• The UK government to set 12 new missions to drive real change to people’s lives by spreading opportunity and reversing geographical inequalities

• Inspired by the success of the vaccine rollout, Secretary of State Michael Gove to invite the First Ministers of the devolved governments to work together to level up the whole United Kingdom

• Leaders across the UK will be asked to find new ways to collaborate and learn from each other’s successes as we face common challenges

The UK government’s Levelling Up white paper will today set out an ambitious blueprint to improve lives and expand opportunities across the whole United Kingdom.

Following publication of the white paper, Secretary of State for Levelling Up Michael Gove will invite the First Ministers of Scotland, Wales, and Northern Ireland to join a new collective effort to level up the whole of the United Kingdom.

Secretary of State for Levelling Up, Rt Hon Michael Gove MP said:

“The United Kingdom is an unparalleled success story with one of the world’s biggest and most dynamic economies.

“But not everyone shares equally in the UK’s success. Great cities like Glasgow, Belfast, Swansea and Manchester, and proud towns from Aberystwyth to Armagh, to Bangor and Yeovil, have huge potential but contain inequalities which hold too many back.

“Our ambitious plan to unite and level up the whole UK seeks to end that historic injustice and call time on the postcode lottery.

“We will only succeed if all layers of government – UK, devolved, and local – work together.

“We have seen through the success of the vaccine roll-out what we can achieve when we pull together. United, there is no challenge we cannot meet.”

Prime Minister Boris Johnson said:

“From day one, the defining mission of this government has been to level up this country, to break the link between geography and destiny so that no matter where you live you have access to the same opportunities.

“The challenges we face have been embedded over generations and cannot be dug out overnight, but this White Paper is the next crucial step.

“It is a vision for the future that will see public spending on R&D increased in every part of the country; transport connectivity improving; faster broadband in every community; life expectancies rising; violent crime falling; schools improving; and private sector investment being unleashed.

“It is the most comprehensive, ambitious plan of its kind that this country has ever seen and it will ensure that the government continues to rise to the challenge and deliver for the people of the UK.”

Among the White Paper’s 12 central missions are plans to: close the gap between the UK’s highest and lowest performing cities; improve educational attainment among children leaving primary school; narrow the gap in healthy life expectancy between the best and worst performing areas of the UK; and close gaps in transport and connectivity.

These missions will drive real change by spreading opportunity and prosperity and reverse the postcode lottery of life chances in the UK.

Where policies are reserved, the UK Government will lead on delivery UK-wide. Where missions fall in devolved policy areas, the UK Government will seek to work collaboratively with the devolved governments to deliver for the people we jointly serve.

The Secretary of State for Levelling Up, Michael Gove, will write to the leaders of the devolved administrations to invite them to work together to deliver for people across the UK.

Proposals will include using the new structures created in the landmark Intergovernmental Relations Review to drive collaboration to overcome geographical disparities and the creation of new body to share evidence and analyse success in devolved policy areas across the UK.

Amongst the UK-wide policies the UK Government will drive are:

A 40% increase in domestic public investment in R&D outside the Greater South East of England by 2030. The Department for Business, Energy, and Industrial Strategy (BEIS) have committed to invest at least 55% of their domestic R&D funding outside the Greater South East by 2024/5. Nationwide gigabit-capable broadband and 4G coverage across the UK and 5G coverage for most of the population.

New proposals to reclassify the first HRT product for self-care (Gina 10), formally known as Vagifem, microgram vaginal tablets would mean that women in the UK could access a menopausal treatment over the counter at a pharmacy, without requiring a prescription for the first time. This is the MHRA’s first reclassification consultation for a Hormone Replacement Therapy (HRT) product locally applied in the vagina. This product is inserted into the vagina and not taken orally.

Millions of women in the UK go through the menopause every year, with the majority experiencing some symptoms that can be severe and have a negative impact on everyday life. These vaginal tablets are a form of hormone replacement therapy (HRT) that treat vaginal dryness; caused by estrogen deficiency in postmenopausal women.

We are asking GPs, pharmacists and members of the public for their views on whether this product should become a pharmacy medicine and available over the counter, without a prescription.

This consultation seeks views on making this product available over the counter to women aged 50 years and above, who have not had a period for at least 1 year. This is the first time such a change has been considered, making it important that women’s and the public’s views are heard.

Pharmacists are trained healthcare professionals. If the product is reclassified, pharmacists will have access to training materials and a checklist to enable them to identify women who can be supplied with this medicine safely.

Dr Laura Squire, Chief Healthcare Quality and Access Officer at the MHRA, said:

“Every response we receive will be vital in helping us gain a better picture of whether people think this form of vaginal HRT should be available over the counter.

“The menopause can cause unpleasant symptoms and HRT-based medications form an important part of alleviating them. This is why it’s so important for us to hear what women think about this possible reclassification.

“We want to hear from as many people, health care professionals and women’s groups as possible.”

Should this product be reclassified, topical HRT products containing estradiol will still be available on prescription from GPs.

The Commission on Human Medicines has advised that it is safe for this product to be made available as a Pharmacy (P) medicines.

Minister for Women’s Health, Maria Caulfield, said:

“As a woman and a nurse, I know how challenging the symptoms of the menopause can be. In the Women’s Health Strategy call for evidence, women across the country were clear – menopause support is a key issue which we need to do more to address.

