Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
PRAC Adopts Rules for Public Hearings on Safety Reviews Ahead of dry run in July
The Pharmacovigilance Risk Assessment Committee (PRAC) has adopted rules of procedure for public hearings on safety reviews. PRAC, which could hold its first public hearing by the end of the year, is working on the initiative to give its members a way to gather the views of patients on safety issues affecting certain medicines.
A dry run is scheduled for the PRAC meeting in July. If successful, the trial could lead to PRAC running its first public hearing in the fourth quarter of 2016. PRAC will consider views expressed by the public at the hearings when it comes to make a decision regarding its recommendations for a medicine. As it stands, the group most intimately affected by safety issues associated with medical interventions — patients — have no means of directly influencing PRAC’s decisions. In theory, this could lead to PRAC recommending the withdrawal of a product over safety concerns that are tolerable to patients.
Recognition of the shortcomings of this approach have led PRAC, along with other divisions of the European Medicines Agency (EMA), to begin to open up. “Public hearings will enrich the scientific decision-making process on the safety of medicines,” Noël Wathion, EMA’s deputy executive director, said. “Although we have many years of experience in involving patients and healthcare professionals in our work, public hearings are a new concept for EMA as they will open up the process of assessing medicines in the [European Union] to the wider public for the first time.”
Ahead of the start of this new way of working, PRAC has established rules of procedure covering the process and practicalities of preparing, running and following up on public hearings. The document puts the public hearing toward the end of the review process. Having assessed evidence from various traditional sources, PRAC may turn to the public to gauge the wider public health consequences of its actions before making a recommendation. The affected marketing authorization holder will have the opportunity to present its views at the public hearing.
PRAC will only opt to hold a public hearing in certain circumstances. In some situations, the urgency of the safety concern may render it impractical to hold a meeting before issuing a recommendation. If this is not the case, PRAC will evaluate the nature and extent of the safety concern, the effect of the medicine being reviewed and availability of alternatives, the possible impacts of its decision and the level of public interest before deciding whether to schedule a meeting.
Press Release, Procedure Rules, More
EMA Adds Assessment of Liver Cancer Risk to Hepatitis C Drug Safety Probe
PRAC has expanded its review of the safety of direct-acting hepatitis C drugs including Gilead Sciences’ Sovaldi and Harvoni. The PRAC review, which began last month with a focus on the risk of hepatitis B reactivation following treatment, is now also assessing reports linking the blockbuster class of products to liver cancer.
PRAC initiated the expansion of the review after viewing the results of a study conducted at four Spanish hospitals. The study linked treatment of hepatitis C with direct-acting antivirals to the early, unexpected recurrence of hepatocellular carcinoma. PRAC is taking the study seriously enough to add the assessment of the risk of liver cancer to its ongoing review into the safety of hepatitis C drugs. The review is assessing the aforementioned drugs from Gilead alongside rival products from AbbVie, Bristol-Myers Squibb and Johnson & Johnson.
To assess the benefit-risk balance of the products in light of the liver cancer reports, PRAC has put five additional questions to the marketing authorization holders of the drugs under review. The list of questions calls for the companies to conduct comprehensive reviews of data they and third parties have generated through clinical trials and observational studies of the drugs. Specifically, PRAC wants to know how the number of recurrent cases of liver cancer in patients treated with the antivirals compares to forecasts for patients with hepatitis C who were not treated with such drugs.
PRAC is also requesting that the manufacturers carry out a systematic review of publications and abstracts to identify the incidence of liver cancer in patients who achieve sustained virological response following treatment with their drugs. After conducting these reviews and assessing the biological mechanisms that could be driving the early recurrence of liver cancer, the companies are to propose measures to minimize the risk of liver cancer and clinical or epidemiological studies to generate data on the early recurrence of the disease.
EMA Statement, PRAC Questions
Germany Joins EU Medical Countermeasure Procurement Alliance
Germany has signed up to the European Union joint agreement covering procurement of pandemic vaccines and other medical countermeasures. The signature of Germany means 24 countries representing 88% of the population of the European Union are now involved in the program.
An initial group of 14 member states signed up to initiative in 2014, four years after the European Commission began work on the project with a view to eradicating weaknesses in equitable access and purchasing power that were exposed by the 2009 H1N1 pandemic influenza outbreak. The terms of the agreement are intended to ensure that sufficient quantities of medical countermeasures are available in all participating member states, a goal that is underpinned by joint procurement.
Bringing Germany on board is a notable boost for the program, which has expanded quickly over the past year. Around 15% of the entire population of the European Union lives in the country. With France, Austria and Ireland also signing up over the past year, the population covered by the program has increased by more than 50% in a matter of months. The five largest member states by population are all now part of the alliance.
EMA Sets Date for Workshop on Pediatric Clinical Trials
EMA has scheduled the eighth annual workshop of the European Network of Pediatric Research for 2 June. The two-day event will include a debate on how the European Union Clinical Trial Regulation will affect the handling of ethical aspects of studies involving children.
Panelists will discuss this topic as part of a program spanning multiple aspects of what is required to run high-quality clinical trials in pediatric populations. This year, EMA will use the meeting to discuss the revision of a regulatory document covering the ethical considerations associated with running clinical trials in pediatric populations. The current version of the document was put together in 2006, a time before the creation of the pediatric research network.
EMA has worked with the pediatric research network, which added four members in 2015, since 2011. Interested parties can register for the first day of the latest event until 24 May. Attendance of the second day is limited to members of the pediatric research network and its coordinating group, which intends to use the day to define priorities for the initiative in 2016 and 2017.
The United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) has issued an alert reminding healthcare professionals of the dangers of giving live attenuated vaccines to people who are clinically immunosuppressed. MHRA released the alert following reports of the deaths of four newborns after exposure to a TNFα antagonist in utero. MHRA Alert