EU Regulatory Roundup: Trade Group Warns Preparing UK for October No-Deal Brexit is ‘Impossible’
Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.Trade Group Warns Preparing UK for October No-Deal Brexit is ‘Impossible’
A biopharma trade group has warned it will be “impossible” to prepare the UK medicine supply chain to withstand the impact of a no-deal Brexit by October. The warning comes as the leading candidate to take over as Prime Minister committed to take the UK out of the EU on 31 October, “do or die, come what may.”
The inability of Theresa May to get the EU withdrawal deal past the UK parliament led her to resign from the position of prime minister last month, triggering a race to replace her. Boris Johnson, the strong favorite to win the race, has won over the Eurosceptic wing of his party by promising the UK will leave the EU when the extension secured by May comes to an end. Johnson is challenging his one remaining competitor for the prime minister job to make the same promise.
In light of the tone of the leadership race, the parliamentary committee monitoring the UK’s split from the EU discussed the potential impact of a no-deal Brexit with representatives of the medicine manufacturing and distribution industries.
Steve Bates, CEO of the UK BioIndustry Association, outlined the multi-step, cross-border process of manufacturing drugs, explaining that making changes to the system at speed is “very, very difficult” as it involves “factories which are regulated by international regulators.” Bates is highly pessimistic about the likelihood of the industry being able to make the required changes by 31 October.
“The idea that the new things can be done in the timeframes we are looking at is impossible. Building a regulated manufacturing process ... takes years. We’re looking at 130-odd days to the October deadline. Moving things at that pace is undoable,” Bates said.
Bates and other representatives of the biopharma industry have made similar warnings in the past. Yet, many politicians and members of the public continue to see a no-deal Brexit as a viable, and in some cases desirable, option. If those voices get their way, medicine distributors and wholesalers anticipate negative outcomes for patients.
“We would expect medicine shortages and a lot of price rises for the NHS to happen pretty quickly. If we don’t get the product into the UK in the first place, then we’ve only got about two weeks stock in the wholesale sector,” Martin Sawer said. Sawer is executive director of the Healthcare Distributors Association, a group that represents wholesalers and distributors with 54 warehouses around the UK.
The government’s position in the run up to the original date of a potential no-deal Brexit was that drug supplies would continue as normal if everyone did what they were supposed to do. The industry was less optimistic, although both Bates and Sawer praised the preparations of public bodies for a no-deal exit.
“I can’t criticize the preparation that the department has done. The Department of Health and the NHS have done fantastic planning. We’ve been talking to them for a year, almost on a weekly basis,” Sawer said.
Meeting Replay
EU Extends Deadline for EMA Executive Director Job Applications Again
The European Commission has extended the deadline for applications for the upcoming executive director job vacancy at the European Medicines Agency (EMA) for a second time.
When the Commission began recruiting for a new EMA executive director on 14 May, it set a 13 June deadline for applications. That deadline was subsequently extended by one week and has now been pushed back again.
The Commission is now accepting applications until midday Central European Time on 4 July, more than 20 days after the original deadline. As in the past, EMA warned that the Commission will not accept applications submitted after the deadline.
Despite the delay, the Commission still has a lot of time to complete the recruitment process. EMA’s current executive director, Guido Rasi, will complete his second five-year term on 15 November 2020. The Commission began the hiring process 18 months before Rasi’s departure “to enable a seamless transition between the current and future jobholder.”
Whoever replaces Rasi will need a rare set of knowledge and skills. The Commission is looking for a leader who has characteristics including proven experience in budgetary, financial and human resources management, a solid track record in international negotiations and a good understanding of the operation and interaction of European institutions.
EMA Notice, Vacancy Notice
EMA Sets Temporary Acceptable Intakes for Impurities in Sartan Medicines
EMA has set temporary acceptable intake levels for more impurities found in sartan blood pressure medicines.
The agency’s Safety Working Party (SWP) calculated limits by analyzing the available experimental toxicology data on the impurities. As previously disclosed, SWP thinks the acceptable daily intakes of N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) are 96.0 ng and 26.5 ng, respectively. The figures are derived from results from carcinogenicity studies in rats
SWP looked at potential contamination with other N-nitrosamines that can emerge under certain conditions, but its work was hindered by a lack of data. The EMA group found no data on one of the contaminants and deemed the information on another two impurities to be insufficient, preventing it from calculating acceptable intake levels. SWP’s sole conclusion is that the two impurities are potent carcinogens in rats.
Following guidance set out in ICH M7, SWP sought to fill in the gaps in the data by looking at results from closely related structures. That led SWP to conclude that data on NDMA and NDEA can be used to derive acceptable intake levels for the three other contaminants. SWP used the methodology to generate a table of data on the acceptable intake levels of the other three impurities.
The publication of the limits means EMA now has caps on five sartan impurities. EMA has given companies two years to transition to new manufacturing processes and testing regimes that stop contamination, beyond which it will lower the acceptable level of the contaminants.
EMA Notice
Spain Orders Withdrawal of Homeopathic Medicines Amid Regulatory Changes
The Spanish Agency of Medicines and Medical Devices (AEMPS) has ordered the withdrawal of 66 homeopathic products. AEMPS ordered the withdrawal because the manufacturers failed to present the documentation required for authorization.
Last year, Spain adopted minimum requirements for homeopathic products and a related procedure. The changes to the regulation required manufacturers to submit documents to support evaluation of their products by AEMPS. Manufacturers of 66 products failed to comply with the request, leading AEMPS to order their withdrawal.
AEMPS is continuing to assess whether the evidence supports keeping other homeopathic products on the market.
AEMPS Notice (Spanish)
Other News:
The Committee for Medicinal Products for Veterinary Use (CVMP) has elected Gerrit Johan Schefferlie as vice chair. Schefferlie will serve a three-year term. CVMP disclosed the news at a meeting at which it adopted positive opinions on several veterinary medicines and finished a review into a product used in sheep, concluding changes are needed to assure consumer safety. CVMP Notice
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has added a request form to its guidance on how to apply to run a clinical trial. The form is designed to help sponsors understand whether a proposed study comes under the scope of clinical trial regulations. MHRA Notice