The German Parliament has approved legislation that could help accelerate patient access to cell and gene therapies by addressing a bureaucratic barrier that delayed their availability in hospitals.
Advanced therapy trade group The Alliance for Regenerative Medicine (ARM) has highlighted the passage of legislation to ease reimbursement for advanced therapies in Germany.
Seven gene therapies are approved in the United States and a few more are sold in Europe or elsewhere. In 2017, when the first ones were OK’d in the U.S., 854 companies were developing them. That grew to 1,085 by the end of last year, according to the Alliance for Regenerative Medicine, an advocacy group for the field. More than 400 gene therapy trials are underway now.
Advanced therapy medicinal products (ATMPs) should be exempt from EU legislation on genetically modified organisms because complying with GMO requirements is complex and causes delays in carrying out clinical trials with such products, potentially putting the EU at a competitive disadvantage, according to three bodies representing the biopharmaceutical industry.
If there’s one person who’s tested the suitability of the existing legal framework to support the EU arrival of groundbreaking cell and gene therapies (for rare inherited diseases), it’s Guido Rasi, the former head of the European Medicines Agency, who steered the regulatory ship as it found a way to assess the first such treatments. Speaking at ARM’s Cell and Gene Therapy event, he said while some therapies will have an immediate benefit for patients, for others the benefits would not be known for months or years.
In a joint paper and press release, major trade associations for cell and gene therapy developers are calling for relaxation of EU regulations that treat these advanced therapies as genetically modified organisms (GMOs). The Alliance for Regenerative Medicine (ARM), European Federation of Pharmaceutical Industries and Associations (EFPIA), and the European Association of Bioindustries (EuropaBio) joined in the 24 May publication of the paper in Human Gene Therapy, issuing a press release the next day.
In a paper published by the Alliance for Regenerative Medicine (ARM), the European Federation of Pharmaceutical Industries and Associations (EFPIA), and the European Association of Bioindustries (EuropaBio), the groups state that current GMO legislation hurts Europe’s ability to attract clinical trials and delays patient access to transformative medicines.
The European Commission should exempt advanced therapies from Genetically Modified Organism (GMO) legislation, which hurts Europe’s ability to attract clinical trials and delays patient access to transformative medicines.
