RAPS recognizes that the current situation in Ukraine impacts our members and customers on many levels. If you are directly impacted by the current situation in the region and are challenged to meet your deadlines or obligations to RAPS, please reach out to raps@raps.org so that we can defer those challenges. Your health and safety are paramount to us.

Regulatory Focus™ > News Articles > 2020 > 1 > EU Regulatory Roundup: Pharmacists in 87% of EU Countries Report Drug Shortages got Worse in 2019

EU Regulatory Roundup: Pharmacists in 87% of EU Countries Report Drug Shortages got Worse in 2019

Posted 30 January 2020 | By Nick Paul Taylor 

EU Regulatory Roundup: Pharmacists in 87% of EU Countries Report Drug Shortages got Worse in 2019

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
Pharmacists in 87% of EU Countries Report Drug Shortages got Worse in 2019
A survey of community pharmacists in 24 European Union countries has found drug shortages got worse across the region last year. Almost 90% of respondents said the situation deteriorated in 2019, showing why regulators including DKMA have made tackling drug shortages a priority.
According to the respondents, all 24 EU countries covered by the survey suffered shortages last year. The situation got worse than in 2018 in 21 of the countries and remained the same in the other three member states. No respondent reported an improvement. At the time of the survey, two thirds of the respondents said more than 200 drugs were in short supply in their countries.
The shortages are causing problems for pharmacists and patients alike. Respondents cited distress and inconvenience as the most common way that shortages adversely affect patients. Pharmacists suffer from reduced patient trust and financial losses from time spent mitigating shortages.
Country-to-country regulatory variation means the tools available to pharmacists to tackle medicine shortages differ across the EU. In Austria, for example, generic substitution is not allowed, closing off one way of working around a shortage.
PGEU Report
MHRA Narrows Mean Gender Gap in Hourly Pay to 7.1%
The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has reported its gender pay gap figures for the last financial year. MHRA narrowed the mean gap in hourly pay compared to the previous year but made less progress in addressing the larger differences in the size of the bonuses received by males and females.
Under UK law, organizations with above a certain number of employees need to publish details of the gap between what their male and female workers earn. MHRA is one of the organizations affected by the law. As such, MHRA has published pay gap data in each of the past three financial years.
The latest set of figures shows some progress. When MHRA first reported its figures, the mean and median gender gap in ordinary pay were 10.5% and 9.4%, respectively. The median gap narrowed to 5.5% the following year but the mean difference remained stuck above 10%. Now, MHRA has shown the mean pay gap fell to 7.1% in its 2018 to 2019 financial year, the lowest difference since it began publishing the data.
Other aspects of the data show trends going in the opposite direction, though. The median hourly pay gap ticked up from 5.5% to 6.2%, while the mean gender gap in bonus pay rose from 22.4% to 28.2%. Using the median figures, the gender pay gap was 25.4% in both years.
MHRA framed the progress made to date and the persistence of pay differences as a consequence of the ongoing nature of its move away from legacy pay policy differences.
“The majority of the pay gap relates to employees who joined the agency or our legacy organizations, more than five years ago. We are pleased to note that our gender pay gap has reduced by 3.5% in the last year, which we believe is mainly as a result of the increase of the number of women in higher graded posts,” the agency wrote.
MHRA outlined the steps it is taking to continue to close the pay gap. The agency expects its efforts to receive a boost following a change in its systems, which will enable it to analyze the demographics of applicants at each stage of its recruitment process.
MHRA Report
EMA Revises Antibiotic Advice After Danish Regulator Expresses ‘Major Concerns’
The European Medicines Agency (EMA) has revised its advice on the categorization of antibiotics. EMA made the changes in response to feedback from groups including the Danish Medicines Agency (DKMA), which expressed “major concerns” with aspects of the original text.
EMA created the advice in response to a European Commission request for input on how the use of antibiotics in veterinary contexts affects the health of humans and animals. The advice ranks animal antibiotics by their risks and benefits. A consultation run early last year led to comments from 41 people and organizations, including the government of the United States and the Public Health Agency of Canada.
DKMA was among the more outspoken commentators, highlighting three sets of major concerns it had with the original position adopted by EMA. The concerns including comments on the description of Antimicrobial Advice Ad Hoc Expert Group categories, which DKMA found lacked “consistency and scientific rationale.”
EMA accepted that piece of DKMA criticism, leading it to provide “more detailed explanations of the scientific rationale for the categorization.” The agency was less accepting of other pieces of DKMA feedback, calling one comment “not relevant.”
EMA Statement, Final Advice, Collated Feedback
MHRA Clarifies Procedure for Raising Potential Conflicts of Interest
MHRA has clarified its procedure for raising and dealing with potential conflicts of interest. In a new section of its policy, MHRA set out how cases are identified, escalated and considered, as well as the process for implementing agreed actions.
The UK regulator first set out its conflict of interest policy in 2014. Since then, MHRA has updated the policy twice, with the most recent change going live this week. MHRA said, “The procedure for raising and dealing with a potential conflict of interest has been made clear” in the latest version.
To make the situation clear, MHRA has created a new section. In most cases, MHRA will manage a potential conflict of interest internally. However, if “part of the Regulator identifies something that may create a perceived or possible COI with another part of the Regulator or the rest of the Agency,” it will escalate the matter to a subgroup that handles potential conflicts of interest.
The MHRA policy sets out the steps the subgroup should take to work toward a decision and covers the implementation of measures to mitigate potential conflicts of interest. Those measures may entail asking another regulatory authority to review an MHRA decision or finding.
MHRA Policy 
Dutch MEB Restores Citrix Systems After Cybersecurity Scare
The Dutch Medicines Evaluation Board (MEB) has restored employee access to Citrix systems after installing patches to eliminate a cybersecurity vulnerability.
Last week, MEB stopped its employees from accessing its Citrix systems, rendering staff “unable to do their work” or severely limited in the tasks they could perform. MEB took the action on the advice of the Dutch cybersecurity center, which was concerned about the risks posed by a vulnerability that was known to hackers.
With safety patches from Citrix now available and installed on MEB systems, the Dutch regulator has begun using the technologies again. However, lingering effects of the shutdown remain, with MEB yet to restore access to its portal and still working through the backlog that built up while its staff were unable to work. The portal is offline “because additional research into safety is still ongoing.”
MEB Notice
Other News:
The French National Agency for Medicines and Health Products Safety (ANSM) has clarified the conditions of its assessment of the use of medicinal cannabis. ANSM will only permit the use of cannabis that comes as a finished product that requires no preparation or processing. ANSM Notice (French)


© 2022 Regulatory Affairs Professionals Society.