UK biotech revolts at tripling of human tissue license price

The BioIndustry Association (BIA), along with the Association of British Healthcare Industries and the British In Vitro Diagnostics Association, have expressed anger at a tripling of the license fees charged by the Human Tissue Authority (HTA) the regulator that oversees the use of human tissue in the UK.

The three organisations say that at a time when many companies are already suffering severe financial difficulties, this adds further and unexpected costs at extremely limited notice. They claim that not only is the increase in fees counter to the government’s attempts to promote development of the sector, but that the manner in which the fees have been introduced goes against its principles of good regulation.

The organisations claim that the HTA is less efficient in processing licence applications, and its costs higher, in comparison with other EU countries. They argue that this makes the UK a less attractive location for inward investment

Aisling Burnand, Chief Executive of the BIA, said the consultation that led to the increase lacked rigour. “Limited consideration has been given to the serious and very real concerns of industry. The fee increases remain substantial given the current economic climate.” Burnand claims that some organisations have stopped procuring tissue because of the increase in licence fees.

Lincoln Tsang, Chairman of the BIA’s Regulatory Affairs Advisory Committee, added that the industry needs transparency and predictability from regulatory agencies. “The whole process by which licence fees are set is unsustainable and needs urgent review. Fees should be value-based and proportionate to the level of service provided, taking into full account the impact on the sector.”