Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
MHRA Finances Hit by Brexit-Triggered Drop in Income From EMA
The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) suffered a £5.7 million ($7.1 million) drop in its income from external customers last year. MHRA attributed the 5.6% decline to the fall off in work from the European Medicines Agency (EMA) ahead of Brexit.
In the 2017-2018 financial year, MHRA generated £101.9 million from external customers. Last year, the figure fell to £96.2 million, a trend MHRA pinned on the UK’s preparations to leave the European Union. As the UK was due to leave the EU in March, the 2018-2019 financial year was characterized by a reduction in revenue from centralized and decentralized license applications.
Last year, the UK was a rapporteur or co-rapporteur on one initial marketing authorization request received by EMA. That one co-rapporteurship was later transferred from the UK to another national competent authority.
The drop-off in work from EMA was expected, and the UK took action to mitigate its effects. Notably, the Department of Health and Social Care gave MHRA an additional £6 million, more than offsetting the loss of EMA revenues. The extra £6 million amounted to a 66% increase in the level of government funding for MHRA.
Buoyed by the government support, MHRA’s total income was up slightly on the previous year. MHRA posted an even bigger increase in its profit, swinging from a £4.1 million loss to a £16.6 million profit. The improved financial performance was underpinned by a sharp fall in indirect costs stemming from lower computing costs. MHRA and related organizations spent £24.7 million on computing last year, down from £40.4 million in the 2017-2018 financial year.
The upshot is MHRA weathered the initial impact of the UK’s departure from the EU. However, as the agency noted in its annual report, the full effect of Brexit is still to come. MHRA listed Brexit as the top risk it faces. That reflects the potential for Brexit to cause MHRA to lose still more business and access to EU systems and data.
France Seeks Feedback on Draft Good Preparation Practices Guidance
The French National Agency for Medicines and Health Products Safety (ANSM) is seeking feedback on a new guide to the preparation of medicinal products in healthcare establishments.
While many medicines are made in industrial settings under good manufacturing practices (GMPs), some drugs are prepared at healthcare facilities for direct supply to the patients they treat. France established rules covering the preparation of medicines at pharmacies in 2007, but since then global views on the subject have moved on. Most notably, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) published a revised guide to good preparation practices in 2014.
The ANSM guide released for consultation this week follows the same format as the PIC/S document. Both documents detail the requirements and principles that should inform decisions about quality control, personnel, product recalls and other areas involved in the preparation and supply of safe medicinal products by healthcare establishments.
In updating the guide, ANSM has placed greater emphasis on risk assessments. ANSM wants sites that prepare medicinal products to formally assess and prioritize threats to cut the risk of harm. The new guide also features stronger minimum quality requirements, specifically in relation to personnel training and controls.
ANSM is accepting feedback on the draft until 23 September.
NICE Starts Review of its Health Technology Assessment Practices
The UK National Institute for Health and Care Excellence (NICE) has begun a review of the methods it uses to develop guidance on drugs, diagnostics and medical devices.
NICE is embarking on the review to optimize its “evaluation methods to support the ambition of the NHS to provide high quality care that offers good value to patients and to the NHS.” With that in mind, NICE has tied the drug component of the review to commitments made in the 2019 Voluntary Scheme for Branded Medicines Pricing and Access. Stakeholder input has informed the focus, too.
These talks and considerations have given NICE a shortlist of topics it wants to address in the review. The topics fall into three categories: Factors that will address the expectations outlined in the 2019 voluntary scheme, scientific and methodological innovations affecting the types of products NICE will evaluate in the future and other general improvements to methods. NICE has made factors related to the voluntary scheme the top priority of the review.
NICE has disclosed plans to evaluate how it manages and reduces uncertainty, for example when it has to make assumptions to create economic models. NICE wants to assess the use of data analytics and real-world evidence in this context. The review will also look at the role quality of life measures play in economic analyses and technology-specific issues, such as the emergence of cancer drugs targeted at genetic markers found in tumors in a range of organs.
Parliament Health Committee Pushes EU to Increase EMA Headcount
The European Parliament’s health committee has called for EMA to receive more resources. Noting that the 2020 EU budget keeps EMA’s headcount flat, the committee stated that, “Where appropriate,
more financial and human resources must be allocated” to enable EMA to fulfill its mandate.
The Committee on the Environment, Public Health and Food Safety (ENVI) made a similar comment on the 2019 budget, which also proposed keeping EMA’s headcount flat. The year before that, ENVI responded even more strongly to plans to reduce EMA’s headcount by five people, arguing that “cuts have been carried out without taking into consideration either the additional workload created by increasing numbers of applications, or the corresponding increase in income from fees.”
It is possible to reach more upbeat interpretations of the latest staffing proposal, though. While there are no plans to significantly increase EMA’s overall headcount, the budget does call for a rise in the proportion of staff in higher-level administrative positions. Under the proposal, the number of administrators is forecast to rise by 7%, while the number of assistants falls by 11%.
Denmark Responds to Increase in Questions About Drug Supply Problems
The Danish Medicines Agency (DKMA) has issued a statement responding to an increase in questions about problems with the supply of certain medicines. DKMA said it is working with organizations in Denmark and overseas to remedy the problems.
DKMA is yet to name the drugs with the supply problems, opting instead to outline the situation and its response. The agency has “received a number of enquiries from the general public, medical professionals and pharmacies regarding problems with the supply of medicine.” DKMA cites product discontinuations and gaps in the supply at pharmacies as examples of the problems.
None of the problems have led to reports of “serious, critical supply shortages,” DKMA said, but the supply disruptions have inconvenienced patients, doctors and pharmacies and wasted their time.
’s Federal Institute for Drugs and Medical Devices
(BfArM) has issued recommendations to cut the risk of anesthesia incidents stemming from incorrect connection of breathing tubes. BfArM made the recommendations after receiving reports of problems that harmed patients. The agency is encouraging healthcare professionals to use hoses that prevent incorrect connections. BfArM Notice