The Early Access to Medicines Scheme (EAMS) gives patients with life threatening or seriously debilitating conditions early access to new medicines that do not yet have a marketing authorisation, when there is a clear unmet medical need. 

Since the scheme launched in 2014, over 1,500 patients have benefited from EAMS, with 69 Promising Innovative Medicine (PIM) designations and 22 Scientific Opinions (SOs) being issued.
 
The Office for Life Sciences (as part of the Department for Health and Social Care) is seeking to collect views from industry to assess i) overall awareness of the scheme, ii) how widely it is being used, iii) how it is perceived and iv) the priority potential areas for change.

OLS have asked the ABPI, BIA and EMIG to circulate this survey to their members to obtain a wide-range of views.
 
The survey should take around 10 minutes to complete. Please limit your responses to one per company; this will ensure results are weighted appropriately. A word version of the survey was attached to the email you received from your Trade Association. You can use the word document to consolidate responses from colleagues across your organisation and collate a single 'UK company view' to submit through this online portal. The deadline for responses is Friday 15 March 2019. Only responses received via this survey portal by this date will be accepted. 

Responses to the survey will be kept confidential and will not be shared outside of the survey team. The anonymised results will be used by the Office for Life Science to assess EAMS and to support a workshop later in 2019 to identify further steps which may need to be taken to improve the scheme.

If you have any further questions, please contact: paul.blakeley@officeforlifesciences.gov.uk. Please include the name of your company and your contact details alongside your question.

We would be very grateful if you could take the time to submit your views. This will help to inform our thinking by identifying what currently works well and how EAMS could potentially be improved.

Best wishes,

Paul Blakeley
Policy Advisor
Office for Life Sciences
Explanatory notes for completing the survey: 
 
  1. Not all questions may apply to your company. For example, if you are not a large multinational you do not need to comment on the view from your global HQ. Please therefore feel free to skip any questions you are unable or unwilling to answer. However, providing as much detail as possible will help us to better understand how the scheme is performing and areas for potential future improvements.
  2. Please provide the 'UK-view' of EAMS. For example, if you represent a multinational company with its HQ in another location, please respond as the UK representative with your views reflecting how the scheme is perceived by your company within the UK.
  3. A Promising Innovative Medicine (PIM) designation: indicates a product may be eligible for EAMS based on early clinical data. The PIM designation will be issued after an MHRA scientific meeting and could be given several years before the product is licensed.
  4. A Scientific Opinion (SO): describes the risks and benefits of the medicine based on data gathered from the patients who will benefit from the medicine. The opinion supports the prescriber and patient to make a decision on whether to use the medicine before its licence is approved.
  5. Information on the EAMS Taskforce and guidance referenced in question 13 is available here: https://www.gov.uk/government/publications/early-access-to-medicines-scheme-eams-how-the-scheme-works/early-access-to-medicines-scheme-eams-task-group-and-principles

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* 1. What is the name of the company you are responding on behalf of? [Note: this question is optional. If you would prefer to answer anonymously, please leave this box blank]

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* 2. What is your role in the company? [Note: if you are providing a single UK company-wide view then please confirm here]

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* 3. How would you describe your company? [Please select the option that is most relevant]

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* 4. Has your company ever submitted a product to the Early Access to Medicines Scheme (EAMS)? [Please select one response]

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* 5. If your company hasn't submitted a product to EAMS or, if you have applied for multiple PIMs but no (or only a single) SO, what are the reasons for this?  [Please select all those that apply]

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* 6. If your company is a large multinational and your global HQ has not supported your engagement with EAMS, why is this? [Please select all those that apply]

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* 7. Overall how does your company think EAMS is performing?

0 (very poor) (average) 10 (very good)
i We adjusted the number you entered based on the slider’s scale.

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* 8. What do you consider the main priorities to be for EAMS? Drag the rows below to rank in order of priority (i.e. 1 = highest priority and 5 = lowest priority)

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* 9. Do you consider EAMS to be an important component of the UK's wider medicines offer, to ensure the UK's regulatory system remains competitive? [Please select one option]

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* 10. What do you think would be the most effective next step(s) to help improve EAMS? [Please select all those that apply]

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* 11. Do you consider that EAMS could be a useful vehicle to collect real-world evidence? [Please select one response]

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* 12. What are your future plans to engage with EAMS in the next 12 months? [Please select one response]

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* 13. Are you aware of the EAMS Taskforce and the guidance documents which exist on Gov.UK? If you are, then do you find this information and these guidance documents useful? [Please select one response]

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* 14. We would really welcome any other feedback or views on EAMS, including the design of the scheme and/or the way it is administered etc...

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* 15. Would you be happy to be contacted to provide an EAMS case study or quote? If yes, please provide your name and email address below

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