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Identifying Unmet Medical Needs (UMNs) in the cardiovascular field

Survey introduction
Unmet medical need (UMN) is a regulatory term meaning that adequate treatment for your patient is not yet available or not satisfactory. Financial and regulatory incentives are provided to foster research in these areas and bring new therapies to the market, including funding and so-called accelerated pathways. The goal of this survey is to gather evidence from the cardiovascular community on UMNs in the cardiovascular field and to collect feedback on a new definition currently under discussion by EU institutions, who are currently negotiating a reform of the EU general pharmaceutical legislation. Findings will be shared with policymakers and contribute to the shaping of relevant provisions and to regulatory practice.

Disclaimer
May we remind you of the codes of conduct related to market research among healthcare professionals:
  • We comply with the European General Data Protection Regulation (GDPR) 2016/679. Any personal data processed in connection with this survey will be treated confidentially and only used for the purpose of market research. Material and data collected from you will be analysed overall, used internally by the ESC and kept for a maximum of 24 months for analysis and quality control purposes. We take all reasonable care to prevent any unauthorised access to your personal data. We respect your privacy and your right to access, modify, or suppress your personal data. At any time, you can ask to know what personal data is being held. If you have any questions about data protection or require further information, please contact our data protection officer DPO@escardio.org
  • This survey is anonymous. We will not disclose your identity to any third party
  • You have the right to end your participation in this survey at any time
1.Please confirm whether you have considered all the clauses above and accept to participate in this survey.
General questions
2.Which best describes your profession?
3.What is your medical sub-specialty?(Required.)
4.In which country do you currently work?
5.Do you belong to any of the following ESC Communities? (Tick all that apply)(Required.)
Unmet Medical Needs in Cardiology
6.What are the most crucial unmet medical needs in your field?(Required.)
7.Why would you consider them unmet medical needs?
8.Can you provide any literature reference or other supporting material, if available?
Definition and criteria proposed by EU regulators

Instruction: Please read carefully the following article (article 83 of the draft Directive on medicinal products for human use as approved by the European Parliament)
Article 83 - Medicinal products addressing
an unmet medical need


1. A medicinal product shall be considered as addressing an unmet medical need if at least one of its therapeutic indications relates to a life threatening or severely debilitating disease and the following conditions are met:
  • (a) there is no medicinal product authorised in the Union for such disease, or, where despite medicinal products being authorised for such disease in the Union, the disease is associated with a remaining high morbidity or mortality; AND
  • (b) the use of the medicinal product results in a meaningful reduction in disease morbidity or mortality for the relevant patient population.

2. Designated orphan medicinal products referred to in Article 67 of [revised Regulation (EC) No 726/2004] shall be considered as addressing an unmet medical need.
9.In your view, would the cardiovascular Unmet Medical Needs (UMNs) that you indicated in question 6 be captured by this definition?(Required.)
Yes
No (go to Q10)
First mentioned
Second mentioned
Third mentioned
10.If no to the above, which ones are not? Please explain why?
Criterion (a)
11.Considering criterion (a) of the definition, should the definition of UMN include not only diseases but also “conditions” (for example syndromes, specific subsets of patients, etc. as it is defined for Orphan Medical Devices)?(Required.)
Yes
No
Syndromes
Specific subsets of patients
Others
12.Can you provide any examples of cardiovascular diseases/conditions for which there is no medicinal product authorised in the European Union yet? If you do not know, please leave blank
13.Can you provide any examples of cardiovascular diseases/conditions for which one or more medicinal products are available, but which are still associated with high rates of morbidity and mortality? If you do not know, please leave blank
14.How would you define/measure “high morbidity” and “high mortality” ?
15.Should other measures of disease burden, independent from “high morbidity” and “high mortality” be added to the definition?(Required.)
Criterion (b)
16.Considering criterion (b) of the definition, how should a “meaningful reduction” in disease of high morbidity be measured? Why?
17.How should a “meaningful reduction” in disease mortality be measured? Why?
18.In addition to morbidity and mortality, should improvements in quality of life also be considered in the definition?(Required.)
Paragraph 2
19.Focusing on paragraph 2 (orphan medicinal products), can you provide any examples of cardiovascular conditions affecting not more than 5 in 10,000 persons in the European Union and for which no satisfactory method of diagnosis, prevention or treatment exist (i.e. orphan conditions according to the draft legislation)?
Conclusions
20.Do you have any suggestions to avoid a too broad and non-specific application of the UMN definition, ensuring that only “real” unmet needs are prioritised?
Many thanks for your contribution
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