Regulation of medicines and devices and potential reforms following the IMMDS review

Earlier in July the Independent Medicines and Medical Devices Safety Review (MHRA) released their report titled ‘First Do No Harm’ (the Report).

The two year review, prompted by patient-led campaigns, All-Party Parliamentary Groups and the media, was led by Baroness Julia Cumberlege. It examined the health service responded to concerns over three treatments: –

1. Sodium Valproate – an effective anti-epileptic drug which causes physical malformations, autism and developmental delay in many children when it is taken by their mothers during pregnancy.
2. Pelvic Mesh Implants – used in the surgical repair of pelvic organ prolapse and to manage stress urinary incontinence.
3. Primodos hormone pregnancy tests (HPTs) – withdrawn from the market in the late 1970s and are thought to be associated with birth defects and miscarriages.

The review focussed on the healthcare system, including:

• The NHS
• Private providers
• Regulators and professional bodies
• Pharmaceutical and device manufacturers
• Policymakers

It found that the current system is disjointed and not good enough at spotting trends in practice and outcomes that give rise to safety concerns.

Current regulation of medicines and devices

One of the common themes in the three treatments examined was whether the current way medicines and devices are regulated is adequate.

It was recognised that current pharmaceutical and devices regulatory systems have gaps and inefficiencies in:

• Being fully transparent in all their operations
• Systematically evaluating outcomes
• Delivering real-time risk assessment based on all relevant sources of evidence including patient experience
• Including risk management tools validated by behavioural science
• Incorporating current best practice in risk communication

What is the impact of Brexit on medicine and device regulations?

Following Brexit, the UK is due to implement The Product Safety and Metrology etc. (Amendment etc) (EU exit) Regulations 2019 at the end of December 2020. This will amend current product safety laws as governed by the EU.

From December 2020 and onwards, the Medicines & Healthcare Products Regulatory Agency (MHRA) will be required to update their legal framework in line with the updated law surrounding the regulation of

• Medicines
• Medical devices
• Blood components for transfusions.

Strengthening patient safety and transparency

The Report recognised that now was an ideal time for the MHRA to strengthen patient safety by improving medical device regulation. A number of changes to regulations have been made to accommodate this, including:

• Establishing clear legal frameworks around safety-based decision-making which involve patients and the public.
• Transforming adverse event reporting to create a transparent, user-friendly system that recognises contributors and improves analysis and decision-making.
• Placing clear obligations on manufacturers, healthcare professionals and the MHRA including:
  • Identifying risk profiles and teratogenicity for medicines used in pregnancy.
  • Developing a protocol for a prompt system-wide co-ordinated response to safety decisions related to a medicine or medical device.

The Report also highlighted the importance of making sure medical professionals fully inform patients of the risks and benefits of each product, as they are the ones who may have to live with the consequences for the rest of their lives.

What does the report recommend?

The Report outlines several recommendation to meet the health needs of the general public and ensure that patients are kept safe and fully informed about their medication options. These recommendation include:

Collective decision making

A recommendation was made that regulatory decisions should be published together with the fullest possible supporting evidence, evaluation (including all areas of uncertainty) and justification for actions.

Improved decision making

The Report suggests that MHRA should be bound by strict timescales for decisions on risk management when a medical device or medicine safety issue is raised.

To protect patients, the MHRA should have legal authority to apply their decision about a given product to other products in the same class which should be binding on all manufacturers.

Keeping patients informed

Where new safety information comes to light, information for patients should be provided or updated without delay. The updated benefits and risks should be described in a way which will be understood by patients.

How does the MHRA currently control medication and devices?

Currently, the MHRA maintain a register of products and splits them into different classes based on their perceived risk.

Class I

Products deemed as Class I are considered low risk. This includes:

• Dental and surgical instruments
• Stethoscopes and ophthalmoscopes
• Bandages and splints
• Spectacle lenses and frames
• Treatment chairs
• Hospital beds.

Class IIa and IIb

Devices which are considered medium to high risk are deemed Class lla, and llb. These include:

• Surgical gloves
• Hearing aids
• Corrective contact lenses
• Surgical lasers.

Class III

Products in Class III have the highest perceived risks, covering:

• Hip-joint implants
• Prosthetic heart valves.

The MHRA does not keep a register of Class III products, but they are subject to further scrutiny under current EU law. This means, the MHRA may only be aware if a product is being used in the UK if there is a problem.

The Report recommends that all manufacturers should register their products, which would enable the MHRA to track all devices used in the UK at any given time. The MHRA will also be given the ability to remove products from sale if such a product is deemed unsafe.

What is the Yellow Card Scheme for medical devices?

It is currently the responsibility of patients, healthcare professionals and manufacturers to report any incidents with devices to the MHRA under the Yellow Card Scheme. This is a system for collecting and monitoring information on suspected safety concerns or incidents involving medicines and medical devices.

The Scheme currently relies on voluntary reporting of suspected adverse incidents with devices to provide an early warning that the safety of a product may require further investigation.

What are the issues with the Yellow Card Scheme?

Whilst this seems appropriate, many individuals may not be aware that the issues they have suffered are due to a device or they may not have the data or information required to document the incident. The Report notes that the current system is not well documented or well used by healthcare professionals or patients.

How can the Yellow Card Scheme be improved?

The Report suggests the need to create more user-friendly reporting and a more efficient system-wide healthcare intelligence unit to facilitate early signal detection. This would draw on various sources of information, including information regarding implantation of devices at the time of operation.
It was also suggested that reporting suspected adverse incidents should be a legal requirement on all healthcare professionals to protect patient safety.

What happens next?

Overall, the Report has been welcomed by the government, patient groups and medical organisations. There is a clear need for better engagement with patients and tighter regulation of medicines and medical devices.

The Government have been asked to immediately set up a task force to implement the Review’s recommendations, the first task being to set out a timeline for their implementation.

Injuries caused by defective medicines and medical devices can be complex and strict time limits apply. If you consider that you may have suffered such an injury, then please contact our specialist product liability experts on 0330 822 3451 who will offer a free initial interview to assess and advise you about your legal options.