Contrary to the Lancet’s assertion, ‘Guidance on collaboration between healthcare professionals and the pharmaceutical industry’ is not an ABPI document, nor is it led by the ABPI, but was agreed and signed by a range of healthcare organisations.
The guidance is a live document and is reviewed regularly to ensure that it continues to represent best practice across all the organisations involved through the Ethical Standards in Health and Life Sciences Group (ESHLSG).
The ABPI continues to drive change within the pharmaceutical industry which was reflected in the decision to cease the provision of promotional aids. One of the significant areas in which there has been change is on the issue of the disclosure of payments to medical professionals. The pharmaceutical industry, with the ABPI at the forefront, has publicly stated its commitment to introducing disclosure of payments to health professionals on an individual basis by 2016 for payments in 2015. Separately, there is a consultation underway run by the ESHLSG to look at how this can be taken forward. Healthcare professionals are encouraged to take part by visiting www.eshlsg.org.
On the question of clinical trials, it is important to note that since 2012, the ABPI Code of Practice requires companies to disclose details of the results of all clinical trials in accordance with the International Federation of Pharmaceutical Manufacturers and Association’s (IFPMA) Joint Position on Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases. This includes that all clinical trial results must be published within one year of marketing authorisation. Companies must also publically register clinical trials within 21 days of initiation of patient enrolment. There have been similar requirements in the Code since 2008.
On the issue of past trials, highlighted by alltrials.net, there is more common ground than the Lancet suggests. We believe that greater transparency of clinical trial data is in the best interests of patients, medicine and science. Our differences lie in how this should be achieved. We are part of the EMA working groups which are looking into the mechanics of exactly how to do this, and we await their findings which will be reported later this year.
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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.