Month: September 2018

Key themes for the day included the UK regulatory environment now and post Brexit, the accelerated access pathway for breakthrough therapies and technologies, drug device combinations and the importance of real world evidence in regulatory decision-making.

Sir Michael Rawlins, Chairman of Medicines and Healthcare products Regulatory Agency delivered the keynote address on accelerating access to innovative therapies and implementing the AAR recommendations under the Life Sciences Industrial Strategy.

The report brings together highlights from the day including perspectives from senior experts from across the sector including: MHRA the UK regulator, the National Institute for Biological Standards and Control (NIBSC), the Clinical Practice Research Datalink (CPRD), the Department of Health and Social Care, the National Institute for Health and Care Excellence (NICE), the Office for Life Sciences, notified bodies, the life science industry, research charities and patient organisations.

Chief Executive of the Medicines and Healthcare products Regulatory Agency, Dr Ian Hudson, said:

It is an important part of the agency remit to support innovation, improving access to new medicines and promoting public health gains. The record number of delegates at this annual conference reflects the value of continued dialogue between regulators and stakeholders in helping to achieve this objective and to drive innovation forward.

Commenting on the publication of the report, BIA CEO, Steve Bates, said:

As the UK moves closer to Brexit it is vital that industry, the regulators and wider stakeholders work together to ensure the best possible outcome for patients in the UK and Europe, and this event provides a useful forum to bring key players in the sector together. The fantastic line up of speakers and excellent attendance demonstrate the value of this forum.

The full report can be downloaded here and you can also find the full programme and slide presentations for this year on the conference website.

NAEH Ltd, Wise Auto Enrolment Ltd (Wise) and National Auto Enrolment Helpline Ltd were all wound up by the High Court in Manchester on 17 September 2018.

NAEH Ltd and Wise acted as introducers where they referred employers, required by law to enrol certain staff into a pension scheme, to a pension administrator in order to set up new schemes.

However, the Insolvency Service received complaints about the two companies and with assistance from The Pensions Regulator (TPR), investigators found that NAEH and Wise traded with a lack of commercial probity.

The two pension enrolment companies would make misleading and unfounded statements on their websites and to employers, as well as charge advance fees for services which they then completely failed to provide.

Investigators also found that the two companies operated with a lack of transparency. They would use incorrect company names on invoices and it was unclear who was in control of NAEH and Wise.

The third company that was wound up, National Auto Enrolment Helpline, had not conducted any activities but investigators demonstrated to the court there were strong grounds to believe that the company would have been used to continue the activities carried out by NAEH and Wise.

Scott Crighton, Chief Investigator at the Insolvency Service, said:

The Insolvency Service will investigate and bring to a halt the activities of companies that fail to meet the required standards of commercial probity and transparency and that are found to be operating against the public interest.

The Official Receiver is now responsible for the affairs of the companies and we want to assure the public that the court’s actions have put an immediate stop to their activities.

All enquiries concerning the affairs of the companies should be made to: The Official Receiver, Public Interest Unit, 2nd Floor, 3 Piccadilly Place, London Road, Manchester M1 3BN, Email: PIU.North@insolvency.gsi.gov.uk.

Notes to Editors

NAEH Ltd (CRN 7928084) was incorporated on 30 January 2012 as Ventica Limited. Its name was changed to NAEH Ltd on 9 August 2016. NAEH’s registered office is at 23 New Mount Street, Manchester, M4 4DE.

Wise Auto Enrolment Ltd (CRN 10617040) was incorporated on 13 February 2017. Its registered office is at 21 Broad Street, Bury, BL9 0DA.

National Auto Enrolment Helpline Ltd (CRN 10180658) was incorporated on 16 May 2016. Its registered office is at Companies House, Crown Way, Cardiff, CF14 3UZ.

The petitions to wind up the companies were presented in the High Court Manchester on 19 July 2018, under the provisions of section 124A of the Insolvency Act 1986 following confidential enquiries by Company Investigations under section 447 of the Companies Act 1985, as amended. Company Investigations, part of the Insolvency Service, uses powers under the Companies Act 1985 to conduct confidential fact-finding investigations into the activities of live limited companies in the UK on behalf of the Secretary of State for Business, Energy and Industrial Strategy (BEIS).

The Insolvency Service administers the insolvency regime, investigating all compulsory liquidations and individual insolvencies (bankruptcies) through the Official Receiver to establish why they became insolvent. It may also use powers under the Companies Act 1985 to conduct confidential fact-finding investigations into the activities of live limited companies in the UK. In addition, the agency deals with disqualification of directors in corporate failures, assesses and pays statutory entitlement to redundancy payments when an employer cannot or will not pay employees, provides banking and investment services for bankruptcy and liquidation estate funds and advises ministers and other government departments on insolvency law and practice.

