EU (Parliament Politic Magazine) – The European Parliamentary Research Service (EPRS) did a study. They found that the EU and the UK need to agree more on how they see if products are okay and safe. This will help them trade things like medical stuff more easily.
Before the UK left the EU (called Brexit), they both followed the same rules for products. If a product was checked and approved in the EU, it could be sold in the UK without more checks. The same went for UK products going to the EU. This made trading between them really smooth. But some people who wanted Brexit thought the UK should make its own rules. So, the UK wanted to make things a bit harder for trading with the EU.
Trade Deal Between EU and UK is Working
The EPRS made a report about how the trade deal between the EU and the UK is working. They talked to a German report that said the deal was good for trade but had some issues. One problem is that they don’t agree on product rules and checks anymore. This makes it tough to trade, especially for things like machines and money.
The UK changed its mind about some of its own rules to match the EU’s. But for medical stuff, they still want to use different rules. The EPRS thinks it’s a good idea for both the EU and the UK to make trading easier, especially for medical things.
One problem is that the UK’s current government chose to make its own rules, even if it means less trade with the EU. How the UK uses these new rules will decide if they can agree with the EU on products. The EPRS says it would be best if the UK makes its rules in a way that other countries can understand.
The Rules About Older Medical Devices
The European Commission made a chart to help people understand the rules about older medical devices. These devices are from the past and special class III implantable devices. These rules are part of a law called the Medical Device Regulation (MDR). This law says that companies can still sell some old devices even though there are new rules. But there are some conditions they need to follow.
The Commission made two charts to help companies know if their devices can still be sold. The first chart asks 15 questions about things like certificates, changes, and other factors. Depending on the answers, it says if the device can be sold until the end of 2027 or 2028.
The second chart is for a specific kind of device. It only has two questions and two possible answers. The Commission says that the main law (MDR) is more important than these charts. The utilization of Merck & Co’s Keytruda in cases of tumors exhibiting microsatellite instability-high (MSI-H) or mismatch repair deficiency (dMMR) has been endorsed by The National Institute for Health and Care Excellence (NICE). This recommendation stems from the outcomes of a basket trial.
NICE backs UK use of Keytruda
In this particular basket trial, Merck established a connection between the checkpoint inhibitor and positive responses among adults who had previously undergone treatment for endometrial, biliary, colorectal, gastric, and small intestine cancers displaying MSI-H or dMMR.
The innovative design of the basket trial allowed Merck to assess the impact of Keytruda across 27 different tumor types within a single comprehensive study. Consequently, despite the intricate nature of the data, NICE extended its endorsement to Keytruda for five specific tumor types.
NICE highlighted the distinctive aspect of this evaluation, which lies in the basket-style framework of the trial evidence. The conventional methods for extrapolating survival outcomes are further complicated due to uncertainties regarding whether each distinct tumor site should be treated as an independent entity or if there should be a sharing of information across tumor sites (such as gastric or endometrial) during the extrapolation of survival data.
This recommendation represents a significant milestone, as it marks the first instance in which NICE has granted approval based on findings from an immunotherapy basket trial. BioIntegral decided to suspend the use of its bioprosthetic heart valves last year due to concerns about the potential presence of Mycobacteria chelonae.