European Regulatory Roundup: Romania Investigates Roche and 10 Other Drugmakers in Corruption Probe (6 August 2015)

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

Romania Investigates Roche and 10 Other Drugmakers in Corruption Probe

Roche has been targeted in a corruption investigation by Romanian officials. The probe has entailed a series of searches at the offices of drugmakers and hospitals as officials try to ascertain whether 11 companies paid doctors bribes to prescribe cancer drugs.

Officials visited 61 sites in Romania on July 28 to look for evidence to support their investigation, Reuters reports. Roche has confirmed it was among the businesses visited, adding that its Romanian general manager and finance chief left the company earlier in 2015. Romanian news outlets reported 10 other drugmakers are part of the National Anti-corruption Directorate (DNA) investigation, which is looking at the sales of generic and innovative cancer medicines since 2012.

“The file is related to suspicions of corruption offences regarding the manner in which a series of medicines were prescribed and purchased by certain health institutions and medical doctors in Romania,” DNA said. News of the probe emerged a day after fresh corruption allegations against GlaxoSmithKline came to light. The claims are unrelated to the DNA probe. A whistleblower is saying the firm paid doctors to prescribe Avodart, Duodart, Requip and other drugs between 2009 and 2012.

Reuters broke news of the allegations, which the whistleblower emailed to top management at the company. “We do receive letters of this sort from time to time. Sometimes we do find things and we act on it; sometimes our findings do not substantiate the matters being raised,” GSK said in a statement.

Reuters, More

EMA Posts Incident Management Plan to Guide Handling of Health Crises

The European Medicines Agency (EMA) has co-authored an incident management plan. EMA and the Heads of Medicines Agencies (HMA) drafted the document to shape how the region monitors, prevents and responds to potential health crises relating to the use of medicines

A crisis management plan has existed in the European Union since 1997 and has undergone revisions as officials have learned from their experiences. The latest document, the result of those lessons, is designed to help authorities meet three broad goals, starting with the continuous monitoring and reviewing of the effects of medicines on public health. When necessary, officials should take steps to prevent crises from occurring, a strategy EMA and HMA call “proactive incident management.”

When such steps prove insufficient to quash the chance of a crisis, the document calls for the Incident Review Network to order the creation of a Preliminary Risk Analysis (PRA). The outcome of the PRA dictates what happens next. If the threat is viewed as serious, officials will trigger the crisis management phase, in which the EU Executive Task Force and EU Operational Task Force will lead a reactive incident response.

Incident Management Plan

EMA Starts Publishing Herbal Medicine Recommendations

EMA has started publishing recommendations made by its Committee on Herbal Medicinal Products (HMPC). By sharing what HMPC said about the medicinal properties of herbal products, EMA hopes to help the public make more informed decisions about the therapies they use.

The initiative started this week with the publication of summaries for six herbal medicines that were assessed by HMPC earlier this year. For each of the herbal medicines — eschscholzia, ginkgo, symphytum, capsicum, agrimonia and hieracium — EMA has released details of the substance being assessed, HMPC’s stance on its recommended uses, supporting data and an overview of potential side effects. The move will increase access to HMPC’s rulings on the safety and efficacy of products.

EMA will raise the number of substances for which such information is available over time by adding documents whenever HMPC assesses a new medicine or reviews an existing product. Since it was set up in 2004, HMPC has published more than 130 monographs to help member states evaluate marketing authorizations. The new initiative expands on these activities by making more details of what HMPC recommended and why available to the public.

Press Release

EMA Schedules Clutch of Workshops with Focus on Pharmacovigilance

EMA has scheduled a handful of workshops and meetings for the second half of 2015, most of which relate to its pharmacovigilance program. The regulator is offering the industry support with the basics of pharmacovigilance and detailed advice on the use of its EudraVigilance system.

The season of pharmacovigilance sessions is due to start on 10 November, at which time newcomers to the topic will gather at EMA’s headquarters in London for a training event covering the basics of the topic. Attendees will learn about the format, structure and content of individual case safety reports (ICSRs), knowledge that people must have before attending the more advanced events. EMA is aiming the session at anyone involved with data entry and expedited reporting.

Additional details will be provided later in November in a two-day session. The meeting in late November is intended to provide a face-to-face forum at which the regulator can discuss practical aspects of complying with pharmacovigilance requirements, such as mandatory data elements. Finally, EMA has scheduled a three-day session covering the key elements of electronic reporting of ICSRs for early December. Officials also released dates for pediatric and risk minimization events.

Pharmacovigilance, Practical Aspects, Electronic Reporting, Pediatric Research, Risk Minimization

Other News:

EMA has released five International Conference on Harmonisation (ICH) documents, three of which are draft guidelines open for comment. The drafts cover good clinical practice, residual solvents and compound-specific acceptable intakes. Another two files, covering active ingredients and electronic Common Technical Documents, are now final. E6(R2), Q3C (R6), ICH M7, Q7, M8

The United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) has released two medical device safety alerts. MHRA noted a risk of needlestick injury from Medicina’s faulty retractable syringes and a recall of Medtronic tracheostomy tubes that are causing some patients to have difficulty breathing. Medicina, Medtronic

EMA Deputy Executive Director Andreas Pott has released guidelines on reimbursing the travel costs of people coming for an interview or medical examination with the regulator. Applicants who live within around 90 miles of the test location are ineligible for reimbursement. For everyone else, the four-page document covers what they can expect to receive from EMA. Executive Director Ruling 

The Excipients Drafting group has released two draft Q&A documents. The group posted the papers on the use of boric acid and sodium laurilsulfate to bring its advice in line with the updated guideline on “Excipients in the label and package leaflet of medicinal products for human use.” Boric Acid Q&A, Sodium Laurilsulfate Q&A

EMA has published updated draft guidelines on the processing of renewals in the centralized procedure. Work on the original document, which was revised in 2005 and again in 2012, dates back to 2000. The document is designed to help marketing authorization holders meet their obligation to renew their approvals every five years. Draft Guidelines

Health policy researchers William Walter and Tom Doughty have argued EMA should increase its level of cooperation with the United States Food and Drug Administration, citing plans in Australia to accept approvals by comparable regulators as a model to emulate. EurActiv

MHRA has enforced the European decision to ban drugs tested by GVK Biosciences. The regulator has allowed 12 drugs tested by the Indian company to remain on sale because they are classed as critical. MHRA Notice