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Thursday, May 23, 2024
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Government throws safeguards out of the window in rush for new gene drugs

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IN THE autumn of 2022, the UK government directed the Chief Scientific Adviser Sir Patrick Vallance to conduct a review into ‘pro-innovation regulation’ to enable the ‘rapid and safe’ introduction of emerging technologies. The review sought to ‘give confidence to innovators’ that the UK will ‘safely and ethically accelerate the development, testing, route to market and uptake of new technology products’ which in the realm of life sciences means more gene therapies, gene editing and RNA-based therapies. 

The review was published in May 2023 by Vallance’s successor as Chief Science Adviser, Dame Angela McLean, who wrote: ‘We have heard from industry that the current position is too slow and prevents the UK’s regulatory system from being truly competitive in global markets beyond the EU.’ 

Really so? The speed with which the Medicines Healthcare Products Regulatory Agency (MHRA) waved through the mRNA Covid-19 injectables in record time during 2020 suggests quite the opposite: that its self-declared new enabling role recklessly favoured competition over risk and safe regulation. It certainly proved itself willing to make life easier for those Big Pharma gene therapy innovators.

Despite an assurance made to the public during the August 2020 consultation on the use of Regulation 174 of the Human Medicines Regulations 2012 that ‘unlicensed does not mean untested’, the MHRA went ahead and authorised batches of an inferior quality mass-produced version of BioNTech’s BNT162b2 covid injectable, which was different from the product tested during the trials and which was 13 times more reactive. It has subsequently become the first regulator to authorise a CRISPR gene-editing product. Yet the pro-innovation report claims to ‘have heard from industry that the lingering effect of the Covid-19 pandemic on MHRA has been that industry no longer get the kind of rapid and engaged responses that would make businesses choose to bring products to market here.’ It sounds as if they are pushing at an open door.

Prior to his departure from government, and as a result of discussions with Sir John Bell, in March 2023 Vallance provided interim advice to Jeremy Hunt, Chancellor of the Exchequer, on his pro-regulation review. He said that the MHRA was recognised as a global leader in life sciences regulation and bragged that the ‘regulatory response to covid demonstrated the speed and agility with which the UK can act’. He then asked the government for an increase in MHRA funding. Regulators and innovators, Vallance insisted, needed to interact ‘from a very early stage to define a route to approval, and ensure that regulators play an enabling role throughout the journey to approval’.

Making specific mention of cancer vaccines and AI-based mental ill-health therapeutics, he went on: ‘It should now be our ambition to deliver a progressive UK regulatory offer to unlock innovation in diagnostics, drugs and medical technologies (including devices), and provide a simple regulatory journey for companies to engage with.’

His pitch was that the MHRA needed funds to get on with the business of carving itself a competitive niche in enabling ‘innovation pathway’ products, funds that would help it free its resources by simply adopting products other‘trusted’ regulators had already authorised in a ‘thorough but shortened process to speed up the approval process for cutting-edge treatments’. Furthermore, the extra money would enable MHRA to ‘monitor effects in clinical practice and take proactive action as necessary’ for these adopted products and help bring innovative new medicines and medical technologies to UK patients more quickly.  

As the agency has amply demonstrated with its approach to monitoring the after-effects of the covid vaccine rollout, post-marketing safety monitoring entails no apparent obligation on the part of the agency to do anything to mitigate harms caused by a product by, for instance, removing dangerous products from the market.   

What Vallance asked for, the MHRA got: ‘We greatly welcome the £10million funding announced by HM Treasury today, which will be used to fund our ongoing innovation work and to accelerate the development of ground-breaking global recognition routes, which will give UK patients faster access to the most cutting-edge medical products in the world,’ said Dr June Raine, CEO of the MHRA in response to the Chancellor’s March 2023 Budget announcement.

The review also noted that there was a higher than usual turnover of staff at the MHRA. The solution the review proposed was to create a revolving door between industry and the regulator, including systematically using secondments to build ‘capability and capacity in the regulator and improve understanding of the regulator within industry’. Civil service pay-scales needed, the review said, to be more flexible to make the regulator an attractive career option to private sector employees. Greater collaboration between UK Research and Innovation and the regulators was also to be encouraged. Regulatory capture by industry, which is usually seen as problematic, is now actively promoted by the UK government.  

As of January 2024, companies may leverage a new drug or product authorisation issued by regulators in Canada, Australia, Switzerland, the US and the EU and apply to the MHRA for a fast-tracked authorisation. You might think that the primary duty of care owed by the regulator is to you as the consumer, but in fact the new process is intended to ‘result in a more rapid, efficient, and cost-effective process for applicants’. It also removes an important patient safeguard. If one ‘trusted regulator’ incompetently or even corruptly authorises a product, there is far greater potential for harm to be caused if other regulators’ reviews are less exhaustive.

The pro-innovation report repeatedly calls for the adoption of ‘a proportionate approach’ (a seemingly cynical misnomer) which is a standard for evaluating risk introduced by the European Union in 2017. This says that one consideration which should be taken into account is that some clinical trials are only minimally more risky to participants’ safety compared with normal clinical practice. This so-called proportionate approach was applied when the MHRA became the first regulator to authorise a CRISPR gene-editing product called CASGEVY which the MHRA said is no riskier to adults than a stem-cell transplant, while ignoring the fact that while CRISPR is reputed to be more precise than other gene-editing techniques, it can sometimes edit out larger chunks of DNA than it’s supposed to, with potentially catastrophic consequences for the patient.  

The pharmaceutical industry and its satellite scientists in UK universities and science parks must be cheering. There is an added attraction for this ever-expanding life sciences industry as the UK government intends to do more to facilitate a commercial market for the products. The pro-innovation review also opined that the procurement of products by the NHS was repeatedly brought up as an issue due to approvals by the National Institute for Health and Care Excellence (NICE), the agency which does cost-effectiveness approvals for medical products used by the NHS, being too slow.The solution proposed is that the pro-innovation proportionate approach is to be applied by NICE, too, to ‘streamline patient access to safe, financially sustainable and innovative products’. NICE was told to ‘consider how it can enable the innovation pathway by speeding up decisions that allow NHS adoption’ and given targets for the speed of decision making. 

In the end, it seems to be a case of ‘consumer beware’ as all the risk now falls on the patient guinea pig. The pro-innovation review claims to be creating an environment where innovators can create societal and patient benefits. The main benefits appear to be for the pharmaceutical companies and their bottom lines. It’s a brave new world where our government is eroding long-established safeguards and offering up patients as lab rats in the name of innovation.

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Paula Jardine
Paula Jardine
Paula Jardine is a writer/researcher who has just completed the graduate diploma in law at ULaw. She has a history degree from the University of Toronto and a journalism degree from the University of King’s College in Halifax, Nova Scotia.

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