Mr. Chair, only two weeks ago in this Council, we reminded Russia of its obligations, under international law, to protect civilians, civilian infrastructure and those seeking medical care, including combatants.  We also reminded Russia of the consequences of turning its back on these obligations.  However, once again, we are presented with yet more evidence of Russia’s callous disregard for life in the pursuit of its illegal invasion.

The second Moscow Mechanism report made for sobering reading, detailing Russia’s continued targeting of healthcare facilities and personnel in direct contravention of International Humanitarian Law.  According to the WHO, Russian forces have repeatedly attacked Ukrainian medical facilities, striking hospitals, ambulances, medics, patients, and even newborns.  At least 395 attacks have been reported since Russia’s invasion of Ukraine on 24 February, particularly impacting the most at-risk and marginalised groups in Ukraine such as women, children, minority groups, the disabled and the elderly.  We will not let these actions go unanswered.

Russia’s invasion has injured thousands, mentally as well as physically, and then deprived them of treatment and care when they needed it the most.  It is heartless and unforgivable.  As well as those who have been injured as a direct result of the Russian government’s actions, many more are at risk of ill-health due to reduced access to routine and preventative healthcare, including pharmacy services; sexual and reproductive health care; and vaccination for diseases such as COVID-19 and polio.  In addition, organisations such as Médecins Sans Frontières and UNICEF have reported on the devastating effects of the invasion on mental health, particularly amongst children who have been injured, witnessed acts of violence and displaced from the familiarity of their homes. The UK is the largest donor to the UN Ukraine Humanitarian Fund, providing life-saving assistance, however we are concerned that this will not reach all those who so desperately need it.

The Moscow Mechanism report highlighted the ‘catastrophic’ conditions in areas under temporary Russian control.  Major cities such as Kherson are likely to face a humanitarian crisis due to a shortage of medicines, yet humanitarian aid organisations are being denied access to deliver urgently needed supplies and medical expertise.  The WHO have warned of a lack of antibiotics for battlefield injuries, patients unable to receive early diagnosis and treatment for cancer; people unable to receive medications for hypertension; and diabetics who cannot access insulin, resulting in worsening illness and preventable deaths.

We have also heard the horrific reports of ‘filtration camps’, disappearances, and illegal detentions in these areas.  We were shocked and appalled to learn of the reported death of British National Paul Urey, whilst in the custody of Russian proxies in eastern Ukraine.  Mr. Urey was a civilian who was detained whilst undertaking humanitarian work in Ukraine.  I reiterate the words of my Foreign Secretary, “the Russian government and its proxies are continuing to commit atrocities. Those responsible will be held to account.”

Russia must bear full responsibility for Mr. Urey’s death.  Just as Russia must bear full responsibility for the countless other deaths of those illegally detained and tortured; of those targeted at medical facilities and hospitals when at their most vulnerable; for the heroic and selfless medical staff who only wanted to help and heal; for four year old Liza Dmitrieva on the way home from her speech therapy session in Vinnytsia.  The list tragically goes on. We will ensure that justice is delivered for Liza, for all those who have suffered and for those who have lost their lives at the hands of President Putin.  As has been said many times, he alone can stop this horror and bloodshed, he simply chooses not to.

Through humanitarian assistance, and our commitments on military aid, economic assistance, sanctions and accountability, we will support and stand by Ukraine in their fight against Russia’s tyranny.  On many fronts, Russia has already lost.  It must end this illegal war now, withdraw its troops from the whole of Ukraine, and take responsibility for its actions.

The Parole Board is in the process of updating its guidance to reflect these changes but in the meantime the information below sets out key changes.

Community Offender Managers, Prison Offender Managers and prison Psychologists will no longer be providing recommendations or views on a prisoner’s suitability for release or transfer to open conditions in the reports they provide to the Parole Board. While HMPPS report writers are unable to provide a recommendation/view, they must still provide a rigorous and comprehensive assessment of the prisoner’s risks and needs, using accredited tools and applying their professional judgement, as well as a statement of outstanding risk factors and identifying protective factors.  For all cases, a risk management plan must be provided that presents an evidence-based assessment of the risk the prisoner presents, setting out how the Probation Service would manage the prisoner, if the panel were minded to direct release.

In some cases, the Secretary of State will present a single view on the prisoner’s suitability for release. These cases will be selected by the Secretary of State, taking account of advice from officials.

The set aside process will give the parties to parole reviews (the Secretary of State and the prisoner) the right to ask for a final parole decision to be looked at again by the Parole Board. This is only applicable for cases where release is being considered and not for recommendations for open conditions. Guidance will be published on setting aside shortly.

The Secretary of State now makes an automatic referral to the Board for consideration of terminating an IPP licence rather than the individual on licence making an application direct to the Board.

