Euro Roundup: EU report identifies ‘greater mutual recognition’ as way to boost medicine trade with UK

The European Parliamentary Research Service (EPRS) has found that greater mutual recognition of product rules and conformity assessments between the EU and the UK is needed to drive the trade in goods including medical products.

Before Brexit, the two sides adhered to the same product rules, and conformity assessments performed in the EU unlocked the UK market and vice versa. The arrangement enabled seamless cross-border trade in goods and services. However, for some of the politicians and voters who wanted Brexit to happen, part of the point of leaving the EU was to allow the UK to set its own rules and standards. That thinking led the UK to seek a deal that erected barriers to trade with its biggest buyer of goods and services.

A new report from EPRS, which provides members of the European Parliament with independent analysis and research, assesses the effects of the EU-UK Trade and Cooperation Agreement.

The report draws on sources including a German report that concluded that the agreement “has been a 'success' from the point of view of the Bavarian economy, in terms of facilitating EU-UK trade in goods” but noted that “various areas are not sufficiently regulated or are too complicated, and new trade barriers have emerged.” EPRS identified the cause of the problems.

“Trade in goods is hampered by the lack of mutual recognition of product regulations and conformity assessments, which have been made more difficult; new UK certification and registration systems apply,” EPRS wrote.

The UK has rowed back from the implementation of its own standards in some areas by pausing plans to adopt its own certificate for many products. UK plans to adopt an alternative to the EU’s CE mark for medical devices are going ahead, though. EPRS sees value in the EU and UK taking additional steps to lower barriers to trade, specifically in a few areas including medical products.

“Trade in goods would be facilitated by greater mutual recognition of product rules and conformity assessments, especially for the automated and financial sectors, but also for agricultural or medical products,” according to the report.

One challenge is that, under the current government, the UK has decided to sacrifice trade with the EU to gain the freedom to set its own rules. How the UK uses that freedom, and the extent to which it opts to diverge from the EU, will influence the feasibility of mutual recognition. “Where the UK government wishes to use the leeway it has gained unilaterally, it would be best if it did so in a way that is also calculable for foreign partners,” EPRS wrote.

EU Report

European Commission publishes flowchart for understanding rules on legacy MDR devices

The European Commission has posted a flowchart about the conditions and deadlines for placing legacy devices and class III custom-made implantable devices on the market.

Under the amended Medical Device Regulation (MDR), manufacturers can keep selling some products covered by certificates issued under the old directives during an extended transitional period. However, certain conditions apply. To help manufacturers understand the conditions, the Commission has created two flowcharts for determining if a device is eligible for the transitional period.

The first flowchart covers legacy devices and features 15 questions about certification, notified bodies, significant changes and the other factors that determine if a product is eligible for the transition period. Depending on the answers, the flowchart either says the device is ineligible or can continue to be sold until either the end of 2027 or the end of 2028.

A second, smaller flowchart covers Class III custom-made implantable devices. That flowchart only has two questions and two possible outcomes. The Commission said that the text of MDR takes precedence over either flowchart.

Commission Flowchart

NICE backs UK use of Keytruda across 5 tumor sites on basis of immunotherapy basket trial

The National Institute for Health and Care Excellence (NICE) has recommended the use of Merck & Co’s Keytruda in tumors with microsatellite instability-high (MSI-H) or mismatch repair deficiency (dMMR) on the strength of a basket trial.

In the basket trial, Merck linked the checkpoint inhibitor to responses in adults with previously treated endometrial, biliary, colorectal, gastric and small intestine cancer with MSI-H or dMMR. The basket trial design enabled Merck to evaluate the effect of Keytruda on 27 tumor types within a single study, and to get a NICE recommendation in five of the tumor types, despite the data posing challenges to the body.

“A unique characteristic of this appraisal is the basket nature of the trial evidence,” NICE wrote. “The standard methods for extrapolating survival outcomes are further complicated by assumptions about whether each tumor site should be treated independently or whether some borrowing of information should take place between tumor sites (e.g., gastric or endometrial) when extrapolating survival data.”

The recommendation is the first granted by NICE on the basis of an immunotherapy basket trial.

NICE Recommendation, Press Release

France’s ANSM suspends BioIntegral Surgical devices over potential risk of contamination

The French National Agency for the Safety of Medicines and Health Products (ANSM) has suspended trade in BioIntegral Surgical medical devices incorporating porcine tissues over contamination concerns.

Last year, BioIntegral placed a hold on the use of its bioprosthetic heart valves in response to the possible presence of Mycobacteria chelonae. At the time, the company said it “strongly” believed its devices were not the source of the bacteria and in March, after seeing the results of tests run in Canada, concluded “probably a false alarm, they were sterile the whole time.”

Holds outside the EU were lifted last year. BioIntegral voluntarily withdrew its CE mark, ending sales in the EU, but some products were placed on the market before it took that action. Previously, quarantines prevented the use of the devices but, with Italy lifting its restrictions, ANSM has acted to stop products from reaching the French market.

ANSM Notice (French)

EMA seeks feedback on using modern manufacturing techniques for herbal preparations

EMA has released a draft concept paper on modern manufacturing techniques used for herbal preparations.

The draft, which is open for comment until 15 November, outlines the need to discuss opportunities and challenges posed by the application of modern technologies for the extraction of plants, as well as “the expectations when they are included in the marketing authorization/registration dossier.” EMA is seeking examples of the use of modern technologies.

Based on the feedback, the agency plans to draft a reflection paper. EMA expects to release the draft reflection paper for public comment around nine to 12 months after it receives feedback on the concept paper.

Concept Paper

Other news:

The Italian Medicines Agency (AIFA) has issued a statement of noncompliance with good manufacturing practices. AIFA published the statement after finding 18 deficiencies, including one critical issue, during an inspection of a Istituto Biochimico Italiano Giovanni Lorenzini plant. The critical fault related to aseptic production and triggered a recall of drug substances. AIFA Statement

Euro Roundup: EU report identifies ‘greater mutual recognition’ as way to boost medicine trade with UK

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