Pharma lawyers and industry groups have said the UK government’s publication of a series of planning papers on the impact of a “no-deal” Brexit on the sector is “good news” for companies that have long been demanding clarity on the possible repercussions of such a scenario, but have also noted the huge regulatory burden it will impose.
On 23 August, the government released 25 technical notices covering the impact of a no-deal Brexit on a range of sectors, including papers on medicine, medical device and clinical trial regulation; submitting regulatory information on medical products and batch testing.
“It is essential to any business to know what “plan B” will look like, namely in this instance, what would happen if no deal is reached by the two parties,” Sidley Austin partner Marie Manley told PLN: “but the position taken by the UK is also reassuring for patients and healthcare professionals in the UK who would not be faced with a shortage of supplies in the short term.”
Absent a deal with the EU, the first notice says, the UK will cease to participate in the European regulatory network for medicines approval, and the domestic Medicines and Healthcare products Regulatory Agency (MHRA) will take over the functions currently performed by the EU. This will require further changes to UK law, the government noted, and the MHRA is planning a series of public consultations in early autumn on some of the key proposed legislative changes, including those affecting orphan drugs and paediatric medicines.
While most of the medicines currently on the market in the UK have been specifically approved for use in the country and consequently won’t be affected by Brexit, new treatments usually come to market under a licensing programme overseen by the European Medicines Agency. With this in mind, the MHRA has pledged to convert EU centralised marketing authorisations into UK authorisations using a “grandfathering” process from March 2019.
The notice also commits the UK to recognising medical devices approved for the EU market and to complying with the Medical Devices Regulation and the in vitro diagnostic Regulations, which will apply in the EU from May 2020 and 2022 respectively. The UK’s 2004 clinical trials regulations, which implemented the EU’s 2001 Clinical Trials Directive, will remain in force with certain undisclosed modifications “to make sure they still work in the UK after exit”. The EU’s updated clinical trials rules meanwhile will not be incorporated into UK law, but the government has said it will align with the new rules where possible after they come into force “subject to usual parliamentary approvals.”
Exiting the EU regulatory network will also have the effect of ending the UK’s use of the common systems for submitting regulatory information that are in effect across the bloc and the wider European Economic Area. The second notice says the government will set up new portals to allow companies to submit information and applications directly to the MHRA, and notes that they will need to go through an entirely separate process for EU approval. To limit the administrative burden on companies, the government says it will continue to accept EU application forms and EU standards for submission.
The UK will also continue to accept batch testing of human medicines carried out in countries named on a list set out by the MHRA, including EU and EEA countries, as well as third countries with which the EU has mutual recognition agreements.
“The technical notices give pharmaceutical companies more clarity that in the event of 'no deal', the UK Government will take a pragmatic approach to the regulation of medicines by recognising and using medicines and vaccines which have been licensed and manufactured in the EU,” the Association of the British Pharmaceutical Industry said in a statement following the publication of the notices: “Companies can now focus on those medicines which have the most complex supply chains.”
Manley, however, noted that the UK still has “serious decisions” to make to ensure it remains an attractive place for pharma companies to do business. “Indeed, the UK is already a rather tough market for life sciences products since obtaining effective access to the market and therefore a positive opinion from NICE [the National Institute for Health and Care Excellence] is challenging,” she said. There was “serious concern” that, absent regulatory alignment with the EU, the UK would not be among the first round of countries where new products will be authorised but would fall behind the US, the EU, Japan and China; “this would not be good news for the patients in the UK.”
Lincoln Tsang of Arnold & Porter in London said the MHRA’s proposals to replicate certain existing EU frameworks in the UK “will demand additional resources and will certainly have cost implications”. He added that, with just six months to go until March 2019, time is short for the MHRA’s proposed public consultations and the full implementation of the EU regulatory framework, making it uncertain whether the proposals in the technical notices will be achievable.
He also pointed out that the EU has consistently indicated that the UK’s commitment to continue accepting batch testing from the continent will not be reciprocated, meaning “additional importation testing and certification will be performed for products exported from the UK into the EU even though the UK batch release certification scheme is firmly based on EU rules.”
Tsang also noted that, alongside the specific concerns of the pharma industry, the wider issue of customs and excise post-Brexit are still to be decided. “One should also bear in mind the broader tariffs implications for imported goods,” he said.
All parties, and indeed the technical papers themselves, agreed that it remained in the best interests of the UK and the EU to strike some kind of deal to avoid a so-called hard Brexit scenario in which the UK is forced to fall back on World Trade Organisation rules. “We need to be clear that a ‘no deal’ scenario is not in the interest of patients,” ABPI chief executive Mike Thompson said in a statement: “Both sides must rapidly agree the terms of the UK’s withdrawal and a future relationship based on cooperation to protect public health, control infectious diseases and manage medicine safety.”