Thousands of parents whose babies require specialist care after birth will be able to take additional paid time off work, under new legislation backed by the government today (Friday 15 July).

A baby who is born prematurely or sick will receive neonatal care in hospital or another agreed care setting – often for a prolonged period of time. This can put parents in a difficult position of having to use their existing leave entitlements to be by their baby’s side, or worse, having to return to work while their baby is still receiving hospital care.

Today’s Neonatal Care (Leave and Pay) Bill, introduced by Stuart C McDonald MP and backed by government, will allow parents to take up to 12 weeks of paid leave, in addition to other leave entitlements such as maternity and paternity leave, so that they can spend more time with their baby at what is a hugely stressful time.

Once in law, neonatal care leave will be available to employees from their first day in a new job and will apply to parents of babies who are admitted into hospital up to the age of 28 days, and who have a continuous stay in hospital of 7 full days or more.

As many parents across the UK are facing rising cost of living, today’s reforms will help ease future pressures on families whose children require neonatal care by ensuring they aren’t forced with the choice of taking unpaid leave or continue working. As well as supporting families, it will also help employers who want to better support their staff.

Business Minister Jane Hunt said:

Having a new-born in neonatal care is an incredibly worrying time for parents. No family should also have to agonise about their return to work, or whether they have enough leave in place.

By putting our full weight behind this Bill, I hope we can take one concern off the minds of new parents and give them the additional paid time off they need to care for their poorly baby.

The reforms will be a huge boost for parents across the UK, with up to 12 weeks of paid leave for each parent. Mothers of children who have an extended stay in hospital at the start of their lives often find that 39 weeks of paid maternity leave does not give them enough time with their loved one before they need to go back to work. Similarly, the change in law will ensure fathers and partners have the flexibility to share caring responsibilities by increasing the amount of paid leave they can access beyond the usual 2 weeks of paternity leave. It will also fit alongside Shared Parental Leave, and the flexibility that this provides, which will mean both parents feel able to prioritise their child, and family, in that precious time after birth.

Stuart C McDonald, MP for Cumbernauld, Kilsyth and Kirkintilloch East said:

No parent should have to choose between being with their premature or sick baby in neonatal care and having to return to work to earn a living; or enjoying the full benefits of parental leave and going back to work.

With the cost of living soaring, it is more important than ever that we secure an urgent change in the law so that parents of babies in neonatal care get the paid leave and support they need at an incredibly challenging time.

I’m delighted to bring forward this Bill with the backing of Bliss and families across Scotland and the UK.

Bliss Chief Executive, Caroline Lee-Davey, said:

We are thrilled that the Neonatal Care (Leave and Pay) Bill has passed Second Reading in Parliament and has support from the government. This is a huge milestone after years of campaigning and is a significant step towards tens of thousands of parents having paid leave while their baby is critically ill in hospital every year.

We know how much this entitlement will mean to families, and the difference it will make to babies. Currently, thousands of parents every year have no choice but to return to work while their baby is in hospital or spend months of their maternity leave next to an incubator. After the progress made today, we are one step closer to giving many parents the much-needed time to be where they need to be – by their baby’s side in hospital.

We know there is now more to do to continue the Bill’s passage through Parliament, and we look forward to continuing to work with Stuart McDonald MP and the government, and MPs across all parties to ensure that this Bill becomes law as quickly as possible.

The government already has package of measures in place to support the most vulnerable families and those on lower incomes. Earlier this year earlier the government increased the National Living Wage to £9.50 per hour – equivalent to an extra £1,000 a year for a full-time worker – with a full campaign underway encouraging workers to check their pay.

Neonatal care leave will be paid if the parents meet certain conditions regarding continuity of service and minimum earnings.

The Issues

Technology is enabling the creation of new medicinal product types with features such as very short shelf lives, in the range of 30 seconds to a few hours, necessitating manufacturing at the point of care (POC), as well as other highly personalised products. The types of products with these features include Advanced Therapy Medicinal Products (ATMPs), blood products, 3D-printed small molecules and some medical gases.

Through horizon scanning and examining trends in information obtained from requests for regulatory and scientific advice, borderline classification opinions and the presence of some products in clinical trials MHRA identified that there are a wide range of medicinal products in development that will require POC manufacture. The issue with these products is that they do not fit the current ‘standard model’ of manufacture and supply, which typically features centralised manufacture of large batches of stable products at a few manufacturing sites.

The change that is needed

The current legislative framework is geared for the centralised manufacture of medicinal products which, for each product type, is manufactured in a relatively small number of sites each at large scale. This is primarily because the products have a long shelf life and are then distributed globally to a mass market.

Current regulations require each manufacturing site to be named on the Marketing Authorisation and to inspect and authorise each of those sites, horizon scanning identified a need for a new regulatory framework to enable the development of POC manufacture and supply in the UK. This framework will accommodate the needs of medicines products manufacture at POC but will also provide control measures equivalent to those currently in place for medicinal products manufactured in factory-based locations, this will ensure that POC products have appropriate quality, safety, and efficacy attributes.

What the MHRA did

Following internal discussions, we engaged extensively with stakeholders involved in the development, manufacture, testing, clinical trials and licensing of POC products in the UK. We organised workshops in 2020 to explore the technologies and products that are applicable to POC manufacture and the control measures that would need to be established to support their safe development.

In March 2021, we held a stakeholder engagement event with over 50 attendees from across the healthcare sector to build on the learning points from the previous meetings. At this event we presented a high-level view of a proposed regulatory framework for POC manufacture, which is centred on the concept of a Control site. This Control site would be named on clinical trial and marketing authorisation applications and would oversee all aspects of the POC manufacturing system including the individual manufacturing locations and their activities. The proposed regulatory framework is based on and links into current regulatory systems for medicines approvals, clinical trials, evaluation of regulatory compliance at manufacturing sites and safety monitoring.

