Office for Life Sciences Bulletin – 3 April 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. Future Relationship with the EU The first meeting of the Withdrawal Agreement Joint Committee was held on 30 March. Please find the government readout here, and a statement by the European Commission here. Support for the COVID-19 response – testing kits and services Please find forms for organisations that can manufacture and supply testing consumables, equipment and laboratory PPE as part of the coronavirus (COVID-19) response here.
Support for research NEW – On behalf of DHSC, the National Institute for Health Research (NIHR) is funding and helping to deliver a range of “rapid response” research to better understand and tackle COVID-19, including research into vaccines, treatments and diagnostic tests, and real-time collection of samples and data from people undergoing treatment in hospitals. Please find more information here. NEW – NIHR have launched a single point of entry for prioritisation of all COVID-19 related health and care research to connect researchers into an expedited regulatory approvals process which will run in parallel to prioritisation. Please find more information here. NEW – The Health Research authority have produced guidance for industry covering the COVID-19 outbreak, please find it here.
Regulations (Medical devices) NEW – On 3 April the European Commission adopted a proposal to postpone by one year the date of application of the Medical Devices Regulation to allow Member States, health institutions and economic operators to prioritise the fight against the COVID-19 pandemic. This decision takes into account the unprecedented challenges of the pandemic and the need for an increased availability of vitally important medical devices across the EU whilst continuing to ensure patient health and safety until the new legislation becomes applicable.
Workforce NEW – Please find COVID-19 frequently asked questions here that businesses might like to share with their employees. NEW – Temporary changes to Right to Work checks during the COVID-19 outbreak to make it easier for employers to carry them out. Until further notice, employers do not need to see original documents and can complete Right to Work checks over video calls. Please find more information here. NEW – Please find advice and information on how employees can look after their mental health and wellbeing during the COVID-19 outbreak here.
Support to business NEW – UKRI open call for research and innovation ideas to address COVID-19. UKRI are inviting proposals for projects of up to 18 months to address the health, social, economic and environmental impacts of the COVID-19 outbreak. Please find the criteria and further details here. NEW – Guidance for industry on exceptional good distribution practice (GDP) flexibilities for medicines during the COVID-19 outbreak can be found here. UPDATED – MHRA guidance for the pharmaceutical and healthcare industry covering the COVID-19 outbreak can be found here. UPDATED – please find a range of FAQ pages for businesses, employers and employees on the Business Support page here. NEW – Government amends insolvency law to help companies keep trading while they explore options for rescue. The plan includes: • • • •
A moratorium for companies, giving them breathing space from creditors enforcing their debts for a period of time whilst they seek a rescue or restructure Protection of their supplies to enable them to continue trading during the moratorium A new restructuring plan, binding creditors to that plan Key safeguards for creditors and suppliers to ensure they are paid
NEW – The government will also temporarily suspend the wrongful trading provisions to give company directors greater confidence to use their best endeavours to continue to trade during the pandemic, without the threat of personal liability, should the company ultimately
fall into insolvency. The proposals will also include key safeguards for creditors and suppliers to ensure they are paid. Find out more here. NEW – Government to ease administrative requirements and barriers to imports to ensure hand sanitiser and personal protective equipment (PPE) reaches NHS staff more quickly, without compromising on safety. By easing regulations, new suppliers and businesses that produce ingredients for hand sanitiser will be able to bring their products to market in a matter of days. Please find further information here. UPDATED – Guidance on the Coronavirus Job Retention Scheme has been published here. The government will now cover the employer national insurance and minimum autoenrolment pension scheme contributions employers pay on the wages they must pay their furloughed staff – on top of the wages covered under the scheme. Guidance for employers on the Coronavirus Job Retention Scheme can be found here whilst guidance for employees can be found here. NEW – Rules on carrying over annual leave to be relaxed. Workers who have not taken all of their statutory annual leave entitlement due to COVID-19 will now be able to carry it over into the next 2 leave years. Please find more information here. NEW – Exemptions from Devices regulations during the COVID-19 outbreak. Please find guidance on the fast-track approval of medical devices here. UPDATED – Following the coronavirus outbreak, the Intellectual Property Office have made a number of alterations to their services. This includes alterations to trademarks and designs, patents and interrupted days. UPDATED – Guidance on business support grant funding can be found here. NEW – Slides to accompany the 30 March COVID-19 press conference can be found here, the 31 March press conference here, the 1 April press conference here and the Business Secretary’s statement on COVID-19 here. NEW – Chancellor waives duties and VAT on vital medical imports including ventilators, COVID-19 testing kits and protective clothing. Find out more here. NEW – A notification to data controllers in healthcare organisations, GPs, local authorities and arm’s lengths bodies that they should share information to support efforts against COVID-19 can be found here. NEW – Guidance about moving goods through customs during the COVID-19 outbreak can be found here. NEW – Guidance about temporary changes to customs policy and authorisations to assist businesses during the COVID-19 outbreak can be found here. UPDATED – Guidance on the temporary changes to the use and supply of denatured alcohol and duty-free spirits, to help businesses who produce hand sanitiser and gel can be found here.
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. 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