Further information about the work of the Insolvency Service, and how to complain about financial misconduct, is available.

Contact Press Office

Media enquiries for this press release – 020 7637 6498 or 020 7596 6187

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The Queen has been pleased to appoint Mr Edmund Bailey as Constable of Caernarfon Castle in succession to the late Lord Snowdon GCVO.

Biographical Notes

Edmund Bailey has been the Lord-Lieutenant of Gwynedd since 2014. A farmer with business interests in tourism and renewable energy, he has previously served as President of NFU Cymru, as a member of the Lord Chancellor’s Agricultural Land Tribunal and as High Sheriff of Gwynedd. He lives at Llanbedr.

The Charity Commission, the independent regulator of charities in England and Wales, has opened a statutory inquiry into The Moss Side and Hulme Community Development Trust (1093592). The inquiry was opened on 28 August 2018.

The charity’s objects include urban and rural regeneration, relief of poverty, advancement of education, conservation of the environment, and the advancement of education in African Caribbean heritage and culture within Moss Side, Hulme and adjacent areas of Manchester.

In October 2017, the charity was included in the Commission’s class statutory inquiry, which looked into charities that had defaulted on their annual reporting obligations two or more times in the last five years. The charity filed its outstanding financial information and was removed from the class statutory inquiry on 29 March 2018. The fact that the charity has yet again failed to meet its statutory requirement to file its financial accounting documents on time is a serious regulatory concern to the Commission, and evidence of misconduct and mismanagement in the administration of charity.

The financial information submitted by the charity has also raised further regulatory concerns for the Commission in relation to potential unauthorised payments to a trustee, and other breaches of charity law affecting the management of the charity.

As a result the inquiry will look at the extent to which the trustees are complying with their legal duties in respect of their administration, governance and management of the Charity and in particular:

• the trustees’ compliance with their legal obligations for the preparation and filing of the charity’s accounts and other information or returns
• the extent to which the trustees have complied with previously issued regulatory guidance
• the extent to which there has been any unauthorised trustee remuneration

It is the Commission’s policy, after it has concluded an inquiry, to publish a report detailing what issues the inquiry looked at, what actions were undertaken as part of the inquiry and what the outcomes were. Reports of previous inquiries by the Commission are available on GOV.UK.

Ends

Notes to editors

1. The Charity Commission is the regulator of charities in England and Wales. To find out more about our work see the about us page on GOV.UK.
2. Search for charities on our check charity tool.
3. Section 46 of the Charities Act 2011 gives the commission the power to institute inquiries. The opening of an inquiry gives the commission access to a range of investigative, protective and remedial legal powers.

To help registered providers understand their relative performance on the Regulator of Social Housing’s Value for Money metrics, RSH has today (27 September 2018) published an analysis of the last 3 years of annual accounts data.

The Value for Money report is part of the regulator’s continuing work to help the sector contextualise the performance of individual providers more easily. It aims to help boards compare themselves to organisations with similar business models and geographical locations. The summary report is accompanied by a detailed Value for Money metrics – Technical regression report, which explains the analysis in greater depth.

The reports are based on electronic Annual Accounts returns submitted to the regulator for financial years from 31 March 2015 to 31 March 2017 by private registered providers with more than 1,000 homes. The regulator has also carried out additional analysis at a sub-sector level to provide more detailed insight into the differences between different types of registered provider.

Some of the main findings include:

• Supported housing and housing for older people are associated with higher costs, and lower operating margins with fewer resources likely to be available for new development – this is likely to be linked to the broader scope of activities undertaken by providers with a specialised focus.
• London based providers also face higher costs, but this is partially compensated for by higher rents and scope for sales revenues – providers in this high demand area are therefore still able to develop social housing at a rate slightly above the sector average.
• Landlords in their first seven years following a Large Scale Voluntary Transfer are characterised by high levels of reinvestment in existing stock, but have little capacity for investment in new supply – this could be as a result of the higher costs associated with completing major repair commitments made at the time of transfer from the local authority
• The analysis shows that there is not a statistically significant relationship between the size of provider and either costs or the level of new supply of sub market homes – it is important to bear in mind that the analysis covers a limited time period and with many of the sector’s most significant mergers having only recently taken place, the picture on supply and longer-term business performance may change in the years following merger.

