Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
UK NHS Calls for Changes to Pricing Legislation to Lessen Focus on Fostering Competition
The United Kingdom National Health Service (NHS) has called for legislative changes to the rules and processes covering pricing and procurement. NHS officials think the law currently favors fostering competition at the expense of their ability to make decisions about pricing and licensing conditions.
The UK Competition and Markets Authority (CMA) has sided with the NHS in disputes in recent years, giving the healthcare service a way avoid being overcharged by companies with dominant positions in the market for particular drugs. However, NHS officials also think powers granted to CMA by a law passed in 2012 hinder their ability to serve patients. The officials think these powers can be removed without preventing CMA from helping the healthcare service in other regards.
“We propose to remove the CMA’s ... powers in relation to NHS pricing and NHS provider licence condition decisions,” NHS leaders wrote in their 10-year plan. “This would not affect the CMA’s critical investigations work in tackling abuses and anti-competitive behaviour in health-related markets such as the supply of drugs to the NHS.”
The 10-year plan published this week sets out how the NHS envisions adapting to the resourcing challenges it faces and other issues that will affect it in the years to come. Most of the document is only tangentially related to the rules covering drugmakers in the UK, but aspects of it are pertinent to these businesses.
ABPI, the trade group that represents branded drugmakers in the UK, welcomed aspects of the plan, singling out its endorsement of the Voluntary Pricing and Access Scheme (VPAS) as of particular importance. The UK drug industry reached an agreement on VPAS last year, thereby capping growth in spending on branded medicines at 2% a year while securing commitments to accelerate uptake of new products.
The NHS expects to benefit from the agreement, too.
“We will reduce the prescribing of low clinical value medicines and items which are readily available over the counter to save over £200 million ($254 million) a year. This aim is supported by agreed measures to manage branded health service medicines through the new statutory and voluntary pricing and access schemes,” NHS leaders wrote.
, ABPI Response
Swissmedic Posts Endoscope Reprocessing Checklist After Inspectors Find Faults
The Swiss Agency for Therapeutic Products (Swissmedic) has published a checklist to support the reprocessing of thermolabile endoscopes. Swissmedic shared the checklist after hospital inspections identified deficiencies with the cleaning of the reusable devices.
Difficulties with the cleaning of endoscopes have become a focus for authorities around the world as the reusable devices have become more complex and, by extension, harder to clean properly before being used on another patient. The problem has led to damning reports in the United States by the Government Accountability Office, and now to the publication of a checklist in Switzerland.
Publication of the checklist follows the identification of “certain deficiencies” with the reprocessing of thermolabile endoscopes during recent Swissmedic inspections of hospitals. To help hospitals to clean the devices to regulatory standards, Swissmedic has shared the checklist its inspectors use.
The checklist, which is yet to be published in English, is designed to assess whether the people who reprocess endoscopes are adequately trained and work out of premises suitable for the task. The document also addresses points about the presence of traceability and quality management systems and instructions for cleaning the devices.
While the checklist was designed for use by Swissmedic inspectors, the agency thinks it can help hospitals to ensure they are equipped to perform regulatory-compliant reprocessing of endoscopes.
ABPI Tweaks Advertising Code in Response to Advance of Digital Promotions
ABPI has revised the advertising code that covers companies that promote medicines in the UK. The changes reflect the evolution of online advertising since the guide was last updated in 2016.
Large sections of the 2019 code are the same as its predecessor text, but there is a thread running through some of the revisions to the document. In multiple sections, ABPI has revised the code in light of changes to online advertising and other evolutions of the digital marketing landscape in recent years.
The 2016 section on advertising in journals placed limitations on the use of two-page adverts in print publications, but made no mention of equivalent promotions in their digital versions. The 2019 code addresses that gap, stating that, “Where a digital advertisement is made up of a number of screens, no page or screen must be false or misleading when read in isolation.”
ABPI has also clarified its position on the certification of digital materials. The 2016 code observed that digital content can be dynamic and stated that material must comply as a standalone item and in the context in which it appears. The 2019 code builds upon this position by stating that companies do not need to certify each possible configuration of marketing materials and dynamic content.
The section of the code specifically focused on the internet is largely unchanged in the 2019 text. The most notable change is the expansion of the scope of the code to cover “other digital platforms” in addition to the internet.
Other sections of the text reflect different ways in which the industry has changed. For example, the 2019 code covers conditional marketing authorizations, the Early Access to Medicines Scheme and compassionate use, subjects that are more prominent now than they were in 2016. ABPI has also made changes in response to changes to the codes of conduct covering the behavior of healthcare professionals in the U.K. in relation to their interactions with the biopharma industry.
The 2019 document also features a new page setting out the principles of self-regulation. The new section lays out the thinking behind the code, its goals and what it means for drugmakers and other groups in the UK. In the section, ABPI states that complaints made under the code are “regarded as a serious matter both by that company and by the industry as a whole.”
MHRA Recalls Actavis’ Irbesartan Products Amid NDEA Contamination Fears
The Medicines and Healthcare products Regulatory Agency (MHRA) is recalling certain irbesartan products due to possible contamination with N‑nitrosodiethylamine (NDEA). The recall is the latest event in the ongoing wave of regulatory actions involving sartan products.
Initially, concerns about sartans centered on the potential for valsartan made at a single site in China to be contaminated with the carcinogen N-nitrosodimethylamine (NDMA). Subsequently, the focus of regulatory concerns expanded to cover other manufacturers and products in the sartan class, leading to the recall of irbesartan made by Actavis in the UK.
Actavis and MHRA are recalling four batches of blood pressure products that contain irbesartan and hydrochlorothiazide. MHRA said there is no evidence of the tablets causing harm to patients, and not all irbesartan products are affected. The agency is now working with European agencies and other member states to investigate the contamination and determine what further actions are needed.
The recall follows earlier MHRA actions against valsartan products made by Actavis, Mylan and Teva due to concerns about contamination with NDEA and NDMA.
, Recall Notice
The European Union
has published the veterinary medicine legislation that it voted on late last year. Legislation