The first Access to Cancer Medicines (ACMC) meeting since December last year took place last week! As you can appreciate, not a lot has happened during the COPVID-19 pandemic:
European Union – we leave the EU on 31 December 2020 and on 1 January 2021 the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK takes over from the EMA: MHRA post-transition period information – GOV.UK This timeline will not be delayed. Movement of medicines at the time of the EU exit will likely be affected and some drugs might not launch in the UK as expected. The EU is likely to have access to new drugs before the UK, as the MHRA gets up to speed. There are concerns about the speed of bringing new drugs through the regulatory process. Larger pharmaceutical companies are already negotiating with the MHRA.
NICE methods/process review – timelines have shifted considerably and the first 6 week public consultation will be in November this year for NICE methods and during the spring for NICE processes. It is expected that the manual for methods and processes will be published next September 2021. Cancer52 have already done a lot of work on this. There are concerns that the NICE methods and processes are not future-proof and there will need to be further engagement around this. The Charities Medicines Access Coalition (CMAC) will be submitting a response and focussing on process and patient involvement, better communication and engagement with patient groups.
Cancer Drugs Fund will now become known as the Innovative Medicines Fund (IMF). Consultation is ongoing until the end of the year. The budget for 2021/22 not known.