|Date:||17 July 2012|
|Subject:||MHRA asks for views about giving patients earlier access to medicines|
|Contact:||Press Office 020 3080 7651
Out-of-hours 07770 446 189
The Medicines and Healthcare products Regulatory Agency (MHRA) today launched a 12-week public consultation on proposals to launch an Early Access to Medicines Scheme.
This consultation is a key part of the Government’s commitment to growing the UK’s life sciences sector and economy. Under the scheme, the MHRA would provide a scientific opinion on the benefits and risks of medicines. This would assist the NHS in making decisions about making medicines available for patients with life threatening, chronic or debilitating conditions.
We expect that in most cases the scheme would be available for medicines at the end of Phase 3 trials although in exceptional cases it could apply to medicines at an earlier stage of development such as the end of Phase 2.
The MHRA welcomes comments on the proposed scheme by the 5 October 2012 and once we have analysed the responses we will make a decision on implementing the scheme by the end of the year. Comments can be posted or emailed to the MHRA at email@example.com
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.
“We welcome all comments on the proposed Early Access to Medicines Scheme and we will carefully consider these and ministers will make a decision on implementing the scheme by the end of the year.”
Notes to Editor1. More information about the consultation can be found on the MHRA website here:
Public consultation (MLX 376): Proposal to introduce an early access to medicines scheme in the UK
2. The MHRA is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. No product is risk-free. Underpinning all our work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks. We keep watch over medicines and devices, and take any necessary action to protect the public promptly if there is a problem. We encourage everyone – the public and healthcare professionals as well as the industry – to tell us about any problems with a medicine or medical device, so that we can investigate and take any necessary action. www.mhra.gov.uk
3. The UK Government’s Plan for Growth states that the life sciences and social care sectors employ huge numbers of people across a wide skills range. The NHS itself is a huge purchase which in turn supports a number of supplier business and staff in the UK. Moreover, the sector is a huge investor in research and development. The potential benefits to the UK economy and the health of the nation as a result of a thriving healthcare and life sciences sector are clear. Further information can be found at:
The Government plan for a secure data service: strengthening the international competitiveness of UK life sciences research (link to DH)
4. The Plan for Growth, published in March 2011, is a ‘call to action’ detailing the steps the Government will take to enable the British economy to become more internationally competitive.
The Plan for Growth (external link)