European Regulatory Roundup: UK to Seek ‘Closest Possible Regulatory Equivalence’ With EMA Post-Brexit (26 January 2017)

Posted 26 January 2017 By Nick Paul Taylor

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

UK to Seek ‘Closest Possible Regulatory Equivalence’ With EMA Post-Brexit

UK Health Secretary Jeremy Hunt has called for the country to seek the “closest possible regulatory equivalence” with the European Medicines Agency (EMA) after Brexit. Exactly what this means will depend on the outcome of upcoming negotiations, but Hunt is open to the UK automatically licensing drugs that win approval in the EU.

Biopharma executives, including AstraZeneca CEO Pascal Soriot, have warned a divergence of the regulatory systems post-Brexit could result in the UK gaining access to new drugs later than the rest of Europe. In this scenario, the need to file separately for approval in the UK would make the country a second-tier priority for drugmakers, which would target the United States and EU before making submissions in the UK, Australia and Canada. Some politicians have argued this risk means the UK should remain in the EU-wide regulatory network, but Hunt has slightly different priorities. 

“I don't expect to remain within the European Medicines Agency, but I am very hopeful that we will continue to work very, very closely with the EMA. We have a closer relationship with the EMA in this country than any other member state of the EU. I think that we have the foundations for a sensible, strong partnership going forward, which means that we could potentially have mutual recognition between the EMA and the MHRA,” Hunt said at a health-focused political committee.

Asked why the UK cannot remain in EMA, Hunt cited Prime Minister Theresa May’s prioritization of freeing the country from the ruling of the European Court of Justice (ECJ). ECJ rules on company appeals against EMA and disputes that require interpretation of pharmaceutical legislation, such as the clash between Novartis and Apozyt over the off-label use of Avastin.

May’s position is seen as precluding the UK from staying part of EMA, but Hunt thinks both sides will benefit from retaining close ties. One option is to have drugs and medical devices approved in the UK automatically upon them being cleared for sale in the EU. However, as with everything related to Brexit, the final form of the regulatory relationship will depend on the outcome of negotiations between the UK and EU.

One area that is clearer, at least to Hunt, is the likelihood of EMA not remaining in London after the UK leaves the EU. Some politicians have argued everyone will benefit from EMA staying in London, but Hunt, in keeping with the prevailing view in the EU, thinks the headquarters will leave the city.

“I think it is likely in a post-Brexit scenario that the EU will decide to move the headquarters of the EMA outside the UK,” Hunt said. That statement prompted criticism from some other politicians, who accused Hunt of giving up too easily and too early.

Hunt’s position on the likely location of EMA was one of several points of friction between him and his colleagues. The health secretary tried to allay the worries expressed by other politicians, but failed to completely quell their fears Brexit will contribute to the UK becoming a backwater for the biopharma industry.

MP Dr Philippa Whitford said: “I have real concerns that, along with the consultation on NICE and the new NHS England process around rare diseases and the £20 million limit and so on, that pharma are simply going to see the UK as a hostile market. And it's not just that we'll be there with Canada and Australia, six months to a year behind, [but] we'll slide further down. We don't want that research that's done here that eventually becomes a drug doesn't become available. This is really crucial.”

Meeting Replay

Germany Creates Innovation Office to Provide Early Regulatory Advice

Germany has set up an innovation office to provide early regulatory advice to developers of drugs and medical devices. The office’s creation is an attempt to ensure no startup fails to efficiently advance a drug or device because of a lack of regulatory understanding.

The Federal Institute for Drugs and Medical Devices (BfArM) has joined with the Ministry of Health to set up the unit. Officials hope biotech startups, research institutes and other organizations with limited regulatory experience will turn to the office as they set out to develop new products.

By engaging early, BfArM thinks it can help companies avoid costly and time-consuming missteps, such as failing to properly design a clinical trial. The regulator also foresees the office helping developers of mobile apps understand whether their product will be classed as a medical device. 

In setting up an innovation office, BfArM is following a path established by the UK Medicines and Healthcare Products Regulatory Agency and, more recently, the Health Products Regulatory Authority of Ireland.  

Press Release (German)

EMA, EFSA Officials Call for Phasing out of Preventative Antimicrobial use in Animals

EMA officials have joined with their peers from the European food regulator to call for the phasing out of the preventative use of antimicrobials in animals. The regulatory staffers set out their case in a joint scientific opinion on measures to cut the use of antimicrobials used in animal husbandry.

In the joint opinion, the EMA and European Food Safety Authority (EFSA) officials say the goal should be to phase out preventative use of antimicrobials at the national and farm level. The report advocates for this process to be based on a structured review of national and regional use of antimicrobials. Livestock professionals with knowledge of local endemic disease epidemiology, risk factors for disease and husbandry systems are seen as best placed to conduct the review.

Some officials have issues with the document. Notably, three members of EMA’s Committee for Medicinal Products for Veterinary Use (CVMP), while agreeing broadly with the recommendations, formally expressed a “divergent opinion” on one point.

“We do not support the recommendation for the preventive use of antimicrobial substances in herds. This recommendation is made for exceptional cases and it contains a number of criteria. Examples of cases where preventive use is recommended, are Actinobacillus pleuropnemoniae and Streptococcus suis in pigs,” the CVMP members wrote.

The CVMP officials see the recommendation as running counter to their own 2016-2020 strategy on antimicrobials, and they fear it will “legitimize marketing authorizations for veterinary medicinal products with preventive mass medication as an indication for use.”

Press Release, Joint Report

UK Starts Recruiting for Chair of NICE

The UK National Institute for Health and Care Excellence (NICE) has started recruiting for a new chair. Professor David Haslam, the current chair of NICE, was appointed on a four-year term that is due to end in April.

Government officials are aiming to select their preferred candidate around the time that Haslam will be stepping down. The candidate will then answer the questions of a health-focused political committee.

NICE is seeking an individual with the “ability to command the respect of leaders in the life sciences sector” and “substantial experience in clinical or public health practice.”

Whoever takes on the position will join an organization being pressured by drugmakers and patient lobbying groups to reform. Last year, AstraZeneca, Roche and a collection of cancer charities were among the organizations to call for changes at NICE.

With the government keen to give drugmakers what they want to ensure continued investment in the UK post-Brexit, the establishment may be more amenable to these calls than in the past, although this may clash with attempts to control healthcare costs. 

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Categories: Biologics and biotechnology, Drugs, Medical Devices, Government affairs, News, Europe, EMA, EC, MHRA, NICE, Business and Leadership

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