Based on discussions and feedback from attendees of this event we produced a consultation document, which went out for formal public consultation for 6 weeks in the summer of 2021. Responses were significantly positive and there was positive support for the framework to apply across the full range of manufacturing scenarios, from modular manufacture to home-based manufacture – see diagram below.

Outcomes

Through horizon scanning and review of the regulatory and scientific advice signals received, we identified a need to amend The Human Medicine Regulations 2012 and The Medicines for Human Use (Clinical Trials) Regulations 2004. These changes are required to create a new framework to enable the supply and increase the availability of innovative new medicinal products made at POC to patients.

Legal instructions are being developed to amend these two areas of UK medicines legislation, these changes are made possible by the Medicines and Medical Devices Act 2021. These new Statutory Instruments are due to be laid in Parliament later in 2022. At that time, guidance documents will be developed in consultation with stakeholders.

The UK will be the first country to introduce a tailored framework for the regulation of innovative products manufactured at the point where a patient receives care. MHRA is in discussion with a range of international regulators to support the development of a similar framework in those territories to allow patients to access POC products.

The Ian Rees, the regulatory science expert who is leading on the work for the MHRA said:

This is a clear example of proactive and responsive regulatory action, where the MHRA identified a step-change in approach to medicines development and manufacture that will benefit from and require changes to the regulatory framework.

Yesterday (Thursday 14 July) the UK Government removed 23 foreign criminals on a charter flight to Albania.

Two individuals who entered the UK illegally were also swiftly removed after they were first encountered by Immigration Enforcement in the past few weeks.

This is testament to the dedicated and tireless work of Home Office teams in returning those with no right to be in the UK.

Individuals returned on the flight to Albania include:

• An individual first encountered in June 2022 following his arrest on suspicion of driving with excess drugs. He claimed to have entered the UK in the back of a lorry in 2021 but did not make himself known to authorities. The individual was detained for removal to Albania and agreed voluntarily to return.
• An individual who claimed to have entered the UK by yacht in 2021 but did not make himself known to the authorities. He was first encountered in July 2022 following an arrest on suspicion of driving offences, for which no further action was taken. He was detained for removal to Albania and agreed voluntarily to return.
• An individual sentenced to five and a half years’ imprisonment for intent to supply Class A drugs.
• An individual sentenced to three years and four months’ imprisonment for the production of Class B drugs.

The foreign national offenders removed had received combined prison sentences of more than 55 years and were convicted of crimes including the production and supply of controlled drugs, return in breach of a deportation order, illegal entry and destruction of property.

Home Secretary Priti Patel said:

These criminals are responsible for appalling drug offences, which destroy lives, families and communities. They have violated our laws and our values, leaving their victims living with the scars of their crimes.

The British public should be in no doubt of my determination to remove them by all available means to make our streets safer. Our new Nationality and Borders Act will help end the cycle of last-minute claims and appeals that can delay removals.

We are continuing to remove foreign criminals and those with no right to be here, as the public rightly expects.

The removal flight forms part of a regular schedule of returns to multiple countries, to remove those with no right to remain in the UK.

Over the last few weeks, the enforced removal of more foreign criminals from the UK has taken place. Individuals removed on charter flights include three individuals removed to Romania, who were sentenced to over seven years for facilitating illegal entry to the UK.

In June 2022, 240 foreign national offenders were removed from the UK on both charter and scheduled flights. These individuals had been convicted of offences including:

• 98 convictions for drugs offences
• 35 convictions for sex offences
• 29 convictions for violent crimes
• 27 convictions for threatening behaviour
• 16 convictions for immigration offences

Since March 2021 more than 10,000 people have been removed by both scheduled and charter flights, with 86 flights chartered to 13 different countries.

The Nationality and Borders Act will further deter illegal entry into the UK, breaking the business model of people-smuggling networks and speed up the removal of those with no right to be in the UK.

Social factors can include issues ranging from workforce conditions and supply chains to community engagement, consumer protection and modern slavery, among others.

The taskforce – led by the Minister for Pensions – will support pension scheme trustees and the wider pensions industry with some of the challenges around managing social factors, including the identification of reliable data and metrics.

Minister for Pensions Guy Opperman said:

I’m proud of the progress we have made in bringing environmental and climate issues up the pensions agenda, but climate change should not be trustees’ sole consideration.

Financially material social factors also pose risks and provide opportunities to schemes’ investments, and our taskforce will help ensure that focus on social factors continues to grow among pension schemes and throughout the investment chain.

The UK is already a world leader in tackling climate risk. From October this year, 80% of UK pension scheme members will be invested in schemes measuring and publishing how their investments support the Paris Agreement climate goal of limiting global warming to 1.5 degrees Celsius above pre-industrial levels. 

The responses to the government’s Consideration of social risks and opportunities by occupational pension schemes Call for Evidence highlighted the need for a proactive approach to embedding social factors within pension schemes’ investment decisions and stewardship policies.

The new minister-led taskforce will help identify reliable data sources and useful resources for pension schemes to assess and manage financially material social risks and opportunities. This work will contribute towards the development of wider principles, standards, and metrics.

To further drive progress in this area, DWP continues to encourage pension schemes to join the Occupational Pensions Stewardship Council – an industry-backed forum working to move the dial on stewardship through collective engagement and sharing best practice.

• The taskforce will be a minister led, cross-department working group, with invitations extended to financial regulators.

The full consultation response – Consideration of social risks and opportunities by occupational pension schemes, can be found on gov.uk.

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