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Regulatory News | 03 September 2015 | By Nick Paul Taylor
Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
European pharmaceutical trade groups have increased their reported spending on lobbying by 235% over the past three years, campaign group Corporate Europe Observatory (CEO) reports. The jump was driven by the European Federation of Pharmaceutical Industries and Associations (EFPIA).
In 2010, EFPIA declared an outlay on lobbying of less than €50,000 ($56,000). Last year, the group’s spending on lobbying topped €5 million, more than eight times as much as any other pharma trade association. In May, EFPIA attributed the increase in its spending to changes to the scope of the transparency registry and the calculation for outlay on full-time equivalents. CEO, an organization with an anti-lobbying agenda, is dismissive of the argument.
“Although it is true that the register’s guidelines have become more specific over time, the general instructions concerning what should be included as lobbying expenses were reasonably comprehensible before,” CEO wrote in a report into lobbying by the pharma industry. The release of the report follows a period in which the influence of the pharma industry over regulations has come under particular scrutiny, notably because of concerns over trial data transparency and other issues.
Some of the issues came to a head in the period following the appointment of Jean-Claude Juncker as president of the European Commission. Juncker sparked an outcry by proposing the transfer of responsibility for pharmaceutical policies from DG Sanco to DG Enterprise, a proposal critics saw as putting the interests of business before public health. From 1 November, when Juncker came to power, to mid-March, EFPIA reportedly had more than 50 meetings with the commission.
CEO Report, The Independent
France has escalated its row with Roche over the use of Avastin to treat wet age-related macular degeneration (AMD). Having authorized the off-label use of Avastin for that indication earlier this year, the French government has now gone a step further by allowing reimbursement.
The decision means doctors, under certain, strict conditions, can use Avastin to treat a disease Roche never tested it for and be reimbursed for the cost of the product. Roche and the wider biopharma industry are unhappy with the decision. Politico reports a complaint has been sent to the European Commission, in which the authors argue the actions of the French government are in violation of the rules of the Union.
France’s decision to reimburse off-label Avastin use from 1 September is the latest in a long-running global row over its use as a treatment for AMD. Europe has emerged as a focal point for the row as countries look to off-label use to cut their healthcare costs. The economics are compelling. France is expecting to pay €10 ($11) per injection of Avastin. A single injection of Lucentis, the AMD drug Roche would like to see used, can reportedly cost as much as €900 ($1,010).
Opponents of off-label use are unconvinced it is clinically appropriate to use Avastin to treat AMD though, pointing to the reliance on data from the Comparison of Age-Related Macular Degeneration Treatments Trials research group and safety issues to make their case. “Because Avastin is not formulated for wet age-related macular degeneration and it has to be repackaged, and with that it increases the risk of infections,” Catherine Daly, a senior analyst at GlobalData Healthcare, said.
The medical literature monitoring program set up by the European Medicines Agency (EMA) is now fully operational. Having started with a launch phase of the program that was limited to 50 active substance groups in July, EMA expanded the program eightfold this week.
As of 1 September, EMA is monitoring the medical literature for suspected adverse events relating to 400 active substance groups. Keeping track of adverse events relating to the 300 chemical and 100 herbal active substance groups is intended to improve the monitoring of the safety of medicines in Europe, notably by cutting the incidence of duplicated reporting by multiple companies. Producers of drugs included in the program will no longer need to enter safety reports into EudraVigilance.
The system will also support the flow of information from EMA to manufacturers. EMA will provide reports of suspected adverse events that it finds in the literature to the marketing-authorization holders of the affected products. The manufacturers can then add the information to their internal safety databases and use it to comply with adverse event reporting requirements outside the European Economic Area.
EMA expects the initiative will help more than 4,000 companies. Manufacturers can check if they are affected by the program by looking at the spreadsheet of monitored substances EMA made available when it first unveiled the initiative in May.
Swissmedic has refuted allegations that the product information for Bayer’s hormonal contraceptive Yasmin is “incomplete, misleading and incorrect in parts.” The Swiss regulator went on the defensive after the CSS Institute for Empirical Health Economics fired off the accusation about the labelling.
Health insurance provider CSS made the accusation in a media briefing that centered on the case of a 16-year-old girl who suffered a serious pulmonary embolism after taking Yasmin. After analyzing the situation, CSS concluded that the labelling for Yasmin, particularly regarding thromboembolisms, is lacking. Swissmedic has responded with a press release that picks apart what it sees as the flaws in the CSS report.
As Swissmedic sees it, the labelling for Yasmin when the 16-year-old suffered an embolism, March 2008, accurately reflected what was known of the risks at that time. Since then, Bayer has paid more than $400 million in the United States to settle cases of Yasmin-related blood clots, but Swissmedic argues that in 2008 it was unaware the drug posed a greater risk than older preparations. Having rejected CSS’ argument outright, Swissmedic concludes there are no actions it needs to take.
Pfizer has come out against greater clinical trial data transparency. The campaign for greater openness has continued to gather pace in the wake of Europe adopting transparency-encouraging regulations, but Pfizer sees no need to change its current approach, The Guardian reports.
A representative for Pfizer made the comments ahead of the release of a report by campaign group AllTrials that will rank the data disclosure policies of 50 leading drugmakers. The ranking is expected to provide investors, a group that is increasingly agitating for greater transparency, a way to push certain companies to change their policies. Pfizer, which is unlikely to be among the lowest ranked companies on the list, thinks it already strikes the right balance.
“We don’t believe that further investment beyond this would offer value to patients, health services or to our shareholders,” the representative said. Pfizer has made data available for trials dating back to 2007 and considers requests for results from earlier studies on a case-by-case basis. The likes of AllTrials see that older data, which covers some of the most widely used drugs today, as a valuable resource that should be shared more widely.
InsideMedicalDevices has released an analysis of the state of play in the ongoing attempts to revise rules covering medical devices and in-vitro diagnostics. InsideMedicalDevices
Tags: European Regulatory Roundup, Regulatory Roundup, EU Regulatory Roundup