Your monthly round-up of market access news No Images? Click here What was new to MAP in MarchInformation on the Upcoming Medical Devices RegulationsThe European Council has released the final texts of the Medical Device Regulations (MDR) and In Vitro Diagnostics Regulations (IVDR) and on 7th March 2017, the Council adopted its much expected First-Reading Position on both the Medical Devices Regulations. Shortly after, on 9th March 2017, the EU Commission and Competent Authorities for Medical Devices (CAMD) organised their first multi-stakeholder implementation workshop which EUCOPE attended and have kindly provided a summary of the meeting. This is available to read on the MAP Europe site. Consultation TrackerMAP have created a new consultations tracker which lists consultations, their opening date, close date and provides a link to the consultation website. The consultations are also prioritised based on their likely impact on the medical device and pharmaceutical industries. One of the key features of this tracker is that the table can be searched by key words, so that subscribers can access a list of current and previous consultations in their area of interest. National Tariff Reference CostsTo date, the national tariff has been based on the average cost of the services, which comes from data submitted by NHS organisations during the annual NHS reference costs collection. Reference costs are the average unit cost to the NHS of providing a defined service in a given financial year.This new diagram explains how reference costs are created from ICD and OPCS codes which are all defined in detail on the "Key Components of the Payment by Results System" page on the MAP UK site. Rare Disease APPG Meeting NotesAll Party Parliamentary Groups (APPGs) are informal, cross-party groups of MPs and Peers who share an interest in a specific topic. Although they have no official status in Parliament, the activities of these high profile groups are tracked in the media and are therefore accorded a level of status and indirect influence. There are many health-related APPGs in Parliament, with many of the groups focusing on specific diseases or industry issues. MAP have shared notes made during an APPG meeting on rare diseases in February to provide subscribers with an example of the information discussed at these meetings. Sustainability and Transformation PlansThe idea of the Sustainability and Transformation Plans (STPs) was first announced in December 2015 as part of the NHS planning guidance. To create the plans, organisations across the country have come together to design “place-based plans” which will ensure the sustainability of health and care services in their area. MAP have created a table summary of each of the 44 plans highlighting the key areas of focus for each STP. March Market Access NewsNICE to Update its Appraisal ProcessThe new measures include:
Final Texts of the Medical Device Regulations and In Vitro Diagnostics Regulations ReleasedThe European Council has released the final texts of the Medical Device Regulations (MDR) and In Vitro Diagnostics Regulations (IVDR). The MDR and IVDR are likely to be published in the Official Journal at the end of April/beginning of May. There will be a transition period which will begin once the texts are published and companies will have 3 years to comply with the MDR and 5 to comply to the IVDR. It is important that MedTech companies begin to consider their transition plans as there is no grandfathering under the new legislation.Along with the final texts, the European Council also published two Draft Statements of the Council’s Reasons which include some useful background. To read the Medical Device Regulations, please click here. To read the In Vitro Diagnostics Regulations, please click here. NHS to Launch App LibraryThe NHS app library will be hosted on NHS Choices and co-designed with NICE, the Medicines and Healthcare Products Regulatory Agency, Public Health England (PHE) and NHS Digital, and will be live by the end of March. NHS Contract for Remote Monitoring of Cardiac HealthMobihealthnews has reported that the UK-based digital health company Inhealthcare is now working with Medway Community Healthcare to provide remote monitoring services to people who are self-managing cardiac health. The telehealth platform allows certain patients to self-manage their condition completely remotely, freeing up time that they would otherwise have to spend going to the doctor, as well as reducing pressure on the healthcare system. Questions Over Sustainability and Transformation FundingNHS leaders have said that the majority of agreed STP (sustainability and transformation plan) proposals should be implemented by 2021, however, there have been no formal plans to establish the necessary capital funding. BMA News has reported that it is likely that NHS England will provide some explanation of the capital funding available at the end of this month in the Five Year Forward View Delivery Update. The Chancellor’s budget revealed that £325m would be made available for the “strongest” STPs to begin implementing the plans and the Chancellor has also stated that more capital may be made available in the Autumn statement, but did not clarify how the £9.5bn capital costs identified by the BMA would be funded. To read more about this on the BMA website, please click here. The Committee for Human Medicinal Products (CHMP) Concept Paper on Quality Requirements of Medicinal Products Containing a Device ComponentAnnex 1 of the Directive 2001/83/EC, requires that details are provided for the medical devices with the medicinal product. However, given the differences in medical device and medicinal product legislation, the data supplied in the dossiers of the marketing authorisation applications has found to be inconsistent and often incomplete. The Committee for Human Medicinal Products (CHMP) have published their concept paper on developing a guideline on quality requirements of medicinal products containing a device component for delivery or use of the medicinal product. More News:For more news, events and consultations, please click here.Save the Date - 12th July!The Future of Life Sciences and EU Co-operation after March 2019The Adam Smith Institute and MAP BioPharma are working together on a Conference entitled “The Future of Life Sciences and EU Co-operation after March 2019”. This will be held from 9.30am – 2.30pm on Wednesday 12 July at Europe House in central London (Smith Square). Speakers will include senior representatives from:
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