Human Medicines (Amendment etc.) (EU Exit) Regulations 2019

Debate between Baroness Wheeler and Baroness Manzoor

Thursday 7th March 2019 Lords Chamber

[Baroness Manzoor (Con)]

My Lords, I am confident that we have a shared intention to protect and improve the safety of patients using medicines and medical devices, while enabling their access to the most innovative of treatments. Our regulator, the Medicines and Healthcare products Regulatory Agency, MHRA, has over 30 years’ experience as a leading regulator in the EU. This expertise and experience is globally recognised and respected; we want to ensure that this continues, to the benefit of UK patients. It is with this at the forefront of our minds that the UK’s plans for the regulation of medicines, medical devices and clinical trials in a no-deal scenario have been developed. Before I set out these plans, it is important to restate our aim to retain a close working partnership with the EU, in order to ensure that patients in the UK and the EU continue to have timely access to safe and effective medicines and medical devices through the co-operative network we have built over the years.

As described in the published Explanatory Memoranda, the system for regulating medicines, medical devices and clinical trials is currently set out in EU legislation. These SIs have been laid to ensure that our national regulatory system continues to function appropriately in the event of the UK leaving the EU without a deal.

In developing these regulations, my department’s priorities have been to make sure that timely availability of safe, effective medicines and devices continues whilst minimising disruption to patients, businesses and ongoing trials, and to ensure that the UK regulator is able to continue to protect public health.

The House will note that these regulations have been developed through continued close consultation and co-operation with stakeholders. After a period of informal consultation, in August last year the MHRA published an initial proposal for the UK’s medicines, medical devices and clinical trials regulation framework, and then followed this up through a four-week public consultation in October. The feedback from that consultation, which received around 170 responses, led to revised proposals, which were published in January and inform these SIs.

Wherever possible we have sought to maintain existing arrangements to ensure continuity and to minimise any disruption. In medicines, the UK regulator already operates a national licensing route and some 90% of medicines used by patients within the UK will already have a national licence. These licences will continue to be valid. Noble Lords will know that in leaving the EU without a deal, the UK will no longer be part of the European Medicines Agency, so this legislation also provides for the automatic conversion of all existing centrally authorised product—CAP—licences into UK licences to ensure continuity for patients.

Given that the system for clinical trials is currently based on national decision-making—both in Europe and globally—in some key areas we have not had to make any substantial change. For example, the ability of the UK to participate in multinational trials, in the EU or the rest of the world, will not change. The data gained from trials in the UK can still be used internationally, deposited in international repositories and be accessed by others.

On devices, the UK is currently a part of the EU system of conformity assessment for medical devices. This system sets out the standards for pre-market and post-market assessment of medical devices and the MHRA is the competent authority within the UK. These standards will not change and this SI will ensure that UK law aligns with EU regulations in this area after we leave.

In other areas, we have faced a choice regarding the UK’s regulatory requirements, and in those instances we have sought to maintain current arrangements while ensuring the regulator still has sufficient ability to protect public health. For example, for medicines we will continue to recognise batch-testing of medicines in the countries we recognise today.

To ensure continuity of the existing clinical trials landscape and to maintain the UK as an attractive, open environment in which to conduct clinical trials, the MHRA will continue to recognise a sponsor or legal representative established in an approved country, which on exit day will include all EU and EEA states. We will continue to recognise existing UK clinical trials approvals and will require the same information requirements as the EU for any new applications for multistate trials in the UK.

We will continue to recognise the CE mark on medical devices and in vitro diagnostics which have demonstrated their conformity with EU regulatory requirements. We will do this for a time-limited period while we consider the need to revise the UK system of regulation.

However, there are a few areas where it has been necessary to add a new requirement as a result of the UK no longer being part of the wider European regulatory framework for medicines. For example, the new requirements for medicines are to ensure that medicines do not enter the UK supply chain without having been certified by a qualified person. Therefore, we are creating a new position within the wholesale licence-holder regime of a responsible person for import, or RPI. This person will be responsible for providing assurances that such certification is in place.

