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.