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

Lead Brexiteer Muddies Waters on Future UK-EMA Relationship

Secretary of State for Exiting the EU David Davis has raised doubts about the likely relationship between the UK and the European Medicines Agency (EMA) after Brexit. Asked about the health secretary’s comments that Brexit would likely result in Britain leaving EMA, Davis said his colleague was “misreported and misinterpreted.”

Speaking to fellow politicians last week, Health Secretary Jeremy Hunt’s said, “I don't expect to remain within the European Medicines Agency.” Hunt made this point multiple times during the debate, citing Prime Minister Theresa May’s desire to leave the jurisdiction of the European Court of Justice to explain why a close but separate relationship is the most likely outcome.

Davis was asked about Hunt’s comments during a session in the House of Commons to discuss exiting the EU. Luciana Berger, a politician in the opposition Labour Party, asked Davis “why his Government have so readily given up our membership of this vital body?” and what measures he will introduce to ensure Britain gains access to new medicines at the same time as the EU. Davis dismissed the question on the grounds it misrepresented Hunt’s position.

“The complete premise of the question is wrong,” Davis said. “That is not what the Health Secretary said; he was misreported and misinterpreted.” Davis went on to say he will put the “clinical safety of the British people at the front of the priority list” and also seek to look after the interests of the UK life sciences sector, but added no details to how Hunt was “misreported and misinterpreted” or what it means for the likely relationship with EMA.

Regulatory Focus contacted the Department for Exiting the European Union (DExEU) for clarification on how Hunt’s words were misreported and whether the government expects to leave EMA.

In response, a DExEU spokesperson said: “As the Health Secretary has said, the Government has not ruled out retaining the European Medicines Agency, nor did he rule out that we would continue to be a beneficiary and contributor to the EMA licensing regime. All future decisions are subject to the negotiations and we will be seeking the best deal for Britain, for our life sciences companies and for our NHS.”

The UK politicians in charge of Brexit have a history of contradicting each other, with Boris Johnson and Davis himself having both been publicly overruled by May after speaking up about how they see aspects of the exit progressing.

In a separate exchange, Davis discussed how Britain will seek to avoid disruption when exiting the EU by enshrining region-wide regulations into its national law. “The Great Repeal Bill will convert EU law as it applies, including EU regulations, into domestic law on exit. If needs be, we can reform the regulations after that,” Davis said. One concern raised in the run up to the referendum was that Brexit would leave the UK subject to EU regulations but with no power to influence them.

Debate Transcript, More

Ireland Updates Advice on Reclassifying Prescription Drugs as OTC Products

The Health Products Regulatory Authority (HPRA) of Ireland has updated its advice on switching drugs from prescription to over-the-counter (OTC) status. HPRA has used the update to encourage marketing authorization holders (MAHs) to contact it with switching proposals, and provided new details of how to retain prescription-only status while adding an OTC version of a product.

While most of the text is unchanged from the version HPRA introduced in 2010, the regulator has made two substantial amendments to the original text. The guide covers products approved nationally by HPRA, or through the mutual-recognition or decentralized procedures. Products approved centrally by EMA are outside the scope of the guide. 

The first significant change relates to the process for applying to reclassify the legal status of a product from prescription-only to pharmacy-only, or from pharmacy-only to general sale. Since HPRA released the original guide, it has adopted a “proactive approach” to switching the status of “products containing specified active ingredients in the interest of public health.” HPRA has added details of this approach to the guide, and called for MAHs to email it with expressions of interest in switching the legal status of their products.

Officials have also added details of what happens after an expression of interest is submitted. HPRA will work with applicants to establish a timeframe for filing the switching application and supporting documents. The agency is encouraging MAHs to contact it as early as possible in the process.

The other substantial change to the text relates to companies that want to retain one legal status while adding another. HPRA thinks dual status could be useful when a product serves multiple indications or populations. Companies in this situation can make an “informed consent” application. In this instance, the product leaflet for the application should be the same as that for the authorized drug. The non-prescription product must have a new name.

HPRA Guide

Dutch Regulator Starts Search for New Chair Ahead of Leufkens’ Departure

The Netherlands’ Medicines Evaluation Board (MEB) has started recruiting for a replacement for Bert Leufkens, who is set to step down as chairman in August after 10 years in the role. MEB is looking to replace Leufkens with a doctor, pharmacist or pharmacologist.

Applicants for the position are also expected to have a thorough knowledge of drug development, pharmacotherapy and related regulations, plus managerial and administrative experience. MEB expects the chairman to apply their experience and knowledge to untangle complex issues and represent the agency.

Leufkens, a pharmacist and epidemiologist, announced his intention to step down as chairman late last year. By the time Leufkens leaves MEB in August to focus on his academic work at Utrecht University, he will have spent exactly 10 years in charge of the agency.

MEB Statement, Job Posting (both Dutch)

Lithuania Warns of Tamiflu Shortage After Flu Epidemic Hits Country

The State Medicines Control Agency (SMCA) of Lithuania has warned of disruption to the supply of Roche’s Tamiflu. SMCA attributed the short-term shortage to a flu epidemic and subsequent rise in demand for the antiviral.

Faced with this situation, SMCA has cleared 75mg hard capsule formulations of Tamiflu with English language packs and leaflets for sale. The move is intended to ensure Tamiflu remains on the market while the country is waiting for supplies of local language packs to meet demand.

SMCA blamed a flu epidemic for the shortage. Data from Lithuania’s Centre for Communicable Diseases and AIDS (ULAC) show one-third of the country’s 60 municipalities is now experiencing a flu epidemic. In one municipality, the incidence rate is 247 per 10,000 inhabitants. That region is one of three where the incidence rate has risen to above 200 per 10,000 inhabitants.

Three people have died from influenza in the current flu season.

SMCA Notice, ULAC Data (both Lithuanian)

Other News:

EMA Chief Guido Rasi has expressed concern about the potential for Brexit to disrupt the agency’s operation. “We are 3,000 experts, delegates, and people are walking exactly in the right time in this assembly line. If they cannot be there, you have to replan everything. The sequence is crucial,” Rasi told AFP. Rasi wants to know the new location of EMA as soon as possible. AFP