Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
Prime Minister May Hints at Desire for UK to Remain Part of EMA During Brexit Transition Period
Prime Minister Theresa May has implied the UK will stay in the European regulatory network during the anticipated Brexit transition period. Delaying the date on which the UK cuts its ties to the European Medicines Agency (EMA) would give businesses and regulators more time to prepare for the new relationship.
Nothing about the transition, or, in UK government parlance, “implementation” phase, is certain, even down to whether such a staggered exit from the EU will happen. The UK wants to leave the EU in 2019 but avoid the cliff-edge scenario by maintaining something like the status quo for about two years. If the EU agrees, it is unclear how the UK will handle drug and medical device regulation during the transition.
Labour politician Heidi Alexander, having failed to get a clear answer from the UK Brexit secretary, asked May if a “company wanting authorization to market a new cancer drug in the UK during transition would do so via EMA or a new system as yet undefined?”
May’s desired position is relatively clear, while still leaving ample scope for a hard split from EMA in 2019.
“The intention of the implementation period is, as far as possible, to ensure that there is not a cliff edge so that people are able to operate on the same basis as they do at the moment as they put in place the necessary changes leading up to the future partnership,” May said.
May opened the door to the UK’s continued, time-limited participation in EMA earlier this month by conceding the country will remain under the jurisdiction of the European Court of Justice (ECJ) during the transition phase. That statement overruled comments made by UK Brexit Secretary David Davis just weeks earlier.
The shift is important, as ECJ jurisdiction and EMA involvement go hand in hand. May’s decision to use Brexit to sever UK ties to the ECJ is why the country looks set to leave EMA at some point.
A lack of clarity about when that will happen and what will follow — something the UK cannot provide until negotiations with the EU advance — is causing consternation at companies.
At the session in which Davis dodged Alexander’s question, another politician said they had met with people from the pharmaceutical industry who “are desperate for some clarification on future trading relations and regulation.” Without clarity, the industry representatives will delay investments or reallocate cash to facilities outside the UK.
The politician was Helen Goodman, whose constituency includes a GlaxoSmithKline manufacturing facility that is a major employer in the region. Responding to Goodman’s concerns, Davis said he has “met industry representatives a couple of times” and that the transition phase will give them another two years of decision making.
Davis’ position assumes the EU will agree to a two-year transition period, something that is far from certain. The Brexit secretary expects to reach an agreement on the transition deal in the first quarter of next year.
Debate Transcript, More
Legibility of Redacted Clinical Trial Data Praised by Respondents to EMA Survey
An EMA survey has found 87% of people think the clinical data it publishes is in an understandable format. The regulator presented the result as evidence the reports shared under its clinical trial transparency initiative are understandable despite undergoing redaction and anonymization.
EMA will share full results from the survey in the future, but posted select points this week to mark the first anniversary of the scheme, which is sharing the data companies submit to win marketing authorizations. The survey results suggest the public has broadly welcomed the initiative and the data it has shared.
According to EMA, 62% of the researchers, healthcare professionals, patients and industry staffers who responded to the survey said the reports it shares are useful.
The 62% and 87% figures are the only results released by EMA so far. The agency was more forthcoming about how much its open-access data service has been used over its first year online. EMA said about 3,600 users have viewed around 22,000 documents and downloaded more than 80,500 files for noncommercial research purposes.
These documents cover the 50 medicines for which EMA has uploaded reports so far. EMA had expected the scheme to be further along, but “extensive pilot phases for first publications” have slowed progress. That cautious approach follows industry pushback against the sharing of data.
UK Watchdog Opens Four Probes Into Alleged Anti-Competitive Drug Practices
The UK antitrust watchdog has opened another probe into suspected anti-competitive agreements and conduct in the pharmaceutical industry. Initiation of the investigation brought the 10-day tally of probes kicked off by the Competition and Markets Authority (CMA) up to four.
CMA’s latest investigation is looking into “suspected anti-competitive agreements and/or concerted practices and suspected abuse of dominance in relation to the supply of certain generic pharmaceutical products.” The watchdog is yet to say which companies are under investigation or reach a conclusion about whether they have breached competition laws.
The investigation is one of four similar probes begun by CMA in quick succession. CMA’s wording of its motivation for starting one of the probes is identical to the section quoted above. Another swaps the sword “suspected” for “alleged” but is otherwise identical. The third is identical up to the line about abuse of dominance, which is absent from the case information.
While CMA is yet to provide details about the investigations beyond these snippets, the other cases that have occupied it and exercised UK legislators and newspapers in recent years provide a guidepost to the areas the watchdog may be looking into.
CMA ended 2016 by fining Pfizer and Flynn £90 million for their roles in hiking the price of an epilepsy drug. In April, UK politicians sought to prevent future price hikes by passing legislation. The passing of the law followed reports of drug prices increasing by as much as 5000% from 2005 to 2015.
CMA Probe, Pharmaceutical Investigations
EMA Calls for Manufacturers of Certain Antibiotics to Change Their Production Processes
Manufacturers of vancomycin drugs should adjust their manufacturing processes to ensure their products are the right strength, EMA said. The request was prompted by changes to the potency of vancomycin specified in the European Pharmacopoeia monograph.
The Pharmacopoeia now specifies a minimum potency of 1,050 IU/mg, an increase of 50 IU/mg over the historic figure. This led to errors in the potency listed on product information. Companies listed the potency of their 500 mg vancomycin products as 500,000 IU. That was correct under the old potency, but off by 25,000 IU using the Pharmacopoeia’s current monograph.
In response, EMA wants manufacturers to adjust the amount, in terms of milligrams, of drug their products contain. To achieve a potency of 500,000 IU, manufacturers need to reduce the amount of drug to 476 mg.
EMA made the comment in an answer setting out its thinking on how the product information for vancomycin products should state the potency. The clarification is intended to avoid confusion in clinical practice while ensuring the established therapeutic dose is maintained.