Commenting on the NHS Clinical Commissioners’ call for the ‘removal of barriers preventing CCGs from prescribing Avastin to treat wet AMD’, Paul Catchpole, ABPI’s Director of Value and Access, says “seeking to bypass the regulatory system potentially threatens patient safety”.
24 Feb 2015 Posted in News Release By Press Office
"Rigorous safety testing and medicines licensing requirements exist in the UK in order to protect the public's interests in medicines development and monitor the safe and appropriate use of medicines. Be in no doubt - seeking to bypass the regulatory system by calling for local clinical commissioning groups to prescribe an unlicensed medicine on the grounds of cost alone potentially threatens patient safety. In this case, there are a number of MHRA and NICE approved licensed medicines available to treat this condition.
"The ABPI believes that medicines should only be used outside of their marketing authorisations within established General Medical Council prescribing guidelines in order to meet the specific needs of individual patients where there is no suitably licenced medicine available. The MHRA and NICE are the proper authorities to issue guidance to the NHS on the safety, quality and clinical and cost effectiveness of medicines and commissioners are legally obliged to implement NICE guidance. Patients' right to access treatments recommended by NICE are included in the NHS Constitution. NHSCC's call to bypass national guidance on economic grounds is completely inappropriate, particularly so, when under the terms of the current PPRS Agreement, the pharmaceutical industry has recognised the financial challenge faced by the NHS and is currently underwriting the NHS branded medicines bill, within agreed limits, until 2018. An estimated £4 billion over the lifetime of the scheme will be paid back to the NHS and this provides a unique opportunity for NHS clinicians to use the best branded medicines and innovative treatments for the benefits of their patients at minimal additional budgetary cost."
The ABPI represents innovative research-based biopharmaceutical companies, large, medium and small, leading an exciting new era of biosciences in the UK.
Our industry, a major contributor to the economy of the UK, brings life-saving and life-enhancing medicines to patients. Our members supply 90 per cent of all medicines used by the NHS, and are researching and developing over two-thirds of the current medicines pipeline, ensuring that the UK remains at the forefront of helping patients prevent and overcome diseases.
The ABPI is recognised by government as the industry body negotiating on behalf of the branded pharmaceutical industry, for statutory consultation requirements including the pricing scheme for medicines in the UK.
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