What principles inform the decisions?

1. Medicines and medical devices bring widespread benefits for patients and the public but no product is free of risk. Many decisions involve weighing risks of harm against the likelihood of benefits. If a product is available for use, its risks must be acceptable in relation to the potential benefits to patients and users.
   
   
   
2. Some risks are known when a product goes on the market but others will only become known later when it is widely used, especially if adverse events are rare.
   
   
   
3. Decisions will be based on good science and robust methodology.  Judgements on safety, quality and performance will be informed by all available, relevant and reliable evidence, with the burden of proof often resting on companies.
   
   
   
4. A cautious approach to a decision will be needed where there is scientific uncertainty about the existence or extent of a risk but reasonable grounds for anticipating the possibility of severe adverse effects.
   
   
   
5. The Agency is concerned about the safety, quality, performance and use of a medicine or device throughout its life. The Agency will continue to seek and require additional information on risk and benefit, particularly since the initial authorisation or compliance with requirements may have been based on limited information. If the relationship between risk and benefit changes, so may the approval or classification of the product, or the advice to prescribers and users
   
   
   
6. The Agency is committed to the principles of equality, and will not improperly or arbitrarily discriminate, for example on the basis of age, sex or race.  However, the initial and ongoing approval of a product will legitimately take account of factors such as age, sex or race, particularly if any of these populations is a specific target for benefits or poses specific risks. So, for example, the effects of a product on children, on the elderly or in pregnancy may require explicit consideration
   
   
   
7. The financial cost of a product does not enter into the Agency’s decision-making processes, though bodies such as NICE and the NHS are concerned with costs.
   
   There is widespread confusion between the roles of MHRA and NICE (the National Institute for Health and Clinical Excellence). MHRA is concerned about the relationships between benefits and risks; NICE is concerned, inter alia, about the relationships between benefits and costs. As a considerable over-simplification, MHRA says a product can be sold while NICE says it can be bought (by the NHS).
   
   
   
8. The Agency’s decisions will as far as possible take account of the known views of relevant stakeholders such as medical specialists and patient representative groups
   
   
   
9. Decisions are made within processes which comply with legal obligations and in which the public can have confidence
   
   
   
10. The Agency’s decisions will as far as possible be transparent and open to public scrutiny; a reasonable person reviewing our decision should understand the rationale
    
    
    
11. If the Agency withholds information because of legal obligations such as the requirement to protect confidentiality, it will give its reasons for doing so.
    
    
    
12. The staff of the Agency and the members of its Advisory Committees are not influenced in their decisions by financial or other interests in the industries concerned.

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