Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
ENVI Calls for Temporary Increase in EMA Budget to Mitigate Effects of Brexit
The European Parliament’s health committee has called for an increase to the region’s regulatory budget and staffing levels. Members of the committee think the European Medicines Agency (EMA) needs the extra resources to maintain its normal level of service while relocating to Amsterdam.
If the current draft European Union budget is enacted, EMA will have revenues of almost €349 million ($406 million) in 2019. That amounts to a 3% increase over the estimate for this year. Most of the rise — and total revenues — is expected to come from the work EMA does, not an increase to the amount the EU gives the agency. The cap on staffing levels is also due to increase from 810 to 814, although in practice EMA may struggle to hit that level. EMA had 764 staff at the end of 2017.
The modest increases come at a time when EMA is putting non-core tasks on hold to ensure it can continue functioning while relocating from London to Amsterdam. Members of the European Parliament’s Committee on the Environment, Public Health and Food Safety (ENVI) think the EU should be doing more to help EMA through this tricky period.
“[ENVI] believes that additional financial resources and staff should be authorized for a limited period, so that EMA can transfer and retain the critical knowledge and skills necessary to continue to carry out its tasks effectively and to resume currently postponed activities,” the committee wrote in its feedback on the draft budget.
The committee has made similar points before. Last year, ENVI called for the creation of a budgetary reserve that EMA could use to help it through periods of Brexit-related volatility, such as changes to the Euro-Sterling exchange rate. ENVI was also very critical of plans to reduce the number of people in temporary positions at EMA from 596 to 591.
European politicians stuck with the 591 figure in the face of the criticism and have kept it in place for the 2019 draft. The four-person increase to the total proposed headcount comes from a change to the number of contract agents. However, while that implies the budget is the same as last year, there are differences in the details. Notably, the EU is proposing to allow EMA to take on 25% more people in administrative roles. The increase will be facilitated by cuts to the number of assistants.
Ireland Creates Scheme to Coordinate Management of Drug Shortages
The Health Products Regulatory Authority (HPRA) of Ireland has adopted a framework for managing drug shortages. HPRA thinks the framework will facilitate better management of supply constraints and thereby mitigate the impact of shortages, or even avert them altogether.
The framework sets out the shortage-related responsibilities of a range of groups involved in the supply and use of medicines and details the process that should be followed when evidence of a potential shortage emerges. To support the framework, HPRA has established an internal function that will work to coordinate the management of drug shortages and created a section on its website that will keep people informed of the status of supply constraints.
HPRA released a draft version of the framework for consultation in June. Most of the text is the same as the draft version. The changes include the addition of a new example of when a medicine will not be classed as being in short supply. The example covers situations in which supply to a wholesale distributor has been delayed, but there is enough stock in the supply chain to ensure patients can access the product.
Other changes to the final version include the removal of a statement that marketing authorization holders should submit a shortage notification form to authorities as soon as they become aware of a supply constraint.
Although HPRA has finalized the framework, it has not stopped working on its approach to shortages. HPRA sees the framework as part of an iterative approach to the development of mechanisms to mitigate the risk of shortages. The next steps in the process include the creation of strategies to avert shortages altogether, not just lessen their impact on patients.
, Shortage Framework
Denmark Creates Scientific Advice Program, Sets Fees for Feedback
The Danish Medicines Agency (DKMA) has started offering a scientific advice service. DKMA is pitching the service to companies, hospitals and other organizations that want feedback on their plans to run clinical trials or file for marketing authorizations.
Organizations developing human and veterinary medicines can approach DKMA to get advice on procedural issues via face-to-face meetings, conference calls or in writing. The format depends on the complexity of the topic being discussed. DKMA sees the service furthering Denmark’s efforts to foster innovation by supporting the work of startups and academic groups.
DKMA is charging a range of prices for the services. At the top of the range, complete multidisciplinary advice on clinical trials, chemistry, manufacturing and controls and preclinical development costs DKK 35,000 ($5,450). If a company just needs simple advice, for example about preclinical development, DKMA will charge them around half that amount. The rate for advice on first-in-human clinical trials falls between those extremes.
The service is closed off to some topics. DKMA will not issue advice on most medical devices, patent questions, good practices and matters related to health technology assessments. Companies that have already filed applications via centralized or national procedures cannot seek advice, either. If a company meets the criteria, it can submit an application for advice to DKMA.
MHRA Reclassifies Glucosamine Products as Medicines Above Dose Threshold
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has reclassified glucosamine products above a certain dose as medicines. MHRA’s action means companies will need to receive marketing authorizations to sell products that deliver a daily glucosamine dose of 1,178 mg or more.
Glucosamine is a widely used joint health supplement. However, in recent years Blue Bio, a Chinese pharma company that sells a prescription-only glucosamine product, has mounted a legal campaign to get regimens of 1,500 mg a day reclassified as medicines. The UK Court of Appeal ruled against Blue Bio in 2016, clearing food supplement manufacturers to continue selling 1,500 mg-a-day doses. However, the court also asked MHRA to take a closer look at the matter.
That has led to restrictions on the sale of glucosamine that are tougher than those sought through the courts. MHRA settled on 1,178 mg as the boundary between glucosamine supplements and medicines after looking at evidence of the pharmacological effects of the active ingredient. Clinical trials of glucosamine often use daily doses of 1,500 mg.
Going forward, food supplement manufacturers will no longer be able to supply glucosamine at this widely used dose. These companies will be free to provide products with recommended doses below 1,178 mg, but will need to seek a marketing authorization to go above that threshold. However, it is questionable whether MHRA can stop consumers from buying glucosamine supplements and taking enough to reach a 1,500 mg dose.
has issued a notice about the proper use of neonatal diabetes treatment Amglidia
. EMA Notice