The life sciences sector fears the potential consequences of the United Kingdom exiting the European Union without an agreement. Is their anxiety justified?
As we recently wrote, the consequences of a “no-deal” or “hard” Brexit could be apocalyptic for the life sciences sector, with shortages of vital medicines, shortages of devices to administer the vital medicines, and shortages of trained personnel to operate the devices that administer the vital medicines being just the tip of the iceberg reported on in the government’s “Yellowhammer” document that was leaked in September.
In what could be seen as an effort to counterbalance Yellowhammer, on October 8 the government published a 159-page “No Deal Readiness” report that puts an optimistic spin on the prospect of a “hard” Brexit, setting out tariffs and extra administration costs for importing and exporting goods, clarifying changes to data protection laws, and laying out exactly what Britons who insist on travelling to the EU on holiday can expect. Fortunately, the report has plenty to say regarding the life sciences sector as well.
Not if, but when
The explicitly stated position of the Yellowhammer report was that medical supply chains would be “particularly vulnerable” to disruption at Channel ports after October 31. The document also noted that not all supplies can be stockpiled, meaning there could be delays of up to six months. The new report claims that extra freight capacity and stockpiling will mitigate the chaos, but still talks about disruptions as a fait accompli.
The report also takes care to note that the UK will no longer be part of the European medicines regulatory network and states that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) will take over its functions. The report goes on to state that “the Government has put processes in place to support the timely availability of new medicines for patients in the UK” but doesn’t provide much detail on those processes. Furthermore, the burden of confirming import licenses and ensuring legal presence requirements is placed squarely on pharmaceutical manufacturers themselves.
Left to their own devices
The MHRA will also take on the responsibilities for the UK market currently undertaken through the EU system regarding medical devices, as the UK will no longer be part of the European regulatory network. The UK government will continue to recognize CE-marked medical devices that are approved for the EU market, but manufacturers will need to bear the burden of regulatory compliance when placing medical devices on UK or EU markets.
Manufacturers that want to place a medical device on the EU market will also need to manage the following:
- Have a valid CE certificate in place and apply for transfer to the EU/EEA notified body accredited to assess the device
- Establish an authorized representative within an EU member state and register with the national competent authority
- Make sure all associated documentation is up to date and make all necessary labelling changes to products
Hope for the best, prepare for the worst
The question remains – is a “hard” Brexit going to look like the nightmare envisioned in the Yellowhammer document, or is the rosier scenario painted by the new report more likely? Nobody will know until the UK finally makes its grand exit, but we’d advise staying on your toes and being prepared for any possible scenario. Argos Multilingual has a solid track record of guiding our customers through complex regulatory changes. For more information about how we can help you keep your business compliant in the EU, get in touch with us.