In principle, the ABPI is in favour of sharing CSRs; however this needs to be done in a way that is responsible, reliable and reproducible across the world since clinical research is a global activity. The EMA working groups are going to report on the mechanics of exactly how to do this, therefore it would be prudent to await the results of their work, which will be later this year.
Do you agree that this information should be publicly available?
In principle yes. But there has to be a process involving the company in identifying what elements should not be disclosed due to data privacy concerns or to protect commercially confidential information. Our industry would urge civil society to prioritise what studies are most important to release. It is simply impossible for regulators and companies to release all study reports at once. Companies would rather spend time developing new medicines than going through millions of pages of historic data. Also, there must be a process of co-ordinating this process among the regulatory agencies - the same study reports have been submitted to agencies all around the world.
Will you amend your 2012 guidelines to this effect?
The discussions on release of data are being carried out at a European level through EMA and, from an industry perspective, through the European Federation of Pharmaceutical Industries and Associations (EFPIA). EFPIA has indicated it is open to discuss future changes to its Code depending on on-going discussions with EMA. The ABPI would ensure its Code was aligned to the wider European position.
Will you support an amendment to the EU Clinical Trials Regulation to this effect?
We support rules that require the publication of all clinical studies. For studies intended to support marketing authorisation applications, the studies should be made public once the product is approved.
What, if any, are your commercial objections to publication of clinical study reports?
As clinical study reports, until now, have been written for a regulatory audience and assuming confidentiality, they may describe commercial plans of the company. For instance, the development strategy for future studies on new indications may be described to put the particular study in context. In some cases, companies may consider that a particular study design is a trade secret that competitors can learn from. Furthermore, study reports often include appendices with detailed information on analytical methods (chemical and physical) and on the manufacturing of the clinical trials material. This is a key area the EMA working groups will examine.
What kind of situations do you think would justify withholding clinical study reports?
In general patient identifiable data and commercially sensitive information can be redacted rather than the study report withheld. However, when a company does not have a patent for a product it relies on 'regulatory data protection' to get the necessary market exclusivity to recoup the investment made. This period is 10 years in the EU. If the entire file with all studies is released other companies can get approvals around the world. Anyone can get an approval as long as they submit the necessary data - regulators do not require that they generate the data themselves. This would not support the development of innovative medicines.
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Notes to editors
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.