RE:RE:Hemerion Planning Phase 2 Trial at Mt. Sinai NY in 2022Hi Fred - I don't think this is about protectionism, it's about
orphan designation for
5-ALA for the treatment of glioma.The purpose of orphan designation is to encourage the development of medicines for rare diseases by providing incentives such as market exclusivity. The
EMA made the decision to grant this status to
5-ALA for the treatment of glioma in January 2017 based on the fact that glioma affects only 2.6 out of 10,000 people in the EU which is below the ceiling of 5 out of 10,000 people required for the orphan designation.
According to the EMA in 2017:
"The sponsor has provided sufficient information to show that 5-aminolevulinic acid might be of significant benefit for patients with glioma because early studies show that it may improve patients’ survival when used in combination with authorised treatments. This assumption will need to be confirmed at the time of marketing authorisation, in order to maintain the orphan status." The FDA also has an orphan drug designation program for rare diseases which provides designees with seven years of market exclusivity (along with exemption from user fees and tax credits for clinical trials)
Unlike the EU and the US, Canada does not provide a specific orphan drug framework.
https://www.ema.europa.eu/documents/orphan-designation/eu/3/16/1811-public-summary-opinion-orphan-designation-5-aminolevulinic-acid-treatment-glioma_en.pdf fredgoodwinson wrote: Interesting that Eog.
The vaccine farce and their disgraceful treatment of AZ looks unlikely to be the only case where the naked protectionism of the EU leads to poor health outcomes for those under its`control.
Should we take it from your last para that those in Europe with GBM would now have to travel to Toronto if they wished to be treated with Rutherrin?
Chinese disregard of patents is one thing but with regard to healthcare the citizens of the Western World have for decades been victims of politico/corporate stitch-ups that have probably been more damaging to them as end users.
How much further down the road would we be in the humane treatment of disease had the placemen of those with vested interests not inhibited their competitors`progress at every level?