As to the new requirements for clinical trials, the MHRA is putting in place a new national IT system for clinical trial submissions and safety reporting. This portal will also be important to maintaining the transparency of clinical trials by allowing the MHRA to publish information on UK trials as is currently done on international registries. The MHRA is communicating with trial sponsors to update them on how to use the new submissions portal.

As to the new requirements for devices, we will ensure that all new medical devices and in vitro diagnostics being placed on the UK market are registered with the MHRA by establishing a new national database of all devices. Manufacturers based outside of the UK will be required to have a UK-based responsible person who is legally responsible for deficiencies or required improvements in those devices. There will also be a transitional period to enable industry to implement these requirements.

The Government are working towards securing a deal. However, in the event of no deal, these regulations will put in place a pragmatic solution that ensures the UK’s medicines, medical devices and clinical trials regulation legislation continues to function effectively after exit day. These provisions will minimise any impact on patients and businesses and ensure the timely availability of safe, effective medicines on the UK market.

The devolved Administrations have been consulted during this process and they support these regulations, which apply across the UK. I beg to move.

[Baroness Wheeler (Lab)]

My Lords, I thank the Minister for introducing these three EU exit instruments on human medicines, medicines for human use in clinical trials and medical devices, two of which are long, complex and tortuous documents full of technical guidance and information and new schedules—so much so that the relatively short and straightforward clinical trials SI comes as light relief. Thank goodness for the Explanatory Notes.

It is hard to see how even the most enthusiastic advocate of separating ourselves from the EU and going alone on such crucial medical treatment and patient safety issues and provisions on which we have worked for so long in partnership with the EU, to mutual benefit, can view these instruments with any enthusiasm, clarity and certainty about the efficacy and quality of what is to replace the current arrangements, particularly in the event of a no-deal Brexit.

The human medicines and medical devices regulations were considered in the Commons yesterday, and a range of issues and concerns were raised that will need to be addressed. There is no time today to raise all these issues, but I can assure the Minister that we will vigorously pursue these key matters at every opportunity in the future. The regulations we are discussing now are nearly or over 200 pages long, cover several EU directives and cannot possibly be read in the time left before so-called Brexit day, let alone debated and scrutinised sensibly. We therefore place on record our deepest concerns that the process for these regulations is not as accessible and transparent as it needs to be.

The first SI, on human medicines, makes amendments to legislation and the regulation of medicinal products for human use. It allows the UK licensing authority, acting through the MHRA, to operate the functions previously carried out by the European Medicines Association and other EU bodies and procedures and to function as a stand-alone regulator in the event of a no-deal EU exit.

Sadly, as a direct consequence of Brexit, the European Medicines Agency has relocated to Amsterdam. Indeed, it closed its London offices at the start of this month. However, we know that in a post-Brexit scenario, deal or no deal, there must be a strong and close relationship and alignment with the EMA to protect UK patients’ swift access to new medicines. As Cancer Research UK has pointed out, without an agreement to participate fully, licensing could be disrupted and there could be serious delays in life-saving medicines reaching UK patients.

Paragraph 2.5 of the Explanatory Memorandum to the statutory instrument contends that the MHRA as a stand-alone regulator will be able to,

“ensure patient access to safe and effective medicines as well as monitor the ongoing safety of those medicines and where necessary to protect patients”.

Can the Minister explain how this is to be achieved, particularly in the transition period when the new UK processes and structures are being established, or in a no-deal scenario?

I understand that the MHRA will not be able to act as the lead authority on marketing authorisation applications for new drugs in the transition period. Without the ability to act as a lead assessor, there could be ramifications for patients around Europe, given the loss of MHRA capacity and expertise, which could undermine the UK’s world-leading life sciences environment.

With regard to supply, it is imperative that we retain the uninterrupted movement of medicines and medical supplies between the UK and EU in any eventuality. Pragmatic government and industry planning to secure the supply of medicines in the short term is vital, but any delays in cross-border supply as a result of new customs or regulatory checks would be damaging, especially for novel medicines that are not easily stockpiled.

