29 Transitional arrangements will be needed over the next few years, in particular for medicines, since any clinical research needed to satisfy licensing requirements will already be underway. Under these circumstances it would be unreasonable to require information which was not obtainable from the research already underway, since that would imply new research and might delay, perhaps by several years, the launch of the product. We believe that this would be unrealistic for many companies, especially those with international markets. However, we wish the transitional period to be as short as is reasonably practicable.
   
30 The devices industry may face problems of a different kind. Current regulations require evidence only of safety and performance, not of clinical efficacy in the sense required for pharmaceuticals; some of the building blocks for the appraisal of clinical cost effectiveness are not therefore readily to hand. Some medical devices companies are very small, and may find it difficult to fund clinical trials of sufficient power to produce evidence of cost-effectiveness. Finally, the issue already discussed (para 27) of a number of companies developing similar products for the same procedure is likely to be far more common than the comparable issue for pharmaceuticals.
   
31 These issues do not weaken the case for introducing the appraisal process across all sectors; they merely argue for a process which is sensibly adapted to the circumstances of each industry. A possible way forward in the transitional period might be as follows:
  i the information requirements which will apply when the system is mature (as in para 19 above) should be published as soon as possible;
  ii sponsoring companies will be invited to approach the secretariat at the earliest possible stage - for any intervention appearing on the Department's provisional short list of candidates for appraisal - and discuss what clinical research (if any) is already in train, and how far there might be scope to modify/extend it to help provide information which will not be a direct output of the research;
  iii the secretariat will be given the discretion to agree that, where it would be unreasonable or disproportionately expensive to expect the sponsoring company to provide research evidence fully conforming to the requirements, any "gaps" can be filled by modelling. The secretariat will also have the discretion to discuss information gaps with the Department, who may in exceptional cases agree to commission research to help fill the gaps. The sponsoring company might be required to make a contribution to the cost;
  iv in such cases the sponsoring company will be required to indicate, as part of their submission, what further post-marketing research they intend to carry out to fill any remaining gaps in the available evidence.
     
The process will then continue as in para 23 above.
 

We would welcome comments on

  • the contents of the industry submissions (para 22 and Annex C)
  • the proposed process, in particular the suggested iteration between the sponsoring company and secretariat (paras 23-24)
  • the possible role of patient groups (paras 24-26)
  • the proposed timescale (para 25)
  • the involvement of independent assessment providers for interventions without a clear sponsor (para 26) or for the "mixed models" of paras 27-28
  • the proposed transitional arrangements (paras 29-31)