Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
UK Tasks ex-GSK CEO With Highlighting Drugs Eligible for Accelerated Access Pathway
The UK has tasked former GlaxoSmithKline CEO Sir Andrew Witty with highlighting products suitable for its incoming accelerated access pathway (AAP). Products that follow AAP will benefit from support with evidence generation and a more seamless journey to market, features the government thinks could shave four years off timelines.
Witty’s role in the process is to chair the Accelerated Access Collaborative (AAC), the group that will decide which drugs and medical technologies will get the special treatment. The decision will ultimately be made by the organizations responsible for regulating, evaluating and delivering new products, including the UK Medicines and Healthcare products Regulatory Agency (MHRA) and National Institute for Health and Care Excellence.
As the independent chair of AAC, Witty will work with representatives of these organizations and gather input from patients, clinicians and the industry. The government will provide more details of the membership of AAC soon, with a view to having the group in place by the end of the year. That timeline will set AAC up to identify the first batch of products for when AAP goes live in April.
The pathway’s go-live date will mark the culmination of several years of thinking inside and outside government about how to use the UK’s healthcare infrastructure to support innovation and save the country money. George Freeman, then the UK life sciences minister, got the process started in 2014 by proposing to use the NHS’ cradle-to-grave data and ability to generate real-world evidence to help industry, turning the healthcare infrastructure from a cost into an asset.
AAP has echoes of this thinking.
“Each breakthrough product will benefit from bespoke case management, which will coordinate across partners to streamline the journey. In return for these commercial benefits, we expect industry to come forward with a cost proposition that delivers additional value for patients and the NHS beyond that achieved under the current system, and is affordable,” the government wrote in its endorsement of the Accelerated Access Review.
The government sees AAP generating real-world evidence, in addition to clinical trials data, and cutting the gap between market authorization and patient use. If the pathway works as hoped, the government thinks it could knock four years off the time it takes products to reach patients. That prediction is based on the government-commissioned review that spawned AAP. The authors of the review noted scientific opinions from the early access to medicines scheme can save up to 18 months, while technology appraisals and NHS commissioning each take about two years.
Officials expect something in return for generating these savings for companies. The government expects accelerated access to be “cost neutral” to the NHS. Some products can add to NHS costs, but these outlays must be offset by savings from some of the other five or so drugs and devices the government plans to add to the pathway each year. Officials are creating a Strategic Commercial Unit within the NHS to negotiate “cost-effective deals.”
The question now is whether the pathway will find favor with industry and deliver on its promises. One of AAC’s jobs is to monitor performance against a range of yardsticks, such as industry interest, speed of progression through AAP and health outcomes.
Press Release, Government Statement
EMA Prepares for 17-Month Race to Move from London to New Home
The European Medicines Agency (EMA) has outlined what it will take to complete its relocation to its new home by March 2019. EMA will have 17 months to relocate, a timeline it thinks will force it, other European institutions and the host country to deviate from standard processes.
Officials at the regulator think some processes will need to be accelerated or run in parallel if it is to be in its new home and ready to start work on the day the UK leaves the European Union.
That warning is based on predictions of how long certain steps will take. Typically, it takes six to eight months for local authorities, EMA’s management board and the EU budgetary authority to sign off on building plans. EMA expects to spend 12 to 15 months fitting out the building to its specifications. Performed in sequence, those steps will take longer than the 17 months EMA has to relocate, hence the call for truncated timelines and parallel processing.
The challenge of getting the building ready is magnified by the other tasks EMA and the host city need to work on in parallel. EMA’s statement about its preparations highlights the need to arrange accommodation for its staff and schools for their children. The agency wants the host city to share information about school places available for around 600 children by February. EMA has given the host the same deadline for providing information on “affordable, good quality housing for up to 900 new households.”
EMA is prioritizing the delivery of this information so its staff members have time to get their children into schools suited to their language skills in time for the 2018/2019 academic year. Failure to reassure staff early in the process that suitable accommodation and schools await them in the new host city could cut the proportion of employees who relocate with EMA, leading to the major problems the agency sketched out in a report earlier this year.
Parallel Importer Suspended After Failing to Meet Quality Standards
The Danish Medicines Agency (DKMA) has temporarily banned Europharma from manufacturing activities by suspending its license. DKMA took the action against the repackager of parallel imports over its continuing failure to comply with good practices.
Europharma found itself in the regulatory crosshairs at the start of the year after inspectors found fault with its operation. The repackager had prepared a plan to fix the problems by the time inspectors visited again in March, prompting DKMA to allow it to continue operating.
However, an inspection in September found Europharma had failed to improve significantly in the intervening months. In response, DKMA has suspended the company’s license. DKMA expects the action to be temporary, but will only lift it once Europharma has upgraded its quality department and enacted improvements to address the previously identified deviations.
If inspectors find Europharma has taken these actions, DKMA will lift the suspension.
DKMA Notice (Danish)
Danish Regulator Hires Pharmacovigilance Leader From Celgene
DKMA has named a Celgene employee as the director of its pharmacovigilance and medical device unit. Jens Piero Quartarolo will leave his post as senior director, medical affairs at Celgene to join the Danish regulator at the start of next year.
Thomas Senderovitz, director general of DKMA, talked up Quartarolo’s “international experience” in a statement to disclose his appointment. Quartarolo joins DKMA at a time when the regulator is seeking to position itself as a top-tier regulatory agency that can take on some of the EMA work currently performed by MHRA.
Quartarolo comes to DKMA following a career in large biotech and pharmaceutical companies. Prior to joining Celgene in 2015, Quartarolo spent seven years at Abbott Laboratories and its spinoff AbbVie. Quartarolo also worked at Merck and Schering-Plough earlier in his career.
Health charity The Nuffield Trust has warned a no-deal Brexit would risk “chaotic disruption” to drug supply in the UK. Report