Specifically on serious shortage powers—SSPs—this contingency legislation enables regulations to be made to modify the application of the 2012 regulations to deal with a serious shortage of medicinal products, which, as we know, is a matter of great public interest. That would replace the regulation-making power in the European Communities Act 1972 for certain limited purposes and ensure that the Government continue to have the power to make temporary changes to the 2012 legislation in a no-deal scenario. Is this not yet another example of Ministers being given Henry VIII powers over regulations if they think there is an urgent need because of shortages? Does the Minister anticipate a doomsday scenario in which it will be necessary to use these powers, or are the Government saying that they do not anticipate any problems but need the powers anyway? Will the Minister outline how the process will be handled if there are shortages and what scrutiny will be available for decisions made under it? Will the Minister also say how the Government intend to secure the supply of novel investigational medicinal products—IMPs—used in clinical trials? The regulations for them are also under consideration today. Many of the IMPs used in CRUK trials would prove very difficult to stockpile and would suffer from delays at borders, causing significant disruption to trials.

Finally on the first set of regulations, will the Minister acknowledge the serious concerns in the NHS and in the pharma and biotech industries about the MHRA’s announcement that the falsified medicines directive will not apply in the UK under a no-deal Brexit? Not only would we have no access to key EU-wide safety databases and checking systems, but the tougher rules to ensure that all medicines are safe and that trade is rigorously controlled will not apply to us. We were told last month that the Government were evaluating the options for a future framework. Will the Minister explain how interim arrangements will work to protect patients from fake medicines? Will she also respond to the warnings from the UK pharmaceutical and biotech industries about a no-deal Brexit increasing the risk of counterfeit medicines entering the UK and EU supply chains, and the UK becoming a target for counterfeiters? How are the Government going to ensure that the UK and the EU will co-operate on protecting citizens from counterfeit medicines and prevent fake or fraudulent medicines entering the legal supply chain?

NHS: Stroke Care

Debate between Baroness Wheeler and Baroness Manzoor

Tuesday 5th March 2019 Lords Chamber

[Baroness Wheeler]

To ask Her Majesty’s Government what steps they are taking to ensure that there are sufficient specialist medicine, nursing, rehabilitation and community staff to achieve the priority ambition for stroke care set out in the NHS Long Term Plan, to meet both current and future needs.

[Baroness Manzoor (Con)]

My Lords, the recently published NHS Long Term Plan outlined commitments to improve stroke services, including better stroke rehabilitation services and increased access to specialist stroke units. The Secretary of State has commissioned my noble friend Lady Harding, the chair of NHS Improvement, to work with Health Education England to oversee the delivery of a workforce implementation plan. This will include proposals to grow the workforce, consideration of additional staff and of the skills required, and building a supportive leadership culture in the NHS.

[Baroness Wheeler (Lab)]

My Lords, as a carer keen to see improved stroke services, I welcome the recognition in the NHS Long Term Plan of stroke as a clinical priority. Excellent stroke care saves lives and needs a range of professionals across the whole stroke care pathway, including GPs, paramedics, nurses, psychologists, physiotherapists, occupational and speech language therapists, and social care workers. Not only are there chronic staff shortages among all those key groups but high turnover is a major challenge, particularly among nursing and care staff. It is small wonder that nearly half of all stroke survivors say that they do not have enough nursing and therapy support in hospitals, and that when they get home they feel abandoned because of a lack of rehabilitation and care that would help them improve or cope with living with stroke disability. Does the Minister agree that the high-intensity care models for rehabilitation for stroke promised in the NHS plan are urgently needed, and what immediate actions will be taken by the Government to ensure that there are enough trained staff and specialist staff to deliver the promises for future care and treatment?

[Baroness Manzoor]

My Lords, I agree with the noble Baroness, Lady Wheeler, that it is very important that we have the relevant NHS workforce to deliver the care needed in this very important area. Stroke is a devastating disease for patients and their families. The Stroke Association estimates that it costs the NHS around £3 billion per year, with lost productivity, disability and formal care costing the economy an additional £4 billion. To that end, we are putting in place funding of £20.5 billion each year over the next five years, with cardiovascular also being a clinical priority. This will support the national plan for stroke.

