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UK’s MHRA seeks views on scheme to provide early access to medicines

Consultation process launched on programme to launch drugs in UK ahead of formal licensing

UK regulators have launched a public consultation on plans to introduce a programme to provide early access to medicines in the country before they are formally licensed.

The Medicines and Healthcare products Regulatory Agency (MHRA) is seeking views up until October 5, 2012, on the scheme that would see the Agency provide a scientific opinion on the benefits and risks of medicines to assist the NHS to make a decision on whether they should be available.

The opinion will be made available on the MHRA's website to assist clinicians and patients to make this decision, while NHS payers will make the final choice on whether such treatments should be funded.

The voluntary, on-statutory scheme will be limited to medicines that represent a “significant advance in treatment in an area of unmet need”, said the MHRA, and only one or two medicines per annum are expected to qualify.

It would be available for drugs at the end of phase III trials, although it could be applied even earlier in “exceptional cases”, according to the MHRA.

Professor Sir Kent Woods, chief executive of the MHRA, said: “We have launched this consultation because we are committed to ensuring that where pharmaceutical companies want to make their new medicines available under this scheme, clinicians treating patients have access to robust scientific information to help them to make appropriate treatment decisions.”

The scheme was initially proposed in September 2007 by the Ministerial Industry Strategy Group (MISG) - a committee of pharma CEOs and relevant government ministers.

A working group comprising representatives from the MHRA, National Institute for Health and Clinical Excellence (NICE), the NHS, industry and the Department of Health, was then set up to develop an initial framework for the early access scheme, although further developments were later postponed due to other initiatives in the NHS, such as the cancer drugs fund.

The programme has been taken on by the current coalition government as part of its strategy to boost life sciences in the UK.

The strategy set out the guiding principles for the scheme as: “Eligible products will be determined by a scientific opinion that the likely clinical benefits outweigh the risks identified to date where there is high unmet need; NHS funding for product must be cost effective; the UK economy should benefit from the scheme.”

The MHRA must also take proactive steps to highlight to small- to medium-sized businesses the existing regulatory tools to support patient access to innovative breakthrough products, as part of the life sciences strategy.

One group who will add their voice to the consultation process will be the UK's BioIndustry Association (BIA), which said the current proposed scheme does not go far enough in encouraging early access to medicines.

“The proposal to limit the scheme to only one or two medicines a year, targeted at the end of phase III trials, does not, in the BIA's view, meet the ambition the UK government set out in its strategy for UK life sciences,” said the trade body's new CEO Steve Bates.

“This included an option to fully discuss the review of innovative medicines at an earlier stage of development, where supported by suitable data."

Stephen Whitehead, CEO of the Association of the British Pharmaceutical Industry (ABPI) also commented on the consultation launch: “ABPI will work closely with all relevant stakeholders to ensure that the scheme achieves its primary aim of improving patient access to the most promising treatments whilst closely monitoring patient safety.”

18th July 2012

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