Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
EU Downplays Likelihood of UK Staying in EMA After Brexit
The European Council has downplayed the likelihood of the United Kingdom staying in the regional regulatory network after Brexit. British Prime Minister Theresa May talked up the mutual benefits of the UK becoming an associate member of the European Medicines Agency (EMA) last week, only for the Council to dismiss the idea.
May won strong support from the biopharma industry by calling for the UK
to continue paying into and taking its lead from EMA. However, the EU’s willingness to countenance the model was quickly called into question. Doubts about the viability of May’s proposal then hardened when details of the Council’s draft guidelines for EU Brexit negotiators emerged.
“The European Council further reiterates that the Union will preserve its autonomy as regards its decision-making, which excludes participation of the United Kingdom as a third-country to EU institutions, agencies or bodies,” the EU body wrote in draft guidelines
That statement looks to preclude the UK from continuing to participate in EMA after Brexit.
Other sections of the guidelines also have negative implications for the UK and its biopharma industry. The guidelines state the anticipated free trade agreement between the UK and EU “cannot offer the same benefits as membership and cannot amount to participation in the single market or parts thereof,” suggesting it will become harder to move goods across the UK-EU border.
The Council’s position reflects the UK’s repeated assertions that it will leave the single market and customs union after Brexit. Given that the single market and customs union appear to be red lines for UK politicians, the Council is unwilling to offer its negotiating partner the frictionless trade and agency memberships enjoyed by countries in those frameworks.
If the UK were willing to stay in the single market, it is feasible it could join Norway and other countries as a non-EU member of EMA. Instead, the UK wants to leave the single market and gain the power to “decide not to accept” EMA rules. For the Council, those wishes are incompatible with EMA membership.
The Council document remains a draft, but its stipulations are in keeping with comments made by prominent EU figures on either side of May’s speech.
Talking between May’s speech and the release of the Council guidelines, Stefaan De Rynck, the main adviser to the EU’s chief Brexit negotiator, explained why the legal basis of the Union — known as the “acquis” — creates “challenges and tensions” relating to UK membership in EMA.
“These agencies operate in a context where single market principles operate. They work based on legislation, based on Commission work. Their work is integrated into that so called ‘acquis’, which is why so far only three countries participate in these agencies without having a voice in the decision making. [They are] the three countries that adopt the full single market acquis. That’s the reality, the lay of the land,” De Rynck said at an event hosted by the London School of Economics.
De Rynck framed EMA and other European agencies as being integrated into the EU machinery that the UK is leaving. The adviser argued EMA’s power derives from democratic decisions made by EU institutions, adding that it is “embedded in a political sphere where ... Parliament, the Council need to play their role.” Seen that way, the UK’s decision to leave the single market amounts to a decision to leave EMA.
If negotiations progress as foreseen in the EU guidelines, the UK will need to have its own regulatory infrastructure in place by this time next year, or later if a transition period is agreed. Prior to the vote on EU membership, Sir Michael Rawlins, chair of the Medicines and Healthcare products Regulatory Agency, said the UK was “certainly not” equipped to operate independently of EMA.
, De Rynck Speech
EMA Suspends Biogen Multiple Sclerosis Drug After Urgent Safety Review
EMA has recommended the immediate suspension and recall of AbbVie and Biogen’s Zinbryta. The agency advocated the action just days after initiating an urgent review of the safety of the multiple sclerosis drug.
Biogen opted to voluntarily withdraw Zinbryta’s marketing authorizations when EMA began looking into cases of inflammatory brain disorders linked to the drug. Subsequent events showed EMA would have forced Biogen’s hand had it not acted voluntarily. The speed and strength of EMA’s response reflects fast-escalating concerns about the safety of Zinbryta.
When EMA began its urgent review, it had learned of eight cases of encephalitis, meningoencephalitis and other inflammatory brain disorders linked to the drug in Europe. Days later, EMA put the global number of cases at 12. Three of the affected patients died.
In response, EMA has asked the European Commission to suspend and recall the drug and informed doctors about how to mitigate the risks it poses. EMA wants doctors to stop prescribing Zinbryta to new patients and switch people already on the drug to an alternative. Doctors should regularly test the blood of patients for six months after they stop taking Zinbryta.
The recommendations follow earlier restrictions on the use of the drug. EMA approved Zinbryta in 2016, and by the following year had already seen enough safety signals to make it a drug of last resort. Those safety signals related to the effect of Zinbryta on the liver.
Having concluded its urgent review, EMA will now carry out a more detailed assessment of the risks of Zinbryta. The review will look at cases of inflammatory brain disorders and evidence linking the drug to other immune-mediated conditions.
, Initial Notice
Ubiquity of Marketing Authorization Validation Issues Prompts EMA to Plot Awareness Strategy
EMA raises validation questions in almost all marketing authorization (MA) filings, according to a survey. The finding prompted EMA to mull actions to make such questions less common and thereby reduce the burden on its own staff and industry.
EMA discovered the ubiquity of validation issues in a survey covering 65 MA submissions. The poll found validation questions were raised in 97% of the applications. All but four of the applicants affected by the questions responded in time, but further follow-up was required in more than half of the cases. The findings and their effect on regulatory workloads suggest EMA needs to take action.
“Results indicated that EMA should look for ways to increase awareness about the validation process and the most common issues encountered at validation, as well as the procedural pre-submission guidance available to applicants,” the agency wrote in its report on the findings.
The validation finding was one of several recommendations made on the basis of the survey data. EMA also sees scope for both its staff and applicants to get better at communicating delays. More than one-third of applicants affected by delays did not tell EMA or the rapporteurs about the hold up. Similarly, delays to EMA assessment reports are “not uncommon” and “not always proactively communicated to the applicant.”
The European Commission
has given drugmakers three years to update their excipient label information. The timeline relates to the need to update information about excipients that have a recognized action or effect. Typically, the Commission expects companies to update the information while making other regulatory changes. Commission Guidelines