EU Regulatory Roundup: UK Dismisses Rumors of 20-Week Stockpile Request but Admits Extensions Are Possible

Regulatory NewsRegulatory News
| 01 November 2018 | By Nick Paul Taylor 

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
ENVI Calls for Parliament Role in Agency Locations as EU Considers Governance Problems
The European Parliament’s health committee wants to use a review of the governance of agencies as an opportunity to ensure it plays an active role in future decisions. Members of the Committee on the Environment, Public Health and Food Safety (ENVI) put forward the ideas as a result of grievances over the handling of the relocation of the European Medicines Agency (EMA).
Parliament played a limited role in the Brexit-triggered relocation of EMA. The body voted to approve Amsterdam as the agency’s new home, but the original decision was taken by the European Council. In theory, Parliament could have voted against the move but, with EMA facing a time-pressured relocation, doing so would likely have caused significant disruption. ENVI and other parliamentary bodies have since criticized the process repeatedly.
Now, ENVI has spotted an opportunity to ensure Parliament is not shut out of important decisions about European Union agencies in the future. In light of governance challenges related to EMA and other EU agencies, another parliamentary committee is preparing a report that will look into political oversight of arm’s-length institutions. ENVI wants to get its views on EMA’s move into the report.
“We would like to use this report to remind us all of the fact that we want to be involved as a Parliament in this decision in relation to the future locations of agencies,” Ivo Belet, the rapporteur for ENVI on the governance initiative, told the Committee on Constitutional Affairs.
The day after expressing his views to the committee, Belet published ENVI’s draft opinion on the report. ENVI’s draft reiterated Belet’s position on the need to ensure Parliament is involved in decisions about EU agencies, stating that the body “should be systematically involved, and on equal terms with the Council and the Commission.”
With EMA unlikely to move again in the coming years, other aspects of ENVI’s opinion and the final report on governance may have more direct effects on the agency. Explaining the need for a report, European parliamentarian György Schöpflin outlined a dilemma in how to oversee the “enormous institutional complexity” that stems from the more than 40 agencies and joint enterprises now in the EU. 
Schöpflin sees benefits in these agencies being independent from government so that, for example, EMA decisions about drugs are not influenced by politicians. However, the agencies are part of the EU and collectively spend significant amounts of money, suggesting they should be accountable to voters. Schöpflin is trying to figure out an answer to the problem and thereby ensure oversight.
 ENVI Opinion, Committee Debate
UK Dismisses Rumors of 20-Week Stockpile Request but Admits Extensions Are Possible
The United Kingdom health minister has dismissed rumors that the government has asked the drug industry to stockpile 20 weeks of medicines. However, in a separate exchange, another minister left the door open to the extension of the government’s current request for a six week stockpile.
Facing the prospect of a no-deal Brexit and the disruption of trade with the EU, the government has asked manufacturers to stockpile six weeks of drugs to ensure patient access. However, it is unclear whether the UK could resolve a breakdown of trade with the EU within six weeks, and it emerged last week that the industry is unsure how the government came up with the six-week figure.
With preparations for a no-deal Brexit ramping up on both sides of the English Channel, reports of a government request for a 20-week stockpile reached Ben Bradshaw, a Labour politician. Bradshaw, a member of the committee that is looking into the impact of a no-deal Brexit on drug supplies, asked the government whether the reports are true. Government health minister Matthew Hancock denied the reports.
However, two days after Hancock’s comment, one of his colleagues said longer stockpiles are possible. Responding to a question about the possibility of longer stockpiles, the Brexit minister Dominic Raab said the government is keeping the option “under review.”
“Government and the pharmaceutical industry already liaise on stockpiling for far longer periods in other circumstances, including in relation to vaccines. This is something the industry is used to doing and we are used to cooperating with it,” Raab said during a discussion in parliament.
Raab’s confidence that longer stockpiles are possible and a normal part of industry practices clashes, to an extent, with comments made by the heads of manufacturing and distribution trade groups. Speaking last week, the industry leaders warned that the UK lacks the cold-chain capacity to meet the request for a six-week stockpile.
The government is working to bring additional cold-chain capacity online, but there are doubts about whether it will have the space to store six weeks of temperature-sensitive products by the time the UK leaves the EU in March.
If all goes to plan, the UK will never need the stockpile. Raab told the Exiting the EU Committee he expects to have finalized the deal with the EU by 21 November but then quickly backtracked. A successful conclusion of the negotiations should ensure drugs continue to flow across the EU-UK border after Brexit.
Hancock Comment, Raab Comment, Barclay Comment, Raab Letter
EMA Provides Update on Processing of Brexit-Related Variation Submissions
EMA has said marketing authorization holders (MAHs) that submit Brexit-related type IA variation filings in December will receive acknowledgements of the validity of submissions within 30 days. The time frame is the standard response window for minor, type IA variation submissions.
MAHs can make type IA variations and then tell EMA of their actions, either immediately or within 12 months depending on the nature of the revision. Type IA changes cover some of the modifications necessitated by Brexit, such as updates to the names of manufacturers, and in the past EMA has said notifications related to the UK-EU split must be filed by late May 2019.
This week, EMA followed up on its earlier advice with the clarification about the processing of type IA notifications during the holiday-disrupted month of December. 
While EMA is sticking to its standard timeline for Brexit-related notifications, filings about other variations may take longer to process. EMA is encouraging MAHs to submit type IA notifications by the end of November. The agency will acknowledge the validity of these submissions before it closes for Christmas on 21 December.
EMA Notice
MHRA Accepts GSK Request to Make Larger Packs of Allergy Drug Available OTC
The Medicines and Healthcare Products Regulatory Agency (MHRA) has accepted GlaxoSmithKline’s request to allow the over-the-counter (OTC) sales of 120-dose packs of Pirinase Allergy 0.05% nasal spray.
A spray containing fluticasone propionate, the active ingredient in Pirinase Allergy, was approved as a prescription-only medicine in 1990. Twelve years later, the UK cleared a 60-dose version of the nasal for sale in pharmacies.
In assessing whether to permit the sale of 120-dose packs, MHRA looked at the direct and indirect risks OTC sales could pose. With the reviewers concluding the larger packs are unlikely to pose risks to patients, MHRA has agreed to GSK’s request. The decision was based, in part, on the fact that the larger packs will run out before patients should seek medical advice for persistent symptoms.
MHRA reached the decision without seeking advice from the Commission on Human Medicines.
MHRA Assessment


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