EU policy on clinical trials could have negative implications for the region in terms of its attractiveness for research and development (R&D) investment, experts have warned.
Consultancy Pugatch Consilium concluded that a draft policy by the European Medicines Agency (EMA) on the publication and access to clinical trial data was flawed and required a rethink.
While the report acknowledged that greater transparency could lead to better outcomes in clinical research, there was concern the EMA’s policy did not fully take into account the problems generated making this information public, including the possible impact on investment in future R&D.
Specifically, the report identified the need for better understanding of the realities of the pharmaceuticals market. Primary clinical trials data can be regarded as private property; the release by regulators of such detailed information might distort competition in the pharmaceutical market.
In addition, the impact of policy on biopharmaceutical innovation needed to be considered. The report found that proposed policy was likely to lead to further ‘bureaucratisation’ of the current system, and increase the complexities and costs involved in establishing and operating a system for the early release of clinical trial data.
The report has recommended policymakers should take into account the overall strategic goals of growing the knowledge economy and the importance of high-tech industries, such as the biopharmaceutical field, to this growth.
The report said: "Measures that reduce incentives for further investment by private innovator companies in Europe, including the additional uncertainty and erosion of existing intellectual property protection and the subsequent distortion of competition, risk not only diminishing Europe’s access to advanced medical treatment, but also further weakening the industry’s vital contribution to European economic growth and jobs."
Regulations governing clinical trials in Europe have steadily become more detailed and demanding. The past decade has seen the total number of procedures required per trial more than double, while demands for staff and infrastructure have grown by more than 60% and the length of trials have risen by a quarter. The complexity of conducting clinical trials and generating the necessary data for regulators requires an ever-increasing level of investment by biopharmaceutical companies. The ability to safeguard proprietary elements of clinical data is all the more valuable and necessary for securing a return on investment.
Eroding existing guarantees on secrecy of clinical data, such that competitors get a free ride, was not likely to encourage greater investment in biopharmaceutical R&D. The most recent data from Pugatch Consilium and the US National Institute of Health showed that the EU was already losing ground as a competitive biopharmaceutical environment compared with other biopharmaceutical innovation hubs, for instance the US, Singapore and Australia, and the average amount of clinical trial activity down on previous years.
Professor Meir Pugatch, a co-author of the report, said: “The ‘litmus test’ for new policies on clinical trials and access to data in the EMA’s possession should be the yielding of concrete and direct benefits to public welfare in the form of enhancing the use of existing medicines as well as the creation of new medicines. The draft policy should be assessed and reworked in order to meet these objectives.”