After the post-Brexit transition period ended at the start of 2021, the new trading environment has brought major implications for many sectors, one being the medical devices market. Medical products developer pfm medical originally hails from Cologne, Germany, but has prided itself on operating internationally for decades. Its UK arm was established in 2007 and offers an end-to-end solution for clients as a developer, manufacturer, and distributor of medical devices.
According to UK managing director, Gemma Borgert, the new market conditions have affected the sector drastically by bringing rising costs and timescale pressures, all of which will have a detrimental knock-on effect running down to the NHS and its patients.
How has this happened?
The UK government ruled that once Brexit was fully enacted at the beginning of this year; the EU standard CE mark would be replaced by the new UKCA product mark.
The new UKCA mark since January 2021 has become the recognised UK standard product mark for certain goods, including medical devices. Essentially, if any business wishes to place a product on the British market that these rules apply to, it must bear the UKCA mark to be legally tradeable.
From a practical perspective, compliance with these new trading rules has brought major challenges for medical device distributors such as pfm medical, along with various other entities wishing to market their product in Great Britain.
As well as having to abide by the new UKCA marking regulations, businesses are also feeling the effects of increased costs around imports, with new tariffs and rules now applying and a significant amount of paperwork required to be completed in order to bring materials into the UK.
The first impact all of this has on the market is rising cost for business which force cutbacks, as Borgert elaborates.
She tells The Leaders Council: “The increased costs around importing actually equal the planned annual salary for a marketing manager within our business. As a result, we have had to cancel a vacancy for a marketing manager that we had been advertising. To import, we have to plan ahead of time and complete a lot more paperwork which means increased expenditure in terms of financial and human capital.
“With supply and demand still very much uncertain, not just because of the trading environment but also the after-effects of Covid, we have had to double our warehouse space to accommodate. We also have to be mindful of keeping a stock of market products specifically intended for the UK that bear the UKCA mark.
“Since we sell internationally, we need our products to bear the CE mark and the UKCA mark, too. This means that we have to re-register all our products into the UK system so that they can be sold here, and this is an expensive and arduous process. We have had to spend more money as a global business deploying regulatory teams in our manufacturing supply chain and back at the premises of our European parent company.
“With more resources being spent on storage space and compliance in terms of labour, time and finance, this has a major impact on our bottom line, meaning we have to cut back on operating costs and reduce our marketing budget to balance the books.”
In the eyes of Borgert and many more industry operators, however, the additional cost and expenditure around compliance brings no benefit for manufacturers, clinicians, or patients. Instead, she adds, it leads to a domino effect that could spiral to the extent of hampering patient outcomes from 2023.
The 2023 ‘cliff edge’
Indeed, 2023 poses something of a cliff edge for businesses. The government has announced a grace period, with the CE mark continuing to be recognised in the UK until June 30, 2023. However, from July 1 that year, the UKCA mark will be required on medical device product packaging across the board if that product is to be placed on the UK market. The UKCA mark will only be eligible in the UK: it is not recognised in the European Union [EU], European Economic Area [EEA] or Northern Ireland markets.
Borgert says: “The UKCA mark will be the only recognised standard in this country by 2023. The requirements any market operator must meet to achieve this are enormous. Every device, every consumable and every last bit of medication must bear the UKCA mark on its packaging. Given that it is only recognised in our country, global suppliers need to change their packaging just for our market. The costs for regulatory compliance are so significant and yet it seems the government are doing this for the sake of it. EU standards are in no way inferior to our own and were used in this country for years before now.
“My worry is the effect this will have not just on medical device suppliers, but also the NHS and patients. Some suppliers have already pulled out of the UK market because the regulatory requirements are not commercially viable. They cannot absorb the costs of the extra time, labour and finance around compliance, and with companies leaving the market because of this, we could find ourselves priced out of some of the latest innovations entirely of our own accord.”
No pros, all cons
With less competition and less innovation in the market, Borgert explains that the consequence will be a lack of NHS access to the cutting-edge in medical technology, which will leave clinicians and patients worse off.
“After a while, clinicians are likely to become frustrated at the lack of access to the latest technologies. Not only will this mean patient treatments are not up to date, but if it persists, we could see an exodus of healthcare talent heading abroad where they’ll be able to access the latest in medicine. The NHS and patients could lose out on both skills and improved patient outcomes because of this.”
With time short until the UKCA regulations come into full force, Borgert is urging the government to reconsider its position and think again over the impact that the rules will have.
“I am angered by the lack of consideration for how the NHS and in the end, patients, will be adversely affected by this. However, the government is determined to go ahead with regulatory changes, seemingly for the sake of being able to say we have our own national standards.
“These rules do not bring any benefit to businesses, the market, the NHS, nor patients. Everyone’s life is harder and we’re all worse off for it. I would ask the government to review these plans as quickly as possible, because we are approaching a cliff edge and the long-term effects could be detrimental for our country at large.”
pfm medical is an internationally operating, medium-sized family company based in Germany, offering solutions in the field of healthcare. For over 40 years, the business has successfully developed, manufactured and distributed quality products, while simultaneously offering reliable services. Its focus is on therapeutic success to improve quality of life for patients, as well as offering the best possible working conditions for users in hospitals, practices, care facilities and laboratories.
pfm medical’s products, services, and treatment portfolio cover the medical focus fields of surgery, histotechnology, cardiovascular technologies and infusion. It consistently strives to develop the quality of its services in collaboration with leading medical practitioners and partners to offer flexible, individual solutions for the treatment of patients in hospital, rehabilitation facilities or outpatient care.
Further information on pfm medical can be found here.
Photo by Christian Lue on Unsplash
