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How to set up a LEMS

8 months ago
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I am currently working with a pipeline portfolio and I think the activity I want to conduct is a LEMS. I have had a look in the ABPI code of practice but I couldn’t find much information about the considerations. Is there a guide or additional information on how to conduct this type of activity? 

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PharmAffinity Forum: How to set up a LEMS

Yes, you are correct, there is very little information in the ABPI Code of Practice regarding the legitimate exchange of medical and scientific information during the development of a medicine (also known as LEMS). All the Code states is that ‘it is not prohibited, provided that any such information or activity does not constitute promotion…’

There is further information, although not much more, in the now archived Clause 3 Guidance, which is still available on the PMCPA website. The Guidelines on Company Procedures Relating to the ABPI Code of Practice suggests that companies should have an SOP relating to LEMS, if the company where you are working has an SOP or policy relating to LEMS this would be a good place to start. If not, then consulting the past PMCPA cases relating to LEMS would be helpful. From the past cases, some key principles are:

  • The medicine must still be in development. If a licence has been applied for in any country then this is unlikely to be the case.
  • There should be sufficient time to act on the information gained from the LEMS to impact the development of the medicine.
  • There should be a two way exchange of information. A Q&A at the end of a presentation is unlikely to meet this requirement. 
  • The audience should be capable of exchange.
  • There should be no promotional content during the meeting, for example discussing another licensed medicine that the company has.

It you think that you have a need for LEMS and it meets the criteria in past cases or you company’s SOP/policy then it might be useful to discuss this with a final signatory in advance of commencing any work.

Answered 8 months ago

Would keypad polling throughout a presentation be an acceptable way for a two way exchange?

8 months ago
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