To ask the Secretary of State for Health what (a) requirements and (b) regulations govern the promotion of medicines outside their licensed indication by (i) manufacturers, (ii) healthcare providers and (iii) other parties. (281583)

The promotion of medicines is regulated under the Medicines (Advertising) Regulations 1994, which implement Title VIII of Directive 2001/83/EC. These regulations prohibit the promotion of a medicine outside its licensed indication. The prohibition applies to industry, healthcare providers and other parties.

To ask the Secretary of State for Health with reference to the answer to the hon. Member for South Cambridgeshire of 24 November 2008, Official Report, column 927W, on the NHS: drugs, whether the review by strategic health authorities into collaboration in their areas to support effective decision-making has been concluded; and if he will make a statement. (281676)

We would expect that all strategic health authorities will have complied with the NHS chief executive’s letter of 4 November 2008 asking them to review the arrangements in place in their local area and how collaboration could be encouraged to support better decision making. It is the responsibility of each organisation’s board to ensure that this has been followed in their area.

Since then, the NHS constitution, launched in January 2009, says that patients have the right to expect local decisions on funding of other drugs and treatments to be made rationally, following a proper consideration of the evidence. This right is underpinned by:

defining guiding principles for processes supporting local decision making about medicines, published in January 2009;

www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_093413

supporting rational local decision-making about medicines and treatments: A handbook of good practice guidance, published by the National Prescribing Centre in March 2009;

www.npc.co.uk/policy/local/constitution_handbook.htm

and

new statutory directions to primary care trusts (PCTs) and NHS trusts concerning decisions about drugs and other treatments 2009, which came into force on 1 April 2009

www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsLegislation/DH_096067

As a result of the various measures we have put in place, we expect to see significant improvements in PCTs’ decision-making processes, including increased transparency and consistency in the way these decisions are made. This will mean that patients and the public can be very clear about what the national health service is offering them by way of access to drugs and how those decisions about funding are taken.

To ask the Secretary of State for Health what progress his Department has made in commissioning a national audit of demand for unfunded drugs, as referred to on page 6 of Improving access to medicines for NHS patients; what estimate he has made of the cost of meeting such demand; and if he will make a statement. (281585)

We are currently developing proposals for pilots—which should begin later this year—to audit the demand for unfunded drugs. Until we have carried out the pilots, we cannot estimate the cost of meeting the demand for unfunded drugs.