Health and Safety – February 2020Print publication
New Medicines and Medical Devices Bill presented to Parliament; HSE news and sentencing round-up.
Health and Safety Executive (HSE) – news and sentencing round-up
The HSE is reminding employers that they must protect their workers’ health by controlling the risks from welding fume. The HSE is carrying out a programme of inspections following a safety alert issued in February 2019 after new evidence showed exposure to mild steel welding fume can cause cancer.
Saint-Gobain Construction Products UK Limited was fined £400,000 after an employee suffered life-changing injuries when a rock handling belt failed. The HSE investigation found no risk assessment or safe system of work in place for clearing rock safely from tail-end drums. The HSE inspector said: “This injury could easily have been prevented, had the risk been identified. Employers should make sure they properly assess and apply effective control measures to minimise the risk from dangerous parts of machinery”.
A waste management company was fined £140,000 after an agency worker was struck by a moving excavator and suffered lower leg amputation. The HSE investigation found no evidence of any system by which new agency hired staff were shown the site’s safety rules, meaning that the injured worker was unaware that he was to stand in the safe refuge areas while vehicles were moving around the site.
A car retailer was fined £120,000 after it failed to ensure adequate control measures were in place to minimise exposure to paints containing isocyanates, exposing an employee (who was a car bodywork sprayer) to the risk of asthma.
New Medicines and Medical Devices Bill introduced
A new Medicines and Medical Devices Bill 2019-21, sponsored by the Secretary of State for Health and Social Care, was introduced to the House of Commons on 13 February 2020.
As the explanatory notes set out, one of the things that the Bill does is introduce targeted delegated powers to enable the existing regulatory frameworks in the fields of human medicines, veterinary medicines and medical devices to be updated following the UK’s departure from the EU. After the end of the Brexit transition period, the current mechanism for updating these regulatory schemes will no longer be available and it would be necessary to enact primary legislation even in relation to minor updates. The Bill seeks to address this issue.
Medical devices are regulated in the UK by the Medical Devices Regulations 2002 (the Regulations). There are two new EU laws in this area, the EU Regulation on Medical Devices (MDR) and the EU Regulation on In Vitro Medical Devices (IVDR). The MDR covers all general medical devices, including active implantable devices. It will apply across the EU and in the UK from 26 May 2020. The IVDR will not fully apply until 26 May 2022, outside the Brexit transition period. The notes explain that the UK will therefore need to make its own decisions about the future regulation of in vitro medical devices.
The Bill seeks to consolidate the enforcement regime for medical devices, which is currently spread across a number of different pieces of legislation, creating uncertainty. The proposed new regime means that the powers to issue enforcement notices are contained solely in the Bill, and a bespoke criminal offence is created to clarify which contraventions of the Regulations could result in prosecutions. The explanatory notes stress that this does not criminalise new behaviour but for the most part reflects the existing position in a more transparent and focussed manner. The existing maximum penalties are retained.
There are also new powers to impose civil sanctions for breaches of the Regulations, as an alternative to criminal prosecution. The Secretary of State would have the power to impose monetary penalties and accept enforcement undertakings.
Finally, there are new powers for the Secretary of State to share information held about medical devices in limited circumstances, including in order to warn the public about safety concerns relating to a device.
The general principles and themes of the Bill will be debated at the next reading, on 2 March 2020.