EU Regulatory Roundup: UK Government Resists Calls to Commit to EMA in Brexit Legislation

| 23 January 2020 | By Nick Paul Taylor 

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
UK Government Resists Calls to Commit to EMA in Brexit Legislation
The UK government has held off attempts by the House of Lords to shape its approach to the European Medicines Agency (EMA) and regulatory standards after Brexit.
Members of the House of Lords proposed multiple amendments to Brexit legislation related to EMA. One amendment called on the government to “take all necessary steps” to stay in the European medicines regulatory network. Other amendments covered the UK’s relationship to EU agencies more broadly. None of those amendments passed. 
In each case, the member of the House of Lords who proposed the amendment subsequently pulled the planned change to the draft legislation after a representative of the government said it could not accept the revision. Lord Duncan of Springbank was one of the people tasked with setting out the government’s position.
“We have also made declarations about which bodies we have a particular ambition to remain active in after that implementation period, covering things such as aviation safety, the chemicals agency and the medicines agency. We can all see the value in those. However, I must stress again that these elements will be subject to an ongoing negotiation. They cannot be secured by unilateral demand. There will be a discussion to take that matter forward,” Lord Duncan said.
The comments came days before Sajid Javid, the chancellor of the Exchequer, discussed how the government will approach regulatory standards after leaving the EU in an interview with The Financial Times. Javid said, “There will not be alignment, we will not be a ruletaker,” thereby raising fears among businesses that it will become significantly harder to trade and collaborate with EU member states after Brexit.
Exactly what Javid’s position will mean in practice will only become clear once trade talks between the EU and UK are finalized. However, there are concerns that the hard split pointed to by Javid will force biopharma companies to follow two separate approval processes, leading them to deprioritize the smaller of the two markets.
“We will be leaving a body that constitutes 25% of the global pharmaceutical market to be a stand-alone country that makes up only 3% of that market. The sad fact is that the UK will not be seen as a priority, and patients will inevitably see delays in accessing new medicines,” Baroness Brinton said.
The debate in the UK overlapped with similar conversations in the EU, notably at the European Parliament Committee on the Environment, Public Health and Food Safety (ENVI).  an option, ENVI asked the Committee on Constitutional Affairs to write a motion for a resolution that positions the EU to take “targeted actions” to “ensure continued and rapid access to safe medicines and medical devices for patients, including a secure and consistent supply of radioisotopes.”
Debate Transcript, FT, ENVI Opinion
Dutch MEB Staff ‘Unable to do Their Work’ Amid Cybersecurity Threat
The Dutch Medicines Evaluation Board (MEB) has warned that its staff “are currently unable to do their work or can only work to a limited extent.” MEB issued the notice after switching off its Citrix systems in response to recent safety warnings.
Citrix, a developer of networking applications and other software, issued a statement late last year about a vulnerability that had been exploited by hackers. The American software company went on to post details of ways to mitigate the threat but the first permanent fixes only became available on Wednesday.
By then, MEB had decided to switch off its Citrix systems and disable its portal. The action has stopped MEB employees from doing their jobs but the agency concluded the disruption is a price worth paying to mitigate the cybersecurity threat.
MEB took the action after the Dutch National Cyber Security Center (NCSC) published advice on the topic. NCSC advised government agencies to eliminate Citrix where possible but left the decision on whether to do so up to the individual groups. The decision rested on whether the risks posed by the vulnerability were perceived to be more serious than the disruption caused by shutting the systems down.
MEB Notice
German BfArM Asks Companies to Complete Pharmacovigilance Questionnaire
Germany’s Federal Institute for Drugs and Medical Devices (BfArM) has asked companies to fill in a pharmacovigilance questionnaire. The questionnaire is part of BfArM’s efforts to base its decisions about which organizations to inspect and when on the level of risk they pose.
To make best use of its resources, BfArM wants to classify potential risks associated with companies’ pharmacovigilance systems and design its inspection schedule around that information. Sending out the questionnaire is intended to further that effort by giving BfArM additional insights into how the companies it regulates handle pharmacovigilance requirements.
The questionnaire provides a detailed assessment a company’s pharmacovigilance activities, digging down into details such as the number of case reports that were added to the database last year and changes to contracts with pharmacovigilance service providers. Other questions cover the number of full-time employees focused on pharmacovigilance and whether any marketing authorizations have been acquired in the past two years.
BfArM has sent out questionnaires to the contact people in its database. If a marketing authorization holder has not received the questionnaire, BfArM is recommending they check whether the contact data in the system are correct.
BfArM Statement (German), BfArM Questionnaire
Relocation of Finnish Regulator Disrupts Operations
The Finnish Medicines Agency’s (Fimea) move to new premises have disrupted its operations. Fimea moved into the offices on Monday and soon encountered problems receiving faxes.
At the time of writing, applications for special permits cannot be faxed to Fimea. The disruption led Fimea to advise people to send applications for special permits by post or email. Fimea added that it does not want people to make inquiries by phone as it is overloading the processing of permits.
The fax problem relates to Fimea’s move to new facilities linked to the Finnish National Institute for Health and Welfare. Fimea moved into the facilities on Monday and issued a statement about the fax problem the next day.
Fimea Notice, More (both Finnish)
Other News:
EMA has published a reflection paper on good manufacturing practices (GMPs). The paper covers the responsibilities of marketing authorization holders. While these organizations may not manufacture their products, they do have some GMP responsibilities. The reflection paper is an attempt to clarify those responsibilities and what they mean in practice for affected companies. Reflection Paper
EMA has changed its position on the updating of the contact information of sponsors. If the change only affects the telephone number or email address on the public summary of an orphan designation on EMA's corporate website, the sponsor can share the updated details with the EMA service desk. Sponsors need to use the IRIS system to make more significant changes to their details. EMA Update
EMA has named Hilmar Hamann as head of its information management division. Hamann joins EMA from the United States Food and Drug Administration, where he worked as director for the Office of Business Informatics starting in 2011. EMA highlighted cloud-enabled technologies and robotic process automation as areas Hamann has focused on recently. EMA Notice
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has shared details of reports of health problems associated with breast implants. MHRA Notice


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