EU Regulatory Roundup: EMA Set to Restart Activities Despite Brexit Impact on Staff Numbers

RoundupsRoundups | 13 February 2020 |  By 

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
EMA Set to Restart Activities Despite Brexit Impact on Staff Numbers
The European Medicines Agency (EMA) is preparing to restart activities it paused as part of its move from London to Amsterdam. However, with EMA suffering the highest rate of staff turnover in its history, the work will be spread across a smaller number of employees than in the past.
EMA still expects to lose up to 25% of the 901 staff it employed at the end of 2018. More than 70% of the departures have involved people who worked on EMA’s most critical tasks. In many cases, the people have resigned. EMA has also lost “a large number” of staff on short-term contracts, putting the “continuity of operations under significant pressure,” according to the agency.
Based on its hiring and retention plans, EMA expects staff numbers to grow in 2020. EMA is unsure of how quickly its headcount will grow, in part because, “There is still uncertainty as to the impact of the end of the staff retention measures that are in place until 30 June 2020.”
Whatever the impact of those measures, EMA expects headcount to remain below the level it was at before the agency began its Brexit preparations in 2016. Despite that, EMA plans to relaunch the activities it suspended during its move to Amsterdam.
EMA will need to manage the work with a reduced headcount while also handling tasks necessitated by Brexit. For example, EMA’s work plan for 2020 includes the creation of guidance documents to help the pharmaceutical industry manage the impact of Brexit on marketing authorizations. EMA thinks Brexit-related tasks will occupy 10 full-time equivalents in 2020.
The agency expects the amount of time it spends on Brexit-related tasks to fall beyond 2020, which it wants to make the final year of transition. EMA has already identified some of the tasks, such as work on good manufacturing practices, that will take up its time beyond 2020.
EMA Report
Ireland Sets Timeline for Phased Enforcement of Falsified Medicine Safety Features
Ireland has laid out the timeline for the phased end to the “use and learn” stage of the introduction of the safety features mandated by the Falsified Medicines Directive. The staggered process is set to start in March with the full enforcement of the safety features rules on primary wholesalers.
In Ireland, as in other parts of the European Union, the safety feature requirements came into effect in February 2019. However, Ireland opted against taking a hard line on enforcing the rules from day one, choosing instead to see the first few months as a chance for everyone to get used to the system and iron out any bugs.
That process took longer than expected, leading to repeated extensions to the use and learn phase, but Ireland’s Health Products Regulatory Authority (HPRA) has now published concrete plans for the transition to full enforcement.
Parallel imported and distributed medicines and products handled by primary wholesalers are set to become the first drugs subject to the fully enforced rules. The use and learn phase for those products will end on 2 March. From then on, primary wholesalers will need to quarantine packs that trigger alerts and ask the marketing authorization holder to investigate the issue.
HPRA has confirmed 2 March as the start of the staggered end of the use and learn phase, but it is yet to firm up dates for the next steps. The current plan is to start enforcing the rules on all wholesalers in May. That will leave pharmacies, hospitals and other groups that supply medicines to the public as the only organizations still in the use and learn phase. HPRA plans to end the use and learn phase for those groups in September, although it is yet to set exact dates beyond the first change in March.
The timeline is less ambitious than the one sketched out in October. Back then, HPRA outlined plans to begin the staggered cessation of the use and learn phase at the end of January, reflecting progress including a sharp decline in the alert rate.
HPRA Update
UK Rules out Including Drug Prices in Upcoming Free Trade Negotiations With US
The United Kingdom government has ruled out including drug pricing in upcoming negotiations of free trade deals.
With the UK keen to grow trade with the United States and other countries outside the European Union, thereby offsetting downsides from Brexit, there has been speculation that it will acquiesce to demands to change how it prices drugs. Doing so could help the UK get a more favorable trade deal, particularly with the US, but that route is also politically problematic.
Going into the recent election, Boris Johnson sought to neutralize the issue and, having gone on to win a big majority, his government has reiterated its opposition to including any parts of the National Health Service in the agreements it strikes with countries based outside the EU.
“The Government has been clear that when we are negotiating trade deals, the NHS will not be on the table. The price the NHS pays for drugs will not be on the table. The services the NHS provides will not be on the table. We will not agree measures which undermine the Government’s ability to deliver on our manifesto commitments to the NHS,” Elizabeth Truss, the secretary of state for international trade, told the House of Commons.
UK trade group ABPI responded to Truss’ statement, calling for the government to strike a deal with the US “that builds on our mutual strengths, so that we can better develop the treatments of the future together.”
Truss Statement, ABPI Response
Finnish Regulator Urges Manufacturers to Assess Impact of Coronavirus on Supply
The Finnish Medicines Agency (Fimea) has urged manufacturers to assess how coronavirus may hit their supply chains and inventory. Fimea wants companies that sell drugs in Finland to ensure their supply chains are resilient enough to withstand any disruption caused by the viral outbreak.
Given China’s major role in the global supply of intermediates and active pharmaceutical ingredients, the coronavirus outbreak has the potential to cause drug shortages and drive up prices. Fimea wants companies active in Finland to assess whether their products are vulnerable to that threat and, if so, take actions including stockpiling and the identification of alternative sources of materials.
Such actions could enhance precautions built into the law in Finland, where pharmaceutical companies and other stakeholders are required to keep medicine stocks above a certain level. The law insulates Finland somewhat from short-term supply disruptions.  
Fimea Statement (Finnish)
UK Competition Watchdog Merges Investigations Into Hydrocortisone Pricing
The UK Competition and Markets Authority (CMA) has combined three previously separate investigations into the alleged unfair pricing of hydrocortisone.
CMA accused Actavis of breaching UK and EU competition law late in 2016 and, following another investigation, leveled the same allegation against Concordia the next year. The allegations against Concordia also involved Actavis, which CMA accused of offering incentives to stop a potential rival from entering the market. CMA made a third set of allegations against Auden Mckenzie and Waymade last year.
Now, CMA has merged the cases in light of the “interrelationship of the facts and allegations in the three hydrocortisone investigations.” The action follows the assessment of new evidence.
CMA Statement


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