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