An opinion by Jolyon Gumbrell.
The CE label that appears on many products shows that a product complies with EU health, safety and environmental standards. Although the United Kingdom left the EU on 31st January 2020 these standards still apply to products sold in the UK until the end of the transition period on 31st December 2020. After that date UK consumers will no longer be protected by European health, safety and environmental standards, unless these protections are written into a future trade agreement between the EU and the UK.
Why is this important? Because once the transition period for the UK ends at the end of 2020, items such as “active implantable medical devices” and “invito diagnostic medical devices” as well as other “medical devices” used by the NHS might be below standard, and thus endanger the lives of patients in the UK. This situation will be exasperated by the Covid-19 pandemic.
Concern has already been shown over the accuracy of 90-minute rapid coronavirus tests procured by the UK Government. In an article by Sarah Boseley published in The Guardian on 8th August 2020 entitled: ‘UK’s rapid Covid-19 test not passed by regulator and no data on accuracy’, it said: “The test, from Oxford Nanopore, a young biotech company spun off from Oxford University, has not yet gained a CE mark. Before Covid-19, Oxford Nanopore had been involved only in research, not tests for patients.”
The article went on to mention another company DnaNudge that was granted an “emergency exemption by the Medicines and Healthcare Products Regulatory Agency” from having to display the CE mark. According to the article DnaNudge was awarded a £3.2 million contract in April and a £161 million contract on 1st July from the government. If either of these – Oxford Nanopore and DnaNudge – testing systems were unreliable, then it could mean that some people would receive the wrong results for their Covid-19 tests.
What will happen to the people of the UK when they finally lose the protection of European law on 31st December 2020? One of the consequences of this will be the loss of the CE mark for consumer products sold in the UK, so the British public will no longer know how safe or reliable a product – such as an plug on an electrical device, a kettle, light bulb, laptop, mobile phone, or child’s toy – is, that they are purchasing from a retailer or online supplier.
The CE mark does not mean that a product has been manufactured within the European Economic Area (EEA). An electrical device could have been made in China for example and still display a CE label, but when the product was imported into Europe it would have had the CE marking placed on it by the manufacturer’s authorised representative in Europe. The product would have had to comply with European health, safety, and environmental standards before it could legally be distributed for sale to consumers living in the EEA area.
If high standards of protection are to be maintained for consumers living in the UK next year, then the UK will either have to stay in the EEA along with EU and EFTA member states or come to a bilateral relationship with the EU similar to that of Switzerland. Either way no trade deal will take place between the UK and EU unless the UK Government accepts these high standards as recognised with the CE mark.
Boseley, Sarah; (08.08.2020) ‘UK’s rapid Covid-19 test not passed by regulator and no data on accuracy’ The Guardian.
©Jolyon Gumbrell 2020COMMENT