A joint industry report called on the European Commission “to use its right of initiative to put forward a legislative proposal to exempt ATMPs in clinical development from the EU GMO legislation” before the end of the year. The EU should then implement this exemption before the end of 2023 — in line with the Clinical Trials Regulation, to avoid duplicate GMO assessments for clinical trials of these products in EU countries.
According to the Alliance for Regenerative Medicine (ARM), the European Federation of Pharmaceutical Industries and Associations (EFPIA), and the European Association of Bioindustries (EuropaBio), the existing patchwork of national regulations for the approval and environmental impact assessment of multicentre clinical trials of gene and cell therapies is hindering the development of life-saving therapies in Europe. While in Asia and the USA a strong increase in corresponding clinical studies can be observed, in Europe there is almost a standstill due to the complex and nationally different legislations, stress EuropaBio, EFPIA and ARM in the journal Human Gene Therapy.
The European Commission (EC) should exempt advanced therapies from Genetically Modified Organism (GMO) legislation, said the Alliance for Regenerative Medicine (ARM), the European Federation of Pharmaceutical Industries and Associations (EFPIA), and the European Association of Bioindustries (EuropaBio) in a paper published online in the journal Human Gene Therapy. The industry bodies maintain that the GMO legislation hurts Europe’s ability to attract clinical trials and delays patient access to transformative medicines
The pandemic has delayed work on the next iteration of the 21st Century Cures Act, but lead House sponsors Diana DeGette (D-Colo.) and Fred Upton (R-Mich.) expect a discussion draft to drop in the next few weeks, POLITICO’s Lauren Gardner writes.
Expect the latest iteration of the 21st Century Cures Act to drop in the next few weeks, Reps. Diana DeGette (D-Colo.) and Fred Upton (R-Mich.) said Monday during a “fireside chat” (let’s call it “Zoom-side”) hosted by the Alliance for Regenerative Medicine.
Reps. Diana DeGette and Fred Upton are looking to President Biden and his new plan for a translation health research group at NIH to get their next itineration of 21st Century Cures across the finish line. A discussion draft is expected in early June.
Key House lawmakers are in talks with the White House about using upcoming Cures 2.0 legislation as a vehicle for the Biden administration’s proposed new biomedical research agency, the Advanced Research Projects Agency for Health (ARPA-H), which would sit within the National Institutes of Health and bring together the government, private sector and academia to research new therapies for diseases such as cancer, diabetes and Alzheimer’s.
Draft legislation to update the landmark biomedical innovation law 21st Century Cures will likely come out in early June, lawmakers behind the bill said. Reps. Diana DeGette (D-Colo.) and Fred Upton (R-Mich.) indicated they want to pass their bill, known as Cures 2.0, by the end of the year, although they acknowledged the pandemic has set back their work. The bill offers a chance for an increasingly divided Congress to pass legislation to remove hurdles to cutting-edge treatments when science is moving at a rapid pace.