Fiona MacGregor, Director of Regulation said:

Our regression analysis provides useful insight into the factors that impact on registered providers’ performance across the suite of VfM metrics. It also informs the important debate about the potential to deliver greater value for money in the sector: whether that is improving services to existing tenants, building much needed new homes or working to improve the areas in which they operate. However, the analysis can only provide a partial picture, and cannot substitute for an organisation’s own understanding of its operating environment and its use of resources and assets.

The real question for boards is how to maximise the delivery of their strategic objectives and how they measure and demonstrate that they are doing so to key stakeholders including tenants, local communities and others.

The Value for Money – Summary report and the Value for Money metrics – Technical regression report can both be found on the RSH Gov.uk website.

Further information

1. The VfM metrics set out by the regulator focus on seven financial metrics using existing regulatory data to minimise interference and potential burdens on providers.
2. The regulator’s purpose is to promote a viable, efficient and well-governed social housing sector able to deliver homes that meet a range of needs. It does this by undertaking robust economic regulation focusing on governance, financial viability and value for money that maintains lender confidence and protects the taxpayer. It also sets consumer standards and may take action if these standards are breached and there is a significant risk of serious detriment to tenants or potential tenants.
3. For more information visit the Gov.uk website

Our About the Regulator of Social Housing page has contact details for media enquiries.

For general queries to RSH, please email enquiries@rsh.gov.uk or call 0300 124 5225.

International Development Secretary Penny Mordaunt announced at the UN General Assembly yesterday (Wednesday 26 September) that UK aid will be dedicated to developing shorter, safer and more effective treatments for TB.

These new treatments could also help tackle the rise of drug resistant TB. In 2017 an estimated 600,000 people developed drug resistant TB but the success rate with current treatments is 55 per cent – making it a major public health crisis.

Scientists and health workers in developing countries are constantly battling to combat this leading killer infectious disease, with mortality rates being higher in low income countries such as Mozambique and the Central African Republic.

This latest support for the TB Alliance will help develop new, safer drugs for the disease, which last year infected 10 million people.

Speaking after a high-level meeting on TB at UNGA yesterday Ms Mordaunt said:

TB is the biggest killer among infectious diseases globally. The UK is already leading the way to tackle TB through investment in research and development. UK aid will help develop three new TB drugs, which offer quicker-acting treatments for the millions of people affected by drug-resistant TB each year.

The work of our expert scientists is bolstering our efforts to ensure we can tackle these diseases that do not respect borders. It is a win for the UK and a win for the developing world.

The UK government has been clear this research alone is not enough to meet the Global Goal target to end TB by 2030. That is why Heads of State will meet at the high-level meeting at UNGA to sign a political declaration, signalling a step-change in the international leadership and commitments necessary to drive progress on fighting TB.

DFID has also supported Aeras, a non-profit organisation working with GSK and other partners, to develop and test a new TB vaccine. Early results show the number of HIV-negative people developing TB was reduced by about half.

The UK already provides substantial support to international organisations, including the Global Fund, Unitaid and world-class research to develop new health products. These investments support large-scale TB programmes and critical research into innovative new medicines and diagnostics to help tackle TB. The UK’s work in strengthening country health systems also plays a vital role in tackling the disease.

Yesterday the University of Oxford also announced its team of scientists and global experts have led a major breakthrough in the understanding of TB’s genetic code. Their research has the potential to shape how TB is diagnosed in the future to make sure the right drugs are prescribed.

Dr Timothy Walker, Academic Clinical Lecturer in Infectious Diseases and Microbiology at the University of Oxford, said:

This is a new exciting era for TB diagnostics. These advances will soon mean those suffering with TB can get individual treatment that is right for them to help them fight the disease, moving beyond treating patients on a “best guess” basis.

Public Health England announced this week TB rates in England have dropped to the lowest level since 1990. The data showed a 38 per cent drop in new diagnoses from the peak in 2011 to 2017 (from 8,280 to 5,102).

Notes to editors

• £7.5 million new UK aid support has been given to the TB Alliance to develop shorter, simpler treatments against TB that are affordable to the poorest countries in the world.
• The latest figures on TB published by the World Health Organization show that in 2017, 10 million people developed this preventable and treatable disease and 1.6 million people died.
• Through our support to the Global Fund in the fourth replenishment round (2014-2016) the UK ensured TB treatment was provided to 1.26m people worldwide.
• The UK supports the Foundation for Innovative New Diagnostics, which is developing new diagnostic tests for TB. Funding to date has included support for the highly successful GeneXpert test, which is now used in 140 countries, including the UK, to help improve diagnosis for TB.