Draft Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2022 Draft Human Medicines (Amendments Relating to the Early Access to Medicines Scheme) Regulations 2022

Andrew Gwynne Excerpts

Tuesday 8th March 2022 General Committees

[Andrew Gwynne (Denton and Reddish) (Lab)]

It is a pleasure to see you in the Chair, Ms Rees. I also wish to join the Minister in paying tribute to all those who got us through the last two years in relatively one piece. It has been a remarkable effort on behalf of so many people and serves to show how exemplary our health and care staff and others in public services from local government right the way through to national Government have been in getting us through the pandemic.

The covid-19 pandemic has been the most serious domestic challenge we have had to face in the post-war era. It would be remiss of me not to mention that, in the last two years, we have seen more than 150,000 lives lost. The impact on our own lives and liberties has been totally unprecedented. There were times when it felt like there was no light at the end of the tunnel, on those long lockdown days when we would stay at home, away from friends and loved ones, only to flick on the news and see the numbers of cases rising and rising. A lot has changed since those first few months. Thanks to our NHS, our incredible scientists and the British public, who have been vaccinated in their millions, we have several highly effective covid-19 vaccines. The entire eligible population has been offered a third booster dose and, while the virus is still with us, we are in a much stronger position than back in March 2020. The impact of the vaccination programme cannot be overstated. It has allowed us to reclaim our liberties, which we were forced to forfeit back in 2020, driven down hospitalisations and saved countless lives.

This statutory instrument continues this good work and it will be of no surprise that Labour finds it non-contentious and will support it today. Indeed, it is wholly necessary that the amendments to the human medicines regulations are made. The statutory instrument enables us to continue with mass vaccination campaigns for covid-19 and influenza and extends temporary provisions relating to manufacturing licences and marketing authorisations. It permanently broadens the healthcare groups that are entitled to administer parenteral vaccines in an NHS or local authority setting and enables community pharmacists to deliver flu and covid vaccines outside their normal premises.

The changes are sensible and will ensure that in any future mass vaccination roll-out, the requisite resources will be available to administer vaccinations. That will be particularly useful over the winter months, when we will need to contend with seasonal influenza alongside a potentially large uptick of covid-19 cases.

As I say, covid has not disappeared and we need to be prepared and ensure that the population remains protected against rising case numbers and possible mutations. That also means ensuring we do more to reduce health inequality in vaccine uptake. The under-30s, some ethnic minority groups and pregnant women disproportionately make up the estimated 8.5% of the 12-plus population who remain unvaccinated. We cannot afford to be complacent, and we need to be doing as much as possible to encourage people to take up the vaccine. It would be helpful if the Minister could set out what further action his Department will take to reduce those inequalities in vaccine uptake and outline how the extension of the provisions will enable his Department to tackle vaccine hesitancy better.

On the second SI before the Committee, the early access to medicines scheme has been place for almost eight years, and it is managed by the MHRA. It aims to provide patients with life-threatening or seriously debilitating conditions access to medicines that are either not authorised generally or for the specific clinical use proposed. It provides necessary regulatory flexibility for medicines that can often be a matter of life or death. More 100 medicines have been granted promising innovative medicine status and more than 40 scientific opinions have been awarded in areas with unmet patient need. The Labour party support that wholeheartedly. Cutting-edge medication and treatment can often take years to receive full approval and in that time lives can be lost. It speaks to the necessity of the scheme that more than 1,600 patients have benefited from EAMS medicines since the scheme’s implementation.

An example of the efficacy of EAMS was given in a recent article on it published by the British Liver Trust. It cited Roche’s Tecentriq, which helps to treat people with lung cancer. Because of EAMS, 63 patients were able to access the drug after a specialist review, which gave those individuals access to life-saving treatments four months’ earlier than expected. Four months is an exceptionally long time when suffering from a life-threatening condition and can make all the difference to long-term outcomes. Pharmaceutical companies have raised concerns that EAMS is not delivering an attractive proposition for the industry and that the scale of early patient access originally envisioned has not been delivered. Given the example cited by the British Liver Trust, however, I do not think such concerns stand scrutiny.

The EAMS independent review, published back in 2016, identified areas for improvement. The SI addresses some of those concerns, but I will seek further clarifications from the Minister in due course. Placing EAMS on a statutory footing will give pharmaceutical companies and patients necessary legal clarity. I am grateful that the SI is clear about the need to continue to protect patient safety and that it aims to simplify EAMS’s requirements where feasible.

It is notable that the proposed legislation will support the collection of real-world data, which will no doubt incentivise medical innovation. I am also grateful that the SI makes it clear that patient consent to data collection is not a condition of EAMS supply.

I have a particular keen interest in EAMS as Labour’s lead in the shadow health team for clinically vulnerable, extremely vulnerable and immunocomprised people. Recently I heard from a charity about the anti-viral drug Evusheld. It is a preventive antibody treatment for the benefit of people with compromised immune systems, who cannot get a sufficient antibody boost from vaccines. That medication received approval in the United States and France in December last year, but patients in the UK cannot yet access that treatment because the approval process is ongoing.

It has been reported that for some pharmaceutical companies there is a black hole in the system once the marketing authorisation is granted. Once MA is approved, EAMS designation falls away, and that can lead to a gap of several months in which no further patients can gain access to a given drug as it goes through NICE’s final assessment. That treatment gap has been recognised in the independent review and by pharmaceutical companies and charities. Can the Minister offer an assessment of that, and say whether the Department is considering a mechanism to ensure smoother transition from EAMS to full Health TechConnect and NICE approval?

The scheme is a great illustration of the fantastic work that can be done when industry works alongside healthcare agencies with the patient’s best interests at heart, but we must not take our foot off the pedal. We need to keep working to ensure that cutting-edge research is properly supported and the needs of patients are put first. My apologies to you, Ms Rees, for getting some of my words garbled; it is the long covid. That will be the excuse for evermore, I fear, but we are happy to support the SIs.