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ABPI position on mandatory disclosure of clinical data
29 October 2012
Eleanor Malone

Scrip asked the UK industry association, the ABPI, if it would support legislation to make it universally obligatory to publish clinical study reports, both new and old, relating to currently available drugs and to those that are in development or have been discontinued. Scrip also asked if ABPI could identify potential problems with such legislation, and propose ideas for avoiding or overcoming them.

The response from the association’s Chief Executive, Stephen Whitehead, is reproduced in full below.

It is clear that the association did not say whether or not it would support legislation.

The Association of the British Pharmaceutical Industry (ABPI) welcomes the discussion in Parliament on clinical trials data transparency. We have been and continue to work with stakeholders to support and drive best practice in clinical trial data reporting across the research community. We recognise that there is still work to be done which requires the involvement of a range of stakeholders, who, along with us, are committed to ensuring that patients have access to safe and effective medicines when they need them.

Our industry discloses data both positive and negative, in line with national and international regulatory standards – medicines cannot be approved for use in patients without first undergoing rigorous scrutiny.

We have been and continue to work in collaboration with Government, regulators, health technology assessors, healthcare professionals, journals, patient groups and the wider research community to ensure that we continue to meet the needs of patients and protect their interests.

The pharmaceutical industry undertakes clinical trials in partnership with health professionals, academia and the NHS with one common purpose: to deliver innovative medicines that help patients to live longer, healthier lives. Greater transparency and access to data from across the research community helps us deliver more for patients and our industry is committed to working together with our partners to achieve this.

Stephen Whitehead, Chief Executive, Association of the British Pharmaceutical Industry”



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