The most obvious purpose of this legislation is to provide a post-Brexit mechanism for the UK to update and maintain the existing rulebook that will be copied over from EU legislation.
It also provides an opportunity for a change of direction for the UK in line with current concerns over regulatory transparency and patient involvement.
Why is legislation needed?
The current systems for regulating medicinal products and medical devices in the UK are based on EU law. The medicinal products legislation involves authorisation of products either centrally at the European Medicines Agency, or through national assessment, often involving elements of cooperation between member states (the decentralised and mutual recognition procedures). Medical device assessment and regulation is done within member states, but applying EU legislation and with recognition across the EU of nationally-approved products.
Both systems are regularly updated by the EU. Periodically, the system receives a more dramatic upgrade. For example, the current overhaul of the EU medical devices system will bring into effect revamped systems from May 2021 (general medical devices) and May 2022 (in vitro diagnostic medical devices). Once fully rolled out, these changes apply to all EU member states.
However, after the end of the UK’s Brexit transition period (31 December 2020) automatic updating to track EU legislation will no longer apply. Imported EU law will be “frozen” for the UK as at that date. If the UK wishes to remain in step EU developments it will have to make corresponding changes to UK legislation. The method for doing this is set out in the Medicines and Medical Devices Bill – Government will be able to tweak and update the rulebook as necessary.
A brave new world?
The legislation could stop there, maintaining close alignment with the EU rulebook. But does the UK intend to go further? We noted in our earlier article the wider policy aims for this legislation, notably to:
“ensure that our NHS and patients can have faster access to innovative medicines, while supporting the growth of our domestic sector.”
This clearly goes beyond an updating and alignment functionality, and signals a change of direction.
When presenting the Bill to Parliament, Health Secretary Matt Hancock set out four aims for the legislation:
- a means to depart from EU rules and regulations in future, moving at a faster pace, if that is what the UK chose to do as an independent, self-governing nation
- a system of regulation that will be flexible and responsive, quick to adapt to innovation and quick to respond when a safety issue emerges
- to strengthen the Medicines and Healthcare Products Regulatory Agency to improve patient safety, including new powers for the MHRA in areas such as medical devices registration
- to strike the right balance between capturing the benefits of innovation without compromising patient safety.
The Bill states that any regulations made must take account of the following considerations:
- the safety of human medicines/medical devices
- the availability of human medicines/medical devices
- the attractiveness of the UK as a place in which to conduct clinical trials, supply human medicines or develop or supply medical devices.
All of this indicates that UK Government intends to set its own path from 2021, aiming to balance improved patient safety with an increased emphasis on promoting innovation.
Meanwhile, the Cumberlege report
New legislation in the medicines and medical devices space often follows a widely-publicised scandal or in-depth review of adverse events. Widespread publicity and concern over problems relating to metal-on-metal hips and PIP breast implants provided the impetus for overhaul of the EU medical devices system.
Now, the Independent Medicines and Medical Devices Safety Review, chaired by Baroness Julia Cumberlege, has published its “First Do No Harm” report. The review focused on the experiences of patients in relation to three widely varying medical interventions. These were Primodos (a pregnancy test using orally administered hormones), sodium valproate (an medicine for the treatment of epilepsy) and pelvic mesh for treatment of pelvic organ prolapse and stress urinary incontinence. Each of these has resulted in serious adverse effects, either for the patient themselves, or their unborn children.
The Cumberlege Report looks across a wide range of topics and areas for improvement. Particularly striking are the proposals for a new direction for regulation of medicines and medical devices. The report identifies the post-Brexit period as an opportunity to implement change.
The report sees the following high-level changes as important next steps:
- clear legal frameworks around safety-based decision-making, including systematic involvement of patients and the public
- improving medical device regulation
- overhauling adverse event reporting to create a transparent, user-friendly system with clear obligations on manufacturers, healthcare professionals and the MHRA
- identification of risk profiles and teratogenicity for medicines used in pregnancy
- a protocol for a system-wide coordinated response to safety decisions
A far stronger focus on the patient voice and a tighter regime for medical devices more akin to the medicines approval process are key themes in the report.
Medical devices – time for change
The EU’s new medical devices regime will not automatically apply in the UK once it comes into full effect. The medical devices regulation (Regulation 2017/745) now becomes fully applicable from 26 May 2021 (put back one year in response to the COVID-19 pandemic). Regulation 2017/746 on in vitro diagnostic medical devices is fully applicable from 26 May 2022.
The UK has indicated its intention to enhance the system applicable to medical devices, without necessarily following the new EU regime in detail.
The Cumberlege Report, for example, highlights concerns on the part of the MHRA about the level of transparency around adverse events and safety reports, with other EU member states less willing to embrace full transparency.
What can we expect to see in a new UK system?
We do not yet know exactly how the powers in the Bill will be used. However, we expect to see a change of direction along the following lines:
- Greater emphasis on patient voice and patient safety
- A pre-approval system for medical devices more akin to that for medicines
- Less reliance on the Notified Body system for medical devices
- Registration of all medical devices with the MHRA
- Greater transparency around the reporting of adverse events
- A closer connection between approval and enforcement
- A focus on enabling innovation and speed-to-market, but not at the expense of rigorous safety measures.
Many life sciences businesses are wary about divergence from the EU pattern, particularly given integrated supply chains for products and the importance of Europe as a market. However, if the UK government keeps its promises, there may also be opportunities to take advantage of a new and streamlined approach to innovation.