Office for Life Sciences Bulletin - 7th May 2020

Office for Life Sciences Bulletin – 7 May 2020

OLS Introduction The Office for Life Sciences (OLS) is a joint unit between the Department of Health & Social Care (DHSC) and Department for Business, Energy & Industrial Strategy (BEIS).

This bulletin aims to keep the life sciences sector up to date on the latest guidance whilst the UK is in the transition period and during the Coronavirus (COVID-19) outbreak, providing you with information from Government to help your members and networks prepare.

If you would like to be added to the distribution list, please email Anisha.Visram@beis.gov.uk Request for feedback Help us shine a light on the stories of key workers and tell us about key workers you know that are helping to keep the UK moving during the Coronavirus pandemic.

Please fill in this online form for key workers in the following sectors: manufacturing, consumer goods, scientists/researchers and servicing.

Request for MAH volunteers to test new medicine supply reporting system DHSC are developing a new system for use by Marketing Authorisation Holders (MAHs) of licensed medicines to report supply issues, including potential shortages and discontinuations, to DHSC. This system will improve DHSC’s ability to manage supply issues and joint working with industry and will work to the requirements found within the Health Service Products Regulations 2018.

The new system will launch October 2020, and so DHSC would like to recruit MAHs to act as volunteers to test and provide feedback on the system over the summer. Please contact medicinescontingencyplanning@dhsc.gov.uk if you would like to be involved.

After initial testing all MAHs will be invited to access the system and provided opportunities to understand how to use it ahead of the launch date.

MAHs should continue to report supply issues to the DHSC Medicines Supply Team. Should you foresee disruption to supply and/or potential impact on the supply of your products to any part of the UK at: • • •

Branded Medicine Shortages: Brandedmedicineshortages@dhsc.gov.uk Generic Medicine Shortages: Genericmedicineshortages@dhsc.gov.uk Medicine Discontinuations: MB-discontinuedmedicines@dhsc.gov.uk

Events Government departments are hosting a series of free webinars to help businesses understand the support available. Keep up to date with all the latest available webinars here.

Monday May 11 – Coronavirus Job Retention Scheme – How to make a claim Monday May 11 – Coronavirus COVID-19 Statutory Sick Pay Rebate Scheme NEW - You can now review individual topics from our webinar on financial support for small businesses during coronavirus.

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Tax deferral Loans for small businesses Business support grant funds Support for wages

Workforce UPDATED - Frequently asked questions on what you can and can’t do during the coronavirus outbreak have been updated to reflect updated regulations and the latest PHE guidance.

NEW - HMRC are beginning to contact customers who may be eligible for the government’s Self-Employment Income Support Scheme (SEISS) .

Those who are eligible will be able to claim a taxable grant worth 80% of their average trading profits up to a maximum of £7,500 (equivalent to three months’ profits), paid in a single instalment.

You can check your eligibility using the new online checker tool.

NEW - People who cannot work their normal hours because of coronavirus (COVID-19) will still receive their usual tax credits payments. Find out more information here.

Support to business UPDATED - The new Bounce Back Loans Scheme is now open for applications. The scheme allows small and medium-sized businesses to borrow between £2,000 and £50,000 and access the cash within days. Please find further information on the scheme here and how to apply here.

More than 69,000 Bounce Back Loans worth over £2 billion have been approved during the first 24 hours of the scheme, the Chancellor has announced. Find out more here.

NEW – A discretionary fund has been set up to accommodate certain small businesses in England previously outside the scope of the business grant funds scheme. This additional

fund is aimed at small businesses with ongoing fixed property-related costs. Please find further information here.

NEW - £6.1 million funding boost to help high streets and town centres through the pandemic. Business Improvement Districts in England will receive funding in response to the coronavirus pandemic. Find out further information here.

NEW - The Government has announced a range of measures to protect students and the higher education sector in England from the impact of coronavirus, including £100m from BEIS to help vital university research activities to continue during the crisis. Find further detail here.

UPDATED - Guidance for businesses setting out details of the Small Business Grants Fund (SBGF) and Retail, Hospitality and Leisure Grant Fund (RHLGF) has been updated with information on tax.

UPDATED - The privacy notice on COVID-19 virus testing for critical workers and their household members who are self-isolating because they're showing symptoms has been updated to reflect the latest testing information.

UPDATED - Updated information from the IPO regarding new patent applications and subsequently filed documents, patent applications under section 22 of the National Security Act, international applications, time periods for reply, requests, correspondence and journal and publication.

UPDATED - Updated information from the IPO on alterations to services: trade marks and designs.

UPDATED - Information on Certified Office Copies (COCs) and payments and refunds has been added.

NEW - A revaluation of business rates will no longer take place in 2021 to help reduce uncertainty for firms affected by the impacts of coronavirus.

NEW – Guidance on how businesses can offer services, funds and volunteers to civil society during the coronavirus (COVID-19) outbreak. Find out more information here.

NEW - Information is available for HE providers on the Government support package available for universities and students, including information on the University Research Sustainability Taskforce.

Guidance from MHRA NEW – MHRA launched a new reporting site for any suspected adverse drug reactions or side effects from medicines and adverse incidents involving medical equipment relating to COVID-19 treatment, please find it here and further guidance here.

NEW – MHRA have a new biological reagent available to laboratories around the UK and the world that will help them to set up and develop accurate diagnostic tests for COVID-19.

The reagent is intended to be used in tests that confirm whether an individual is currently infected with the virus. Please find further information here.

UPDATED – additional information on additional pharmacovigilance and medical devices regulatory flexibilities.

Useful Links • • •

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Gov.uk/transition provides a central hub of resources for the transition period You can sign up to email alerts about the transition period on GOV.UK at this link.

EU citizens and other interested stakeholders can sign up for Home Office email updates about developments on the status of EU citizens in the UK after we leave the EU and the next steps for EU citizens in the UK at this link.

Access the ‘Check How to Export Goods’ tool here for the information you need to export goods out of the UK market.

Click here for more information and advice on exporting.

Click here for updated information on the Covid-19 response from the Department for Health and Social Care and Public Health England.

Click here for a list of Business Representative Organisations and Trade Associations you can speak with to get advice.

Specific information for businesses and employers in Northern Ireland, Scotland, and Wales is available. In England, Growth Hubs can advise on local and UK Government business support.

COVID 19 key contact details: o General offers of help from industry: gcfcovid19enquiries@cabinetoffice.gov.uk, or visit this webpage. o To offer your support producing ventilators please contact the Business Support Helpline for England on 0300 456 3565 or ventilator.support@beis.gov.uk. o If you have already offered to assist on the ventilators project but not received a reply, please contact existing.ventilators@dhsc.gov.uk. o Share the impact COVID-19 is having on your organisation with intel@beis.gov.uk o To provide feedback on MHRA engagement please contact engagement@mhra.gov.uk