What questions should be considered to ensure that reasonable decisions are made?

We do not expect that all these questions will be considered in all situations or that there will be simple yes or no answers to many of them. The list is not exhaustive, and other questions may be relevant in particular situations.

1. Does the product work and offer useful clinical benefit if used in its specified way?
   
   Is there robust evidence that the product will do what the company says it will do?
   
   
   
2. What impact will the product have, or is it having, on both the quality and length of life in those patients who are treated with it or on whose behalf it is used?
   
   
   
3. Has the manufacturer demonstrated that it can consistently and reliably make the product to the required level of quality?
   
   
   
4. Does the evidence available before a product is marketed give a clear indication of all adverse effects that have been discovered, the likelihood that they will occur and their severity?
   
   Have companies done all they reasonably can to identify, reduce and communicate risks?
   
   
   
5. If the available evidence on safety, quality or performance is uncertain or unclear, is more needed before a decision can be made?
   
   
   
6. Is there relevant evidence about everyday use of this or similar products, or do we need to seek such evidence?
   
   A scientifically excellent clinical trial is of limited value if its design does not reflect the likely use of the product in everyday situations
   
   
   
7. From knowledge of how the product works, is it possible to predict other adverse effects that may occur when the product is used with larger and wider groups of people, or in conjunction with other products?  If so, are there clear plans in place to track and manage the risks?
   
   
   
8. Can the risk of adverse effects be limited by restricting the product’s use to specific groups of patients, or to particular dosages or durations of use?
   
   
   
9. What risks are associated with the condition the product is designed to manage?
   
   Do the risks of not treating the condition outweigh the risks associated with the product? Is it a very serious/debilitating condition, or a mild and self-limiting one? Greater risks may be acceptable for products that markedly reduce suffering or treat life-threatening conditions, especially those for which no other effective treatment is available
   
   
   
10. Can the Agency accept less evidence on which to base its decision if the rarity of the clinical condition means that more detailed evidence cannot reasonably be gathered?
    
    
    
11. Is the Agency prepared to accept early and limited evidence on which to come to a decision if a product, while appearing to have acceptable risks, offers significant or urgent benefits to public health or outstanding benefits to patients?
    
    
    
12. Are there, or can there be, warnings for the public as well as for healthcare professionals about the nature and likelihood of adverse effects, warnings that are understandable and specific enough for them to make informed choices or to restrict the usage?
    
    If not, how else might the risks be managed? Would it be better not to allow the product to come onto or to remain on the market, or to restrict its availability?
    
    
    
13. Does the Agency’s decision take account of the known views of the public about the balance between risks and benefits? If the public’s views are in conflict with robust and comprehensive scientific evidence, should they carry any weight? 
    
    
    
14. Does the Agency need to seek further views from relevant parties?
    
    In addition to the scientific evidence, do we need views from healthcare professionals, organisations concerned with specific conditions, and/or patients who have used the product?
    

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