Your monthly round-up of market access news No Images? Click here What was new to MAP in JanuaryMAP's Brexit Speech SummaryIn a major speech outlining the 12 objectives for the negotiations for leaving the EU, the Prime Minister set out her vision for a “Global Britain”. The speech was intended to give confidence and reassurance regarding the Government’s negotiating position and to provide some certainty and clarity. MAP have created a summary of the Prime Minister's speech highlighting areas which will be of potential interest to the pharmaceutical and MedTech industries. Information on the Upcoming Medical Devices RegulationsAfter a political agreement was reached between the Council, the EU Parliament and Commission for both the Medical Devices Regulation (MDR) and in vitro diagnostics Regulation (IVDR) proposals in June, the consolidated legal texts were translated into 24 EU languages during the summer, and are now being checked for legal conformity. MAP have created a summary of the upcoming legislations for medical devices and in vitro diagnostics. High Cost DevicesFor some high cost devices, reimbursement occurs through a separate price negotiation to the National Tariff and is paid in addition to the national price related to the service. This page outlines the process for nominating a high cost device for consideration and the criteria that needs to be met in order for a device to be considered as an exclusion from the National Tariff. Tenders OverviewThe national tender system is the procurement of goods and services on behalf of a public authority, such as a government agency. Instead of each organisation purchasing its own supply of a particular product or service, the government purchases what is needed for the entire country or population. The Europe Section on MAP, now describes the tendering process, the advantages and disadvantages and the measures put in place to harmonise standards across countries. January Market Access NewsNICE Pauses Cost Recovery PlansThe controversial plans (which were first announced in October) for NICE to recover the costs of its appraisals of drugs, medical devices and diagnostics, through charges to the companies which make them, have been put on hold until the Government completes its life sciences strategy. Members of the cross-party Exiting the European Union Committee have concluded in a recent report, that the Government should publish its Brexit plan by mid-February at the latest. The Small Business Research Initiative Supports Health Tech InnovationThe Small Business Research Initiative (SBRI) has announced £4.3m in funding for healthcare technology firms to help improve outcomes for NHS patients. Technologies selected to participate in the scheme were those that had the potential to releave pressure in A&E departments, such as apps and diagnostics. Department of Health £12 Million “Scan4Safety” PilotThe Department of Health have funded a £12 million ‘Scan4Safety’ project which is designed to enable staff to quickly and easily track each patient through their hospital journey. As part of the project, barcodes are being placed on breast implants, replacement hips, medication and surgical tools, in a new drive to keep patients safe. There are currently six pilots running across the country whereby patients receive uniquely barcoded wristbands as they enter hospital, and barcodes are then used to record their medication and the equipment used in their treatment. Select Committee on the Long-Term Sustainability of the NHS – Evidence DocumentsThe Lords Sustainability Committee have collated all of their written evidence and oral evidence on the long-term sustainability of the NHS into two interesting documents. These documents include responses discussing a range of themes, including life sciences, medical technologies and the pharmaceutical industry. To read the written evidence, please click here. To read the oral evidence, please click here. The committee expect to publish their report in late March. NHS Digital Releases First Version of the Improved Innovation ScorecardNHS Digital has been given access to an improved reporting suite so the innovation scorecard is now somewhat different to what was seen previously. The new scorecard is considered to be a much more guided analysis through dashboards than a complete analytical tool. The January release of the Innovation Scorecard is now live. In response to a user consultation undertaken in 2016, this publication sees the initial release of a new web platform/online visualisation tool to enhance user experience in accessing the data. This should make it easier for commissioners and users to find information on what medicines (and later medical technologies and diagnostic tools) are available in their region and allow for easier comparison with other areas. The new web platform/online visualisation tool can be accessed here. The Innovation Scorecard Official Statistic publication can be accessed here. NHS England Publishes its Methods for the Development of National Clinical Policies and Service SpecificationsNHS England has published two documents that describe the process NHS England follows when developing national clinical policies and service specifications. These documents outline the methods implemented in the development and approval of national policies and service specifications for directly commissioned services. The documents detail the three phases in development of a policy or service specification, from initiation of the topic to publication. Please find below links to these documents: Methods: National Service Specifications More News:For more news, events and consultations, please click here. |