Life sciences industry “overcharged” by regulator

The UK life sciences industry is involved in an unseemly spat with one of its regulators.

Three trade bodies have accused the Human Tissue Authority of introducing “unrealistically excessive” fee increases that “show complete disregard of economic environment and run counter to government support of the life sciences sector”.

The HTA licence fee for a company using human tissue for clinical applications rises today by 45 per cent to £11,000 for its main site and by 280 per cent to £3,800 for each satellite site. The new fees were only announced on Friday, following a consultation exercise.

In a joint statement the BioIndustry Association, Association of British Healthcare Industries and British In Vitro Diagnostics Association say: “Coming at a time when many companies are already suffering severe financial difficulties, this adds further and unexpected costs with extremely limited notice.”

According to the trade associations, the HTA charges much more than its counterparts in other European countries for regulating human tissues and cells intended for medical applications.

In response, Adrian McNeil, HTA chief executive, says: “We have done everything we can to keep licence fees to a minimum. These include applying the lightest possible touch when implementing complex legislation and introducingstreamlined systems and processes.” The whole fee structure will be reviewed this year.

But the underlying problem is that UK Treasury guidelines require the HTA to recover regulatory costs from licence fees, without cross-subsidy between different sectors.

The associations are unlikely to change matters merely by complaining. A concerted refusal by every member company to pay the increased fees might force the government to rethink its policy – but such ungentlemanly action is not on the agenda.

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