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

Baroness Wheeler Excerpts

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?