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Government reviews pharma regulation

The UK government is set to examine how regulations imposed on the pharmaceutical industry affect how it conducts business.

The UK government is set to examine how regulations imposed on the pharmaceutical industry affect how it conducts business.

The Cabinet Office's business regulation team revealed that it has earmarked pharma as one of three industries to investigate this year, with an in-depth study expected to start this summer.

Although the Team is still to decide which areas of pharma regulation to examine, the Team has revealed on its website that two of the main areas which are currently being considered for more detailed investigation are the regulation of animal scientific procedures, under the Animals (Scientific Procedures) Act 1986 and the regulation of clinical trials, under the Clinical Trials Directive which came into force on May 1, 2004.

The Cabinet Office's Scoping Report 2005, delves further and lists seven further issues including: Control of Entry Regulations 1987, data exclusivity and the ten-year rule, GP software, generic substitution, the NHS drug tariff, NHS procurement of medicines and braille medicine labelling.

ìNo decisions have been taken at this stage about which of the issues might be most appropriate for shortlisting for further review,î the report states. ìFurther discussions are likely to be needed with interested parties in industry and government before decisions are taken.

ìRelevant factors affecting the choice of issues for the shortlist are likely to include the potential benefit to industry from resolving the issue and whether there are good prospects for taking remedial action,î it adds.

The Team argues that pharma should form one of the main strands of its work in 2005 because it is a major contributor to the UK's gross domestic product; there is a risk that R&D activities could leave the UK if regulation is not examined and organisations in the sector are keen for the team to become involved.

Environmental services and logistics are the other two sectors to be examined by the Team this year.

30th September 2008

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