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Regulatory Focus™ > News Articles > 7 > EU Regulatory Roundup: Brexit Forces EMA to Halt Product Information Improvement Plan

EU Regulatory Roundup: Brexit Forces EMA to Halt Product Information Improvement Plan

Posted 05 July 2018 | By Nick Paul Taylor 

EU Regulatory Roundup: Brexit Forces EMA to Halt Product Information Improvement Plan

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
Brexit Forces EMA to Halt Product Information Improvement Plan
The European Medicines Agency (EMA) has hit pause on plans to improve product information after assessing the capacity constraints imposed by Brexit. EMA had hoped to spend the next two years implementing the plan, but will now hold off on starting most of the work until at least 2020.
European officials began formally assessing the shortcomings of package leaflets and the summary of product characteristics years before the United Kingdom voted for Brexit. The product information initiative continued after the vote, leading to the publication of an action plan by EMA in November. The plan detailed what EMA would do over the following two years to improve product information but was made without taking the impact of Brexit into account.
Since then, EMA has factored Brexit and the associated business continuity plan (BCP) into its resourcing projections. That led the agency to decide to delay most aspects of the plan. EMA will still work on actions related to electronic product information in 2018 and 2019, but everything else is on hold.
The decision means it will be 2020 or later by the time EMA starts improving the readability of product information, sharing best practices with industry and gathering more input from patients. Until then, EMA will persist with product information the European Commission called “too complex” and “not always user friendly” in a 2017 assessment. A report ordered by the Commission found the shortcomings could lead to non-adherence and patient distrust of medicines.
While those shortcomings will remain in place until the sometime after 2020, EMA has the means to start to address the parts of its plan related to electronic product information formats. EMA wants to explore the use of electronic media to communicate product information and plans to hold a multi-stakeholder workshop in the third quarter to discuss the implications of this idea. After the workshop, EMA will develop key principles for electronic product information.
The agency disclosed details of the delayed start to its product information plan in its 2017 report on stakeholder engagement. EMA engaged in more activities in 2017 involving patients and healthcare professionals than in the preceding year, but nonetheless felt the impact of Brexit.
“Despite the limitations imposed by Brexit preparedness and BCP, ... the agency has continued to experience some benefit from the input of patients and healthcare professionals into its activities,” EMA wrote in the report.
Annual Report
UK Watchdog Plots Appeal Against Overturning of $110M Pfizer Fine
The UK Competition and Markets Authority (CMA) is planning to appeal the overturning of a $110 million fine it imposed on Pfizer over the pricing of an epilepsy drug. Pfizer successfully appealed the fine last month, but may now face another legal tussle with CMA.
CMA said it was considering appealing when the Pfizer fine was overturned last month, and this week firmed up its plans. The UK watchdog is seeking permission from the Competition Appeal Tribunal to fight the ruling against its $110 million infringement decision. If the request is granted, the Court of Appeal — the second highest court in the UK — will hear the case.
The difference of opinion between CMA and the Tribunal centers on the watchdog’s application of a legal test for assessing whether a price is unfair. The Tribunal agreed with much of CMA’s decision but felt it failed to apply the legal test correctly. That ruling could allow Pfizer to escape a big fine.
CMA imposed the fine on Pfizer over the pricing of phenytoin sodium, a drug used in the treatment of seizures. Pfizer sold the rights to phenytoin sodium to Flynn Pharma in an agreement that saw it continue to make the drug for its new partner. Flynn promptly increased the price of the drug by 2,600%, causing NHS expenditure on the product to rise by a similar amount.
CMA concluded the actions represented the abuse of a dominant market position and issued fines that reflected this position. Given CMA is currently running several investigations into drug pricing, the appeals court’s views on whether the watchdog or Tribunal is right will have effects beyond Pfizer.
CMA Update
MHRA Extends Transition to Online Medical Device Regulatory Service
The Medicines and Healthcare products Regulatory Agency (MHRA) has extended the transition to its online medical device regulatory service. MHRA had hoped to move users over to the new system by March, but now thinks it will need until the end of the year to complete the transition.
Officials at the UK agency began moving companies across to the new online accounts late last year. As of mid-January, MHRA thought it would need another six weeks to finish the move. Now, MHRA has pushed back the deadline by nine months. MHRA is yet to provide an explanation for the major delay to the rollout of the service.
MHRA is moving to the system to give medical device companies a single online account for all their interactions with the agency. Companies can use the account and associated online portal to access services related to device registration and certificates of free sale.
The agency is moving companies that use these services across to the new system in batches.
MHRA Notice
EMA Stops Processing ex-EU Document Access Requests Amid Resourcing Pressures
EMA has stopped accepting requests to access documents sent from outside the European Union. The agency took the action after the volume of ex-EU requests threatened to jeopardize its core tasks and performance.
Previously, EMA granted anyone access to its business-related documents, provided the release of the materials did not have implications for privacy or the agency’s arrangements with international groups. However, facing a “high volume” of requests from outside the EU, EMA has now limited the right to access documents to EU citizens and organizations with a registered office in the region.
EMA thinks freeing itself from the “excessive workload” created by ex-EU requests will ensure it can properly perform its core business tasks. The brief notice disclosing the policy change does not cite Brexit, but given the effect of the UK-EU split on EMA resources it may be a contributing factor.
EMA Notice
EMA Starts Tendering for Services to Support its Work in Amsterdam
EMA has begun tendering for services to support its work once it moves to Amsterdam. The request for courier services marks the first time EMA has formally tendered for work centered on its new site in the Netherlands.
Officials are offering a contract worth around $290,000 to a courier that can ship consignments from Amsterdam to locations around the world, and bring packages to its Dutch headquarters. The courier will also ship materials from EMA’s current home in the UK to its new base. As many of the materials are scientific documents, EMA is prioritizing the security and speed of the courier service.
The contract is the first Amsterdam-focused notice posted by EMA on the EU’s tendering platform, but preparations have already begun to advance elsewhere. Last month, EMA indicated its intent to procure Dutch employment law services. Prior to that, a pan-agency request for journal access and a Dutch construction contract published on the tendering platform referenced EMA’s Amsterdam base.
Contract Notice

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