UK to probe pharma regulations
government's Cabinet Office as one of its priority projects in a
review of business regulation.
According to the Office's Business Regulation Team, which has just released its Scoping Report for the current year, the pharma industry is a major contributor to the UK's Gross Domestic Product, with strong growth prospects. But a review is needed because it is also extensively regulated, and there is a risk that activities such as R&D will move elsewhere if the regulatory regime is disproportionate.
Discussions with drug industry organisations and individual companies have already raised a number of key issues which the industry is keen for the team to examine.
These include the European Union Clinical Trials Directive, which came into effect last year but is already being criticised by some elements of the pharma industry for adding an unnecessary layer of bureaucracy for companies carrying out testing in humans.
Another topic for review include data exclusivity and the 10-year rule, which refers to the intellectual property on the clinical and preclinical data aimed at proving that a new compound is safe and effective. At present, there is a block on the approval of generic versions of drugs that have been registered for less than six years in the EU. However, under the new framework for pharmaceuticals, adopted by the European Parliament last year, this period will be extended to 10 years, which would affect the entry of generic products into the market.
The Team could also tackle issues such as National Health Service drug tariff and NHS procurement of pharmaceuticals, procedures for the use of animals in scientific testing, and braille medicine labelling.
However, it emphasised that the inclusion of an issue on this list does not necessarily mean that it has been selected for more detailed review, nor does a topic's exclusion from the list mean that it will not be covered.
Further discussions are likely to be needed with interested parties in the industry and government before decisions are taken, says the report, which adds that relevant factors affecting the choice of issues for the final shortlist are expected to include the potential benefit to industry from resolving the issue and whether there are good prospects for remedial action being taken.
