The BioIndustry Association (BIA) welcomes the government's plans to introduce a Promising Innovative Medicine (PIM) designation and an Early Access to Medicines Scheme (EAMS). However, by deciding not to fund the scheme the government is undermining its attractiveness to UK SMEs and to global corporations choosing the UK as a location for their clinical trials and runs the risk of the scheme being under-utilised.
- The Early Access to Medicines Scheme (EAMS) aims to support access in the UK to unlicensed or off-label medicines in areas of unmet medical need.
- The Promising Innovative Medicine (PIM) designation will provide an early indication that a product may be a possible candidate for the Early Access to Medicines Scheme.
- The MHRA will issue an EAMS opinion if the quality, safety and efficacy data provided in support of the application is sufficiently compelling for a positive benefit:risk balance and added clinical value.
- The EAMS scheme will be complemented by the introduction of a new NICE technology appraisal and NHS England Commissioning process.
- The EAMS will be limited to medicines representing a significant advance in treatment in an area of unmet need.
- On 28 April the BIA and the ABPI are holding a event to discuss the practicalities of the scheme for companies in the UK.
Steve Bates, BIA Chief Executive Officer:
"The BIA supports the government's decision to introduce a Promising Innovative Medicine (PIM) designation and an Early Access to Medicines Scheme (EAMS) which shows the UK is committed to an "all hands on deck approach" to speedily progress promising innovative therapies to the patients that need them.
"As it is currently envisaged, without centrally funded reimbursement, the scheme runs the risk of being under-utilised. The BIA remains committed to working in partnership with all stakeholders to ensure that this is not the case and the scheme remains globally competitive.
"To ensure that patients receive the next generation of breakthrough therapies in the UK, while supporting overarching industry objectives, under the EAMS companies will need to be reimbursed at an earlier stage in development at a price that recognises the uncertainty of the effectiveness of early stage products."
Strategy for UK Life Sciences: http://bia.me/StrategyUKLifeSci
FDA breakthrough therapy designation: http://bia.me/FDA_breakthrough
The timeline of BIA activity on the Early Access to Medicines Scheme (EAMS):http://bia.me/EAMStimeline
Photo of Steve Bates, BIA Chief Executive Officer: http://bia.me/biaSteveBates
Founded 25 years ago at the infancy of biotechnology, the BioIndustry Association (BIA) is the trade association for innovative enterprises involved in UK bioscience. Members include emerging and more established bioscience companies; pharmaceutical companies; academic, research and philanthropic organisations; and service providers to the bioscience sector. The BIA represents the interests of its members to a broad section of stakeholders, from government and regulators to patient groups and the media. Our goal is to secure the UK's position as a global hub and as the best location for innovative research and commercialisation, enabling our world-leading research base to deliver healthcare solutions that can truly make a difference to people's lives.
For further information, please go to www.bioindustry.org and twitter.com/BIA_UK
Head of Communications, BioIndustry Association
Email: [email protected]
Phone: 020 7630 2191 or 07825 942 934