European Regulatory Roundup: New Pressure to Reverse Brexit Regulatory Split (13 July 2017)

Regulatory NewsRegulatory News | 13 July 2017 |  By 

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Drug Supply Fears Prompt Politicians to Pressure PM to Reverse Brexit Regulatory Split

Politicians have begun pressuring United Kingdom Prime Minister Theresa May to reverse her decision to leave the European nuclear energy regulator. Interest in the UK’s planned exit from Euratom surged after newspapers published long-standing fears about the effect of the split on the supply of medical radioisotopes.

Experts have warned about the potential for Brexit to disrupt the supply of radioisotopes used to treat and diagnose diseases for months. Politicians have discussed Euratom a little, too. Yet the agency remained a niche subject until this week, when the combination of headlines about cancer drug shortages, a debate about Euratom membership and May’s weakened political position combined to move the topic toward the top of the political agenda.

“The real issue with these radioisotopes is that their half-lives are so short that any delay in getting them to the UK — even hours — means that they will have expired,” Layla Moran, a Liberal Democrat politician and former physics teacher, said at the debate. A badly handled Brexit and split from Euratom could cause such delays.

The UK signaled its intent to leave Euratom in the same notification that triggered the countdown to its exit from the European Union. Some politicians and experts in the UK and the EU think leaving Euratom is an automatic consequence of Brexit. Others disagree. Either way, the UK wrote plans to leave Euratom into its Article 50 notification. That tied together the UK’s departure from Euratom and the EU. Politicians voted down an amendment that would have divorced the two issues.

Yet now, with May unable to easily quell revolts by small numbers of her MPs following her failed election gamble, members of her Conservative party are pressing for a U-turn on Euratom. Some people in the nuclear industry think such a reversal is possible, Politico reports, although how this could be achieved without revoking or amending the formal notification to leave the EU is unclear.     

Rebel politicians will have a chance to pressure the government to remain part of Euratom when a bill transposing EU law to the UK is debated. The government is seeking to calm the rebellion ahead of the debate by promising to publish position papers and reassuring politicians it will avoid the worst-case scenarios.

“We will avoid the cliff edge feared. We are preparing the domestic Nuclear Safeguards Bill, we are opening negotiations with the EU, we are talking to third countries about bilateral agreements and we are talking to the International Atomic Energy Agency. Nobody doubts the UK’s credentials as a responsible nuclear state, and everyone in the UK and elsewhere is keen to see that continue,” Richard Harrington, a politician involved with the government’s energy strategy, said.

Some of the issues surrounding Euratom membership overlap with those related to the European Medicines Agency (EMA). Staying part of either agency would keep the UK under the jurisdiction of the European Court of Justice, a red line for May. That said, some people in the government think May now lacks enough votes in parliament to win a vote on Euratom membership, Newsnight reports.

Euratom’s unique situation could render such a rebellion moot. The same could not be said if the rebellion spreads to EMA membership.

Debate Transcript, Politico, Newsnight, Financial Times, More

ABPI Takes NICE to Court to Stop Changes to Drug Reimbursement Process

The Association of the British Pharmaceutical Industry (ABPI) has begun legal action to stop the UK from imposing new limits on drug pricing. ABPI wants the court to shoot down a National Institute for Health and Care Excellence (NICE) initiative to force manufacturers of drugs forecast to cost the UK more than £20 million ($26 million) a year to negotiate with the government.

NICE proposed the extra negotiation in 2015 to lessen the strain put on the National Health Service (NHS) by new, fast-selling medicines such as Gilead Sciences’ Sovaldi. In the case of Sovaldi, the drug was deemed cost effective but a combination of its cost and the unmet need in hepatitis C patients meant it put a strain on NHS resources. Making manufacturers of similarly costly drugs enter into commercial negotiations with the NHS is intended to prevent such cash crunches.

The result is a manufacturer could persuade NICE of the value of its drug only to hit a roadblock down the line because of its cost to the NHS. ABPI thinks that is unacceptable.

“It fundamentally crosses a line to not grant mandatory funding for NICE-approved medicines,” Richard Torbett, executive director at ABPI, told the Financial Times.

ABPI said it “reluctantly” took legal action after attempts to get NICE to implement alternative ideas failed to deliver the desired outcome. The action lacks the full support of the industry. GlaxoSmithKline is against resolving the situation in the courts. AstraZeneca has reservations about the approach.

The trade group’s decision to push ahead with the legal action despite these concerns puts it at loggerheads with one part of the state at the same time it is trying to negotiate a sector deal and favorable Brexit with another.

ABPI Statement, FT

EMA Creates Guidance for Participants in Public Hearings Ahead of First Open Safety Review

EMA has created guidance for participants in public hearings. The document provides attendees at the upcoming public hearing on the safety of valproate with an overview of what they can expect before, during and after the meeting.

Valproate is the first medicine to undergo a safety review featuring a public hearing. The treatment for epilepsy, bipolar disorder and migraine can cause malformations and neurodevelopmental problems in babies who are exposed to it in the womb. EMA thinks there is value in understanding how patients and their families feel about the risks and benefits of the drug.

EMA opened registration for the 26 September hearing this week and gave the public about seven weeks to file an application to speak. Officials have published a guidance document to support the public through the process.

The guidance explains what public hearings are before detailing how people can participate in and prepare for such events. EMA also covers travel to the event and what happens when attendees arrive, during the meeting and following the event.

Some of the advice overlaps with the guidance EMA provides to other types of attendees, such as healthcare professionals. The document also acknowledges differences between the public and other stakeholders, for example by featuring a link to an explanation of technical terms and abbreviations. 

EMA Guidance, EMA Notice, Hearing Questions, Application Form

CHMP Starts Consultation on Definitions of Metabolic Phenotyping Terms

EMA’s Committee for Medicinal Products for Human Use (CHMP) has started a consultation on the need for clear definitions of terms used for metabolic phenotyping. The planned guidance will dictate how the degree of genotype-determined metabolism is described.

Today, overlapping terms are used to describe the rate at which patients metabolize a drug. People with a lack of metabolic capacity are described as having a “poor” or “slow” status. Others are said to have “intermediate” or “normal” capacity. Yet there is no clear boundary between these terms.

EMA wants to create such delineations by drafting an addendum to an existing guideline. The agency outlined its plans in a draft concept paper.

Concept Paper


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