UK Dept of Health agrees to full consultation over bid for Automatic Generic Substitution

The UK Department of Health plans to conduct a full, formal consultation on the arrangements for the implementation of Automatic Generic Substitution this fall. This will be welcome news to many who have serious concerns about the clinical implications that compulsory generic substitution would have for patients, comments local drugmaker Norgine.

The decision follows representations made by patients, health care professionals and pharmaceutical companies opposed on several grounds to the Association of the British Pharmaceutical  Industry's (ABPI) proposal, initially rejected, but subsequently accepted by the DoH, to introduce Automatic Generic Substitution in January 2010. The intention to conduct a formal consultation represents a significant milestone and will be welcomed by many stakeholders who have petitioned the DoH to go public on the proposal to ensure that the practical impact of generic substitution upon patients' outcomes, as well as safety, concordance and the National Health Service medicines' bill, is considered, says Norgine.

Earlier this year, the paper 'Automatic generic substitution: Clinical implications for patients" highlighted the need for public consultation. The paper was written and endorsed by a multidisciplinary group of health care professionals and patient groups and Norgine provided funding for the group.

Norgine chief operating office  Peter Martin, said: 'It is vital that all stakeholders continue to raise issues with the DoH to ensure that all angles are covered in the proposed formal consultation. We will continue to work with industry partners, healthcare professionals, professional bodies and patient groups to ensure that all voices are heard. We want to ensure the best outcomes for the patients and for the taxpayer. It is hoped that these open discussions, focussing on the key area of patient safety, will prevent the proposal of Automatic Generic Substitution from being implemented in the UK.'

Commenting to The Pharma Letter on the situation, a spokesman for the ABPI said that the DoH's proposed consultation had always been expected and is welcomed by the industry. However, he stressed that the ability to be able to exclude some medicines from automatic substitution is vitally important, and this was highlighted in the trade body's original submission to the government.