Fieldfisher launches white paper titled ‘the future of medicine: Cell and gene therapy’, an insight into the regulatory landscape for advanced therapy medicinal products and the potential of cell and gene therapy in the UK and other key hotspots in Europe.
Cell and gene therapy (CGT) has been heralded as the future of medicine, as news of successful CGT trials has led to this treatment gaining serious momentum and attention from investors, academic institutions, pharmaceuticals, regulators and the media.
However, like with most strides towards innovation, they are fraught with legal bottlenecks from regulation to intellectual property, privacy and commercial law, which slows the journey in getting to market.
Fieldfisher’s white paper hones in on the regulatory landscape in the UK and key hotspots in Europe, showing how changing attitudes of regulators and willingness by healthcare systems across Europe to reimburse producers for this treatment signals that the European cell and gene therapy market is opening up and capable of closing the gap between Europe and North America.
Cliodhna McDonough, life sciences regulatory lawyer at Fieldfisher, commented that Cell and gene therapy is showing that it has the potential to revolutionise healthcare, shifting the possibilities of medicine from illness management to curative. While the Covid-19 pandemic did have a negative impact on funding, research, manufacturing and supply chains, it is likely to see that the new found reality for cell and gene therapy will be much more positive. In fact, the pandemic may have straightened the roads for cell and gene therapy to reach patients. McDonough also added that the commitment of regulators and the flurry of attention from the media and investors on the pharmaceutical industry as they raced to find a vaccine, shows that the world’s interest in the innovation that the life sciences industry can bring has been heightened. Europe has a proud heritage for innovation within cell and gene therapy. However, it did experience a brief period of stagnation when it seemed that reimbursement was incompatible with the nationalised healthcare systems that many countries have. However, due to numerous successful trials, reimbursement across Europe is becoming more prominent. Cell and gene therapy is the pinnacle of innovation and now is the prime time for cell and gene therapy across Europe as routes to market become clearer.