that could happen were a vet unable to prescribe a suitable alternative.

The cascade goes through the various stages of decision-making in the treatment of animals in descending order of suitability, commencing with the desired outcome of using an available authorised UK veterinary medicine and going through other stages, including the use of clinically suitable alternatives of, for example, human medicines authorised in the UK or in another member state for use in animals. The final provision is for the use of a medicine prescribed by the vet responsible for treating the animal and prepared specially on the occasion of the treatment being required—known as “extemporaneous preparation”. This has to be prepared by a vet or a pharmacist or a person holding an appropriate manufacturer’s authorisation.

In exceptional circumstances, where no suitable veterinary medicine is available either as an authorised product or under the cascade, a vet may treat an animal with a medicine authorised in a country outside the EU via the Special Imports Scheme. Clearly, the guidelines and appropriate primary legislation will need to be amended in the light of our forthcoming exit from the EU—or if there is no deal. So can the Minister tell the Committee what preparations are being made in respect of this very important matter?

Prescribing decisions under the cascade are made on a case-by-case basis. The prescribing vet is personally responsible for the choice of product, is subject to the Royal College of Veterinary Surgeons’ code of professional conduct and must always obtain the owner’s consent for their animal to be treated under the cascade. Accurate record keeping is also required under the guidelines. Supplies of products used under the cascade and associated records can be examined during inspections of vets’ premises by the VMD and the RCVS. Under the last tier of the cascade, extemporaneous preparations —also known as veterinary specials—can legally be prescribed, supplied and used, recognising that they carry a higher risk than authorised medicines.

So this is an important scheme and the maintenance of the veterinary medicines cascade is a vital issue in the medical treatment of animals post Brexit, particularly in the event of no deal, as I said. I look forward to the Minister’s explanation of the action being taken to ensure that the cascade is maintained, continued and, if possible, simplified in line with the BVA’s recommendations. We need assurance that the Government will not use the powers in this Bill to diverge from the cascade after it is passed.

Finally, the BVA has underlined that, if it is to remain as one of the leading agencies in Europe and beyond, the Bill must be used to establish a national authorisation procedure for veterinary medicines, on the same scientific and evidence-based technical requirements as adopted by the EU, firmly rooted in the established standards set for quality, safety and effectiveness. The association has emphasised that, to have an influential voice in global veterinary regulatory affairs, it is vitally important for the UK to seek full membership of the international technical requirements registration body, the VICH, to which I referred earlier. I look forward to the Minister’s response on this vital issue.

[Baroness Jolly (LD) [V]]

The noble Baroness, Lady Wheeler, has given a really good description of the cascade and the way in which it works. It is a risk- based decision process whereby vets can dispense different medicines to animals beyond the term of authorisation. The BVA supports maintaining the cascade. Can the Minister confirm the arrangements if no suitable UK drugs are available? Can she also confirm that veterinary drugs will be part of trade deals with both the EU and the US?

Medicines and Medical Devices Bill

Debate between Baroness Wheeler and Baroness Jolly

Committee stage & Committee: 4th sitting (Hansard) & Committee: 4th sitting (Hansard): House of Lords
Wednesday 4th November 2020 Grand Committee

[Baroness Jolly (LD) [V]]

My Lords, this amendment would require the Secretary of State to establish the innovative medicines fund, as promised in the Conservative’s 2019 manifesto. It provides that it is funded from rebates paid to the Government under the terms of the pharmaceutical price regulation scheme.

The Cancer Drugs Fund was a Cameron initiative from the general election of 2010, and the 2019 general election saw a Johnson extension: the innovative medicines fund. He promised that

“doctors can use the most advanced, life-saving treatments for conditions such as cancer or autoimmune disease, or for children with other rare diseases.”

The promise was to increase the funding to £0.5 billion. Can the Minister confirm the figure and clarify how “innovative” will be defined? Importantly, how will the fund address the UK issue of combination pricing, where some new cancer treatments are not cost effective, even when the price is nothing?

There are questions about what drugs outside of cancer drugs could qualify to go into the new fund. Can the Minister help with a response here? There might be candidates from medicines selected for the early access to medicines fund, a pre-licensing indicator of promising innovation given by the MHRA. This would allow them to be funded while further evidence is generated. Given the focus on innovation and the very reason for EAMS to designate a drug as a promising innovative medicine, which is a prerequisite for any drug to get a full, positive EAMS designation, there looks to be a good fit, and we support it.

[Baroness Wheeler (Lab)]

My Lords, I support this amendment from the noble Lord, Lord Patel. It is very much the ambition to ensure access for UK patients to the latest and most innovative treatments. This is reflected in many of our amendments to this Bill, relating to attractiveness, clinical trials and regulatory alignment with the European Medicines Agency.

We fully support the Government’s commitment to extend the Cancer Drugs Fund into a £0.5 billion innovative medicines fund to be used for

“the most advanced, life-saving treatments for conditions such as cancer or autoimmune disease, or for children with other rare diseases”.

If, at last, the principle of using the rebates from the pharmaceutical rebates scheme could be achieved so that they are used for the benefit of the NHS and patients, then this will represent progress indeed, particularly ensuring that the money is used as an additional source of income and revenue for the NHS and is not part of expected and planned funding.

Like other noble Lords, we are very much looking forward to hearing from the Government the detail of their proposals, when they intend to commence the promised consultation and the proposed timetable for implementation.

We heard in previous debates important questions as to how the new fund will relate to the current NICE process for reviewing new cancer drugs, particularly those to treat rare cancers, and, more broadly, around what drugs will qualify, outside of cancer, to be covered by the new fund. For example, there may be candidates from medicines selected for the early access to medicines fund, the MHRA’s pre-licensing indicator of promising innovation, allowing them to be funded while further evidence is generated. Given the focus on innovation and the very reason for EAMS to designate a drug as a promising innovative medicine, a prerequisite for any drug to get a full, positive EAMS designation, what consideration have the Government given to this?

Detail, too, is needed, as we have heard, on the criteria that will apply to any prospective drug for the fund. I certainly endorse the comments of the noble Lord, Lord O’Shaughnessy, on needing to have an ambitious definition of innovation. Will the criteria mirror the current processes that the NICE committee considers for funding under the CDF, or will it be widened to reflect and include some of the criteria for highly specialised technologies, where NICE takes a different approach to treatments for some of the rarest conditions?

One of the key concerns in earlier discussions in Committee was the need for reassurances about NICE’s work to support innovation and to ensure that the current NICE review of its methods and processes is open and transparent and delivers real and effective change. As was made clear, it is important that we learn lessons from both the strengths and criticisms of the CDF, and that we ensure speedy access to new medicines going forward. I look forward to the Minister’s response.