At the end of this month, the European Medicines Agency will close the consultation on its draft policy on Publication and access to clinical-trial data. The aim of the policy is laudable: to open up as much information as possible into the public domain with the aim of stimulating new avenues of research. So far so good, it might seem. But what impact will the policy have on Europe being seen as an attractive place to conduct clinical trials? And how does it sit with the aims of another Brussels initiative, spearheaded this time by the European Commission, to reform the Clinical Trials Directive into a new Clinical Trials Regulation?
When we look at the details, we can see that, like the famous “Push Me-Pull You” character from Dr. Doolittle, these two policies are actually pulling in opposite directions with the former potentially reducing the likelihood of clinical trials taking place in Europe while the latter is designed to to encourage it.
In light of its dwindling position as a biopharmaceutical hub, there has been extensive debate in Europe on streamlining the regulatory requirements for conducting clinical trials. A key element of this debate has been whether or not to include stronger language in EU law on disclosure of clinical trials data, such that clinical trial results would be more publicly accessible. The current draft Regulation being considered by the European Parliament would not view data in clinical study reports as trade secrets once a marketing authorisation is granted to the product under investigation in the study. The Regulation would also require the publishing of summary results of clinical studies by a deadline of one year following the completion of the study.
Meanwhile, the EMA’s proposed policy on publication and access to clinical trials data reflects a shift towards an even fuller and more open approach. The stated objective of the draft policy issued in June 2013 is to increase access to data and scrutiny of decisions by the EMA without compromising personal privacy or long-term incentives for biopharmaceutical R&D.
Despite its laudable aims, the reality of the current draft of the EMA policy is that it is likely to provide disincentives to future investors in R&D and therefore reduce the likelihood that Phase 2 clinical trials, in particular, may move to jurisdictions where the burdens of cost, bureaucracy and data transparency are less onerous.
So how does this sit with Europe’s desire to be considered a critical part of the global knowledge economy? Europe’s economy and jobs market rely heavily on the growth of its knowledge-based firms. Indeed, the Commission’s own press release about the proposal for a Clinical Trials Regulation states that “clinical research with over 20 billion Euros of investment per year in the EU makes a significant contribution to the growth policy of the Europe 2020 agenda”.
Within the pharmaceutical industry, which ranks as one of Europe’s top-performing high-tech sectors, Europe’s receptiveness to the conduct of CTs is a key indicator of its attempt to meet these strategic goals. In an era of austerity measures and on-going criticism of the pharmaceutical industry, the challenges of conducting cutting-edge research in Europe are many and varied and the statistics bear this out. As noted again by the Commission itself, the number of applications for CTs in the European Union fell by 25% from 2007 to 2011 – and the majority of this decrease is recent, from 2010 to 2011. Also according to recent calculations made by Pugatch Consilium and based on data from the portal clinicaltrials.gov, Europe (on average) has a low level of clinical trials activity compared to other developed countries, including the US and Singapore.
Of course, the potentially negative outcomes of the EMA draft policy are not just limited to economic considerations but also to public health including the danger of misleading re-analyses by third parties, which could lead to the spread of misinformation on health technologies. There still remain worries about patient confidentiality and personal privacy and the bureaucracy and resource implications of introducing a process for reviewing requests to access clinical trials data and de-identifying patient data will be substantial not just for the EMA but also for scientists and manufacturers.
Last but not least, there is a ‘third head’ to the beast, since the EU is also considering changes to Regulatory Data Protection under the Data Protection Directive. Significant erosion of existing levels of regulatory data protection could lead to premature competition from generic and other competitors and reduce companies’ willingness and ability to invest in development of future health technologies.
Whichever direction the EU finally decides to take on clinical trials and data transparency is likely to have a notable effect on Europe’s attractiveness as a site for future investment in pharmaceutical research. At the moment, however, policy is being scattered in all directions. If there is a single message to come from the EMA consultation it is that when it comes to clinical trials and data sharing, Europe needs a more holistic approach and one where the litmus test is whether or not more transparency leads to more lives being saved.
Professor Meir Pugatch is the founder of Pugatch Consilium and co-author of Clinical Trials and Data Transparency – The Public Interest Case. The full paper is available at www.pugatch-consilium.com.