Coming at a time when many companies are already suffering severe financial difficulties, this adds further and unexpected costs with extremely limited notice. The HTA fees policy runs counter to the Government’s efforts to facilitate the development of the life sciences sector, and the manner in which the consultation has been executed and the fees introduced goes against the Government’s principles of good regulation.
Given the current economic climate, the fee increases are unrealistically excessive, and will have a profoundly negative impact on the UK life sciences sector and the UK’s competitiveness as a location for the development of new innovative medicines. Furthermore, these increases will result in patients being denied access to medical treatments.
The industry’s specific concerns are that:
• The HTA is not providing “value for money – efficient, effective, economical” as stated in the HTA’s consultation document. It is less efficient in processing licence applications and the costs are higher in comparison with other EU countries
• This decreases the attractiveness of the UK as a location for future development of new medicines and threatens the viability of the UK life sciences industry
• This will drive out small companies and act as a deterrent to the development of innovative medicines, including regenerative medicines, for unmet medical needs
• The proposed changes to the licence fees are unjustified and lacking in rationale
• Certain aspects of regulation of human tissue create an unnecessarily burdensome regulatory regime. Given that there are sector-specific rules which are already robustly enforced by the MHRA (Medicines and Healthcare products Regulatory Agency), the regulation of human tissue does not add further in terms of public health protection or improving patient safety.
Among the recommendations in a joint industry response to the consultation were that the fees charged by the HTA should be appropriate for and proportionate to the level of activities carried out by the Authority, and to the size of the establishment and the number of activities at the site.
Aisling Burnand, Chief Executive of the BIA, commented:
“The whole consultation process has been conducted with a lack of rigour and limited consideration has been given to the serious and very real concerns of industry. The fee increases remain substantial given the current economic climate where many companies are struggling to get adequate funding. This Government has consistently been a strong supporter of the UK life sciences sector, however actions such as this could have a profoundly destabilising effect and force businesses out of the UK. Already some organisations have stopped procurement activities because of increased licence fees, thereby withdrawing treatments from patients. This is deeply concerning.”
Dr Lincoln Tsang, Chairman of the BIA’s Regulatory Affairs Advisory Committee, added:
“Companies need 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.”