Where the individual on licence has been recalled to custody, the panel must consider both whether the IPP licence should be terminated and whether the test for release is met.

For more information on IPP licence termination please see here: Termination of Licence for Individuals serving Imprisonment for Public Protection (IPP) – GOV.UK (www.gov.uk)  

The new Parole Board Rules make it possible for public parole hearings to be held in some cases where circumstances justify it. The prisoner, victim, the media or the wider public may now make an application requesting that a case be heard in public.

Applications have to be made no less than 3 months before a parole board hearing is scheduled to take place.

More information on this process and the application from can be found here: Applying for a Parole review to be public – GOV.UK (www.gov.uk)

Topiramate is used for the treatment of epilepsy and migraine. It is used specifically:

• to prevent migraine headaches in adults after consideration of possible other treatments
• alone to treat seizures in adults and children older than age 6 years
• with other medicines to treat seizures in adults and children aged 2 years and above

It should only be prescribed under the supervision of a healthcare professional.

Topiramate is already known to harm the way an unborn baby grows and develops if it is used during pregnancy. Therefore, women should already be advised to use highly effective birth control while on topiramate and to avoid becoming pregnant while using this medicine.

There are other treatments for use in pregnancy that are safer for the baby such as lamotrigine and levetiracetam. Information shows that these medicines do not increase the risk of physical birth abnormalities compared with the general population.

A safety review is today being initiated into topiramate following an observational study suggesting a potential increased risk of neurodevelopmental disabilities (including autism spectrum disorder and effects on learning and development) in children exposed to topiramate during pregnancy.

Women on topiramate who are planning a pregnancy should speak to their doctor about other treatment options, but they should not stop taking topiramate without first discussing it with a healthcare professional.

Topiramate is available as tablets, a liquid oral solution, or as capsules that can be swallowed whole or sprinkled on soft food. The brand name of topiramate is Topamax.

Previous reviews of topiramate and harms in pregnancy

Following a review by the Commission on Human Medicines into the safety of antiepileptic drugs in pregnancy, including topiramate, in January 2021 we published new safety advice in Drug Safety Update with patient advice, and a Public Assessment Report.

Topiramate use in pregnancy is linked to an increased risk of birth defects and an increased risk of the baby being born of low birth weight and small for gestational age (fetal growth restriction).

Scope of this review

The Medicines and Healthcare products Regulatory Agency (MHRA) routinely undertakes reviews of the safety of medicines, seeking independent expert advice from the Commission on Human Medicines. The MHRA is responsible for the safety, efficacy and quality of medicines and so this safety review focuses on the regulatory position in the UK.

The scope of the review is:

1. To evaluate information from all Marketing Authorisation Holders and available sources, including relevant stakeholders (patients, patient representatives, healthcare professionals, healthcare organisations, researchers, charity and patient organisations) on the possible harms associated with the use of topiramate during pregnancy.
2. To consider whether further regulatory action is required to minimise risk and ensure awareness of the risks.
3. To consider the impact of the available information considered as part of this review on the balance of benefits and risks of topiramate.
4. To consider what research could be undertaken to further elucidate the long-term impact on children of exposure to topiramate during pregnancy.
5. To make recommendations to the Commission on Human Medicines to improve the balance of benefits and risks for topiramate, to raise awareness of the associated risks and for further research to evaluate the risks.

Following completion of this safety review, a report of the CHM’s conclusions and recommendations will be published on this website and will also be sent to those who have indicated that they would like to receive notifications.

Timeframes for the review

After the CHM has considered the review, the MHRA will take forward the recommendations and update the timelines for the review where necessary.

If you would like to receive notifications in relation to this safety review please contact MHRACustomerServices@mhra.gov.uk to register your details. We will only use these details to notify you about this review.

Information on opportunities to contribute to the review will be published on this webpage as they arise and notifications will be sent to individuals who have indicated they wish to receive them.

Advice for patients

Patients are advised to not stop taking topiramate without discussing with your doctor.

If you are taking topiramate for epilepsy or migraine and are planning a pregnancy, urgently talk to your doctor – there are treatments for use in pregnancy which are safer for the baby.

For epilepsy, consult our information on epilepsy medicines and pregnancy, including that lamotrigine (brand name Lamictal) and levetiracetam (brand name Keppra) are safer for the baby during pregnancy since they do not increase the risk of physical birth abnormalities compared with the general population.

Advice for healthcare professionals

Continue to advise patients on the already known risks associated with topiramate during pregnancy. See article in the MHRA’s Drug Safety Update from July 2022 for a reminder of current advice.

Before starting topiramate in a woman of childbearing potential, fully inform the patient of the risks and the need to use highly effective contraception throughout treatment with topiramate.

