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Regulatory News | 10 November 2016 | By Nick Paul Taylor
Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
A senior politician overseeing the United Kingdom’s exit from the European Union has dismissed the need to retain certain aspects of the country’s current regulatory model post-Brexit. Asked in the House of Commons whether he agreed with industry leaders on the need for the UK to be part of a Europe-wide regulatory system, Liam Fox gave a blunt answer: No.
The response shows at least some members of the group of politicians tasked with extracting the UK from the EU are willing to contemplate a hard split from the regulatory system on the continent. That prospect has prompted warnings from leaders including AstraZeneca CEO Pascal Soriot, who said last month the UK faces waiting longer and paying more for drugs if it sets up its own approval system. Other members of the government have talked up ongoing engagement with Europe, but Fox, when asked to give a yes or no answer, showed an openness to the UK taking its chances on its own.
Fox’s response prompted a letter from Daniel Zeichner, the politician who asked the question. As the representative of the life science hotspot of Cambridge, Zeichner has led attempts to get Fox and his colleagues in government to clarify their plans for regulating the biopharma industry. In keeping with the government's refusal to give a “running commentary” on its Brexit strategy, the answers to these questions have yielded few concrete details. However, the tone and substance of the responses have suggested the government sees value in working with the EU on biopharma regulations.
Speaking last month, David Davis, the Secretary of State for Exiting the European Union, said the plan was to make the UK approval process “standardized” with the EU. David Mowat, the Parliamentary Under-Secretary of State for Health, went further. Mowat said the UK may adopt the same model as Liechtenstein and Norway. This approach would see the UK remain in the Europe-wide regulatory system. For drugmakers and the UK Medicines and Healthcare Products Regulatory Agency (MHRA), that scenario is likely to be the least disruptive in the near term.
Where the government stands on the topic is less clear. Zeichner is seeking clarification from Fox on whether he wants to remain part of a European regulatory framework and, if not, what relationship he foresees the UK having with EMA post-Brexit. Debate Transcript, Zeichner Letter
The cosponsors of a European Parliament Committee on Environment, Public Health and Food Safety (ENVI) motion have called for the European Commission to release a report on pediatric medicine regulation.
Members of the committee have given the Commission until the end of January. The politicians are particularly keen to see an analysis of the estimated public health consequences of the regulation of pediatric medicines. ENVI discussed the topic at a meeting this week. The session continued ENVI’s oversight of the gains made since regulations on pediatric medicines came into force in 2007.
A 2013 European review of the impact of the regulation found it had achieved many of its objectives, but also identified areas in which further advances were needed. The low uptake of pediatric-use marketing authorizations and issues relating to oncology were among the areas highlighted as ongoing weaknesses.
ENVI published its own report into whether children are missing out on treatments last year after attending a workshop at which the Commission and industry discussed the question. The report picked out recruiting children to participate in clinical trials as a problem and proposed incentives for developing specific pediatric drugs.
MHRA has started a social media campaign to encourage people to report suspected side effects. The push is part of an EU-wide initiative to raise awareness about national systems for reporting adverse events.
To get the message across, MHRA has created a video detailing how the reporting of side effects can lead to changes to the labels of medicines. Labels that better reflect the side effect profile of drugs can help doctors make better prescribing decisions, resulting in other patients receiving medicines that are less likely to cause them harm.
The goal is to instill a thought process in patients so, when they suspect they have experienced a side effect, they read the product label, talk to their healthcare professional and report the event. Patients in the UK can report suspected adverse events through MHRA’s Yellow Card website and mobile app.
MHRA is working with regulators in 21 other countries on the campaign as part of the Strengthening Collaboration for Operating Pharmacovigilance in Europe (SCOPE) project. SCOPE works to ensure the pharmacovigilance systems of national regulators meet EU requirements. MHRA leads two of SCOPE’s work packages and is a driving force behind another EU side effect alliance, Web-Radr.
MHRA Statement, More
EMA has finalized the agenda for a workshop on the role of big data in medicine development and regulation. Representatives of IBM, Google, the US Food and Drug Administration (FDA) and other organizations will speak alongside EMA employees at the event next week.
The two-day event is intended to provide EMA with information that helps it make best use of data for medicine development, authorization and post-market oversight. EMA is already using real-world evidence to support its pharmacovigilance activities, but it thinks there are opportunities to use large datasets in other areas. The regulator is also aware of potential pitfalls, including the consequences of failing to understand the limitations of data, protect patient privacy or use analytics appropriately.
To provide insights on these and other topics, EMA has invited people from IBM and Google to talk about their work on big data and cloud computing. The event also features the Association of Clinical Research Organizations and the European Federation of Pharmaceutical Industries and Associations discussing their respective takes on big data. Multiple academic researchers are due to present at the event, too.
On the regulatory side, EMA has put forward its own employees to talk and chair panels. People from MHRA, the Danish Medicines Agency, the Dutch Medicines Evaluation Board and FDA are also taking part. FDA has sent David Martin to discuss how it is handling the analytical challenges posed by large datasets.
EMA Statement, Final Agenda
Mark Garnier, a politician at the UK Department for International Trade, has said the government is working to ensure pharmaceutical trade with Israel is unaffected by Brexit. Garnier was responding to a question about what will happen if the UK is no longer covered by the EU-Israel agreement to mutually recognize pharmaceutical certificates. Written Answer
EMA is holding a workshop on the development of treatments for spinal muscular atrophy. The meeting brings two nonprofits, patients, industry representatives, researchers and regulators to EMA’s headquarters to discuss the indication. Topics up for discussion include the use of biomarkers in drug development. EMA Notice
The UK is set to offer women a non-invasive prenatal screening test for Down’s, Edwards’ and Patau’s syndromes from 2018. Adoption of the test by the healthcare system follows a recommendation by the National Screening Committee. The test is thought to be safer for women and their babies than the existing screening procedure. Press Release
Tags: Brexit, Big Data, regulatory science, social media, adverse event reporting