Fintech meet up
Out-Law News | 04 Mar 2019 | 3:59 pm | 4 min. read
Lord O'Shaughnessy said the new office could serve as "a compassionate, patient-facing agency that is the first port of call when harm is suffered, that can provide the analytical rigour needed to look at cases on their merits, and that can provide a single focal point for action among the many professional and product regulators that operate in the system".
Lord O'Shaughnessy, who resigned from his ministerial position in December, made the recommendation in a debate on the safety of medicines and medical devices held in the House of Lords last week. His successor, Baroness Blackwood of North Oxford, said O'Shaughnessy's idea "has much to recommend it".
An independent review into the medicine and medical device safety regime in England is currently being carried out. The review follows patient-led campaigns against three treatments – the use of oral pregnancy test Primodos, the use of the drug sodium valproate by pregnant women, and the use of vaginal mesh implants.
Baroness Blackwood said the government would wait for the review to report later this year before confirming any potential reforms.
The review is being led by another former junior health minister, Lady Cumberlege, who served as parliamentary under-secretary of state for health under the John Major-led Conservative government in the 1990s. In the Lords debate, she provided some insight into what had been uncovered in the review so far.
"We have more evidence to hear before we write our report, but there are some emerging themes: the lack of proper warnings about risks; the lack of informed consent; a system whose first inclination is to deny there is a problem or simply to ignore concerns; where concerns are eventually heard, the sluggishness of a proper response; the dismissiveness and arrogance of some – I stress only some – in the medical profession; the byzantine complexity of a regulatory system that few within it, let alone patients and the public, seem to fully understand; the fight for diagnosis and support when things have gone wrong; and the inadequate resources available, whether for follow-up surgery in the case of mesh, or medical, social and educational care in the case of sodium valproate and Primodos," Lady Cumberlege said.
The fact that the issues brought to the review's attention have been raised through "people power" and not by regulators, doctors or the NHS indicates "something is seriously wrong; the system is not working as it should", Lady Cumberlege said.
The peer said a balance needs to be struck between providing scope for innovation in health care and protecting against potential patient harm.
Lady Cumberlege said: "No medical procedure is without risk, and innovation is crucial in healthcare; we must not stifle it. But it is vital that an individual is able to make an informed decision, based on a clear and full explanation of the benefits and risks, about a medicine or procedure."
"It is vital that regulators act with independence and impartiality in approving a medicine or device, that safety comes before commercial interest, and that they listen carefully to patient-reported concerns and act swiftly on them. It is vital that surgeons carry out operations for which they are suitably trained, that they have the right level of experience, that they show compassion and that a comprehensive database exists. When things go wrong and avoidable harm is suffered, the test of a good healthcare system – indeed, of a good society – is our ability to listen, to say sorry, to learn and to provide the right care and redress," she said.
Louise Fullwood of Pinsent Masons, the law firm behind Out-Law.com, said Lady Cumberlege's comments reflect an existing "pattern of recommendations and good practice in UK healthcare in recent years".
"These range from the enshrining of the 'duty of candour' in the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 to the often stated view of Jeremy Hunt that the NHS could learn good lessons from the airline industry in increasing reporting of potential issues and incidents but in the spirit of openness without the intent of ascribing blame," Fullwood said. "If this intention can be carried through by a new patient safety office then this would have the potential to improve the early identification and management of potential safety problems."
In his speech, Lord O’Shaughnessy said the move towards more personalised medicine would require "the balance between innovation and safety … to evolve".
"The regulatory regime we need to create must be able to draw a much more sophisticated distinction between the balance of safety and innovation, so that it is dependent on the needs of each individual patient," he said.
Lord O'Shaughnessy called on the UK government to "support the MHRA and other agencies to use technology and other innovations to improve post-licensing surveillance of medicines and medical devices", including through its implementation of the reforms to the EU's medical device regulations.
In response, Baroness Blackwood said there are currently "comparative limitations on the amount of pre-market assessment that can be conducted for devices", as medical devices can be put on the UK or EU markets without first having to obtain a marketing authorisation, unlike in the case of medicines. Instead, improvements to medical devices and their safety are driven by a post-market assessment regime, she said.
The minister confirmed, though, that the UK would deliver reforms through its implementation of the EU medical device reforms in spite of Brexit.
Baroness Blackwood said: "The government intend to fully align the UK with the new EU medical devices regulations and in vitro diagnostic medical devices regulations... We will do this even though we are leaving the EU institutions because we are confident that doing so will drive system-wide improvement, including to the levels of clinical data that are mandated before products can be placed on the market, the scrutiny placed on notified bodies, the level of post-market surveillance conducted and the traceability of medical devices. We think this will improve the safety of medical devices."
"This approach will establish a stronger and improved baseline for any future system change that we implement after our departure from the European Union. We will proactively ensure that innovative technology and processes are utilised by the UK healthcare system where this can enhance the role of the MHRA, including in relation to data, as well as increasing patient safety and confidence," she said.
Fintech meet up