12 Jun 2013 Posted in ABPI statement By Press Office
The medicines researched and developed by the pharmaceutical industry have transformed and saved the lives of people right across the world. We invest billions of pounds every year to research and develop new treatments as we continue to fight disease and improve the lives of patients.
To bring a medicine to market, clinical research and clinical trials must be conducted in order to demonstrate its safety and efficacy. The relevant data generated in this process is always submitted to the regulators – the European Medicines Agency (EMA) and the Medicines and Healthcare Products Regulatory Agency (MHRA). Only after the regulators are satisfied that a medicine has a favourable benefit to risk profile, can it be used to treat patients.
The ABPI is a strong advocate of transparency in clinical trial information and our Code of Practice goes above and beyond the legal requirement for companies to submit data to the EMA and MHRA. The Code requires companies to publish all clinical trial results within one year of marketing authorisation and new clinical trials must be publically registered within 21 days of the first patient being enrolled. The latest research available, which is being prepared for publication in the coming weeks, shows that for recently approved medicines, the vast majority of the evaluable trials conducted in patients have been published within a year of completion or product launch.
To add to this and to reach our goal of 100 per cent disclosure of trial results, the ABPI will be introducing a transparency toolkit and a compliance monitoring service to help companies meet their obligations.
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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.