One word can make a huge difference. This became very clear to me as EFPIA finalised its submission to the European Medicines Agency’s draft policy on the publication and access to clinical-trial data. Today EFPIA made that response, in full, publicly available. I hope that this will help people better understand our concerns about the EMA’s approach to transparency – it’s one I have some serious reservations about. Why? To make a very long story short, I’d like to point to a single word. In line 15 of the EMA policy, are written the words “There is a growing demand for full transparency from certain external stakeholders in the debate...”. This, I believe, needs further consideration.
To me, the EMA’s policy suggests a move towards transparency simply for the sake of transparency. A full transparency should not be the goal – a responsible or appropriate transparency is what is needed to best improve access to clinical trials data, while taking into account the need to protect public health. A move towards “total” transparency carries real dangers – and we are seeing this in the EMA’s proposal, which does not provide adequate protections for patients, regulatory systems, or research. As I’ve noted before, transparency measures must take into account all three of these in the interest of positive public health impact.
By sharing our response to the EMA draft policy publicly, I hope that people will better understand the reasoning behind these concerns. Of course, I don’t expect everyone to read the full EFPIA response, which runs over 25 pages. The submission process is a line-by-line, word-by-word procedure. We have had an expert team working on the response for some time. But we also want to be sure that our concerns are clearly communicated and as broadly as possible. For this reason, we’ve prepared an executive summary of the EFPIA submission, which highlights some of the key concerns. This has also been published today, alongside the full EFPIA response.
“The aim of the European Medicines Agency ('the Agency') is to protect and foster public health. Transparency is a key consideration for the Agency in delivering its service to patients and society.” – this is how the EMA’s draft policy begins. Of course, there is no disputing that the EMA serves to protect and foster public health. However, I think that the EMA’s approach to clinical trials data sharing is not the best path towards achieving that goal.