Healthcare (International Arrangements) Bill

Debate between Baroness Wheeler and Baroness Manzoor

Committee: 1st sitting (Hansard - continued): House of Lords
Tuesday 19th February 2019 Lords Chamber

[Baroness Manzoor]

I can clarify that NHS trusts are funded on the basis of existing agreements and will provide additional funding for any new agreements reached within the powers of the Bill. The same thing will apply to GPs where charges need to be made for people who are not entitled to that care and do not fall within the reciprocal arrangements that we have in place. The procedure would apply as it currently applies and such people would be charged as appropriate. If they are part of the reciprocal agreements that we have, whether bilaterally or multilaterally, such charges will not be incurred.

[Baroness Wheeler]

I thank the Minister for her response. Whichever way you look at it, it is a complex system for reporting information across a wide range of different sources. The point made by the noble Baroness, Lady Brinton, about having the information in one place as part of the ministerial Statement needs to be pursued, and I hope that the Minister will do that. I noted her agreement to discussing it or exchanging correspondence about it, but important matters need to be set out in the ministerial Statement—albeit that the information is presented elsewhere—in order to reassure and inform us about how these agreements are working. With that proviso, I withdraw the amendment.

NHS Staffing: Long-term Plan

Debate between Baroness Wheeler and Baroness Manzoor

Monday 4th February 2019 Lords Chamber

[Baroness Wheeler]

To ask Her Majesty’s Government how they will ensure that there are sufficient nurses, doctors and community specialist care staff to deliver the National Health Service long-term plan, published on 7 January 2019.

[Baroness Manzoor (Con)]

My Lords, the Secretary of State for Health and Social Care has commissioned the chair of NHS Improvement, working closely with the chair of Health Education England, to lead a number of programmes to engage with key NHS interests to develop a detailed workforce implementation plan. These programmes will consider proposals to grow the workforce, including consideration of additional staff and the skills required to build a supportive working culture and ensure first-rate leadership for NHS staff.

[Baroness Wheeler (Lab)]

I thank the Minister for her Answer. Both the NAO and the Commons Public Accounts Committee have stressed that the NHS long-term plan is at risk and cannot be delivered if current staff shortages of over 100,000 are not addressed, and if we do not recruit more staff in key specialities to meet future need and demand. Last Thursday’s major debate on the plan showed that this view is shared across the House.

Today is World Cancer Day. The ambition in the plan, for example, to diagnose 75% of cancers at stage one or two by 2028 is welcome, but there are chronic staff shortages in the cancer workforce across both primary and acute care, with more than one in 10 diagnostic posts currently unfilled. It is the same scenario for other key priority ambitions in the plan, but the long-term workforce implementation plan, as the noble Baroness said, has yet to be drawn up, developed and costed, and is not included in the extra funding promised for the NHS. Do the Government have any idea how they are going to take the NHS plan forward?

[Baroness Manzoor]

We absolutely do. The NHS employs record numbers of staff now compared to any other time in its 70-year history, with significant growth in newly qualified staff over the period from 2012. There are almost 13,400 more nurses on our wards since 2010. However, the noble Baroness is right—the current vacancy levels are not sustainable. Therefore the Government have put several actions in place to increase nursing workforce supply, covering improving staff retention, return to practice, overseas recruitment, expanding nursing associates, improving sickness absence and a review of language controls.

Health: Chief Medical Officer’s Recommendations

Debate between Baroness Wheeler and Baroness Manzoor

Monday 21st January 2019 Lords Chamber

[Baroness Manzoor]

My Lords, my noble friend is absolutely right. We need to ensure that we get even better at looking at integrated healthcare so that elderly people are looked after in their homes with the services they need. That is why we are looking at putting £4.5 billion into the NHS every year to find creative solutions to keep older people in their homes.

[Baroness Wheeler (Lab)]

My Lords, following on from my noble friend’s question, some 85% of councils plan to reduce their public health budgets in the next year. Spending on obesity and sexual health programmes will be cut. How can the Government deliver their preventive health agenda or address the key issues raised in the CMO report in the light of all that?

[Baroness Manzoor]

My Lords, in answering the noble Baroness, Lady Jolly, I stated that we are working closely with local authorities to look at the wider detriments of ill health. We have put in place significant sums of money, including committing £20.5 billion to the NHS every year over the next five years. We are working closely with local authorities to see what works so that we can improve health in the local population. The lessons learned will be shared across the country.