Do not prescribe topiramate during pregnancy for migraine prophylaxis. Specialist advice should be sought for patients with epilepsy who are pregnant.

Reporting suspected side effects to topiramate

We continuously monitor the safety of medicines in the UK using information from various sources including the Yellow Card scheme.

If you suspect that you have experienced a side effect with use of topiramate, we encourage you to submit a report. Anyone in the UK can submit a report to the Yellow Card scheme.

If you have any questions about this review please contact us at MHRACustomerServices@mhra.gov.uk

Three years into the small boats crisis, the Independent Chief Inspector of Borders and Immigration has found the Home Office response is both ineffective and inefficient, exposing gaps in security procedures and leaving vulnerable migrants at risk.

In 2021, 28,526 people arrived on the south coast in small boats, according to Home Office statistics – a significant increase from 236 in 2018.

An inspection of the Tug Haven processing facilities, which have since closed, along with those at Western Jet Foil, both in Dover, found the Home Office’s response to the challenge of increasing numbers of migrants was poor, particularly in terms of systems, processes, resources, data collection and accurate record keeping. A new processing centre for migrants opened in January 2022 at a former Ministry of Defence site at Manston, also in Kent, and further facilities are also due to open later this year at Western Jet Foil.

David Neal, the Independent Chief Inspector of Borders and Immigration (ICIBI), said:

These migrants crossed the Channel in dire circumstances. Many were vulnerable and at risk, including children and women on their own, and when they arrived in Dover the way they were dealt with was unacceptable. This is because the Home Office has failed over the past three years to move from a crisis response to having better systems and procedures in place and treating this as business as usual.

Data, the lifeblood of decision-making, is inexcusably awful. Equipment to carry out security checks is often first-generation and unreliable. Biometrics, such as taking fingerprints and photographs, are not always recorded.

The Home Office told our inspectors that 227 migrants had absconded from secure hotels between September 2021 and January 2022, and not all had been biometrically enrolled. Over a five-week period alone, 57 migrants had absconded – two-thirds of whom had not had their fingerprints and photographs taken.

Put simply, if we don’t have a record of people coming into the country, then we do not know who is threatened or who is threatening.

To move migrants quickly through Tug Haven, effective safeguarding was sacrificed because of the large numbers of migrants from small boats coming into the country. There was limited reflection by staff at all grades of the connection between vulnerability and security – that identifying a trafficking victim could feed the intelligence cycle and reveal intelligence about organised criminal gangs. The ability of staff to identify and safeguard vulnerable migrants was also hindered by the fact that no interpreters were used in the procedures carried out at Tug Haven.

Many of the issues identified were also picked up in a separate inspection undertaken last year by Her Majesty’s Chief Inspector of Prisons, which found that migrants were being held in unsatisfactory conditions, with weak Home Office systems relating to governance, accountability and safeguarding.

Mr Neal added that the Home Office team charged with responding to the crisis, the Clandestine Channel Threat Command, is pulled between day-to-day operations and developing a deterrent, as well as responding to the constant requests for strategic briefings. The majority of its Campaign Plan objectives focus on strategic effects at the expense of delivering security and dealing humanely with the here and now. In simple terms, the focus on the ‘Prevent’ function has eclipsed the need to do simple things well on the quayside in Dover.

He added that although staff were doing their very best, they were tired, and high volumes of migrants led to poor record keeping and data collection and processes that do not work.

The workforce can do no more. They have responded with enormous fortitude and exceptional personal commitment, which is humbling, and they are quite rightly proud of how they have stepped up. However, we found there was a lack of effective and visible leadership.

This is not about rank and file staff working hard on the quayside at Dover, this is about effective leadership, grip and the ability to bring in systems that work. Border Force and Immigration Enforcement officers at home and overseas are doing a great job on a daily basis.

He added:

A new model for Borders and Enforcement is desperately required if our border is to be secured and vulnerability effectively addressed. There needs to be a strategic approach by the Home Office to regularise their response to small boats, as this has become business as usual and moved beyond an emergency response.

The inspection was undertaken between December 2021 and January 2022 and the report made four recommendations, all of which the Home Office has accepted, with priority placed on ensuring that staff received training and updated guidance by March 2022 in security matters, including how the Biometric Recording Stations are operated.

By June 2022 further improvements needed to have been made, including identifying migrants who are vulnerable such as children, single women and families, and ensuring information is properly recorded and acted upon. Further detailed recommendations call for the improvement of overall data quality and resourcing needs.

Our recommendations are not intended to supersede those provided by Her Majesty’s Chief Inspector of Prisons and the Home Office’s own Joint Review, but clearly point to a need for the Home Office to urgently implement all recommendations as a priority.

We will reinspect the processing facilities later this year.