Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
UK Sets up Logistics Hub in Belgium to Support Post-Brexit Drug Shipments
The United Kingdom has created a logistics hub and bought tickets from ferry operators to mitigate the risk that a no-deal Brexit will disrupt the supply of drugs and medical devices.
In the event of a no-deal Brexit, preferred shipping routes between Dover, Calais and other towns and cities located at narrow stretches of the English Channel may clog up, stopping supplies of drugs and medical devices from getting into the UK. That fear underpins the stockpiling effort underway in the UK but, as those supplies could run out in six weeks, the UK is also working to establish routes via which products can enter the country if the disruption drags on for months.
The extent of the preparations was laid out recently in a statement by Stephen Hammond, a minister in the Department of Health, and a letter obtained by UK health journal HSJ. Hammond revealed the UK has signed six-month deals with two ferry companies to ship products via some of the longer, less well-traveled nautical links between the UK and mainland Europe.
Through these deals, the government has acquired tickets from shipping freight operators covering a handful of routes between the UK and France and the Netherlands. The government plans to sell the tickets at market rate to companies that need to get drugs and medical devices into the country. The government is currently talking to the industry to gauge interest in the tickets. In parallel, officials are working with industry to ensure planes are contracted to fly in medical isotopes.
A letter from Steve Oldfield, chief commercial officer at the Department of Health & Social Care, to update suppliers on the government's contingency planning provides additional details of the ticketing scheme. The government will begin selling the tickets on 4 March and make more available on a rolling basis.
Companies need to register their interest in the service and buy tickets for the shipping routes in advance. The government is encouraging all suppliers that think they will need the capacity, as well as those that are unsure, to register as soon as possible to help with its contingency planning.
Oldfield outlined the registration process alongside information about the dedicated NHS shipment channel the government has set up. The channel will serve as a backup in the event the contingency measures taken by healthcare companies that operate just-in-time supply chains are disrupted. DHSC will control the supply chain and grant access to it based on the needs of the healthcare system.
Suppliers that use the channel will send products to a logistics hub created by DHSC in Belgium. The hub will then use the shipment channel to get products to sites in the UK, typically within three days of receiving supplies. Oldfield wants all suppliers with just-in-time supply chains to register for the dedicated shipment channel, using a different form than the ferry tickets, regardless of whether they think their internal contingency measures will be sufficient.
, Hammond Statement
EMA Offers Type I Advice Ahead of Forecast Jump in Brexit-Related Filings
The European Medicines Agency (EMA) has asked marketing authorization holders (MAHs) to submit Brexit-related Type IA and IB filings early next month. EMA made the request so it has enough time to process the submissions before the UK leaves the EU on 29 March.
As a result of Brexit, MAHs may need to change the sites responsible for batch release, importation and finished product batch control testing, as well as update CE marking documentation for devices co-packaged with medicinal products. EMA treats all these changes to marketing authorizations as minor, Type I variations.
If MAHs follow Type I variation checklists to ensure their filings are complete and submit requests early next month, EMA thinks it will be able to process the applications in time for companies to receive confirmation of compliance by 29 March.
The work could put strains on EMA, though. EMA expects the number of Type I variations it receives to increase by more than 50% over the next three months as companies file pending Brexit-related changes. The anticipated surge in Type I variations comes at a time when the agency is contending with disruption and staff losses as a result of its move to Amsterdam.
To help it manage the workload, EMA has asked MAHs not to include editorial changes in their Type IA and IB submissions over the next three months. The deferral of these non-urgent changes until after the Brexit rush is over may make it easier for EMA to handle the spike in variation filings.
NICE Rejects BioMarin Rare Disease Drug Amid Doubts About Long-Term Efficacy
The National Institute for Health and Care Excellence (NICE) has rejected BioMarin’s Batten disease drug Brineura (cerliponase alfa). NICE took the action after efforts to get BioMarin to price the drug at a level that would alleviate doubts about its long-term efficacy broke down.
Batten disease affects 30 to 50 children in the UK. These children lack treatments that address the underlying cause of the disease and typically die between 8 years of age and early adolescence.
In a 48-week clinical trial, Brineura stabilized the disease in two-thirds of patients, leading the NICE panel to conclude it has positive short-term effects on motor and language function. However, NICE also felt “assumptions about disease stabilization, and late stabilization in particular, were associated with substantial uncertainty” and adjusted its cost-effectiveness model accordingly,
With BioMarin pricing Brineura at £522,782 ($695,267) a year per person, the divergence between it and NICE’s assumptions about long-term efficacy were significant enough to cause the cost watchdog to doubt the value of the drug. NICE laid the blame for failing to clear the impasse at BioMarin’s door.
“We and NHS England have been very clear with the company about what would be needed in order for us to be able to recommend cerliponase alfa. However, despite being given ample opportunity to come up with a workable solution, regrettably the company has not been able to do so,” Meindert Boysen, director of the Centre for Health Technology Evaluation at NICE, said.
, Final Evaluation
Spain to Mandate Inclusion of Information in Braille for Some Animal Drugs From 2020
The Spanish Agency of Medicines and Medical Devices (AEMPS) has issued a circular about incoming Braille labeling requirements. AEMPS will require the labels of some drugs for companion animals to carry information in Braille starting next year.
As of 1 January, newly registered veterinary medicines that meet the criteria will need to use Braille. Any MAHs that make variations affecting the outer packaging of previously authorized medicines will also need to comply with the Braille rules starting next year. The final deadline for compliance by all companies is the start of 2022.
AEMPS detailed the timelines in a circular that also covered the minimum information MAHs need to communicate in Braille. The Braille requirement only applies to the name of the product, MAH and pharmaceutical form on the outer packaging of the product.
If the MAH is unable to fit the information on the outer packaging, even by using multiple surfaces, AEMPS may authorize the company to remove details of the pharmaceutical form and its name.