“This consultation is another step forward to ensure women’s voices are being heard loud and clear on how they want to access HRT to reduce the impact of the menopause on their lives.

“More widely, we’ve set up a UK-wide Menopause Taskforce and we’ll continue to address the menopause as part of the Women’s Health Strategy, as well as working with campaigners and stakeholders, to make sure we’re supporting women as best we can.”

Details about the consultation, including how to take part can be found here.

Systemic HRT medicines circulate in the blood and are used to treat hot flushes and other menopausal symptoms. They include oral tablets and patches (transdermal patches) and gels which are put on the skin. Local HRT such as Gina works directly where it is applied with very little absorption into the bloodstream.

Notes to Editors

1. Consultation on proposal to make Gina 10 microgram vaginal tablets (Estradiol) available from pharmacies
2. Medicines and Healthcare products Regulatory Agency (MHRA)is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
3. MHRA is an executive agency of the Department of Health and Social Care.
4. The Commission on Human Medicines (CHM) advises ministers on the safety, efficacy and quality of medicinal products.

The Early Access to Medicines Scheme (EAMS) is a vitally important scheme that gives patients with life-threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorisation, when there is a clear unmet medical need. The scheme, which has been running since 2014, has to-date granted 100 medicines a Promising Innovative Medicine status and more than 40 Scientific Opinions have been awarded in a variety of therapeutic areas with unmet patient need.

The Scheme is an excellent demonstration of healthcare agencies and industry working together to get ground-breaking treatments to patients more quickly. An example of the scheme in action is Roche’s atezolizumab (Tecentriq), which helps treat people with lung cancer. As a result of the scheme, 63 patients were able to access atezolizumab after a review with their specialist. This meant patients had access to the life-saving treatment around 4 months earlier. EAMS also accelerated access to pembrolizumab for 500 patients with advanced melanoma skin cancer. Most notably during the pandemic, EAMS was responsible for the select use of the first COVID-19 medicine, Gilead’s remdesivir, to shorten hospital stay.

Following an analysis of the responses to the six-week consultation the MHRA launched last year, the UK regulator has prepared a Government response outlining key legislative changes. These changes will provide the UK with an opportunity to maximise the Scheme’s impact by accelerating availability of medicines for patients, reducing the burden on manufacturers supplying EAMS medicines and facilitating the collection of real-world data which may potentially be used as evidence to support regulatory decision making for future authorisations. This will help support more patients benefiting from important EAMS medicinal products and ensure that the UK remains internationally competitive in the pre-market access landscape.

Dr June Raine, Chief Executive of the MHRA said:

“This is a ground-breaking move, demonstrating our commitment to ensuring that patients can have fast access to promising new treatments ahead of normal licensing timeframes. This life-changing scheme, which has remained running throughout the pandemic, gives patients with life-threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorisation when there is a clear unmet medical need.

“We have seen positive support for these new changes in the responses to our consultation and a clear indication that patients, clinicians and industry are supportive of introducing a bespoke EAMS provision within the UK medicines legislation. We will now take the steps needed to provide a legislative framework for EAMS. This comprehensive framework will not only benefit patients in need of innovative and cutting-edge treatments but will also provide detailed real-world evidence for our future regulatory decisions.”

“We would like to thank all those who took part in this important consultation which has resulted in making these innovative changes to UK legislation. Your feedback and views were critical in putting together this robust legislation and delivering a legal basis for this vitally important scheme.”

Fiona Loud, Policy Director at Kidney Care UK, said:

“As the UK’s leading kidney patient support charity, Kidney Care UK frequently hears from families and people who need hope. When new treatments emerge, such as those for rare conditions like Primary Hyperoxaluria Type 1 (PH1), they are often excited but frustrated as they wish to access them as soon as possible. It is good to see this scheme is making this happen. The opportunity to benefit from new treatments early as part of a well-informed and shared decision is both helpful and hopeful. We hope that more people with kidney disease will be able to benefit from new medicines as the EAMs scheme proceeds.”

Pamela Healy, Chief Executive at the British Liver Trust said:

“Many patients with liver cancer and liver disease are often diagnosed at an advanced stage when there are limited treatment options. Sometimes, new innovative treatments take a long time to go through the regulatory processes. This early access scheme is extremely important for patients and has the potential to save lives. It means that patients can potentially receive medicines that are deemed safe much more quickly whilst further evidence is collected.”

A review of the consultation responses can be found here.

Notes to Editors

1. The Medicines and Healthcare products Regulatory Agency is responsible for regulating all medicines and medical devices in the UK.
2. The MHRA is a centre of the Medicines and Healthcare products Regulatory Agency which also includes the National Institute for Biological Standards and Control (NIBSC) and the Clinical Practice Research Datalink (CPRD). The MHRA is an executive agency of the Department of Health and Social Care.
3. Further information on EAMS and a case study on Roche’s atezolizumab (Tecentriq) can be found here.
4. A case study on pembrolizumab can be found here.
5. See further information on Gilead’s COVID-19 treatment, remdesivir.
6. We carried out a public consultation from the 6 August 2021 to the 17 September 2021 on proposals to clarify the legal basis for EAMS within the Human Medicines Regulations (the HMRs).