HDA UK Media And Political Bulletin – 4 January 2017

London-based regulator for EU drugs fears staff exodus

Financial Times, Gonzalo Viña, 3 January 2016


Guido Rasi, executive director of the European Medicines Agency (EMA), the European Union’s London-based drug regulator, warned that the agency has already lost an unprecedented number of senior staff and as much as half could leave if the transition is not carefully managed. This warning is further reminder of the administrative and logistical complexity which will result from the UK exiting the European Union. Considering the importance of the MHRA’s role in approving medicines in the EU, some see the relocation of the EMA as a bargaining chip for the UK in Brexit negotiations. However, the UK is set to be lose more with the MHRA facing greater challenges if it stands on its own. The UK pharmaceutical industry is lobbying against the creation of a standalone British regulator, arguing this would turn the UK in a third-class market.


Class 4 MHRA drug alert – Arava (leflunomide) 10mg film-coated tablets (Sanofi-Aventis Deutschland GmbH)

PSNC, 3 January 2016


Drug alert number: EL(17)A/01


Date issued: 3rd January 2017


The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class 4 pharmacy level caution in use, for certain batches of:


Arava (leflunomide) 10mg film-coated tablets (Sanofi-Aventis Deutschland GmbH)


Sanofi on behalf of Sanofi-Aventis Deutschland GmbH, has informed the MHRA that there is an error in the Braille on 1 in 5 cartons from certain batches. On affected cartons, the strength of the product reads ‘20mg’ instead of ‘10mg’ in Braille. The printed text is correct on all packaging.


There is a risk to patients who have compromised eye-sight and who rely solely on Braille to determine their tablet strength. Packs with the specified batch numbers should not be dispensed to patients who rely solely on Braille.


To view the alert please visit the MHRA website.


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Full Coverage

London-based regulator for EU drugs fears staff exodus

Financial Times, Gonzalo Viña, 3 January 2016


The head of the EU’s London-based drugs regulator said the agency had lost an unprecedented number of senior staff since the Brexit vote and warned that as many as half could walk out unless its future is handled properly.


For Guido Rasi, executive director of the European Medicines Agency, its probable relocation once Britain leaves the EU poses a unique challenge but is also a stark reminder of the broader administrative and logistical quagmire that is likely to follow Brexit.


The EMA’s Canary Wharf headquarters plays host to 36,000 national regulators and scientists each year from across the continent who come to London to approve the safety and efficacy of drugs for the EU’s 500m people. London’s 890-strong secretariat plays a central role in coordinating that work.


Prof Rasi said seven senior executives had quit the agency since the referendum, more than in the past decade put together. A staff survey presented to the agency’s governing board last week showed that about 50 per cent would leave in the event of relocation to an undesirable city.


We are experiencing a lack of candidates in the selection procedures, we are experiencing many more people leaving the agency


For the majority still in place, morale has plunged to worrying depths, Prof Rasi adds: “That’s becoming worse and worse; the uncertainty, of course, is generating all the bad things you might expect. We are experiencing a lack of candidates in the selection procedures, we are experiencing many more people leaving the agency.”


The EMA is also likely to suffer a large loss of capacity because of the work the UK regulator does on its behalf. The Medicines & Healthcare Products Regulatory Agency punches above its weight and currently approves about a fifth of all medicines in the EU.


While the loss to the EMA might raise the hopes of Brexiters looking for bargaining chips in negotiations with the EU, Prof Rasi warns that the challenge facing the UK regulator will be even greater.


“I assume if we are going to lose the 20 per cent, it means they are going to lose the 80 per cent,” Prof Rasi said.


The pharmaceuticals industry in the UK is lobbying against the creation of a standalone British regulator following Brexit, arguing that severing ties with Europe would turn the country into a third-class market, where drugs are approved in larger countries first. Some ministers — mainly those in favour of a “hard Brexit” — are said to want a new UK body.


Without expressing any preference, Prof Rasi said a “good deal” could still see Britain as part of the EU regulatory network.


“That, I think, might affect the decision to relocate or not, but that’s really beyond me,” he said.


Sweden is the latest EU country to pitch for the EMA to relocate to its capital. Others have included Denmark, Spain, Italy, Ireland and France. Prof Rasi said the number one priority was transport “connectivity” followed closely by a long enough window — two years — to relocate the headquarters.


Running the EMA, he said, is like running an “assembly line, which means they [delegates] have to come at the right time, in the right room, in the right sequence, to meet the right people. So, it is a machinery, very complex, so the logistics matters a lot; that is my concern. That’s why I would like to have the longest possible time to organise.”


Without a proper amount of time — a minimum of two years — Prof Rasi fears the approval of drugs in the EU could suffer and recent improvements in approval times could stall or even go into reverse, leaving Europe’s burgeoning biotech sector to seek approval in the US or Japan or in future in Korea or Singapore.


“If we are losing expertise we have to focus on managerial things, HR issues, of course our capacity and commitment to provide additional support to this community would be decreased, and that would make a fragmented Europe in terms of pricing and enforcement. We will give the opposite of being competitive.”

HDA UK Media And Political Bulletin – 4 January 2017

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