Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
EMA Scales Back Medium-Priority Activities as Brexit Bites
The European Medicines Agency (EMA) has scaled back certain medium-priority activities to offset the effect of Brexit on its capacity. EMA is further pulling back from international collaborations and suspending certain types of meeting until at least 30 June.
EMA triggered the changes by initiating the third phase of its Brexit preparedness business continuity plan at the start of the month. The plan sets out how EMA will ensure it retains the capacity to carry out its core functions while contending with its relocation to Amsterdam and the likely loss of the support of the UK’s Medicines and Healthcare products Regulatory Agency. To achieve this goal, EMA is sacrificing activities outside its core functions.
The retreat from low-priority activities began in August. Now, EMA is stopping some medium-priority work. EMA has focused its cutbacks on tasks that occupy a large number of staff but do not directly and immediately affect its responsibility to ensure the safety, efficacy and quality of drugs and devices made and sold in the European Union.
That means EMA will largely limit its involvement in international initiatives to product-related requests, supply chain integrity and EUMed4all procedures. At the same time, EMA will stop work on the development of most guidelines. EMA is temporarily scaling back its interaction with stakeholders and suspending the activities of most working groups, too.
EMA published details of the changes alongside a document setting out the cut-off dates for the appointment of UK rapporteurs to pre- and post-authorization procedures involving centrally authorized products. The cut-off dates for certain pre-authorization procedures have already passed. The other cut-off dates run from now through mid-January.
Officials decided on the cut-off dates by subtracting the average durations of the procedures from 30 March, the day the UK is set to leave the EU.
, Brexit Plan
, Rapporteurship Update
Ireland Blames Brexit for Planned Jump in Regulatory Fees
Ireland’s Health Products Regulatory Authority (HPRA) is planning to raise the amounts it charges for human and veterinary regulatory services. HPRA cited the effect of Brexit on its work and finances to justify the first major increase to its fees since 2010.
Over the past eight years, HPRA has been able to significantly increase its headcount without raising the fees for regulatory services because of an agreement that kept wages down. However, with the wage reductions enacted by the agreement now being reversed, HPRA expects its payroll costs to rise sharply in 2019 and carry on that upward trajectory in the years the follow. In response, HPRA wants to raise its fees by 8%.
HPRA thinks the fee hike will help it to cope with the imminent rise in its costs at a time when its income is flat, at best. Over the first eight months of 2018, HPRA saw an 8% decline in incoming new applications compared to the prior year. HPRA also reported a significant increase in project withdrawals.
Exactly why new applications are going down while withdrawals go up is unclear. HPRA has a theory, though. The agency thinks “Brexit-related caution” could be behind the dip in incoming applications. HPRA thinks the withdrawal trend may stem from Brexit, too.
The theory is one of several ways in which HPRA links its current financial difficulties to Brexit.
“The impact of Brexit is twofold,” HPRA wrote. “In 2018 and into 2019 we will have significant numbers of staff working on Brexit and its impact for the Irish market to process additional regulatory procedures mandated by changes in registered MAH’s or supply chain elements due to Brexit. In addition we have committed to take on any of the work currently carried out by the UK. This will impact on the mix of work HPRA undertakes.”
The change in mix predicted by HPRA is expected to see the agency take on far more work it classes as “outgoing.” HPRA has historically performed little such work and, in its view, charges “modest” fees for it compared to other member states. This is set to change. HPRA called its current fees “unsustainable,” adding that they fail to cover the time or cost of providing the services.
HPRA’s broad response to the financial situation is to raise fees by 8%. The agency also wants to take some more targeted actions. Fees for all types of national, decentralized and mutual recognition applications are set to increase sharply. For example, HPRA plans to hike the fee for reduced dossier standard applications by 28%. The agency wants to raise other application fees by similar amounts.
Other fees will increase even more. HPRA is proposing to quadruple the cost of making clinical trial amendments. The agency pointed to the complex amendments now made by some trials, particularly basket studies of cancer drugs, to justify the increase.
HPRA is seeking feedback on the fee increases until the end of the month.
, Veterinary Consultation
PRAC Calls for Limits on Use of Antibiotics Following Public Hearing
EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommending restricting the use of the fluoroquinolone and quinolone classes of antibiotics. PRAC reached its decision after a review process that featured its second public hearing on the risks and benefits of drugs.
Patients who attended the public hearing told PRAC of the adverse events they suffered after taking the antibiotics and how they felt dismissed when they told the medical community of their suffering.
The statements made at the public hearing factored into PRAC’s conclusion that the antibiotics can, in a very small number of cases, cause disabling, long-lasting side effects related to muscles, tendons, bones and the nervous system.
PRAC responded to its conclusion by proposing to withdraw all products that contain quinolone from the market. The committee wants to restrict use of fluoroquinolone, too. If PRAC’s recommendations come into force, fluoroquinolone products will not be used in a range of circumstances, including the treatment of any infection that may get better without treatment.
The committee made the recommendations at a meeting last week. PRAC also used the meeting to confirm its earlier, precautionary advice on the use of HIV drug dolutegravir in pregnant women.
HPRA Clarifies Stance on Multilingual Packaging Requirements
Ireland’s HPRA has revised its guide to human medicine labels and leaflets. Most of the changes to the 2017 version of the guide relate to the use of multilingual packaging in Ireland.
Multilingual text is permitted by European law and, with its new guide, HPRA is actively encouraging companies to take advantage of this flexibility if sticking to single-country packaging would threaten the availability of their products in Ireland. To ensure the availability of products, HPRA is willing to be flexible about some of the issues that crop up when multilingual packaging is used.
HPRA lists examples of when it will be flexible in the new guide. The examples relate to differences in conventions in Ireland and other parts of the EU. For example, HPRA will accept labels and leaflets that write milliliter as “ml,” not its preferred “mL.”
The Dutch Medicines Evaluation Board
(MEB) has published information about the shelf lives of products that come in resealable packaging. MEB Notice