MAP status30 Sep 2020 11:57
Can anyone enlighten me as to the details of this. I attach an extract from Wikipedia below but I am not sure if this is relevant or correct. Is there a difference between 'EAMS' and 'MAP'?
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'Europe
In Europe, the European Medicines Agency issued guidelines that members may follow. Each country has its own regulations, and they vary. In the UK, for example, the program is called "early access to medicine scheme" or EAMS and was established in 2014. If a company that wants to provide a drug under EAMS, it must submit its Phase I data to the Medicines and Healthcare products Regulatory Agency and apply for what is called a "promising innovative medicine" (PIM) designation. If that designation is approved, the data is reviewed, if that review is positive, the National Health Service is obligated to pay for people who fit the criteria to have access to the drug. As of 2016, governments also paid for early access to drugs in Austria, Germany, Greece, and Spain.[1]
Companies sometimes make use of expanded programs in Europe even after they receive EMA approval to market a drug, because drugs also must go through regulatory processes in each member state, and in some countries this process can take nearly a year; companies can start making sales earlier under these programs.[1]'
Does anyone know iof we have 'PIM' status or have applied for it? If we have this then WIKI says the NHS is obligated to pay for the treatment if requested by Doctor/patient. Is this right?
Many thanks
Spinnaker