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

Posted on 16th July 2020

On the 8th July 2020 the Independent Medicines and Medical Devices Safety (IMMDS) Review released their report titled ‘First Do No Harm’ (the Report).

The two year review was led by Baroness Julia Cumberlege and examined how 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 Primodos hormone pregnancy tests (HPTs), which were withdrawn from the market in the late 1970s and which are thought to be associated with birth defects and miscarriages;

The review was prompted by patient-led campaigns, All-Party Parliamentary Groups and the media. Over 700 people, mostly women, gave evidence for the inquiry detailing their harrowing experiences with the three treatments.

The Report found that the healthcare system including the NHS, private providers, the regulators and professional bodies, pharmaceutical and device manufacturers, and policymakers is disjointed, siloed, unresponsive and defensive. It does not adequately recognise that patients are the most important reason or purpose for its existence.

Whilst the review was intended to examine the three treatments as listed above, it also considered how the healthcare system reacted as a whole and how it can be improved. It found that the current system in place is not good enough at spotting trends in practice and outcomes that give rise to safety concerns.

Regulation of medicines and devices and potential reforms

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 the following;

  • 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; and
  • incorporating current best practice in risk communication

Post 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 the current product safety laws which are governed by EU law.

From December 2020 and onwards, the Medicines & Healthcare Products Regulatory Agency (MHRA) who regulate medicines, medical devices and blood components for transfusion in the UK will be required to update their legal framework in line with the updated law.

The Report recognised it was an ideal time for the MHRA to strengthen patient safety by improving medical device regulation. The Report recommended the following changes;-

  • Establishing clear legal frameworks around safety-based decision-making which include the systematic involvement of patients and the public:
  • Overhauling adverse event reporting to create a transparent, user-friendly system that recognises the contribution of those who make reports and engages with them throughout the analysis and decision-making process. There must be delineated obligations placed on manufacturers, healthcare professionals and the MHRA:
  • Identifying risk profiles and teratogenicity for medicines used in pregnancy: and
  • Developing a protocol for a prompt system-wide co-ordinated response to safety decisions related to a medicine or medical device.

The Report recognised the importance of transparency for patients who take a medicine or use devices to be fully informed 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. 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. The 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. Additionally, 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.

Currently, the MHRA maintain a register of products deemed as class 1 products which are considered to be low risk. This includes, dental and surgical instruments, stethoscopes and ophthalmoscopes, bandages and splints spectacle lenses and frames, treatment chairs and hospital beds. Devices which are considered to be medium to high risk are deemed class lla, and llb, which include surgical gloves, hearing aids, corrective contact lenses, surgical lasers. Class lll are the most high risk products and include hip-joint implants, and prosthetic heart valves. These are not maintained on a register by the MHRA, but are subject to further scrutiny under current EU law and as such are not maintained on a register by the MHRA. This means, the MHRA may only be aware if a product is being used in the UK if there is a problem with the product. 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) and also have the ability to remove them from sale if a safety concern is raised.

The onus is currently on 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. Whilst this seems appropriate, many individuals may not be aware that the issues they have suffered are due to a particular device or they may not have in their possession 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. A suggestion for more user-friendly reporting was made 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. Furthermore, it was also suggested that reporting suspected adverse incidents should be a legal requirement on all healthcare professionals to protect patient safety.

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 the regulation of medicines and medical devices has clearly not been highly effective to date. 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 who will offer a free initial interview to assess and advise you about your legal options. Call 0808 231 6369 or request a call back online.

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